ACC/AHA/SCAI 2014 Health Policy Statement on Structured … · 2016-11-13 · Sanborn et al. JACC...

Journal of the American College of Cardiology� 2014 by the American College of Cardiology Foundation, the American Heart Association, Inc.,and the Society for Cardiovascular Angiography and Interventions Foundation

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HEALTH POLICY STATEMENT

ACC/AHA/SCAI 2014 Health Policy Statementon Structured Reporting for theCardiac Catheterization LaboratoryA Report of the American College of Cardiology Clinical Quality Committee

Developed in Collaboration With the American Association for Critical-Care Nurses,

Asian Pacific Society of Cardiology, Canadian Cardiovascular Society, Health Level Seven International,

Inter-American Society of Cardiology, Integrating the Healthcare Enterprise,

Society of Thoracic Surgeons, and Society for Vascular Surgery

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The American College of

lows: Sanborn TA, Tchen

Caro MV, Durack JC, Ev

Timothy A. Sanborn, MD, MS, FACC,

FAHA, FSCAI, Chair*

James E. Tcheng, MD, FACC, FSCAI,

Vice-Chair*

H. Vernon Anderson, MD, FACC, FSCAI*

Charles E. Chambers, MD, FACC, FSCAIySharon L. Cheatham, PHD, APRNzMatthew V. DeCaro, MD, FACC

Jeremy C. Durack, MDxAllen D. Everett, MD, FACC*

John B. Gordon, MD, FACC*

William E. Hammond, PHDjjZiyad M. Hijazi, MBBS, MPH, FACCzVikram S. Kashyap, MD, FACS{Merrill Knudtson, MD, FRCP(C), CM#

Michael J. Landzberg, MD, FACC**

ommittee members are required to recuse themselves

ich their specific relationship with industry and other

dix 1 for recusal information.

ed by the American College of Cardiology Board of

art Association Science Advisory and Coordinating

for Cardiovascular Angiography and Interventions

es in February 2014; and endorsed by the American

Nurses Board of Directors, the EXCO Committee

of Cardiology, the Canadian Cardiovascular Society

lth Level Seven’s Board of Directors, Inter-American

ité Ejecutivo, Integrating the Healthcare Enterprise

ety of Thoracic Surgeons Board of Directors, and the

oard of Directors in March 2014. For the purpose of

sure information for the ACC Board of Trustees, the

ization of this document, is available at: http://www.

-ACC/Leadership/Officers-and-Trustees.aspx. ACC

relationships with industry to the document may re-

cument but may not vote on approval.

Cardiology requests that this document be cited as

g JE, Anderson HV, Chambers CE, Cheatham SL,

erett AD, Gordon JB, Hammond WE, Hijazi ZM,

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Marco A. Martinez-Rios, MD, FACC, FSCAIyyLisa A. Riggs, CNSzzKui Hian Sim, MBBS, FACCxxDavid J. Slotwiner, MD, FACCjjjjHarry Solomon{{Wilson Y. Szeto, MD##

Bonnie H. Weiner, MD, FACC, FSCAIyWilliam S. Weintraub, MD, FACC, FAHA

John R. Windle, MD, FACC*

*American College of Cardiology representative. ySociety for Cardio-

vascular Angiography and Interventions Foundation representative.

zAmerican Heart Association representative. xSociety of Interventional

Radiology representative. kHealth Level Seven International representa-

tive. {Society for Vascular Surgery representative. #Canadian Cardio-

vascular Society representative. **International Society for Adult

Congenital Heart Disease representative. yyInter-American Society of

Cardiology representative. zzAmerican Association for Critical-Care

Nurses representative. xxAsian Pacific Society of Cardiology representa-

tive. kkIntegrating the Healthcare Enterprise representative. {{Digital

Imaging and Communications in Medicine representative. ##Society of

Thoracic Surgeons representative.

VS, Knudtson M, Landzberg MJ, Martinez-Rios MA, Riggs LA, Sim

twiner DJ, Solomon H, Szeto WY, Weiner BH, Weintraub WS,

R. ACC/AHA/SCAI 2014 health policy statement on structured

for the cardiac catheterization laboratory: a report of the American

of Cardiology Clinical Quality Committee. J Am Coll Cardiol

591–623.

ticle has been copublished in Circulation.

: This document is available on the World Wide Web sites of the

College of Cardiology (www.cardiosource.org), the American Heart

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ventions (www.scai.org), Health Level Seven International (https://www.

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Sanborn et al. JACC Vol. 63, No. 23, 20142014 Structured Reporting in the Cardiac Catheterization Laboratory HPS June 17, 2014:2591–623

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ACC ClinicalQualityCommitteeMembers

Joseph P. Drozda, JR, MD, FACC, Chair

Deepak L. Bhatt, MD, MPH, FACC

Joseph G. Cacchione, MD, FACC***

Paul N. Casale, MD, FACC

Blair D. Erb, JR, MD, FACC

Thomas A. Haffey, DO, FACC

Robert A. Harrington, MD, FACC***

Jerry D. Kennett, MD, MACC***

Richard J. Kovacs, MD, FACC

Harlan M. Krumholz, MD, SM, FACC

Frederick A. Masoudi, MD, MSPH, FACC

Eric D. Peterson, MD, MPH, FACC

Athena Poppas, MD, FACC

Richard L. Prager, MD, FACC

Michael J. Reardon, MD, FACC***

David J. Sahn, MD, MACC

Mark L. Sanz, MD, FACC***

David M. Shahian, MD, FACC***

M. Eugene Sherman, MD, FACC

Eric Stecker, MD, FACC

Henry H. Ting, MD, FACC

Judy Tingley, RN, AACC

Mary Norine Walsh, MD, FACC

W. Douglas Weaver, MD, MACC

John R. Windle, MD, FACC

***Clinical Quality Committee representative during this

writing effort.

TABLE OF CONTENTS

Preamble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2593

Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2593

1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2594

1.1. Document Development Process . . . . . . . . . 2594

1.1.1. Writing Committee Organization . . . . . . 25941.1.2. Document Development and Approval . . 2594

1.2. Background and Rationale . . . . . . . . . . . . . . . . 2594

2. Principles of Structured Reporting . . . . . . . . . . . 2596

2.1. General Principles . . . . . . . . . . . . . . . . . . . . . . . . 2596

2.2. Integration of Data Acquisition WithWorkflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2596

2.3. Capture of Information as DataRather Than Prose . . . . . . . . . . . . . . . . . . . . . . . 2598

2.4. Role of the Physician in Authoring theStructured Procedure Report . . . . . . . . . . . . . 2599

2.5. The Best Practice Model . . . . . . . . . . . . . . . . . 2599

3. Catheterization Procedure Reporting:Anticipating 2 Different Reports . . . . . . . . . . . . . 2601

3.1. The Procedure Log Report . . . . . . . . . . . . . . . . 2601

3.2. The Physician-Authored StructuredProcedure Report . . . . . . . . . . . . . . . . . . . . . . . . 2601

4. The Prototype Formatted, Tabular,Structured Procedure Report . . . . . . . . . . . . . . . . . 2602

4.1. Front Page Summary: Highest ValueInformation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2602

4.2. Graphics and Images Section . . . . . . . . . . . . . 2604

4.3. Report Body: Details . . . . . . . . . . . . . . . . . . . . . 2604

4.3.1. Administrative Information . . . . . . . . . . . . 26044.3.2. History and Risk Factors . . . . . . . . . . . . . . 26044.3.3. Procedure Details . . . . . . . . . . . . . . . . . . . . 26054.3.4. Diagnostic Results . . . . . . . . . . . . . . . . . . . 26054.3.5. Intervention . . . . . . . . . . . . . . . . . . . . . . . . . 26054.3.6. Final Diagnoses . . . . . . . . . . . . . . . . . . . . . . 26074.3.7. Operators, Titles, Regulatory

Attestation . . . . . . . . . . . . . . . . . . . . . . . . . . 2609

4.4. Procedure-Specific Content . . . . . . . . . . . . . . . 2609

4.4.1. Cardiac Catheterization (Right, Left,Coronary Intervention) . . . . . . . . . . . . . . . . 2609

4.4.2. Peripheral Vascular Catheterization . . . . . 26104.4.3. Cerebrovascular Catheterization . . . . . . . . 26104.4.4. Valvular Heart Disease: Transcatheter

Aortic Valve Replacement . . . . . . . . . . . . . 26114.4.5. Congenital and Structural Heart

Catheterization . . . . . . . . . . . . . . . . . . . . . . 26114.4.6. Combination Procedures . . . . . . . . . . . . . . 2612

4.5. Structured Report Style Guide . . . . . . . . . . . . 2612

4.6. Data Export . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2613

4.7. Paradigm Expansion . . . . . . . . . . . . . . . . . . . . . . 2613

5. Adoption and Implementation . . . . . . . . . . . . . . . . 2614

6. Extending the Structured Reporting UseCase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2615

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2616

Appendix 1. Author Relationships WithIndustry and Other Entities (Relevant) . . . . . . . . . . . . 2618

Appendix 2. Peer Reviewer Relationships WithIndustry and Other Entities (Relevant) . . . . . . . . . . . . 2620

Appendix 3. Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . 2623

JACC Vol. 63, No. 23, 2014 Sanborn et al.June 17, 2014:2591–623 2014 Structured Reporting in the Cardiac Catheterization Laboratory HPS

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Preamble

This document has been developed as a health policystatement (HPS) by the American College of Cardiology(ACC). HPSs are intended to promote or advocate a po-sition, be informational in nature, and offer guidance tothe stakeholder community regarding the stance of theACC and other contributing organizations on healthcarepolicies and programs. HPSs are not intended to offerclinical guidance and do not contradict existing ACCclinical policy. They are overseen by the ACC ClinicalQuality Committee (CQC), the group responsible fordeveloping and implementing all HPS policies and pro-cedures related to topic selection, commissioning writingcommittees, and defining document development meth-odologies. The CQC brings together various areas of theCollege such as the Advocacy Committee, the NationalCardiovascular Data Registry (NCDR), the ACC/AmericanHeart Association (AHA) Task Forces on Guidelines andPerformance Measurement, and the ACC Appropriate UseCriteria (AUC) Task Force.The CQC recommended the development of this HPS

to document the ACC’s official position on structuredreporting of cardiac catheterization procedures. A numberof organizations were invited to coauthor this statementwith the goal of sharing a unified message on thisimportant topic. Structured reporting is believed to befoundational to the provision of high-quality care for pa-tients undergoing procedures in the cardiac catheterizationlaboratory. As such, the intended audience for this docu-ment includes third-party payers; electronic health record(EHR) and clinical software vendors; accrediting andcertifying organizations; and regulators whose areas ofresponsibility include electronic health data.To avoid actual, potential, or perceived conflicts of in-

terest that may arise as a result of industry relationshipsor personal interests among the writing committee, allmembers of the writing committee, as well as peer re-viewers of the document, are asked to disclose all currenthealthcare-related relationships, including those existing12 months before initiation of the writing effort. TheCQC reviews these disclosures to determine what com-panies make products (on market or in development) thatpertain to the document under development. On the basisof this information, a writing committee is formed toinclude a majority of members with no relevant relation-ships with industry and other entities (RWI), led by a chairwith no relevant RWI. Authors with relevant RWI arenot permitted to draft initial text or vote on recommen-dations pertaining to their RWI. RWI is reviewed on allconference calls and updated as changes occur. Authorand peer reviewer RWI pertinent to this document aredisclosed in Appendices 1 and 2, respectively. In addition,to ensure complete transparency, authors’ comprehensivedisclosure informationdincluding RWI not pertinent to

this documentdis available as an online supplement.Disclosure information for the ACC CQC is also availableonline at http://www.cardiosource.org/ACC/About-ACC/Who-We-Are/Leadership/Guidelines-and-Documents-Task-Forces.aspx, as well as the ACC disclosure policy fordocument development at http://www.cardiosource.org/Science-And-Quality/Practice-Guidelines-and-Quality-Standards/Relationships-With-Industry-Policy.aspx. Thework of the writing committee was supported exclusively bythe ACC without commercial support. The writing com-mittee members volunteered their time to this effort. Con-ference calls of the writing committee were confidentialand attended only by committee members.

Joseph P. Drozda, Jr., MD, FACCChair, ACC Clinical Quality Committee

Executive Summary

The final report is an essential component of every invasiveand operative procedure. This vital document records keydata used to assess indications and appropriateness of care,details technical aspects of the procedure, describes find-ings and observations, lists results and calculations, pro-vides the interpretation of the study, and conveys patientcare recommendations. In addition to providing essentialinformation to the entire team of care providers, the finalreport is utilized in billing and inventory management,process and performance improvement, outcomes analysis,teaching and education, and as a data source for registries(1). The final report is a legal medical record documentand should be of the highest quality so as to optimize bothpatient outcomes and institutional operational efficiencies.A structured report generated by a structured reportingprocess is the most suitable vehicle for these goals, butthis approach is only slowly being adopted despite priorrecommendations and endorsements. This HPS is inten-ded to provide a general model for structured reportingfor invasive and interventional cardiovascular proceduresand thus catalyze and accelerate implementation of struc-tured reporting. Through endorsement of this document,the cardiovascular community recognizes the critical im-portance of structured reporting and calls for its uniformadoption.

The general principles of structured reporting in car-diovascular imaging are well established. Informationshould be captured as data rather than prose; these datashould flow bidirectionally to and from the EHR forsubsequent presentation and analysis. The final reportshould be clear, concise, organized, consistent, reproduci-ble, understandable, and in a format that is flexible toaccommodate evolutionary procedural changes and docu-mentation requirements.

Key considerations for generating a structured report arediscussed in detail, with a structured procedure reportprototype included for modeling purposes. The prototype

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final report is segmented into 3 principal sections. The firstsection (front page) is a single (physical) page that containsthe highest value clinical information. Because angiographyis inherently visual, the second section is dedicated to thegraphical representations of the findings and (optionally)images imported into the report. The body (third section)contains all of the remaining data presented as a seriesof structured, formatted tables. Procedure-specific contentis outlined for diagnostic cardiac catheterization, percuta-neous coronary intervention (PCI), peripheral vascularand cerebral vascular procedures, valvular heart diseaseincluding transcatheter aortic valve replacement (TAVR),structural and congenital heart disease (CHD), and com-bination procedures. The concepts enumerated in thisHPS are applicable to nonsurgical endovascular proceduresperformed in a cardiac catheterization laboratory, hybridcatheterization/operating room suite, and interventional/neuroradiology suite.Universal adoption of structured reporting for invasive

cardiovascular imaging procedures requires the acknowl-edgment of its potential benefits and acceptance of theresponsibilities entailed. In order to stimulate structuredreporting implementation, key groups including physicianoperators, catheterization laboratory personnel, the soft-ware vendor community, and leadership of registries mustbe on the forefront of advocating the adoption of struc-tured reporting. The ACC/AHA/Society for Cardiovas-cular Angiography and Interventions Foundation (SCAI)recognize that the development and deployment of struc-tured reporting will be an ongoing process and, therefore,strongly encourage the view that structured reportingbe considered one component of the overall qualityimprovement imperative for cardiovascular care.

1. Introduction

1.1. Document Development Process

1.1.1. Writing Committee Organization

The writing committee consists of a broad range ofmembers from the ACC as well as the following societies:American Association of Critical-Care Nurses (AACN),AHA, Asian Pacific Society of Cardiology (APSC),Canadian Cardiovascular Society (CCS), Digital Imagingand Communications in Medicine (DICOM), HealthLevel Seven International (HL7), Inter-American Societyof Cardiology (IASC), Integrating the Healthcare Enter-prise (IHE), International Society for Adult CongenitalHeart Disease (ISACHD), SCAI, Society of Interven-tional Radiology (SIR), Society of Thoracic Surgeons(STS), and Society for Vascular Surgery (SVS). Repre-sentatives from these societies included those with exper-tise in cardiothoracic surgery, interventional cardiology,interventional radiology, general cardiology, echocardiog-raphy, and cardiac nursing. Along with these specialties,

specific knowledge in the areas of TAVR, carotid andcerebrovascular disease, vascular medicine, structuralheart disease, patient outcomes, data interoperability, andcatheterization laboratory workflows were also reflectedin the workgroup to provide an appropriate balance ofperspectives. Geographically, the writing committeeincluded both domestic and international members. Re-lationships with EHR companies and software vendorsactive in cardiovascular medicine were deemed relevant tothis writing effort. This writing committee met theCollege’s disclosure requirements for RWI as describedin the Preamble.

1.1.2. Document Development and Approval

The writing committee convened by conference call ande-mail to finalize the document outline, develop theinitial draft, revise the draft per committee feedback, andultimately approve the document for external peer review.Each participating organization provided peer reviewers,resulting in 32 reviewers representing 410 comments. Toincrease its applicability further, the document was pos-ted online for a 3-week public comment period, resultingin 4 people providing 19 additional comments. Allcomments were reviewed and addressed by the writingcommittee, resulting in change to the manuscript. Amember of the ACC CQC served as lead reviewer toensure that all comments were addressed adequately.Both the writing committee and CQC approved theversion of the final document sent for board review.The ACC Board of Trustees, the AHA Science Advisoryand Coordinating Committee, and the Society forCardiovascular Angiography and Interventions Founda-tion Board of Trustees reviewed the document, includingall peer review comments and writing committee re-sponses, and approved the document in February 2014.The AACN, APSC, CCS, HL7, IASC, IHE, STS,SVS, endorsed the document in March 2014. Thisdocument is considered current until the CQC revises orwithdraws it from publication.

1.2. Background and Rationale

A final procedure report is essential and required for allcardiovascular catheterization procedures. The procedurereport documents key data used to assess indications andappropriateness of care, details technical aspects of theprocedure, describes findings and observations, lists re-sults and calculations, provides the interpretation of thestudy, and conveys patient care recommendations. It isa vital means of communication between the physicianoperator and the team of care providers. Additionally, itis utilized in billing and inventory management, processand performance improvement, patient outcomes anal-ysis, teaching and education, and participation in dataregistries. The final procedure report is a legal medicalrecord document often accessible to patients via internetportals and personal health records. Patient education,


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enablement, and participation in their health care areaugmented by unambiguous information returned to thepatient, a movement that is facilitated by better procedurereporting. Accordingly, it is imperative that completereports of the highest quality are authored. Elements ofquality achieved through structured reporting includeclarity and completeness of documentation, consistencyin the organization and presentation of information, andfulfillment of requirements for quality reporting, regula-tory compliance, coding and billing, all while reducingthe time devoted to documentation and improvingoperator efficiency. Furthermore, structured reportingcreates the potential for patient-specific risk prediction(e.g., bleeding, restenosis, mortality) and other types ofclinical decision support at the point of care.The concept of a structured procedure report is not

new (2,3). In 2006, a multistakeholder group recom-mended the use of structured reports as a key componentto achieving quality in cardiovascular imaging (4).The subsequent “2008 ACCF/ACR/AHA/ASE/ASNC/HRS/NASCI/RSNA/SAIP/SCAI/SCCT/SCMR HPSon Structured Reporting in Cardiovascular Imaging”articulated the framework for structured reporting forcardiovascular imaging procedures (5). Structuredreporting was again endorsed in the “2012 ACCF/SCAIExpert Consensus Document on Cardiac Catheteriza-tion Laboratory Standards Update” as the instrument fordocumenting cardiac catheterization laboratory pro-cedures (6). Nonetheless, adoption of structured reportinghas been slow, and even today the majority of catheteri-zation reports are dictated and transcribed in unstructuredformats. Even when structured reporting is used, there is alack of consistency from laboratory to laboratory, andfrom vendor to vendor. This suggests several reasons forthe failure to universally adopt structured reporting:insufficient understanding of the specifics of structuredreporting; inadequate guidance to both the clinical com-munity and administrative management as to exactly whatto demand; and an absence of sufficient economic, pro-fessional, and regulatory motivation to adopt structuredreporting as a “requirement.” This HPS addresses thesedimensions, leveraging advances in standards (such asthe HL7 Consolidated Clinical Document Architecture[C-CDA] [7] and the Integrating the Healthcare En-terprise Cath Report Content [IHE CRC] profile [8]) toprovide explicit technical specifications while articulatingthe clinical, scientific, social, economic, and regulatoryadvantages of structured reporting in the cardiovascularcatheterization suite.It is critical to differentiate the narrow concept of the

“structured report” from the more comprehensive processof “structured reporting.” Structured reporting begins withthe explicit use of standardized, controlled vocabularies ofclinical data elements, integrates workflow and documen-tation processes, and achieves data interoperability amonginformation technology systems as a natural and intended

result. The authoring of formatted, structured catheteri-zation procedure reports in a coherent, consistent, andclinically relevant manner is perhaps the most valuableoutcome of a structured reporting environment. However,this HPS purposefully expands beyond the narrow conceptof the structured report to include the entire data acqui-sition and reporting process.

Controlled vocabularies are selected lists of words andphrases (standardized data elements) with explicit defini-tions that convey specific (human interpretable) meaningwhile achieving computational interoperability. Controlledvocabularies are foundational to structured reportingbecause they enable the computational assessment of sys-tems, processes, performance, and outcomes. The con-sistent use of controlled vocabularies among disparateencounters allows organizations to assess procedure ap-propriateness and determine compliance with practiceguidelines of professional societies (9–15). Althoughstandardized data can improve care within an individualorganization, the larger impact occurs when the data areshared externally for analysis and reporting. Specifically,this standardization facilitates the extraction, transmission,and analysis of the data via registries such as the ACCNCDR (16). At the clinician level, the use of controlledvocabularies, coupled with report formats that are consis-tent in key elements, improves understanding of reportcontent critical to direct patient care. Analysis of datasetscomprising uniformly defined data elements can bereturned to the clinician to identify opportunities for careimprovement and, encourage lifelong professional learningactivities. For patients, data terminology standards facili-tate a better understanding of the documents that describetheir process. For society, the capability of aggregatingdata in a semantically meaningful way enables device anddrug surveillance, including comparative effectivenessresearch that strives to best understand the risks andbenefits of treatments and alternatives.

On February 17, 2009, the U.S. federal governmentenacted the Health Information Technology for Economicand Clinical Health (HITECH) Act of the AmericanRecovery and Reinvestment Act of 2009 legislation (17). Akey goal of HITECH is to achieve interoperability ofstandardized, structured data. Interoperability is the ca-pacity of information technology systems and softwareapplications to communicate and exchange data accurately,effectively, and consistently, as well as to use the infor-mation that has been exchanged meaningfully (18).Achieving true semantic interoperability, which refers to theinterchange of data while retaining the meaning of thecontained information, is the ultimate goal. In health care,semantics are represented in controlled vocabularies such asSystemized Nomenclature of Medicine–Clinical Terms(SNOMED CT), with the semantic relationships amongterms modeled in the Unified Medical Language System(UMLS) (19,20). However, the SNOMED CT vocabu-lary set is substantially limited by not including many of


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the detailed findings required for the completion of atypical cardiac catheterization procedure report, signalingthe necessary development of additional data standards inthe cardiovascular arena. For cardiovascular procedures, theNCDR data dictionary provides a comprehensive list ofmany of the terms critical to a complete cardiovascularcatheterization report (21), as does the CCS (22). Inaddition, the ACC and AHA both have a methodology(23) and ongoing projects to formalize and harmonize thevocabularies of cardiovascular medicine with relevant pro-fessional societies and the U.S. Food and Drug Adminis-tration, including an imaging lexicon (24). Importantly,the informatics formalisms to achieve semantic interoper-ability of these terms are still under developmentdin otherwords, many of the above efforts are better described as theauthoring of clinical dictionaries rather than the develop-ment of the specifics required for semantically interoper-able controlled vocabularies. Despite the absence of aformal controlled vocabulary for cardiovascular catheteri-zation procedures, it is nonetheless believed that thestructured reporting principles (including the structuredreport format construct described herein) can be adoptedby the clinical and vendor communities.In the healthcare environment, data interoperability

through controlled vocabularies will ultimately allow us toachieve a “collect once, verify often, use many times”approach to data, rather than the manual, inefficient, re-petitive, and potentially inaccurate acquisition of data (andthe corresponding entry and re-entry of that data intoinformation systems) that characterizes healthcare opera-tions today. However, the work required to achieve thisinteroperability is extensive and complex. Data standard-ization goes beyond simply defining the data elements (thepackets); these electronic elements must be delivered,received, and opened across the information technologysystems found in our complex healthcare ecosystem. TheAmerican Health Information Management Associationlists 16 standards development organizations and 45groups working on structure and content standards,functional EHR standards, technical and interoperabilitystandards, and vocabulary, along with terminology andclassification systems (25). This only serves to highlightthe complexities of positioning and aligning this struc-tured reporting initiative within the larger context ofhealthcare information management.This HPS is intended to provide a general model for

structured reporting for invasive and interventional cardio-vascular procedures. Of note, the principles and practicesespoused by this HPS are also applicable to nonsurgicalendovascular procedures performed in a cardiac catheteri-zation laboratory, hybrid catheterization/operating roomsuite, and interventional/neuroradiology suite, given thesimilarities in workflows. Use of controlled vocabulariescoupled with formatted reporting will facilitate qualityimprovement activities and provide the ability to interactwith data registries for data exchange. All healthcare

providers will find catheterization reports easier to under-stand when they are presented in a consistent format usingdefined and standardized terminologies. Comparisons be-tween studies performed by other operators or at otherinstitutions will be facilitated by following structuredreporting principles.

Implementation of structured reporting is thus botha clinical practice and healthcare policy imperative.Through the creation and endorsement of this document,the organizations involved recognize the critical impor-tance of structured reporting and call for its uniformadoption. This includes the collection of standardizeddata via controlled vocabularies in all cardiovascular pro-cedure settings, the use of structured reports for thereporting of these procedures by all physicians, andadherence to standards for data interoperability, transfer,and communications (1).

2. Principles of Structured Reporting

2.1. General Principles

The general principles of structured reporting in car-diovascular imaging have been published previously andremain current, relevant, and applicable (5). The keycharacteristics of a proper structured report are as follows:1) it must be inclusive of all information relevant to bothclinical care and operational administration; 2) it shouldbe clear, concise, organized, and reproducible, as well asstraightforward, to cognitively assimilate and compre-hend, while being sufficiently flexible to accommodateevolutionary changes in procedures and documentationrequirements; 3) it should contain all the required ele-ments for documenting procedure indications andassessing appropriateness per local coverage determina-tion rules and/or published AUC (9–11); 4) a consistentminimum dataset should be included in the content ofeach report, anticipating clinical, operational, regulatory,and financial uses of the data therein; and 5) the reportshould be devoid of extraneous content and be brief yetthorough.

2.2. Integration of Data AcquisitionWith Workflow

The processes of structured reporting extend the emphasisfrom structure and format of the report to the integrationof data acquisition with workflow, maximizing the accu-racy, completeness, and efficiency of procedure reportgeneration. In this paradigm, complete and accurate doc-umentation occurs at every step of the workflow; the re-sponsibility for data acquisition is shared by the entirehealthcare team. Ideally, proper system design will enablethis tight coupling, resulting in a final structured procedurereport within minutes of procedure completion.

Typical steps that comprise a cardiovascular catheterizationprocedure encounter are depicted in Figure 1. In a structured

Figure 1. Sequence Diagram for Cardiovascular Catheterization Procedures

This schematic illustrates the temporal relationships and dependencies among the events, individuals, and actions that occur from the point of requesting/scheduling a

catheterization procedure through the data outputs arising from the procedure. The diagram depicts the sequence of the Duke University Hospital Catheterization Laboratory;

modification may be needed to represent the sequence of other catheterization laboratories. Time is nonlinear and is oriented along the horizontal axis in this depiction.

ACC NCDR indicates American College of Cardiology National Cardiovascular Data Registry; ACTION-GWTG, Acute Coronary Treatment and Intervention Outcomes Network–Get

With The Guidelines (registry); Cath Lab, catheterization laboratory; CathPCI, Cardiac Catheterization and Percutaneous Coronary Intervention (registry); H&P, history and physical;

Hemo, hemodynamic; HER, electronic health record; HIS, hospital information system; IMPACT, Improving Pediatric and Adult Congenital Treatment (registry); IP, inpatient; IT,

information technology; IV, intravenous; MRN, medical record number; NP, nurse practitioner; OP, outpatient; PA, physician assistant; PACS, picture archiving and communication

system; RN, registered nurse; STS CT Surgery, Society of Thoracic Surgeons Cardiothoracic Surgery (registry); and Tech, technologist.


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reporting environment, the opportunity for data gatheringbegins with the request to the scheduling office. This includesrequesting the capture of demographic information andprocedures. Additional clinical information such as a basichistory, medications, allergies, risk factors, previous pro-cedures, and laboratory data should be available at this junc-ture. The idealized workflow imports (or otherwise) capturesthese data before the patient presents for the procedure.Ideally, data shouldflowbidirectionally to and from theEHR.This basic paradigmdusing optimized technology so-

lutions to accomplish data collection by the individualshandling the data when the information becomesavailabledis then extended to the other steps involved in acatheterization procedure, with the data aggregated and

stored for subsequent presentation and analysis (Figure 2).The need to establish specific responsibilities andaccountability of the individuals for specific sets of data isan implicit step at every point in the process. No singleindividual is to be overburdened with responsibility. Theform factor used to record information is to be optimizedfor both user and task, with the user interface designedfrom a usability perspective. Again, data are capturedsimultaneously and in real time, because delayed or retro-spective data entry creates an opportunity for recall errors.

For intraprocedural data, structured reporting requiresan individual be assigned the responsibility of enteringdata into a procedure logging system. Typically, this in-dividual also has the responsibility for simultaneously

Figure 2. Data Flow Diagram for Cardiovascular Catheterization Procedures

This diagram identifies sources, contributors, outputs, and users of data associated with cardiovascular catheterization procedures.


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monitoring patient clinical data such as cardiac rhythmsand hemodynamic status. In order for this approach towork effectively, it is incumbent upon the physicianoperator, nursing staff, and technologists to articulate everyprocedure detail relevant to the individual documentingthe details. In turn, the monitoring individual has the re-sponsibility of assuring the accuracy of data as they arecollected. Functionally, multiple individuals (technologists,nursing staff, and physician operators) should be able toenter data such as hemodynamics, medications, and find-ings simultaneously. This approach to data capture in thecatheterization laboratory is required, not only to generatethe procedure log report (see section 3.1, The ProcedureLog Report) but also to provide source data for populatingthe final structured procedure report.Unfortunately, inaccurate or inconsistent data entry does

occur and requires a systematic means of identificationand correction (26,27). The data management systemshould include range, data format, validation checks, andother verification features to augment data accuracy at thepoint of entry. Even with a rich set of validation checks,the system must also allow updates, edits, and correctionsas needed. Data entry should be ascribable to the individualentering the information in the event that an investigationof data provenance is needed. Default values should beused sparingly, or only when appropriate.

2.3. Capture of Information asData Rather Than Prose

The first tenet of structured reporting is that the entireprocess requires the capture of information as discrete,

defined, computable, and reusable data elements insteadof dictated or typed (free text) prose. In a structuredreport, prose is purposefully limited to those circumstanceswhere capture of the information as data is unwieldy orinefficient. These limited circumstances could include abrief history, details of complex procedures not otherwiseadequately represented by the data, and the final impres-sions and recommendations. For a structured report to besuccessful, the permissible values of the structured dataelements of the controlled vocabulary must be anticipateda priori, but the system must also have sufficient flexibilityto capture ad hoc values where appropriate, because frus-tration can foster nonadherence and overuse of free-formdata fields.

A second tenet is that all phases of data acquisitionutilize the same controlled vocabulary. At a minimum, acontrolled vocabulary consists of clinical data elementconcepts, definitions of those data elements, and notationsregarding the format specific to each data type (e.g., text,integer, yes/no, date/time, or alphanumeric) along withpermissible (or allowed) values. Typically, data standardscommittees, such as the ACC/AHA Task Force on Clin-ical Data Standards (23), oversee this process on behalfof many stakeholders, with the technical representationof the data elements made available via an authoritativeInternational Organization for Standardization 11179–compliant reference resource, such as the National CancerInstitute Enterprise Vocabulary Services system (28). As ofthe time of this publication, the data standards for cathe-terization procedure reporting remain a work in progress,anticipated for completion within the next several years. In


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lieu of a completely modeled and vetted controlled vocab-ulary for catheterization procedure reports, the ACCNCDR and the CCS data dictionaries provide a compre-hensive list of the majority of the requisite data elementconcepts to provide a basis on which to begin structuredreporting today (21,22).A third tenet is the augmentation of the completeness of

data capture, a natural consequence of structured reporting.Systematic, template-based documentation reduces errorsof omission while accruing a more complete set of infor-mation compared with text-based procedure reporting.More complete and consistent structured reporting reducesambiguity and the effort required to extract the informa-tion necessary to support other activities such as billing,quality improvement, and clinical research. Note that thisshould not be interpreted as a call for exhaustive datacapture; instead, the guiding principle is data parsimony.For structured reporting to be successful, all members mustrecognize that they are contributing to the creation of thefinal structured procedure report while not being burdenedwith redundant and/or unnecessary data capture.

2.4. Role of the Physician in Authoring theStructured Procedure Report

A structured reporting process succeeds only if the integ-rity of both the structure and meaning of the data aremaintained. The physician operator is primarily respon-sible for interpretation, description, and documentation ofresults and findings (i.e., the “meaning” of the data). Thephysician also validates (and assumes responsibility for)data that others have entered throughout the sequenceof events related to the catheterization. In this construct,the structure of the data is largely the province of the in-formation technology solution used to manage the data.With all parties contributing, the procedure report is thenproduced automatically based upon reporting templatespopulated by the entirety of the data. Additionally, thedata can be exported into standard (machine-interpretable)file formats such as an .xml representation, a ClinicalDocument Architecture (CDA) file, or a Clinical DataInterchange Standards Consortium (CDISC) file formachine-to-machine data transfer and subsequent analysis.By shifting data collection (and data quality) respon-

sibilities to others involved in the process of care, physiciantime devoted to repetitive recapture and redocumentationof data is reduced whereas a more complete set of datain the report is ensured. Optimally, this reduced workloadtranslates into time saved, because the required respon-sibility for the physician operator is focused on interpreta-tion and results documentation. Preliminary findings mayeven be entered by experienced catheterization laboratorystaff, fellows, or Advanced Practice Practitioners (APPs) tofurther reduce physician operator time. Of note, theresponsible physician must directly review, edit, or amendthe data, an essential component of the data managementsystem, as a well-designed and orchestrated structured

reporting process will promote an accurate, efficient, andtimely final catheterization report.

Because angiography is inherently visual, documentationof angiographic findings may be provided by graphicalvascular tree and structural anatomy diagrams as well asby the inclusion of images in the report. The captureof these data in a graphical or image format is a highly ac-curate mechanism for representing angiographic findings.Although the use of a graphical vascular tree program isstrongly encouraged, the specifications for vascular treeprograms are beyond the scope of this document. Finally,it is recognized that there is both a paucity of data, andconflicting evidence regarding best practices in data collec-tion and presentation. The idea that a structured reportin the catheterization suite can deliver on the promisesoutlined in this HPS is perhaps most strongly supportedby the success of the Veterans Administration ClinicalAssessment, Reporting, and Tracking System for CathLabs (CART) program (29). The CART program isembedded in the Veterans Administration’s EHR systemand used in place of dictation and typing, following princi-ples of the structured reporting process. Analysis of theCART system has demonstrated excellent data quality,marked improvements in timeliness in reporting, andthe ability to use the data for quality improvement andregistry reporting. So although the recommendationspresented herein are largely based on expert consensus,the existing evidence base does support the structuredreporting approach endorsed by this HPS as state of theart, evidence based, and patient centered.

2.5. The Best Practice Model

Building a best practice model for the cardiac catheteri-zation laboratory begins with an understanding of thetemporal sequence of events associated with the procedure(Figure 1) and identifying the data, systems, and in-dividuals associated with each step of the sequence(Figure 3). Events that typically occur in the context ofa catheterization procedure include the following:

1. Scheduling of the procedure2. Preprocedure evaluation and consent by an operator

or designee3. Nursing preprocedure evaluation4. Catheterization procedure5. Documentation and interpretation of findings,

analysis, and procedure report generation6. Finalization and distribution of the report and report

data

At the initiation of a procedure request, administrativepatient data (e.g., patient identifiers, demographics) areobtained from source systems such as the EHR andcombined with clinical information to schedule the pro-cedure. The IHE Cardiac Catheterization Workflow(CATH) profile integrates ordering and scheduling ofcardiac catheterization procedures and ensures the accurate

Figure 3. Process–Interaction Matrix for Cardiovascular Catheterization Procedures

This chart maps the processes (across the top) that occur to accomplish a catheterization procedure and the contributions of the constituent components (left side of figure) to

be coordinated with each process.

Cath lab indicates catheterization laboratory; and EHR, electronic health record.


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transfer of patient identification data (8). In subsequentsteps, these data, coupled with other sources of information(e.g., laboratory results, previous procedure findings), arefurther collected and again converted into data. In infor-matics modeling terms, actors are the individuals respon-sible for capturing the information, with the mechanismfor capturing the information as data determined by theinformation systems being used by that individual. Thebest-practice model specifies that the form factor (e.g.,workstation, mobile tablet, hemodynamic monitoring sta-tion) is optimized to the actors and their respectiveworkflows and operational logistics. A portion of the datapopulates subsequent downstream information systems.Regarding the data themselves, the preprocedure eval-

uation, consent, and nursing preprocedure evaluation stepscapture demographic, history, physical, laboratory, andmedications data. The cardiac catheterization procedureutilizes these data and adds new data: hemodynamic in-formation, administered medications, inventory utilization,

as well as angiography findings, therapeutic interventions,results, and complications. Combined with the final anal-ysis and interpretation, report generation merges and in-corporates the new data recorded, calculated, and capturedduring the procedure into the final structured procedurereport. Catheterization reports are distributed across theenterprise for clinical care, and the data are extracted andanalyzed for inventory management, process assessment,quality improvement, billing, and other administrativepurposes. Combined with in-hospital and follow-up in-formation, the data are also packaged for transmission todata registries. The IHE Cross Enterprise DocumentSharing (XDS) profile exists to ensure that reports (andimages) can be effectively exchanged within and betweenentities (30). The ultimate goal of modeling best practicein the cardiac catheterization laboratory is to explicitlyidentify and specify the processes, systems, and personnelthat are required to interact smoothly as a coordinatedentity. This creates an environment in which the


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interaction of the clinical team and the patient is the focus,with information and data sources available to each actorin whatever form factor will distract the least from theclinician–patient interaction. At any stage of the procedure,data are readily available to any actor, whereas data systemsremain “invisible” to the actors and unobtrusive to theirpatient care focus. This model allows quality and processefficiency to be the primary drivers of the structuredreporting process.

3. Catheterization Procedure Reporting:Anticipating 2 Different Reports

Although the focus of this HPS is the final (physician-authored) structured procedure report, a second comple-mentary procedure log report is also created for eachprocedure via the same structured reporting process. Thestructured reporting process is thus designed with both ofthese critical reports in minddthe catheterization proce-dure log report and the final procedure structuredreportdas integrated, seamless, consistent, and intrinsic tothe catheterization procedure. As a final step, both of thesereports should be uploaded into the EHR system, occur-ring automatically once electronic signature attestation hasbeen completed.

3.1. The Procedure Log Report

The procedure log is the documentation record of theevents (as time-stamped entries) occurring during a cath-eterization procedure, from patient entry to exit from thecatheterization suite. Documentation of these events is theresponsibility of the individual monitoring the procedureand is accomplished using the database of a hemodynamicmonitoring system. Most vendors are already producingthe procedure log report in a tabular (table-based) format,albeit without standardized definitions or structure. Thisdetailed procedure log report is an integral part of themedical record, reflecting the chronological occurrence ofevents during a procedure.Although there may be substantial overlap with the

physician-authored procedure report, the procedure logreport is constrained to the duration of the procedure,largely reflecting nursing and technologist responsibilities.As the monitoring individual transcribes events on behalfof the entire team (including the physician operator),communication among the team members is essential foraccurate and complete documentation. The procedure logreport should reflect the temporal occurrence of events,including documentation of the preprocedure “time-out,”the preprocedure immediate reassessment required by TheJoint Commission (31), vital signs, levels of consciousness,oxygen saturations, and other assessments and measure-ments performed over the course of a procedure. In addi-tion, recording of procedural personnel, proceduresperformed, equipment used, medications administered,

contrast volume, and radiation exposure parameters shouldbe included. To reduce variability in the format of the databeing captured, it is highly recommended that macros,drop-down lists, coded phrases, or other structured ap-proaches be utilized in accordance with the underlyingcontrolled vocabulary data element specifications. Thispractice improves both accuracy and efficiency for themonitoring recorder. Ideally, data interfaces should beimplemented to automatically export data from ancillarymodalities and other external equipment (e.g., fractionalflow reserve, intravascular ultrasound) into the proceduredocumentation system.

The data collected via the procedure logging processform the foundation for the procedural data section of thephysician-authored structured procedure report. A degreeof data transformation is needed to convert data recordedchronologically into the summary representation moreappropriate for the physician-authored report. Forexample, a medications tally is needed in the structuredprocedure report, rather than a more simplistic time-stamped listing of a medication administration record.For interventions, implanted devices are associated withlesions, along with the respective device parameters (e.g.,stent size, maximum balloon inflation pressure); a time-stamped listing of the actual events is of much less value.As noted previously, the extraction and transformation ofthese data from the procedure log should be as automatedas possible to reduce the workload on the physician,allowing the physician to focus on the accuracy of thedocumentation itself.

3.2. The Physician-AuthoredStructured Procedure Report

The physician-authored final catheterization procedurereport fulfills the long-standing requirements for anoperator-authored synthesis and summary document ofthe salient points of an operative or invasive procedure.In the United States, content requirements are stipulatedin state and federal statutes as well as guidance providedby The Joint Commission (31). It is recommended thatthese content requirements (e.g., documentation of in-dications for the procedure, procedures performed, re-sults, complications, and recommendations; logistical,operational, and administrative information) serve as thefoundation of catheterization structured reporting aroundthe world. Of note, what is not specified by regulation ishow to accomplish the specifics: whether to even use acomputerized information system, the capture of dataversus prose, and the format and structure of the reportsthemselves. This HPS fills that gap, developing the baseregulatory requirements into an explicit reference stan-dard. Specifically, Section 4 describes the specifics of theprototype formatted, tabular, structured procedurereport.

Intentionally, it is recommended that the report shouldavoid listing the absence of a finding in certain situations.


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Specifically, the absence of disease in the coronary arteries(and other vascular territories) is denoted by describingthe primary vessels (left main, left anterior descending,left circumflex, and right coronary artery) as “normal”without further listing the absence of pathology in theterminal branches. Conversely, when coronary disease ispresent, only the segments with disease are listed (i.e., theterm “normal” is not printed with vessels and segments freeof disease). Similarly, the lack of occurrence of an adverseevent is summarized by the word “none,” rather thandenoting that every possible adverse event (e.g., ventricularfibrillation, cardiopulmonary resuscitation, or death) didnot occur. The concept of pertinent positives also extendsto the listing of risk factors on the procedure report.When a risk factor is not present, the report should notlist “no” (as in “no hypertension” in the patient who isnormotensive). This allows the clinician to rapidly un-derstand what is known to be abnormal while implicitlyaccepting as absent (or unknown) what is not otherwisementioned or described. Of note, depending on thespecifications of a secondary consumer of the data (e.g.,NCDR registry), there may be a requirement for acqui-sition of the data as either a “yes” or “no” response.Regardless of the data in the database, on the report itself,only the pertinent positives are to be listed. Although itis acknowledged that this representation is incomplete(i.e., it does not differentiate negation from the absenceof information), this HPS endorses “charting by excep-tion” as a mechanism to reduce clutter and maximizereadability, and because there are essentially no differencesin terms of analytics among the various representations of“no” and “null.”

4. The Prototype Formatted, Tabular,Structured Procedure Report

The 2008 HPS on Structured Reporting in Cardiovas-cular Imaging provides a general procedure reportframework for all cardiovascular imaging modalities (5).Given the additional documentation requirements forinvasive and operative procedures, coupled with the vari-ability and volume of data acquired across the spectrum ofcardiovascular catheterization procedures, extensions tothis general framework are necessary to handle cardio-vascular catheterization reports. The need to restructuredata from multiple sources into the final report, and thedesire for consistency across procedures also influencesthis framework. These factors collectively contribute tothe rationale for the organization and formatting ofcatheterization procedure reports using the schemadescribed next. A key concept is that each section of theprocedure report has specific content and compositionattributes that remain relatively constant from one pro-cedure type to the next.

The final catheterization procedure report is to be orga-nized into 3 primary sections, with each containing section-specific content (Table 1). The first sectiondideally a singlepage of textdis an easily understood, focused summary ofthe salient points, that is directed to the clinical community.All clinicians (spanning the spectrum from the highlytechnical procedural cardiologists to nurses and othermembers of the clinical care team) should not need to lookfurther than this first page to ascertain the procedures per-formed, diagnostic findings, and recommendations. Thesecond section is focused on images, including a comput-erized depiction of the observed anatomy, findings, and re-sults. Optionally, captured images (with or withoutannotations) are included in this section. Finally, the thirdsection includes the details of the procedure. This includesadministrative data, the preprocedure history (particularlyinformation captured as structured data), most of the pro-cedural detail, free-text descriptions of technical details, andother content relevant to the final procedure report. Inaddition to the content included in the published versionof this HPS, additional resource information such as asample procedure report and accompanying style guide areavailable in an online supplement.

4.1. FrontPageSummary:HighestValueInformation

The front page is explicitly intended to be a single(physical) page that contains the highest value clinical in-formation. The purpose of this page is to communicate thekey findings, interpretation, and patient care recommen-dations from the physician operator to the clinical careproviders of the patient. The objective is for this front pagesummary to include all of the information needed byproviders to understand the context of the procedure,what was performed, the relevant findings, and the rec-ommendations for care. As such, it replaces (and largelymimics) the preliminary procedure note.

For all catheterization procedures, the front pagesummary includes the following information in theheader: facility information, patient identifiers (name,date of birth, and medical record number), date of pro-cedure, referring physician(s) and physician operator(s).In the first part of the body of the summary page, theprimary indication for the procedure by InternationalClassification of Diseases (ICD) code and a brief prosehistory describe the circumstances leading to the proce-dure. Recognizing that structured data will never sub-stitute for the richness of language, a short description(1 to 3 sentences) of the patient’s presentation isendorsed as the most efficient mechanism to convey theclinical context. (The remaining structured data obtainedduring the preprocedure history and physicaldsuch asthe cardiovascular risk factors, noninvasive test findings,past procedure history, and medicationsdare placed inthe third “report body” section). The prose history isthen followed by a tabular listing of the composite

http://jaccjacc.cardiosource.com/DataSupp/2014_Cathlab_HPS_CathReportStyleGuide.pdf

Table 1. Organization of the Structured CatheterizationProcedure Report

Header (top of summary page, top of details section)Facility information: healthcare entity, catheterization laboratory locationPatient identifiers: name, medical record number, date of birth, ageProcedure datePhysician operatorReferring provider(s)

Section 1: Summary Page1. Primary Indication (ICD terminology)2. History

a. 1-3 sentences of prose describing circumstances of the presentation3. Procedures (list of procedures, grouping individual procedures together

by composite CPT code)4. Procedure details

a. Vascular access site(s)i. Sheath size, sheath status at end of procedure, vascular closure

methodb. Catheters [diagnostic imaging / guide catheters]

i. Diagnosticii. Intervention

c. Diagnostic findings [“Box 1” on sample report – see Table 2 for details]i. Findings, hemodynamics, calculations

d. Interventions [“Box 2” on sample report – see Table 2 for details]i. Target lesions: devices implanted, results

5. Adverse Events6. Medication and Contrast Totals7. Impressions

a. Prose listing of summary findings8. Recommendations

a. Prose listing of care recommendations

Section 2: Graphics and Images1. Diagram (graphical tree representation) of vascular anatomy, annotated

a. Diagnostic findingsb. Intervention results

2. Image capturea. Hemodynamic tracingsb. Images þ/- annotations (embedded at a reduced resolution, with

reference to DICOM image)

Section 3: Report Body1. Administrative InformationPatient

� Patient full name, date of birth, age, gender� Race, ethnicity� Insurance� Medical record number� Case accession number (or other unique study ID)

Healthcare Facility� Complete facility information: name of healthcare entity, catheteri-

zation location (laboratory), address, FAX number, phone number,laboratory accreditation

Operator, Staff� Referring Providers� Primary care provider� Cardiologist� Reason for request (ideally, replica of information received via EHR)� Procedure requested, date of request� Requestor

Encounter Category� Elective, urgent, emergency, salvage (and subcategories)

2. History and Physical� Symptom class� Medical history (risk factors-pertinent positives only, unless a negative

finding is explicitly captured)� Family history (pertinent positives only)� Previous procedures and previous events, with pertinent results� Allergies and sensitivities� Physical examination (limited)� Laboratory values (limited: BMP, WBC, Hgb, Hct, platelet, PT, INR, PTT)� Procedure indications (ICD terminology)

Continued in the next column

Table 1. Continued

3. Procedure� Individual (component) procedures performed (as CPT codes, or using

other standardized procedure terminology – these are not theaggregate procedures reported on the summary page)

� Logistics (time in, time out, consent / sedation consents, timeoutperformed, final patient condition and logistics)

� Starting vital signs: BP, pulse� Access site (location(s), sheath(s) size and manufacturer, brand, other

sheath information); sheath disposition at end of case, vascularhemostasis method

� Anesthesia support (if applicable)� Surgical support (if applicable)� Hemodynamic support (if applicable)

� Type of support: when initiated (e.g., elective at the start of thecase, planned for the case, urgent in response to a complication),and disposition at end of case

4. Diagnostic FindingsDiagnostic findings (organized by anatomic structure or physiologicfunction) [“Box 3” on sample procedure report – see Table 3 for details]� Equipment� Hemodynamic measurements, calculations (plus reference to DICOM

Hemodynamics Report if applicable)� Angiography findings, interpretations (plus reference to DICOM

Quantitative Analysis Report if applicable)5. Intervention (grouped by anatomic target, if multiple lesions treated)

[“Box 4” on sample procedure report – see Table 3 for details]� Equipment� Baseline anatomy� Devices deployed, device deployment parameters� Intervention results

6. Summaries� Medications in-lab (time-stamped)� Drips running at completion of case (if applicable)� Contrast type and total� Radiation exposure (fluoroscopy time, dose area product, cumulative

air kerma, reference to DICOM Dose Report)� Estimated blood loss� Specimens removed� Final ICD diagnoses� Final procedure notes

BMP indicates basic metabolic profile; BP, blood pressure; CPT, current procedural termino-

logy; DICOM, Digital Imaging and Communications in Medicine; EHR, electronic health record;

Hct, hematocrit; Hgb, hemoglobin; ICD, implantable cardioverter defibrillator; INR, international

normalized ratio; PT, prothrombin time; PTT, partial thromboplastin time; and WBC, white blood

cell count.


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procedures performed along with their correspondingCPT procedure codes.

The next section of the front page summary describes thekeyfindings of the procedure, with the content of this sectionspecific to the actual procedure(s) performed. This is toinclude vascular access site details, type and size of sheath,key hemodynamic and diagnostic findings and measure-ments, intervention results, and devices implanted, as well asmedication and contrast totals, listed in a summary tabularformat. The findings of diagnostic procedures are presentedas a sequence of modular tables, listing only key findings.The complete listing of all findings is included in the thirdsection of the report. Interventions are organized by thetreatment target, which includes a listing of the equipment,implanted devices, and results in association with the targetlesion. A listing of complications and estimated blood loss(or acknowledgement of the absence of complications) fol-lows this procedure-specific information section.


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4.2. Graphics and Images Section

The second section of the structured report is optionalbecause it is dedicated to images, including graphicalrepresentations of the findings or images imported intothe report. The vascular “tree” diagram should include arepresentation of the vascular anatomy specific to the pa-tient, including graphics depicting vascular abnormalities,anomalies, disease, and interventions. Although vendorshave developed a number of different systems to depictcardiovascular anatomy, the key criterion is the accuratedepiction of the vessels in a manner that facilitates therapid understanding of the major features of the anatomy,including the 3-dimensional relationships of key vascularstructures. As such, accuracy as to the curves and squigglesof a vessel are much less important than the distribution ofmajor and minor branches of that same vessel. Unfortu-nately, there is currently no unifying data schema that al-lows the vascular tree created by 1 vendor to be exportedand reproduced by the vascular tree program of a second. Itis hoped that an effort to standardize this will occur in thenear future to facilitate the exchange and interoperability ofgraphical data. For now, the vascular tree graphics will beconveyed necessarily from provider to provider and systemto system as images, rather than data. Nonetheless, thecomputerized graphical vascular tree representation is feltto be a critical element of the structured catheterizationprocedure report given its utility in communicating pro-cedure findings and results. Similarly, a graphical de-scription of the anatomy with structural heart disease isalso a critical element. Finally, in addition to the graphicaldepictions generated by computerized vascular tree pro-grams, other images can be critical to capture in thestructured procedure report. These include hemodynamictracings, angiographic still frames, ultrasound images, andother potential image types. These images are also housedin the second section of the report. Annotation of theseimages should be allowed.

4.3. Report Body: Details

The body (third section) of the structured procedure reportcontains all of the remaining data accrued during theprocedure not listed on the front page summary. As nearlyall of the information reproduced in the body of the reportcan be expected to be data, the layout of this section is aseries of structured, formatted tables. In sequential order,the information in the body is included in the followingsubsections.

4.3.1. Administrative Information

The capability of information systems to meaningfullyinteroperate requires context, starting with the adminis-trative data uniquely identifying the patient and procedure.Accuracy along with the ability to share data acrosssystems is critical, not only for clinical care, but also forsupply chain management, charging and billing, laboratory

administration, quality assessment, and performance andoutcomes analyses. Patient demographics provide personalinformation and unique patient identifiers to link thepatient to the report. Demographic elements include thefull name of the patient at the time of the procedure,medical record number, date of birth, gender, and race. Allof these should be included to provide sufficient informa-tion to correct errors and to allow comparison of data overtime and across providers. Special care must be taken in theidentification of fetal and newborn patients, as names andother identifiers may change following birth. Insuranceinformation or other payer information may be included.In most healthcare organizations, all of these data areavailable electronically through the relevant admission-discharge-transfer and order management data streams,and it is highly recommended that these data streams beused to initialize and populate the catheterization labora-tory modality, hemodynamic, and procedure reportingsystems. Populating these systems with data from thehospital database limits errors and facilitates bidirectionalinformation interchange.

Information identifying the healthcare organization,laboratory, operators, and staff are key administrative dataincluded in this section of the body of the report. Thefacility name, address and other contact information, andthe specific laboratory (if there are multiple laboratories inthe facility) are noted. Accreditation status and entity areincluded, given the increasing importance of accreditationof cardiac catheterization laboratories. Along with thephysician operator, the report lists the names and identi-fiers of all individuals involved in the study, including thenames and credentials of the nurses, technologists, APPs,trainees, and all others involved in the performance of theprocedure. The list of referring providers, consisting of notonly the requestor of the procedure, but also the primarycare and referring cardiologist, facilitates distribution of thefinal report.

An objective of the HITECH Act of 2009 is to improvecommunication of the specifics of consultation requests,and the catheterization procedure environment presents aprime opportunity to leverage the functionalities beingadded to EHR systems to fulfill this objective (17). A fullyformed EHR procedure request describes the clinical sit-uation, question, and study indication, as well as identifiesthe provider requesting the procedure. The request alsoincludes the date and time of the order, study priority(elective, urgent, or emergency), and special handling in-structions such as a callback number. Inclusion of thisstudy referral information should be anticipated for thenear future as these data become electronically available bydirect data transfer.

4.3.2. History and Risk Factors

Two complementary sets of history information are to becaptured for documentation purposes. As described inSection 4.1, because the complexities and nuances of


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patient history are unlikely to be adequately conveyed usinga structured data construct, a brief sentence history (1 to 3sentences) is to be included on the front page summary.However, this analog history is largely unusable for pur-poses other than human cognitive interpretation. Thisnecessitates the structured capture of key elements ofthe history (typically the class of symptoms, includinglimited details regarding the acuity of those symptoms)along with risk factors, medications, and previous pro-cedures. The structured data are to be included in the bodyof the report. As data, these elements are used in coveragedeterminations as well as in the assessment of appropri-ateness per the relevant AUC and other practice guidelinerecommendations for invasive and interventional pro-cedures. Of note, AUC criteria are being developed foradditional procedures, which will expand the requirementsfor the collection of history and risk factor informationas data.Historical data are typically first available from the

referring physician requesting the procedure. Personnelinvolved in the scheduling of procedures are positioned tocapture this data, with those on the clinical team evaluatingthe patient prior to catheterization (particularly APPs orthe actual physician operator) then being in the positionto confirm and validate these data. Although some trans-lation may be required (e.g., free-text information found inthe EHR), the ideal workflow accommodates even thisissue by having all individuals upstream of the actualprocedure participate in the process of converting infor-mation into data.

4.3.3. Procedure Details

The capture of procedure details is largely the re-sponsibility of the laboratory nursing and technologiststaff. From the time of laboratory entry to departure, allrelevant events are to be captured in a time-stamped log,typically via the hemodynamic monitoring system of thelaboratory. This includes the component parts of theprocedure as it is being performed, patient status and he-modynamics, names and doses of medications, observa-tions and measurements, and other pertinent actions andevents.The conversion of the events from a time-stamped log

database structure into the format of a structured reportrequires summarization and transformation of that data.This postprocessing necessarily impacts database design,because the database must support direct data conversion,preferably in real time. Aside from the medication log, atime-stamped log of the other events is generally not usefulin the final procedure report. Instead, the information isarranged in a fashion that makes the most clinical sense,grouping and organizing related information in a clinicallycogent manner. This applies to the detailed list of the in-dividual (component-level) procedures performed, logistics,consent and other required documentation, vascular accessand disposition, details regarding ancillary hemodynamic

support, total volume and name of contrast agent(s), radi-ation exposure parameters (fluoroscopy time, cumulative airkerma, and dose-area product), as well as intraproceduralfindings, measurements, observations, and results. In thisparadigm, data entered by staff into the documentationsystem are converted from individual time-stamped lineitems into aggregate information ready for the final(physician-authored) structured procedure report. Doneproperly, the summary data are directly imported into thestructured procedure report without further physician pro-cessing or handling. This in turn further reduces the timerequired of the physician to review the data and completethe final report. To improve patient safety, the cumulativecontrast volume and radiation dose for all diagnostic andinterventional procedures should be recorded and incor-porated into the electronic medical record as readilyaccessible data elements.

4.3.4. Diagnostic Results

Study findings will vary substantially depending on thestudy performed, and therefore, specifics by procedure arecovered in much greater detail in the sections to follow(Table 2). At a general level, for the reporting of procedureresults, the layout paradigm common to the diagnosticresults section is to group all quantitative measurements,qualitative assessments, and calculated data with a givenanatomic structure and/or physiological function, begin-ning the grouping with an appropriate label. For example,under a header of “left ventricle,” the findings includeleft ventricular size, dilation, ejection fraction, segmentalwall motion, and end-diastolic pressure. Groupings arepresented successively in a logical anatomic or physiologicalsequence established by the conventions of medicine.Measurements should be properly referenced to norms forbody size, gender, and age. Abnormal or inappropriatephysiological and hemodynamic changes observed duringthe procedure, whether spontaneous or in response to stressor other interventions, are also included. Reported datashould be based upon standardized data elements foranatomic, morphological, physiological, and functionalfindings as developed and recommended by relevant datastandards groups.

4.3.5. Intervention

Similar to the diagnostic results section, the interventionsection will vary substantially depending on the procedureperformed (Table 3). A dedicated section for interventionsexplicitly separates diagnostic components from interven-tional procedures, with reporting in the intervention sec-tion organized by the anatomic treatment target of theintervention. The common layout paradigm of the inter-vention section is to describe the treatment target first,followed by the equipment used, parameters of thatequipment, and the results of the intervention. Pre- andpostprocedure results are described in sufficient detail todetermine procedure success or failure. Because free-text

Table 2. Diagnostic Procedures Report Content.For each procedure, the content listed under the header“Summary Page” corresponds to content placed inBox 1 on the prototype report. Content listed under theheader “Details Section” corresponds to content placed inBox 3 on the prototype report.

Diagnostic: Right / Left Heart Catheterization

Summary PageRight heart cathRA meanRV systolic, diastolic, EDPPA meanPCW meanAV 02 diffCardiac output, cardiac indexQpQs [only if not 1.0]PVR, SVR

Details SectionRight heart j right / left heart catheterization1. Assessment conditions: baseline / rest; [challenge with vasoactive agent]

a. Patient height, weight, BSAb. Patient blood pressure, heart ratec. Inspired O2:d. Vasoactive agent [intravenous vasodilator, inhaled vasodilator, vaso-

pressor, inotrope]:2. Oxygen saturation (%)

a. Innominateb. SVCc. IVCd. RAe. RVf. MPAg. LPAh. RPAi. LAj. Pulm veink. LVl. Asc ao

m. Desc ao3. Pressures (mm Hg)

a. Hepatic wedge: meanb. RA: a wave, v wave, meanc. RV: systolic / diastolic, end diastolicd. MPA: systolic / diastolic, meane. RPA: systolic / diastolic, meanf. LPA: systolic / diastolic, meang. RPCW: a wave, v wave, meanh. LPCW: a wave, v wave, meani. LV: systolic / diastolic, end diastolicj. Asc ao: systolic / diastolic, meank. Desc ao: systolic / diastolic, mean

4. Pressure gradients [specify mean / peak-peak / or both] (mm Hg)a. PCW-PAb. RPA-MPAc. LPA-MPAd. MPA-RVe. RV inflow-RV outflowf. RV-RAg. RA-hepatic wedgeh. LA-LV diastolici. LV inflow-LV outflowj. LV-Asc aok. Asc ao-Desc ao

Table 2. Continued

5. Calculationsa. Hemoglobin: gm/dLb. O2 consumption: mL O2/minc. CO [method]: L/mind. CI: L/min/m2e. AVO2 diff: vol%f. Qp: L/ming. Qp index: L/min/m2h. Qs: L/mini. Qs index: L/min/m2j. Qp:Qsk. PVR: Wood units [or] dynes-sec/cml. SVR: Wood units [or] dynes-sec/cm

m. Valve area by [method]: cm2

Diagnostic: Congenital Disease Angiography

Summary PageAngiography of [structure]: summary findings

Details Section (table)Structure Catheter Angles FindingsRA angiogramRight ventriculogramMPA angiogramRPA angiogramLPA angiogramRPAW angiogramLPAW angiogramRUPV angiogramLeft ventriculogramAscending aortogramDescending aortogramOther angiogram [specify location, e.g., MAPCA, decompressing vein,collaterals]

Diagnostic: Left Heart Cath / Left Ventriculography / Aortography

Summary PagePressures:

Aorta: systolic / diastolic, meanLeft ventricle: systolic / diastolic, LVEDP

Left ventriculogramEjection fractionLV segmental wall motion: [abnormal only; if none, then “normal”]Mitral regurgitation: [grade]Other findings: [describe]

Details SectionPressures:

Aorta: systolic / diastolic, meanLeft ventricle: systolic / diastolic, LVEDP

Left ventriculogramEjection fractionLV segmental wall motion: [table of all segments per the 5 segmentmodel:

RAO includes anterior, apical, inferior; LAO includes septal,posterolateral segments]

Mitral regurgitation: [grade]Other findings: [describe]

AortogramFindings: [describe]

Diagnostic: Coronary Arteriography

Summary PagePressures:

Aorta: systolic / diastolic, meanCoronary angiography (summary findings)

Dominance: [if not right dominant]Left main: [normal, insignificant, or list of significant lesions]Left anterior descending: [normal, insignificant, or list of significant lesions]Left circumflex: [normal, insignificant, or list of significant lesions]Right coronary: [normal, insignificant, or list of significant lesions]Number of diseased vessels: [0, 1, 2, 3]

Continued in the next column

Continued on the next page


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Table 2. Continued

Graft angiographyNumber of grafts (origins)Number of distal anastomoses placedNumber of distal anastomoses patentSignificant graft lesions

Details SectionCoronary angiography(table)

DominanceArtery-segment (size) % stenosis Descriptors TIMI flow

Graft angiography (table)Graft type-anastomosis Segment % stenosis Descriptors TIMI flow

Adjunctive diagnostic assessment (table)Modality Segment Findings

[FFR][IVUS][OCT]

Diagnostic: Peripheral Arteriography

Summary PagePeripheral vascular angiography (summary findings)

[Vessel / segment]: [normal, insignificant, or list of significant lesions]Graft angiography: [normal, insignificant, or list of significant lesions]Number of diseased leg vessel segments: [based on aorto-iliac, femoro-popliteal, and tibial-crural segmentation schema]

Details SectionNumber of diseased leg vessel segments: [based on aorto-iliac, femoro-popliteal, and tibial-crural segmentation schema]

Peripheral vascular angiography (table)Artery-segment % stenosis Lesion type

Graft angiography (table)Graft type-anastomosis Segment % stenosis Lesion type

Adjunctive imaging (table)Modality Segment Findings[IVUS][OCT]

Diagnostic: Cerebrovascular Arteriography

Summary PageAortic arch typeCerebrovascular angiography (summary of lesions in injected arteries):[normal, insignificant, or list of significant lesions]

Details SectionAortic arch type (i.e. Types 1-3, bovine)Hemispheric cross-fillingCerebrovascular angiography (table)

Artery-segment % stenosis Lesion type

ASC ao indicates ascending aorta; AV O2 diff, arteriovenous oxygen difference; BSA, body

surface area; Desc ao, descending aorta; EDP, end diastolic pressure; FFR, fractional flow

reserve; IVC, inferior vena cava; LA, left atrium; IVUS, intravascular ultrasound; LAO, left anterior

oblique; LPA, left pulmonary artery; LPAW, left pulmonary artery wedge; LPCW, left pulmonary

capillary wedge; LV, left ventricle; LVEDP, left ventricular end diastolic pressure; MAPCA, major

aortopulmonary collateral artery; MPA, main pulmonary artery; OCT, optical coherence tomog-

raphy; PA, pulmonary artery; PCW, pulmonary capillary wedge; PVR, pulmonary vascular resis-

tance; QpQs, pulmonary systemic flow ratio; RA, right atrium; RAO, right anterior oblique; RPA,

right pulmonary artery; RPAW, right pulmonary artery wedge; RPCW, right pulmonary capillary

wedge; RUPV, right upper pulmonary vein; RV, right ventricle; SVC, superior vena cava; and SVR,

systemic vascular resistance.

Table 3. Intervention: Coronary Artery Disease

Summary PagePCI of [coronary segment]Devices: [type(s) of interventions – e.g. balloon angioplasty, atherectomy,

stent implantation, aspiration thrombectomy, etc.]; stent-brand name,diameter x length, bare metal or drug-eluting, UDI; final balloon if no stent

Results: pre % stenosis to post % stenosis [pre TIMI flow to post TIMI flow,if either abnormal (i.e., not TIMI 3); no reflow]

Details SectionPCI of [coronary segment]Intervention:

Guide catheters: manufacturer, Fr size, modelGuide wires: manufacturer, diameter, modelDevices: balloons – timing (pre versus post stent implantation), diameter xlength, max pressure x duration; other devices – with parameters;stent – manufacturer, brand name, diameter x length, max pressure xduration, bare metal or drug-eluting, UDI

Results: pre % stenosis to post % stenosis [pre TIMI flow to post TIMI flow,if either abnormal (i.e., not TIMI 3); no reflow]

Technical notes (analog text)

Intervention: Peripheral Artery Disease

Summary PagePVI of [peripheral artery segment]Devices: [type(s) of interventions – e.g. balloon angioplasty, atherectomy,

stent implantation, etc.]; stent -brand name, diameter x length, baremetal or drug-eluting, UDI; final balloon if no stent

Results: pre % stenosis to post % stenosis [pre TIMI flow to post TIMI flow,if either abnormal (i.e., not TIMI 3)]

Details SectionPVI of [peripheral artery segment]Intervention:

Guide catheters: manufacturer, Fr size, modelGuide wires: manufacturer, diameter, modelDevices: balloons – timing (pre versus post stent implantation),diameter x length, max pressure x duration; other devices – withparameters; stent – manufacturer, brand name, diameter x length,max pressure x duration, bare metal or drug-eluting, UDI

Results: pre % stenosis to post % stenosis [pre TIMI flow to post TIMI flow,if either abnormal (i.e. not TIMI 3)]


Intervention: Cerebrovascular Disease

Summary PagePTA of [cerebrovascular artery segment]Devices: [type(s) of interventions – e.g. balloon angioplasty, atherectomy,

stent implantation]; embolism protection; stent -brand name, diameter xlength, bare metal or drug-eluting, UDI

Results: pre % stenosis to post % stenosis

Details SectionPTA of [cerebrovascular artery segment]Intervention:

Guide catheters: manufacturer, Fr size, modelGuide wires: manufacturer, diameter, modelDevices: balloons – timing (pre versus post stent implantation), diameter x

length, max pressure x duration; embolism protection – manufacturer,brand name, timing; other devices – with parameters; stent – manu-facturer, brand name, diameter x length, max pressure x duration, baremetal or drug-eluting, UDI

Results: pre % stenosis to post % stenosisTechnical notes (analog text)

Intervention: Transcatheter Aortic Valve Replacement (TAVR)

Summary PageIntervention: valve – manufacturer, brand name, size; de novo or valve in

valveResults: mean gradient pre to mean gradient post; regurgitation post – grade

and location (paravalvular, central)



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Table 3. Continued

Details SectionAngiographya. Femoral artery angiogram: RFA / LFA, findingsb. Ascending aorta angiogram: findingsAortic valve-baselinea. Previous aortic valve bioprosthesis (make and size)b. Dimensions by [CT / MR / echo]

Annulus (mm):STJ (mm):Sinus segment (mm):

c. Hemodynamic assessmentLV pressureAsc aorta pressurePeak-peak gradient, mean gradientValve area by [method]:Measurement condition: resting / inotrope and dose

Interventiona. RV pacing

Rate:Timing: (when pacing used during procedure)

b. Balloon aortic valvuloplasty:Guide wire: manufacturer, diameter, modelBalloon – manufacturer, brand name, diameter � lengthInflation duration (sec):Inflation pressure (atm):

c. Transcatheter aortic valve replacementValve system – manufacturer, brand name, sizeDe novo or valve in valve

d. Maldeployment – present or absent; if present:Valve embolization: LV or aorticManagement: open conversion, deployment in desc thoracic ao

Results:a. Hemodynamic assessment

LV pressureAsc aorta pressurePeak-peak gradient, mean gradientValve area by [method]:Measurement condition: resting / inotrope and dose

b. Ascending aorta angiogram:Paravalvular regurgitation: [none, 1þ, 2þ, 3þ, 4þ]

c. Iliac / femoral artery angiogram: findingsd. Transesophageal echocardiogram

Paravalvular regurgitation: [none, 1þ, 2þ, 3þ, 4þ]Central regurgitation: [none, 1þ, 2þ, 3þ, 4þ]

Access Site Closurea. Closure method: open surgical, closure device – manufacturer, brand

nameb. Angiogram: findingsc. Crossover technique

Sheath used – manufacturer, brand, size; balloon used – manufacturer,brand, size

Intervention: Congenital Stenosis

Summary PageTarget: RPA, LPA, Coarcation, other stenosis [specify lesion]Devices: [type(s) of interventions – e.g. balloon angioplasty, stent implan-

tation]; stent - brand name, diameter � length, bare metal or covered,UDI

Results: gradient pre to gradient post; MLD pre to MLD post

Details SectionTarget: RPA, LPA, Coarcation, other stenosis [specify lesion]Intervention:

Guide catheters: manufacturer, Fr size, modelGuide wires: manufacturer, diameter, modelDevices: balloons – timing (pre versus post stent implantation), diameter x

length, max pressure x duration; other devices – with parameters;stent – manufacturer, brand name, diameter x length, max pressure xduration, bare metal or covered, UDI

Table 3. Continued

Results: gradient pre to gradient post; MLD pre to MLD post; nominal(adjacent) diameter (PA stenosis); isthmus and descending ao @diaphragm diameter (coarct)


Intervention: ValvuloplastySummary Page

Target: aortic valve, mitral valve, pulmonic valve, tricuspid valveDevices: final balloon – diameter � lengthResults: gradient pre to gradient post; MLD pre to MLD post

Details SectionTarget: aortic valve, mitral valve, pulmonic valve, tricuspid valve; annulus diameterIntervention:Guide wires: manufacturer, diameter, modelDevices: balloons – diameter x length, max pressure x duration

Results: peak-peak gradient pre to post; mean gradient pre to post; valvearea by [method] pre to post

Measurement condition, pre: resting / inotrope and doseMeasurement condition, post: resting / inotrope and dose


Intervention: Defect Closure

Summary PageTarget: ASD, PFO, PDA, VSD, fistula, other defect [specify defect]Devices: closure device - brand name, size, UDIResult: successful closure, unsuccessful closure

Details SectionTarget: ASD, PDA, VSD, other defect [specify defect]

ASD characteristics:ASD type:Size by echo (mm):Size by balloon (mm):Anterior rim, posterior rim, inferior rim, superior rim

PFO characteristics:Size by echo (mm):Size by balloon (mm):

PDA characteristics:Size at pulmonic end (mm):Length (mm):

VSD characteristics:VSD location:VSD size (mm):

Aortopulmonary collateral:APC location:

Coronary fistulaFistula location

Other abnormal conduit:Conduit location / description:

Intervention:Guide catheters: manufacturer, Fr size, modelGuide wires: manufacturer, diameter, modelDevices: balloons –manufacturer, brand name, diameter� length; closure

device – manufacturer, brand name, size, UDIResults: successful closure, unsuccessful closure

Intervention: Cardiac Biopsy

Summary PageBiopsy: [location] � [# specimens]

Details SectionBiopsy: right ventricle [or other location]

Guide catheter: manufacturer, Fr size, modelBioptome: manufacturer, modelNumber of specimens removed:Pathology requisition number:

Ao indicates aorta; APC, aortopulmonary collateral; Asc, ascending; ASD, atrial septal defect;

Atm, atmospheres; Desc, descending; Fr, French; LFA, left femoral artery; LPA, left pulmonary artery;

LV, left ventricle; MLD, minimum luminal diameter; PA, pulmonary artery; PCI, percutaneous coro-

nary intervention; PDA, patent ductus arteriosus; PFO, patent foramen ovale; PTA, percutaneous

transluminal angioplasty; PVI, peripheral vascular intervention; RFA, right femoral artery; RPA,

right pulmonary artery; RV, right ventricle; Sec, seconds; STJ, sinotubular junction; TIMI, Throm-

bolysis in Myocardial Infarction; UDI, unique device identifier; and VSD, ventricular septal defect.Continued in the next column


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notes are occasionally needed to further characterize theintervention, a limited free-text section (a few sentences)may be associated with each treatment target. Again, thespecific data to be reported by procedure are covered inmuch greater detail in the sections to follow.

4.3.6. Final Diagnoses

With respect to the interpretation of the results and the finalrecommendations thereof (impressions and recommenda-tions), this set of information is included on the summary(front) page. As described previously, the relatively shortimpressions and recommendations sections on the summarypage are concise free-text descriptions of the findings, com-parison to prior studies (where applicable), impressionsand conclusions, immediate care recommendations, and thelong-term management plan. The original question forwhich the study was performed should be explicitly answered.In the final diagnoses section of the report body, a list

of the ICD-encoded diagnoses reflecting the final inter-pretation of the procedure is included (largely for billingand regulatory purposes). Although discouraged, if a tra-ditional dictated note is created, it is included at the endof the body of the structured report.

4.3.7. Operators, Titles, Regulatory Attestation

The e-signature process embeds the date and time ofthe finalization of the procedure report and identifiesthe signatory. If any portion of the procedure is performedby a trainee, an attestation clause is added stating thatthe supervising physician operator was present for theentire procedure or key parts of the procedure. Finally,amendments to a finalized report must include the dateand time of the change, along with the identification ofthe individual making the change, per the processes andpolicies of the healthcare organization.

4.4. Procedure-Specific Content

As listed in Table 1, the structured cardiac catheterizationreport uses a modular approach, with the report consistingof content created via the same workflow processesregardless of the type of catheterization procedure. Theonly portion where data content varies substantially fromprocedure to procedure on the front summary page is theinformation in the procedure details section, where sum-mary data specific to the actual procedures performed isincluded. Similarly, the report body (details) section of thereport recapitulates this modular approach. Specifically, the2 portions entitled: 1) diagnostic findings; and 2) inter-vention will necessarily have data content in subsectionsof each portion specific to the procedures performed,whereas the remaining sections will have a high degree ofoverlap because they are derived from the same workflowprocesses across all procedure types. The following textdescribes the variable, procedure-specific portions by typeof procedure.

4.4.1. Cardiac Catheterization(Right, Left, Coronary Intervention)

The hemodynamic data acquired during right heartcardiac catheterization provides an assessment of cardiacperformance along with the physiological impact of anumber of cardiac structural abnormalities. Data importedfrom a hemodynamic monitoring system must be easilyedited and corrected in the reporting system. Critically,despite advances in the computerized algorithms forautomated detection and measurement of hemodynamics,all data obtained during a right heart catheterization shouldnot just be accepted as an import or pass-through from thehemodynamic recording system but must be reviewed,verified, and corrected by the physician operator. Sub-stantive discrepancies between what is automaticallydetermined by the hemodynamic recording system andmore relevant measurements identified manually by thephysician operator can be present and result in major errorsof interpretation or incomplete conclusions.

An extensive set of data can be acquired during aright heart catheterization, particularly if a shunt run isperformed, an assessment of a therapeutic intervention isconducted (e.g., nitric oxide challenge, exercise, volumechallenge, intra-aortic balloon pump placement), or astructural defect is present. Right heart catheterizationresults to be reported on the summary page should reflectthe key findings, focusing on mean filling pressures,pulmonary pressures and resistance, cardiac performance(cardiac output and index), responses to intervention(if conducted), and summary calculations (e.g., valve areaor shunt magnitude). On the other hand, the completeset of data, such as the fraction of inspired oxygen (FiO2),end-expiration phasic pressures, oxygen content and satu-rations measurements, dose of nitric oxide administered,and formal calculations are to be reported in the reportbody section. In the evaluation of restrictive cardiomyop-athy, constriction, and valvular abnormalities, the quali-tative and quantitative assessment and comparison ofmultiple simultaneous waveforms is to be reported, in-cluding pertinent negatives. On the summary page, thefindings are to be reported in the interpretation section,with representative tracings included in the second(graphics and images) section that support the qualitativeinterpretation of the waveforms.

Although the formal term “left heart” catheterizationimplies placement of a catheter in the left ventricle, the moregeneric concept of left heart catheterization includes coro-nary angiography, left ventriculography, and transvalvularhemodynamics for the assessment of valvular abnormalities.The summary page is to convey a sufficient amount of in-formation for the clinician to understand the anatomyvisualized during left heart catheterization. This includes anotation regarding the number of diseased vessels, coronarydominance, coronary anomalies, and summary findingsrelated to bypass graft anatomy. Optionally, a listing of the


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hemodynamically significant lesions organized by coronary(or graft) segment location can be listed on the summarypage. If left heart catheterization is performed, left ven-tricular end-diastolic pressure (LVEDP) and mean aorticvalve gradient (if a gradient is present) should be reported onthe summary page. If left ventriculography is performed, theejection fraction and mitral regurgitation grade should alsobe reported on the summary page.The complete details of left heart catheterization are

to be reported in the third (report body) section, includinga description of the coronary anatomy and branches,dominance, anomalies, a listing of all coronary lesions withcorresponding anatomic location, and additional qualita-tive terms that further describe the extent and type ofdisease. Of note, the reporting of coronary disease is byexceptiondreporting of “0% stenosis,” “no disease,” orother similar approaches denoting the absence of diseaseis of no real utility and increases clutter. The simultaneoushemodynamic measurements of the aorta and left ventricleare reported, including peak-peak and mean differencesbetween pressure measurements. For left ventriculography,in addition to the ejection fraction, regional wall motion isdescribed as normal, hyperkinetic, hypokinetic, akinetic, ordyskinetic by specific wall segment. Quantitative regur-gitant volume or percent by volumetric analysis of the leftventriculogram versus forward cardiac output is included(and labeled as such) if performed. Other observations suchas calcification and other findings are reported in sufficientdetail to meaningfully contribute to the overall interpre-tation of the study.Key data reported regarding PCI include identification

and description of the lesion(s), equipment used, equip-ment parameters (e.g., balloon type and nominal balloondiameter, stent type, nominal stent diameter and length,maximum inflation pressures), technical details if excep-tional (e.g., retrograde crossing of a chronic total occlusion)along with the angiographic results (32). On the summarypage, this information is concatenated into a single lineof text, listing the lesion, stent information, notation ofthe type of intervention if stent implantation is not per-formed, and the pre and post results. In the report bodysection, parameters associated with each device are recor-ded. If an invasive evaluation is performed of an interme-diate lesion, the details of the findings are reported. Inthe case of fractional flow reserve, the specific value shouldbe reported along with the coronary segment(s) interro-gated. Similar results from intravascular ultrasound,including intraluminal diameter (33), extent of calcifica-tion, evidence of prior stent placement, and presence orabsence of dissection or thrombus, are listed. The currentrole for optical coherence tomography is unclear, but ifperformed, pertinent findings should be described in detail.

4.4.2. Peripheral Vascular Catheterization

The performance of peripheral vascular catheterizationoften requires different techniques, tools, and implantable

devices from those required for cardiac catheterization.The scope of this HPS covers peripheral vascular pro-cedures for atherosclerotic occlusive disease. Thus, renal,aorto-iliac, femoro-popliteal, and tibial catheterizationand intervention are included. Endovascular aneurysmrepair of the thoracic aorta, endovascular aneurysm repairof the abdominal aorta, and all venous procedures (inferiorvena cava filters, thrombolysis for deep vein thrombosis,venous intervention, etc.) are purposefully not modeledvia this initiative, although extensions to include theseprocedure types may be added in the future.

The history, physical, and vascular anatomic descriptionsfor peripheral vascular disease reporting are target-lesionspecific; use of the anatomic lexicon published by theAmerican College of Cardiology Foundation/AmericanHeart Association Task Force on Clinical Data Standards(Writing Committee to Develop Clinical Data Standardsfor Peripheral Atherosclerotic Vascular Disease) (34)or the TransAtlantic Inter-Society Consensus is recom-mended (35,36). Vascular access for peripheral catheter-ization is much more varied than for cardiac catheterizationand can include femoral retrograde, femoral antegrade,brachial, axillary, radial, popliteal, and other accesssites. As with cardiac catheterization, the summarypage is to convey summary information sufficient forthe clinician to understand the approach used andthe anatomy visualized. For lower extremity disease,analogous to coronary disease, this includes notationregarding the “number” of diseased vessels per leg,using aorto-iliac, femoro-popliteal, and tibial-cruralgroupings as equivalents to the coronary concept ofa “vessel,” along with summary findings of bypass graftanatomy. This section can optionally include a listingof hemodynamically significant lesions. A summary ofinterventions and results is included, patterned afterthe approach used for the reporting of coronaryinterventions.

In the report body, the anatomy visualized is matchedwith the specific diagnostic catheter type and shape. Thefindings of arteriography are reported via a formatted table,inclusive of lesion segment location, maximum percentstenosis, and qualitative descriptors of the disease whereappropriate. If abnormal, the condition of previouslydeployed devices (e.g., migrated, fractured, stenosed) isdescribed. The details of endovascular intervention in-cluding the technique for crossing a lesion (true lumenversus subintimal or 0.035” versus 0.014” wire, recanali-zation adjuncts), and the sequence, types, and parametersof endoluminal treatment (e.g., balloon size, length, dila-tion pressures) are listed. Alternative endoluminal treat-ments are noted (e.g., plaque debulking, atherectomy,cryoplasty, scoring balloon thrombolysis). When a stent isdeployed, the stent type (e.g., balloon-expandable versusself-expanding) and size parameters are listed in conjunc-tion with the target lesion and the final residual percentstenosis.


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4.4.3. Cerebrovascular Catheterization

Catheterization of the cerebrovasculature includes theaortic arch, brachiocephalic branches, carotid, and verte-bral artery territories. The scope of this HPS covers cere-brovascular procedures for atherosclerotic occlusive andother types of obstructive disease, and specifically excludesintracranial disease, including aneurysms. Imaging andintervention of intracranial arteriovenous aneurysm, fistula,and venous anatomy are not modeled in this initiative,although extensions to include these procedure types maybe added in the future.Given the variability of anatomy of the vessels of the

aortic arch, the actual arch and great vessel anatomy aredocumented on the front page summary as are the specializedcatheters required to study the cerebrovasculature. Similarto the cardiac and peripheral vascular catheterization usecases above, description of cerebrovascular interventionshould be displayed as a single concatenated line of text,listing the lesion, stent data, notation of the type ofintervention if stent implantation is not performed, and thepre and post results.Full details of the cerebrovascular catheterization pro-

cedure are to be included in the report body. In additionto documentation of vascular diseasedfor extracranial andintracranial imagingdthe carotid system, cerebral system,Circle of Willis and cross-filling of hemispheric bloodflow are described. For carotid stenting, the time intervalbetween the deployment of an embolic protection devicein the internal carotid artery and the carotid interventionis noted in addition to the standard documentationregarding the equipment used, devices deployed, and theparameters thereof.

4.4.4. Valvular Heart Disease:Transcatheter Aortic Valve Replacement

TAVR for the treatment of severe symptomatic aorticstenosis has been shown to be a viable therapy for patientsdeemed at high or extreme risk for conventional surgicalaortic valve replacement (AVR) (37,38). As a result of thecomplexity of these patients and their significant medicalcomorbidities, the concept of the multidisciplinary heartteam (MHT) has been accepted and embraced by therespective professional societies (39). Furthermore, thecomplexity of the cases and the requirement of theexpertise of the multiple specialties have resulted in thegeneral acceptance that these procedures should be per-formed in a hybrid operating room/catheterization labo-ratory setting, with full and engaged participation of theentire MHT. Therefore, the structured procedure reportmust reflect this genuine multispecialty collaborationamong the subspecialties.On the Front Page Summary, vascular access informa-

tion, anesthesia, circulatory support, and a summary of theTAVR procedure and results (concatenated preprocedurestenosis severity, device implanted, and final result) are

listed. However, most of the actual data of a TAVRprocedure are reported in the report body (Table 3).This begins with a listing of all of the physicians andhealthcare providers contributing to the performance ofthe TAVR procedure, including anesthesiologists, neu-rologists, sonographers, and other imaging specialists,nurses, and technologists. As recently mandated by thecoverage decision of the U.S. Centers for Medicare andMedicaid Services, at least 1 surgeon and 1 interventionalcardiologist must be present for the procedure. These in-dividuals (and their respective specialties) are identified asthe operators of the procedure.

Data in the report history to substantiate the decision ofthe MHT to perform TAVR instead of surgical AVR arelisted as discrete data elements. The rationale for TAVR,however, is documented for each patient via the free-texthistory on the front page summary.

From a procedural standpoint, routes of vascular access(i.e., transfemoral, transapical, transaortic, or subclavian),as well as the method of access (i.e., percutaneous, surgicalcutdown, or vascular conduit), for TAVR are documentedin the respective sections of both the summary page andprocedure details section. For percutaneous access, thetype and number of closure devices used are also listed.For surgical cutdown, the location of the incision is listed.

If right heart catheterization is performed, the data arereported as described in the right heart catheterizationsection above. Specifics related to positioning and rapidventricular pacing are captured as data. At the completionof deployment, the final TAVR positioning, function ofthe prosthesis, and evidence of paravalvular leak areessential data of the report.

Complication management and bailout maneuverersare often required in TAVR procedures. If cardiopulmo-nary bypass is required for hemodynamic support, durationof bypass time, as well as technique, route, and size ofcannulation, are recorded. Open conversion to sternotomyand conventional AVR or surgical repair of complications,such as aortic dissection or access vessel complications,should be included and details provided clearly. If a secondTAVR is needed due to malpositioning or paravalvularleak, the valve-in-valve procedure is described in the de-tails. The method and success of hemostasis are alsodocumented, including details regarding surgical repair,if needed.

4.4.5. Congenital and Structural Heart Catheterization

Few fields cover as much variety in every aspect of anat-omy, history, presentation, physical exam, physiology,diagnostic and interventional approaches, proceduraltechnique, and follow-up events as CHD. Nonetheless,these procedures share sufficient commonalities with theother procedures described above to utilize the structuredreporting construct of this HPS. Compared with adultcardiac catheterization, however, the clinical drivers of


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invasive assessment and intervention in this populationemanate from first principles quite different from thoseapplicable to adult acquired heart disease, and there isa paucity of quality outcomes analyses related to theseprocedures. Substantial work has been completed indeveloping pediatric nomenclatures, particularly the In-ternational Paediatric and Congenital Cardiac Code vo-cabulary (40,41); these are to be used as the foundationof CHD structured catheterization procedure reports. Useof consistent terminology across the myriad of proceduresperformed to evaluate and treat CHD will in turn helpadvance understanding of the principles and practice ofcardiac catheterization in this arena.Although the specifics are much more varied than

the other types of cardiovascular catheterization describedabove, the organization of the structured report and sec-tions are more similar than different. The clinical questionresulting in referral for catheterization is captured, alongwith a brief (prose) history, sufficiently broad to convey thecontext of the referral. This complements details of thehistory captured as data specific to the disease state andprocedure being performed. Details of sedation, medica-tion administration, anesthesia, and vascular support arecaptured in the corresponding sections of the structuredprocedure report. Short- and long-term clinical plans asmodified by the outcome of the procedure are includedin the impressions and recommendations sections.Compared with adult cardiovascular disease, there are

a greater number of modules (and much more overlap ofthose modules) in the congenital space. The diagnosticprocedures include standard right and left heart cardiaccatheterization as well as angiography of other vascularstructures (Table 2). On the summary page, pertinentsummary findings are to be listed, whereas a more com-plete tabular listing in the report body (details) sectionreflects the combination of anatomy, findings, and tech-nical approach. This includes documentation of the con-ditions under which hemodynamics are obtained (with therecording of hemodynamics, such as the pressures andoximetry from cardiac chambers and vascular passages),together with unique aspects of hemodynamics.For reporting congenital intervention, a series of tem-

plates is needed, given that intervention is used to openstenoses, close defects, and variations thereof (Table 3).Specific documentation regarding devices used, theanatomic and physiological targets of the intervention,technical success, and physiological measurements (preand post) is included. In addition, specific and customizablediagrams that reflect unique physiologies, anatomic variants,structural abnormalities, and the interventions thereofare crucial to the graphics/images section of the report.The principles described above (and throughout thisHPS)

similarly apply to reporting on structural heart disease andother catheterization procedures. These procedures include(but are not limited to) percutaneous valve implantation(in addition to TAVR), balloon valvuloplasty, percutaneous

repair of mitral valve regurgitation, atrial appendage occlu-sion, and alcohol ablation of the septum in hypertrophicobstructive cardiomyopathy. We believe the examples des-cribed above and modeled in the prototypes (Tables 2 and 3)provide a template sufficient to create structured reportsconsistent with this HPS and have, therefore, not furtherrepresented these procedures in the report prototype tables.

4.4.6. Combination Procedures

The performance of multiple procedures in a single casesetting occurs frequently in the catheterization laboratory.From a structured reporting perspective, the modularapproach to organizing the collection and reporting of datain segments corresponding to the procedures performedallows for straightforward construction of a final, single,organized, and cogent procedure report. This “stacking” ofreport modules should logically follow the temporalsequence of the events that occurred in the catheterizationvisit. Note that this is not to facilitate “drive-by” pro-cedures; just being in the lab for one procedure is not anindication for a second. Instead, this modular approach isto facilitate the complete reporting of all that transpiredduring a catheterization visit. Indeed, indications for allprocedures performed need to be present in the finalprocedure report. Complex procedures also raise issuesincluding radiation exposure and radiographic contrastmedia volume that must be carefully managed by thephysician operator(s).

One comprehensive report should be generated for theentire case so as to avoid confusion that could arise ifmultiple individual procedure reports are generated from asingle patient visit to the catheterization suite. Reporting ofthese procedures must follow the standards set for the in-dividual procedures being performed as described inthe previous sections. The front page should clearly reflectthe performance of each separate procedure within thetotal case. Demographics, history, and indications thatsupport each procedure are required. Impressions and rec-ommendations should reflect the entire set of proceduresperformed.

4.5. Structured Report Style Guide

The capture of structured data via structured reportingprocesses serves little utility if that same data cannot bepresented in a format easily understood by human readers.Optimally, structured data are coupled with standardizedtemplates to produce structured reports that require theleast amount of cognitive processing to comprehend andassimilate. To accomplish this goal, this HPS calls for acertain degree of cross-vendor conformity with respect tothe appearance and organization of catheterization proce-dure reports. Within this general framework, specifics offormatting (e.g., conventions for indentation, alignmentand justification, even font size) further reduce the cogni-tive burden, particularly when reading reports created bydiffering software solutions. To this end, a style guide has


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been created that articulates formatting recommendationsfor the final structured procedure report. See the separateCath Report Style Guide attachment.

The style guide builds on the content recommendationsof the previous sections to detail the specifications forpresentation of that content. The style recommendationsfocus on the consistency needed to improve the readabilityand usability of the (printed) physician-authored, finalstructured procedure report. A degree of consistencyand reproducibility reduces the effort required to findspecific pieces of information. A specific emphasis is thepresentation of data in a tabular (table-based) formattedlayout. This includes right justification to align labels andleft justification to align data where feasible. For example,the layout of the pressure readings of a right heart cathe-terization might appear in text as the following:Right Heart Catheterization

RA: a¼6 v¼4 mean¼3 (If a wave is absent in atrialfibrillation, suggest N/A or �)

RV: 30/7, EDP 11PA: 30/13, mean¼18PCW: a¼14 v¼12 mean¼10DAVO2: 4.3 vol%CO: 4.4 L/minCI: 2.5 L/min/m2

The overall construct is to present information in a label:finding format. Inconsistent with structured reporting ispresenting data as prose, whether the prose is created viadictation or a computerized conversion of data into aphrase. The sentence “The results of the right heartcatheterization are as follows: RA a¼6, v¼4, and mean¼3;RV 30/7, EDP 11; PA 30/13, mean¼18; and PCW a¼14,v¼12, mean¼10, AV O2 difference of 4.3 volume percent,cardiac output of 4.4 L/min, and cardiac index of 2.5 L/min per m2

” includes all the data; however, none of theprosaic elements (including the words added to create thesentence and the structure of the sentence itself) addanything to the meaning of the data. In fact, the prosesubstantially reduces the efficiency of comprehending andretaining the data as information.As noted previously, report layout is purposefully

modular. Certain sections are universal regardless of theprocedure being performed. For example, a brief (prose)history, a tabular listing of the procedures performed, andthe impressions and plans (prose) section appearing onthe front page summary are universal to all procedures,as is the medications log in the report body. Dependingon the actual procedures performed, the other sections ofthe reportdhistory and physical data relevant to the pro-cedure and the underlying disease state, procedural details,findings, interpretation, and recommendationsdfollowin the same general order regardless of the procedure.What varies is the content within each modularsection, with the content specific to the procedureactually performed. Institutional preference for the use of

a vendor-based or a “home-grown” standardized report-ing system should be viewed in the context of the re-quirements of this HPS and compatibility with nationalregistries and other reporting mechanisms. Finally, thechoice of design and layout should also consider thedistribution and forwarding of the report to the patient,referring physician, and primary care physician as anexpected standard practice.

4.6. Data Export

A key objective of the capture of structured data is theinterchange of the same data among information systems.To convert structured data into a printed format suitablefor interpretation, the typical solution is to use a reportwriter application that converts the data stored in adatabase into a formatted layout that is pleasing to thehuman eye and understandable to the human mind.Similarly, to accomplish interoperability among informa-tion systems, the data in a database must be first con-verted into a file format suitable for data transfer, withlabeling and organization of the data content following aspecific set of rules so that the receiving system can in-terpret the file and convert the content back into con-sumable data.

The general specification endorsed by this HPS for thispurpose is the HL7 Consolidated Clinical DocumentArchitecture (C-CDA) standard, which is the standardfor the electronic transfer of clinical information perthe standards and certification for Stage 2 MeaningfulUse of EHR (7). This specification has been furtherdeveloped into a Cath Report Content (CRC) profile bythe organization IHE and successfully balloted by HL7,inclusive of the specifications and discrete data elementsfor the CDA-format report for a PCI procedure (42).Although a detailed discussion of the specifics of theC-CDA standard and the supporting IHE CRC profile iswell beyond the scope of this HPS, a requirement ofconformance with this HPS is the ability of the system toexport and import C-CDA documents specific to thecardiovascular catheterization procedures covered herein.Finally, it is anticipated that as the C-CDA becomes theelectronic standard for the interoperable exchange of in-formation, this format will become the standard for thetransmission of data to registries such as the ACCNCDR CathPCI registry.

4.7. Paradigm Expansion

This ACC/AHA/SCAI HPS summarizes the rationale,principles, processes, and components of structured re-porting in cardiac catheterization laboratories. The result-ing structured procedure reports will be clear, concise, andpractical. Compared with dictated reports, they will bereadily interoperable among clinical information systems.We believe this basic paradigm to be easily extensible toother areas of cardiology, such as electrophysiology, and

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ultimately scalable to all procedure types, particularly thoseperformed under semisterile conditions without routinegeneral anesthesia. Of note, the workflows and data flowsof the operating room environment are substantiallydifferent from the “laboratories” where cardiac catheteri-zation and other semisterile procedures are typically per-formed, and thus the framework presented here will likelyhave less applicability to open surgical procedures. Asmedicine moves into the era of EHRs, standardizedstructured reporting will ensure completeness of the cap-ture of the data elements representing the key componentsof these procedures and operations.

Table 4. Vendor Responsibilities

� Usability: interfaces designed and built for maximum efficiency (humanfactors design)

� Input devices: specific to use case (e.g., workstations, tablets, interfaces withhemodynamic and administrative systems)

� Input handling: use of controlled vocabulary with specific permissible values,range checking, consistency checking, other types of data validation on input

� Database: based on a patient-centric (not procedure-centric) data model, useof a controlled vocabulary

� Outputs: structured report per specifications of this HPS including healthinformation exchanges for a full report and reporting to registries such as theNCDR for subset data.

� Interoperability: adherence to the IHE CRC profile (42), which specifies cath-eterization report content; the IHE CATH profile (43), which specifies the basicpatient data flow of catheterization procedures; and ACC/AHA Task Forceon Data Standards key data elements for cardiac imaging documents (44)

� Partnership with professional societies in developing the structured reportingenvironment

� Dissemination of best practices in structured reporting to the usercommunity

� Report exchange: seamless movement of procedure reports between pro-cedure reporting systems and EHR systems

� Graphics: software solution for the graphical depiction of anatomic findingsand treatment results

ACC indicates American College of Cardiology; AHA, American Heart Association; CATH,

cardiac catheterization workflow; CRC, catheterization report content; EHR, electronic health

record; HPS, Health Policy Statement; IHE, Integrating the Healthcare Enterprise; and NCDR,

National Cardiovascular Data Registry.

5. Adoption and Implementation

Universal adoption of structured reporting processes forinvasive cardiovascular catheterization requires both ac-knowledgement of benefits and acceptance of responsibilitiesby key groups. In order to stimulate the implementation ofstructured reporting, it is critical to articulate these aspectsas they directly affect physician operators, catheterizationlaboratory management and personnel, and the softwarevendor community.For physician operators, the key benefit is that structured

reporting is inherently more thorough, complete, and ac-curate than other approaches, particularly dictation. Boththe quality and quantity of the information are enhanced,reducing potential compliance, regulatory, and legal lia-bilities. A complete set of data is captured that conveys theinformation needed to optimize care of the patient.Nonetheless, 3 concerns are typically expressed by physi-cians transitioning from dictation to structured reporting:1) the time required to directly input data into a computercompared with dictation; 2) the additional learning andcognitive effort required to use computerized solutions;and 3) the difficulty of capturing complexity as data.Although dictation is admittedly time efficient, the actualamount of time required to enter data into a well-engineered, high-usability system can be approximatelythe same or less than that required to dictate, review,correct, and sign a dictated report. Furthermore, creationof a final procedure report within minutes of completingthe procedure eliminates the need for a preliminaryhandwritten or hand-typed report (and the time requiredthereof). The communication of standardized findings andtechnical details to referring clinicians via the EHR will befaster, more efficient, and more accurate. The systematiccollection of standardized procedural data elements pro-vides high-quality data for process and performanceimprovement, comparative effectiveness and other types ofclinical research, and drug and device surveillance. It canalso be used to populate state and national registries,inform health services research, and generate the founda-tion for feedback-based lifelong learning and maintenanceof certification opportunities.

For catheterization laboratory staff, a period of transitionand adaptation to new structured reporting processes willbe followed by greater coordination of activities with lessredundancy and repetition, thus allowing the staff to focusmore attention and energy on the delivery of care. Giventhe degree of coordination required to optimize a struc-tured reporting environment, education and training ofstaff is critical in accomplishing a smooth transition;therefore, a budget for training programs must be antici-pated prospectively. Unquestionably, structured datacollection offers the potential to achieve operational effi-ciencies and inventory management gains as well as opti-mized catheterization laboratory workflows. By usingwell-defined data standards, operational insights can beshared among institutions and across systems to developand refine best practice workflows. Additionally, ongoingmonitoring of performance measure data will foster anenvironment based on individual accountability and iden-tify areas for potential improvement.

The success of structured reporting is highly dependentupon the software vendor community. While the mostobvious and visible product of a structured reportingapproach is the structured report itself, this is only 1 aspectof the totality of requirements and responsibilities of ven-dors (Table 4). The structured reporting system mustrecognize the sources of information, data to be captured,the actors (personnel handling the data), and data output ateach step of the process of a catheterization procedure,starting with the scheduling of the patient through thegeneration of the final procedure report (see the separate


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Cath Report Sample attachment). In other words, thefocus should be on the tasks and the way the tasks areaccomplished, with the technology solutions designed tosupport the task flow. In this model, the input devices (e.g.,tablets and workstations) are optimized to the data man-agement requirements of each step. The data model of thedatabase must be both robust and flexible, not only tocapture data associated with a specific episode of care, butalso to span multiple episodes. The human interfaces usedto capture the data must be maximally efficient andeffective, built using principles of human factors and er-gonomics. A key metric of successdperhaps singularly themost powerful criterion of alldis the capability to generatethe final procedure report within a few minutes of thecompletion of the catheterization procedure. Anything lesswill mean that the potential of structured reporting has notbeen realized. Furthermore, it is anticipated that the vendorcommunity will have a key role in teaching best-practicestructured reporting processes to healthcare enterprises.

As the expertise that must be brought together to createan integrated structured reporting environment is spreadacross multiple disciplines, partnership between the pro-fessional societies and the vendor community is required toidentify best practices, specify requirements, evaluate so-lutions, iteratively improve systems, and promulgatestructured reporting processes. To this end, the ACC/AHA/SCAI anticipates that the development anddeployment of structured reporting in the catheterizationsuite will be an ongoing process for some period of time.The expectation is that the physiological monitoring,procedure reporting, and EHR vendor communities willrespond quickly to create linkages between the wealth ofinformation entered into the physiological recorder and theformat requirements specified herein. Accomplishing thedesired state defined in this HPS requires the careful co-ordination of all of these groups. Given the complexities,implementation of the recommendations of this HPS mayneed to occur in stages. An absolute requirement is theprocedure documentation and reporting system, along withinterfaces for the exchange of data (e.g., orders and resultsmessages). Changes to workflows and responsibilities arenot trivial and demand careful orchestration. Planning(including budgeting) to achieve a structured reportingenvironment must therefore be coordinated among thesegroups, including catheterization laboratory and cardio-vascular service line administrations and enterprise infor-mation systems management.

Ultimately, it is our patients who have the most togain. Understanding the risks, benefits, and alternativesof any medical intervention requires a foundation ofevidence-based knowledge. To easily convey this know-ledge to patients, the data must be available, reliable, andrelevant. The widespread implementation and adoptionof structured reporting will build this indispensablefoundation.

6. Extending theStructured Reporting Use Case

Professional societies active in the cardiovascular field havecritical roles in defining and establishing the guidelinesand performance metrics for cardiovascular procedures.Comprising voluntary representatives, societies have theresponsibility for determining standards, norms, and ex-pectations of professionalism of their members. No one isbetter positioned to understand the issues involved. Asdevelopers and shapers of clinical guidelines, performancemeasures, AUC, and educational and training programsthat produce the specialists trained in these procedures,professional societies must lead the efforts to establishstandards in reporting.

As described in this document, 1 critically importanttask in this effort is establishing a controlled vocabulary orterminology of relevant data elements for catheterizationprocedures. The individual terms selected for inclusion inthis controlled vocabulary must be clinically appropriateand relevant to the patient and the procedure, and haveprecise and mutually agreed upon definitions so that theelements have unambiguous shared meanings (i.e., se-mantic interoperability). Closely aligned with data elementspecification is determination of the data structures thatcombine individual elements into meaningful statements.It is the combination of a controlled vocabulary and a datastructure that provides semantic interoperability. Althoughthese concepts may seem obtuse to clinicians, they arecrucially important for ensuring that data can be trans-mitted, received, and used as real information.

In order to obtain compatibility with EHRs and operateacross computer networks, the standardized data elementsand structures must meet technical language standards fordata interchange. The primary technical standard forprocedure report data structures is the HL7 CDA, withterminology encoded using recognized vocabulary stan-dards such as the SNOMED/CT, the ICD-9 and ICD-10,the Logical Observation Identifiers Names and Codes forlaboratory values, and RxNorm for drugs and pharmacysystems. However, these lexicons are relatively incompletefor representing the depth and breadth of cardiovascularprocedure terminology, so stewardship of the controlledvocabulary of standardized data elements is required of thecardiovascular professional societies. As the primary per-formers, interpreters, and users of the procedures, thesesocieties must maintain close supervision of the specializedvocabulary. Other data element terminology coding sys-tems will have to be mapped and cross-referenced with theprofessional society system in order to ensure appropriatecorrespondences and eliminate confusion. This necessarilyentails collaboration to help establish and maintain theformal technical features required of a controlled vocabu-lary compatible with EHRs and operating on multiplecomputer networks in the healthcare environment. An

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example of this is the International Society for Pediatricand Congenital Heart Disease. Founded in 2000, the In-ternational Society for Pediatric and Congenital HeartDisease is a multinational andmultisocietal group composedof cardiologists, cardiac surgeons, cardiac pathologists, andmorphologists. Since the group was founded, it has beentasked with developing a common and harmonized hierar-chical coding structure of terms and definitions identified asthe International Pediatric and Congenital Cardiac Code(IPCCC) (40,41). The IPCCC has been endorsed oradopted by a number of pediatric specialty societies inEurope and the United States. The challenge and also theopportunity are that constant interaction among all thegroups, with constant review and periodic revision, will benecessary.In the past, catheterization laboratory accreditation

standards did not mandate structured reporting. However,this is changing. In the recently published 2012 ExpertConsensus Document on Cardiac Catheterization Labo-ratory Standards, the recommendation is made that astructured report using standardized data should be final-ized in a timely fashion following procedure completion(6). The ACC- and SCAI-endorsed Accreditation forCardiovascular Excellence program (www.cvexcel.org)specifies the generation of structured reports as a criterionfor accreditation, similar to criteria established by therespective Intersocietal Commissions in echocardiography,nuclear cardiology, and cardiac magnetic resonance imag-ing (www.intersocietal.org). In short, structured reportingmust be considered 1 component of the overall qualityimprovement imperative for cardiovascular care.

ACC President and Staff

John Gordon Harold, MD, MACC, PresidentShalom Jacobovitz, Chief Executive OfficerWilliam J. Oetgen, MD, MBA, FACC, Executive Vice

President, Science, Education, and QualityCharlene L. May, Senior Director, Science and Clinical

PolicyDawn R. Phoubandith, MSW, Director, ACC Clinical

DocumentsTanja Kharlamova, Associate Director, Clinical Policy and

DocumentsTiffany M. Jones, MA, Specialist, Clinical Policy and

DocumentsAnneMarie Boeve, Specialist, Clinical Policy and

DocumentsAmelia Scholtz, PhD, Publications Manager, Clinical

Policy and Pathways

Acknowledgment

We wish to acknowledge Frances L. Kosik, RN, MSN,MPH, for her foundational contributions to the develop-ment of this health policy statement.

REFERENCES

1. Nallamothu B, Tommaso C, Anderson H. ACC/AHA/SCAI/AMA–Convened PCPI/NCQA 2013 performance measures foradults undergoing percutaneous coronary intervention: a report of theAmerican College of Cardiology/American Heart Association TaskForce on Performance Measures, the Society for CardiovascularAngiography and Interventions, the American Medical Association–Convened Physician Consortium for Performance Improvement, andthe National Committee for Quality Assurance. J Am Coll Cardiol2014;63:722–45.

2. Clunie D. DICOM Structured Reporting. PixelMed Publishing;2000.

3. Bidgood WD Jr. Clinical importance of the DICOM structuredreporting standard. Int J Card Imaging 1998;14:307–15.

4. Douglas P, Iskandrian AE, Krumholz HM, et al. Achieving qualityin cardiovascular imaging: proceedings from the American Collegeof Cardiology–Duke University Medical Center Think Tank onQuality in Cardiovascular Imaging. J Am Coll Cardiol 2006;48:2141–51.

5. Douglas PS, Hendel RC, Cummings JE, et al. ACCF/ACR/AHA/ASE/ASNC/HRS/NASCI/RSNA/SAIP/SCAI/SCCT/SCMR 2008health policy statement on structured reporting in cardiovascularimaging. J Am Coll Cardiol 2009;53:76–90.

6. Bashore TM, Balter S, Barac A, et al. 2012 American College ofCardiology Foundation/Society for Cardiovascular Angiography andInterventions expert consensus document on cardiac catheterizationlaboratory standards update. A report of the American College ofCardiology Foundation Task Force on Expert Consensus Docu-ments. J Am Coll Cardiol 2012;59:2221–305.

7. U.S. Health and Human Services Office of the National Coordinatorfor Health IT. Standards & Interoperability Framework: CompanionGuide to HL7 Consolidated CDA for Meaningful Use Stage 2.Available at: http://wiki.siframework.org/file/view/Companion_Guide_Draftþ3þforþConsensus_10012012.pdf. Accessed February28, 2014.

8. Integrating the Healthcare Enterprise. Cardiac Cath Workflow. Avail-able at: http://wiki.ihe.net/index.php?title¼Cardiac_Cath_Workflow.Accessed May 6, 2013.

9. Patel MR, Dehmer GJ, Hirshfeld JW, et al. ACCF/SCAI/STS/AATS/AHA/ASNC 2009 appropriateness criteria for coronaryrevascularization: a report by the American College of CardiologyFoundation Appropriateness Criteria Task Force, Society for Car-diovascular Angiography and Interventions, Society of ThoracicSurgeons, American Association for Thoracic Surgery, AmericanHeart Association, and the American Society of Nuclear Cardiology.J Am Coll Cardiol 2009;53:530–53.

10. Patel MR, Dehmer GJ, Hirshfeld JW, et al. ACCF/SCAI/STS/AATS/AHA/ASNC/HFSA/SCCT 2012 appropriate use criteria forcoronary revascularization focused update: a report of the AmericanCollege of Cardiology Foundation Appropriate Use Criteria TaskForce, Society for Cardiovascular Angiography and Interventions,Society of Thoracic Surgeons, American Association for ThoracicSurgery, American Heart Association, American Society of NuclearCardiology, and the Society of Cardiovascular Computed Tomog-raphy. J Am Coll Cardiol 2012;59:857–81.

11. Patel MR, Bailey SR, Bonow RO, et al. ACCF/SCAI/AATS/AHA/ASE/ASNC/HFSA/HRS/SCCM/SCCT/SCMR/STS 2012 app-ropriate use criteria for diagnostic catheterization: a report of theAmerican College of Cardiology Foundation Appropriate UseCriteria Task Force, Society for Cardiovascular Angiography andInterventions, American Association for Thoracic Surgery, AmericanHeart Association, American Society of Echocardiography, AmericanSociety of Nuclear Cardiology, Heart Failure Society of America,Heart Rhythm Society, Society of Critical Care Medicine, Society ofCardiovascular Computed Tomography, Society for CardiovascularMagnetic Resonance, and Society of Thoracic Surgeons. J Am CollCardiol 2012;59:1995–2027.

12. Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention: a report ofthe American College of Cardiology Foundation/American HeartAssociation Task Force on Practice Guidelines and the Society forCardiovascular Angiography and Interventions. J Am Coll Cardiol2011;58:e44–122.

http://www.cvexcel.org/

http://www.intersocietal.org/

http://refhub.elsevier.com/S0735-1097(14)01729-X/sref1




























http://wiki.siframework.org/file/view/Companion_Guide_Draft+3+for+Consensus_10012012.pdf





http://wiki.ihe.net/index.php?title=Cardiac_Cath_Workflow

http://wiki.ihe.net/index.php?title=Cardiac_Cath_Workflow





































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13. Brott TG, Halperin JL, Abbara S, et al. 2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranialcarotid and vertebral artery disease: executive summary: a reportof the American College of Cardiology Foundation/AmericanHeart Association Task Force on Practice Guidelines, and theAmerican Stroke Association, American Association of Neuro-science Nurses, American Association of Neurological Surgeons,American College of Radiology, American Society of Neurora-diology, Congress of Neurological Surgeons, Society of Athero-sclerosis Imaging and Prevention, Society for CardiovascularAngiography and Interventions, Society of Interventional Radi-ology, Society of NeuroInterventional Surgery, Society forVascular Medicine, and Society for Vascular Surgery. J Am CollCardiol 2011;57:1002–44.

14. Rooke TW, Hirsch AT, Misra S, et al. 2011 ACCF/AHA focusedupdate of the guideline for the management of patients with peripheralartery disease (updating the 2005 guideline): a report of the AmericanCollege of Cardiology Foundation/American Heart Association TaskForce on Practice Guidelines. J Vasc Surg 2011;54:e32–58.

15. Bonow RO, Douglas PS, Buxton AE, et al. ACCF/AHA method-ology for the development of quality measures for cardiovasculartechnology: a report of the American College of Cardiology Foun-dation/American Heart Association Task Force on PerformanceMeasures. J Am Coll Cardiol 2011;58:1517–38.

16. Moussa I, Hermann A, Messenger JC, et al. The NCDRCathPCI Registry: a US national perspective on care and out-comes for percutaneous coronary intervention. Heart 2013;99:297–303.

17. 111th United States Congress. American Recovery and ReinvestmentAct of 2009. Available at: http://www.gpo.gov/fdsys/pkg/BILLS-111hr1enr/pdf/BILLS-111hr1enr.pdf. Accessed January 10, 2013.

18. Institute of Electrical and Electronics Engineers. Standards Glossary.Available at: http://www.ieee.org/education_careers/education/standards/standards_glossary.html. Accessed January 8, 2013.

19. Musen MA. Dimensions of knowledge sharing and reuse. ComputBiomed Res 1992;25:435–67.

20. U.S. National Library of Medicine. Unified Medical Language Sys-tem. Available at: http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html. Accessed January 8, 2013.

21. National Cardiovascular Data Registry. Cath PCI Registry. Available at:https://www.ncdr.com/webncdr/cathpci/home/datacollection. AccessedApril 26, 2013.

22. Canadian Cardiovascular Society. Data Definitions and QualityIndicators. Available at: http://ddqi.ccs.ca/. Accessed April 26,2013.

23. Hendel RC, Bozkurt B, Fonarow GC, et al. ACC/AHA 2013methodology for developing clinical data standards: a report ofthe American College of Cardiology/American Heart AssociationTask Force on Clinical Data Standards. J Am Coll Cardiol 2014;63:2323–34.

24. Weintraub WS, Karlsberg RP, Tcheng JE, et al. ACCF/AHA2011 key data elements and definitions of a base cardiovascularvocabulary for electronic health records: a report of the AmericanCollege of Cardiology Foundation/American Heart AssociationTask Force on Clinical Data Standards. J Am Coll Cardiol 2011;58:202–22.

25. AHIMA. Data Standards, Data Quality, and Interoperability(AHIMA Practice Brief) Appendix A: Data Standards Resource.Available at: http://library.ahima.org/xpedio/groups/public/documents/ahima/bok1_033588.hcsp?dDocName¼bok1_033588. Accessed January8, 2013.

26. O’Donnell HC, Kaushal R, Barron Y, et al. Physicians’ attitudestowards copy and pasting in electronic note writing. J Gen InternMed 2009;24:63–8.

27. Stengel D, Bauwens K, Walter M, et al. Comparison of handheldcomputer-assisted and conventional paper chart documentation ofmedical records. A randomized, controlled trial. J Bone Joint SurgAm 2004;86-A:553–60.

28. National Cancer Institute. NCI thesaurus. Available at: http://ncit.nci.nih.gov. Accessed March 22, 2013.

29. Byrd JB, Vigen R, Plomondon ME, et al. Data quality of an elec-tronic health record tool to support VA cardiac catheterizationlaboratory quality improvement: the VA Clinical Assessment,

Reporting, and Tracking System for Cath Labs (CART) program.Am Heart J 2013;165:434–40.

30. Integrating the Healthcare Enterprise. Cross Enterprise DocumentSharing. Available at: http://wiki.ihe.net/index.php?title¼Cross_Enterprise_Document_Sharing. Accessed October 1, 2013.

31. The Joint Commission. Comprehension Accreditation Manual forHospitals. Available at: http://www.jcrinc.com/Joint-Commission-Requirements/Hospitals/#UPDATES. Accessed April 12, 2013.

32. Krone RJ, Shaw RE, Klein LW, et al. Evaluation of the AmericanCollege of Cardiology/American Heart Association and the Societyfor Coronary Angiography and Interventions lesion classificationsystem in the current “stent era” of coronary interventions (from theACC-National Cardiovascular Data Registry). Am J Cardiol 2003;92:389–94.

33. Mintz GS, Nissen SE, Anderson WD, et al. American College ofCardiology clinical expert consensus document on standards foracquisition, measurement and reporting of intravascular ultrasoundstudies (IVUS): a report of the American College of Cardiology TaskForce on Clinical Expert Consensus Documents. J Am Coll Cardiol2001;37:1478–92.

34. Creager MA, Belkin M, Bluth EI, et al. 2012 ACCF/AHA/ACR/SCAI/SIR/STS/SVM/SVN/SVS key data elements and definitionsfor peripheral atherosclerotic vascular disease: a report of the Amer-ican College of Cardiology Foundation/American Heart AssociationTask Force on Clinical Data Standards (Writing Committee toDevelop Clinical Data Standards for Peripheral AtheroscleroticVascular Disease). J Am Coll Cardiol 2012;59:294–357.

35. Dormandy JA, Rutherford RB. Management of peripheral arterialdisease (PAD). TASC Working Group. TransAtlantic Inter-SocietyConsensus (TASC). J Vasc Surg 2000;31:S1–296.

36. Norgren L, Hiatt WR, Dormandy JA, et al. Intersociety consensusfor the management of peripheral arterial disease (TASC II). J VascSurg 2007;45 Suppl S:S5–67.

37. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgicalaortic-valve replacement in high-risk patients. N Engl J Med 2011;364:2187–98.

38. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valveimplantation for aortic stenosis in patients who cannot undergosurgery. N Engl J Med 2010;363:1597–607.

39. Holmes DR Jr., Mack MJ. Transcatheter valve therapy: a professionalsociety overview from the American College of Cardiology Founda-tion and the Society of Thoracic Surgeons. Ann Thorac Surg 2011;92:380–9.

40. Bergersen L, Everett AD, Giroud JM, et al. Report from The In-ternational Society for Nomenclature of Paediatric and CongenitalHeart Disease: cardiovascular catheterisation for congenital andpaediatric cardiac disease (Part 1-Procedural nomenclature). CardiolYoung 2011;21:252–9.

41. Bergersen L, Giroud JM, Jacobs JP, et al. Report from The Inter-national Society for Nomenclature of Paediatric and CongenitalHeart Disease: cardiovascular catheterisation for congenital andpaediatric cardiac disease (Part 2-Nomenclature of complicationsassociated with interventional cardiology). Cardiol Young 2011;21:260–5.

42. Integrating the Healthcare Enterprise. Cath Report Content. Availableat: http://wiki.ihe.net/index.php?title¼Cath_Report_Content. AccessedApril 26, 2013.

43. Integrating the Healthcare Enterprise. Cardiac Imaging ReportContent. Available at: http://wiki.ihe.net/index.php?title¼Cardiac_Imaging_Report_Content. Accessed May 6, 2013.

44. Hendel RC, Budoff MJ, Cardella JF, et al. ACC/AHA/ACR/ASE/ASNC/HRS/NASCI/RSNA/SAIP/SCAI/SCCT/SCMR/SIR 2008key data elements and definitions for cardiac imaging: a report of theAmerican College of Cardiology/American Heart Association TaskForce on Clinical Data Standards (Writing Committee to DevelopClinical Data Standards for Cardiac Imaging). J AmColl Cardiol 2009;53:91–124.

Key Words: ACC Health Policy Statements - best practice model -

cardiac catheterization - cardiac catheterization laboratory workflow -

clinical data interchange - clinical document architecture -

electronic health records - percutaneous coronary interventions -

structured reporting.






























http://www.gpo.gov/fdsys/pkg/BILLS-111hr1enr/pdf/BILLS-111hr1enr.pdf

http://www.gpo.gov/fdsys/pkg/BILLS-111hr1enr/pdf/BILLS-111hr1enr.pdf

http://www.ieee.org/education_careers/education/standards/standards_glossary.html

http://www.ieee.org/education_careers/education/standards/standards_glossary.html



http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html

http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html

https://www.ncdr.com/webncdr/cathpci/home/datacollection

http://ddqi.ccs.ca/












http://library.ahima.org/xpedio/groups/public/documents/ahima/bok1_033588.hcsp?dDocName=bok1_033588










http://ncit.nci.nih.gov

http://ncit.nci.nih.gov






http://wiki.ihe.net/index.php?title=Cross_Enterprise_Document_Sharing



http://www.jcrinc.com/Joint-Commission-Requirements/Hospitals/#UPDATES

http://www.jcrinc.com/Joint-Commission-Requirements/Hospitals/#UPDATES















































http://wiki.ihe.net/index.php?title=Cath_Report_Content

http://wiki.ihe.net/index.php?title=Cath_Report_Content

http://wiki.ihe.net/index.php?title=Cardiac_Imaging_Report_Content










ry and Other Entities (Relevant)d


2618

Appendix 1. Author Relationships With Indust
ACC/AHA/SCAI 2014 Health Policy Statement on Structured Reporting for theCardiac Catheterization Laboratory
Committee Member Employment ConsultantSpeaker’sBureau

Ownership/Partnership/Principal

PersonalResearch

Institutional,Organizational,

or Other FinancialBenefit

ExpertWitness

Timothy Sanborn(Chair)

NorthShore UniversityHealthSystemdProfessorof Medicine

None None None None None None

James Tcheng(Vice Chair)

Duke University MedicalCenterdProfessor of Medicine

� Cardiovascular

Systems

None None � National

Institutes

of Health*

� Duke University

Medical Center*

None

H. Vernon Anderson University of Texas CardiologyDivisiondProfessor of Medicine


Charlie Chambers Penn State Milton S. HersheyMedical CenterdProfessor ofMedicine and Radiology


Sharon Cheatham Nationwide Children’sHospitaldInterventionalCardiology Nurse Practitioner


Matthew V. DeCaro Jefferson UniversityHospitalsdDirector, CoronaryCare Unit; Assistant Professor


Jeremy Durack Memorial Sloan-Kettering CancerCenterdInterventionalRadiologist


Allen Everett Johns Hopkins HospitaldAssociateProfessor Pediatric Cardiology


John Gordon San Diego Cardiac Center MedicalCorporationdCardiologist


William Hammond Duke Center for HealthInformaticsdDirector


Ziyad Hijazi James A. Hunter, MD, University,Rush Center for Congenital &Structural Heart DiseasedChairProfessor of Pediatrics &Internal Medicine Director


Vikram S. Kashyap Case Western Reserve University,Harrington Heart and VascularInstitutedProfessor of Surgeryand Chief, Division of VascularSurgery and EndovascularTherapy; University HospitalsCase Medical CenterdCo-Director


Merrill Knudtson University of CalgarydProfessorof Medicine


Michael Landzberg BACH Pulmonary HypertensionService, Departments ofPediatrics, Medicine,SurgerydMedical Director,Boston Adult Congenital Heart


Marco A. Martinez-Rios Instituto Nacional de Cardiologiade MexicodDirector General


Lisa Riggs St. Luke’s HospitaldDirectorof CV Quality

None None None None None � 2012,

Defendant,

post-procedural

bleeding

Kui Hian Sim Sarawak General Hospital,MalaysiadVisiting SeniorConsultant Cardiologist


David Slotwiner Long Island Jewish MedicalCenterdAssociate Director,Electrophysiology Laboratory


Harry Solomon GE HealthcaredInteroperabilityArchitect

None None None None � General Electric

Healthcare*

None


Appendix 1. Continued

Committee Member Employment ConsultantSpeaker’sBureau

Ownership/Partnership/Principal

PersonalResearch

Institutional,Organizational,

or Other FinancialBenefit

ExpertWitness

Wilson Y. Szeto Hospital of the University ofPennsylvania Division ofCardiothoracicSurgerydSurgical Director,Transcatheter Cardio-AorticTherapies; Associate Director,Thoracic Aortic SurgeryProgram; Associate Chief ofCardiovascular Surgery please


Bonnie Weiner St. Vincent Hospital WorcesterMedical CenterdTrainingDirector


William Weintraub Christiana Care HealthSystemdSection Chief,Cardiology

None None None None None � 2012, Defendant,

celebrex litigation

� 2011, Defendant,

oral contraceptive

litigation

John Windle University of Nebraska MedicalCenter CardiologySectiondProfessor and Chief,Internal Medicine, Division ofCardiology


This table represents the relationships of committee members with industry and other entities that were determined to be relevant to this document. These relationships were reviewed and updated in

conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarily reflect relationships with industry at the time of

publication. A person is deemed to have a significant interest in a business if the interest represents ownership of �5% of the voting stock or share of the business entity, or ownership of �$10,000 of

the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. Relationships that exist with no

financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted.

According to the ACC, a person has a relevant relationship IF: a) The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the

document; or b) The company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document;or c) The person or a member of the person’s household, has a reasonable potential for financial, professional, or other personal gain or loss as a result of the issues/content addressed in the document.*Significant relationship.

yNo financial benefit.

ACC indicates American College of Cardiology; AHA, American Heart Association; and SCAI, Society for Cardiovascular Angiography and Interventions.


2619


2620

Appendix 2. Peer Reviewer Relationships With Industry and Other Entities (Relevant)dACC/AHA/SCAI 2014 Health Policy Statement on Structured Reporting for the
Cardiac Catheterization Laboratory
Peer Reviewer Representation Employment Consultant

Speaker’s

Bureau

Ownership/

Partnership/

Principal

Personal

Research

Institutional,

Organizational,

or Other

Financial

Benefit

Expert

Witness

Deepak L.Bhatt

Official ReviewerdCQC LeadReviewer

Brigham and Women’sHospital Heart andVascular Center;

Harvard MedicalSchooldExecutive

Director ofInterventionalCardiovascular

Programs; Professor ofMedicine

None None None � Medtronicy None None

GregoryDehmer

Official ReviewerdACC BOT

Texas A&M, College ofMedicine, Scott &

White Clinic CardiologyDivisiondProfessor ofMedicine; Director of

Cardiology

� Clinical Advisory

Group, Maryland

� Health Care

Commission

� Society for

Cardiovascular

Angiography and

Interventions*

� U.S. Food &

Drug

Administration

None None None None None

JacquelineKreutzer

Official ReviewerdAHA

Children’s Hospital ofPittsburghdDirector,

Cardiac CatheterizationLaboratory

� Medtronic

� St. Jude Medical


Sunil Rao Official Reviewerd

SCAI

Duke Cardiologyd

Associate Professorof Medicine

None None None None None � Defendant,

Catheterization-

related

complications,

2011

Rose Shaffer Official ReviewerdAHA

Thomas JeffersonUniversityHospitaldCardiology

Nurse Practitioner


Barry Uretsky Official ReviewerdSCAI

University of ArkansasMedical

SciencesdClinicalProfessor of Medicine


Robert Vincent Official ReviewerdIASC

Children’s Healthcare ofAtlantadCo-Medical

Director, HeartTransplant Program;Director, Cardiac

Catheterization Lab;Pediatric Cardiologist

None None None None � AGA* None

Tom Dolan OrganizationalReviewerdDICOM

PhilipsHealthcaredDirector

Interoperability andStandards

� Integrating the

Healthcare

Enterprise*


Bob Dolin Organizational

ReviewerdHL7

Lantana Consulting Group,

Health LevelSevendPresident andChief Medical Officer


Jorge Gaspar-

Hernandez

Organizational

ReviewerdIASC

Instituto Nacional De

Cardiologiad


Boris Nikolic OrganizationalReviewerdSIR

Albert Einstein MedicalCenterdInterventionalRadiologist





Speaker’s

Bureau

Ownership/

Partnership/

Principal

Personal

Research

Institutional,

Organizational,

or Other

Financial

Benefit

Expert

Witness

Blair O’Neill OrganizationalReviewerdCCS

Mazankowski AlbertaHeart InstitutedHead,Division of Cardiology


Kristine J.

Peterson

Organizational

ReviewerdAACN

Aspirus Wausau

HospitaldCardiacClinical Nurse

Specialist


Teri M. SippelSchmidt

OrganizationalReviewerdIntegratingthe Healthcare

Enterprise

Radiological Society ofNorthAmericadTechnical

Project Manager, IHECardiology


SunaryaSoerianata

OrganizationalReviewerdAPSC

Indonesian HeartAssociationdPresident


brachial artery

pseudoaneurysm,

2013

Ravi Veeraswamy Organizational ReviewerdSVS

Emory University School ofMedicinedAssociateProfessor of Surgery


Gary Webb Organizational

ReviewerdISACHD

Cincinnati Children’s

Hospital MedicalCenterdDirector,Cincinnati Adolescent

and Adult CongenitalHeart Center


Mathew R.Williams

OrganizationalReviewerdSTS

New York PresbyterianHospital-Columbiad

Co-Director, HeartCenter

� Edwards

Lifesciences

� Medtronic


Anita Arnold Content Reviewerd

Advocacy SteeringCommittee

USF Department of

Cardiology TampaFloridadAssistantProfessor of Medicine


Herbert Aronow Content Reviewerd

PVD Committee

St. Joseph Mercy Ann

ArbordCardiovascularDisease Specialist


Eric Bates Content ReviewerdPCI GL

University of MichiganHospitals and Health

CentersdProfessor ofMedicine


Lisa Bergersen Content Reviewerd

ACPC

Children’s Hospital

BostondAssistantProfessor of Pediatrics


Thomas Bashore Content ReviewerdCath Lab

Standards ECD

Duke University MedicalCenterdSenior Vice

Chief of Cardiology


JamesBlankenship

Content ReviewerdPCI GL

Geisinger MedicalCenterdDirector,Cardiac Catheterization

Lab


Joaquin Cigarroa Content ReviewerdISC

Oregon Health & ScienceUniversitydAssociate

Professor of Medicine


Coronary

artery disease

review, 2011

Stephen Ellis Content Reviewerd

InformaticsCommittee

Cleveland Clinic

FoundationdDirector,Sones CardiacCatheterization Lab

� Abbott Vascular

� Boston Scientific

� Celera Diagnostic

� Cordis


Phillip Greenland Content ReviewerdCouncil on CV Care

in Older Adults

Northwestern UniversityFeinberg School of

MedicinedProfessorand Chair, Departmentof Preventive Medicine




2621



Speaker’s

Bureau

Ownership/

Partnership/

Principal

Personal

Research

Institutional,

Organizational,

or Other

Financial

Benefit

Expert

Witness

Glenn Levine Content ReviewerdPCI GL

Baylor College of Medicine;Michael E. DeBakeyMedical

CenterdProfessor ofMedicine; Director,

Cardiac Care Unit


Marian Limacher Content ReviewerdProvider RadiationSafety ECD

University of FloridaDivision ofCardiovascular

MedicinedSuncoastEndowed Professor ofCardiovascular

Medicine Research

None None None NIHy None None

Howard C. Lewin Content ReviewerdImaging Council

Positron Imaging Partnersin Los Angelesd

Medical Director

None None None None None � Plantiff,

interpretation

of perfusion

scan, 2012

Ehtisham

Mahmud

Content Reviewerd

ISC

University of California San

Diego, School ofMedicined Chief ofCardiovascular

Medicine

� Medtronic � Medtronic None None None None

Sandra Oliver-McNeil

Content ReviewerdCardiovascularCare Team

William BeaumontHospital; Wayne StateUniversity dNurse

Practitioner; AssistantProfessor


Debabrata

Mukherjee

Content Reviewerd

ISC

Texas Tech University

Health ScienceCenterdChief,Cardiovascular

Medicine


Manesh Patel Content ReviewerdAppropriate UseCriteria;

AUC for DiagnosticCatheterization; AUC

for CoronaryRevascularization

Duke University MedicalCenterdDirector ofInterventional

Cardiology and CardiacCatheterization Labs


Rajan Patel Content ReviewerdImaging Council

Ochsner MedicalCenterdInterventional

Cardiologist


Marwan Refaat Content ReviewerdEP Committee

American University ofBeirutdAssistantProfessor of Medicine


Vinod Thourani Content Reviewerd

Surgeon ScientificCouncil

Emory University Division

of CardiothoracicSurgerydAssociate

Professor of Surgery

� Edwards

Lifesciences

None � Apica

Cardiovascular*

None None None

Henry H. Ting Content ReviewerdTask Force onPerformance Measures

Mayo ClinicdProfessor ofMedicine; Director,Mayo Clinic Quality

Academy


Robert Touchon Content ReviewerdPrevention Committee

Huntington InternalMedicine GroupdMember, Cardiology

Staff


Robert Vincent Content ReviewerdACPC (and OfficialBOG)

Children’s Healthcare ofAtlantadCo-MedicalDirector, Heart

Transplant Program;Director, Cardiac

Catheterization Lab;Pediatric Cardiologist




2622



Speaker’s

Bureau

Ownership/

Partnership/

Principal

Personal

Research

Institutional,

Organizational,

or Other

Financial

Benefit

Expert

Witness

Thad Waites Content ReviewerdAdvocacy SteeringCommittee

Mississippi State Board ofHealth; HattiesburgClinic; Forrest General

HospitaldCardiologist;Director of

Catheterization Lab


This table represents the relationships of reviewers with industry and other entities that were disclosed at the time of peer review and determined to be relevant to this document. It does not necessarily

reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of �5% of the voting stock or share of the

business entity, or ownership of �$10,000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person’s gross income for the

previous year. A relationship is considered to be modest if it is less than significant under the preceding definition. Relationships that exist with no financial benefit are also included for the purpose of

transparency. Relationships in this table are modest unless otherwise noted. Names are listed in alphabetical order within each category of review. Please refer to http://www.cardiosource.org/Science-

And-Quality/Practice-Guidelines-and-Quality-Standards/Relationships-With-Industry-Policy.aspx for definitions of disclosure categories or additional information about the ACC Disclosure Policy for writing

committees.

According to the ACC, a person has a relevant relationship IF: a) The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the

document; or b) The company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document;or c) The person or a member of the person’s household, has a reasonable potential for financial, professional, or other personal gain or loss as a result of the issues/content addressed in the document.*No financial benefit.

ySignificant relationship.ACC indicates American College of Cardiology; AACN, American Association for Cardiac-Care Nurses; ACPC, Adult Congenital and Pediatric Cardiology; AHA, American Heart Association; APSC, Asian

Pacific Society of Cardiology; BOG, Board of Governors; BOT, Board of Trustees; CCS, Canadian Cardiology Society; CQC, Clinical Quality Committee; CV, Cardiovascular; DICOM, Digital Imaging and

Communications in Medicine; ECD, expert consensus document; EP, electrophysiology; HL7, Health Level Seven; IASC, Inter-American Society of Cardiology; ISACHD, International Society of Adult

Congenital Heart Disease; ISC, Interventional Scientific Council; PCI GL, percutaneous coronary intervention guideline; PVD, peripheral vascular disease; SCAI, Society for Cardiovascular Angiography and

Interventions; SIR, Society of Interventional Radiology; STS, Society of Thoracic Surgeons; and SVS, Society for Vascular Surgery.


2623

Appendix 3. Abbreviations

AACN ¼ American Association for Cardiac-Care NursesACC ¼ American College of Cardiology FoundationAHA ¼ American Heart AssociationAPP ¼ Advanced Practice PractitionersAPSC ¼ Asian Pacific Society of CardiologyAUC ¼ appropriate use criteriaAVR ¼ aortic valve replacementCART ¼ Clinical Assessment, Reporting, and Tracking System for Cath LabsC-CDA ¼ Consolidated Clinical Document ArchitectureCCS ¼ Canadian Cardiovascular SocietyCDA ¼ Clinical Document ArchitectureCDISC ¼ Clinical Data Interchange Standards ConsortiumCHD ¼ congenital heart diseaseCQC ¼ Clinical Quality CommitteeCRC ¼ Cath Report ContentDICOM ¼ Digital Imaging and Communications in MedicineEHR ¼ electronic health recordHITECH ¼ Health Information Technology for Economic and Clinical HealthHL7 ¼ Health Level Seven, Incorporated

HPS ¼ health policy statementIASC ¼ InterAmerican Society of CardiologyICD ¼ International Classification of DiseasesIHE ¼ Integrating the Healthcare EnterpriseIPCCC ¼ International Pediatric and Congenital Cardiac CodeISACHD ¼ International Society of Adult Congenital Heart DiseaseMHT ¼ multidisciplinary heart teamNCDR ¼ National Cardiovascular Data RegistryPCI ¼ percutaneous coronary interventionRWI ¼ relationships with industry and other entitiesSCAI ¼ Society for Cardiovascular Angiography and InterventionsSIR ¼ Society of Interventional RadiologySNOMED CT ¼ Systemized Nomenclature of Medicine – Clinical TermsSTS ¼ Society of Thoracic SurgeonsSVS ¼ Society for Vascular SurgeryTAVR ¼ transcatheter aortic valve replacementUMLS ¼ Unified Medical Language SystemXDS ¼ Cross Enterprise Document Sharing



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