Intermac ppt 1

8/13/2019 Intermac ppt 1

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Interagency Registry for Mechanically

Assisted Circulatory SupportNHLBI Contract #HHSN268200548198C


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NOTICE

INTERMACS is currently using Protocol 2.2;however, the slides that you are about to vieware in reference to Protocol 2.3.

Protocol 2.3 will go live on March 4, 2009.


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Learning Objectives

Participants will be familiar with the purpose andstructure of INTERMACS

Participants will know how to enroll and activatetheir centers in INTERMACS

Participants will be familiar with hospitalmembership criteria and the audit process

Participants will be familiar with INTERMACS

Adverse Event Definitions

Participants will know how to contactINTERMACS Support for help with enrollmentand data entry issues


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Implantation of an MCSS is not a simple, time -limited

treatment episode. Because of the patients totaldependence on the device and because problems canoccur at any time, clinical trial subjects should be followedclosely during the trials: they and other MCSS patientsshould be followed, through a registry, for the remainder oftheir lives...Maintaining a registry of MCSS recipientsshould be considered a routine aspect of this careThecommittee recommends that NHLBIsupport long termfollow up studies of an adequate sample of MCSS

patients.

The Art i f ic ial Hear t : Prototy pes Pol ic ies and Pat ients ; Ins t i tu te ofMedic ine Repo rt, 1991.


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NHLBI Contract #HHSN268200548198C

Award date: June 1, 2005Duration: 5 yearsTo: University of Alabama at BirminghamSubcontracts: United Network for Organ Sharing

University of PittsburghBrigham and Womens Hospital Cleveland Clinic

PI: James K. Kirklin, MDCo PIs: Robert L. Kormos, MD

Lynne W. Stevenson, MDDavid C. Naftel, PhD

Study Chair: James B. Young, MD


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Interagency

means

NHLBI, CMS, and FDANational Heart, Lung and Blood Institute Centers for Medicare and Medicaid Services Food and Drug Administration


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Steering CommitteeOperations Committee

Marissa Miller, Karen Ulisney, James Young, James Kirklin, LynneStevenson, Robert Kormos, Tim Baldwin, Patrice Nickens, David

Naftel, Leah Edwards, Eric Chen, Wolf Sapirstein

Subcommitees

Data Access,Analysis andPublications

F Pagani

Hospital Trainingand Standards

W. Pae

Adverse EventsAnd Adjudication

R KormosW Holman

Pediatrics

E Blume

Industry RelationsAnd

Device Development

J Watson

Focused Researchand

Mission Activities

S KoenigM Jessup

CoordinatorsCouncil

K ChisholmT Martin

S Wissman


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NHLBI

FDACMS

Clinical sites(data collection)

Physician

ExpertiseIndustry

Data AnalysisExpertise

Web-basedData entryExpertise


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Facilitate the refinement of patient selection to maximizeoutcomes with current and new device options.

Improve and expedite new device clinical trials by providinghistorical control data, reliable enough to serve as ObjectivePerformance Criteria (OPC) standards for FDA.

Develop consensus best practice guidelines to improve clinicalmanagement by reducing short and long term complications ofMCSD therapy.

Goals of the Registry


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Improve economic outcomes by identifying and optimizingfactors affecting cost-effectiveness.

Utilize MCSD Registry information to guide improvements intechnology, particularly as next generation devices evolve.

Promote research into the underlying pathophysiologicsubstrate of advanced heart failure in order to define and

promote the conditions necessary for myocardial recovery.

Evaluate parameters of quality of life before and after deviceimplantation.

Goals of the Registry (continued)


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Medical Center Eligibility

Any medical center in the United States

that has an active ventricular assist devicetherapy program is eligible to contribute toINTERMACS.


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INTERMACS Support

Available Monday - Friday, 8:00 5:00 EST

Rochelle TaylorINTERMACS Coordinator(804) 782-4869 [email protected]

Susan Groff INTERMACS Coordinator

(804) [email protected]

Ruth Henson

INTERMACS Audit Coordinator(804) [email protected]

Jo Smith INTERMACS Coordinator

(804) [email protected]
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]


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INTERMACS Support

Available Tuesday - Friday, 8:00 5:00 EST

Kathryn PhilibinAssistant Director, Clinical Affairs(804) [email protected]
mailto:[email protected]:[email protected]


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Participation Requirements1. Completion of INTERMACS online training (this PowerPoint

Presentation)2. Enrollment3. IRB Approval and IRB-approved Informed Consent

Templates, and current FWA number

4. Participation Agreement, signed by legally authorizedrepresentative of the hospital

5. Conflict of Interest Disclosure Form for each PrincipalInvestigator and all Co-Investigators

6. Documentation of Human Subjects Protection training forevery user who has INTERMACS-related contact withpatients

7. Completion of INTERMACS practical training (remoteMicrosoft Live Meeting session with INTERMACS Trainer)


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Requirement #1

INTERMACS Online Training

A minimum of one staff member from yourinstitution should review this online PowerPointpresentation in its entirety before proceeding tosteps 2 7.


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Requirement #2

Online Enrollment

Enroll your medical center by accessing thefollowing link: www.intermacs.org , then click onthe INTERMACS Membership link.

INTERMACS Support is available Monday

through Friday, 8:00 5:00 (EST) to providetechnical assistance. Contact INTERMACSSupport at [email protected] .
http://www.intermacs.org/mailto:[email protected]:[email protected]://www.intermacs.org/


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Enrollment (cont)

In order to complete the online enrollmentprocess, you will be required to assign staff tothe following roles from your facility:

Principal Investigator : responsible for oversight ofdata submission and registry compliance

Site Administrator : responsible as point person for data related inquiries, receipt of reports and auditcoordination


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Enrollment (cont)

Membership Changes after enrollmentprocess is complete:

Once initial enrollment has been completed, youwill no longer be able to make changes to yourINTERMACS account.

INTERMACS Support will add and remove staffmembers only as requested by your medicalcenter Site Administrator.


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Requirement #3 (cont.)

Informed Consents

Three patient Informed Consents may be

required by your IRB:

Patient consent for data entry into INTERMACSHIPAA Authorization

Blood and Tissue Collection


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Requirement #4Conflict of Interest Disclosure

Before data entry in INTERMACS cancommence, your Principal Investigator and anyCo-Investigator(s) must complete the Conflict ofInterest Disclosure Form included in the Manualof Operations, Appendix E, located at thefollowing link: www.intermacs.org , then click onthe All Things INTERMACS link.
http://www.intermacs.org/http://www.intermacs.org/


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Requirement #5Participation Agreement

Before entering patients, a legally authorizedrepresentative from your hospital is required to sign

the participation agreement. This form is located in theManual of Operations, Appendix D, and may bedownloaded and printed from the following link:www.intermacs.org , then click on the All ThingsINTERMACS link.

Please fax your participation agreement to INTERMACSSupport at 1-800-809-7688.


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Requirement #6

Documentation of Human Subjects Training Documentation of Human Subjects Training

(CITI or other NIH-approved HST course) must

be submitted for every INTERMACS user whohas or intends to have INTERMACS-relatedcontact with patients.


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Requirement #7Practical Training

Complete a live, interactive training withINTERMACS Support after your center hassubmitted all required documents (IRB Approval,Informed Consent Templates, Human SubjectsTraining Documentation, Conflict of Interest

Disclosure Form, and Participation Agreement)


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Activation

Upon completion of all seven membershiprequirements, a medical center is eligible foractivation.

Once activated , your center will be eligible toenter patient data online at www.intermacs.org

Upon activation by INTERMACS Support, eachenrolled user at the medical center will receivenotification and usernames and passwords.


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Data Security


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Data Security

INTERMACS is fully compliant with the HealthInsurance Portability and Accountability Act(HIPAA)

UNOS is Certified by the Health Resources andServices Administration (HRSA)

Access to INTERMACS data by UNOSpersonnel is limited based on job description


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Data Security (cont.)

The database and web servers reside in an environmentproviding multiple levels of physical and systemssecurity.

INTERMACS is fully compliant with the Security Act of2002 and the Federal Information System Management

Act. Routine audits verify compliance.

Microsoft best security practices and group policyrecommendations from the National Institute forStandards in Technology are followed for the Windows2003 framework.


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Data Security (cont.)

Servers are monitored 24 / 7 for intrusion andvulnerabilities by an integrated third party softwarepackage.

The network is protected by an anti-virus retrieval anddeployment system.

Firewall software prevents hacking, virus and otheroutside security risks.

Servers reside on a segmented part of the VLAN thatprotects it from any adverse internal forces.


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Users Access to INTERMACS

Access to INTERMACS is login and passwordprotected.

Logins and passwords are assigned to enrolledhospital participants by INTERMACS Supportand relayed via e-mail.

Know your username and password.

Keep them secure.


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Compliance


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INTERMACS Data Compliance

Participating medical centers must submit dataon all consented recipients of a durable, FDA-

approved MCSD.

Participating medical centers should maintain a

screening record of all MCSD recipients that donot meet the inclusion criteria for enrollment intoINTERMACS .


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Data Compliance (cont)

All data fields must be completed before a formcan be submitted.

Status Fields (ST = ) will provide alternativeoptions if requested data is unavailable.

Examples of Status field options may include:unknown

not donenot done, too sicknot done, other


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Data Submission Schedule

Patient Demographics 30 days from implant datePre-Implant 30 days from implant dateOperative Details 30 days from implant date1 Week Follow-up 30 days from implant dateDischarge 30 days from discharge date3 & 6 month Follow-ups 30 days from exam dateQ6 month Follow-ups 30 days from exam dateRehospitalization 30 days from occurrenceAdverse Events 30 days from occurrence

*Device Malfunction

Explant 30 days from date of explant Death 30 days from date of death* FDA requires initial device malfunctions be reported within 72 hours of occurrence. (See Users Guide for instructions)


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Site Audits


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Web-Based Data Entry

Application


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How will data be collected for

submission to INTERMACS? Medical Record Review

EUROQoL Questionnaire (Quality of Life patientself-assessment)

Trail Making Test (Neurocognitive evaluation)

Blood and Tissue information at:ImplantExplant/Transplant


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Time Points for Data Collection

Pre-Implant

Implant Hospitalization Discharge Form

Follow-Up

1 week, 1 Month, 3 Months, 6 Months and q 6 Months

Adverse Events (AEs) and Serious AdverseEvents (SAEs)

Rehospitalization Death

Explant/Transplant


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Adverse Event Definitions


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An episode of suspected internal or external bleeding that results in one or

more of the following:a. Death,b. Reoperation,c. Hospitalization,d. Transfusion of red blood cells as follows:

During first 7 days post implant Adults ( 50 kg): 4U packed red blood cells (PRBC) within any 24 hour

period during first 7 days post implant.

Pediatric (< 50 kg) : 20 cc/kg packed red blood cells (PRBC) within any24 hours period during first 7 days post implant.

After 7 days post implant

Any transfusion of packed red blood cells (PRBC) after 7 days followingimplant with the investigator recording the number of units given.(record number of units given per 24 hour period)

NOTE: Hemorrhagic stroke is considered a neurological event and not as a separate bleeding event.

Major Bleeding


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Cardiac Arrhythmia

Any documented arrhythmia that results inclinical compromise (e.g., diminished VAD flow,oliguria, pre-syncope or syncope) that requireshospitalization or occurs during a hospital stay.Cardiac arrhythmias are classified as 1 of 2types:

1) Sustained ventricular arrhythmia requiring

defibrillation or cardioversion.

2) Sustained supraventricular arrhythmia requiringdrug treatment or cardioversion.


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Pericardial Fluid Collection

Accumulation of fluid or clot in the pericardialspace that requires surgical intervention orpercutaneous catheter drainage.

This event will be subdivided into those withclinical signs of tamponade (e.g. increasedcentral venous pressure and decreasedcardiac/VAD output) and those without signs oftamponade.


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Device Malfunction

Device malfunction denotes a failure of one or more of the Componentsof the MCSD system which either directly causes or could potentiallyinduce a state of inadequate circulatory support (low cardiac outputstate) or death. The manufacturer must confirm device failure. Afailure that was iatrogenic or recipient-induced will be classified as anIatrogenic/Recipient-Induced Failure.

Device failure should be classified according to which componentsfails as follows:

1) Pump failure (blood contacting components of pump and any motor orother pump actuating mechanism that is housed with the blood contactingcomponents). In the special situation of pump thrombosis, thrombus is

documented to be present within the device or its conduits that result in orcould potentially induce circulatory failure.

2) Non-pump failure ( e.g., external pneumatic drive unit, electric powersupply unit, batteries, controller, interconnect cable, compliancechamber)


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Hemolysis

A plasma-free hemoglobin value that is greaterthan 40 mg/dl, in association with clinical signsassociated with hemolysis (e.g., anemia, low

hematocrit, hyperbilirubinemia) occurring afterthe first 72 hours post-implant.

Hemolysis related to documented non-device-related causes (e.g., transfusion or drug) isexcluded from this definition.


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Hepatic Dysfunction

An increase in any two of the following hepaticlaboratory values (total bilirubin, aspartate

aminotransferase/ AST and alanineaminotranferease/ ALT ) to a level greater thanthree times the upper limit of normal for thehospital, beyond 14 days post-implant (or ifHepatic dysfunction is the primary cause ofdeath).


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Hypertension

New onset of blood pressure elevation greaterthan or equal to 140 mm Hg systolic or 90 mmHg diastolic (pulsatile pump) or 110 mm Hg

mean pressure (rotary pump).

Pediatric patients: for patients under 18 yearsof age weighing < 50 kg, hypertension is defined

as systolic, diastolic, or mean blood pressuregreater than the 95th percentile for age whichrequires the addition of iv or oral therapy formanagement.


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Major Infection

A clinical infection accompanied by pain, fever, drainage and/orleukocytosis that is treated by anti-microbial agents (non-prophylactic).

A positive culture from the infected site or organ should be presentunless strong clinical evidence indicates the need for treatment despitenegative cultures.

The general categories of infection are listed below:

Localized Non-Device Infection

Infection localized to any organ system or region (e.g., mediastinitis)without evidence of systemic involvement (see sepsis definition),ascertained by standard clinical methods and either associated withevidence of bacterial, viral, fungal or protozoal infection, and/or requiringempirical treatment.

(continued on next slide)


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Myocardial Infarction

Two categories of myocardial infarction will be identified :

Peri-Operative Myocardial Infarction Clinical suspicion of myocardial infarction together with CK-MB or Troponin> 10 times the hospital upper limits of normal, found within 7 days followingVAD implant with local ECG findings consistent with acute myocardial

infarction. (This definition uses the higher suggested limit for serum markersdue to apical coring at the time of VAD placement, and does not use wallmotion changes because the apical sewing ring inherently creates new wallmotion abnormalities).

Non-Perioperative Myocardial Infarction Presence at greater 7 days post implant of two of the three following three

criteria:a) Chest pain which is characteristic of myocardial ischemia,b) ECG with a pattern or changes consistent with a myocardial infarction,andc) Troponin or CK (measured by standard clinical pathology/laboratorymedicine methods) greater than the normal range for the local hospital withpositive MB fraction ( 3% total CK). This should be accompanied by a newregional LV or RV wall motion abnormality on a myocardial imaging study.


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Neurological Dysfunction

Any new, temporary or permanent, focal or global neurological deficitascertained by a standard neurological examination (administered by aneurologist or other qualified physician and documented with appropriatediagnostic tests and consultation note). The examining physician willdistinguish between a transient ischemic attack (TIA), which is fullyreversible within 24 hours (and without evidence of infarction), and a stroke,which lasts longer than 24 hours (or less than 24 hours if there is evidenceof infarction). The NIH Stroke Scale (for patients > 5 years old) must be re-administered at 30 and 60 days following the event to document thepresence and severity of neurological deficits. Each neurological eventmust be subcategorized as:

1) Transient Ischemic Attack (acute event that resolves completely within 24 hourswith no evidence of infarction)

2) Ischemic or Hemorrhagic Cardiovascular Accident/CVA (event that persistsbeyond 24 hours or less than 24 hours associated with infarction on an imagingstudy.

In addition , to above, for patients < 6 months of age, any of the following:

3) New abnormality of head ultrasound

4) EEG positive for seizure activity with or without clinical seizure


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Psychiatric Episode

Disturbance in thinking, emotion or behavior thatcauses substantial impairment in functioning or

marked subjective distress requiringintervention. Intervention is the addition of newpsychiatric medication, hospitalization, orreferral to a mental health professional for

treatment. Suicide is included in this definition.


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Renal Dysfunction

Two categories of renal dysfunction will be identified:

Acute Renal Dysfunction Abnormal kidney function requiring dialysis (includinghemofiltration) in patients who did not require this procedureprior to implant, or a rise in serum creatinine of greater than 3times baseline or greater than 5 mg/dL (in children, creatininegreater than 3 times upper limit of normal for age) sustained forover 48 hours.

Chronic Renal Dysfunction An increase in serum creatinine of 2 mg/dl or greater abovebaseline, or requirement for hemodialysis sustained for at least90 days.


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Respiratory Failure

Impairment of respiratory function requiringreintubation, tracheostomy or (for patients older

than age 5 years) the inability to discontinueventilatory support within six days (144 hours)post-VAD implant. This excludes intubation forre-operation or temporary intubation for

diagnostic or therapeutic procedures.


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Right Heart Failure

Symptoms and signs of persistent rightventricular dysfunction [central venous pressure(CVP) > 18 mmHg with a cardiac index


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Arterial Non-CNS Thromboembolism

An acute systemic arterial perfusion deficit inany non-cerebrovascular organ system due tothromboembolism confirmed by one or more ofthe following:

1) standard clinical and laboratory testing2) operative findings3) autopsy findings

This definition excludes neurological events.


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Venous Thromboembolism Event

Evidence of venous thromboembolic event (e.g.deep vein thrombosis, pulmonary embolism) by

standard clinical and laboratory testing.


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Wound Dehiscence

Disruption of the apposed surfaces of a surgicalincision, excluding infectious etiology, and

requiring surgical repair.


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Other AE

An event that causes clinically relevant changesin the patients health (e.g. cancer)


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Demonstration Site

Please take the time to browse the Web-BasedData Application demo site prior to enrolling in alive practical training session:

https://test.intermacs.org/registry/login.aspx

Username: training1Password: training1
https://test.intermacs.org/registry/login.aspxhttps://test.intermacs.org/registry/login.aspx


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Practical Web-Based DataEntry Training


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One coordinator from every participating centermust attend a live practical training session withINTERMACS Support prior to activation.


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The live practical training session may beattended remotely from any location that hasboth:

1. Telephone access2. High speed internet connection

The live session should take approximately 2

hours to complete.


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After your center has completed this onlinepresentation and submitted all required documentsto INTERMACS Support, please contact Rochelle

Taylor at 804-782-4869 or [email protected] toschedule a practical data entry training session.
mailto:[email protected]:[email protected]

Intermac ppt 1

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