1-Year Outcomes for Transcatheter Repair in Patients With ...

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10-26-2020

1-Year Outcomes for Transcatheter Repair in Patients With Mitral 1-Year Outcomes for Transcatheter Repair in Patients With Mitral

Regurgitation From the CLASP Study Regurgitation From the CLASP Study

John G. Webb

Mark Hensey

Molly Szerlip

Ulrich Schäfer

Gideon N. Cohen

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Authors Authors John G. Webb, Mark Hensey, Molly Szerlip, Ulrich Schäfer, Gideon N. Cohen, Saibal Kar, Raj Makkar, Robert M. Kipperman, Konstantinos Spargias, William W. O'Neill, Martin KC Ng, Neil P. Fam, Michael J. Rinaldi, Robert L. Smith, Darren L. Walters, Christopher O. Raffel, Justin Levisay, Azeem Latib, Matteo Montorfano, Leo Marcoff, Maithili Shrivastava, Robert Boone, Suzanne Gilmore, Ted E. Feldman, and D. Scott Lim

1-Year Outcomes for TranscatheterRepair in Patients With MitralRegurgitation From the CLASP StudyJohn G. Webb, MD,a Mark Hensey, MB, BCH, BAO,a Molly Szerlip, MD,b Ulrich Schäfer, MD,c Gideon N. Cohen, MD,d

Saibal Kar, MD,e Raj Makkar, MD,f Robert M. Kipperman, MD,g Konstantinos Spargias, MD,h William W. O’Neill, MD,i

Martin K.C. Ng, MBBS, PHD,j Neil P. Fam, MD,k Michael J. Rinaldi, MD,l Robert L. Smith, MD,b

Darren L. Walters, MBBS,m Christopher O. Raffel, MBBS,m Justin Levisay, MD,n Azeem Latib, MD,o

Matteo Montorfano, MD,p Leo Marcoff, MD,g Maithili Shrivastava, PHD,q Robert Boone, MD,a

Suzanne Gilmore, MPIA,q Ted E. Feldman, MD,n,q D. Scott Lim, MDr

ABSTRACT

OBJECTIVES The authors report the CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study)

expanded experience, 1-year outcomes, and analysis by functional mitral regurgitation (FMR) and degenerative mitral

regurgitation (DMR).

BACKGROUND The 30-day results from the CLASP study of the PASCAL transcatheter valve repair system for clinically

significant mitral regurgitation (MR) have been previously reported.

METHODS Eligible patients had symptomatic MR $3þ, were receiving optimal medical therapy, and were deemed

candidates for transcatheter mitral repair by the local heart team. Primary endpoints included procedural success, clinical

success, and major adverse event rate at 30 days. Follow-up was continued to 1 year.

RESULTS One hundred nine patients were treated (67% FMR, 33% DMR); the mean age was 75.5 years, and 57% were in

New York Heart Association functional class III or IV. At 30 days, there was 1 cardiovascular death (0.9%), MR #1þ was

achieved in 80% of patients (77% FMR, 86% DMR) and MR#2þ in 96% (96% FMR, 97% DMR), 88% of patients were in

New York Heart Association functional class I or II, 6-min walk distance had improved by 28 m, and Kansas City Cardio-

myopathy Questionnaire score had improved by 16 points (p < 0.001 for all). At 1 year, Kaplan-Meier survival was 92%

(89% FMR 96%DMR) with 88% freedom from heart failure hospitalization (80% FMR, 100% DMR), MR was#1þ in 82%

of patients (79% FMR, 86% DMR) and #2þ in 100% of patients, 88% of patients were in New York Heart Association

functional class I or II, and Kansas City Cardiomyopathy Questionnaire score had improved by 14 points (p < 0.001 for all).

CONCLUSIONS The PASCAL transcatheter valve repair system demonstrated a low complication rate and high survival,

with robust sustained MR reduction accompanied by significant improvements in functional status and quality of life at

1 year. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study [CLASP]; NCT03170349)

(J Am Coll Cardiol Intv 2020;13:2344–57) © 2020 by the American College of Cardiology Foundation.

ISSN 1936-8798/$36.00 https://doi.org/10.1016/j.jcin.2020.06.019

From the aSt. Paul’s Hospital, Vancouver, British Columbia, Canada; bBaylor Scott and White The Heart Hospital Plano, Plano,

Texas; cMarienkrankenhaus, Hamburg, Germany; dSunnybrook Health Sciences Centre, Toronto, Ontario, Canada; eLos Robles

Regional Medical Center, Thousand Oaks, California; fCedars-Sinai Medical Center, Los Angeles, California; gAtlantic Health

System Morristown Medical Center, Morristown, New Jersey; hHygeia Hospital, Athens, Greece; iHenry Ford Hospital, Detroit,

Michigan; jRoyal Prince Alfred Hospital, Camperdown, Australia; kSt. Michael’s Hospital, Toronto, Ontario, Canada; lSanger Heart

& Vascular Institute, Charlotte, North Carolina; mThe Prince Charles Hospital, Chermside, Australia; nNorthShore University

Health System, Evanston Hospital, Evanston, Illinois; oMontefiore Medical Center, Bronx, New York; pSan Raffaele Institute,

Milan, Italy; qEdwards Lifesciences, Irvine, California; and the rUniversity of Virginia Health System Hospital, Charlottesville,

Virginia. This study was funded by Edwards Lifesciences. Drs. Lim, Fam, Webb, and Schäfer have received speaking honoraria,

travel support, or grant support from Edwards Lifesciences. Drs. O’Neill, Ng, and Smith have received grant support from Edwards

Lifesciences. Drs. Szerlip, Spargias, and Marcoff are speakers or consultants for Edwards Lifesciences. Dr. Feldman, Dr. Shriv-

astava, and Ms. Gilmore are employees of Edwards Lifesciences. Dr. Rinaldi teaches courses and is a proctor, speaker, and

consultant for Abbott Vascular; is an advisory board member, a consultant, and a speaker for Boston Scientific; has received

J A C C : C A R D I O V A S C U L A R I N T E R V E N T I O N S V O L . 1 3 , N O . 2 0 , 2 0 2 0

ª 2 0 2 0 B Y T H E A M E R I C A N C O L L E G E O F C A R D I O L O G Y F O U N D A T I O N

P U B L I S H E D B Y E L S E V I E R

Downloaded for Anonymous User (n/a) at Henry Ford Hospital / Henry Ford Health System (CS North America) from ClinicalKey.com by Elsevier on November 06, 2020.For personal use only. No other uses without permission. Copyright ©2020. Elsevier Inc. All rights reserved.

https://clinicaltrials.gov/ct2/show/NCT03170349

https://doi.org/10.1016/j.jcin.2020.06.019

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M itral regurgitation (MR) is the most preva-lent valvular disease in the United Statesand the second most common in Europe

(1,2). MR is associated with increased mortality andheart failure hospitalizations. Despite this, only 15%of patients with MR undergo mitral surgery (3–7).

Percutaneous technologies, including trans-catheter mitral valve repair and replacement devices,are under investigation for treating patients withfunctional MR (FMR) (8,9). The COAPT (Cardiovas-cular Outcomes Assessment of the MitraClip Percu-taneous Therapy for Heart Failure Patients WithFunctional Mitral Regurgitation) trial demonstrated asignificant reduction in hospitalizations for heartfailure and all-cause mortality in patients treatedwith the MitraClip (Abbott Vascular, Santa Clara,California) compared with medical therapy alone (10).

The PASCAL transcatheter valve repair system(Edwards Lifesciences, Irvine, California) is a leafletrepair therapy for the treatment of MR (11,12). ThePASCAL repair system uses 2 clasps and paddles toachieve plication of the mitral valve leaflets, whileplacing an anatomic spacer to fill the regurgitantorifice between the native valve leaflets. The claspsare adjustable for optimal leaflet positioning, and thecontoured paddles are designed to reduce leafletstress.

CLASP (Edwards PASCAL Transcatheter MitralValve Repair System Study) is an ongoing multi-center, multinational, single-arm, prospective studyof the safety, performance, and outcomes of thePASCAL repair system to treat patients with grade 3þor 4þ MR. The first report of 30-day outcomes for 62patients revealed reduced MR severity, improvedfunctional status, increased exercise capacity, andimproved quality of life, with 98% of participantsachieving grade 2þ or less MR (12). One-year out-comes are detailed in this report.

METHODS

PATIENT SELECTION AND STUDY CONDUCT.

Eligible patients were $18 years of age with symp-tomatic grade 3þ or 4þ MR as confirmed by

echocardiograms reviewed by the core labo-ratory prior to enrollment. All patients werein New York Heart Association (NYHA) func-tional class II, III, or ambulatory IV despiteoptimal medical therapy and deemed appro-priate candidates for transcatheter mitralvalve repair by the local multidisciplinaryheart team, including specialists in heartfailure, interventional cardiology, cardiacsurgery, and imaging. Echocardiographiceligibility criteria included presence of anoncommissural primary regurgitant jet withabsence of a clinically significant secondaryjet and left ventricular (LV) ejectionfraction $20%. Patients with FMR etiology weresubjected to additional eligibility criteria re-quirements of 6-min walk distance (6MWD) $150 mand #400 m within 2 months prior to intervention,brain natriuretic peptide >150 pg/ml or corrected N-terminal pro–brain natriuretic peptide >600 pg/mlmeasured within 3 months prior to enrollment, orheart failure hospitalization within 1 year priorto enrollment.

Patients were excluded because of mitral valvearea <4.0 cm2 as measured by planimetry; LV end-diastolic diameter >8.0 cm; previous mitral valvesurgery or transcatheter procedure; severe aorticstenosis (aortic valve area <1.0 cm2) or regurgitation;severe tricuspid valve regurgitation; untreated sig-nificant coronary artery disease, unstable angina,myocardial infarction (MI), transient ischemic attack,or stroke within 30 days prior to intervention; andpercutaneous cardiovascular intervention, carotidsurgery, cardiovascular surgery, rhythm managementdevice implantation, or atrial fibrillation ablationwithin 90 days prior to intervention. Other exclusioncriteria have been previously detailed (12).

Patient eligibility was evaluated by a multidisci-plinary central eligibility committee. All echocardio-grams were analyzed by an independent corelaboratory (Cardiovascular Core Lab at MorristownMedical Center, Morristown, New Jersey), and allmajor adverse events (MAEs) were adjudicated by anindependent clinical events committee. The studywas approved by local ethics committees andrespective health authorities of the participating

SEE PAGE 2358

AB BR E V I A T I O N S

AND ACRONYM S

6MWD = 6-min walk distance

DMR = degenerative mitral

regurgitation

FMR = functional mitral

regurgitation

LV = left ventricular

MAE = major adverse event

MI = myocardial infarction

MR = mitral regurgitation

NYHA = New York Heart

Association

a research grant from Boston Scientific; and teaches courses and is a consultant, proctor, and speaker for Edwards Lifesciences. All

other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ in-

stitutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit

the JACC: Cardiovascular Interventions author instructions page.

Manuscript received May 11, 2020; revised manuscript received June 1, 2020, accepted June 9, 2020.

J A C C : C A R D I O V A S C U L A R I N T E R V E N T I O N S V O L . 1 3 , N O . 2 0 , 2 0 2 0 Webb et al.O C T O B E R 2 6 , 2 0 2 0 : 2 3 4 4 – 5 7 CLASP Study 1-Year Outcomes

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http://interventions.onlinejacc.org/content/instructions-authors

CENTRAL ILLUSTRATION PASCAL Transcatheter Mitral Valve Repair System With 1-YearSurvival and Echocardiographic Outcomes From the Edwards PASCAL Transcatheter Mitral ValveRepair System Study

Kaplan-Meier Survival Analysis

Overall 623824

583523

573423

543222

FMRDMR

1 Year6 MonthsTime from Implant

No. at Risk:

30 Days0

60

70

80

90

100

100 ± 0% 100 ± 0%98 ± 2% 97 ± 2%97 ± 3% 95 ± 4%

96 ± 4%92 ± 4%89 ± 5%

Surv

ival

(%)

B

p < 0.001n = 50

p < 0.001n = 29

p < 0.001n = 21

34%

66%66%

21%

14%42%

24%

58%

14%

62%

Mitral Regurgitation

0

20

40

60

80

100

Patie

nts (

%)

C

44%

57%

18%

64%

18%

Baselinen = 62

1 Yearn = 50

Overall

82%100%

Baselinen = 24

1 Yearn = 21

Degenerative MitralRegurgitation

86%100%

Baselinen = 38

1 Yearn = 29

Functional MitralRegurgitation

79%100%

Severe (4+) Moderate-Severe (3+) Mild-Moderate (2+) Mild (1+) None/Trace (0-1+)

A PASCAL Transcatheter Mitral Valve Repair System(1) Optimized leaflet

capture(2) Broad paddles and spacer

for effective mitral regurgitation reduction

(3) Elongation for safesubvalvular maneuvering

Webb, J.G. et al. J Am Coll Cardiol Intv. 2020;13(20):2344–57.

(A) PASCAL transcatheter mitral valve repair system. (B) Kaplan-Meier survival analysis. (C) Reduction in mitral regurgitation. Graphs show

unpaired data. The p values were calculated using the Wilcoxon signed rank test for paired patients (n).

Webb et al. J A C C : C A R D I O V A S C U L A R I N T E R V E N T I O N S V O L . 1 3 , N O . 2 0 , 2 0 2 0

CLASP Study 1-Year Outcomes O C T O B E R 2 6 , 2 0 2 0 : 2 3 4 4 – 5 7

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countries. All patients provided written informedconsent. The study was conducted in conformity withthe Declaration of Helsinki, Good Clinical Practiceprinciples, and ISO 14155:2011. The study is sponsoredby Edwards Lifesciences and registered at Clinical-Trials.gov (NCT03170349).

THE PASCAL TRANSCATHETER VALVE REPAIR SYSTEM.

The PASCAL repair system allows transcatheter mitralvalve repair by using clasps, paddles, and a spacer(12). The clasps and paddles gently grasp leaflets tofacilitate coaptation, while the spacer is intended tofill the regurgitant orifice area and prevent backflow,thus reducing MR. The clasps can be operated eithersimultaneously or independently to facilitate opti-mized leaflet capture, especially in complex anato-mies. The broad contoured paddles are designed tomaximize leaflet coaptation and minimize stressconcentration on native leaflets. The low-profile de-livery system consists of a 22-F guide sheath, with 3independent catheters that facilitate simplifiedmaneuvering in 3 different planes and stabilizers thatlock catheter handles in place for procedural ease.

During instances of implant repositioning, thePASCAL repair system also allows elongation of theimplant for low-profile and atraumatic maneuveringwithin the subvalvular anatomy (Central Illustration).

THE PASCAL IMPLANTATION PROCEDURE.

Transvenous, transseptal access to the left atrium isobtained using standard percutaneous techniques.The guide sheath with introducer is inserted over the

TABLE 1 Baseline Characteristics

Overall (N ¼ 109) FMR (n ¼ 73) DMR (n ¼ 36)

Age (yrs) 75.5 � 11.0 73.1 � 11.6 80.5 � 7.7

Male 54.1 (59) 54.8 (40) 52.8 (19)

NYHA functional class III or IV 57.4 (62) 60.3 (44) 51.4 (18)

NT-proBNP (pg/ml) 4148.7 � 6430.8 (36) 5122.3 � 7271.9 (26) 1617.2 � 2018.9 (10)

eGFR (ml/min/1.73 m2) 59.0 � 20.5 (99) 59.1 � 20.8 (67) 58.8 � 20.2 (32)

Mitral annular calcification mild or less 96.3 (105) 97.3 (71) 94.4 (34)

Vena contracta width, A-P (mm) 6.3 � 1.4 (97) 6.2 � 1.4 (67) 6.7 � 1.5 (30)

Jet width, commissural (mm) 13.3 � 3.8 (89) 13.7 � 3.6 (62) 12.5 � 4.1 (27)

ComorbiditiesHypertension 73.4 (80) 72.6 (53) 75.0 (27)Pulmonary hypertension 19.3 (21) 16.4 (12) 25.0 (9)Cardiomyopathy 54.5 (54) 70.3 (45) 25.7 (9)Previous myocardial infarction 33.9 (37) 39.7 (29) 22.2 (8)Prior TIA or stroke 15.6 (17) 19.2 (14) 8.3 (3)Aortic valve disease* 41.7 (43) 42.0 (29) 41.2 (14)Pulmonic valve disease† 40.4 (44) 45.2 (33) 30.6 (11)Tricuspid valve disease 60.6 (66) 65.8 (48) 50.0 (18)Coronary artery disease 44.0 (48) 56.2 (41) 19.4 (7)Heart failure 59.6 (65) 64.4 (47) 50.0 (18)AV block, first degree or greater 22.9 (25) 21.9 (16) 25.0 (9)Diabetes 29.4 (32) 32.9 (24) 22.2 (8)Renal disease 26.6 (29) 27.4 (20) 25.0 (9)Chronic lung disease 6.4 (7) 8.2 (6) 2.8 (1)

MedicationsACE inhibitors or angiotensin receptor blockers 54.1 (59) 57.5 (42) 47.2 (17)Beta-blockers 72.5 (79) 87.7 (64) 41.7 (15)Diuretic agents 86.2 (94) 87.7 (64) 83.3 (30)Aldosterone antagonist agents 12.8 (14) 16.4 (12) 5.6 (2)

Values are mean � SD (n) or % (n). *Aortic valve disease includes regurgitation and stenosis. †Pulmonic valve disease includes rheumatic, syncope, and thromboembolic.Tricuspid valve disease includes regurgitation and stenosis.

ACE ¼ angiotensin-converting enzyme; A-P ¼ anteroposterior; AV ¼ atrioventricular; DMR ¼ degenerative mitral regurgitation; eGFR ¼ estimated glomerular filtration rate;FMR ¼ functional mitral regurgitation; NT-proBNP ¼ N-terminal pro–brain natriuretic peptide; NYHA ¼ New York Heart Association; TIA ¼ transient ischemic attack.

TABLE 2 Procedural Measures

Overall (N ¼ 109) FMR (n ¼ 73) DMR (n ¼ 36)

Successful implantation 95 (104) 96 (70) 94 (34)

Time from skin incision to femoralvein access closure (min)

128.2 � 59.6 (109) 134.1 � 65.2 (73) 116.3 � 44.9 (36)

Fluoroscopy duration (min) 34.8 � 25.1 (109) 36.2 � 26.9 (73) 31.9 � 20.9 (36)

Contrast volume, if used (ml) 20.6 � 21.7 (17) 24.6 � 24.2 (12) 11.2 � 11.1 (5)

Number of devices implanted, mean 1.4 1.5 1.3

Length of hospital stay (days)* 2.4 � 3.3 (108) 2.5 � 3.8 (72) 2.2 � 2.1 (36)

Patients discharged home 93.5 (101) 91.7 (66) 97.2 (35)

Values are % (n) or mean � SD (n). *Study procedure date to hospital discharge date.

Abbreviations as in Table 1.


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https://clinicaltrials.gov/ct2/show/NCT03170349

guidewire and positioned securely across the septumusing the flex mechanism. The implant system isinserted into the guide sheath using a loader andadvanced until the PASCAL implant exits the distalend of the guide sheath. Using transesophagealechocardiographic guidance, the steerable catheterand guide sheath are maneuvered until the implant isappropriately centered in the target leaflet coaptationzone and aligned with the mitral annular plane. Theimplant catheter within the steerable catheter isadvanced across the mitral valve, and the implant isopened in the capture-ready position. Implantposition and leaflet capture are confirmed by sys-tematically assessing the residual MR and trans-valvular gradient. The implant can be adjusted asnecessary to achieve optimal desired outcome beforefinal deployment.

STUDY ENDPOINTS. The primary safety endpointwas a composite of MAEs, defined as cardiovascularmortality, stroke, MI, new need for renal replacementtherapy, severe bleeding (major, extensive, life-threatening, or fatal bleeding, as defined by theMitral Valve Academic Research Consortium) (13),and reintervention for study device–related compli-cations at 30 days.

The primary performance endpoints included pro-cedural success and clinical success. Procedural suc-cess was defined as at least 1 device deployedand delivery system successfully retrieved asintended at the time of the patient’s exit from thecardiac catheterization laboratory and evidenceof MR reduction #2þ without the need for a surgicalor percutaneous intervention prior to hospital

discharge. Clinical success was defined as proceduralsuccess with absence of MAEs at 30 days.

Secondary endpoints included MR reduction,MAEs, all-cause mortality, recurrent heart failurehospitalization, and reintervention rates for MR at 1year. Clinical outcomes included change in NYHAfunctional class, 6MWD, and quality-of-life score asmeasured using the Kansas City CardiomyopathyQuestionnaire and EuroQoL–5 Dimension at 30 daysand 1 year.

ECHOCARDIOGRAPHIC ASSESSMENT. Transthoracic echo-cardiography and transesophageal echocardiographywere performed and their results assessed by an in-dependent core laboratory (Cardiovascular Core Labat Morristown Medical Center) for patient screening,baseline, and follow-up evaluations according to corelaboratory protocols and American Society of Echo-cardiography guidelines (13–16), previouslydescribed (12). Patients with mixed etiology werefurther assessed by the core laboratory for determi-nation of predominant FMR or degenerative MR(DMR) and included in the respective etiologyfor analysis.

STATISTICAL ANALYSIS. Continuous variables arepresented as mean � SD and categorical variables aspercentages. Comparison between a specific timepoint and baseline was statistically analyzed usingpaired Student’s t-tests for continuous variables andWilcoxon signed rank tests for categorial variables.Analysis of variance was used for analyses of trans-valvular gradient. Significance tests were 2 tailed at aconfidence level of 95%. Delta values were calculatedusing paired analyses. Event-free rate was estimatedusing Kaplan-Meier survival method, and the stan-dard error was calculated using the exponentialGreenwood method (17). The duration of follow-up issummarized as median (interquartile range). All an-alyses were performed using SAS version 9.4 (SASInstitute, Cary, North Carolina).

RESULTS

Between June 2017 and September 2019, 109 patientswere treated at 14 sites worldwide, inclusive of roll-inpatients. We previously reported 30-day results from62 patients, which supported Conformité Européennemark approval of the PASCAL repair system for mitralvalve reconstruction (12). We currently report theexpanded 30-day experience with 109 patients fromthe ongoing CLASP study, 1-year follow-up of the 62patients, and analysis by FMR and DMR etiologies.For the 62 patients, the median duration of follow-upis 596 days (interquartile range: 544 to 642 days).

TABLE 3 Clinical Events Committee–Adjudicated Events at 30 Days and 1 Year

MAE

Overall FMR DMR

30 Days(N ¼ 109)

1 Year(N ¼ 62)

30 Days(n ¼ 73)

1 Year(n ¼ 38)

30 Days(n ¼ 36)

1 Year(n ¼ 24)

Cardiovascular mortality 0.9 (1) 6.5 (4) 1.4 (1) 10.5 (4) 0.0 (0) 0.0 (0)

Stroke 0.9 (1) 0.0 (0) 1.4 (1) 0.0 (0) 0.0 (0) 0.0 (0)

Myocardial infarction 0.0 (0) 1.6 (1) 0.0 (0) 0.0 (0) 0.0 (0) 4.2 (1)

New need for renalreplacement therapy

0.0 (0) 0.0 (0) 0.0 (0) 0.0 (0) 0.0 (0) 0.0 (0)

Severe bleeding* 7.3 (8) 9.7 (6) 9.6 (7) 15.8 (6) 2.8 (1) 0.0 (0)

Reintervention for study device–related complications

0.9 (1) 1.6 (1) 1.4 (1) 2.6 (1) 0.0 (0) 0.0 (0)

Composite MAE rate 8.3 (9) 14.5 (9) 11.0 (8) 21.1 (8) 2.8 (1) 4.2 (1)

Other events

All-cause mortality 0.9 (1) 8.1 (5) 1.4 (1) 10.5 (4) 0.0 (0) 4.2 (1)

Heart failure rehospitalization 0.9 (1) 11.3 (7) 1.4 (1) 18.4 (7) 0.0 (0) 0.0 (0)

Values are % (n). *Major, extensive, life-threatening, or fatal bleeding defined by the Mitral Valve AcademicResearch Consortium.

MAE ¼ major adverse event; other abbreviations as in Table 1.



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Baseline characteristics are provided in Table 1. Inthe overall patient population, the mean age was 75.5years, 54% were men, and the mean Society ofThoracic Surgeons score was 4.7%. All patients hadMR grade 3þ or 4þ, with 57% of patients in NYHAfunctional class III or IV. Etiologic classificationresulted in 67 patients (61.5%) with FMR, 34 (31.2%)with DMR, and 8 (7.3%) with mixed disease. The casesof mixed disease were further assessed by the corelaboratory and categorized as either predominantlyFMR (n ¼ 6) or DMR (n ¼ 2), resulting in a total of 73patients (67%) with FMR and 36 patients (33%) withDMR for analysis.PROCEDURAL OUTCOMES. Successful implantationwas achieved in 104 patients (95%). Of the 5 unsuc-cessful implantations, there were 3 cases of inability

to adequately grasp leaflets to allow desirable MRreduction, 1 case of unsuitable venous anatomy, and 1case of single-leaflet device attachment that wassuccessfully converted to surgical mitral valvereplacement. Among patients who underwent suc-cessful implantation, the mean number of implantswas 1.4 per patient, with 49% of patients receiving 1implant, 45% receiving 2 implants, and 2% receiving 3implants. The mean time from skin incision tofemoral vein access closure was 128 min. Only 16% ofprocedures required contrast media, with a meanvolume of 20.6 ml. The mean length of hospital staywas 2.4 days, and 94% of patients were dischargedhome. The overall procedural success rate was 94%(100 of 107 patients). Additional procedural measuresare provided in Table 2.

FIGURE 1 Kaplan-Meier Estimates of Survival and Freedom From Heart Failure Hospitalization at 1 Year

(A) Survival; (B) freedom from heart failure hospitalization. DMR ¼ degenerative mitral regurgitation; FMR ¼ functional mitral regurgitation;

HF ¼ heart failure.


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CLINICAL OUTCOMES. Clinical success was achievedin 86.0% (92 of 107 patients). The primary safetyendpoint, defined as a composite MAE rate at 30 daysin 109 patients, was 8.3% (Table 3). At 30 days, therewas 1 cardiovascular death (0.9%) due to sequelaefrom contralateral arterial access-site bleeding

further complicated by disseminated intravascularcoagulation, as previously described (12). One patientexperienced a stroke (0.9%) presenting with cognitivedeficits 15 days post-procedure, confirmed bycomputed tomography as an ischemic stroke with amodified Rankin Scale score of 1 and adjudicated as

FIGURE 2 Severity of Mitral Regurgitation at 30 Days and 1 Year

(A) Overall population; (B) FMR cohort; (C) DMR cohort. Graphs show unpaired data. The p values were calculated using the Wilcoxon signed

rank test for paired patients (n). †1 patient had mitral regurgitation grade 1þ by transthoracic echocardiography but 3þ by transesophageal

echocardiography. Abbreviations as in Figure 1.



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possibly procedure related. There was no MI or newneed for renal replacement therapy. One patient hada surgical reintervention (0.9%) because of single-leaflet device attachment as previously described.Severe bleeding occurred in 8 patients (7.3%). Anal-ysis by etiology revealed that all events at 30 daysoccurred in the FMR population except for 1 bleedingevent in the DMR population. In the patients withDMR, there was no cardiovascular mortality, stroke,MI, new need for renal replacement therapy, orreintervention at 30 days.

At 1-year follow-up in 62 patients, there were 2additional cardiovascular deaths between 30 daysand 1 year, resulting in a 1-year cardiovascular mor-tality rate of 6.5%. No late stroke, reintervention, ornew need for renal replacement therapy occurred.One patient experienced an MI (1.6%), which wasadjudicated as unrelated to the device or procedure.Two severe bleeding events occurred between30 days and 1 year. Analysis by etiology revealed allevents at 1 year occurred in the FMR population

except 1 MI in the DMR population. In the patientswith DMR, there was no cardiovascular mortality,stroke, new need for renal replacement therapy, se-vere bleeding, or reintervention at 1 year.

The all-cause mortality rate at 1 year was 8.1%.Kaplan-Meier 1-year survival estimates for the over-all, FMR, and DMR populations were 92%, 89%, and96%, respectively.

The heart failure hospitalization rate at 1 year was12%. Freedom from heart failure hospitalizations at 1year for the overall, FMR, and DMR populations was88%, 80%, and 100%, respectively (Figure 1).

ECHOCARDIOGRAPHIC RESULTS. At 30 days, 80% ofpatients had MR #1þ and 96% of patients hadMR #2þ (p < 0.001 vs. baseline). In the 62 patients at1 year, 82% of patients had MR #1þ and 100% hadMR #2þ (p < 0.001) (Figure 2). In the FMR populationat 30 days, 77% of patients achieved MR #1þ and 96%MR #2þ. At 1 year, 79% achieved MR #1þ and 100%MR #2þ. In the patients with DMR at 30 days, 86% ofpatients achieved MR #1þ and 97% MR #2þ. At 1

TABLE 4 Echocardiographic Outcomes at 30 Days and 1 Year: Overall

Baseline (n ¼ 109) 30 Days (n ¼ 109) p Value Baseline (n ¼ 62) 1 Year (n ¼ 62) p Value

LV end-diastolic diameter (mm) 61.2 � 7.9 (108) 58.5 � 8.6 (104) <0.001 59.4 � 6.9 (61) 56.1 � 7.8 (49) <0.001

LV end-diastolic volume (ml) 176.9 � 59.5 (94) 164.5 � 62.0 (88) 0.001 168.8 � 47.3 (54) 147.2 � 45.6 (43) <0.001

Ejection fraction (%) 44.9 � 14.4 (109) 44.0 � 13.6 (105) 0.009 46.7 � 13.8 (62) 46.4 � 12.8 (50) 0.044

PISA EROA (cm2)* 0.38 � 0.16 (88) 0.17 � 0.21 (24) <0.001 0.39 � 0.17 (46) 0.16 � 0.06 (6) NA

Mean gradient (mm Hg) 2.3 � 1.0 (93) 3.9 � 1.7 (103) <0.001 2.3 � 0.9 (52) 4.0 � 1.9 (50) <0.001

Regurgitant volume (ml)* 57.2 � 20.6 (86) 24.9 � 19.1 (24) <0.001 59.7 � 24.3 (45) 24.8 � 8.8 (6) NA

Vena contracta width, A-P (mm) 6.3 � 1.4 (97) 4.4 � 1.2 (43) <0.001 6.0 � 1.1 (52) 4.1 � 1.4 (22) 0.001

PASP (mm Hg) 45.8 � 12.9 (99) 42.0 � 11.2 (87) 0.004 45.5 � 13.3 (56) 40.9 � 11.5 (42) 0.169

Values are mean � SD (n). The p values were calculated using Student’s t-test or the Wilcoxon signed rank test compared with baseline. *Number of measurements was limitedbecause of the difficulty of measuring small regurgitant volumes. Bold values indicate statistical significance.

A-P ¼ anteroposterior; EROA ¼ effective regurgitant orifice area; LV ¼ left ventricular; NA ¼ not applicable because of small sample size; PASP ¼ pulmonary artery systolicpressure; PISA ¼ proximal isovelocity surface area.

TABLE 5 Echocardiographic Outcomes at 30 Days and 1 Year: Functional Mitral Regurgitation


LV end-diastolic diameter (mm) 64.4 � 6.7 (72) 61.7 � 7.7 (69) <0.001 62.7 � 6.2 (37) 59.1 � 7.9 (29) <0.001

LV end-diastolic volume (ml) 194.3 � 58.6 (64) 186.4 � 62.4 (57) 0.045 186.1 � 47.3 (33) 166.1 � 47.1 (25) 0.007

Ejection fraction (%) 37.7 � 10.5 (73) 37.1 � 9.6 (70) 0.113 38.6 � 10.2 (38) 39.5 � 10.4 (29) 0.847

PISA EROA (cm2)* 0.33 � 0.11 (61) 0.19 � 0.25 (16) 0.004 0.32 � 0.10 (29) 0.17 � 0.07 (4) NA


Regurgitant volume (ml)* 49.9 � 13.1 (61) 24.7 � 22.3 (16) <0.001 47.2 � 11.3 (29) 25.6 � 10.5 (4) NA

Vena contracta width, A-P (mm) 6.2 � 1.4 (67) 4.5 � 1.2 (25) <0.001 5.7 � 0.9 (32) 4.0 � 1.3 (13) 0.021

PASP (mm Hg) 46.0 � 12.1 (66) 42.9 � 11.9 (57) 0.049 45.7 � 11.3 (34) 41.7 � 11.2 (26) 0.454




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year, 86% of patients with DMR had MR #1þ and100% MR #2þ.

Echocardiographic measurements for overall pa-tients are shown in Tables 4 to 6. There were signifi-cant reductions in all echocardiographic MR indexesat 30 days. Proximal isovelocity surface area effectiveregurgitant orifice area decreased from 0.38 to0.17 cm2 (p < 0.001), regurgitant volume decreasedfrom 57.5 to 24.9 ml (p < 0.001), and LV end-diastolicdiameter decreased from 61.2 to 58.5 mm (p < 0.001).At 1 year, LV end-diastolic diameter showed a sus-tained reduction from 59.4 to 56.1 mm (p < 0.001).Significant improvements were observed at 30 daysand 1 year in both the FMR and DMR populations(Tables 5 and 6).

At 30 days, patients with $2 implants showedhigher mean transvalvular gradients (4.4 mm Hg;p ¼ 0.03) compared with patients with 1 implant(3.6 mm Hg).

FUNCTIONAL AND QUALITY-OF-LIFE OUTCOMES.

At 30 days, 88% of patients were in NYHA functionalclass I or II (p < 0.001 vs. baseline) (Figure 3). Func-tional improvements were sustained at 1 year, with88% of patients in NYHA functional class I or II(p < 0.001 vs. baseline). Mean 6MWD (Figure 4)increased by 28 m at 30 days (p < 0.001). In patientswith 1-year follow-up, 6MWD showed sustainedimprovement of 21 m (p ¼ 0.124). Average Kansas CityCardiomyopathy Questionnaire score (Figure 5A)improved by 16 points at 30 days (p < 0.001) andshowed sustained improvement of 14 points at 1 year(p < 0.001). Mean EuroQoL–5 Dimension score(Figure 5B) improved by 11 points at 30 days(p < 0.001), with sustained improvement of 6points at 1 year (p ¼ 0.0788). Similar functional andquality-of-life improvements were observed in theFMR and DMR populations.

DISCUSSION

The results with the PASCAL repair system in theCLASP study demonstrate favorable clinical andechocardiographic results in a heterogeneous popu-lation of patients with FMR and DMR. MAE rates werelow at 30 days and 1 year, and MR was reduced to #2þin 96% and 100% of patients, and #1þ in 80% and82%, respectively. There was a significant reductionin all echocardiographic MR indexes and resultant LVreverse remodeling with a significant reduction inboth LV end-diastolic diameter and volume. One-yearmortality was 8%, and heart failure hospitalizationsat 1 year were only 12%. Functional status andquality-of-life indexes were also significantlyimproved. These results compare favorably withexperience with other transcatheter mitral valverepair devices (10,18–20).

The COAPT trial examined the use of the MitraClipsystem in patients with severe FMR (10). Althoughthe 2 studies cannot be compared directly because ofdifferent trial designs and populations, two-thirds ofCLASP patients were treated for FMR. At 1 year, thereduction in MR grade to #2þ and #1þ was seen in100% and 79% of CLASP patients with FMR (n ¼ 73)versus 95% and 69% reported in COAPT (n ¼ 273). Thereduction in NYHA functional class to I or II at 1 yearwas seen in 83% of CLASP patients with FMR versus72% in COAPT patients.

The EXPAND (n ¼ 422) and EVEREST (n ¼ 82)studies reported the use of the MitraClip system inpatients with DMR at 30 days and 1 year, respec-tively (18,21). At 30 days, the reduction in MR gradeto #2þ was seen in 97% and NYHA functional classI or II in 88% of CLASP patients with DMR (n ¼ 36),similar to EXPAND, which reported 97% of patientswith MR grade #2þ and 84% in NYHA functionalclass I or II. One-year outcomes in the CLASP

TABLE 6 Echocardiographic Outcomes at 30 Days and 1 Year: Degenerative Mitral Regurgitation


LV end-diastolic diameter (mm) 54.8 � 6.0 (36) 52.1 � 6.5 (35) 0.003 54.4 � 4.6 (24) 51.7 � 5.4 (20) 0.041

LV end-diastolic volume (ml) 139.6 � 42.2 (30) 124.1 � 35.6 (31) 0.003 141.7 � 32.8 (21) 121.1 � 27.5 (18) 0.004

Ejection fraction (%) 59.6 � 9.1 (36) 57.8 � 9.4 (35) 0.026 59.5 � 7.9 (24) 56.0 � 9.1 (21) <0.001

PISA EROA (cm2)* 0.49 � 0.19 (27) 0.13 � 0.06 (8) NA 0.51 � 0.19 (17) 0.14 � 0.05 (2) NA


Regurgitant volume (ml)* 75.3 � 24.5 (25) 25.5 � 11.3 (8) NA 82.4 � 25.5 (16) 23.3 � 7.4 (2) NA

Vena contracta width, A-P (mm) 6.7 � 1.5 (30) 4.4 � 1.2 (18) <0.001 6.6 � 1.2 (20) 4.2 � 1.6 (9) NA

PASP (mm Hg) 45.4 � 14.7 (33) 40.3 � 9.6 (30) 0.029 45.2 � 16.2 (22) 39.6 � 12.3 (16) 0.224





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FIGURE 3 Functional Outcomes at 30 Days and 1 Year

Graphs show unpaired data. The p values were calculated using the Wilcoxon signed rank test for paired patients (n). (A) Overall population;

(B) FMR cohort; (C) DMR cohort. Abbreviations as in Figure 1.


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FIGURE 4 6-Minute Walk Distance at 30 Days and 1 Year

(A) Overall population; (B) FMR cohort; (C) DMR cohort. Mean � 95% confidence interval. Graphs show unpaired data. The p values were

calculated using Student’s t-test for paired patients (n). Delta values are for paired patients corresponding to p values.



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patients with DMR (n ¼ 24) continued to be favor-able, with 100% of patients achieving MRgrade #2þ and 95% in NYHA functional class I or IIcompared with EVEREST, which reported 83% pa-tients with MR grade #2þ and 87% in NYHA func-tional class I or II.

Achieving a suboptimal reduction in MR post-implantation has been shown to result in poor clin-ical outcomes in both surgical and transcathetertreatment of severe MR, emphasizing the need toachieve MR #1þ (22–24). There are now increasingtranscatheter options for severe MR, includingtranscatheter mitral valve replacement, which haveshown very low rates of significant residual MR(8,25,26). As such, there are theoretical design ad-vantages to the PASCAL repair system. The maneu-verability of the PASCAL repair system simplifiesnavigation into the left atrium, while the broadpaddles, spacer, and ability to independently cap-ture leaflets help achieve reduction of MR with nodetrimental impact on post-procedural mitral valvegradient. Previous results suggest that these uniquefeatures of the PASCAL repair system allow treat-ment of patients with challenging mitral anatomies,such as short posterior leaflets and flail and prolapsegaps >10 mm, for which other transcatheter thera-pies were judged inappropriate (11). Hence, thePASCAL repair system may potentially increase the

number of patients eligible for transcatheter mitralvalve repair.

Characteristics of the PASCAL repair system alsomay allow a reduction in the number of implantsrequired, thereby reducing procedural time andcomplexity. The mean number of devices implantedin the COAPT trial was 1.7 per patient, with 62% ofpatients requiring more than 1 device. In the CLASPstudy, the mean number of devices implanted overalland in patients with FMR was 1.4 and 1.5 per patient,with 47% and 54% requiring more than 1 device,respectively. Patients with $2 implants still main-tained mean gradients <5 mm Hg.

STUDY LIMITATIONS. This study was limited by thesample size of the overall population and commen-surately by that of each etiology. The sample sizes forsome quantitative echocardiographic measurementswere limited in part because of technological diffi-culty in measuring small regurgitant volumes, butthis is also likely reflective of general limitations inobtaining consistent and high-quality imaging in thisstudy. The study protocol did not stipulate datacollection regarding medications at discharge andduring the follow-up period. Therefore, thesedata were not collected during the course of the trial.One-year follow-up was achieved by a subset ofpatients, and continued follow-up will be important.

FIGURE 5 KCCQ and EQ5D Scores at 30 Days and 1 Year

KCCQ p<0.001(n=106; ∆=16)

p<0.001(n=51; ∆=14)100

80

60

40

20

0Over

all s

core

(poi

nts)

5571

5570

Baseline Baseline30 days 1 yearn=109 n=106 n=62 n=51

Overall

p<0.001(n=71; ∆=15)

p=0.002(n=30; ∆=13)100

80

60

40

20

0Over

all s

core

(poi

nts)

6954 53

66


FMR

p<0.001(n=35; ∆=18)

p=0.001(n=21; ∆=15)100

80

60

40

20

0Over

all s

core

(poi

nts)

7658 59 75


DMR

p<0.001(n=102; ∆=11)

p=0.079(n=50; ∆=6)100

80

60

40

20

0Over

all s

core

(poi

nts)

7564 65

73


Overall

EQ5D p<0.001(n=68; ∆=10)

p=0.676(n=30; ∆=2)100

80

60

40

20

0Over

all s

core

(poi

nts)

7363 62 67


FMR

p<0.001(n=34; ∆=14)

p=0.004(n=21; ∆=11)

100

80

60

40

20

0Over

all s

core

(poi

nts)

7966 69

81


DMR

A

B

(A) KCCQ score (overall population, FMR cohort, DMR cohort). (B) EQ5D score (overall population, FMR cohort, DMR cohort). Mean � 95% confidence interval. Graphs

show unpaired data. P values were calculated using Student’s t-test for paired patients (n). Delta values are for paired patients corresponding to p values.

EQ5D ¼ EuroQoL–5 Dimension; KCCQ ¼ Kansas City Cardiomyopathy Questionnaire.


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CONCLUSIONS

At 1 year, the PASCAL transcatheter repair systemresulted in high survival and low complication rateswith robust and sustained MR reduction, accompa-nied by significant improvements in functional statusand quality of life. Analysis by etiology showedsimilar favorable results in patients with FMR orDMR. The CLASP IID/IIF randomized clinical trial isunder way.

ACKNOWLEDGMENTS The authors thank Dr. Pra-shanthi Vandrangi, Dr. Min Tang, Johnny Wu, andThomas Greene from Edwards Lifesciences for theirsupport.

ADDRESS FOR CORRESPONDENCE: Dr. John G.Webb, St. Paul’s Hospital, 1081 Burrard Street, Van-couver, British Columbia V6Z 1Y6, Canada. E-mail:[email protected].

RE F E RENCE S

1. Nkomo VT, Gardin JM, Skelton TN,Gottdiener JS, Scott CG, Enriquez-Sarano M.Burden of valvular heart diseases: a population-based study. Lancet 2006;368:1005–11.

2. Lung B, Fondard O, Gilon D, et al. Predic-tion of operative mortality during valve sur-gery. Lessons from the Euro Heart Survey onvalvular heart disease. Eur Heart J 2004;25:656.

3. Dziadzko V, Clavel MA, Dziadzko M, et al.Outcome and undertreatment of mitral regurgi-tation: a community cohort study. Lancet 2018;391:960–9.

4. Baumgartner H, Falk V, Bax JJ, et al. 2017ESC/EACTS guidelines for the management ofvalvular heart disease. Eur Heart J 2017;38:2739–91.

5. Nishimura RA, Otto CM, Bonow RO, et al.2017 AHA/ACC focused update of the 2014AHA/ACC guideline for the management ofpatients with valvular heart disease: a report ofthe American College of Cardiology/AmericanHeart Association Task Force on Clinical Prac-tice Guidelines. J Am Coll Cardiol 2017;70:252–89.

6. Sannino A, Smith RL II, Schiattarella GG,Trimarco B, Esposito G, Grayburn PA. Survivaland cardiovascular outcomes of patients withsecondary mitral regurgitation: a systematic re-view and meta-analysis. JAMA Cardiol 2017;2:1130–9.

7. Goliasch G, Bartko PE, Pavo N, et al. Refiningthe prognostic impact of functional mitral

regurgitation in chronic heart failure. Eur Heart J2018;39:39–46.

8. Webb JG, Murdoch DJ, Boone RH, et al.Percutaneous transcatheter mitral valve replace-ment: First-in-human experience with a newtransseptal system. J Am Coll Cardiol 2019;73:1239–46.

9. Sorajja P, Leon MB, Adams DH, Webb JG,Farivar RS. Transcatheter therapy for mitralregurgitation clinical challenges and potential so-lutions. Circulation 2017;136:404–17.

10. Stone GW, Lindenfeld J, Abraham WT, et al.Transcatheter mitral-valve repair in patients withheart failure. N Engl J Med 2018;379:2307–18.

11. Praz F, Spargias K, Chrissoheris M, et al.Compassionate use of the PASCAL transcathetermitral valve repair system for patients with severemitral regurgitation: a multicentre, prospective,observational, first-in-man study. Lancet 2017;390:773–80.

12. Lim DS, Kar S, Spargias K, et al. Transcathetervalve repair for patients with mitral regurgitation30-day results of the CLASP study. J Am CollCardiol Intv 2019;12:1369–78.

13. Stone GW, Adams DH, Abraham WT, et al.Clinical trial design principles and endpoint defi-nitions for transcatheter mitral valve repair andreplacement: part 2: endpoint definitions: aconsensus document from the Mitral Valve Aca-demic Research Consortium. J Am Coll Cardiol2015;66:308–21.

14. Zoghbi WA, Adams D, Bonow RO, et al. Rec-ommendations for noninvasive evaluation of

native valvular regurgitation: a report from theAmerican Society of Echocardiography developedin collaboration with the Society for Cardiovascu-lar Magnetic Resonance. J Am Soc Echocardiogr2017;30:303–71.

15. Biaggi P, Felix C, Gruner C, et al. Assessment ofmitral valve area during percutaneous mitral valverepair using the MitraClip system: comparison ofdifferent echocardiographic methods. Circ Car-diovasc Imaging 2013;6:1032–40.

16. Altiok E, Hamada S, Brehmer K, et al. Analysisof procedural effects of percutaneous edge-to-edge mitral valve repair by 2D and 3D echocar-diography. Circ Cardiovasc Imaging 2012;5:748–55.

17. Klein JP, Logan B, Harhoff M, Andersen PK.Analyzing survival curves at a fixed point in time.Stat Med 2007;26:4505–19.

18. Lim T, Kar S, Reynolds R, et al. Improvedfunctional status and quality of life in prohibitivesurgical risk patients with degenerative mitralregurgitation after transcatheter mitral valverepair. J Am Coll Cardiol 2014;64:182–92.

19. Messika-Zeitoun D, Nickenig G, Latib A, et al.Transcatheter mitral valve repair for functionalmitral regurgitation using the Cardioband system:1 year outcomes. Eur Heart J 2019;40:466–72.

20. Obadia JF, Messika-Zeitoun D, Leurent G,et al. Percutaneous repair or medical treatment forsecondary mitral regurgitation. N Engl J Med2018;379:2297–306.

21. Lim S, Rottbauer W, Mahoney P, et al.Contemporary outcomes with MitraClip� (NTR/

PERSPECTIVES

WHAT IS KNOWN? Severe MR can lead to mortality

and poor quality of life when untreated. Evidence for

transcatheter repair and replacement is growing, with

multiple therapeutic options now available.

WHAT IS NEW? The PASCAL repair system shows

favorable results in patients with symptomatic, clini-

cally significant MR. The study demonstrates

remarkable MR reduction, with 100% of patients

achieving MR #2þ, and 80% MR #1þ, sustained at 1

year. Results show high survival and low complication

rates and sustained improvements in functional status

and quality of life at 1 year.

WHAT IS NEXT? The CLASP IID/IIF randomized

clinical trial is under way.



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mailto:[email protected]

http://refhub.elsevier.com/S1936-8798(20)31345-5/sref1

































































































XTR) system in primary mitral regurgitation: re-sults from the global EXPAND study. Presented at:ACC.20/WCC Virtual Meeting; March 30, 2020.

22. Buzzatti N, De Bonis, Denti P, et al. Whatis a “good” result after transcatheter mitralrepair? Impact of 2þ residual mitral regurgi-tation. J Thorac Cardiovasc Surg 2016;151:88–96.

23. Sorajja P, Vemulapalli S, Feldman T, et al.Outcomes with transcatheter mitral valve repair in

the United States: an STS/ACC TVT Registryreport. J Am Coll Cardiol 2017;70:2315–27.

24. Suri RM, Clavel MA, Schaff HV, et al. Effect ofrecurrent mitral regurgitation following degener-ative mitral valve repair: long-term analysis ofcompeting outcomes. J Am Coll Cardiol 2016;67:488–98.

25. Bapat V, Rajagopal V, Meduri C, et al. Earlyexperience with new transcatheter mitral nalvereplacement. J Am Coll Cardiol 2018;71:12–21.

26. Muller DWM, Farivar RS, Jansz P, et al. Trans-catheter mitral valve replacement for patients withsymptomatic mitral regurgitation: a global feasi-bility trial. J Am Coll Cardiol 2017;69:381–91.

KEY WORDS CLASP, degenerativemitral regurgitation, functional mitralregurgitation, mitral regurgitation,mitral repair, PASCAL


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