Transcatheter Valve Repair for Patients With Mitral Regurgitation

30-Day Results of the CLASP Study

D. Scott Lim, Saibal Kar, Konstantinos Spargias, Robert Kipperman, William W. O'Neill, Martin K.C. Ng, Neil P. Fam, Darren L. Walters, John G. Webb, Robert L. Smith, Michael J. Rinaldi, A. Latib, Gideon N. Cohen, Ulrich Schäfer, Leo Marcoff, Prashanthi Vandrangi, Patrick Verta, T. E. Feldman

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Objectives: The authors report the procedural and 30-day results of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences, Irvine, California) in patients with mitral regurgitation (MR) enrolled in the multicenter, prospective, single-arm CLASP study. Background: Severe MR may lead to symptoms, impaired quality of life, and reduced functional capacity when untreated. Methods: Eligible patients had grade 3+ or 4+ MR despite optimal medical therapy and were deemed appropriate for the study by the local heart team. All outcomes were assessed through 30 days post-procedure. Major adverse events (MAEs) were adjudicated by an independent clinical events committee, and echocardiographic images were assessed by a core laboratory. The primary safety endpoint was the rate of MAEs at 30 days. Results: Between June 2017 and September 2018, 62 patients with grade 3+ or 4+ MR were enrolled. The mean age was 76.5 years, and 51.6% of patients were in New York Heart Association functional class III or IV, with 56% functional, 36% degenerative, and 8% mixed MR etiology. At 30 days, the MAE rate was 6.5%, with an all-cause mortality rate of 1.6% and no occurrence of stroke; 98% had MR grade ≤2+, with 86% with MR grade ≤1+ (p < 0.0001); and 85% were in New York Heart Association functional class I or II (p < 0.0001). Six-minute walk distance improved by 36 m (p = 0.0018), and Kansas City Cardiomyopathy Questionnaire and EQ-5D scores improved by 17 (p < 0.0001) and 10 (p = 0.0004) points, respectively. Conclusions: The PASCAL repair system showed feasibility and acceptable safety in the treatment of patients with grade 3+ or 4+ MR. MR severity, irrespective of etiology, was significantly reduced and accompanied by clinically and statistically significant improvements in functional status, exercise capacity, and quality of life. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study; NCT03170349)

Original languageEnglish (US)
Pages (from-to)1369-1378
Number of pages10
JournalJACC: Cardiovascular Interventions
Volume12
Issue number14
DOIs
StatePublished - Jul 22 2019

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Mitral Valve Insufficiency
Quality of Life
Safety
Cardiomyopathies
Mitral Valve
Stroke
Exercise
Mortality
Therapeutics

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Lim, D. Scott ; Kar, Saibal ; Spargias, Konstantinos ; Kipperman, Robert ; O'Neill, William W. ; Ng, Martin K.C. ; Fam, Neil P. ; Walters, Darren L. ; Webb, John G. ; Smith, Robert L. ; Rinaldi, Michael J. ; Latib, A. ; Cohen, Gideon N. ; Schäfer, Ulrich ; Marcoff, Leo ; Vandrangi, Prashanthi ; Verta, Patrick ; Feldman, T. E. / Transcatheter Valve Repair for Patients With Mitral Regurgitation : 30-Day Results of the CLASP Study. In: JACC: Cardiovascular Interventions. 2019 ; Vol. 12, No. 14. pp. 1369-1378.
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abstract = "Objectives: The authors report the procedural and 30-day results of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences, Irvine, California) in patients with mitral regurgitation (MR) enrolled in the multicenter, prospective, single-arm CLASP study. Background: Severe MR may lead to symptoms, impaired quality of life, and reduced functional capacity when untreated. Methods: Eligible patients had grade 3+ or 4+ MR despite optimal medical therapy and were deemed appropriate for the study by the local heart team. All outcomes were assessed through 30 days post-procedure. Major adverse events (MAEs) were adjudicated by an independent clinical events committee, and echocardiographic images were assessed by a core laboratory. The primary safety endpoint was the rate of MAEs at 30 days. Results: Between June 2017 and September 2018, 62 patients with grade 3+ or 4+ MR were enrolled. The mean age was 76.5 years, and 51.6{\%} of patients were in New York Heart Association functional class III or IV, with 56{\%} functional, 36{\%} degenerative, and 8{\%} mixed MR etiology. At 30 days, the MAE rate was 6.5{\%}, with an all-cause mortality rate of 1.6{\%} and no occurrence of stroke; 98{\%} had MR grade ≤2+, with 86{\%} with MR grade ≤1+ (p < 0.0001); and 85{\%} were in New York Heart Association functional class I or II (p < 0.0001). Six-minute walk distance improved by 36 m (p = 0.0018), and Kansas City Cardiomyopathy Questionnaire and EQ-5D scores improved by 17 (p < 0.0001) and 10 (p = 0.0004) points, respectively. Conclusions: The PASCAL repair system showed feasibility and acceptable safety in the treatment of patients with grade 3+ or 4+ MR. MR severity, irrespective of etiology, was significantly reduced and accompanied by clinically and statistically significant improvements in functional status, exercise capacity, and quality of life. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study; NCT03170349)",
author = "Lim, {D. Scott} and Saibal Kar and Konstantinos Spargias and Robert Kipperman and O'Neill, {William W.} and Ng, {Martin K.C.} and Fam, {Neil P.} and Walters, {Darren L.} and Webb, {John G.} and Smith, {Robert L.} and Rinaldi, {Michael J.} and A. Latib and Cohen, {Gideon N.} and Ulrich Sch{\"a}fer and Leo Marcoff and Prashanthi Vandrangi and Patrick Verta and Feldman, {T. E.}",
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Lim, DS, Kar, S, Spargias, K, Kipperman, R, O'Neill, WW, Ng, MKC, Fam, NP, Walters, DL, Webb, JG, Smith, RL, Rinaldi, MJ, Latib, A, Cohen, GN, Schäfer, U, Marcoff, L, Vandrangi, P, Verta, P & Feldman, TE 2019, 'Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study', JACC: Cardiovascular Interventions, vol. 12, no. 14, pp. 1369-1378. https://doi.org/10.1016/j.jcin.2019.04.034

Transcatheter Valve Repair for Patients With Mitral Regurgitation : 30-Day Results of the CLASP Study. / Lim, D. Scott; Kar, Saibal; Spargias, Konstantinos; Kipperman, Robert; O'Neill, William W.; Ng, Martin K.C.; Fam, Neil P.; Walters, Darren L.; Webb, John G.; Smith, Robert L.; Rinaldi, Michael J.; Latib, A.; Cohen, Gideon N.; Schäfer, Ulrich; Marcoff, Leo; Vandrangi, Prashanthi; Verta, Patrick; Feldman, T. E.

In: JACC: Cardiovascular Interventions, Vol. 12, No. 14, 22.07.2019, p. 1369-1378.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Transcatheter Valve Repair for Patients With Mitral Regurgitation

T2 - 30-Day Results of the CLASP Study

AU - Lim, D. Scott

AU - Kar, Saibal

AU - Spargias, Konstantinos

AU - Kipperman, Robert

AU - O'Neill, William W.

AU - Ng, Martin K.C.

AU - Fam, Neil P.

AU - Walters, Darren L.

AU - Webb, John G.

AU - Smith, Robert L.

AU - Rinaldi, Michael J.

AU - Latib, A.

AU - Cohen, Gideon N.

AU - Schäfer, Ulrich

AU - Marcoff, Leo

AU - Vandrangi, Prashanthi

AU - Verta, Patrick

AU - Feldman, T. E.

PY - 2019/7/22

Y1 - 2019/7/22

N2 - Objectives: The authors report the procedural and 30-day results of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences, Irvine, California) in patients with mitral regurgitation (MR) enrolled in the multicenter, prospective, single-arm CLASP study. Background: Severe MR may lead to symptoms, impaired quality of life, and reduced functional capacity when untreated. Methods: Eligible patients had grade 3+ or 4+ MR despite optimal medical therapy and were deemed appropriate for the study by the local heart team. All outcomes were assessed through 30 days post-procedure. Major adverse events (MAEs) were adjudicated by an independent clinical events committee, and echocardiographic images were assessed by a core laboratory. The primary safety endpoint was the rate of MAEs at 30 days. Results: Between June 2017 and September 2018, 62 patients with grade 3+ or 4+ MR were enrolled. The mean age was 76.5 years, and 51.6% of patients were in New York Heart Association functional class III or IV, with 56% functional, 36% degenerative, and 8% mixed MR etiology. At 30 days, the MAE rate was 6.5%, with an all-cause mortality rate of 1.6% and no occurrence of stroke; 98% had MR grade ≤2+, with 86% with MR grade ≤1+ (p < 0.0001); and 85% were in New York Heart Association functional class I or II (p < 0.0001). Six-minute walk distance improved by 36 m (p = 0.0018), and Kansas City Cardiomyopathy Questionnaire and EQ-5D scores improved by 17 (p < 0.0001) and 10 (p = 0.0004) points, respectively. Conclusions: The PASCAL repair system showed feasibility and acceptable safety in the treatment of patients with grade 3+ or 4+ MR. MR severity, irrespective of etiology, was significantly reduced and accompanied by clinically and statistically significant improvements in functional status, exercise capacity, and quality of life. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study; NCT03170349)

AB - Objectives: The authors report the procedural and 30-day results of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences, Irvine, California) in patients with mitral regurgitation (MR) enrolled in the multicenter, prospective, single-arm CLASP study. Background: Severe MR may lead to symptoms, impaired quality of life, and reduced functional capacity when untreated. Methods: Eligible patients had grade 3+ or 4+ MR despite optimal medical therapy and were deemed appropriate for the study by the local heart team. All outcomes were assessed through 30 days post-procedure. Major adverse events (MAEs) were adjudicated by an independent clinical events committee, and echocardiographic images were assessed by a core laboratory. The primary safety endpoint was the rate of MAEs at 30 days. Results: Between June 2017 and September 2018, 62 patients with grade 3+ or 4+ MR were enrolled. The mean age was 76.5 years, and 51.6% of patients were in New York Heart Association functional class III or IV, with 56% functional, 36% degenerative, and 8% mixed MR etiology. At 30 days, the MAE rate was 6.5%, with an all-cause mortality rate of 1.6% and no occurrence of stroke; 98% had MR grade ≤2+, with 86% with MR grade ≤1+ (p < 0.0001); and 85% were in New York Heart Association functional class I or II (p < 0.0001). Six-minute walk distance improved by 36 m (p = 0.0018), and Kansas City Cardiomyopathy Questionnaire and EQ-5D scores improved by 17 (p < 0.0001) and 10 (p = 0.0004) points, respectively. Conclusions: The PASCAL repair system showed feasibility and acceptable safety in the treatment of patients with grade 3+ or 4+ MR. MR severity, irrespective of etiology, was significantly reduced and accompanied by clinically and statistically significant improvements in functional status, exercise capacity, and quality of life. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study; NCT03170349)

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