Author + information
- Received February 4, 2019
- Revision received April 8, 2019
- Accepted April 16, 2019
- Published online July 15, 2019.
- D. Scott Lim, MDa,∗ (, )
- Saibal Kar, MDb,
- Konstantinos Spargias, MDc,
- Robert M. Kipperman, MDd,
- William W. O’Neill, MDe,
- Martin K.C. Ng, MBBS, PhDf,
- Neil P. Fam, MDg,
- Darren L. Walters, MBBS, MPhilh,
- John G. Webb, MDi,
- Robert L. Smith, MDj,
- Michael J. Rinaldi, MDk,
- Azeem Latib, MDl,
- Gideon N. Cohen, MDm,
- Ulrich Schäfer, MDn,
- Leo Marcoff, MDd,
- Prashanthi Vandrangi, PhDo,
- Patrick Verta, MD, DVM, MS Stato and
- Ted E. Feldman, MDo,p
- aUniversity of Virginia Health System Hospital, Charlottesville, Virginia
- bCedars-Sinai Medical Center, Los Angeles, California
- cHygeia Hospital, Athens, Greece
- dAtlantic Health System Morristown Medical Center, Morristown, New Jersey
- eHenry Ford Hospital, Detroit, Michigan
- fRoyal Prince Alfred Hospital, Camperdown, Australia
- gSt. Michael’s Hospital, Toronto, Ontario, Canada
- hThe Prince Charles Hospital, Chermside, Australia
- iSt. Paul’s Hospital, Vancouver, British Columbia, Canada
- jThe Heart Hospital Baylor Plano, Plano, Texas
- kSanger Heart & Vascular Institute, Charlotte, North Carolina
- lSan Raffaele Institute, Milan, Italy
- mSunnybrook Health Sciences Centre, Toronto, Ontario, Canada
- nMarienkrankenhaus, Hamburg, Germany
- oEdwards Lifesciences, Irvine, California
- pNorthShore University Health System, Evanston Hospital, Evanston, Illinois
- ↵∗Address for correspondence:
Prof. D. Scott Lim, University of Virginia Health System Hospital, 1215 Lee Street, Hospital Expansion Room 4033, Charlottesville, Virginia 22908.
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)
This study was funded by Edwards Lifesciences. Drs. Lim, Fam, Webb, and Schäfer have received speaker honoraria and travel or grant support from Edwards Lifesciences. Drs. O’Neill and Smith have received grant support from Edwards Lifesciences. Dr. Leo Marcoff is a consultant for Edwards Lifesciences. Drs. Vandrangi, Verta, and Feldman are employees of Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received February 4, 2019.
- Revision received April 8, 2019.
- Accepted April 16, 2019.
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