2-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study

Molly Szerlip; Konstantinos S Spargias; Raj Makkar; Saibal Kar; Robert M Kipperman; William W O'Neill; Martin K C Ng; Robert L Smith; Neil P Fam; Michael J Rinaldi; O Christopher Raffel; Darren L Walters; Justin Levisay; Matteo Montorfano; Azeem Latib; John D Carroll; Georg Nickenig; Stephan Windecker; Leo Marcoff; Gideon N Cohen; Ulrich Schäfer; John G Webb; D Scott Lim

doi:10.1016/j.jcin.2021.04.001

2-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study

JACC Cardiovasc Interv. 2021 Jul 26;14(14):1538-1548. doi: 10.1016/j.jcin.2021.04.001. Epub 2021 May 18.

Authors

Molly Szerlip¹, Konstantinos S Spargias², Raj Makkar³, Saibal Kar⁴, Robert M Kipperman⁵, William W O'Neill⁶, Martin K C Ng⁷, Robert L Smith⁸, Neil P Fam⁹, Michael J Rinaldi¹⁰, O Christopher Raffel¹¹, Darren L Walters¹¹, Justin Levisay¹², Matteo Montorfano¹³, Azeem Latib¹⁴, John D Carroll¹⁵, Georg Nickenig¹⁶, Stephan Windecker¹⁷, Leo Marcoff⁵, Gideon N Cohen¹⁸, Ulrich Schäfer¹⁹, John G Webb²⁰, D Scott Lim²¹

Affiliations

¹ Department of Cardiology, Baylor Scott and White The Heart Hospital Plano, Plano, Texas, USA. Electronic address: molly.szerlip@bswhealth.org.
² Department of Cardiology, Hygeia Hospital, Athens, Greece.
³ Department of Interventional Cardiology, Cedars-Sinai Medical Center, Los Angeles, California, USA.
⁴ Department of Cardiology, Los Robles Regional Medical Center, Thousand Oaks, California, USA.
⁵ Department of Cardiology, Atlantic Health System Morristown Medical Center, Morristown, New Jersey, USA.
⁶ Department of Cardiology, Henry Ford Hospital, Detroit, Michigan, USA.
⁷ Department of Interventional Cardiology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.
⁸ Department of Cardiology, Baylor Scott and White The Heart Hospital Plano, Plano, Texas, USA.
⁹ Department of Cardiology, St. Michael's Hospital, Toronto, Ontario, Canada.
¹⁰ Department of Interventional Cardiology, Sanger Heart and Vascular Institute, Charlotte, North Carolina, USA.
¹¹ Department of Interventional Cardiology, The Prince Charles Hospital, Chermside, Queensland, Australia.
¹² Department of Interventional Cardiology, NorthShore University Health System, Evanston Hospital, Evanston, Illinois, USA.
¹³ Department of Interventional Cardiology, San Raffaele Institute, Milan, Italy.
¹⁴ Department of Interventional Cardiology, Montefiore Medical Center, Bronx, New York, USA.
¹⁵ Department of Interventional Cardiology, University of Colorado, Aurora, Colorado, USA.
¹⁶ Department of Internal Medicine, University Hospital Bonn, Bonn, Germany.
¹⁷ Department of Cardiology, Bern University Hospital, Bern, Switzerland.
¹⁸ Department of Cardiac Surgery, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
¹⁹ Department of Internal Medicine, Marienkrankenhaus, Hamburg, Germany.
²⁰ Department of Interventional Cardiology, St. Paul's Hospital, Vancouver, British Columbia, Canada.
²¹ Department of Cardiovascular Medicine, University of Virginia Health System Hospital, Charlottesville, Virginia, USA.

PMID: 34020928
DOI: 10.1016/j.jcin.2021.04.001

Abstract

Objectives: This study reports 2-year outcomes from the multicenter, prospective, single-arm CLASP study with functional mitral regurgitation (FMR) and degenerative MR (DMR) analysis.

Background: Transcatheter repair is a favorable option to treat MR. Long-term prognostic impact of the PASCAL transcatheter valve repair system in patients with clinically significant MR remains to be established.

Methods: Patients had clinically significant MR ≥3+ as evaluated by the echocardiographic core laboratory and were deemed candidates for transcatheter repair by the heart team. Assessments were performed by clinical events committee to 1 year (site-reported thereafter) and core laboratory to 2 years.

Results: A total of 124 patients (69% FMR, 31% DMR) were enrolled with a mean age of 75 years, 56% were male, 60% were New York Heart Association functional class III to IVa, and 100% had MR ≥3+. At 2 years, Kaplan-Meier estimates showed 80% survival (72% FMR, 94% DMR) and 84% freedom from heart failure (HF) hospitalization (78% FMR, 97% DMR), with 85% reduction in annualized HF hospitalization rate (81% FMR, 98% DMR). MR ≤1+ was achieved in 78% of patients (84% FMR, 71% DMR) and MR ≤2+ was achieved in 97% (95% FMR, 100% DMR) (all p < 0.001). Left ventricular end-diastolic volume decreased by 33 ml (p < 0.001); 93% of patients were in New York Heart Association functional class I to II (p < 0.001).

Conclusions: The PASCAL repair system demonstrated sustained favorable outcomes at 2 years in FMR and DMR patients. Results showed high survival and freedom from HF rehospitalization rates with a significantly reduced annualized HF hospitalization rate. Durable MR reduction was achieved with evidence of left ventricular reverse remodeling and significant improvement in functional status. The CLASP IID/IIF randomized pivotal trial is ongoing.

Keywords: CLASP study; PASCAL; degenerative mitral regurgitation; functional mitral regurgitation; mitral regurgitation; mitral repair.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Heart Valve Prosthesis Implantation* / adverse effects
Humans
Male
Mitral Valve / diagnostic imaging
Mitral Valve / surgery
Mitral Valve Insufficiency* / diagnostic imaging
Mitral Valve Insufficiency* / surgery
Prospective Studies
Treatment Outcome