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. 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.
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.
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.
Authors: Angela McInerney; Luis Marroquin-Donday; Gabriela Tirado-Conte; Breda Hennessey; Carolina Espejo; Eduardo Pozo; Alberto de Agustín; Nieves Gonzalo; Pablo Salinas; Iván Núñez-Gil; Antonio Fernández-Ortiz; Hernan Mejía-Rentería; Fernando Macaya; Javier Escaned; Luis Nombela-Franco; Pilar Jiménez-Quevedo Journal: J Clin Med Date: 2022-05-22 Impact factor: 4.964
Authors: Zhang Xiling; Thomas Puehler; Lars Sondergaard; Derk Frank; Hatim Seoudy; Baland Mohammad; Oliver J Müller; Stephanie Sellers; David Meier; Janarthanan Sathananthan; Georg Lutter Journal: J Clin Med Date: 2022-06-13 Impact factor: 4.964
Authors: Rodrigo Estévez-Loureiro; Marta Tavares Da Silva; José Antonio Baz-Alonso; Berenice Caneiro-Queija; Manuel Barreiro-Pérez; Francisco Calvo-Iglesias; Rocio González-Ferreiro; Luis Puga; Miguel Piñón; Andrés Íñiguez-Romo Journal: Front Cardiovasc Med Date: 2022-09-23