Early outcomes from the CLASP IID trial roll‐in cohort for prohibitive risk patients with degenerative mitral regurgitation
| Autor: | Leo Marcoff, Josep Rodés-Cabau, Robert L. Smith, Ian J. Sarembock, Pinak B. Shah, George Petrossian, Howard C. Herrmann, Chad Kliger, Amit N. Vora, Susheel Kodali, Charles J. Davidson, Samir R. Kapadia, Homam Ibrahim, Linda D. Gillam, Abhijeet Dhoble, Andrew N. Rassi, Mayra Guerrero, Lowell F. Satler, David P. Lee, Paul Mahoney, D. Scott Lim, Adnan K. Chhatriwalla, Clasp Iid Pivotal Trial Investigators, Roger J. Laham, Mohamad Lazkani, William A. Gray, Konstantinos Koulogiannis, Adam Greenbaum, Firas Zahr, James B. Hermiller |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
medicine.medical_treatment 030204 cardiovascular system & hematology law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Quality of life law Internal medicine Mitral valve medicine Humans Radiology Nuclear Medicine and imaging Prospective Studies 030212 general & internal medicine Myocardial infarction Renal replacement therapy Stroke Aged 80 and over Heart Valve Prosthesis Implantation Mitral regurgitation business.industry Mitral Valve Insufficiency General Medicine medicine.disease Treatment Outcome medicine.anatomical_structure Cohort Quality of Life Cardiology and Cardiovascular Medicine business |
| Zdroj: | Catheterization and Cardiovascular Interventions. |
| ISSN: | 1522-726X 1522-1946 |
| DOI: | 10.1002/ccd.29749 |
| Popis: | OBJECTIVES We report the 30-day outcomes from the roll-in cohort of the CLASP IID trial, representing the first procedures performed by each site. BACKGROUND The currently enrolling CLASP IID/IIF pivotal trial is a multicenter, prospective, randomized trial assessing the safety and effectiveness of the PASCAL transcatheter valve repair system in patients with clinically significant MR. The trial allows for up to three roll-in patients per site. METHODS Eligibility criteria were: DMR ≥3+, prohibitive surgical risk, and deemed suitable for transcatheter repair by the local heart team. Trial oversight included a central screening committee and echocardiographic core laboratory. The primary safety endpoint was a 30-day composite MAE: cardiovascular mortality, stroke, myocardial infarction (MI), new need for renal replacement therapy, severe bleeding, and non-elective mitral valve re-intervention, adjudicated by an independent clinical events committee. Thirty-day echocardiographic, functional, and quality of life outcomes were assessed. RESULTS A total of 45 roll-in patients with mean age of 83 years and 69% in NYHA class III/IV were treated. Successful implantation was achieved in 100%. The 30-day composite MAE rate was 8.9% including one cardiovascular death (2.2%) due to severe bleeding from a hemorrhagic stroke, one MI, and no need for re-intervention. MR≤1+ was achieved in 73% and ≤2+ in 98% of patients. 89% of patients were in NYHA class I/II (p |
| Databáze: | OpenAIRE |
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