Xavier Millán1, Sabah Skaf1, Lawrence Joseph2, Carlos Ruiz3, Eulogio García4, Grzegorz Smolka5, Stéphane Noble6, Ignacio Cruz-González7, Dabit Arzamendi8, Antoni Serra8, Chad Kliger3, Ying Tung Sia9, Anita Asgar1, Réda Ibrahim1, E Marc Jolicœur10. 1. Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Québec, Canada. 2. Division of Clinical Epidemiology, McGill University Health Centre, Montreal, Québec, Canada. 3. Division of Structural and Congenital Heart Disease, Lenox Hill Heart and Vascular Institute-North Shore LIJ Health System, New York, New York, USA. 4. Division of Interventional Cardiology, Hospital Universitario Clínico San Carlos, Madrid, Spain. 5. Division of Cardiology, Medical University of Silesia, Katowice, Poland. 6. Department of Medical Specialties, Cardiology Division, Université de Genève, Geneva, Switzerland. 7. Division of Interventional Cardiology, Hospital Universitario de Salamanca, Salamanca, Spain. 8. Division of Interventional Cardiology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain. 9. Centre Hospitalier Universitaire de Montréal, Université de Montréal, Montreal, Québec, Canada. 10. Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Québec, Canada. Electronic address: marc.jolicoeur@icm-mhi.org.
Abstract
BACKGROUND: Significant paravalvular leak (PVL) after surgical valve replacement can result in intractable congestive heart failure and hemolytic anemia. Because repeat surgery is performed in only few patients, transcatheter reduction of PVL is emerging as an alternative option, but its safety and efficacy remain uncertain. In this study we sought to assess whether a successful transcatheter PVL reduction is associated with an improvement in clinical outcomes. METHODS: We identified 12 clinical studies that compared successful and failed transcatheter PVL reductions in a total of 362 patients. A Bayesian hierarchical meta-analysis was performed using cardiac mortality as a primary end point. The combined occurrence of improvement in New York Heart Association functional class or hemolytic anemia and the need for repeat surgery, were used as secondary end points. RESULTS: A successful transcatheter PVL reduction was associated with a lower cardiac mortality rate (odds ratio [OR], 0.08; 95% credible interval [CrI], 0.01-0.90) and with a superior improvement in functional class or hemolytic anemia, compared with a failed intervention (OR, 9.95; 95% CrI, 2.10-66.73). Fewer repeat surgeries were also observed after successful procedures (OR, 0.08; 95% CrI, 0.01-0.40). CONCLUSIONS: A successful transcatheter PVL reduction is associated with reduced all-cause mortality and improved functional class in patients deemed unsuitable for surgical correction.
BACKGROUND: Significant paravalvular leak (PVL) after surgical valve replacement can result in intractable congestive heart failure and hemolytic anemia. Because repeat surgery is performed in only few patients, transcatheter reduction of PVL is emerging as an alternative option, but its safety and efficacy remain uncertain. In this study we sought to assess whether a successful transcatheter PVL reduction is associated with an improvement in clinical outcomes. METHODS: We identified 12 clinical studies that compared successful and failed transcatheter PVL reductions in a total of 362 patients. A Bayesian hierarchical meta-analysis was performed using cardiac mortality as a primary end point. The combined occurrence of improvement in New York Heart Association functional class or hemolytic anemia and the need for repeat surgery, were used as secondary end points. RESULTS: A successful transcatheter PVL reduction was associated with a lower cardiac mortality rate (odds ratio [OR], 0.08; 95% credible interval [CrI], 0.01-0.90) and with a superior improvement in functional class or hemolytic anemia, compared with a failed intervention (OR, 9.95; 95% CrI, 2.10-66.73). Fewer repeat surgeries were also observed after successful procedures (OR, 0.08; 95% CrI, 0.01-0.40). CONCLUSIONS: A successful transcatheter PVL reduction is associated with reduced all-cause mortality and improved functional class in patients deemed unsuitable for surgical correction.
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