Transcatheter reduction of paravalvular leaks: a systematic review and meta-analysis.
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.
Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Québec, Canada.
Xavier
X
Millán
Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Québec, Canada.
Sabah
S
Skaf
Division of Clinical Epidemiology, McGill University Health Centre, Montreal, Québec, Canada.
Lawrence
L
Joseph
Division of Structural and Congenital Heart Disease, Lenox Hill Heart and Vascular Institute-North Shore LIJ Health System, New York, New York, USA.
Carlos
C
Ruiz
Division of Interventional Cardiology, Hospital Universitario Clínico San Carlos, Madrid, Spain.
Eulogio
E
García
Division of Cardiology, Medical University of Silesia, Katowice, Poland.
Grzegorz
G
Smolka
Department of Medical Specialties, Cardiology Division, Université de Genève, Geneva, Switzerland.
Stéphane
S
Noble
Division of Interventional Cardiology, Hospital Universitario de Salamanca, Salamanca, Spain.
Ignacio
I
Cruz-González
Division of Interventional Cardiology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
Dabit
D
Arzamendi
Division of Interventional Cardiology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
Antoni
A
Serra
Division of Structural and Congenital Heart Disease, Lenox Hill Heart and Vascular Institute-North Shore LIJ Health System, New York, New York, USA.
Chad
C
Kliger
Centre Hospitalier Universitaire de Montréal, Université de Montréal, Montreal, Québec, Canada.
Ying Tung
YT
Sia
Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Québec, Canada.
Anita
A
Asgar
Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Québec, Canada.
Réda
R
Ibrahim
Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Québec, Canada. Electronic address: marc.jolicoeur@icm-mhi.org.
E Marc
EM
Jolicœur
D000743:Anemia, Hemolytic / Q000209:etiology; D002986:Clinical Trials as Topic; D017548:Echocardiography, Transesophageal; D019317:Evidence-Based Medicine; D006333:Heart Failure / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D006350:Heart Valve Prosthesis / Q000009:adverse effects; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects*; D006801:Humans; D008943:Mitral Valve / Q000601:surgery; D011475:Prosthesis Failure; D016032:Randomized Controlled Trials as Topic; D012086:Reoperation / Q000379:methods; D012307:Risk Factors; D016896:Treatment Outcome