Daisuke Ueshima1, Luca Nai Fovino1, Sorin J Brener2, Tommaso Fabris1, Andrea Scotti1, Alberto Barioli1, Daniele Giacoppo1, Andrea Pavei1, Chiara Fraccaro1, Massimo Napodano1, Giuseppe Tarantini3. 1. Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua Medical School, Padua, Italy. 2. Department of Medicine, Cardiac Catheterization Laboratory, New York-Presbyterian Brooklyn Methodist Hospital, Brooklyn, New York, United States of America. 3. Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua Medical School, Padua, Italy. Electronic address: giuseppe.tarantini.1@gmail.com.
Abstract
BACKGROUND: Subjects with bicuspid aortic valve (BAV) have been excluded from transcatheter aortic valve replacement (TAVR) randomized trials. METHODS: With this meta-analysis of observational studies we first compared TAVR outcomes of BAV vs. tricuspid aortic valve (TAV) patients, stratifying the results by device generation. Then, we looked for differences between balloon-expandable (BE) and self-expandable (SE) bioprostheses in BAV patients. Primary outcome was 30-day mortality. Secondary outcomes were 30-day stroke, moderate-severe paravalvular leakage, new pacemaker implantation, vascular complications and 1-year mortality. RESULTS: Thirteen studies (11,032 patients, 7291 TAV and 3741 BAV) and seven studies (706 patients, 367 treated with BE, 339 with SE valve) met inclusion criteria. Thirty-day (OR = 1.13; 95% CI 0.88-1.46, p = 0.33) and 1-year mortality (OR = 1.02; 95% CI 0.77-1.37, p = 0.87) were similar between patients receiving TAVR for BAV or TAV. Subjects treated for BAV were at higher risk of conversion to conventional surgery (OR = 2.35; 95% CI 1.30-4.23, p = 0.005), implantation of a second valve (OR = 2.06; 95% CI 1.31-3.25; p = 0.002), moderate/severe paravalvular leakage (PVL) (OR = 1.67; 95% CI 1.29-2.17; p = 0.0001) and device failure (OR = 1.26; 95% CI 1.02-1.56; p = 0.04). Rates of adverse events decreased significantly with the use of new-generation devices, but outcome differences remained consistent. BAV patients treated with BE vs. SE valves had similar 30-day and 1-year mortality, stroke and moderate-severe PVL. Balloon-expandable valves were associated with lower rates of a second valve and new pacemaker implantation but carried higher risk of annular rupture. CONCLUSIONS: BAV patients treated with TAVR had similar 30-day and 1-year mortality as well as stroke and new pacemaker implantation rates compared to TAV subjects, but carried higher risk of moderate/severe PVL, conversion to surgery and device failure. Event rates significantly decreased with the use of new-generation devices, but TAVR still showed better procedural results in TAV compared to BAV.
BACKGROUND: Subjects with bicuspid aortic valve (BAV) have been excluded from transcatheter aortic valve replacement (TAVR) randomized trials. METHODS: With this meta-analysis of observational studies we first compared TAVR outcomes of BAV vs. tricuspid aortic valve (TAV) patients, stratifying the results by device generation. Then, we looked for differences between balloon-expandable (BE) and self-expandable (SE) bioprostheses in BAVpatients. Primary outcome was 30-day mortality. Secondary outcomes were 30-day stroke, moderate-severe paravalvular leakage, new pacemaker implantation, vascular complications and 1-year mortality. RESULTS: Thirteen studies (11,032 patients, 7291 TAV and 3741 BAV) and seven studies (706 patients, 367 treated with BE, 339 with SE valve) met inclusion criteria. Thirty-day (OR = 1.13; 95% CI 0.88-1.46, p = 0.33) and 1-year mortality (OR = 1.02; 95% CI 0.77-1.37, p = 0.87) were similar between patients receiving TAVR for BAV or TAV. Subjects treated for BAV were at higher risk of conversion to conventional surgery (OR = 2.35; 95% CI 1.30-4.23, p = 0.005), implantation of a second valve (OR = 2.06; 95% CI 1.31-3.25; p = 0.002), moderate/severe paravalvular leakage (PVL) (OR = 1.67; 95% CI 1.29-2.17; p = 0.0001) and device failure (OR = 1.26; 95% CI 1.02-1.56; p = 0.04). Rates of adverse events decreased significantly with the use of new-generation devices, but outcome differences remained consistent. BAVpatients treated with BE vs. SE valves had similar 30-day and 1-year mortality, stroke and moderate-severe PVL. Balloon-expandable valves were associated with lower rates of a second valve and new pacemaker implantation but carried higher risk of annular rupture. CONCLUSIONS:BAVpatients treated with TAVR had similar 30-day and 1-year mortality as well as stroke and new pacemaker implantation rates compared to TAV subjects, but carried higher risk of moderate/severe PVL, conversion to surgery and device failure. Event rates significantly decreased with the use of new-generation devices, but TAVR still showed better procedural results in TAV compared to BAV.
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