Sammy Elmariah1, William F Fearon2, Ignacio Inglessis3, Gus J Vlahakes4, Brian R Lindman5, Maria C Alu6, Aaron Crowley6, Susheel Kodali7, Martin B Leon7, Lars Svensson8, Philippe Pibarot9, Rebecca T Hahn7, Vinod H Thourani10, Igor F Palacios3, D Craig Miller2, Pamela S Douglas11, Jonathan J Passeri3. 1. Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts; Baim Institute for Clinical Research, Boston, Massachusetts. Electronic address: selmariah@mgh.harvard.edu. 2. Division of Cardiovascular Medicine, Department of Medicine, Stanford University School of Medicine, Stanford, California. 3. Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. 4. Division of Cardiac Surgery, Department of Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. 5. Cardiovascular Medicine Division, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee. 6. Cardiovascular Research Foundation, New York, New York. 7. Cardiovascular Research Foundation, New York, New York; Division of Cardiology, Department of Medicine, Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York. 8. Department of Cardiothoracic Surgery, Cleveland Clinic Foundation, Cleveland, Ohio. 9. Department of Medicine, Québec Heart and Lung Institute, Laval University, Quebec City, Québec, Canada. 10. Department of Cardiac Surgery, Medstar Washington Hospital Center, Washington, DC. 11. Cardiology Division, Department of Medicine, Duke Clinical Research Institute/Duke University Medical Center, Durham, North Carolina.
Abstract
OBJECTIVES: The authors sought to evaluate the impact of transapical (TA) transcatheter aortic valve replacement (TAVR) on mortality, left ventricular (LV) ejection fraction (LVEF) improvement, and functional recovery in patients with LV dysfunction. BACKGROUND: LV injury inherent to TA access for structural heart disease interventions may be particularly detrimental to the LV, functional recovery, and survival in patients with LV dysfunction. METHODS: The study included patients enrolled within the PARTNER I (Placement of Aortic Transcatheter Valves) trial that underwent transfemoral (TF) or TA TAVR. Analyses of clinical outcomes were stratified by the presence of baseline LV dysfunction (LVEF<50%) and adjusted for the propensity of receiving TA TAVR. RESULTS:Of 2,084 subjects, 1,057 underwent TA TAVR. TA access was associated with increased 2-year all-cause mortality in those with (adjusted hazard ratio [HRadjusted]: 1.52; 95% confidence interval [CI]: 1.12 to 2.07; p = 0.008) and without (HRadjusted: 1.38; 95% CI: 1.10 to 1.74; p = 0.006) LV dysfunction. TA TAVR portended increased 2-year cardiac mortality in subjects with LVEF<50% (HRadjusted: 1.92; 95% CI: 1.21 to 3.05; p = 0.006), but not with LVEF≥50% (HRadjusted: 1.29; 95% CI: 0.87 to 1.90; p = 0.21). In those with LVEF<50%, greater improvements in LVEF (TF-TA difference +4.04%, 95% CI: 2.39% to 5.69%; p < 0.0001) and 6-min walk distance (TF-TA difference +45.1 m, 95% CI: 18.4 to 71.9 m; p = 0.001) occurred within 30 days after TF versus TA TAVR. CONCLUSIONS: Compared with TF TAVR, TA TAVR is associated with a disproportionate risk of cardiac mortality in patients with LV dysfunction and with delayed and less robust improvement in LV function and overall functional status. Caution is warranted when considering TA access for structural heart disease interventions, particularly in patients with LV dysfunction. (Placement of Aortic Transcatheter Valves [PARTNER]; NCT00530894).
RCT Entities:
OBJECTIVES: The authors sought to evaluate the impact of transapical (TA) transcatheter aortic valve replacement (TAVR) on mortality, left ventricular (LV) ejection fraction (LVEF) improvement, and functional recovery in patients with LV dysfunction. BACKGROUND:LV injury inherent to TA access for structural heart disease interventions may be particularly detrimental to the LV, functional recovery, and survival in patients with LV dysfunction. METHODS: The study included patients enrolled within the PARTNER I (Placement of Aortic Transcatheter Valves) trial that underwent transfemoral (TF) or TA TAVR. Analyses of clinical outcomes were stratified by the presence of baseline LV dysfunction (LVEF<50%) and adjusted for the propensity of receiving TA TAVR. RESULTS: Of 2,084 subjects, 1,057 underwent TA TAVR. TA access was associated with increased 2-year all-cause mortality in those with (adjusted hazard ratio [HRadjusted]: 1.52; 95% confidence interval [CI]: 1.12 to 2.07; p = 0.008) and without (HRadjusted: 1.38; 95% CI: 1.10 to 1.74; p = 0.006) LV dysfunction. TA TAVR portended increased 2-year cardiac mortality in subjects with LVEF<50% (HRadjusted: 1.92; 95% CI: 1.21 to 3.05; p = 0.006), but not with LVEF≥50% (HRadjusted: 1.29; 95% CI: 0.87 to 1.90; p = 0.21). In those with LVEF<50%, greater improvements in LVEF (TF-TA difference +4.04%, 95% CI: 2.39% to 5.69%; p < 0.0001) and 6-min walk distance (TF-TA difference +45.1 m, 95% CI: 18.4 to 71.9 m; p = 0.001) occurred within 30 days after TF versus TA TAVR. CONCLUSIONS: Compared with TF TAVR, TA TAVR is associated with a disproportionate risk of cardiac mortality in patients with LV dysfunction and with delayed and less robust improvement in LV function and overall functional status. Caution is warranted when considering TA access for structural heart disease interventions, particularly in patients with LV dysfunction. (Placement of Aortic Transcatheter Valves [PARTNER]; NCT00530894).
Authors: Laura Besola; Anson Cheung; Jian Ye; Myriam Akodad; Andrew Chatfield; Gnalini Sathananthan; Robert Moss; John Webb Journal: Ann Cardiothorac Surg Date: 2021-09