Dhaval Kolte1, Gus J Vlahakes2, Igor F Palacios1, Rahul Sakhuja1, Jonathan J Passeri1, Ignacio Inglessis1, Sammy Elmariah3. 1. Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. 2. Cardiac Surgery Division, Department of Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. 3. Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: selmariah@mgh.harvard.edu.
Abstract
BACKGROUND: Transcatheter aortic valve replacement (TAVR) has emerged as a safe and effective therapeutic option for patients with severe aortic stenosis (AS) who are at prohibitive, high, or intermediate risk for surgical aortic valve replacement (SAVR). However, in low-risk patients, SAVR remains the standard therapy in current clinical practice. OBJECTIVES: This study sought to perform a meta-analysis of randomized controlled trials (RCTs) comparing TAVR versus SAVR in low-risk patients. METHODS: Electronic databases were searched from inception to March 20, 2019. RCTs comparing TAVR versus SAVR in low-risk patients (Society of Thoracic Surgeons Predicted Risk of Mortality [STS-PROM] score <4%) were included. Primary outcome was all-cause death at 1 year. Random-effects models were used to calculate pooled risk ratio (RR) and corresponding 95% confidence interval (CI). RESULTS: The meta-analysis included 4 RCTs that randomized 2,887 patients (1,497 to TAVR and 1,390 to SAVR). The mean age of patients was 75.4 years, and the mean STS-PROM score was 2.3%. Compared with SAVR, TAVR was associated with significantly lower risk of all-cause death (2.1% vs. 3.5%; RR: 0.61; 95% CI: 0.39 to 0.96; p = 0.03; I2 = 0%) and cardiovascular death (1.6% vs. 2.9%; RR: 0.55; 95% CI: 0.33 to 0.90; p = 0.02; I2 = 0%) at 1 year. Rates of new/worsening atrial fibrillation, life-threatening/disabling bleeding, and acute kidney injury stage 2/3 were lower, whereas those of permanent pacemaker implantation and moderate/severe paravalvular leak were higher after TAVR versus SAVR. There were no significant differences between TAVR versus SAVR for major vascular complications, endocarditis, aortic valve re-intervention, and New York Heart Association functional class ≥II. CONCLUSIONS: In this meta-analysis of RCTs comparing TAVR versus SAVR in low-risk patients, TAVR was associated with significantly lower risk of all-cause death and cardiovascular death at 1 year. These findings suggest that TAVR may be the preferred option over SAVR in low-risk patients with severe AS who are candidates for bioprosthetic AVR.
BACKGROUND: Transcatheter aortic valve replacement (TAVR) has emerged as a safe and effective therapeutic option for patients with severe aortic stenosis (AS) who are at prohibitive, high, or intermediate risk for surgical aortic valve replacement (SAVR). However, in low-risk patients, SAVR remains the standard therapy in current clinical practice. OBJECTIVES: This study sought to perform a meta-analysis of randomized controlled trials (RCTs) comparing TAVR versus SAVR in low-risk patients. METHODS: Electronic databases were searched from inception to March 20, 2019. RCTs comparing TAVR versus SAVR in low-risk patients (Society of Thoracic Surgeons Predicted Risk of Mortality [STS-PROM] score <4%) were included. Primary outcome was all-cause death at 1 year. Random-effects models were used to calculate pooled risk ratio (RR) and corresponding 95% confidence interval (CI). RESULTS: The meta-analysis included 4 RCTs that randomized 2,887 patients (1,497 to TAVR and 1,390 to SAVR). The mean age of patients was 75.4 years, and the mean STS-PROM score was 2.3%. Compared with SAVR, TAVR was associated with significantly lower risk of all-cause death (2.1% vs. 3.5%; RR: 0.61; 95% CI: 0.39 to 0.96; p = 0.03; I2 = 0%) and cardiovascular death (1.6% vs. 2.9%; RR: 0.55; 95% CI: 0.33 to 0.90; p = 0.02; I2 = 0%) at 1 year. Rates of new/worsening atrial fibrillation, life-threatening/disabling bleeding, and acute kidney injury stage 2/3 were lower, whereas those of permanent pacemaker implantation and moderate/severe paravalvular leak were higher after TAVR versus SAVR. There were no significant differences between TAVR versus SAVR for major vascular complications, endocarditis, aortic valve re-intervention, and New York Heart Association functional class ≥II. CONCLUSIONS: In this meta-analysis of RCTs comparing TAVR versus SAVR in low-risk patients, TAVR was associated with significantly lower risk of all-cause death and cardiovascular death at 1 year. These findings suggest that TAVR may be the preferred option over SAVR in low-risk patients with severe AS who are candidates for bioprosthetic AVR.
Authors: Lizette N Abraham; Kirstine L Sibilitz; Selina K Berg; Lars H Tang; Signe S Risom; Jane Lindschou; Rod S Taylor; Britt Borregaard; Ann-Dorthe Zwisler Journal: Cochrane Database Syst Rev Date: 2021-05-07
Authors: Robert Adam; Alice Munteanu; Raluca Mititelu; Sebastian Onciul; Dan Deleanu; Vlad Anton Iliescu; Bogdan A Popescu; Ruxandra Jurcut Journal: Clin Interv Aging Date: 2020-10-02 Impact factor: 4.458
Authors: Ahmed A Kolkailah; Rami Doukky; Marc P Pelletier; Annabelle S Volgman; Tsuyoshi Kaneko; Ashraf F Nabhan Journal: Cochrane Database Syst Rev Date: 2019-12-20
Authors: Varsha K Tanguturi; Brian R Lindman; Philippe Pibarot; Jonathan J Passeri; Samir Kapadia; Michael J Mack; Ignacio Inglessis; Nathan B Langer; Thoralf M Sundt; Judy Hung; Sammy Elmariah Journal: JACC Cardiovasc Interv Date: 2020-06-01 Impact factor: 11.195