Author + information
- Received April 3, 2019
- Revision received June 19, 2019
- Accepted June 24, 2019
- Published online September 16, 2019.
- Dhaval Kolte, MD, PhDa,
- Gus J. Vlahakes, MDb,
- Igor F. Palacios, MDa,
- Rahul Sakhuja, MDa,
- Jonathan J. Passeri, MDa,
- Ignacio Inglessis, MDa and
- Sammy Elmariah, MD, MPHa,∗ (, )@SammyElmariahMD
- aCardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
- bCardiac Surgery Division, Department of Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
- ↵∗Address for correspondence:
Dr. Sammy Elmariah, Cardiology Division, Massachusetts General Hospital, 55 Fruit Street, Boston, Massachusetts 02114.
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.
- low risk
- surgical aortic valve replacement
- transcatheter aortic valve implantation
- transcatheter aortic valve replacement
Dr. Palacios is a consultant for Abiomed. Dr. Sakhuja has been a consultant for Medtronic and Edwards Lifesciences. Dr. Passeri has received institutional research support from Edwards Lifesciences; has been a speaker at an educational symposium sponsored by Medtronic; and has received consulting fees from Medtronic. Dr. Inglessis has received institutional research support from Medtronic, St. Jude Medical, and W.L. Gore and Associates; and is a proctor for Medtronic and Edwards Lifesciences. Dr. Elmariah has received research grants from Edwards Lifesciences and Svelte Medical; and has received consulting fees from Medtronic and AstraZeneca. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received April 3, 2019.
- Revision received June 19, 2019.
- Accepted June 24, 2019.
- 2019 American College of Cardiology Foundation
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