TAVI vs. SAVR for Treatment of Severe Aortic Stenosis
What is the collective safety and efficacy of transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR) across the spectrum of risk and in important subgroups?
Trials comparing TAVI vs. SAVR were identified through Medline, Embase, and Cochrane databases. The primary outcome was death from any cause at 2 years. The investigators performed random-effects meta-analyses to combine the available evidence and to evaluate the effect in different subgroups. This systematic review and meta-analysis is registered with PROSPERO (CRD42016037273).
The investigators identified four eligible trials including 3,806 participants, who were randomly assigned to undergo TAVI (n = 1,898) or SAVR (n = 1,908). For the primary outcome of death from any cause, TAVI when compared with SAVR was associated with a significant 13% relative risk reduction [hazard ratio (95% confidence interval) 0.87 (0.76–0.99); p = 0.038] with homogeneity across all trials irrespective of TAVI device (Pinteraction = 0.306) and baseline risk (Pinteraction = 0.610). In subgroup analyses, TAVI showed a robust survival benefit over SAVR for patients undergoing transfemoral access [0.80 (0.69–0.93); p = 0.004], but not transthoracic access [1.17 (0.88–1.56); p = 0.293] (Pinteraction = 0.024) and in female [0.68 (0.50–0.91); p = 0.010], but not male patients [0.99 (0.77–1.28); p = 0.952] (Pinteraction = 0.050). Secondary outcomes of kidney injury, new-onset atrial fibrillation, and major bleeding favored TAVI, while major vascular complications, incidence of permanent pacemaker implantation, and paravalvular regurgitation favored SAVR.
The authors concluded that compared with SAVR, TAVI is associated with a significant survival benefit throughout 2 years of follow-up.
This meta-analysis of the four landmark randomized controlled trials comparing TAVI with SAVR among patients with symptomatic, severe aortic stenosis showed a mortality benefit with TAVI when compared with SAVR at 2 years of follow-up. The effect appears to be consistent across high-risk and lower-risk categories, was independent of device type, and was driven by the subgroup of TAVI patients undergoing transfemoral access and the pronounced effect found in females. Given limitations of a relatively short follow-up of 2 years and lack of individual patient-level data for this analysis, prospective studies with longer-term follow-up are indicated to provide more definitive data.
Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Atrial Fibrillation/Supraventricular Arrhythmias, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and VHD, Interventions and Structural Heart Disease
Keywords: Acute Kidney Injury, Aortic Valve Stenosis, Atrial Fibrillation, Cardiac Surgical Procedures, Heart Valve Diseases, Heart Valve Prosthesis, Hemorrhage, Pacemaker, Artificial, Risk, Transcatheter Aortic Valve Replacement, Vascular Diseases
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