Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients
Stroke
Valve replacement
Investigational device exemption
DOI:
10.1001/jamacardio.2022.2695
Publication Date:
2022-08-24T15:32:12Z
AUTHORS (1637)
ABSTRACT
In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter replacement (TAVR) a self-expanding supra-annular was noninferior to surgery for all-cause mortality or disabling stroke 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these are limited.To report prespecified secondary 5-year from the Symptomatic Aortic Stenosis Intermediate Risk Subjects Who Need Valve Replacement (SURTAVI) randomized trial.SURTAVI is prospective randomized, unblinded trial. Randomization stratified by investigational site need revascularization determined local heart teams. Patients deemed be risk 30-day were enrolled 87 centers June 19, 2012, 30, 2016, Europe North America. Analysis took place between August October 2021.Patients TAVR self-expanding, bioprosthesis.The end points death other adverse events findings 5 An independent event committee adjudicated all serious an echocardiographic core laboratory evaluated echocardiograms years.A total 1660 individuals underwent attempted (n = 864) 796) procedure. The mean (SD) age 79.8 (6.2) years, 724 (43.6%) female, Society Thoracic Surgery Predicted Mortality score 4.5% (1.6%). At rates similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg 11.2 [6.0] Hg; < .001) areas higher 2.2 [0.7] cm2 1.8 [0.6] cm2; surgery. More had moderate/severe paravalvular leak than (11 [3.0%] [0.7%]; difference, 2.37% 0.17%- 4.85%]; .05). New pacemaker implantation years (289 [39.1%] 94 [15.1%]; 3.30 2.61-4.17]; log-rank .001), as reintervention (27 [3.5%] 11 [1.9%]; 2.21 1.10-4.45]; .02), although only 6 who 7 required reintervention.Among intermediate-risk symptomatic stenosis, major associated superior performance but also more reinterventions.
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