Mangi, Abeel A.

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

ObjectivesTo compare the in‐hospital outcomes in cirrhosis patients undergoing transcatheter aortic valve replacement (TAVR) versus those undergoing surgical aortic valve replacement (SAVR).BackgroundOver the last 10 years, TAVR has emerged as a therapeutic option for treating severe aortic stenosis in high‐risk patients. Cirrhosis patients have a high risk of operative morbidity and mortality while undergoing cardiac surgery. This study's hypothesis was that TAVR is a safer alternative compared to SAVR in cirrhosis patients.MethodsThe study population was derived from the National Inpatient Sample (NIS) for the years 2011–2012 using ICD‐9‐CM procedure codes 35.21 and 35.22 for SAVR, and 35.05 and 35.06 for TAVR. Patients <50 years of age and those who concomitantly underwent other valvular procedures were excluded. ICD‐9‐CM diagnosis codes were used to identify patients with liver cirrhosis, portal hypertension, and esophageal varices. Using propensity score matching, two matched cohorts were derived in which the outcomes were compared using appropriate statistical tests.ResultsThere were 30 patients in the SAVR and TAVR group each. Compared to the TAVR group, the patients in SAVR group had significantly higher rate of transfusion of whole blood or blood products (p = 0.037), longer mean postprocedural length of stay (p = 0.006), and nonsignificantly higher mean cost of hospitalization (p = 0.2), any complications rate (p = 0.09), and liver complications rate (p = 0.4). In‐hospital mortality rate was same in the both the groups. No patients in the TAVR group required open‐heart surgery or cardiopulmonary bypass.ConclusionTAVR could be a viable option for aortic valve replacement in cirrhosis patients. © 2015 Wiley Periodicals, Inc.