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.
Assessing Competence in Critical Care Echocardiography: Development and Initial Results of an Examination and Certification Processes*
OBJECTIVES: To describe the development and initial results of an examination and certification process assessing competence in critical care echocardiography. DESIGN: A test writing committee of content experts from eight professional societies invested in critical care echocardiography was convened, with the Executive Director representing the National Board of Echocardiography. Using an examination content outline, the writing committee was assigned topics relevant to their areas of expertise. The examination items underwent extensive review, editing, and discussion in several face-to-face meetings supervised by National Board of Medical Examiners editors and psychometricians. A separate certification committee was tasked with establishing criteria required to achieve National Board of Echocardiography certification in critical care echocardiography through detailed review of required supporting material submitted by candidates seeking to fulfill these criteria. SETTING: The writing committee met twice a year in person at the National Board of Medical Examiner office in Philadelphia, PA. SUBJECTS: Physicians enrolled in the examination of Special Competence in Critical Care Electrocardiography (CCEeXAM). MEASUREMENTS AND MAIN RESULTS: A total of 524 physicians sat for the examination, and 426 (81.3%) achieved a passing score. Of the examinees, 41% were anesthesiology trained, 33.2% had pulmonary/critical care background, and the majority had graduated training within the 10 years (91.6%). Most candidates work full-time at an academic hospital (46.9%). CONCLUSIONS: The CCEeXAM is designed to assess a knowledge base that is shared with echocardiologists in addition to that which is unique to critical care. The National Board of Echocardiography certification establishes that the physician has achieved the ability to independently perform and interpret critical care echocardiography at a standard recognized by critical care professional societies encompassing a wide spectrum of backgrounds. The interest shown and the success achieved on the CCEeXAM by practitioners of critical care echocardiography support the standards set by the National Board of Echocardiography for testamur status and certification in this imaging specialty area.