Citations

BACKGROUND AND OBJECTIVES: Predicting functional outcomes after surgical management of ruptured aneurysms is essential. This study sought to validate the modified Southwestern Aneurysm Severity Index (mSASI), which predicts functional outcomes 1 year after treatment. METHODS: The surgical arm of a randomized controlled trial, the Barrow Ruptured Aneurysm Trial, was used to validate the mSASI model. mSASI scores incorporating the Hunt and Hess scale, Non-Neurological American Society of Anesthesiologists Physical Classification Status, imaging findings, and other modifiers were assigned and evaluated against the Glasgow Outcome Scale (GOS) score at 1 year. The model's performance was assessed for discrimination and calibration. Similar evaluations were constructed using the modified Rankin Scale (mRS) as the 1-year functional outcome measurement. Long-term outcomes (3, 6, 10 years) were also evaluated. RESULTS: Of 280 clinical trial patients treated surgically, 242 met the inclusion criteria. The mean age was 54.1 ± 12.9 years; 31% were men. Favorable GOS score (4-5) and mRS score (0-2) at 1 year were observed in 73.6% and 66.1% of patients, respectively. The mSASI model predicted unfavorable GOS score at 1 year with fair to good discrimination (area under the curve = 0.75, 95% CI = 0.68-0.82) and accurate calibration (R 2 = 0.98). Similar results were obtained when mRS was used as the outcome measure (area under the curve = 0.75, 95% CI = 0.68-0.82; R 2 = 0.95). CONCLUSION: The mSASI model was externally validated in our cohort to predict functional outcomes using the GOS or mRS scores 1 year after surgery. This index may be used for prognosticating outcomes of patients undergoing surgery for ruptured aneurysms at short-term and long-term intervals.

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.