Agarwal, Himanshu

Background Rotational and orbital coronary atherectomy (CA) are commonly utilized to treat complex calcified coronary lesions. We conducted a meta-analysis to evaluate sex differences in procedural complications and clinical outcomes after CA. Methods PubMed, Google Scholar, and Cochrane databases were searched for all studies comparing sex differences in procedural and clinical outcomes following CA. The outcomes of interest were procedural complications (coronary dissection, stroke, major bleeding, coronary perforation, cardiac tamponade, and slow or no flow in target vessel) and the clinical outcomes (including early mortality, mid-term all-cause mortality, stroke, myocardial infarction, and target vessel revascularization). Pooled risk ratios (RRs) with their corresponding 95% confidence intervals (CIs) were calculated using the Mantel–Haenszel random-effects model. Results Six observational studies with 3517 patients (2420 men and 1035 women) were included in this meta-analysis. While there was no significant difference in the early mortality (RR, 1.14; 95% CI, 0.37–3.53; P = 0.83) between men and women, at a mean follow-up of 2.9 years, all-cause mortality was significantly higher in women (RR, 1.29; 95% CI, 1.11–1.49; P = 0.0009). Women had an increased risk of procedure-related stroke (RR, 3.98; 95% CI, 1.06–14.90; P = 0.04), coronary dissection (RR, 2.10; 95% CI, 1.23–3.58; P = 0.006), and bleeding (RR, 2.26; 95% CI, 1.30–3.93; P = 0.004), whereas the rates of coronary perforation, cardiac tamponade, and the risk of slow or no flow in the revascularized artery were similar in both. Conclusion In our analysis, women undergoing CA are at increased risk of mid-term mortality and procedure-related complications including stroke, coronary dissection, and major bleeding.

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.