ImportanceIn 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.ObjectiveTo 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 ParticipantsSURTAVI 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.InterventionPatients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis.Main Outcomes and MeasuresThe 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.ResultsA 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] cm2 vs 1.8 [0.6] cm2; 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 RelevanceAmong 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.
IntroductionWe aimed to develop and validate a prognostic score for disability at discharge and functional outcome at three months in patients with acute ischemic stroke based on clinical information available on admission.Patients and methodsThe Dutch Stroke Score (DSS) was developed in 1227 patients with ischemic stroke included in the Paracetamol (Acetaminophen) In Stroke study. Predictors for Barthel Index (BI) at discharge (‘DSS-discharge’) and modified Rankin Scale (mRS) at three months (‘DSS-3 months’) were identified in multivariable ordinal regression. The models were internally validated with bootstrapping techniques. The DSS-3 months was externally validated in the PRomoting ACute Thrombolysis in Ischemic StrokE study (1589 patients) and the Preventive Antibiotics in Stroke Study (2107 patients). Model performance was assessed in terms of discrimination, expressed by the area under the receiver operating characteristic curve (AUC), and calibration.ResultsAt model development, the strongest predictors of Barthel Index at discharge were age per decade over 60 (odds ratio = 1.55, 95% confidence interval (CI) 1.41–1.68), National Institutes of Health Stroke Scale (odds ratio = 1.24 per point, 95% CI 1.22–1.26) and diabetes (odds ratio = 1.62, 95% CI 1.32–1.91). The internally validated AUC was 0.76 (95% CI 0.75–0.79). The DSS-3 months, additionally consisting of previous stroke and atrial fibrillation, performed similarly at internal (AUC 0.75, 95% CI 0.74–0.77) and external validation (AUC 0.74 in PRomoting ACute Thrombolysis in Ischemic StrokE (95% CI 0.72–0.76) and 0.69 in Preventive Antibiotics in Stroke Study (95% CI 0.69–0.72)). Observed outcome was slightly better than predicted.Discussion: The DSS had satisfactory performance in predicting BI at discharge and mRS at three months in ischemic stroke patients.ConclusionIf further validated, the DSS may contribute to efficient stroke unit discharge planning alongside patients' contextual factors and therapeutic needs.
Aims Modification of health behaviour is an important part of stroke risk management. However, the majority of people with cardiovascular disease fail to sustain lifestyle modification in the long term. We aimed to evaluate the effectiveness of motivational interviewing to encourage lifestyle behaviour changes after transient ischaemic attack (TIA) or minor ischaemic stroke. Methods and results We performed a randomized controlled open-label phase II trial with blinded endpoint assessment. The intervention consisted of three 15-minute visits in 3 months by a motivational interviewing trained nurse practitioner. Patients in the control group received standard consultation after 1 and 3 months by a nurse practitioner. Primary outcome was lifestyle behaviour change, defined as smoking cessation and/or increased physical activity (30 min/day) and/or healthy diet improvement (5 points at the Food Frequency Questionnaire) at 6 months. We adjusted for age and sex with multivariable logistic regression. Between January 2014 and February 2016, we included 136 patients (of whom 68 were assigned to the intervention group). Twenty-five of 55 patients in the intervention group (45%) and 27 of 61 patients in the control group (44%) had changed their lifestyle at 6 months. We found no effect of motivational interviewing on lifestyle behaviour change after 6 months (aOR 0.99; 95% confidence interval: 0.44–2.26). Conclusion Our results do not support the effectiveness of motivational interviewing in supporting lifestyle behaviour change after TIA or ischaemic stroke. However, the overall lifestyle behaviour change was high and might be explained by the role of specialized nurses in both groups.
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