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.

In a high-risk cohort of patients undergoing TA-TAVR for AS, the use of the JenaValve THV is safe and effective. In patients at higher risk for coronary ostia obstruction, annular rupture or with limited aortic valve calcification, the JenaValve might be preferable for implantation due to its clipping-mechanism engaging native aortic valve cusps for fixation with reduced radial forces of the self-expanding stent.

Background-Significant prosthetic paravalvular leakage (PVL) could have serious clinical consequences and impairs survival. Reoperation is associated with a high mortality rate, and transcatheter closure is a new treatment modality for high-risk patients. The goal of this study was to determine safety and midterm clinical efficacy of transcatheter PVL closure using an open transapical approach. Methods and Results-All consecutive patients who underwent transcatheter PVL closure in our center were prospectively enrolled. Pre-and postprocedural quality of life and 6-minute walk test were ascertained. All outcomes were defined according to the Valve Academic Research Consortium-2 consensus document. In total, 37 consecutive patients (mean age 67±12 years, 65% male, logistic European System for Cardiac Operative Risk Evaluation 27±17%, Society of Thoracic Surgeons score 7±4%) with severe symptomatic PVL in mitral (81%) or aortic (19%) position underwent transcatheter PVL closure. Procedure success was 86%. Early safety at 30 days (ie, event-free survival) was 84%. The 1-year survival rate was 66%. New York Heart Association functional class and quality of life significantly improved. Clinical efficacy (ie, survival free of stroke, rehospitalization, New York Heart Association 3/4, and device-related dysfunction) was 49% at 3 months and 31% at 1 year. Moderate to severe residual PVL was associated with all-cause mortality (hazard ratio, 3.9; 95% confidence interval, 1.2-12.1; P=0.03). Conclusions-The open transapical approach to PVL closure in high-risk patients has a high procedural success rate with an acceptable risk of adverse outcomes. This is the first study to prove an increased functional capacity and quality of life after transapical PVL closure. Residual PVL is associated with 1-year mortality. (Circ Cardiovasc Interv. 2014;7:611-620.)Key Words: heart failure ◼ heart valve diseases ◼ heart valve prosthesis ◼ mitral valve insufficiency ◼ quality of life ◼ septal occluder device ◼ surgical procedures, minimally invasive

MECC does not reduce hypertrophic scar formation compared with CECC with dexamethasone, but its use is more beneficial than the use of CECC/dexamethasone because of the circulatory and immunological advantages and because treatment with dexamethasone can be omitted.

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