Marchena, Eduardo de

Introduction: Transcatheter aortic valve replacement (TAVR) is a well-recognized treatment for severe aortic stenosis. One potentially life-threatening complication of TAVR is infective endocarditis (IE). There is limited contemporary data on the clinical characteristics and outcomes of patients undergoing TAVR who develop in-hospital IE. Aim: Describe the clinical characteristics and outcomes of patients undergoing TAVR who develop in-hospital IE. Methods: The National Inpatient Sample Database was queried from 2016 to 2020 for relevant ICD-10 procedural and diagnostic codes. Baseline characteristics and in-hospital outcomes of adult (≥18 years) patients undergoing TAVR who developed in-hospital IE were compared to that of patients who did not develop IE. Multivariate logistic-regression analyses adjusting for age, race, gender, and statistically significant comorbidities between cohort's were performed. A p-value <0.05 was considered significant. Results: A total of 314,250 hospitalizations for patients undergoing TAVR were identified. Of them, 1065 (0.3%) developed in-hospital IE. Overall, mean age of IE patients was 70.3 ± 15.0. Patients were predominantly (62%) males and white (79.5%) ( Table 1) . IE patients had a higher risk of in-hospital all-cause mortality (adjusted odds ratio [95% CI]: 2.07 [1.50-2.86]), septic shock (3.73 [2.71-5.13]), acute respiratory failure (2.59 [2.19-3.06]), ischemic stroke (4.4 [3.48-5.51]), acute kidney injury (3.05 [2.61-3.57]), cardiac arrest (2.82 [1.83-4.37] and cardiogenic shock 3.70 [2.98-4.57]). All p values were <0.01. Conclusion: Patients undergoing TAVR who develop in-hospital IE had higher in-hospital complications when compared to those of patients who did not develop IE. Although the rate of in-hospital IE was low, the number of patients identified in the NIS database was sizable and the syndrome deserves investigation due to its associated complications.

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 &amp;lt; .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm 2 vs 1.8 [0.6] cm 2 ; P &amp;lt; .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 &amp;lt; .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.

This systematic review and meta‐analysis sought to summarize the available evidence on the use of transcatheter aortic valve replacement (TAVR) in patients with Native Aortic Valve Regurgitation (NAVR) and compare outcomes between first and second generation valves. Owing to the improvements in transcatheter heart valve design and procedural success, TAVR has become increasingly performed in broader aortic valve pathologies. We searched Medline, Embase, Cochrane, and Scopus databases from 2007 to 2018 and performed a systematic review on reports with at least 10 patients with aortic valve regurgitation undergoing TAVR procedure. The main outcome of interest was all‐cause mortality at 30 days. A total of 638 patients across 12 studies were included. Mean age ranged from 68 to 84. Society of Thoracic Surgeons score ranged from 5.4% to 13.1% and Logistic EuroSCORE ranged from 18.2% to 33%. The incidence rate of all‐cause mortality at 30 days was found to be 11% (95% CI 7%‐16%; I2 = 20.86%). All‐cause mortality at 30 days for first generation valves had an incidence rate of 15% (95% CI 10%‐20%; I2 = 10%) compared to 7% (95% CI 3%‐13%; I2 = 37%) in second generation valves with subgroup interaction analysis P = 0.059. Device success incidence rate in second generation valves was 92% (95% CI 83%‐99%; I2 = 67%) vs 68% (95% CI 59%‐77%; I2 = 53%) in first generation valves with P = 0.001. TAVR appears to be a feasible treatment choice for NAVR patients at high risk for surgical valve replacement. Second generation valves show promising results in terms of short‐term outcomes.

Background: Contemporary data regarding percutaneous closure of atrial septal defect/patent foramen ovale (ASD/PFO) are lacking. We evaluated the current trends in utilization of ASD/PFO closure in adults and investigated the effect of annual hospital volume on in‐hospital outcomes. Methods: We queried the Nationwide Inpatient Sample between the years 2001 and 2010 using the International Classification of Diseases (ICD‐9‐CM) procedure code for percutaneous closure of ASD/PFO with device. Hierarchical mixed effects models were generated to identify the independent multivariate predictors of outcomes. Results: A total of 7,107 percutaneous ASD/PFO closure procedures (weighted n = 34,992) were available for analysis. A 4.7‐fold increase in the utilization of this procedure from 3/million in 2001 to 14/million adults in 2010 in US (P < 0.001) was noted. Overall, percutaneous ASD/PFO closure was associated with 0.5% mortality and 12% in‐hospital complications. The utilization of intracardiac echocardiography (ICE) increased 15 fold (P < 0.001) during the study period. The procedures performed at the high volume hospitals [2nd (14–37 procedures/year) and 3rd (>38 procedures/year) tertile] were associated with significant reduction in complications, length of stay and cost of hospitalization when compared to those performed at lowest volume centers (<13 procedures/year). Majority (70.5%) of the studied hospitals were found to be performing <10 procedures/year hence deviating from the ACC/AHA/SCAI clinical competency guidelines. Conclusions: Low hospital volume is associated with an increased composite (mortality and procedural complications) adverse outcome following ASD/PFO closure. In the interest of patient safety, implementation of the current guidelines for minimum required annual hospital volume to improve clinical outcomes is warranted. © 2014 Wiley Periodicals, Inc.