Zorn, George L.

Abstract Background Prosthetic valves are considered a risk factor for endocarditis however diagnosing prosthetic valve endocarditis (PVE) is complicated by acoustic shadowing on echocardiography. In 2023, the ISCVID published an update to the Duke Criteria (Duke 2023) which intended to increase the sensitivity in diagnosing PVE. The purpose of this study was to examine how TAVR infective endocarditis (TAVR-IE) was diagnosed at our institution 90 Day Mortality Kaplan Meier Curve Methods HERON was utilized to match cases between ACC/STS databases and the EMR at The University of Kansas Health System (TUKHS). Patients with bacteremia occurring after a TAVR were reviewed. Each case was evaluated if they met rejected/possible/definitive endocarditis criteria in the Modified Duke Criteria (Duke 2005) and the Duke 2023 Criteria. To adjudicate the diagnosis, an expert panel reviewed all cases that met definitive endocarditis criteria in any edition of the Duke Criteria. Results A total of 2371 TAVRs were conducted at TUKHS from 2012 to 2023. We identified 146 cases of post procedure bacteremia. We excluded 53 cases leaving 93 in the cohort. Transeophageal echocardiography was utilized in about half of the cases (TTE 73, TEE 45). F-FDG positron emission tomography/CT was done in six patients and Cardiac CT in one patient. Cultures returning with Enterococcus spp (16). viridans group streptococci (15), and Staphylococcus spp. (15) had similar incidence. About half had either atypical organisms (40) on 2005 Duke criteria or polymicrobial growth (7). Definitive criteria were met in 18 and 21 patients for the Duke 2005 and Duke 2023 Criteria respectively. Two cases had minor microbiological criteria upgraded to major in Duke 2023. One case was promoted to definitive endocarditis based on Cardiac CT. Upon adjudication the panel agreed with Duke 2023 Criteria classification. Sensitivity was calculated 85%/100% for Duke 2005 and Duke 2023 Criteria respectively. Kaplan Meier curves calculated no significant difference of 3 month mortality between TAVR patients who had met definitive criteria and those who did not. (Figure #1) Conclusion The 2023 ISCVID Duke Criteria in this study appeared to have superior sensitivity for TAVR-IE when compared to the older Modified Duke Criteria published in 2005. Disclosures Larry M. Baddour, MD, UpToDate, Inc.: Royalty payments (authorship duties). Wissam El Atrouni, MD, ViiV Healthcare: Advisor/Consultant

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.

Background— The CoreValve US High-Risk Clinical Study compared clinical outcomes and serial echocardiographic findings in patients with severe aortic valve stenosis after transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis or surgical aortic valve replacement (SAVR). Methods and Results— Eligible patients were randomly assigned 1:1 to TAVR with a self-expanding bioprosthesis or SAVR (N=747). Echocardiograms were obtained at baseline, discharge, 30 days, 6 months, and 1 year after the procedure and were analyzed at a central core laboratory. Compared with SAVR patients (N=357), TAVR patients (N=390) had a lower mean aortic valve gradient, larger valve area, and less patient–prosthesis mismatch (all P <0.001), but more paravalvular regurgitation at discharge, which decreased at 1 year. SAVR patients experienced significant right ventricular systolic dysfunction at discharge and 1 month with normal right ventricular function at 1 year. One-year all-cause mortality was 14.2% for TAVR and 19.1% for SAVR patients. Preimplantation aortic regurgitation ≥mild was associated with reduced mortality hazard for both the TAVR (hazard ratio 0.48, 95% confidence interval 0.27–0.85; P =0.01) and the SAVR groups (hazard ratio 0.53, 95% confidence interval 0.32–0.87; P =0.01). Aortic regurgitation ≥mild after TAVR was associated with increased risk for all-cause mortality (hazard ratio 1.95, 95% confidence interval 1.08–3.53; P =0.03). Conclusions— In patients with severe aortic stenosis at increased surgical risk, TAVR was associated with better systolic valve performance, similar left ventricular remodeling, more paravalvular regurgitation, and less right ventricular systolic dysfunction compared with SAVR. Despite an overall mortality reduction for the TAVR group, ≥mild aortic valve regurgitation after TAVR was associated with an increased mortality hazard. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01240902.