Goel, Sachin S.

BACKGROUND: While initial data for transcatheter aortic valve replacement (TAVR) in aortic stenosis patients with mitral stenosis (MS) suggested a poor short-term prognosis, outcomes for contemporary balloon-expandable valves remain unknown. The aim of this retrospective multicenter registry study was to compare the potential impact of MS on TAVR outcomes with balloon-expandable valves. METHODS: Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry and Centers for Medicare & Medicaid Services claims data were used to obtain a cohort of 327 925 patients who underwent TAVR with current balloon-expandable valves (SAPIEN 3, SAPIEN 3 Ultra, or SAPIEN 3 Ultra Resilia) between June 2015 and December 2022 across 791 sites. Severe MS (defined as >10 mm Hg mean gradient or <1.5 cm 2 area) was compared with mild or less MS (defined as <5 mm Hg mean gradient and >2 cm 2 area) using propensity matching to minimize confounding variables. RESULTS: Patients with severe MS (n=8500; 2.6%) had a higher number of comorbid conditions, Society of Thoracic Surgeons risk scores, and were more often women than patients with mild or less MS at the time of index TAVR. While patients with severe MS had worse outcomes at 30 days, when propensity-matched, patients exhibited similar 30-day rates of death (3.2% versus 3.0%), stroke (2.4% versus 2.2%), major vascular complications (1.6% versus 1.6%), device implant success (98.9% versus 99.2%), and new dialysis (0.7% versus 0.5%), with higher rates of pacemaker implantation (11.3% versus 9.4%; P <0.001). By 1 year, there was no difference in the change in the KCCQ (Kansas City Cardiomyopathy Questionnaire) overall score from baseline to 1 year (30.7±27.0 versus 31.9±27.0; P =0.07). By 3 years, an increase in the mortality rate (45.1% versus 40.9%; P <0.001) of patients with severe MS was observed. CONCLUSIONS: MS in isolation is not associated with worsened short-term outcomes among patients undergoing contemporary TAVR with balloon-expandable valves.

Background Coronary microvascular function and hemodynamics may play a role in coronary circulation and myocardial remodeling in patients with aortic stenosis (AS). We aimed to evaluate the relationship between myocardial blood flow and myocardial function in patients with AS, no AS, and aortic valve sclerosis. Methods and Results We included consecutive patients who had resting transthoracic echocardiography and clinically indicated positron emission tomography myocardial perfusion imaging to capture their left ventricular ejection fraction, global longitudinal strain (GLS), and myocardial flow reserve (MFR). The primary outcome was major adverse cardiovascular event (all‐cause mortality, myocardial infarction, or late revascularization). There were 2778 patients (208 with aortic sclerosis, 39 with prosthetic aortic valve, 2406 with no AS, and 54, 49, and 22 with mild, moderate, and severe AS, respectively). Increasing AS severity was associated with impaired MFR ( P <0.001) and GLS ( P <0.001), even when perfusion was normal. Statistically significant associations were noted between MFR and GLS, MFR and left ventricular ejection fraction, and MFR and left ventricular ejection fraction reserve. After a median follow‐up of 349 (interquartile range, 116–662) days, 4 (7.4%), 5 (10.2%), and 6 (27.3%) patients experienced a major adverse cardiovascular event in the mild, moderate, and severe AS groups, respectively. In a matched‐control analysis, patients with mild‐to‐moderate AS had higher rates of impaired MFR (52.9% versus 39.9%; P =0.048) and major adverse cardiovascular event (11.8% versus 3.0%; P =0.002). Conclusions Despite lack of ischemia, as severity of AS increased, MFR decreased and GLS worsened, reflecting worse coronary microvascular health and myocardial remodeling. Positron emission tomography–derived MFR showed a significant independent correlation with left ventricular ejection fraction and GLS. Patients with prosthetic aortic valve showed a high prevalence of impaired MFR.

Introduction: Data on use of ICE guidance in TEER procedure is limited to case reports and small case series. Our study aims to assess the feasibility, safety, utilization patterns and clinical outcomes of mitral TEER procedure with ICE guidance using a nationally representative real-world cohort of patients.Hypothesis: There is no difference between ICE-guided TEER and TEE-guided TEER in the clinical outcomes and complications. Methods: This study used the National Inpatient Sample database from quarter 4 of 2015 to 2020. We used a propensity-matched analysis and adjusted odds ratios for in-hospital outcomes/complications. A P value of <0.05 was considered significant. Results: A total of 38,770 weighted cases of mitral TEER were identified. Of the included patients 665 patients underwent ICE-guided TEER while 38,105 had TEE-guided TEER. There were no differences in the in-hospital mortality between both groups (2.5% vs. 3.0%, p=0.58). Adjusted odds of in-hospital mortality (aOR 0.83, 95%CI [0.42-1.64]) were not significantly different. There were no differences in periprocedural complications including cardiac (aOR 0.85, 95%CI [0.54-1.35]), bleeding (aOR 1.45, 95%CI [0.93-2.33]), respiratory (aOR 0.88, 95%CI [0.61-1.25]), and renal (aOR 0.89, 95%CI [0.66-1.20]) complications between patients undergoing ICE-guided versus TEE-guided TEER. There was no difference in GI complications between both groups (aOR 1.11, 95%CI [0.46-2.70]). The adjusted length of stay was less among ICE-guided TEER (median: 1 vs. 2, p<0.01) with no differences in costs of hospitalization ($137,312 vs. $153,773, p=0.06), Conclusions: In conclusion, ICE-guided mitral TEER is safe when compared with TEE guided TEER with no significant differences in in-hospital mortality, cardiac, bleeding, respiratory, and renal complications. The length of stay in ICE group is shorter as compared with the TEE group.

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.