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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] 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 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.

Objectives The aim of this study was to assess the incidence and prognostic impact of early and late postoperative atrial fibrillation or flutter (POAF) in patients with severe aortic sten...

Transcatheter options for treating significant symptomatic mitral valve regurgitation (MR) have gained a significant role over the past decade in clinical practice. Increasing clinical trial eviden...

Herein we present a case of an 80-year-old gentleman who presented with exertional dyspnea status post aortic valve replacement with #23 Trifecta pericardial St. Jude aortic bioprosthetic valve (BV) 12 years prior. He subsequently underwent valve re-replacement due cusp calcification. Histologically, the surgically explanted BV revealed Congophilic deposits with birefringence under cross-polarized light. Extensive work-up identified no systemic source of amyloid in this patient. Liquid chromatography-tandem mass spectrometry-based (LC-MS/MS) proteomics showed the amyloid was composed of human-origin amyloid signature proteins (apolipoprotein A4, apolipoprotein E, serum amyloid P) and human-origin mu heavy chains. Background bovine collagen was also present. Transmission electron microscopy (TEM) showed collections of 7.5-10 nm nonbranching fibrils, consistent with amyloid. Using these techniques, we classified the amyloid as Mu heavy chain, deposition of which is highly unusual in BV. Finally, we provide a review of the literature regarding isolated amyloid deposition in BV.

Background In low surgical risk patients with symptomatic severe aortic stenosis, the PARTNER 3 (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis) trial demonstrated superiority of transcatheter aortic valve replacement (TAVR) versus surgery for the primary endpoint of death, stroke, or re-hospitalization at 1 year. Objectives This study determined both clinical and echocardiographic outcomes between 1 and 2 years in the PARTNER 3 trial. Methods This study randomly assigned 1,000 patients (1:1) to transfemoral TAVR with the SAPIEN 3 valve versus surgery (mean Society of Thoracic Surgeons score: 1.9%; mean age: 73 years) with clinical and echocardiography follow-up at 30 days and at 1 and 2 years. This study assessed 2-year rates of the primary endpoint and several secondary endpoints (clinical, echocardiography, and quality-of-life measures) in this as-treated analysis. Results Primary endpoint follow-up at 2 years was available in 96.5% of patients. The 2-year primary endpoint was significantly reduced after TAVR versus surgery (11.5% vs. 17.4%; hazard ratio: 0.63; 95% confidence interval: 0.45 to 0.88; p = 0.007). Differences in death and stroke favoring TAVR at 1 year were not statistically significant at 2 years (death: TAVR 2.4% vs. surgery 3.2%; p = 0.47; stroke: TAVR 2.4% vs. surgery 3.6%; p = 0.28). Valve thrombosis at 2 years was increased after TAVR (2.6%; 13 events) compared with surgery (0.7%; 3 events; p = 0.02). Disease-specific health status continued to be better after TAVR versus surgery through 2 years. Echocardiographic findings, including hemodynamic valve deterioration and bioprosthetic valve failure, were similar for TAVR and surgery at 2 years. Conclusions At 2 years, the primary endpoint remained significantly lower with TAVR versus surgery, but initial differences in death and stroke favoring TAVR were diminished and patients who underwent TAVR had increased valve thrombosis. (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis [PARTNER 3]; NCT02675114 )

OBJECTIVES The study compared 1-year outcomes between transcatheter aortic valve replacement (TAVR) patients with bicuspid aortic valve (BAV) morphology and clinically similar patients having tricuspid aortic valve (TAV) morphology.BACKGROUND There are limited prospective data on TAVR using the SAPIEN 3 device in low-surgical-risk patients with severe, symptomatic aortic stenosis and bicuspid anatomy.METHODS Low-risk, severe aortic stenosis patients with BAV were candidates for the PARTNER 3 (Placement of Aortic Transcatheter Valves 3) (P3) bicuspid registry or the P3 bicuspid continued access protocol. Patients treated in these registries were pooled and propensity score matched to TAV patients from the P3 randomized TAVR trial. Outcomes were compared between groups. The primary endpoint was the 1-year composite rate of death, stroke, and cardiovascular rehospitalization.RESULTS Of 320 total submitted BAV patients, 169 (53%) were treated, and most were Sievers type 1. The remaining 151 patients were excluded caused by anatomic or clinical criteria. Propensity score matching with the P3 TAVR cohort (496 patients) yielded 148 pairs. There were no differences in baseline clinical characteristics; however, BAV patients had larger annuli and they experienced longer procedure duration. There was no difference in the primary endpoint between BAV and TAV (10.9% vs 10.2%; P = 0.80) or in the rates of the individual components (death: 0.7% vs 1.4%; P = 0.58; stroke: 2.1% vs 2.0%; P = 0.99; cardiovascular rehospitalization: 9.6% vs 9.5%; P = 0.96).CONCLUSIONS Among highly select bicuspid aortic stenosis low-surgical-risk patients without extensive raphe or subannular calcification, TAVR with the SAPIEN 3 valve demonstrated similar outcomes to a matched cohort of patients with tricuspid aortic stenosis. (C) 2022 by the American College of Cardiology Foundation.

Background Subclinical leaflet thrombosis, characterized by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion observed on 4-dimensional computed tomography (CT), may represent a form of bioprosthetic valve dysfunction. Objectives The U.S. Food and Drug Administration mandated CT studies to understand the natural history of this finding, differences between transcatheter and surgical valves, and its association with valve hemodynamics and clinical outcomes. Methods The PARTNER 3 (The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low-Risk Patients With Aortic Stenosis) CT substudy randomized 435 patients with low–surgical-risk aortic stenosis to undergo transcatheter aortic valve replacement (n = 221) or surgery (n = 214). Serial 4-dimensional CTs were performed at 30 days and 1 year and were analyzed independently by a core laboratory. Results The incidence of HALT increased from 10% at 30 days to 24% at 1 year. Spontaneous resolution of 30-day HALT occurred in 54% of patients at 1 year, whereas new HALT appeared in 21% of patients at 1 year. HALT was more frequent in transcatheter versus surgical valves at 30 days (13% vs. 5%; p = 0.03), but not at 1 year (28% vs. 20%; p = 0.19). The presence of HALT did not significantly affect aortic valve mean gradients at 30 days or 1 year. Patients with HALT at both 30 days and 1 year, compared with those with no HALT at 30 days and 1 year, had significantly increased aortic valve gradients at 1 year (17.8 ± 2.2 mm Hg vs. 12.7. ± 0.3 mm Hg; p = 0.04). Conclusions Subclinical leaflet thrombosis was more frequent in transcatheter compared with surgical valves at 30 days, but not at 1 year. The impact of HALT on thromboembolic complications and structural valve degeneration needs further assessment.

Background There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve r...

Transcatheter aortic valve replacement (TAVR) has become the preferred method for management of severe aortic stenosis in patients who are at high and intermediate surgical risk, and has recently gained approval from the Food and Drug Administration in the US for use in patients at low risk for surgery. Thrombocytopenia and thromboembolic events in patients undergoing TAVR is associated with increased morbidity and mortality, and yet there is insufficient evidence supporting the current guideline-mediated therapy for antithrombotics post-TAVR. In this article, the authors review current guidelines for antithrombotic therapy in patients undergoing TAVR, studies evaluating antiplatelet regimens, and studies evaluating the use of platelet function testing after TAVR. They also offer a potential link between thrombocytopenia and antiplatelet treatments in patients undergoing TAVR.

Background The Cardiac Surgical Societies Valve Labeling Task Force consensus document acknowledged inconsistent sizing and labeling of prosthetic heart valves. This study compared the labeled size, internal diameter, and hemodynamics of different surgical and transcatheter valve types implanted into the same size annulus, measured by preprocedural computed tomography (CT). Methods Patients were retrospectively sorted into 3 CT annular diameter size groups: small (less than 23 mm), medium (23 to less than 26 mm), and large (26 mm or greater). Surgical valves were sorted into 4 categories based on tissue and design: (stentless porcine, standard stented bovine, wraparound stented bovine, and stented porcine). Comparisons were made within the surgical types and with a transcatheter valve. Echocardiograms were independently assessed and CTs were centrally measured. Results We analyzed 726 surgical and 923 transcatheter valve paired data sets. Among the various valve types implanted into the same size CT annulus, there were significant differences regarding size, internal diameter, and hemodynamics within all 3 size groups. Root enlargement procedures occurred in 1.2% with no differences across valve types or size groups. Transcatheter valve hemodynamics were similar to stentless valves and were significantly better than all stented valves. There was no difference in hemodynamics between the 2 bovine stented valve types, and stented porcine valves were inferior to all valve types. Conclusions This study documents that prosthetic heart valve sizing and labeling inconsistencies exist. Use of preoperative CT annular dimensions is the most accurate method to compare size, internal diameter, and hemodynamics of bioprosthetic aortic valves because it compares values among various valve types implanted into the same size annulus.

Objectives The aim of this study was to assess the evolution of early outcomes for 3 iterative self-expanding transcatheter aortic valves. Background Over the past decade there have been r...

Background: Women have a higher rate of adverse events after mitral valve surgery. We sought to evaluate whether outcomes after transcatheter edge-to-edge repair intervention by sex have similar trends to mitral valve surgery. Methods: The primary outcome was 1-year major adverse events defined as a composite of all-cause mortality, stroke, and any bleeding in the overall study cohort. Patients who underwent transcatheter edge-to-edge repair for mitral regurgitation with the MitraClip system in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry were evaluated. Linked administrative claims from the Centers for Medicare and Medicaid Services were used to evaluate 1-year clinical outcomes. Associations between sex and outcomes were evaluated using a multivariable logistic regression model for in-hospital outcomes and Cox model for 1-year outcomes. Results: From November 2013 to March 2017, 5295 patients, 47.6% (n=2523) of whom were female, underwent transcatheter edge-to-edge repair. Females were less likely to have >1 clip implanted ( P Conclusions: No difference in composite outcome of all-cause mortality, stroke, and any bleeding was observed between females and males. Adjusted 1-year all-cause mortality was lower in females compared with males.

As of April 15, 2020, the number of confirmed coronavirus disease-2019 (COVID-19) cases in New York City (NYC) was >110,000, thus making it the global epicenter of the pandemic ([1][1]). This rapid surge in the number of cases imposed a major burden on all hospitals in NYC, as well as causing

This study sought to minimize the risk of permanent pacemaker implantation (PPMI) with contemporary repositionable self-expanding transcatheter aortic valve replacement (TAVR).Self-expanding TAVR traditionally carries a high risk of PPMI. Limited data exist on the use of the repositionable devices to minimize this risk.At NYU Langone Health, 248 consecutive patients with severe aortic stenosis underwent TAVR under conscious sedation with repositionable self-expanding TAVR with a standard approach to device implantation. A detailed analysis of multiple factors contributing to PPMI was performed; this was used to generate an anatomically guided MInimizing Depth According to the membranous Septum (MIDAS) approach to device implantation, aiming for pre-release depth in relation to the noncoronary cusp of less than the length of the membranous septum (MS).Right bundle branch block, MS length, largest device size (Evolut 34 XL; Medtronic, Minneapolis, Minnesota), and implant depthMS length predicted PPMI. On multivariate analysis, only implant depthMS length (odds ratio: 8.04; 95% confidence interval: 2.58 to 25.04; p 0.001) and Evolut 34 XL (odds ratio: 4.96; 95% confidence interval: 1.68 to 14.63; p = 0.004) were independent predictors of PPMI. The MIDAS approach was applied prospectively to a consecutive series of 100 patients, with operators aiming to position the device at a depth of MS length whenever possible; this reduced the new PPMI rate from 9.7% (24 of 248) in the standard cohort to 3.0% (p = 0.035), and the rate of new left bundle branch block from 25.8% to 9% (p 0.001).Using a patient-specific MIDAS approach to device implantation, repositionable self-expanding TAVR achieved very low and predictable rates of PPMI which are significantly lower than previously reported with self-expanding TAVR.

When transcatheter aortic valve replacement (TAVR) was first approved for use in the United States in 2012, multiple leading surgical and cardiology societies were tasked with creating recommendations and requirements for operators and institutions starting and maintaining TAVR programs. Creation of this consensus document was challenging due to limited experience with this new technology, and a lack of robust centralized data that could be used to validate outcome measures and create benchmarks for self-assessment and improvement. Despite these limitations, this document provided government agencies a framework for regulation that ultimately determined requirements for Medicare payment for TAVR and therefore greatly determined how and where care was delivered for patients with aortic stenosis. After the proliferation of TAVR institutions throughout the US and with data from more than 100,000 cases in the STS/ACC Transcatheter Valve Therapies TM Registry, leaders of the same societies reconvened in 2018 to update their consensus document. The new recommendations include suggested personnel, facilities, training, and assessment of outcomes and competencies required to run a safe and efficient TAVR program. This article seeks to detail the changes from the original consensus document with a particular focus on issues relevant to cardiac anesthesiologists as well as important healthcare policy ramifications for patients and providers in the United States.

Background Thrombocytopenia after transcatheter aortic valve replacement (TAVR) is associated with adverse clinical outcomes. Whether preprocedural P2Y12 inhibition prevents postprocedural thrombocytopenia is uncertain. Methods This retrospective analysis identified consecutive patients (n = 266) undergoing TAVR between November 2016 and July 2017. Preprocedure clopidogrel load ≥300 mg or maintenance P2Y12 inhibitor therapy defined preprocedural P2Y12 inhibition. Patients who did not consent for the registry (n = 8), with baseline severe thrombocytopenia ( 20% decrease in platelet count from baseline to day 1 post-TAVR. Results Patients with (n = 134) versus without (n = 106) preprocedural P2Y12 inhibition had no differences in platelet count at baseline. Patients with preprocedural P2Y12 inhibition had a significantly lower proportion of the primary outcome (34.3% vs. 57.5%, p = .001) and a lower absolute decrease in platelet count (32.8 × 103 vs. 45.8 × 103 platelet/μL, p = .01). Of patients without baseline thrombocytopenia (n = 198), a numerically lower rate of patients with versus without preprocedural P2Y12 inhibition developed thrombocytopenia on day 1 post-TAVR (25.5% vs. 36.4%, p = .1). Conclusion Patients who received preprocedural P2Y12 inhibition prior to TAVR were less likely to demonstrate a decrease in platelet count after TAVR. Prospective studies to further understand the clinical implication of these findings are warranted.

Background: For patients with severe aortic stenosis and coronary artery disease, the completely percutaneous approach to aortic valve replacement and revascularization has not been compared with the standard surgical approach. Methods: The prospective SURTAVI trial (Safety and Efficiency Study of the Medtronic CoreValve System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement) enrolled intermediate-risk patients with severe aortic stenosis from 87 centers in the United States, Canada, and Europe between June 2012 and June 2016. Complex coronary artery disease with SYNTAX score (Synergy Between PCI with Taxus and Cardiac Surgery Trial) >22 was an exclusion criterion. Patients were stratified according to the need for revascularization and then randomly assigned to treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients assigned to revascularization in the TAVR group underwent percutaneous coronary intervention, whereas those in the SAVR group had coronary artery bypass grafting. The primary end point was the rate of all-cause mortality or disabling stroke at 2 years. Results: Of 1660 subjects with attempted aortic valve implants, 332 (20%) were assigned to revascularization. They had a higher Society of Thoracic Surgeons risk score for mortality (4.8±1.7% versus 4.4±1.5%; P P P =0.62), or between TAVR and SAVR (11.9%; 95% CI, 9.5–14.7 versus 12.3%; 95% CI, 9.8–15.4; P =0.76). Conclusions: For patients at intermediate surgical risk with severe aortic stenosis and noncomplex coronary artery disease (SYNTAX score ≤22), a complete percutaneous approach of TAVR and percutaneous coronary intervention is a reasonable alternative to SAVR and coronary artery bypass grafting. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01586910.

IMPORTANCE: Surgical aortic valve replacement (SAVR) has increased risk for patients with aortic stenosis (AS) and a history of coronary artery bypass graft (CABG) surgery. Transcatheter aortic valve replacement (TAVR) may be an alternative. OBJECTIVE: To compare TAVR with SAVR outcomes in patients at intermediate operative risk with prior CABG surgery. DESIGN, SETTING, AND PARTICIPANTS: In this post hoc analysis of the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) noninferiority randomized clinical trial, patients with severe, symptomatic AS at intermediate operative risk were enrolled from 87 centers across the United States, Europe, and Canada from June 2012 to June 2016 and followed-up with up to July 2017. Those with a history of CABG surgery were considered for analysis. Data were analyzed from September to December 2017. INTERVENTIONS: A total of 1746 patients were enrolled and randomized 1:1 to self-expanding TAVR or SAVR. An implant was attempted in 1660 patients, of whom 273 had prior CABG surgery, including 136 who underwent attempted TAVR and 137 who underwent attempted SAVR. MAIN OUTCOMES AND MEASURES: The primary outcome was all-cause mortality or disabling stroke at 1-year follow-up. Efficacy outcomes included quality of life, measured using the Kansas City Cardiomyopathy Questionnaire at 30 days, 6 months, and 1 year, and distance walked in 6 minutes, measured using the 6-minute walk test at 30 days and 1 year. RESULTS: Of the 136 patients in the TAVR cohort, 111 (81.6%) were male, and the mean (SD) age was 76.9 (6.5) years; of the 137 in the SAVR cohort, 117 (85.4%) were male, and the mean (SD) age was 76.6 (6.5) years. The mean (SD) Society of Thoracic Surgeons Predicted Risk of Mortality score was 5.0% (1.6%) in the TAVR cohort and 5.2% (1.7%) in the SAVR cohort. All-cause mortality or disabling stroke at 1-year follow-up was 8.9% (95% CI, 5.2-15.2) in the TAVR cohort and 6.7% (95% CI, 3.5-12.8) in the SAVR cohort (log-rank P = .53). Compared with patients receiving SAVR, the mean (SD) Kansas City Cardiomyopathy Questionnaire summary score was significantly better among patients receiving TAVR at 30 days (81.4 [19.2] vs 69.7 [22.6]; P

Medicare's Bundle Payment for Care Improvement (BPCI) Model 2 groups reimbursement for valve surgery into 90-day episodes of care, which include operative costs, inpatient stay, physician fees, postacute care, and readmissions up to 90 days postprocedure. We analyzed our BPCI patients' 90-day outcomes to understand the late financial risks and implications of the bundle payment system for valve patients. All BPCI valve patients from October 2013 (start of risk-sharing phase) to December 2015 were included. Readmissions were categorized as early (≤30 days) or late (31-90 days). Data were collected from institutional databases as well as Medicare claims. Analysis included 376 BPCI valve patients: 202 open and 174 transcatheter aortic valves (TAVR). TAVR patients were older (83.6 vs 73.8 years; P = 0.001) and had higher Society of Thoracic Surgery predicted risk (7.1% vs 2.8%; P = 0.001). Overall, 18.6% of patients (70/376) had one-or-more 90-day readmission, and total claim was on average 51% greater for these patients. Overall readmissions were more common among TAVR patients (22.4% (39/174) vs 15.3% (31/202), P = 0.052) as was late readmission. TAVR patients had significantly higher late readmission claims, and early readmission was predictive of late readmission for TAVR patients only (P = 0.04). Bundled claims for a 90-day episode of care are significantly increased in patients with readmissions. TAVR patients represent a high-risk group for late readmission, possibly a reflection of their chronic disease processes. Being able to identify patients at highest risk for 90-day readmission and the associated claims will be valuable as we enter into risk-bearing episodes of care agreements with Medicare.

Background: Traditionally, hostile peripheral access patients undergo TAVR via alternative access. We describe the “transfemoral-first” (TF-1) approach in patients with hostile peripheral a...

Mitral regurgitation (MR) is one of the most commonly encountered valvular lesions in clinical practice. MR can be either primary (degenerative) or secondary (functional) depending on the etiology of MR and the pathology of the mitral valve (MV). Echocardiography is the primary diagnostic tool for MR and is key in determining this etiology as well as MR severity. While clinicians usually turn to 2 Dimensional echocardiography as first-line imaging, 3 Dimensional echocardiography (3DE) has continually shown to be superior in terms of describing MV anatomy and pathology. This review article elaborates on 3DE techniques, modalities, and advances in software. Furthermore, the article demonstrates how 3DE has reformed MR evaluation and has played a vital role in determining patient management.

Objectives The aim of this study was to clarify the dynamics of the mitral annulus throughout the cardiac cycle and its relevance to transcatheter mitral valve replacement (TMVR) sizing and case selection. Background Limited data are available regarding the relevance of mitral annular (MA) and neo–left ventricular outflow tract (LVOT) dynamics in the overall population presenting with significant mitral valve disease. Methods Patients attending a combined surgical-transcatheter heart valve clinic for severe symptomatic mitral valve disease were assessed using multiphase computed tomography. The relative influence of MA and neo-LVOT dynamics to TMVR case selection was studied. Results A total of 476 patients with significant mitral valve disease were evaluated. In 99 consecutive patients with severe mitral regurgitation, a 10-phase assessment showed that the mitral annulus was on average largest in late systole. On comparing maximal MA dimension with late systolic dimension, TMVR size assignment changed in 24.2% of patients. If the average MA perimeter was used to determine sizing, 48.5% were excluded because of MA dimension being too large; in a multiphase assessment of the neo-LVOT, an additional 16.2% were excluded on the basis of neo-LVOT dimension. In an expanded series of 312 consecutive patients, selection protocol influenced anatomical exclusion: a manufacturer-proposed early systolic approach excluded 69.2% of patients, whereas a late systolic approach excluded 82.7% of patients, the vast majority because of large mitral annuli. Conclusions Contemporary TMVR can treat only a minority of patients with severe mitral regurgitation, principally because of limitations of large MA dimension.

The prognostic impact of preexisting atrial fibrillation or flutter (AF) in low-risk patients with severe aortic stenosis treated with transcatheter (TAVR) or surgical aortic valve replacement (SAVR) remains unknown. In this sub-analysis of the PARTNER 3 trial of patients with severe aortic stenosis at low surgical risk randomized 1:1 to TAVR versus SAVR, clinical outcomes were analyzed at 2 years according to AF status. Among 948 patients included in the analysis (452 [47.7%] in the SAVR vs 496 [52.3%] in the TAVR arm), 168 (17.6%) patients had AF [88/452 (19.5%) and 80/496 (16.1%) treated with SAVR and TAVR, respectively]. At 2 years, patients with AF had higher unadjusted rates of the composite outcome of death, stroke or rehospitalization (21.2% vs 12.9%, p = 0.007) and rehospitalization alone (15.3% vs 9.4%, p = 0.03) but not all cause death (3.8% vs 2.6%, p = 0.45) or stroke (4.8% vs 2.6%, p = 0.12). In adjusted analyses, patients with AF had a higher risk for the composite outcome of death, stroke or rehospitalization (hazard ratio [HR] 1.80, 95% confidence interval [CI] 1.20–2.71, p = 0.0046) and rehospitalization alone (HR 1.8, 95% CI 0.12–2.9, p = 0.015), but not death or stroke. There was no interaction between treatment modality and AF on the composite outcome (Pinter = 0.83). In conclusion, preexisting AF in patients with severe AS at low surgical risk was associated with increased risk of the composite outcome of death, stroke or rehospitalization at 2 years, irrespective of treatment modality.

Background Paravalvular regurgitation (PVR) following transcatheter aortic valve replacement (TAVR) is associated with increased morbidity and mortality. PVR continues to plague TAVR jeopardizing long-term results. New device iterations, such as the self-expandable Evolut PRO valve, aim to decrease PVR while maintaining optimal hemodynamics. This study sought to evaluate clinical and hemodynamic performance of the Evolut PRO system at 3 years. Methods The Evolut PRO US Clinical Study included 60 patients at high or extreme surgical risk undergoing TAVR with the Evolut PRO valve at 8 centers in the United States. Clinical outcomes were evaluated using Valve Academic Research Consortium (VARC)-2 criteria and included all-cause mortality, cardiovascular mortality , disabling stroke and valve complications. An independent core laboratory centrally assessed all echocardiographic measures. Results At 3 years, all-cause mortality was 25.8% (cardiovascular mortality 16.5%) and the disabling stroke rate was 10.7%. There were no cases of repeat valve intervention, endocarditis or coronary obstruction . Valve thrombosis was identified in 1 patient 2 years post-procedure and was treated medically. Hemodynamics at 3 years included a mean gradient of 7.2 ± 4.5 mm Hg, an effective orifice area of 2.0 ± 0.5 cm 2 , and 88.2% of patients had no or trace PVR. The remaining patients had mild PVR. Most of the surviving patients (80.6%) had New York Heart Association class I symptoms at 3 years. Conclusion Outcomes at 3-years following TAVR with a contemporary self-expanding prosthesis are favorable, with no signal of valve deterioration , excellent hemodynamics including very low prevalence of PVR.

Glucose 6-phosphate dehydrogenase (G6PD) deficiency facilitates human coronavirus infection due to glutathione depletion. G6PD deficiency may especially predispose to hemolysis upon coronavirus disease-2019 (COVID-19) infection when employing pro-oxidant therapy. However, glutathione depletion is reversible by N-acetylcysteine (NAC) administration. We describe a severe case of COVID-19 infection in a G6PD-deficient patient treated with hydroxychloroquine who benefited from intravenous (IV) NAC beyond reversal of hemolysis. NAC blocked hemolysis and elevation of liver enzymes, C-reactive protein (CRP), and ferritin and allowed removal from respirator and veno-venous extracorporeal membrane oxygenator and full recovery of the G6PD-deficient patient. NAC was also administered to 9 additional respirator-dependent COVID-19-infected patients without G6PD deficiency. NAC elicited clinical improvement and markedly reduced CRP in all patients and ferritin in 9/10 patients. NAC mechanism of action may involve the blockade of viral infection and the ensuing cytokine storm that warrant follow-up confirmatory studies in the setting of controlled clinical trials.

Left ventricular outflow tract (LVOT) obstruction in hypertrophic cardiomyopathy (HCM) is often caused by systolic anterior motion (SAM) of the mitral valve caused by the interplay between increased left ventricular (LV) wall thickness and an abnormal mitral valve anatomy and geometry. Three-dimensional (3D) echocardiographic imaging of the mitral valve has revolutionized the practice of cardiology, paving the way for new methods to see and treat valvular heart disease. Here we present the novel and incremental value of 3D transesophageal echocardiography (TEE) of SAM visualization. This review first provides step-by-step instructions on acquiring and optimizing 3D TEE imaging of SAM. It then describes the unique and novel findings using standard 3D TEE rendering as well as dynamic mitral valve modeling of SAM from 3D data sets, which can provide a more detailed visualization of SAM features. The findings include double-orifice LVOT caused by the residual leaflet, the dolphin smile phenomenon, and delineation of SAM width. Finally, the review discusses the essential role of 3D TEE imaging for preprocedural assessment and intraprocedural guidance of surgical and novel percutaneous treatments of SAM.

Background The Placement of Aortic Transcatheter Valves 2A (PARTNER-2A) randomized trial compared outcomes of transfemoral transcatheter and surgical aortic valve replacement (SAVR) in intermediate-risk patients with severe aortic stenosis. The purpose of the present study was to perform an in-depth analysis of outcomes after SAVR in the PARTNER-2A trial. Methods From January 2012 to January 2014, 937 patients underwent SAVR at 57 centers. Mean age was 82 ± 6.7 years and 55% were men. Less-invasive operations were performed in 140 patients (15%) and concomitant procedures in 198 patients (21%). Major outcomes and echocardiograms were adjudicated by an independent events committee. Follow-up was 94% complete to 2 years. Results Operative mortality was 4.1% (n = 38, Society of Thoracic Surgeons predicted risk of mortality: 5.2% ± 2.3%), observed to expected ratio (O/E) was 0.8, and in-hospital stroke was 5.4% (n = 51), twice expected. Aortic clamp and bypass times were 75 ± 30 minutes and 104 ± 46 minutes, respectively. Patients having severe prosthesis–patient mismatch (n = 260, 33%) had similar survival to patients without ( p > 0.9), as did patients undergoing less-invasive SAVR ( p = 0.3). Risk factors for death included cachexia ( p = 0.004), tricuspid regurgitation ( p = 0.01), coronary artery disease ( p = 0.02), preoperative atrial fibrillation ( p = 0.001), higher white blood cell count ( p p = 0.0002). Conclusions In this adjudicated prospective study, SAVR in intermediate-risk patients had excellent results at 2 years. However, there were more in-hospital strokes than expected, most likely attributable to mandatory neurologic assessment after the procedure. No pronounced structural valve deterioration was found during 2-year follow-up. Continued long-term surveillance remains important.

Objectives The purpose of this study was to identify sex-specific outcomes of intermediate risk patients undergoing transcatheter aortic valve replacement with the SAPIEN 3 valve. Background A survival difference has been observed in women as compared with men in inoperable and high-risk patients receiving early-generation balloon-expandable valves for transcatheter aortic valve replacement (TAVR). Whether a sex-specific outcome difference persists with newer-generation valves and in lower-risk patients is unknown. Methods The PARTNER (Placement of Aortic Transcatheter Valves) II S3 trial included high-risk (HR) (Society of Thoracic Surgeons risk score >8% or heart team determination) and intermediate-risk (IR) (Society of Thoracic Surgeons risk score 4% to 8% or heart team determination) patients with severe symptomatic aortic stenosis who were treated with TAVR with the SAPIEN 3 valve. Patient characteristics and clinical outcomes at 30 days and 1 year were compared by sex. Results Between October 2013 and December 2014, 1,661 patients were enrolled: 583 were HR (338 men, 245 women) and 1,078 were IR (666 men, 412 women). In both cohorts, women were more likely than men to be frail (22% vs. 13%; p Conclusions The study found no apparent sex-specific differences in survival or stroke in this trial of TAVR. This may reflect the changing demographic of patients enrolled, use of newer-generation valves with more sizes available, and more accurate valve sizing techniques.

Graphical abstract, Highlights • Aorto-right ventricular fistula is a rare diagnosis and is on the spectrum of aortic periannular rupture. • Multimodality imaging is crucial in identifying aortic periannular rupture, defining its course, and for preprocedural planning. • We describe a case of aorto-right ventricular fistula, which was successfully treated using an Amplazter vascular plug intravenous device (St. Jude Medical) and is to our knowledge the first reported case of using a plugging device for this type of disorder.

Objectives: This study sought to evaluate this transcatheter aortic valve (TAV) bioprosthesis in patients who are poorly suitable for surgical aortic valve (AV) replacement.Background: A no...

A 78-year-old man with remote type-A dissection presented with acute-onset dyspnea. Twenty-two years prior, treatment for his aortic disease required replacement of ascending and arch aneurysms with a polyester graft (Dacron) using the graft inclusion technique. He presented currently in cardiogenic shock. Echocardiography demonstrated new severe hypokinesis of all apical segments. Left-heart catheterization revealed a 120 mm Hg intragraft gradient. Computed tomography arteriography was unrevealing, but intraaortic ultrasound demonstrated critical intragraft stenosis. A balloon expandable stent (Palmaz stent, Cordis, Milpitas, CA) was deployed in the stenotic region with gradient resolution. The patient later underwent aortic root replacement and ascending aneurysm repair (Bio-Bentall technique) and is doing well at 24 months.

OBJECTIVE: The types of agents used for monitored anesthesia care (MAC) and their possible differential effects on outcomes have received less study despite increased use over general anesthesia (GA) in transfemoral aortic valve replacements (TAVRs). In this pilot analysis of patients undergoing TAVR using MAC, we described the anesthetic agents used and sought to investigate the possible association of anesthetic agent choice with outcomes, and the extent to which total weight and time-adjusted doses of anesthetics declined with increasing 10-year age-increments. DESIGN: Retrospective observational study. SETTING: Tertiary teaching hospital. PARTICIPANTS: 93 participants scheduled to undergo TAVR with a primary plan of conscious sedation between November 2014 and June 2016 were included. INTERVENTION: None. MEASUREMENTS AND MAIN RESULTS: Types of MAC were divided into four primary groups, but we focused on two groups: propofol (n=39) and dexmedetomidine plus propofol (n=34). Conversion to GA occurred in 6 participants (6.45%) and was not associated with type of sedation received. We also compared patients receiving dexmedetomidine to those who did not in accordance with our a priori analytic plan. There were no associations between the use of dexmedetomidine and postoperative delirium or ICU/hospital length of stay. There were also no significant trends in medication dose adjustments seen across increasing 10-year age increments. CONCLUSIONS: A wide breadth of MAC medications is in use among TAVR patients and does not support differences in outcomes. Despite recommendations to reduce anesthetic drug dosing in the elderly, no significant trends in dose reduction with increasing age were noted.

In patients with severe aortic stenosis (AS) at low surgical risk, treatment with transcatheter aortic valve replacement (TAVR) results in lower rates of death, stroke, and rehospitalization at 1 year compared with surgical aortic valve replacement; however, the effect of treatment strategy on health status is unknown.This study sought to compare health status outcomes of TAVR versus surgery in low-risk patients with severe AS.Between March 2016 and October 2017, 1,000 low-risk patients with AS were randomized to transfemoral TAVR using a balloon-expandable valve or surgery in the PARTNER 3 (Placement of Aortic Transcatheter Valves) trial. Health status was assessed at baseline and 1, 6, and 12 months using the KCCQ (Kansas City Cardiomyopathy Questionnaire), SF-36 (Short Form-36 Health Survey), and EQ-5D (EuroQoL). The primary endpoint was change in KCCQ-OS (KCCQ Overall Summary) score over time. Longitudinal growth curve modeling was used to compare changes in health status between treatment groups over time.At 1 month, TAVR was associated with better health status than surgery (mean difference in KCCQ-OS 16.0 points; p 0.001). At 6 and 12 months, health status remained better with TAVR, although the effect was reduced (mean difference in KCCQ-OS 2.6 and 1.8 points respectively; p 0.04 for both). The proportion of patients with an excellent outcome (alive with KCCQ-OS ≥75 and no significant decline from baseline) was greater with TAVR than surgery at 6 months (90.3% vs. 85.3%; p = 0.03) and 12 months (87.3% vs. 82.8%; p = 0.07).Among low-risk patients with severe AS, TAVR was associated with meaningful early and late health status benefits compared with surgery.

Background: While most self-expanding transcatheter valves are repositionable, only one fully retrievable valve is currently available. The Meridian valve is a new self-expanding valve with full retrievability properties. The objective of our study was to evaluate the early feasibility, preliminary safety, and efficacy of transcatheter aortic valve replacement with the HLT Meridian valve (HLT, Inc). Methods: This was a multicenter early feasibility study including patients with severe aortic stenosis at high surgical risk undergoing transfemoral transcatheter aortic valve replacement with the 25-mm Meridian valve. All serious adverse events were adjudicated by an independent clinical events committee according to Valve Academic Research Consortium-2 criteria. Echocardiography data were assessed by an independent echocardiography core laboratory. Results: A total of 25 patients (mean age, 85±6 years; 80% of men) were included. The valve was successfully implanted in 22 (88%) patients (annulus too large and extreme horizontal aorta in 2 and 1 unsuccessful cases, respectively). Valve retrieval because of an initial nonadequate positioning was attempted and successfully performed in 10 (40%) patients. Echocardiography post-transcatheter aortic valve replacement showed a low mean residual gradient (10±4 mm Hg) and the absence of moderate-severe aortic regurgitation (none-trace and mild aortic regurgitation in 76% and 24% of patients, respectively). Mortality at 30 days was 8%, with no cases of disabling stroke, valve embolization, or major/life-threatening bleeding complications. At 6-month follow-up, the cumulative mortality rate was 12%, with no changes in echocardiographic parameters and no cases of valve dysfunction. The majority of patients (89%) were in New York Heart Association class I-II at 6 months. Conclusions: Transcatheter aortic valve replacement with the Meridian valve was feasible and associated with acceptable early and 6-month clinical results. Valve retrieval after full valve deployment was successfully performed in all attempted cases, and valve performance was excellent, with low residual gradients, no cases of moderate-severe aortic regurgitation, and none-trace residual aortic regurgitation in the majority of patients. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02838680 (RADIANT-Canada); NCT02799823 (RADIANT-US).

The aim of this study was to assess the evolution of early outcomes for 3 iterative self-expanding transcatheter aortic valves.Over the past decade there have been rapid advancements in transcatheter aortic valve replacement (TAVR) technologies, including 3 generations of supra-annular self-expanding transcatheter systems.Data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry for patients undergoing TAVR with CoreValve, Evolut R, or Evolut PRO valves to treat tricuspid aortic stenosis between January 2014 and September 2017 were obtained. Patient risk and echocardiographic data are site reported. Valves analyzed included 23-, 26-, and 29-mm sizes to fit 18- to 26-mm annular diameters. Propensity score matching was performed using the Evolut PRO group as the common reference.Of 18,874 patients undergoing TAVR at 381 centers, 5,514 patients were implanted with CoreValve, 11,295 with Evolut R, and 2,065 with Evolut PRO valves. At 30 days, there were significantly fewer patients with more than mild aortic regurgitation for the unmatched (7.8% CoreValve, 5.2% Evolut R, and 2.8% Evolut PRO; p 0.001) and matched populations (8.3% CoreValve, 5.4% Evolut R, and 3.4% Evolut PRO; p = 0.032). The mean aortic valve gradients at 30 days in the matched populations were 8 mm Hg for all 3 valves (7.3 mm Hg CoreValve, 7.5 mm Hg Evolut R, 7.2 mm Hg Evolut PRO).Advancements in transcatheter valve technologies and expanding indications for TAVR have resulted in improved outcomes for patients undergoing TAVR in the United States with self-expanding, supra-annular valves. In particular, the addition of an outer pericardial tissue wrap designed to enhance sealing at the level of the aortic annulus has resulted in very low rates of significant aortic regurgitation while maintaining excellent hemodynamic status.

Hemodynamic performance of prostheses after transcatheter aortic valve replacement (TAVR) is generally better than after surgical aortic valve replacement (SAVR), especially in patients with a small native annulus size. However, it remains unclear whether differences are consistent for patients with a different propensity for developing prosthesis-patient mismatch (PPM), considering annulus size and body size of patients.The SURTAVI trial (Surgical Replacement and Transcatheter Aortic Implantation) compared TAVR using a self-expandable valve with SAVR in intermediate-risk patients. Multidetector computed tomography-based aortic annulus size consisted of the perimeter-derived diameter, which was divided by body surface area to produce an indexed annulus size. Patients were categorized into a small (9-12 mm/mRates of PPM were significantly lower after TAVR than after SAVR across all groups of indexed annulus size, reflecting better hemodynamic performance of transcatheter versus surgical valves, irrespective of the propensity to develop PPM. More attention should be directed to prevention of PPM after SAVR. This information should be considered by the Heart Team to recommend a specific procedure or valve.URL: https://www.clinicaltrials.gov . Unique identifier: NCT01586910.

INTRODUCTION A common complication of transcatheter aortic valve repair (TAVR) is development of conduction defects requiring pacemaker (PPM) implantation. These defects are not universally permanent. OBJECTIVE To determine the incidence and predictors of persistent device dependency in patients with PPM implantation following TAVR with a self-expanding prosthesis. METHODS Records of patients who underwent post-TAVR PPM implantation were reviewed. Patients with persistent complete AV block (AVBIII) one month post-TAVR were compared to those regaining conduction. RESULTS Between September 2014 and March 2017, 485 patients underwent TAVR with a self-expanding prosthesis; 77 (15.9%) underwent PPM implantation for AVBIII. Device interrogation at one month was available for 61 patients (79%): 22 (36.1%) had resolution of AVBIII while 39 (63.9%) remained pacemaker-dependent. Pre-TAVR right bundle branch block was more frequent in device-dependent patients (19 of 38, 50% vs 4 of 22, 18%; RR 2.75; P = .01). Device-dependence was associated with AVBIII as the first postprocedural rhythm (37 of 39, 95% vs 12 of 22, 55%; RR 1.74; P

BACKGROUND: Renal disease is associated with poor prognosis despite guideline-directed cardiovascular therapy, and outcomes by sex in this population remain uncertain. METHODS AND RESULTS: Patients (n=5213) who underwent a MitraClip procedure in the National Cardiovascular Data Registry Transcatheter Valve Therapy registry were evaluated for the primary composite outcome of all-cause mortality, stroke, and new requirement for dialysis by creatinine clearance (CrCl). Centers for Medicare and Medicaid Services–linked data were available in 63% of patients (n=3300). CrCl was 60 mL/min, 1.4%; 30–60 mL/min. Rates of 1-year mortality were higher with lower CrCl (>60 mL/min, 13.2%; 30–60 mL/min. CONCLUSIONS: The majority of patients who undergo MitraClip have renal disease. Preprocedural renal disease is associated with poor outcomes, particularly in stage 4 or 5 renal disease where 1-year mortality is observed in nearly one-third. Studies to determine how to further optimize outcomes in this population are warranted.

Background: Renal disease is associated with poor prognosis despite guideline-directed cardiovascular therapy, and outcomes by sex in this population remain uncertain. Methods and Results: Patients (n=5213) who underwent a MitraClip procedure in the National Cardiovascular Data Registry Transcatheter Valve Therapy registry were evaluated for the primary composite outcome of all-cause mortality, stroke, and new requirement for dialysis by creatinine clearance (CrCl). Centers for Medicare and Medicaid Services–linked data were available in 63% of patients (n=3300). CrCl was 60 mL/min, 1.4%; 30–P 60 mL/min. Rates of 1-year mortality were higher with lower CrCl (>60 mL/min, 13.2%; 30–P 60 mL/min. Conclusions: The majority of patients who undergo MitraClip have renal disease. Preprocedural renal disease is associated with poor outcomes, particularly in stage 4 or 5 renal disease where 1-year mortality is observed in nearly one-third. Studies to determine how to further optimize outcomes in this population are warranted.

Background: Hemodynamic performance of prostheses after transcatheter aortic valve replacement (TAVR) is generally better than after surgical aortic valve replacement (SAVR), especially in patients with a small native annulus size. However, it remains unclear whether differences are consistent for patients with a different propensity for developing prosthesis-patient mismatch (PPM), considering annulus size and body size of patients. Methods and Results: The SURTAVI trial (Surgical Replacement and Transcatheter Aortic Implantation) compared TAVR using a self-expandable valve with SAVR in intermediate-risk patients. Multidetector computed tomography–based aortic annulus size consisted of the perimeter-derived diameter, which was divided by body surface area to produce an indexed annulus size. Patients were categorized into a small (9–12 mm/m 2 ), medium (>12–14 mm/m 2 ), and large (>14–18 mm/m 2 ) group according to indexed annulus size. We compared TAVR and SAVR for PPM, hemodynamics, and clinical, and functional outcomes through 1-year follow-up within the size groups. Patients who underwent TAVR received a larger prosthesis with increasing indexed annulus size ( P P =0.74). Patients in all size groups had significantly larger indexed effective orifice area and lower mean gradients at discharge after TAVR versus SAVR. Rates of PPM were significantly lower with TAVR versus SAVR in all groups ( P P =0.04) and SAVR ( P =0.03). Indexed annulus size was an independent predictor of PPM after TAVR and SAVR. Clinical outcomes were comparable between TAVR and SAVR across all groups, apart from a significantly higher rate of reintervention after TAVR versus SAVR in the large indexed annulus size group (2.5% versus 0%; P =0.01) but without significant interaction ( P int =0.81). Conclusions: Rates of PPM were significantly lower after TAVR than after SAVR across all groups of indexed annulus size, reflecting better hemodynamic performance of transcatheter versus surgical valves, irrespective of the propensity to develop PPM. More attention should be directed to prevention of PPM after SAVR. This information should be considered by the Heart Team to recommend a specific procedure or valve. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01586910.

Summary Background Transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve demonstrates good 30 day clinical outcomes in patients with severe aortic stenosis who are at intermediate risk of surgical mortality. Here we report longer-term data in intermediate-risk patients given SAPIEN 3 TAVR and compare outcomes to those of intermediate-risk patients given surgical aortic valve replacement. Methods In the SAPIEN 3 observational study, 1077 intermediate-risk patients at 51 sites in the USA and Canada were assigned to receive TAVR with the SAPIEN 3 valve [952 [88%] via transfemoral access) between Feb 17, 2014, and Sept 3, 2014. In this population we assessed all-cause mortality and incidence of strokes, re-intervention, and aortic valve regurgitation at 1 year after implantation. Then we compared 1 year outcomes in this population with those for intermediate-risk patients treated with surgical valve replacement in the PARTNER 2A trial between Dec 23, 2011, and Nov 6, 2013, using a prespecified propensity score analysis to account for between-trial differences in baseline characteristics. The clinical events committee and echocardiographic core laboratory methods were the same for both studies. The primary endpoint was the composite of death from any cause, all strokes, and incidence of moderate or severe aortic regurgitation. We did non-inferiority (margin 7·5%) and superiority analyses in propensity score quintiles to calculate pooled weighted proportion differences for outcomes. Findings At 1 year follow-up of the SAPIEN 3 observational study, 79 of 1077 patients who initiated the TAVR procedure had died (all-cause mortality 7·4%; 6·5% in the transfemoral access subgroup), and disabling strokes had occurred in 24 (2%), aortic valve re-intervention in six (1%), and moderate or severe paravalvular regurgitation in 13 (2%). In the propensity-score analysis we included 963 patients treated with SAPIEN 3 TAVR and 747 with surgical valve replacement. For the primary composite endpoint of mortality, strokes, and moderate or severe aortic regurgitation, TAVR was both non-inferior (pooled weighted proportion difference of −9·2%; 90% CI −12·4 to −6; p Interpretation TAVR with SAPIEN 3 in intermediate-risk patients with severe aortic stenosis is associated with low mortality, strokes, and regurgitation at 1 year. The propensity score analysis indicates a significant superiority for our composite outcome with TAVR compared with surgery, suggesting that TAVR might be the preferred treatment alternative in intermediate-risk patients. Funding None.