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Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to benefit/risk assessment and safety evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, as well as clinical research and real-world implementation through appropriate use criteria. The essential minimum core dataset for these purposes has not previously been defined but is necessary to promote efficient, reusable real-world data collection supporting quality, regulatory, and clinical applications. The authors performed a systematic review of the published research for high-impact TAVR studies and U.S. multicenter, multidevice registries. Two expert task forces, one from the Predictable and Sustainable Implementation of National Cardiovascular Registries/Heart Valve Collaboratory and another from The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry convened separately and then met to reconcile a final list of essential data elements. From 276 unique data elements considered, unanimous consensus agreement was achieved on 132 "core" data elements, with the most common reasons for exclusion from the minimum core dataset being burden or difficulty in accurate assessment (36.9%), duplicative information (33.3%), and low likelihood of affecting outcomes (10.7%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established 132 interoperable, reusable essential core data elements essential to supporting more efficient, consistent, and informative TAVR device evidence for regulatory submissions, safety surveillance, best practice, and hospital quality assessments., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to benefit/risk assessment and safety evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, as well as clinical research and real-world implementation through appropriate use criteria. The essential minimum core dataset for these purposes has not previously been defined but is necessary to promote efficient, reusable real-world data collection supporting quality, regulatory, and clinical applications. The authors performed a systematic review of the published research for high-impact TAVR studies and U.S. multicenter, multidevice registries. Two expert task forces, one from the Predictable and Sustainable Implementation of National Cardiovascular Registries/Heart Valve Collaboratory and another from The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry convened separately and then met to reconcile a final list of essential data elements. From 276 unique data elements considered, unanimous consensus agreement was achieved on 132 "core" data elements, with the most common reasons for exclusion from the minimum core dataset being burden or difficulty in accurate assessment (36.9%), duplicative information (33.3%), and low likelihood of affecting outcomes (10.7%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established 132 interoperable, reusable essential core data elements essential to supporting more efficient, consistent, and informative TAVR device evidence for regulatory submissions, safety surveillance, best practice, and hospital quality assessments., Competing Interests: Funding Support and Author Disclosures This paper reflects the views of the authors and should not be construed to represent the FDA’s views or policies. Dr Vemulapalli has received grants from or has contracts with the American College of Cardiology, The Society of Thoracic Surgeons, the National Institutes of Health (R01 and Small Business Innovation Research), the FDA (National Evaluation System for Health Technology collaborative community), Abbott, Boston Scientific, and Cytokinetics; and is an advisory board member or consultant for Janssen, HeartFlow, Boston Scientific, and the American College of Physicians. Dr Krucoff has received grants from, has contracts with, or is a consultant for Abbott Vascular, Boston Scientific, Medtronic, Mitre Medical, and OrbusNeich. Dr Alu has received institutional research funding from Abbott and Edwards Lifesciences. Dr Leon has received institutional grants for clinical research from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Moderate or worse paravalvular regurgitation (PVR) post transcatheter aortic valve replacement (TAVR) is associated with increased mortality. The mechanisms by which this occurs are not fully understood., Aims: The aim of this study was to determine the mechanism by which PVR leads to worse outcomes., Methods: A total of 1,974 intermediate-risk patients who received TAVR in the PARTNER 2 trial and registries were grouped by PVR severity. Clinical and echocardiographic outcomes were compared., Results: Overall 1,176 (60%) patients had none/trace, 680 (34%) had mild, and 118 (6%) had ≥moderate PVR. At two years, ≥moderate PVR patients had increased risks of all-cause (HR 2.33 [1.41-3.85], p-value=0.001) and cardiovascular death (HR 3.30 [1.74-6.28], p-value <0.001), rehospitalisation (HR 2.68 [1.57-4.58], p-value <0.001), and reintervention (HR 14.72 [3.13-69.32], p-value <0.001). Moderate or worse PVR was associated with larger increases in left ventricular (LV) end-diastolic and systolic dimensions and volumes, LV mass indices, and reductions in LV ejection fractions (LVEFs) from 30 days to two years. Mild PVR was not associated with worse outcomes. Adjusting for LV dimensions and LVEF from the one-year echocardiogram, patients with ≥moderate PVR still had an increased risk of all-cause death or rehospitalisation at two years (HR 2.84 [1.25-5.78], p-value=0.009)., Conclusions: Moderate or worse PVR, but not mild PVR, is associated with an increased risk of all-cause and cardiovascular death, rehospitalisation, and reintervention at two years. Moderate or worse PVR is also associated with adverse LV remodelling, which partially mediates how ≥moderate PVR leads to worse outcomes. These results provide dual insights on the deleterious impact of ≥moderate PVR and the contributing mechanisms of poor clinical outcomes.

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)., Competing Interests: Funding Support and Author Disclosures The PARTNER 3 Trial was funded by Edwards Lifesciences. Dr. Leon has received grant support, paid to his institution, from Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific; and has received advisory board fees from Medtronic, Abbott, Boston Scientific, Gore, and Meril Life Sciences. Dr. Mack has received consulting fees from Gore; has served as a trial coprimary investigator for Edwards Lifesciences and Abbott; and has served as a study chair for Medtronic. Dr. Hahn has received consulting fees from Abbott Vascular, Siemens Healthineers, Boston Scientific, Bayliss, Edwards Lifesciences, Philips Healthcare, 3Mensio, Medtronic, and Navigate. Dr. Thourani has received grant support and has served as an advisor for Edwards Lifesciences. Dr. Makkar has received grant support from Abbott and Edwards Lifesciences. Dr. Kodali holds equity in BioTrace Medical, Dura Biotech, and Thubrikar Aortic Valve; has received grant support from Medtronic and Boston Scientific; has received grant support and consulting fees from Abbott Vascular; and has received consulting fees from Claret Medical, Admedus, and Meril Life Sciences. Ms. Alu has received research funding, paid to her institution, from Edwards Lifesciences and Abbott. Dr. Russo has received consulting fees, lecture fees, and fees for serving as a proctor from Edwards Lifesciences; has received consulting fees and fees for serving as a proctor from Abbott; and has received consulting fees from Boston Scientific. Dr. Malaisrie has received consulting fees from Medtronic; and has received lecture fees from Abbott. Dr. Cohen has received grant support, paid to his institution, from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular; and has received consulting fees from Edwards Lifesciences and Medtronic. Dr. Blanke has received consulting fees from Edwards Lifesciences, Tendyne (Abbott), Circle Cardiovascular Imaging, Neovasc, and Gore. Dr. Leipsic has received grant support from Abbott and Medtronic; and has received consulting fees and holds stock options from Circle Cardiovascular Imaging. Dr. McCabe has received consulting fees from Edwards Lifesciences. Dr. Babaliaros has received lecture fees and consulting fees from Edwards Lifesciences and Abbott. Dr. Goldman has received advisory board fees from Edwards Lifesciences. Dr. Szeto has received lecture fees and has served as an investigator for Edwards Lifesciences. Dr. Genereux has received consulting fees and advisory board fees from Abbott Vascular, Boston Scientific, Cardiovascular Solutions, and Cordis; has received consulting fees and fees for serving as a proctor from Edwards Lifesciences; and has received consulting fees from Medtronic, Saranas, Pi-Cardia, and Sig.Num. Dr. Webb has received consulting fees and fees for serving as a proctor from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Heart failure (HF) hospitalization prior to transcatheter aortic valve replacement (TAVR) is associated with increased post-procedural mortality. We sought to assess the association between recent (≤6 months) HF hospitalization and long-term adverse outcomes in patients with symptomatic, severe aortic stenosis, undergoing TAVR in the PARTNER 2 trial and registries., Methods and Results: Intermediate to high or even prohibitive risk patients who underwent TAVR in the PARTNER 2 trial and registries were included in the analysis. Clinical outcomes at 30 days and 2 years were compared between patients according to whether they were recently hospitalized for HF, using Kaplan-Meier event rates and study-stratified multivariable Cox proportional hazards regression models. A sensitivity analysis was conducted using propensity score matching. Of 3988 patients (99.8%) with available information on recent HF hospitalization, 1622 patients (40.7%) were hospitalized for HF symptoms during the 6 months prior to TAVR. After multivariable adjustments, recent HF hospitalization was associated with increased all-cause mortality at 30 days [adjusted hazard ratio (HR) 1.63, 95% confidence interval (CI) 1.07-2.48, P = 0.02] and 2 years (adjusted HR 1.30, 95% CI 1.13-1.49, P = 0.0003), which was driven by increased cardiovascular mortality. Infective endocarditis rate at 2 years was also higher in patients with recent HF hospitalization (adjusted HR 2.35, 95% CI 1.38-4.01, P = 0.002). These results remained consistent when propensity score matching was used., Conclusion: In a large cohort of patients with severe symptomatic aortic stenosis from the PARTNER 2 trial and registries, all-cause and cardiovascular mortality as well as infective endocarditis rates at 2 years were higher in patients with recent HF hospitalization., (© 2020 European Society of Cardiology.)

Background: Greater early left ventricular mass index (LVMi) regression is associated with fewer hospitalizations 1 year after transcatheter aortic valve replacement (TAVR). The association between LVMi regression and longer-term post-TAVR outcomes is unclear., Objectives: The purpose of this study was to determine the association between LVMi regression at 1-year post-TAVR and clinical outcomes between 1 and 5 years., Methods: Among intermediate- and high-risk patients who received TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) I, II, and S3 trials or registries and were alive at 1 year, we included patients with baseline moderate or severe left ventricular hypertrophy (LVH) and paired measurements of LVMi at baseline and 1 year. The associations between LVMi regression (percent change between baseline and 1 year) and death or rehospitalization from 1 to 5 years were examined., Results: Among 1,434 patients, LVMi was 146 g/m 2 (interquartile range [IQR]: 133 to 168 g/m 2 ) at baseline and decreased 14.5% (IQR: 4.2% to 26.1%) to 126 g/m 2 (IQR: 106 to 148 g/m 2 ) at 1 year. After adjustment, greater LVMi regression at 1 year was associated with lower all-cause death (adjusted hazard ratio [aHR]: 0.95 per 10% decrease in LVMi; 95% confidence interval [CI]: 0.91 to 0.98; p = 0.004; aHR of the quartile with greatest vs. least LVMi regression: 0.61; 95% CI: 0.43 to 0.86; p = 0.005). Severe LVH at 1 year was observed in 39%, which was independently associated with increased all-cause death (aHR of severe LVH vs. no LVH: 1.71; 95% CI: 1.20 to 2.44; p = 0.003). Similar associations were found for rates of cardiovascular mortality and rehospitalization., Conclusions: Among patients with moderate or severe LVH treated with TAVR who are alive at 1 year, greater LVMi regression at 1 year is associated with lower death and hospitalization rates to 5 years. These findings may have implications for the timing of valve replacement and the role of adjunctive medical therapy after TAVR., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Left ventricular pressure overload is associated with activation of the cardiac renin-angiotensin system, which may contribute to myocardial fibrosis and worse clinical outcomes. We sought to assess the association between treatment with angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) at baseline and clinical outcomes in patients with symptomatic, severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) in the PARTNER 2 trial and registries., Methods and Results: A total of 3979 intermediate, high, or prohibitive risk patients who underwent TAVR in the PARTNER 2 trial and registries (excluding the valve in valve registry) were included in the study. Clinical outcomes at 2 years were compared according to baseline ACEI/ARB treatment status using Kaplan-Meier event rates and study-stratified multivariable Cox proportional hazards regression models. Sensitivity analysis was conducted using propensity score matching. Of 3979 patients who were included in the current analysis, 1736 (43.6%) were treated and 2243 (56.4%) were not treated with ACEI/ARB at baseline. Treatment with ACEI/ARB was associated with lower 2-year all-cause mortality (18.6% vs. 27.5%, P < 0.0001), cardiovascular mortality (12.3% vs. 17.9%, P < 0.0001), and non-cardiovascular mortality (7.2% vs. 11.7%, P < 0.0001). Angiotensin-converting enzyme inhibitor/ARB treatment at baseline remained independently associated with a lower hazard of 2-year all-cause and cardiovascular mortality after multivariable adjustment, and propensity score matching., Conclusion: In a large cohort of patients with severe symptomatic AS from the PARTNER 2 trial and registries, ACEI/ARB treatment at baseline was independently associated with a lower risk of 2-year all-cause and cardiovascular mortality., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)