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Background Clinical evidence on the safety and effectiveness of using direct oral anticoagulants (DOACs) in patients with atrial fibrillation after transcatheter aortic valve replacement (TAVR) remains limited. The aim of this study was to investigate the trends and outcomes of using DOACs in patients with TAVR and atrial fibrillation. Methods and Results Data from the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry was used to identify patients who underwent successful TAVR with preexisting or incident atrial fibrillation who were discharged on oral anticoagulation between January 2013 and May 2018. Patients with a mechanical valve, valve-in-valve procedure, or prior stroke within a year were excluded. The adjusted primary outcome was 1-year stroke events. The adjusted secondary outcomes included bleeding, intracranial hemorrhage, and death. A total of 21 131 patients were included in the study (13 004 TAVR patients were discharged on a vitamin K antagonist and 8127 were discharged on DOACs.) The use of DOACs increased 5.5-fold from 2013 to 2018. The 1-year incidence of stroke was comparable between DOAC-treated patients and vitamin K antagonist-treated patients (2.51% versus 2.37%; hazard ratio [HR], 1.00; 95% CI, 0.81-1.23) whereas DOAC-treated patients had lower 1-year incidence of any bleeding (11.9% versus 15.0%; HR, 0.81; 95% CI, 0.75-0.89), intracranial hemorrhage (0.33% versus 0.59%; HR, 0.54; 95% CI, 0.33-0.87), and death (15.8% versus 18.2%; HR, 0.92; 95% CI, 0.85-1.00). Conclusions In patients with TAVR and atrial fibrillation, DOAC use, when compared with vitamin K antagonists, was associated with comparable stroke risk and significantly lower risks of bleeding, intracranial hemorrhage, and death at 1 year.

Background: Stroke remains a devastating complication of transcatheter aortic valve replacement (TAVR), which has persisted despite refinements in technique and increased operator experience. While cerebral embolic protection devices (EPDs) have been developed to mitigate this risk, data regarding their impact on stroke and other outcomes after TAVR are limited., Methods: We performed an observational study using data from the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Patients were included if they underwent elective or urgent transfemoral TAVR between January 2018 and December 2019. The primary outcome was in-hospital stroke. To adjust for confounding, the association between EPD use and clinical outcomes was evaluated using instrumental variable analysis, a technique designed to support causal inference from observational data, with site-level preference for EPD use within the same quarter of the procedure as the instrument. We also performed a propensity score-based secondary analysis using overlap weights., Results: Our analytic sample included 123 186 patients from 599 sites. The use of EPD during TAVR increased over time, reaching 28% of sites and 13% of TAVR procedures by December 2019. There was wide variation in EPD use across hospitals, with 8% of sites performing >50% of TAVR procedures with an EPD and 72% performing no procedures with an EPD in the last quarter of 2019. In our primary analysis using the instrumental variable model, there was no association between EPD use and in-hospital stroke (adjusted relative risk, 0.90 [95% CI, 0.68-1.13]; absolute risk difference, -0.15% [95% CI, -0.49 to 0.20]). However, in our secondary analysis using the propensity score-based model, EPD use was associated with 18% lower odds of in-hospital stroke (adjusted odds ratio, 0.82 [95% CI, 0.69-0.97]; absolute risk difference, -0.28% [95% CI, -0.52 to -0.03]). Results were generally consistent across the secondary end points, as well as subgroup analyses., Conclusions: In this nationally representative observational study, we did not find an association between EPD use for TAVR and in-hospital stroke in our primary instrumental variable analysis, and found only a modestly lower risk of in-hospital stroke in our secondary propensity-weighted analysis. These findings provide a strong basis for large-scale randomized, controlled trials to test whether EPDs provide meaningful clinical benefit for patients undergoing TAVR.

Objectives: This study sought to better understand out-of-hospital 30-day mortality following transfemoral transcatheter aortic valve replacement (TAVR) and identify factors associated with poor outcomes., Background: Despite improvements in outcomes with TAVR for severe aortic stenosis, out-of-hospital 30-day mortality has not been evaluated., Methods: This study examined patients in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry undergoing TAVR for severe aortic stenosis from January 2015 to March 2018. Primary and secondary endpoints were 30-day out-of-hospital all-cause mortality and out-of-hospital cardiovascular mortality, respectively. Logistic regression models were used to assess association between pre-specified factors and endpoints., Results: A total of 106,749 patients underwent TAVR and were eligible for analysis. Transfemoral TAVR was performed in 92.3% of patients. A total of 2,137 (2.2%) transfemoral patients died within 30 days of the procedure, and 623 (29%) patients of these patients experienced out-of-hospital 30-day mortality. Cardiovascular and pulmonary etiologies accounted for the majority of observed mortality. Multivariable regression analysis identified older age, gender, lower body surface area, lower left ventricular ejection fraction, lower hemoglobin, atrial fibrillation or flutter, severe lung disease, home oxygen use, lack of moderate-to-severe aortic insufficiency, urgent TAVR, lower Kansas City Cardiomyopathy Questionnaire score, longer hospital length of stay, and in-hospital complications as being independently associated with the primary endpoint. New onset or pre-existent atrial fibrillation or flutter was also independently associated with 30-day out-of-hospital cardiovascular mortality in the transfemoral population., Conclusions: We identified 30-day all-cause mortality rate for TAVR of 2.2%. Approximately one-third of patients experienced out-of-hospital mortality at 30 days. Several factors were identified as being independently associated with 30-day out-of-hospital all-cause and cardiovascular mortality. Further work is needed to understand how best to improve out-of-hospital mortality following TAVR., Competing Interests: Funding Support and Author Disclosures Dr. Anwaruddin has served on the advisory board for Medtronic and OpSens; has received speaking fees from Medtronic, Edwards Lifesciences, and Siemens; received consulting fees from Edwards Lifesciences; has served as a proctor/consultant for V wave; received institutional research support from the Cardiothoracic Surgery Network; and is on the Steering Committee for Boston Scientific. Dr. Desai has served as a speaker or consultant for Gore and Medtronic. Dr. Vemulapalli has served on the advisory board or as a consultant for Boston Scientific, HeartFlow, Baylabs (Caption Health), Janssen, and American College of Physicians; and has received grants or contracts from Abbott Vascular, Boston Scientific, the National Institutes of Health, Patient-Centered Outcomes Research, Nest (Food and Drug Administration), the American College of Cardiology, and the Society of Thoracic Surgeons. Dr. Marquis-Gravel has received grant support from the Canadian Institute of Health Sciences; and has received honoraria from Servier and Novartis. Dr. Reardon has served on the advisory board for Medtronic and Boston Scientific; and has served as a consultant for Gore. 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.)

Importance: Geographic access to transcatheter aortic replacement (TAVR) centers varies in the United States as a result of controlled expansion through minimum volume requirements., Objective: To describe the current geographic access to TAVR centers in the United States., Design, Setting, and Participants: Observational study from June 1, 2015, to June 30, 2017. United States census data were used to describe access to TAVR center. Google Maps and the Society of Thoracic Surgeons American College of Cardiology Transcatheter Valve Therapy Registry were used to describe characteristics of patients undergoing successful TAVR according to proximity to implanting center. The study analyzed 47 527 537 individuals 65 years and older in the United States and 31 098 patients who underwent successful transfemoral TAVR, were linked to fee-for-service Medicare, and had a measurable driving time., Main Outcomes and Measures: Median driving distance to a TAVR center., Results: Among 40 537 zip codes in the United States, 490 (1.2%) contained a TAVR center, and among 305 hospital referral regions (HRR), 234 (76.7%) contained a TAVR center. Of the 31 749 patients who underwent successful transfemoral TAVR and were linked to fee-for-service Medicare, 31 098 had a measurable driving time. Mean (SD) age was 82.4 (6.9) years, 14 697 patients (47.3%) were women, and 7422 (23.87%) lived in a rural area. This translated to 1 232 568 of 47 527 537 individuals (2.6%) 65 years and older living in a zip code with a TAVR center and 43 789 169 (92.1%) living in an HRR with a TAVR center. Among 31 749 patients who underwent successful transfemoral TAVR and were linked to fee-for-service Medicare, 31 098 had a measurable driving time. All of these patients (100.0%) underwent their procedure in a TAVR center within their HRR, with 1350 (4.3%) undergoing TAVR in a center within their home zip code. Median driving time to implanting TAVR center was 35.0 minutes (IQR, 20.0-70.0 minutes), ranging from 2.0 minutes to 18 hours and 48 minutes., Conclusions and Relevance: Most US individuals 65 years and older live in an HRR with a TAVR center. Among patients undergoing successful transfemoral TAVR, median driving time to implanting center was 35.0 minutes. Within the context of the US health care system, where certain advanced procedures and specialized care are centralized, TAVR services have significant penetration. More studies are required to evaluate the effect of geographic location of TAVR sites on access to TAVR procedures among individuals with an indication for a TAVR within the US population.

Untreated, severe, symptomatic aortic stenosis is associated with a dismal prognosis. The only treatment shown to improve survival is aortic valve replacement; however, before symptoms occur, aortic stenosis is preceded by a silent, latent phase characterized by a slow progression at the molecular, cellular, and tissue levels. In theory, specific medical therapy should halt aortic stenosis progression, reduce its hemodynamic repercussions on left ventricular function and remodeling, and improve clinical outcomes. In the present report, we performed a systematic review of studies focusing on the medical treatment of patients with aortic stenosis. Lipid-lowering therapy, antihypertensive drugs, and anticalcific therapy have been the main drug classes studied in this setting and are reviewed in depth. A critical appraisal of the preclinical and clinical evidence is provided, and future research avenues are presented., (© 2016 American Heart Association, Inc.)

Aortic stenosis (AS) is one of the most common valvular diseases encountered in clinical practice. Current guidelines recommend aortic valve replacement (AVR) when the aortic valve is severely stenotic and the patient is symptomatic; however, a substantial proportion of patients with severe AS are asymptomatic at the time of first diagnosis. Although specific morphological valve features, exercise testing, stress imaging, and biomarkers can help to identify patients with asymptomatic severe AS who may benefit from early AVR, the optimal management of these patients remains uncertain and controversial. The current report presents a comprehensive review of the natural history and the diagnostic evaluation of asymptomatic patients with severe AS, and is followed by a meta-analysis from reported studies comparing an early AVR strategy to active surveillance, with an emphasis on the level of evidence substantiating the current guideline recommendations. Finally, perspectives on directions for future investigation are discussed., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)