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Mitral regurgitation is the most common valvular disease and is estimated to affect over 5 million Americans. Real-world data collection contributes to safety and effectiveness evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, and clinical best practice research. We aimed to establish a minimum core data set in mitral interventions to promote efficient, reusable real-world data collection for all of these purposes. Two expert task forces separately evaluated and reconciled a list of candidate elements derived from: 1) 2 ongoing transcatheter mitral trials; and 2) a systemic literature review of high-impact mitral trials and U.S multicenter, multidevice registries. From 703 unique data elements considered, unanimous consensus agreement was achieved on 127 "core" data elements, with the most common reasons for exclusion from the minimum core data set being burden or difficulty in accurate assessment (41.2%), duplicative information (25.0%), and low likelihood of affecting outcomes (19.6%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established and implemented into the national Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapies Registry 127 interoperable, reusable core data elements to support more efficient, consistent, and informative transcatheter mitral device evidence for regulatory submissions, safety surveillance, best practice development, and hospital quality assessments., Competing Interests: Funding Support and Author Disclosures Dr Vemulapalli has received grants/contracts from the American College of Cardiology, Society of Thoracic Surgeons, National Institutes of Health (R01 and SBIR), Food and Drug Administration (NEST cc), Abbott, Boston Scientific, and Cytokinetics; and is on the advisory board or is a consultant for Edwards Lifesciences, Medtronic, American College of Physicians, and Total CME. Ms Alu has received institutional research funding from Abbott and Edwards Lifesciences. Dr Shahim has received a research grant from the Stockholm county research council. Dr James has been a proctor for Medtronic. Dr Leon has received institutional grants for clinical research from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Thourani has been an advisor for Abbott Vascular, ARtivion, Atricure, Boston Scientific, Edwards Lifesciences, Medtronic, and Shockwave. Dr Carroll has received institutional grants for clinical trials from Edwards Lifesciences, Medtronic, and Abbott; and has been a consultant for Abbott. Dr Krucoff has received grants from Abbott Vascular, Boston Scientific, Medtronic, Mitre Medical, OrbusNeich, and 4C Medical; and has been a consultant for Abbott Vascular, Boston Scientific, Medtronic, Mitre Medical, OrbusNeich, and 4C Medical., (Copyright © 2023 American College of Cardiology Foundation. 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., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to determine the risk period for increased stent thrombosis (ST) after percutaneous coronary intervention (PCI) in patients with acute coronary syndromes (ACS) and whether this increased risk is related to high platelet reactivity (HPR)., Background: ST risk after PCI is higher among patients with ACS than those with stable ischemic heart disease. When ST risk is highest in patients with ACS and how that is affected by HPR is unknown., Methods: Using the ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) registry, ST rates during 2-year follow-up post-PCI with drug-eluting stents were compared among patients presenting with ACS (myocardial infarction [MI] or unstable angina) or stable ischemic heart disease (non-ACS). Landmark analyses were done at 30 days and 1 year post-PCI. Platelet reactivity on aspirin and clopidogrel post-PCI was assessed using VerifyNow assays., Results: Of 8,582 patients, 2,063 presented with MI, 2,370 with unstable angina, and 4,149 with non-ACS. Incidence rates of HPR were 48.0%, 43.3%, and 39.8%, respectively (p < 0.001). Within the first 30 days post-PCI, patients presenting with MI had increased ST risk compared with patients with non-ACS (hazard ratio [HR]: 4.52; 95% confidence interval [CI]: 2.01 to 10.14; p < 0.001). After 30 days, relative ST risks were progressively lower and no longer significant between groups (31 days to 1 year post-PCI: HR: 1.97; 95% CI: 0.80 to 4.85; >1 year post-PCI: HR: 0.89; 95% CI: 0.27 to 2.92). The elevated ST risk in patients with MI within 30 days was largely confined to those with HPR on clopidogrel (HR: 5.77; 95% CI: 2.13 to 15.63; p < 0.001)., Conclusions: Among patients undergoing PCI, rates of ST during 2-year follow-up were highest in those with MI and lowest in those with non-ACS. Increased ST risk in patients with MI was greatest in the first 30 days post-PCI and was observed predominantly among those with increased HPR on clopidogrel. These findings emphasize the importance of adequate P2Y 12 inhibition after MI, especially within the first 30 days after stent implantation., Competing Interests: Funding Support And Author Disclosures The ADAPT-DES study was sponsored by the Cardiovascular Research Foundation, with funding provided by Boston Scientific, Abbott Vascular, Medtronic, Cordis, Biosensors, The Medicines Company, Daiichi-Sankyo, Eli Lilly, Volcano, and Accumetrics. Dr. Chau has received an institutional grant from the National Heart, Lung, and Blood Institute to Columbia University Irving Medical Center (T32 HL007854). Dr. Kirtane has received institutional funding to Columbia University and/or the Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, Cardiovascular Systems, CathWorks, Siemens, Philips, and ReCor Medical (in addition to research grants, institutional funding includes fees paid to Columbia University and/or the Cardiovascular Research Foundation for speaking engagements and/or consulting; no speaker or consulting fees were personally received); and has received reimbursement for travel expenses and meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, Cardiovascular Systems, CathWorks, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr. Weisz is an advisory board member for Corindus, Filterlex, and TriSol; and has received institutional grant support from Abbott, Ancora, Corindus, Cardiovascular Systems, Shockwave, Svelte, and V-Wave. Dr. Stuckey is an advisory board member for Boston Scientific; and has received speaker honoraria from Boston Scientific and Eli Lilly/Daiichi-Sankyo. Dr. Rinaldi is an advisory board member for Abbott, Boston Scientific, Cordis, and 4C Medical; teaches courses for Abbott and Edwards Lifesciences; is a consultant to Abbott, Boston, Edwards Lifesciences, and Cordis; and has received research support and grant funding from Boston Scientific. Dr. Neumann has received institutional research grants, consultancy fees, and speaker honoraria from Daiichi-Sankyo, AstraZeneca, Sanofi, Bayer, The Medicines Company, Bristol Myers Squibb, Novartis, Roche, Boston Scientific, Biotronik, Medtronic, Edwards Lifesciences, and Ferrer. Dr. Metzger has received symposium honoraria from Abbott Vascular and Boston Scientific. Dr. Henry is a scientific advisory board member for Abbott Vascular, Boston Scientific, and The Medicines Company; and is a steering committee member for the TRANSLATE study, sponsored by Eli Lilly and Daiichi-Sankyo. Dr. Cox is a consultant to Abbott Vascular, Boston Scientific, and Medtronic. Dr. Duffy is a consultant and speaker for Philips Medical/Volcano. Dr. Mehran has received institutional research grants from Abbott Laboratories, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Medtronic, Novartis Pharmaceuticals, and OrbusNeich; has received consulting fees from Abbott Laboratories, Boston Scientific, Janssen Scientific Affairs, Medscape/WebMD, Medtelligence (Janssen Scientific Affairs), Roivant Sciences, Sanofi, and Siemens Medical Solutions; has received consulting fees paid to the institution from Abbott Laboratories and Bristol Myers Squibb; is an advisory board member for and has received funding paid to the institution from Spectranetics/Philips/Volcano; holds equity (<1%) in Claret Medical and Elixir Medical; has received data and safety monitoring board membership fees paid to the institution from Watermark Research Partners; is a consultant (no fees) for Idorsia Pharmaceuticals and Regeneron Pharmaceuticals; and is an associate editor for the American College of Cardiology and the American Medical Association; and her spouse is a consultant to Abiomed and The Medicines Company. Dr. Stone has received speaker or other honoraria from Cook, Terumo, Qool Therapeutics, and Orchestra Biomed; is a consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, Matrizyme, and Cardiomech; holds equity or options in Ancora, Qool Therapeutics, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, the MedFocus family of funds, and Valfix. 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.)

Background: Few (conflicting) studies have quantitatively assessed neurocognitive effects of deep hypothermic circulatory arrest (DHCA). We assess neurocognitive function quantitatively before and after DHCA in comparison with non-DHCA patients., Methods: Sixty-two aortic surgical patients underwent a battery of neuropsychometric tests, both preoperative and postoperative, evaluating multiple aspects of memory, processing speed, executive function, and global cognition. Thirty-three patients did not require DHCA, and 29 underwent DHCA as the sole means of cerebral protection. Neurocognitive deficit was defined as greater than 20% decline in 2 or more cognitive areas. Preoperative and postoperative test scores, as well as incidence of neurocognitive deficit, were compared within each group, and between the non-DHCA and DHCA groups., Results: There were no significant differences in the postoperative versus preoperative scores in any cognitive area tested between DHCA and non-DHCA groups. There was also no difference between the 2 groups in incidence of neurocognitive deficit; 13 non-DHCA, 11 DHCA (p = 1.00). In addition, there was no correlation between time under DHCA and incidence of neurocognitive deficit. Within both groups, there was a decline in memory in the areas of acquisition, retention, and delayed recall. Within the DHCA group, recognition was also affected., Conclusions: While cardiac surgery had some effects on memory, overall neurocognitive function was well preserved and not different between DHCA and non-DHCA patients. Time under DHCA up to 40 minutes was also found to be safe neurocognitively. This study provides strong evidence that straight DHCA effectively preserves neurocognitive function., (Copyright © 2013 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)