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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. [Display omitted] [ABSTRACT FROM AUTHOR]

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 &y& Elsevier]