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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. [Display omitted] • Minimum core data elements have not been established for the field of transcatheter mitral valve therapies. • A collaboration of the PASSION-CV, Heart Valve Collaboratory, and STS/ACC TVT Registry has established a set of 127 core data elements based on an extensive systematic review and expert consensus. • Instantiation of core data elements in premarket and postmarket studies of transcatheter mitral interventions will promote consistency, efficiency and quality of data supporting evidence development for quality, regulatory, and clinical applications. [ABSTRACT FROM AUTHOR]

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]

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). 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. 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. 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). 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. [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]

Abstract: Deep hypothermic circulatory arrest (DHCA) is a cerebral protection technique that was developed in the 1950s and popularized in the 1970s. It has become one of the three most common cerebral protection techniques currently used in aortic arch surgeries, with the other two being antegrade cerebral perfusion (ACP) and retrograde cerebral perfusion (RCP). At our institution, DHCA has been the cerebral protection technique of choice for over a quarter century. Our clinical experience with DHCA has been very positive, and our clinical studies have shown DHCA to have outcomes equal to (and sometimes better than) those of ACP and RCP, and DHCA to be very effective at preserving neurocognitive function. Other institutions, however, prefer ACP or RCP to DHCA. Each technique has its own set of pros and cons, and the question regarding which technique is the superior method for cerebral protection is hotly debated. [Copyright &y& Elsevier]

Abstract: Thoracic aortic aneurysms (TAAs) are a prevalent and deadly disease that, without diagnosis and treatment, eventuates in life-threatening aortic dissection or rupture. While TAAs normally grow in an indolent manner, once a certain size (a “hinge point”) is reached, the risk of dissection, rupture, and death increases dramatically. By virtue of their common clinical “silence,” many TAAs are not diagnosed until such complications occur. While size is a helpful criterion for intervention, there is a need for parameters and markers besides aortic aneurysm size for use in diagnosing and monitoring TAAs so as to prevent natural complications of this disease. [Copyright &y& Elsevier]