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Background: The relationship between institutional volume and operative mortality after surgical aortic valve replacement (SAVR) remains unclear., Methods: From January 2013 to June 2018, 234 556 patients underwent isolated SAVR (n = 144 177) or SAVR with coronary artery bypass grafting (CABG) (n = 90 379) within the Society of Thoracic Surgeons Adult Cardiac Surgery Database. The association between annualized SAVR volume (group 1 [1-25 SAVRs], group 2 [26-50 SAVRs], group 3 [51-100 SAVRs], and group 4 [>100 SAVRs]) and operative mortality and composite major morbidity or mortality was assessed. Random effects models were used to evaluate whether historical (2013-2015) SAVR volume or risk-adjusted outcomes explained future (2016-2018) risk-adjusted outcomes., Results: The annualized median number of SAVRs per site was 35 (interquartile range, 22-59; isolated aortic valve replacement [AVR], 20; AVR with CABG, 13). Among isolated SAVR cases, the mean operative mortality and composite morbidity or mortality were 1.5% and 9.7%, respectively, at the highest-volume sites (group 4), with significantly higher rates among progressively lower-volume groups (P trend < .001). After adjustment, lower-volume centers had increased odds of operative mortality (group 1 vs group 4 [reference]: adjusted odds ratio [AOR] for SAVR, 2.24 [95% CI, 1.91-2.64]; AOR for SAVR with CABG, 1.96 [95% CI, 1.67-2.30]) and major morbidity or mortality (AOR for SAVR, 1.53 [95% CI, 1.39-1.69]; AOR for SAVR with CABG, 1.46 [95% CI, 1.32-1.61]) compared with the highest-volume institutions. Substantial variation in outcomes was observed across hospitals within each volume category, and prior outcomes explained a greater proportion of hospital operative outcomes than did prior volume., Conclusions: Operative outcomes after SAVR with or without CABG is inversely associated with institutional procedure volumes; however, prior outcomes are more predictive of future outcomes than is prior volume. Given the excellent outcomes observed at many lower-volume hospitals, procedural outcomes may be preferable to procedural volumes as a quality metric., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The presence of mitral annular calcification (MAC) in patients with mitral valve (MV) stenosis or regurgitation is a difficult scenario for surgeons and the heart team. Patients with MAC most often have a significant number of comorbidities that exclude them as surgical candidates. This review highlights the various contemporary techniques available to manage MAC during treatment of the MV., Methods: This study is a focused review of the anatomy, pathology, and management of MAC. The review describes the surgical and transcatheter techniques with outcomes, where available., Results: The incidence of MAC is between 5% and 42% in patients with severe MV disease. The pathophysiology underlying MAC is not yet clear, but it most likely is related to processes of inflammation and atherosclerosis. Surgical techniques can be grouped into those in which the MAC is completely resected en bloc and those in which the MAC is incompletely resected or left in situ. Transcatheter therapies are feasible in some patients, but they have been limited by the anatomic constraints of MAC; most importantly left ventricular outflow tract obstruction and paravalvular regurgitation., Conclusions: Surgeons as part of the heart team now have a range of techniques to manage MAC in those patients with severe MV disease. Transcatheter therapies may increase the options for patients whose surgical risk is too high., (Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Disclosure B.D. Cohen, M.A. Napolitano, K.V. Thourani, and J.J. Edelman have nothing to disclose. V.H. Thourani serves as an advisor/researcher for Abbott Vascular, Boston Scientific, Edwards Life Sciences, JenaValve, and Gore Vascular.

Background: Aortic valve-sparing operations theoretically have fewer stroke and bleeding complications but may increase late reoperation risk versus composite valve grafts., Methods: We meta-analyzed all studies comparing aortic valve-sparing (reimplantation and remodelling) and composite valve-grafting (bioprosthetic and mechanical) procedures. Early outcomes were all-cause mortality, reoperation for bleeding, myocardial infarction, and thromboembolism/stroke. Long-term outcomes included all-cause mortality, reintervention, bleeding, and thromboembolism/stroke. Studies exclusively investigating dissection or pediatric populations were excluded., Results: A total of 3794 patients who underwent composite valve grafting and 2424 who underwent aortic valve-sparing procedures were included from 9 adjusted and 17 unadjusted observational studies. Mean follow-up was 5.8 ± 3.0 years. Aortic valve sparing was not associated with any difference in early mortality, bleeding, myocardial infarction, or thromboembolic complications. Late mortality was significantly lower after valve sparing (incident risk ratio, 0.68; 95% confidence interval [CI], 0.54-0.87; P < .01). Late thromboembolism/stroke (incident rate ratio, 0.36; 95% CI, 0.22-0.60; P < .01) and bleeding (incident rate ratio, 0.21; 95% CI, 0.11-0.42; P < .01) risks were lower after valve sparing. Procedure type did not affect late reintervention., Conclusions: Aortic valve sparing appears to be safe and associated with reduced late mortality, thromboembolism/stroke, and bleeding compared with composite valve grafting. Late durability is equivalent. Aortic valve sparing should be considered in patients with favorable aortic valve morphology., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background/purpose: We assessed commonly reported patient- and circuit-related adverse events involving extracorporeal membrane oxygenation (ECMO) devices by analyzing post-marketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. ECMO is a rescue therapy for critically ill patients requiring oxygenation and cardiopulmonary support. Key configurations include veno-venous (VV) ECMO for respiratory support and veno-arterial (VA) ECMO for cardio-respiratory support. Robust data on the most commonly reported complications associated with ECMO therapy are limited., Methods/materials: The MAUDE database was queried from January 1, 2009, through March 31, 2019, yielding 93 reports. After excluding duplicate reports, 82 reports were included in the final analysis., Results: Percentages represent the proportion of total submitted MAUDE reports on ECMO. Of the reported cases, 24 were VV-ECMO, 8 were VA-ECMO, and the remainder were unspecified. The most commonly reported patient-related adverse events included hemodynamic decompensation of patients (12.2%), death (12.2%), atrial perforation (7.3%), and bleeding (7.3%). The most commonly reported failure modes were in the following circuit components: mechanical pump (19.5%, mostly due to technical failure or clots), membrane oxygenator (19.5%, mostly due to tear in the membrane or temperature probe), and access cannulae (18.3%, mostly due to structural damage)., Conclusions: Analysis of the MAUDE database demonstrates that in real-world practice, ECMO devices are associated with important complications. With broadened global utilization of ECMO devices, standard complication and failure reporting policies may improve patient selection, operator proficiency, and existing device technology., Summary: An analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience database demonstrates that in real-world practice, extracorporeal membrane oxygenation devices are associated with serious complications. The most commonly reported patient-related adverse events were hemodynamic decompensation of patients and death, and the most commonly reported failure modes were in the device's mechanical pump and membrane oxygenator., Competing Interests: Declaration of competing interest Ron Waksman: Advisory Board: Medtronic; Consultant: Medtronic. Toby Rogers: Consultant: Medtronic. All other authors: None., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Medicare coverage for transcatheter aortic valve replacement (TAVR) in the United States (US) is governed by the 2012 National Coverage Determination (NCD 20.32), which enshrined minimum numbers of TAVR, surgical aortic valve replacement, and percutaneous coronary intervention that centers must perform to begin or maintain TAVR programs. In July 2018, the Centers for Medicare and Medicaid Services (CMS) convened a meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) to review the evidence for setting minimum procedure volume requirements and to evaluate the impact of such requirements on access to care. In this paper, we summarize the MEDCAC panel deliberations, the evidence presented to the panel, and how the panel members voted. CMS is expected to publish a draft decision in March 2019 that may reshape the TAVR landscape in the US for years to come., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Introduction: Epigenetic inactivation of tumor suppressor genes is involved in the development of malignant pleural mesothelioma (MPM). ZIC1, a potential tumor suppressor gene involved in regulating cell growth and apoptosis, was investigated in MPM cell lines and tumors., Methods: ZIC1 expression and promoter methylation were evaluated in MPM cell lines and tumor samples by quantitative polymerase chain reaction (PCR), Combined Bisulfite Restriction Analysis, and methylation-specific PCR. ZIC1 was reexpressed in cell lines and functional effects were assessed. miRNA expression was quantified by microarray and reverse transcription quantitative PCR. ZIC1 knockdown and miRNA inhibitors were used to study the relationship between ZIC1 and miRNA expression and confirmed by chromatin immunoprecipitation PCR., Results: ZIC1 expression was low in MPM cells, and was correlated with ZIC1 promoter methylation and reversed upon decitabine treatment. ZIC1 reexpression inhibited proliferation and invasion in MPM cells whereas knockdown enhanced the growth of MeT-5A. In MPM tumor samples ZIC1 expression was either low or undetectable, with promoter methylation observed in 16 of 24 cases. The overexpression of miR-23a and miR-27a was reduced by ZIC1 reexpression, with inhibitors of miR-23a or miR-27a reducing colony formation. miR-23a overexpression was also associated with shorter survival of MPM patients., Conclusion: ZIC1 is down-regulated in MPM through promoter methylation and acts as a tumor suppressor through down-regulation of its direct targets miR-23a and miR-27a.

Assessment of subtle neurocognitive decline after surgical procedures has been hampered by heterogeneous testing techniques and a lack of reproducibility. This review summarizes the sensitivity and specificity of biomarkers of neurologic injury to determine whether they can be applied in the postoperative period to accurately predict neurocognitive decline. Creatine kinase-brain type, neuron-specific enolase, and S100B can be released into serum during operations by extracranial sources. Glial fibrillary acidic protein is a sensitive marker, and there are extracranial sources that are antigenically different from the brain-derived form. Serum levels of tau protein after acute neurologic injury do not reliability correlate with incidence., (Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Introduction: We investigated the ability of cell-free microRNAs (miRNAs) in plasma and serum to serve as a biomarker for malignant mesothelioma (MM)., Methods: Using miRNA microarrays, we profiled plasma samples from MM patients and healthy controls. miRNAs with significantly different abundance between cases and controls were validated in a larger series of MM patients and in an independent series of MM patients using quantitative real-time polymerase chain reaction. Levels of candidate miRNAs were also quantified in MM tumor samples., Results: We compared cell-free miRNA profiles in plasma from MM patients with healthy controls. Reviewing 90 miRNAs previously reported to be associated with MM, we found that the levels of two miRNAs, miR-29c* and miR-92a, were elevated in plasma samples from MM patients. In addition, we identified 15 novel miRNAs present at significantly higher levels in the plasma of MM patients. Further analysis of candidate miRNAs by real time-quantitative polymerase chain reaction confirmed that one of them, miR-625-3p, was present in significantly higher concentration in plasma/serum from MM patients and was able to discriminate between cases and controls, in both the original and the independent series of patients. MiR-625-3p was also found to be up-regulated in tumor specimens from a group of 18 MM patients, who underwent extrapleural pneumonectomy., Conclusion: Our data confirm the potential of miR-29c* and miR-92a as candidate tumor markers and reveal that miR-625-3p is a promising novel diagnostic marker for MM.

We performed a meta-analysis of all studies comparing off-pump coronary artery bypass graft surgery (OPCABG) and percutaneous coronary intervention (PCI) for patients with coronary artery disease. Ten studies were included in the meta-analysis and 4,821 patients were compared, of whom 3,450 patients underwent PCI and 1,371 patients underwent OPCABG. The rates of stroke, myocardial infarction, cardiac mortality, and all-cause mortality were similar. The 12-month rate of major adverse cardiac or cerebrovascular events and need for repeat revascularization was significantly lower in the OPCABG group when compared with the PCI group., (Copyright © 2010 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)