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Background: Detailed understanding of the association between intraoperative left atrial and left ventricular diastolic function and postoperative atrial fibrillation is lacking. In this post hoc analysis of the Posterior Left Pericardiotomy for the Prevention of Atrial Fibrillation after Cardiac Surgery (PALACS) trial, we aimed to evaluate the association of intraoperative left atrial and left ventricular diastolic function as assessed by transesophageal echocardiography (TEE) with postoperative atrial fibrillation., Methods: PALACS patients with available intraoperative TEE data (n = 402 of 420; 95.7%) were included in this cohort study. We tested the hypotheses that preoperative left atrial size and function, left ventricular diastolic function, and their intraoperative changes were associated with postoperative atrial fibrillation. Normal left ventricular diastolic function was graded as 0 and with lateral e' velocity 10 cm/s or greater. Diastolic dysfunction was defined as lateral e' less than 10 cm/s using E/e' cutoffs of grade 1, E/e' 8 or less; grade, 2 E/e' 9 to 12; and grade 3, E/e' 13 or greater, along with two criteria based on mitral inflow and pulmonary wave flow velocities., Results: A total of 230 of 402 patients (57.2%) had intraoperative diastolic dysfunction. Posterior pericardiotomy intervention was not significantly different between the two groups. A total of 99 of 402 patients (24.6%) developed postoperative atrial fibrillation. Patients who developed postoperative atrial fibrillation more frequently had abnormal left ventricular diastolic function compared to patients who did not develop postoperative atrial fibrillation (75.0% [n = 161 of 303] vs. 57.5% [n = 69 of 99]; P = 0.004). Of the left atrial size and function parameters, only delta left atrial area, defined as presternotomy minus post-chest closure measurement, was significantly different in the no postoperative atrial fibrillation versus postoperative atrial fibrillation groups on univariate analysis (-2.1 cm2 [interquartile range, -5.1 to 1.0] vs. 0.1 [interquartile range, -4.0 to 4.8]; P = 0.028). At multivariable analysis, baseline abnormal left ventricular diastolic function (odds ratio, 2.02; 95% CI, 1.15 to 3.63; P = 0.016) and pericardiotomy intervention (odds ratio, 0.46; 95% CI, 0.27 to 0.78, P = 0.004) were the only covariates independently associated with postoperative atrial fibrillation., Conclusions: Baseline preoperative left ventricular diastolic dysfunction on TEE, not left atrial size or function, is independently associated with postoperative atrial fibrillation. Further studies are needed to test if interventions aimed at optimizing intraoperative left ventricular diastolic function during cardiac surgery may reduce the risk of postoperative atrial fibrillation., (Copyright © 2023 American Society of Anesthesiologists. All Rights Reserved.)

Background: Postoperative atrial fibrillation (POAF) is a frequent complication of cardiac surgery. However, only a few detailed descriptions of the arrhythmia have been reported. We aim to describe the characteristics, outcomes, and variables associated with POAF and to evaluate how posterior pericardiotomy (PP) affects POAF characteristics., Methods: In this post hoc analysis of the Posterior left pericardiotomy for the prevention of AtriaL fibrillation After Cardiac Surgery (PALACS) trial, we describe POAF characteristics based on continuous in-hospital telemetry data., Results: Of 420 patients, 103 (24.5%) developed POAF. Median time to onset was 50.3 hours; 70.9% of events occurred within 3 days. Hemodynamic instability and rapid ventricular response occurred in 8.7% and 51.5% of cases, respectively. Most POAF patients received antiarrhythmics (97.1%), 22.3% electrical cardioversion, and 40.8% systemic anticoagulation. Median POAF duration was 24.0 hours; 70.9% of cases resolved within 36 hours. Median POAF burden was 15.9%. All patients were in sinus rhythm at follow-up. POAF was associated with longer hospitalization (7 vs 6 days; P < .001), but not increased mortality or morbidity. PP reduced POAF incidence (17.7% vs 31.3%; P = .001), especially after postoperative day 2 (time to POAF onset 41.9 vs 57.1 hours; P = .01). Age was associated with POAF. Female sex, coronary artery bypass grafting, beta blockers, and PP were inversely associated., Conclusions: POAF remains frequent after cardiac surgery. Hemodynamic instability is rare, although rapid ventricular response and need for electrical cardioversion are frequent. POAF burden is significant, and the arrhythmias resolve within 30 days. PP reduces POAF especially after postoperative day 2., (Copyright © 2023 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Importance: It has been reported that women undergoing coronary artery bypass have higher mortality and morbidity compared with men but it is unclear if the difference has decreased over the last decade., Objective: To evaluate trends in outcomes of women undergoing coronary artery bypass in the US from 2011 to 2020., Design, Setting, and Participants: This retrospective cohort study at hospitals contributing to the Adult Cardiac Surgery Database of the Society of Thoracic Surgeons included 1 297 204 patients who underwent primary isolated coronary artery bypass from 2011 to 2020., Exposure: Coronary artery bypass., Main Outcomes and Measures: The primary outcome was operative mortality. The secondary outcome was the composite of operative mortality and morbidity (including operative mortality, stroke, kidney failure, reoperation, deep sternal wound infection, prolonged mechanical ventilation, and prolonged hospital stay). The attributable risk (the association of female sex with coronary artery bypass grafting outcomes) for the primary and secondary outcomes was calculated., Results: Between 2011 and 2020, 1 297 204 patients underwent primary isolated coronary artery bypass grafting with a mean age of 66.0 years, 317 716 of which were women (24.5%). Women had a higher unadjusted operative mortality (2.8%; 95% CI, 2.8-2.9 vs 1.7%; 95% CI, 1.7-1.7; P < .001) and overall unadjusted incidence of the composite of operative mortality and morbidity compared with men (22.9%; 95% CI, 22.7-23.0 vs 16.7%; 95% CI, 16.6-16.8; P < .001). The attributable risk of female sex for operative mortality varied from 1.28 in 2011 to 1.41 in 2020, with no significant change over the study period (P for trend = 0.38). The attributable risk for the composite of operative mortality and morbidity was 1.08 in both 2011 and 2020 with no significant change over the study period (P for trend = 0.71)., Conclusions and Relevance: Women remain at significantly higher risk for adverse outcomes following coronary artery bypass grafting and no significant improvement has been seen over the course of the last decade. Further investigation into the determinants of operative outcomes in women is urgently needed.

Background: The prognostic importance of periprocedural myocardial infarction (pMI) and its inclusion in the composite outcomes of coronary revascularization trials are controversial. We assessed whether pMI is a surrogate for all-cause or cardiac mortality and quality of life (QoL) outcomes in coronary revascularization trials., Methods: All randomized trials comparing percutaneous coronary intervention vs coronary artery bypass grafting (MEDLINE, EMBASE, Cochrane Library) were identified. Trials were included if they reported data for pMI and mortality. Trial-level associations between pMI and all-cause or cardiac mortality and QoL were assessed using the coefficient of determination ( R 2 ). The criterion for surrogacy was set at 0.7. Subgroup analyses based on pMI definition and on key clinical/procedural variables were performed., Results: Twelve trials were included (11,549 patients; weighted mean follow-up: 5.6 years). There was a positive correlation between pMI and all-cause mortality (slope, 1.81; 95% CI, 1.00-2.63; R 2 = 0.72). In the trials that defined pMI as a rise in cardiac biomarkers >5 times the upper reference limit, pMI positively correlated with both all-cause (slope, 2.07; 95% CI, 1.00-3.14; R 2 = 0.93) and cardiac mortality (slope, 0.70; 95% CI, 0.20-1.19; R 2 = 0.87); no such relationships were present in trials that used a lower biomarker threshold. An inverse correlation was found between pMI and long-term changes in the Short Form Health Survey Physical Component score (slope, -4.66; 95% CI, -5.75 to -3.57; R 2 =0.99)., Conclusions: In the published coronary revascularization trials, pMI defined by larger biomarker elevations was associated with subsequent mortality and reduced QoL. These findings suggest that large pMI should be included as an outcome measure in coronary revascularization trials., Competing Interests: Antonino Di Franco has consulted for Servier, Novo Nordisk, and is an Advisory Board Member for Scharper. Gianmarco Cancelli is supported by the Enrico and Enrica Sovena Foundation. Deepak L. Bhatt discloses the following relationships – Advisory Board: Bayer, Boehringer Ingelheim, Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, Janssen, Level Ex, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, Regado Biosciences, Stasys; Board of Directors: AngioWave (stock options), Boston VA Research Institute, DRS.LINQ (stock options), Society of Cardiovascular Patient Care, TobeSoft; Chair: Inaugural Chair, American Heart Association Quality Oversight Committee; Data Monitoring Committees: Acesion Pharma, Assistance Publique-Hôpitaux de Paris, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Boston Scientific (Chair, PEITHO trial), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo; for the ABILITY-DM trial, funded by Concept Medical), Novartis, Population Health Research Institute; Rutgers University (for the NIH-funded MINT Trial); Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Chair, ACC Accreditation Oversight Committee), Arnold and Porter law firm (work related to Sanofi/Bristol-Myers Squibb clopidogrel litigation), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Canadian Medical and Surgical Knowledge Translation Research Group (clinical trial steering committees), Cowen and Company, Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), K2P (Co-Chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Oakstone CME, Piper Sandler, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees), Wiley (steering committee); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Research Funding: Abbott, Acesion Pharma, Afimmune, Aker Biomarine, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CSL Behring, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Lilly, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Owkin, Pfizer, PhaseBio, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, 89Bio; Royalties: Elsevier (Editor, Braunwald’s Heart Disease); Site Co-Investigator: Abbott, Biotronik, Boston Scientific, CSI, Endotronix, St. Jude Medical (now Abbott), Philips, Svelte; Trustee: American College of Cardiology; Unfunded Research: FlowCo, Takeda. John Spertus provides consultative services for Bayer, Merck, Janssen, Novartis, Bristol Meyers Squibb, United Healthcare, and Terumo; Has research grants from the American College of Cardiology Foundation, Abbott Vascular, Bristol Meyers Squibb and Jannsen; Owns the copyright to the SAQ, KCCQ, and PAQ; and serves on the Board of Directors for Blue Cross/Blue Shield of Kansas City. Gregg W. Stone has received speaker honoraria from Medtronic, Pulnovo, Infraredx; has served as a consultant to Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Vascular Dynamics, Shockwave, V-Wave, Cardiomech, Gore, Amgen; and has equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, Xenter. Stone’s daughter is an employee at Medtronic. Institutional disclosure: Stone’s employer, Mount Sinai Hospital, receives research support from Abbott, Abiomed, Bioventrix, Cardiovascular Systems Inc, Phillips, Biosense-Webster, Shockwave, Vascular Dynamics and V-wave. All other authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© 2023 The Authors.)

Background: Deep sternal wound infection (DSWI) is a rare but severe complication after cardiac surgical procedures and has been associated with increased early morbidity and mortality. Studies reporting long-term outcomes in patients with DSWI have shown contradictory results. We performed a study-level meta-analysis evaluating the impact of DSWI on short- and long-term clinical outcomes., Methods: A systematic literature search was conducted to identify studies comparing short- and long-term outcomes of patients submitted to cardiac surgical procedures who developed DSWI and patients who did not. The primary outcome was overall mortality. Secondary outcomes were in-hospital mortality, follow-up mortality, major adverse cardiovascular events, myocardial infarction, and repeat revascularization. Postoperative outcomes were also investigated., Results: Twenty-four studies totaling 407 829 patients were included. Overall, 6437 (1.6%) patients developed DSWI. Mean follow-up was 3.5 years. DSWI was associated with higher overall mortality (incidence rate ratio [IRR], 1.99; 95% CI, 1.66-2.38; P < .001), in-hospital mortality (odds ratio, 3.30; 95% CI, 1.88-5.81; P < .001), follow-up mortality (IRR, 2.02; 95% CI, 1.39-2.94; P = .001), and major adverse cardiovascular events (IRR, 2.04; 95% CI, 1.60-2.59; P < .001). No differences in myocardial infarction and repeat revascularization were found, but limited studies reported those outcomes. DSWI was associated with longer postoperative hospitalization, stroke, myocardial infarction, and respiratory and renal failure. Sensitivity analyses on isolated coronary artery bypass grafting studies and by adjustment method were consistent with the main analysis., Conclusions: Compared with patients who did not develop DSWI, patients with DSWI after cardiac surgical procedures had increased risk of death as well as short- and long-term adverse clinical outcomes., (Copyright © 2023 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: A need exists for systematic evaluation of the differences in baseline characteristics and early outcomes between patients enrolled in randomized controlled trials (RCTs) and clinical practice for coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)., Methods: Systematic searches were conducted to identify RCTs comparing CABG vs PCI and CABG or PCI registries. Sixteen predefined baseline characteristics and 30-day mortality were extracted from the included studies. Pooled proportion and mean with 95% CI were calculated for binary and continuous outcomes, respectively, by using the random effects model., Results: Fourteen RCTs and 10 registries including more than 2 million patients were included. Registry patients who underwent CABG had a higher prevalence of hypertension, smoking, reduced left ventricular ejection fraction, and prior myocardial infarction, but a lower prevalence of single-vessel disease when compared with CABG-treated patients included in RCTs. Regarding PCI, hypertension, hyperlipidemia, left main coronary artery disease, triple-vessel coronary disease, and NYHA functional class

Coronary artery disease (CAD) is the most common cardiovascular disease worldwide, affecting over 18 million American adults. Coronary artery bypass grafting (CABG) is the standard of care for patients with left main or triple vessel CAD. Historically, the saphenous vein (SV) has been utilized to bypass the majority of the coronary vessels in patients undergoing CABG, but more recent data suggest that the use of the radial artery (RA), rather than the SV, is associated with improved cardiac outcomes and better survival. The aim of this review is to summarize the current literature on the use of RA and SV for CABG in patients with multivessel CAD., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: Repeat coronary artery bypass grafting (RCABG) and percutaneous coronary intervention (PCI) are both used for the treatment of symptomatic patients with coronary artery disease and prior CABG, but the optimal treatment strategy remains unknown. We sought to perform a systematic review and meta-analysis to compare operative and follow-up outcomes following RCABG versus PCI in patients with prior CABG., Methods: Medline and Embase were searched for studies comparing RCABG versus PCI. The primary outcome was follow-up mortality, and secondary outcomes were follow-up repeat revascularization, operative mortality, periprocedural stroke, and myocardial infarction. Time-to-event outcomes were summarized as incidence rate ratios, whereas operative outcomes were summarized as odds ratios. A random effect meta-analysis was performed. Individual patient survival data was extracted from available survival curves and reconstructed using restricted mean survival time., Results: Among 2982 articles, 7 studies (9945 patients) were included. In the aggregated data meta-analysis, there was no difference in follow-up survival between RCABG and PCI (incidence rate ratio, 1.02; 95% CI, 0.83-1.25); however, restricted mean survival time analysis of individual data showed a survival benefit for RCABG over PCI (0.7 years; 95% CI, 0.23-1.19 years; P  = .004). PCI was found to have a higher incidence rate of follow-up need for repeat revascularization (incidence rate ratio, 1.61; 95% CI, 1.16-2.23), but lower odds for operative mortality and stroke. No difference in the odds for myocardial infarction was found., Conclusions: In patients with prior CABG, PCI is associated with better operative outcomes, but RCABG is associated with better survival and freedom from repeat revascularization at follow-up., (© 2022 The Author(s).)

Postoperative atrial fibrillation (POAF) is the most common complication after cardiac surgery. Patients who develop POAF are more likely to experience adverse outcomes, including increased rates of death, stroke, heart failure, and hospitalizations, and higher hospital costs. Understanding the mechanisms underlying POAF is important to improve patients' outcome and optimize health systems' efficiency. Beyond classic pathogenic hypotheses, emerging evidence suggests that postoperative pericardial effusion and localized pericardial inflammation may trigger POAF. This hypothesis is supported by data from nonhuman animal models and a growing body of evidence showing that reducing postoperative pericardial effusion might reduce POAF incidence. In this review, we summarize the classic pathophysiology theories of POAF following cardiac surgery and discuss new etiologic mechanisms with a specific focus on the role of pericardial effusion and inflammation., Competing Interests: Funding Support and Author Disclosures Dr Di Franco has consulted for Servier; and is an Advisory Board member for Scharper. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Introduction: Despite the significant clinical importance of sex among factors affecting cancer progression and survival, it remains one of the least studied factors. Therefore, we sought to examine these differences in relation to primary malignant cardiac tumors (PMCTs) using a national data set., Methods: The 2004-2017 National Cancer Database was queried for patients with PMCTs. Annual trend of females' percent was assessed. Overall survival predictors were evaluated with Kaplan-Meier and Cox-regression. Subgroup analysis was done based on histology, comorbidity index, race, insurance, and surgical treatment., Results: PMCTs were identified in 736 patients (median age 52, female [47.8%]). Most of them were high-grade (49.2%). About 60% underwent surgery. Angiosarcoma (43%), fibrosarcoma (5.2%), and leiomyosarcoma (5.2%) were the most common pathologies. Based on multivariate Cox-regression, higher income, higher comorbidity index, angiosarcoma, and Stage III/IV were associated with higher late mortality, while year of diagnosis and use of surgery or chemotherapy were associated with lower mortality. Among the surgical group, age, higher income, higher comorbidity index, angiosarcoma, and Stage III/IV were independent predictors of higher late mortality, while private insurance and year of diagnosis were associated with lower late mortality. No difference was seen between males and females in 30-day and late mortality (p = .71). Subgroup analysis based on Cox-regression showed no differences in late mortality between males and females., Conclusion: PMCTs have poor overall survival. Surgery and chemotherapy were associated with longer survival benefits. On the contrary, the associated risk factors for mortality were advanced age, higher comorbidity index, angiosarcoma histology, and Stage III/IV., (© 2022 Wiley Periodicals LLC.)

Background: Racial minorities account for 39.9% of the population in the United States, but are often underrepresented in clinical research. Results from studies predominantly enrolling White patients may not apply to racial minorities. The aim of this analysis is to assess the representation of racial minorities in cardiac surgery randomized clinical trials (RCTs)., Methods: A systematic search of the literature was performed. All RCTs published from 2000 to 2020 including at least 100 patients and comparing two or more adult cardiac surgery procedures were included. Meta-analytic estimates were calculated., Results: Among 51 cardiac surgery RCTs published between 2000 and 2020, only 9 (17.6%) reported the race of patients and were included in the final analysis. All of them were multicentric, with a mean of 33 centers included. Six RCTs enrolled patients undergoing coronary artery bypass grafting (66.7%), while the remaining three were on valve surgery (33.3%). Overall, 9193 patients were included; of them, 8034 (87.4%) were White and 1026 (11.2%) nonWhite (386 [4.2%] Black, 191 [2.1%] Hispanic, 274 [3.0%] from other races, and 175 [1.9%] nonWhite patients of unspecified race). The proportion of nonWhite patients did not change over time., Conclusions: Only 9 (17.6%) of the 51 cardiac surgery RCTs published between 2000 and 2020 reported the race of the patients enrolled and only 11.2% of them were nonWhite patients. Given the association between race and clinical outcomes, future RCTs should either guarantee a balanced inclusion of racial minorities or be designed to specifically enroll them., (© 2022 Wiley Periodicals LLC.)

Background: Retractions of erroneous and fraudulent papers from the biomedical literature continue to be a major concern. The aim of this analysis is to summarize trends of retractions in the cardiovascular literature over the past four decades., Methods: A review of the Retraction Watch database for retracted articles published between 1978 and 2020 in the cardiovascular literature was performed. Retractions with the term "medicine" in the subject code were selected. Titles and abstracts were reviewed and only retractions of articles in cardiovascular medicine and surgery were included., Results: 459 retraction notices published in 228 journals were identified. The number of retractions increased with time from 1 in 1991 to 48 at the end of 2019 (P < 0.001). Overall, the yearly percentage of retraction increased during the study period (P < 0.001) but decreased after 2015. China had the highest percentage of retractions when compared to other countries (P < 0.001). The majority of articles were retracted for scientific misconduct (n = 289, 63.0%); retractions due to scientific misconduct increased significantly over the study period (P = 0.04) but decreased after 2015. The median time from publication to retraction was 1.4 years (interquartile range [IQR]: 0.6-3.8) and decreased significantly over time (P < 0.001). The median number of citations of retracted articles was 8.0., Conclusions: The number of retractions and the yearly percentage of retraction in the cardiovascular literature increased significantly during the study period, although a decrease was seen after 2015. Scientific misconduct represents the most common reason for retraction, although a reduction has been observed in the last five years., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Randomized controlled trials (RCT) were impacted by the COVID-19 pandemic, but no systematic analysis has evaluated the overall impact of COVID-19 on non-COVID-19-related RCTs. The ClinicalTrials.gov database was queried in February 2020. Eligible studies included all randomized trials with a start date after 1 January 2010 and were active during the period from 1 January 2015 to 31 December 2020. The effect of the pandemic period on non-COVID-19 trials was determined by piece-wise regression models using 11 March 2020 as the start of the pandemic and by time series analysis (models fitted using 2015-2018 data and forecasted for 2019-2020). The study endpoints were early trial stoppage, normal trial completion, and trial activation. There were 161,377 non-COVID-19 trials analyzed. The number of active trials increased annually through 2019 but decreased in 2020. According to the piece-wise regression models, trial completion was not affected by the pandemic ( p = 0.56) whereas trial stoppage increased ( p = 0.001). There was a pronounced decrease in trial activation early during the pandemic ( p < 0.001) which then recovered. The findings from the time series models were consistent comparing forecasted and observed results (trial completion p = 0.22; trial stoppage p < 0.01; trial activation, p = 0.01). During the pandemic, there was an increase in non-COVID-19 RCTs stoppage without changes in RCT completion. There was a sharp decline in new RCTs at the beginning of the pandemic, which later recovered.

Importance: Recent evidence has suggested that skeletonization of the internal thoracic artery (ITA) is associated with worse clinical outcomes in patients undergoing coronary artery bypass surgery (CABG)., Objective: To compare the long-term clinical outcomes of skeletonized and pedicled ITA for CABG., Design, Setting, and Participants: The Arterial Revascularization Trial (ART) was a 2-group, multicenter trial comparing the use of a bilateral ITA vs a single ITA for CABG at 10 years. Patients in the ART trial were stratified by ITA harvesting technique: skeletonized vs pedicled. Data were collected from June 2004 to December 2017, and data were analyzed from June to July 2021., Interventions: In this analysis, the 10-year clinical outcomes were compared between patients who received skeletonized vs pedicled ITAs., Main Outcomes and Measures: The primary outcome was all-cause mortality. The secondary outcomes were a composite of major adverse cardiac events (MACE) including all-cause mortality, myocardial infarction, and repeated revascularization and a composite including MACE and sternal wound complication (SWC). Cox regression and propensity score matching were used., Results: Of 2161 included patients, 295 (13.7%) were female, and the median (interquartile range) age was 65.0 (58.0-70.0) years. At 10 years, the risk of all-cause mortality was not significantly different between the pedicled and skeletonized groups (hazard ratio [HR], 1.12; 95% CI, 0.92-1.36; P = .27). However, the long-term risks of the secondary outcomes were significantly higher in the skeletonized group compared with the pedicled group (MACE: HR, 1.25; 95% CI, 1.06-1.47; P = .01; MACE and SWC: HR, 1.22; 95% CI, 1.05-1.43; P = .01). The difference was not seen when considering only patients operated on by surgeons who enrolled 51 patients or more in the trial (MACE: HR, 1.07; 95% CI, 0.82-1.39; P = .62; MACE and SWC: HR, 1.04; 95% CI, 0.80-1.34; P = .78)., Conclusions and Relevance: While the long-term survival of patients was not different between groups, the rate of adverse cardiovascular events was consistently higher in the skeletonized group and the difference was associated with surgeon-related factors. Further evidence on the outcome of skeletonized ITA is needed.

The use of the radial artery (RA) as a conduit in coronary artery bypass grafting (CABG) has been steadily increasing since the early 1990s and based on the most recent data may well become the standard of care for patients with multivessel coronary artery disease requiring multiple arterial grafts. The transradial access (TRA) approach for cardiac catherization has also increased steadily in use by interventional cardiologists owing to its reduction in bleeding and vascular complications when compared with the femoral approach and is now considered the preferred arterial access. However, prior use of TRA for cardiac catherization is a contraindication for the use of the RA for CABG because of high rates of structural damage to the vascular wall and potential for graft failure. In this issue of the Journal of Cardiac Surgery Clarke et al. examine the RA of two patients who had TRA for coronary angiography 8 and 12 years prior and note that both patients had chronic injury with dissection and obstruction of the lumen secondary to fibrosis suggesting that TRA causes long-term and irreversible damage rendering them unsuitable as conduits for CABG., (© 2021 Wiley Periodicals LLC.)