Coronary artery bypass with single versus multiple arterial grafts in women: A meta-analysis.

OBJECTIVE: The study objective was to investigate the impact of multiple arterial grafting on long-term all-cause mortality in women undergoing isolated coronary artery bypass grafting. METHODS: A comprehensive search was performed to identify observational studies reporting outcomes after coronary artery bypass grafting reported by sex and stratified into multiple arterial grafting versus single arterial grafting strategies. Articles were considered for inclusion if they were written in English and were propensity-matched observational studies. Included studies were then pooled in a meta-analysis performed using the generic inverse variance method. The primary outcome was long-term all-cause mortality. Secondary outcomes were operative mortality and spontaneous myocardial infarction. Meta-regression was used to explore the effects of preoperative and intraoperative variables on the primary outcome. RESULTS: A total of 6 studies with 32,793 women (25,714 single arterial grafting and 7079 multiple arterial grafting) were included. Women who received multiple arterial grafting had lower long-term mortality (incidence rate ratio, 0.86; 95% confidence interval, 0.76-0.96; P = .007) and spontaneous myocardial infarction (incidence rate ratio, 0.80; 95% confidence interval, 0.68-0.93; P = .003) compared with women who received single arterial grafting, but the difference in mortality disappeared when including only the 3 largest studies. There was no difference between groups in operative mortality (odds ratio, 0.99; 95% confidence interval, 0.84-1.17; P = .91). Meta-regression did not identify any associations with the incidence rate ratio for long-term mortality. CONCLUSIONS: The use of multiple arterial grafting in women undergoing coronary artery bypass grafting is associated with lower long-term mortality, although the difference is mostly driven by small series. Further studies, including randomized trials, are needed to evaluate the efficacy of multiple arterial grafting in women undergoing coronary artery bypass grafting.

Structural valve degeneration of bioprosthetic aortic valves: A network meta-analysis.

OBJECTIVE: To compare the rate of structural valve degeneration (SVD) following surgical aortic valve replacement associated with the Trifecta (TF) valve (St Jude Medical) versus other bioprosthetic valves. METHODS: A systematic literature search was conducted for studies comparing durability of the TF prosthesis to other valve types, including Perimount (Edwards Lifesciences), Carpentier-Edwards Perimount Magna Ease (ME) (Edwards Lifesciences), and Mitroflow (LivaNova USA) after surgical aortic valve replacement. Random effect pairwise and network meta-analyses were performed to compare the incident rate ratio of the composite primary outcome of SVD or reintervention due to SVD. RESULTS: Ten studies with 31,029 patients were included, of whom 6832 received TF, 19,023 received Perimount, 3514 received ME, and 713 received Mitroflow. When compared with TF, ME was associated with lower rates of SVD or reintervention for SVD (incident rate ratio, 0.13; 95% CI, 0.02-0.92; P = .04). Similarly, at network meta-analysis, when compared with TF, only ME was associated with significantly lower rates of SVD or reintervention for SVD (incident rate ratio, 0.13; 95% CI, 0.02-0.97). ME (incident rate ratio, 0.18; 95% CI, 0.07-0.47) and PM (incident rate ratio, 0.34; 95% CI, 0.12-0.98) were associated with significantly lower rate of all-cause reintervention when compared with TF. No differences in the other secondary outcomes were found. CONCLUSIONS: The TF valve is associated with significantly higher rates of SVD or reintervention for SVD than the ME valve, but not the Mitroflow valve. The TF valve was also associated with higher rates of all-cause reintervention than ME and Perimount valves. The underlying mechanism(s) of these findings warrant further investigation.

Atrial fibrillation after cardiac surgery: A systematic review and meta-analysis.

OBJECTIVE: New-onset postoperative atrial fibrillation (POAF) after cardiac surgery is common, with rates up to 60%. POAF has been associated with early and late stroke, but its association with other cardiovascular outcomes is less known. The objective was to perform a meta-analysis of the studies reporting the association of POAF with perioperative and long-term outcomes in patients with cardiac surgery. METHODS: We performed a systematic review and a meta-analysis of studies that presented outcomes for cardiac surgery on the basis of the presence or absence of POAF. MEDLINE, EMBASE, and the Cochrane Library were assessed; 57 studies (246,340 patients) were selected. Perioperative mortality was the primary outcome. Inverse variance method and random model were performed. Leave-one-out analysis, subgroup analyses, and metaregression were conducted. RESULTS: POAF was associated with perioperative mortality (odds ratio [OR], 1.92; 95% confidence interval [CI], 1.58-2.33), perioperative stroke (OR, 2.17; 95% CI, 1.90-2.49), perioperative myocardial infarction (OR, 1.28; 95% CI, 1.06-1.54), perioperative acute renal failure (OR, 2.74; 95% CI, 2.42-3.11), hospital (standardized mean difference, 0.80; 95% CI, 0.53-1.07) and intensive care unit stay (standardized mean difference, 0.55; 95% CI, 0.24-0.86), long-term mortality (incidence rate ratio [IRR], 1.54; 95% CI, 1.40-1.69), long-term stroke (IRR, 1.33; 95% CI, 1.21-1.46), and longstanding persistent atrial fibrillation (IRR, 4.73; 95% CI, 3.36-6.66). CONCLUSIONS: The results suggest that POAF after cardiac surgery is associated with an increased occurrence of most short- and long-term cardiovascular adverse events. However, the causality of this association remains to be established.

Difference in spontaneous myocardial infarction and mortality in percutaneous versus surgical revascularization trials: A systematic review and meta-analysis.

OBJECTIVES: It has been hypothesized that the survival benefit of coronary artery bypass (CABG) compared with percutaneous interventions (PCI) may be associated with the reduction in spontaneous myocardial infarction (SMI) achieved by surgery. This, however, has not been formally investigated. The present meta-analysis aims to evaluate the association between the difference in SMI and in survival in PCI versus CABG randomized controlled trials (RCTs). METHODS: A systematic search was performed to identify all RCTs comparing PCI with CABG for the treatment of coronary artery disease and reporting SMI outcomes. Generic inverse variance method was used to pool outcomes as natural logarithms of the incident rate ratios across studies. Subgroup analysis and interaction test were used to compare the difference of the primary outcome among trials that did and did not report a significant reduction in SMI- in the patients treated by CABG. Primary outcome was all-cause mortality; secondary outcome was SMI. RESULTS: Twenty RCTs were included in the meta-analysis. A statistically significant difference in SMI in favor of CABG was found in 7 of the included trials (35%). Overall, PCI was associated with significantly greater all-cause mortality (incident rate ratio, 1.13; 95% confidence interval, 1.01-1.28). At subgroup analysis, a significant difference in survival in favor of CABG was seen only in trials that reported a significant reduction in SMI in the surgical arm (P for interaction 0.02). CONCLUSIONS: In the published PCI versus CABG trials, the reduction in all-cause mortality in the surgical arm is associated with the protective effect of CABG against SMI.

Association between sternal wound complications and 10-year mortality following coronary artery bypass grafting.

OBJECTIVE: To evaluate the association between sternal wound complications (SWC) and long-term mortality in the Arterial Revascularization Trial. METHODS: Participants in the Arterial Revascularization Trial were stratified according to the occurrence of postoperative SWC. The primary outcome was all-cause mortality at long-term follow-up. The secondary outcome was major adverse cardiovascular events. RESULTS: Three thousand one hundred two patients were included in the analysis; the median follow-up was 10 years. 115 patients (3.7%) had postoperative SWC: 85 (73.9%) deep sternal wound infections and 30 (26.1%) sterile SWC that required sternal reconstruction. Independent predictors of SWC included diabetes (odds ratio [OR], 2.77; 95% CI, 1.79-4.30; P < .001), female sex (OR, 2.73; 95% CI, 1.71-4.38; P < .001), prior stroke (OR, 2.59; 95% CI, 1.12-5.98; P = .03), chronic obstructive pulmonary disease (OR, 2.44; 95% CI, 1.60-3.71; P < .001), and use of bilateral internal thoracic artery (OR, 1.70; 95% CI, 1.12-2.59; P = .01). Postoperative SWC was significantly associated with long-term mortality. The Kaplan-Meier survival estimate was 91.3% at 5 years and 79.4% at 10 years in patients without SWC, and 86.1% and 64.3% in patients with SWC (log rank P < .001). The rate of major adverse cardiovascular events was also higher among patients who had SWC (n = 51 [44.3%] vs 758 [25.4%]; P < .001). Using multivariable analysis, the occurrence of SWC was independently associated with long-term mortality (hazard ratio, 1.81; 95% CI, 1.30-2.54; P < .001). CONCLUSIONS: In the Arterial Revascularization Trial, postoperative SWC although uncommon were significantly associated with long-term mortality.

Differences Among Clinical Trials and Registries on Surgical and Percutaneous Coronary Interventions.

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

Association of liver dysfunction with outcomes after cardiac surgery-a meta-analysis.

OBJECTIVES: The aim of this study was to perform a meta-analysis of studies reporting outcomes in patients with liver dysfunction addressed by the model of end-stage liver disease and Child-Turcotte-Pugh scores undergoing cardiac surgery. METHODS: A systematic literature search was conducted to identify contemporary studies reporting short- and long-term outcomes in patients with liver dysfunction compared to patients with no or mild liver dysfunction undergoing cardiac surgery (stratified in high and low score group based on the study cut-offs). Primary outcome was perioperative mortality. Secondary outcomes were perioperative neurological events, prolonged ventilation, sepsis, bleeding and/or need for transfusion, acute kidney injury and long-term mortality. RESULTS: A total of 33 studies with 48 891 patients were included. Compared with the low score group, being in the high score group was associated with significantly higher risk of perioperative mortality [odds ratio (OR) 3.72, 95% confidence interval (CI) 2.75-5.03, P < 0.001]. High score group was also associated with a significantly higher rate of perioperative neurological events (OR 1.49, 95% CI 1.30-1.71, P < 0.001), prolonged ventilation (OR 2.45, 95% CI 1.94-3.09, P < 0.001), sepsis (OR 3.88, 95% CI 2.07-7.26, P < 0.001), bleeding and/or need for transfusion (OR 1.95, 95% CI 1.43-2.64, P < 0.001), acute kidney injury (OR 3.84, 95% CI 2.12-6.98, P < 0.001) and long-term mortality (incidence risk ratio 1.29, 95% CI 1.14-1.46, P < 0.001). CONCLUSIONS: The analysis suggests that liver dysfunction in patients undergoing cardiac surgery is independently associated with higher risk of short and long-term mortality and also with an increased occurrence of various perioperative adverse events.

Single versus multiple arterial grafting in diabetic patients at 10 years: the Arterial Revascularization Trial.

AIMS: To evaluate the impact of multiple arterial grafting (MAG) vs. single arterial grafting (SAG) in a post hoc analysis of 10-year outcomes in patients with diabetes mellitus (DM) from the Arterial Revascularization Trial (ART). METHODS AND RESULTS: The primary endpoint was all-cause mortality and the secondary endpoint was a composite of major adverse cardiac events (MACE) at 10-year follow-up. Patients were stratified by diabetes status (non-DM and DM) and grafting strategy (MAG vs. SAG). A total of 3020 patients were included in the analysis; 716 (23.7%) had DM. Overall, 55.8% non-DM patients received MAG and 44.2% received SAG, while 56.6% DM patients received MAG and 43.4% received SAG. The use of MAG compared with SAG was associated with lower 10-year mortality for both non-DM [17.7 vs. 21.0%, adjusted hazard ratio (HR) 0.87, 95% confidence interval (CI) 0.72-1.06] and DM patients (21.5 vs. 29.9%, adjusted HR 0.65, 95% CI 0.48-0.89; P for interaction = 0.12). For both groups, the rate of 10-year MACE was also lower for MAG vs. SAG. Overall, deep sternal wound infections (DSWIs) were uncommon but more frequent in the MAG vs. SAG group in both non-DM (3.3 vs. 2.1%) and DM patients (7.9 vs. 4.8%). The highest rates of DSWI were in insulin-treated patients receiving MAG (9.6 vs. 6.3%, when compared with SAG). CONCLUSION: In this post hoc analysis of the ART, MAG was associated with substantially lower mortality rates at 10 years after coronary artery bypass grafting in patients with DM. Patients with DM receiving MAG had a higher incidence of DSWI, especially if insulin dependent.

Long-term results of surgical ventricular reconstruction and comparison with the Surgical Treatment for Ischemic Heart Failure trial.

OBJECTIVE: The role of surgical ventricular reconstruction (SVR) in patients with ischemic cardiomyopathy is controversial. Observational series and the Surgical Treatment of IsChemic Heart failure (STICH) trial reported contradictory results. SVR is highly dependent on operator experience. The aim of this study is to compare the long-term results of SVR between a high-volume SVR institution and the STICH trial using individual patient data. METHODS: Patients undergoing SVR at San Donato Hospital (Milan) were compared with patients undergoing SVR in STICH (as-treated principle) by inverse probability treatment-weighted Cox regression. The primary outcome was all-cause mortality. RESULTS: The San Donato cohort included 725 patients, whereas the STICH cohort included 501. Compared with the STICH-SVR cohort, San Donato patients were older (66.0, lower quartile, upper quartile [Q1, Q3: 58.0, 72.0] vs 61.9 [Q1, Q3: 55.1, 68.8], P < .001) and with lower left ventricular end-systolic volume index at baseline (LVESVI: 77.0 [Q1, Q3: 59.0, 97.0] vs 80.8 [Q1, Q3: 58.5, 106.8], P = .02). Propensity score weighting yielded 2 similar cohorts. At 4-year follow-up, mortality was significantly lower in the San Donato cohort compared with the STICH-SVR cohort (adjusted hazard ratio, 0.71; 95% confidence interval, 0.53-0.95; P = .001). Greater postoperative LVESVI was independently associated with mortality (hazard ratio, 1.02; 95% confidence interval, 1.01-1.03). At 4 to 6 months of follow-up, the mean reduction of LVESVI in the San Donato cohort was 39.6%, versus 10.7% in the STICH-SVR cohort (P < .001). CONCLUSIONS: Patients with postinfarction LV remodeling undergoing SVR at a high-volume SVR institution had better long-term results than those reported in the STICH trial, suggesting that a new trial testing the SVR hypothesis may be warranted.

A systematic review and meta-analysis of percutaneous coronary intervention compared to coronary artery bypass grafting in non-ST-elevation acute coronary syndrome.

Non-ST-elevation acute coronary syndrome (NSTE-ACS) affects millions of patients. Although an invasive strategy can improve survival, the optimal treatment [i.e., percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)] is not clear. We performed a meta-analysis of studies reporting outcomes between PCI and CABG in patients with NSTE-ACS. MEDLINE, EMBASE and Cochrane Library were assessed. The primary outcome was long-term mortality. Inverse variance method and random model were performed. We identified 13 observational studies (48,891 patients). No significant difference was found in the primary endpoint [CABG vs. PCI, incidence rate ratio (IRR) 0.93, 95% confidence interval (CI) 0.70; 1.23]. CABG was associated with lower long-term major adverse cardiovascular events (MACE) (IRR 0.64, 95% CI 0.54; 0.76) and lower long-term re-revascularization (IRR 0.37, 95% CI 0.30; 0.47). There was no significant difference in long-term myocardial infarction (CABG vs. PCI, IRR 0.96, 95% CI 0.50; 1.84) and peri-operative mortality (CABG vs. PCI, odds ratio 1.36, 95% CI 0.94; 1.95). For the treatment of NSTE-ACS, CABG and PCI are associated with similar rates of long-term mortality and myocardial infarction. CABG is associated with lower rates of long-term MACE and re-revascularization. Randomized comparisons in this setting are necessary.

Spinal cord injury after open and endovascular repair of descending thoracic and thoracoabdominal aortic aneurysms: A meta-analysis.

OBJECTIVE: An inclusive contemporary analysis of spinal cord injury (SCI) rates in patients undergoing aneurysm repair and the factors associated with complications has not been performed. METHODS: Following a systematic literature search, studies from 2008 to 2018 on repair of descending thoracic aneurysm (DTA) and thoracoabdominal aortic aneurysm (TAAA) were pooled in a meta-analysis performed using the generic inverse variance method. The primary outcome was permanent SCI. Secondary outcomes were temporary SCI, operative mortality, long-term mortality, postoperative stroke, and cerebrospinal fluid (CSF) drain-related complications. RESULTS: One-hundred sixty-nine studies (22,634 patients) were included. The pooled rate of permanent SCI was 4.5% (95% confidence interval [CI], 3.8-5.4); 3.5% (95% CI, 1.8-6.7) for DTA and 7.6% (96% CI, 6.2-9.3) for TAAA repair (P for subgroups = .02), 5.7% (95% CI, 4.3-7.5) for open repair and 3.9% (95% CI, 3.1-4.8) for endovascular repair (P for subgroups = .03). Rates for Crawford extents I, II, III, IV, and V aneurysms were 4.0% (95% CI, 3.0-5.0), 15.0% (95% CI, 10.0-22.0), 7.0% (95% CI, 6.0-9.0), 2.0% (95% CI, 2.0-4.0), and 7.0% (95% CI, 2.0-23.0) respectively (P for subgroups <.001). The pooled rates for operative mortality, late mortality at a mean follow-up of 5.0 years, stroke, and temporary SCI were 7.4% (95% CI, 6.1-9.4), 1.0% (95% CI, 0.0-1.0), 4.2% (95% CI, 3.6-4.8), and 3.7% (95% CI, 3.0-4.6), respectively. The pooled rates for severe, moderate, and minor CSF-drain related complications were 5.1% (95% CI, 2.23-11.1), 4.1% (95% CI, 0.6-22.0), and 3.6% (95% CI, 1.2-8.0) respectively. CONCLUSIONS: Despite improvement, both open and endovascular aneurysm repair remain associated with a substantial risk of permanent SCI. The risk is greater for TAAA repair, especially extent II, III, and V.

Cardiac Surgery Outcomes in an Epicenter of the COVID-19 Pandemic.

As New York State quickly became the epicenter of the COVID-19 pandemic, innovative strategies to provide care for the COVID-19 negative patients with urgent or immediately life threatening cardiovascular conditions became imperative. To date, there has not been a focused analysis of patients undergoing cardiothoracic surgery in the United States during the COVID-19 pandemic. Therefore, we seek to summarize the selection, screening, exposure/conversion, and recovery of patients undergoing cardiac surgery during the peak of the COVID-19 pandemic. We retrospectively reviewed a prospectively maintained institutional database for patients undergoing urgent or emergency cardiac surgery from March 16, 2020 to May 15, 2020, encompassing the peak of the COVID-19 pandemic. All patients were operated on in a single institution in New York City. Preoperative demographics, imaging studies, intraoperative findings, and postoperative outcomes were reviewed. Between March 16, 2020 and May 15, 2020, a total of 54 adult patients underwent cardiac surgery. Five patients required reoperative sternotomy and cardiopulmonary bypass was utilized in 81% of cases. Median age was 64.3 (56.0; 75.3) years. Two patients converted to COVID-19 positive during the admission. There was one operative mortality (1.9%) associated with an acute perioperative COVID-19 infection. Median length of hospital stay was 5 days (4.0; 8.0) and 46 patients were discharged to home. There was 100% postoperative follow up and no patient had COVID-19 conversion following discharge. The delivery of cardiac surgical care was safely maintained in the midst of a global pandemic. The outcomes demonstrated herein suggest that with proper infection control, isolation, and patient selection, results similar to those observed in non-COVID series can be replicated.

A tailored strategy for repair of acute type A aortic dissection.

OBJECTIVE: Innumerable surgical techniques are currently deployed for repairing acute type A aortic dissection (ATAAD). We analyzed our results using a conservative approach of root-sparing and hemiarch techniques in higher-risk patients and root and total arch replacement for lower-risk patients. METHODS: We queried our aortic database for consecutive patients who underwent ATAAD repair. Patients who underwent conservative repair (group 1) were compared with those who underwent extensive repair (group 2) using univariable and multivariable analysis. RESULTS: From 1997 to 2019, 343 patients underwent ATAAD repair. Two hundred forty had conservative repair (root-sparing, hemiarch) whereas 103 had extensive repair (root replacement and/or total arch). Group 1 was older with more comorbidities such as hypertension, previous myocardial infarction, and renal dysfunction. Group 2 had more connective tissue disease (2.1% vs 12.6%; P < .01), aortic insufficiency, and longer intraoperative times. The incidence of individual postoperative complications was similar regardless of approach. A composite of major adverse events (operative mortality, myocardial infarction, stroke, dialysis, or tracheostomy) was higher in the conservative group (15.1% vs 5.9%; P = .03). Operative mortality was 5.6% and not different between groups. Ten-year survival was similar with either surgical approach. Ten-year cumulative risk of reintervention was greater in group 2 (5.6% vs 21% at 10 years; P < .01). In multivariable analysis, ejection fraction and diabetes were predictors of major adverse events but not extensive approach. Extensive approach was a predictor of late reoperation (odds ratio, 3.03 [95% confidence interval, 1.29-7.2]; P = .01). CONCLUSIONS: A tailored conservative approach to ATAAD leads to favorable operative outcomes without compromising durability.

Secondary review reduced inpatient MRI orders and avoidable hospital days.

INTRODUCTION: Medical centers have dramatically increased the use of magnetic resonance imaging (MRI). At 2 large academic tertiary care centers in New York City, nearly half of inpatient MRI orders took more than 12 h to complete, delaying patient discharge and increasing avoidable hospital days. We posited that transitioning inpatient MRIs to outpatient facilities, when safe and appropriate, could reduce inpatient MRI orders and avoidable hospital days. METHODS: We manually reviewed 59 inpatient MRI orders delayed on the estimated date of discharge (EDD). These orders were often delayed due to no standard process to escalate orders for medical reasons or no system to coordinate outpatient orders. We developed a revised workflow involving an automation platform that flagged inpatient MRI orders requested within 24 h of the EDD and emailed the care team to request a second review of the order. The care team reconsidered whether the order was (1) required for discharge, (2) non-urgent and could be converted to an outpatient order, or (3) unnecessary and could be canceled. RESULTS: Over 9 months, the automation platform flagged 618 inpatient MRI orders, of which 53.9% (333/618) were reviewed by the care team. Among the orders, 24.0% (80/333) of reviewed orders and 12.9% (80/618) of all orders were transitioned to either outpatient or canceled orders. These transitioned orders were associated with 267 fewer avoidable hospital days and a cost savings of $199,194. CONCLUSION: A standardized process and second review of inpatient MRI orders on the EDD can reduce inappropriate orders and more effectively use inpatient imaging resources. PRECIS: A standardized workflow and automation platform encouraged a second review of inpatient MRI orders to reduce inappropriate orders, avoidable hospital days, and hospital costs.

A survey of retractions in the cardiovascular literature.

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.

Posterior left pericardiotomy for the prevention of atrial fibrillation after cardiac surgery: an adaptive, single-centre, single-blind, randomised, controlled trial.

BACKGROUND: Atrial fibrillation is the most common complication after cardiac surgery and is associated with extended in-hospital stay and increased adverse outcomes, including death and stroke. Pericardial effusion is common after cardiac surgery and can trigger atrial fibrillation. We tested the hypothesis that posterior left pericardiotomy, a surgical manoeuvre that drains the pericardial space into the left pleural cavity, might reduce the incidence of atrial fibrillation after cardiac surgery. METHODS: In this adaptive, randomised, controlled trial, we recruited adult patients (aged ≥18 years) undergoing elective interventions on the coronary arteries, aortic valve, or ascending aorta, or a combination of these, performed by members of the Department of Cardiothoracic Surgery from Weill Cornell Medicine at the New York Presbyterian Hospital in New York, NY, USA. Patients were eligible if they had no history of atrial fibrillation or other arrhythmias or contraindications to the experimental intervention. Eligible patients were randomly assigned (1:1), stratified by CHA2DS2-VASc score and using a mixed-block randomisation approach (block sizes of 4, 6, and 8), to posterior left pericardiotomy or no intervention. Patients and assessors were blinded to treatment assignment. Patients were followed up until 30 days after hospital discharge. The primary outcome was the incidence of atrial fibrillation during postoperative in-hospital stay, which was assessed in the intention-to-treat (ITT) population. Safety was assessed in the as-treated population. This study is registered with ClinicalTrials.gov, NCT02875405, and is now complete. FINDINGS: Between Sept 18, 2017, and Aug 2, 2021, 3601 patients were screened and 420 were included and randomly assigned to the posterior left pericardiotomy group (n=212) or the no intervention group (n=208; ITT population). The median age was 61·0 years (IQR 53·0-70·0), 102 (24%) patients were female, and 318 (76%) were male, with a median CHA2DS2-VASc score of 2·0 (IQR 1·0-3·0). The two groups were balanced with respect to clinical and surgical characteristics. No patients were lost to follow-up and data completeness was 100%. Three patients in the posterior left pericardiotomy group did not receive the intervention. In the ITT population, the incidence of postoperative atrial fibrillation was significantly lower in the posterior left pericardiotomy group than in the no intervention group (37 [17%] of 212 vs 66 [32%] of 208 [p=0·0007]; odds ratio adjusted for the stratification variable 0·44 [95% CI 0·27-0·70; p=0·0005]). Two (1%) of 209 patients in the posterior left pericardiotomy group and one (<1%) of 211 in the no intervention group died within 30 days after hospital discharge. The incidence of postoperative pericardial effusion was lower in the posterior left pericardiotomy group than in the no intervention group (26 [12%] of 209 vs 45 [21%] of 211; relative risk 0·58 [95% CI 0·37-0·91]). Postoperative major adverse events occurred in six (3%) patients in the posterior left pericardiotomy group and in four (2%) in the no intervention group. No posterior left pericardiotomy related complications were seen. INTERPRETATION: Posterior left pericardiotomy is highly effective in reducing the incidence of atrial fibrillation after surgery on the coronary arteries, aortic valve, or ascending aorta, or a combination of these without additional risk of postoperative complications. FUNDING: None.