Predictors of premature termination of cardiac surgery trials: insights from the clinicaltrial.gov database.

OBJECTIVES: Clinical trials that are terminated prematurely may generate incomplete and potentially biased data and the reasons for premature trials termination are poorly understood. Our objective was to describe the incidence of premature trial termination and identify factors associated with it. METHODS: We performed a systematic search on ClinicalTrials.gov to identify all cardiac surgery trials from 1991 to 2023. Trials that were terminated prematurely were identified. Factors independently associated with premature termination were identified using multivariable logistic regression analysis. RESULTS: A total of 746 clinical trials were included; of them 577 were completed and 169 (22.6%) were terminated prematurely. Most of the trials originated from North America (294 [39.4%]), Europe (264 [35.4%]) or Asia (141 [18.9%]). Fourteen of the trials terminated prematurely (8.3%) were phase 1, 75 (44.4%) phase 2, 49 (29.0%) phase 3, and 31 (18.3%) phase 4. Fifty (29.6%) trials were terminated because of slow recruitment, 20 (11.8%) because of sponsor decision and 12 (7.1%) because lack of funding. Left ventricular assist device (LVAD) trials (odds ratio [OR] 3.65, 95% CI: [1.65-8.00] P = 0.001), valve surgery trials (OR 4.30, 95% CI: [2.33-8.00] P < 0.001), aortic surgery trials (OR 2.86 95% CI [1.22-6.43] P = 0.012), Phase 2 (OR 3.02, 95% CI [1.31-7.93] P = 0.015) and phase 4 trials (OR 3.62, 95% CI: [1.43-10.23] P = 0.010) were at higher risk of premature termination while trials performed in Asia (OR 0.18, 95% CI [0.07-0.39] P ≤ 0.001) and Europe (OR 0.49, 95% CI: [0.30-0.80] P = 0.004) were less likely to be terminated prematurely. CONCLUSIONS: Slow recruitment is the most common reason for premature termination of cardiac surgery trials. Trials on LVAD, valve surgery, aortic surgery, phase 2 trials and phase 4 trials are more likely to be terminated, while trials conducted in Asia and Europe are less likely to be terminated prematurely.

Coronary Artery Bypass Graft Failure in Women: Incidence and Clinical Implications.

BACKGROUND: Women have worse outcomes after coronary artery bypass surgery (CABG) than men. OBJECTIVES: This study aimed to determine the incidence of CABG graft failure in women, its association with cardiac events, and whether it contributes to sex-related differences in outcomes. METHODS: A pooled analysis of individual patient data from randomized clinical trials with systematic imaging follow-up was performed. Multivariable logistic regression models were used to assess the association of graft failure with myocardial infarction and repeat revascularization between CABG and imaging (primary outcome) and death after imaging (secondary outcome). Mediation analysis was performed to evaluate the effect of graft failure on the association between female sex and risk of death. RESULTS: Seven randomized clinical trials (N = 4,413, 777 women) were included. At a median imaging follow-up of 1.03 years, graft failure was significantly more frequent among women than men (37.3% vs 32.9% at the patient-level and 20.5% vs 15.8% at the graft level; P = 0.02 and P < 0.001, respectively). In women, graft failure was associated with an increased risk of myocardial infarction and repeat revascularization (OR: 3.94; 95% CI: 1.79-8.67) and death (OR: 3.18; 95% CI: 1.73-5.85). Female sex was independently associated with the risk of death (direct effect, HR: 1.84; 95% CI: 1.35-2.50) but the association was not mediated by graft failure (indirect effect, HR: 1.04; 95% CI: 0.86-1.26). CONCLUSIONS: Graft failure is more frequent in women and is associated with adverse cardiac events. The excess mortality risk associated with female sex among CABG patients is not mediated by graft failure.

Aortic Valve Degeneration After Valve-Sparing Root Replacement in Patients with Bicuspid Aortopathy or Connective Tissue Disorder.

OBJECTIVE: Evaluate outcomes of valve-sparing root replacement (VSRR) in patients with bicuspid aortopathy (BAV) versus other connective tissue disorder (CTD). METHODS: Single-center cohort study of consecutive patients undergoing VSRR via reimplantation from 2000-2023 with BAV or CTD. Operative outcomes, Kaplan-Meier survival estimates, and cumulative risk of reoperation and recurrent aortic insufficiency (AI) with the competing risk of death were assessed. RESULTS: Of 516 VSRR patients, 109 (51.9%) had BAV and 101 (48.1%) had CTD. BAV patients were older (46.9±10.4 vs 38.4±14 years, p<0.001) and more likely male ( 89.0% vs 56.4%, p<0.001) and hypertensive (66.1% vs 28.7%, p<0.001). Preoperative AI was similar (p=0.57) between groups (30.3% mild, 18.3% moderate, 11.1% severe). Most patients had no/trivial immediate postoperative residual AI (96.3% vs 93.1%). Operative mortality was zero; postoperative adverse events were minimal. Mean clinical follow-up was 5.2±4.4 years; ten-year survival was 95.6% vs 95.7% (p=0.70). Echocardiographic follow-up was 3.9±4.1 years; incidence of >2+ AI (9.7% vs 10.1%, p=1.0) was similar between groups, while incidence of moderate or greater aortic stenosis (AS) was higher with BAV (7.5% vs 0%, p=0.02). Reoperation was low in both groups (3.7% vs 5.9%, p=0.65). Competing risk analysis found no difference in reoperation hazard between BAV and CTD groups (hazard ratio 0.36, 95% confidence interval 0.07-1.81, p=0.21). CONCLUSIONS: BAV and CTD patients have excellent operative outcomes, no mortality, and minimal residual AI after VSRR. While the incidence of recurrent AI was similar, BAV patients are at risk for AS.

Impact of Multiarterial Revascularization on Long-term Major Adverse Cardiovascular Events After Coronary Bypass in 23,798 Patients.

BACKGROUND: This study evaluated the association between bypass grafting with multiarterial grafts (MAG) and single arterial grafts (SAG) and all-cause mortality and major adverse cardiovascular and cerebrovascular events (MACCE), overall and across different patient subgroups from a Middle Eastern nation. METHODS: This single-center retrospective cohort study included 23,798 patients. MAG and SAG groups were balanced using inverse probability weighting (IPW). Associations between MAG and outcomes were assessed using Cox regression. A series of covariate-adjusted Cox models were conducted to evaluate the effect of MAG on outcomes at different levels of independent variables, including age, sex, and cardiovascular risk factors. RESULTS: In the study population (73.9% were men, 65.11 ± 9.94 years), 986 patients (4.1%) underwent MAG. Compared with the SAG group, MAG had lower crude mortality (14.1% vs 21.6%) and MACCE (28.8% vs 34.7%) rates during a median follow-up of 9.23 years (quartile 1-quartile 3, 9.13-9.33 years). Although MAG was significantly associated with reduced risk of study outcomes at the univariate level, these associations disappeared after matching (all-cause mortality (IPW hazard ratio, 0.90; 95% CI, 0.67-1.22) and MACCEs (IPW hazard ratio, 0.94; 95% CI, 0.76-1.15). However, covariate-adjusted models indicated that MAG was associated with a significantly reduced risk of adverse events, particularly MACCEs, in men, younger patients, and those without risk factors. CONCLUSIONS: MAG was not associated with improved postsurgery outcomes among the total coronary artery bypass graft population. Our findings, however, should be interpreted in the context of a relatively low total institutional MAG burden. Choosing a second arterial conduit over saphenous vein grafts in specific patient subgroups might be reasonable. This hypothesis-generating finding should be investigated in future clinical trials in these patients.

Exploring the landscape of academic retractions in medicine: a comprehensive umbrella review.

INTRODUCTION: The escalating trend of academic article retractions over the last decades raises concerns about scientific integrity, but heterogeneity in retractions and reasons for them pose a major challenge. We aimed to comprehensively overview systematic reviews focusing on retractions in the biomedical literature. EVIDENCE ACQUISITION: We abstracted salient features and bibliometric details from shortlisted articles. The Joanna Briggs Institute (JBI) Checklist for Systematic Reviews and Research Syntheses was used for validity appraisal. EVIDENCE SYNTHESIS: A total of 11 reviews were included, published between 2016 and 2023, and reporting on a total of 1851 retracted studies. Several major reasons for retractions were identified, spanning both misconduct (e.g., falsification, duplication, plagiarism) and non-misconduct issues (e.g., unreliable data, publishing problems). Correlates include author-related factors (number of authors, nationality) and journal-related factors (impact factor), with repeat offenders contributing significantly. Impacts of retractions is profound, affecting scholarly credibility, public trust, and resource utilization. CONCLUSIONS: In order to prevent retractions and amend their adverse effects, rigorous and transparent reporting standards, enhanced training in research ethics, strengthened peer review processes, and the establishment of collaborative and integrated research integrity offices are proposed.

Pulmonary artery catheter use and in-hospital outcomes in cardiac surgery: a systematic review and meta-analysis.

OBJECTIVES: To determine the association of intraoperative pulmonary artery catheter (PAC) use with in-hospital outcomes in cardiac surgical patients. METHODS: MEDLINE, Embase, and Cochrane Library (Wiley) databases were screened for studies that compared cardiac surgical patients receiving intraoperative PAC with controls and reporting in-hospital mortality. Secondary outcomes included intensive care unit length of stay, cost of hospitalization, fluid volume administered, intubation time, inotropes use, acute kidney injury (AKI), stroke, myocardial infarction (MI), and infections. RESULTS: Seven studies (25 853 patients, 88.6% undergoing coronary artery bypass graft surgery) were included. In-hospital mortality was significantly increased with PAC use [odds ratio (OR) 1.57; 95% confidence interval (CI) 1.12-2.20, P = 0.04]; PAC use was also associated with greater intraoperative inotrope use (OR 2.61; 95% CI 1.54-4.41) and costs [standardized mean difference (SMD) = 0.20; 95% CI 0.16-0.23], longer intensive care unit stay (SMD = 0.29; 95% CI 0.25-0.33), and longer intubation time (SMD = 0.44; 95% CI 0.12-0.76). CONCLUSIONS: PAC use is associated with significantly increased odds of in-hospital mortality, but the amount and quality of the available evidence is limited. Prospective randomized trials testing the effect of PAC on the outcomes of cardiac surgical patients are urgently needed.

Association between lipoprotein levels and outcomes after coronary artery bypass grafting surgery: a systematic review and meta-analysis.

INTRODUCTION: Lipoprotein(a) (Lp[a]) is a variant of low-density lipoprotein (LDL) and has been associated with increased risk of vascular inflammation and thrombosis. Coronary artery bypass grafting (CABG) has been associated with local inflammation of the myocardium. It is plausible, therefore, that patients with elevated baseline Lp(a) may be prone to unfavorable clinical outcomes following CABG. We evaluate differences in outcomes between CABG patients with high and low serum Lp(a) in this meta-analysis. EVIDENCE ACQUISITION: A comprehensive literature search was performed to identify studies reporting outcomes in CABG patients stratified by preoperative Lp(a) level. When possible, the outcomes were pooled in a meta-analysis. We assessed post-operative mortality, major cardiovascular events, stroke occurrence and saphenous graft occlusion. EVIDENCE SYNTHESIS: Eight studies involving 8681 patients were included. Articles used varying cut-offs for high versus low Lp(a), and outcomes varied. In the three studies evaluating mortality, two showed no statistically significant difference between groups while one reported increased mortality associated with high Lp(a) level. Both studies investigating major adverse cardiovascular events reported higher risk in patients with high Lp(a). A study-level meta-analysis of four studies reporting saphenous vein graft occlusion incidence after CABG was performed. High (≥30 mg/dL) preoperative Lp(a) was not associated with an increased risk of graft occlusion compared with low (<30 mg/dL) preoperative Lp(a) (OR=1.88, 95% CI: 0.66-5.36; P=0.15). CONCLUSIONS: Studies evaluating the impact of Lp(a) on outcomes in CABG patients are few, with heterogenous cut-offs and outcomes. In the limited published studies, Lp(a) level was not associated with graft occlusion.

Risk of Pacemaker Implantation After Aortic Root Replacement With and Without Valve Preservation.

BACKGROUND: We compared the outcomes of aortic root replacement by composite valve grafts (CVG) and valve-sparing root replacement (VSRR) operations, with an emphasis on postoperative conduction block and the need for permanent pacemaker implantation (PPM). METHODS: From 1997 to 2023, 1712 consecutive patients underwent ARR by VSRR (501 [29%]) or CVG (1211 [71%]) at a high-volume aortic center. RESULTS: Patients undergoing CVG were older (59 ± 14 vs 49 ± 14 years, P < .001), with more cardiovascular comorbidities. Compared with CVG, there were more women undergoing VSRR (17% vs. 13%, P = .042) and more patients with connective tissue disease (22% vs 7.3%, P < .001). Multivariable analysis found that the risk for PPM was higher after CVG compared with VSRR (6.5% vs 1.2%; odds ratio [OR], 2.83; 95% CI, 1.23-7.69; P = .024). Other variables associated with PPM include older age (OR, 1.03; 95% CI, 1.01-1.05; P = .006) preoperative renal impairment (OR, 2.69; 95% CI, 1.24-5.6; P = .010), previous operation (OR, 2.76; 95% CI, 1.29-5.62; P = .007), and bicuspid aortic valve (OR, 3.63; 95% CI, 2.13-6.33; P < .001). Among the CVG population, patients who are at increased risk are especially those with some degree of aortic stenosis (OR, 2.06; 95% CI, 1.18-3.61; P = .011). Patients who required PPM had no additive risk for long-term mortality (hazard ratio, 1.01; 95% CI, 0.47-2.17; P = .986); however, they were more likely to have reduced ejection fraction (29.3% vs 16%, P = .014). CONCLUSIONS: The incidence of PPM after ARR is low, but rates were higher after CVG compared with VSRR.

Association between overweight and obesity with coronary artery bypass graft failure: an individual patient data analysis of clinical trials.

OBJECTIVES: The association between obesity and graft failure after coronary artery bypass grafting has not been previously investigated. METHODS: We pooled individual patient data from randomized clinical trials with systematic postoperative coronary imaging to evaluate the association between obesity and graft failure at the individual graft and patient levels. Penalized cubic regression splines and mixed-effects multivariable logistic regression models were performed. RESULTS: Six trials comprising 3928 patients and 12 048 grafts were included. The median time to imaging was 1.03 (interquartile range 1.00-1.09) years. By body mass index (BMI) category, 800 (20.4%) patients were normal weight (BMI 18.5-24.9), 1668 (42.5%) were overweight (BMI 25-29.9), 983 (25.0%) were obesity class 1 (BMI 30-34.9), 344 (8.8%) were obesity class 2 (BMI 35-39.9) and 116 (2.9%) were obesity class 3 (BMI 40+). As a continuous variable, BMI was associated with reduced graft failure [adjusted odds ratio (aOR) 0.98 (95% confidence interval (CI) 0.97-0.99)] at the individual graft level. Compared to normal weight patients, graft failure at the individual graft level was reduced in overweight [aOR 0.79 (95% CI 0.64-0.96)], obesity class 1 [aOR 0.81 (95% CI 0.64-1.01)] and obesity class 2 [aOR 0.61 (95% CI 0.45-0.83)] patients, but not different compared to obesity class 3 [aOR 0.94 (95% CI 0.62-1.42)] patients. Findings were similar, but did not reach significance, at the patient level. CONCLUSIONS: In a pooled individual patient data analysis of randomized clinical trials, BMI and obesity appear to be associated with reduced graft failure at 1 year after coronary artery bypass grafting.

Re-exploration for bleeding and long-term survival after adult cardiac surgery: a meta-analysis of reconstructed time-to-event data.

BACKGROUND: Postoperative bleeding requiring re-exploration is a serious complication that occurs in 2.8% to 4.6% of patients undergoing cardiac surgery. Re-exploration has previously been associated with a higher risk of short-term mortality. However, a comprehensive analysis of long-term outcomes after re-exploration for bleeding has not been published. MATERIALS AND METHODS: We performed a systematic, three databases search to identify studies reporting long-term outcomes in patients who required re-exploration for bleeding after cardiac surgery compared to patients who did not, with at least 1 year of follow-up. Long-term survival was the primary outcome. Secondary outcomes were operative mortality, myocardial infarction, stroke, renal and respiratory complications, and hospital length of stay. Random-effects models was used. Individual patient survival data was extracted from available survival curves and reconstructed using restricted mean survival time. RESULTS: Six studies totaling 135,456 patients were included. The average follow-up was 5.5 years. In the individual patient data, patients who required re-exploration had a significantly higher risk of death compared with patients who did not (hazard ratio [HR]: 1.21; 95% confidence interval [CI]: 1.14-1.27; P<0.001), which was confirmed by the study-level survival analysis (HR: 1.32; 95% CI: 1.12-1.56; P<0.01). Re-exploration was also associated with a higher risk of operative mortality (odds ratio [OR]: 5.25, 95% CI, 4.74-5.82, P<0.0001), stroke (OR: 2.05, 95% CI, 1.72-2.43, P<0.0001), renal (OR: 4.13, 95% CI, 3.43-4.39 P<0.0001) respiratory complications (OR: 3.91, 95% CI, 2.96-5.17, P<0.0001), longer hospital length of stay (mean difference [MD]: 2.69, 95% CI, 1.68 to 3.69, P<0.0001), and myocardial infarction (OR: 1.85, 95% CI, 1.30-2.65, P=0.0007). CONCLUSION: Postoperative bleeding requiring re-exploration is associated with lower long-term survival and increased risk of short-term adverse events including operative mortality, stroke, renal and respiratory complications, and longer hospital length of stay. To improve both short- and long-term outcomes, strategies to prevent the need for re-exploration are necessary.

Minimal clinically important differences in patient-reported outcomes after coronary artery bypass surgery in the arterial revascularization trial.

OBJECTIVES: This article identifies minimal clinically important differences (MCIDs) in quality of life (QoL) measures among patients who had coronary artery bypass grafting (CABG) and were enrolled in the arterial revascularization trial (ART). METHODS AND RESULTS: The European Quality of Life-5 Dimensions (EQ-5D) and the Short Form Health Survey 36-Item (SF-36) physical component (PC) and mental component (MC) scores were recorded at baseline, 5 years and 10 years in ART. The MCIDs were calculated as changes in QoL scores anchored to 1-class improvement in the New York Heart Association functional class and Canadian Cardiovascular Society scale at 5 years. Cox proportional hazard models were used to evaluate associations between MCIDs and mortality. Patient cohorts were examined for the SF-36 PC (N = 2671), SF-36 MC (N = 2815) and EQ-5D (N = 2943) measures, respectively. All QoL scores significantly improved after CABG compared to baseline. When anchored to the New York Heart Association, the MCID at 5 years was 17 (95% confidence interval: 17-20) for SF-36 PC, 14 (14-17) for the SF-36 MC and 0.12 (0.12-0.15) for EQ-5D. Using the Canadian Cardiovascular Society scale as an anchor, the MCID at 5 years was 15 (15-17) for the SF-36 PC, 12 (13-15) for the SF-36 MC and 0.12 (0.11-0.14) for the EQ-5D. The MCIDs for SF-36 PC and EQ-5D at 5 years were associated with a lower risk of mortality at the 10-year follow-up point after surgery. CONCLUSIONS: MCIDs for CABG patients have been identified. These thresholds may have direct clinical applications in monitoring patients during follow-up and in designing new trials that include QoL as a primary study outcome. CLINICAL TRIAL REGISTRATION NUMBER: ISRCTN46552265.

Controversy. On pump or off pump: what will I do when I grow up? A narrative systematic review.

The transition from the second to the third millennium happened to be a turning point in the history of myocardial revascularization on a beating heart, which moved from technical development to critical evaluation. This article describes how the initial acceptance and spread of off-pump coronary artery bypass grafting (OPCABG) was followed by the general perception that the technique could not fulfill the expectations placed in it and provides some insight on what should we do with the know-how of OPCABG in the present and the future of coronary surgical revascularization.

Antiplatelet therapy after coronary artery bypass surgery: five year follow-up of randomised DACAB trial.

OBJECTIVE: To assess the effect of different antiplatelet strategies on clinical outcomes after coronary artery bypass grafting. DESIGN: Five year follow-up of randomised Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Grafting (DACAB) trial. SETTING: Six tertiary hospitals in China; enrolment between July 2014 and November 2015; completion of five year follow-up from August 2019 to June 2021. PARTICIPANTS: 500 patients aged 18-80 years (including 91 (18.2%) women) who had elective coronary artery bypass grafting surgery and completed the DACAB trial. INTERVENTIONS: Patients were randomised 1:1:1 to ticagrelor 90 mg twice daily plus aspirin 100 mg once daily (dual antiplatelet therapy; n=168), ticagrelor monotherapy 90 mg twice daily (n=166), or aspirin monotherapy 100 mg once daily (n=166) for one year after surgery. After the first year, antiplatelet therapy was prescribed according to standard of care by treating physicians. MAIN OUTCOME MEASURES: The primary outcome was major adverse cardiovascular events (a composite of all cause death, myocardial infarction, stroke, and coronary revascularisation), analysed using the intention-to-treat principle. Time-to-event analysis was used to compare the risk between treatment groups. Multiple post hoc sensitivity analyses examined the robustness of the findings. RESULTS: Follow-up at five years for major adverse cardiovascular events was completed for 477 (95.4%) of 500 patients; 148 patients had major adverse cardiovascular events, including 39 in the dual antiplatelet therapy group, 54 in the ticagrelor monotherapy group, and 55 in the aspirin monotherapy group. Risk of major adverse cardiovascular events at five years was significantly lower with dual antiplatelet therapy versus aspirin monotherapy (22.6% v 29.9%; hazard ratio 0.65, 95% confidence interval 0.43 to 0.99; P=0.04) and versus ticagrelor monotherapy (22.6% v 32.9%; 0.66, 0.44 to 1.00; P=0.05). Results were consistent in all sensitivity analyses. CONCLUSIONS: Treatment with ticagrelor dual antiplatelet therapy for one year after surgery reduced the risk of major adverse cardiovascular events at five years after coronary artery bypass grafting compared with aspirin monotherapy or ticagrelor monotherapy. TRIAL REGISTRATION: NCT03987373ClinicalTrials.gov NCT03987373.

Revascularisation in Left Ventricular Systolic Dysfunction: A Meta-analysis of Kaplan-Meier Reconstructed Individual Patient Data.

BACKGROUND: Coronary artery disease is a common cause of ischemic left ventricular systolic dysfunction (LVSD), for which the optimal revascularisation strategy remains unclear. We aimed to determine whether percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) results in greater survival advantage in patients with LVSD. METHODS: Study-level (SLMA) and reconstructed individual patient data (rIPDMA) meta-analyses from Kaplan-Meier (KM) survival curves were performed. A systematic search of Medline, Embase, and Cochrane Library was conducted for observational and randomised studies published after 2010 that compared PCI and CABG in patients with left ventricular ejection fraction ≤ 40%. The primary outcome was all-cause mortality at longest follow-up. The secondary outcomes were myocardial infarction (MI), stroke, repeated revascularisation, cardiovascular mortality, and major adverse cardiovascular and cerebrovascular events (MACCE) at longest follow-up. RESULTS: Fourteen studies (11 observational, 3 randomised, 13,063 patients) were eligible for the SLMA. Seven contained digitisable KM curves from which individual patient data could be reconstructed. Study-level analysis found PCI to be associated with increased all-cause mortality (hazard ratio [HR] 1.41, 95% confidence interval [CI] 1.18-1.69), MI (HR 2.10, 95% CI 1.62-2.72), repeated revascularisation (HR 2.39, 95% CI 1.37-4.17), and MACCE (HR 1.58, 95% CI 1.23-2.03), without significant differences in stroke (HR 0.86, 95% CI 0.39-1.92) or cardiovascular mortality (HR 1.42, 95% CI 0.78-2.59). In the rIPDMA, PCI resulted in increased all-cause mortality (HR 1.57, 95% CI 1.34-1.87) and repeated revascularisation (HR 3.63, 95% CI 3.12-4.21) but overall lower risk of stroke (HR 0.62, 95% CI 0.39-0.99) owing to fewer events during initial follow-up. CONCLUSIONS: In patients with ischemic LVSD, PCI was associated with higher risk of all-cause mortality and repeated revascularisation than CABG, but lower risk of short-term stroke. (PROSPERO: CRD42021291408).

Improving diversity in cardiac surgery clinical trials with ROMA:Women as an exemplar.

PURPOSE OF REVIEW: To describe methods to improve representation of women in cardiac surgery clinical trials. RECENT FINDINGS: Cardiovascular disease risk among women is high. Historically, women have been excluded from cardiac surgery trials, in part due to restrictive inclusion criteria. Surgical outcomes, specifically after coronary artery bypass grafting, are consistently worse among female patients, and these outcomes have not improved over the last decade. Addressing treatment effects and clinical benefit among women requires accurate representation in cardiovascular surgery trials. ROMA:Women, is the first cardiac surgery trial to focus solely on women, with the goal of addressing underrepresentation. Through utilizing specific strategies, ROMA:Women is a promising first step in advancing health equity. SUMMARY: Strategies to ensure effective recruitment and representation among women in cardiac surgery clinical trials, such as tailored eligibility criteria and comprehensive strategies to improve communication and increase trust, are two of many potential approaches to address the structural barriers to female representation in cardiac surgery clinical trials. To date, ROMA:Women is an example of a trial that has shown extraordinary preliminary success enrolling women. Designing trials exclusively for women is one strategy to improve the diversity of clinical trial participation.

Subclinical hypothyroidism and clinical outcomes after cardiac surgery: A systematic review and meta-analysis.

Background: Subclinical hypothyroidism (SCH) is associated with major adverse cardiovascular events. Despite the recognized negative impact of SCH on cardiovascular health, research on cardiac postoperative outcomes with SCH has yielded conflicting results, and patients are not currently treated for SCH before cardiac surgery procedures. Methods: We performed a study-level meta-analysis on the impact of SCH on patients undergoing nonurgent cardiac surgery, including coronary artery bypass grafting and valve and aortic surgery. The primary outcome was operative mortality. Secondary outcomes were hospital length of stay (LOS), intensive care unit (ICU) stay, postoperative atrial fibrillation (POAF), intra-aortic balloon pump (IABP) use, renal complications, and long-term all-cause mortality. Results: Seven observational studies, with a total of 3445 patients, including 851 [24.7%] diagnosed with SCH and 2594 [75.3%] euthyroid patients) were identified. Compared to euthyroid patients, the patients with SCH had higher rates of operative mortality (odds ratio [OR], 2.57; 95% confidence interval [CI], 1.09-6.04; P = .03), prolonged hospital LOS (standardized mean difference, 0.32; 95% CI, 0.02-0.62; P = .04), a higher rate of renal complications (OR, 2.53; 95% CI, 1.74-3.69; P < .0001), but no significant differences in ICU stay, POAF, or IABP use. At mean follow-up of 49.3 months, the presence of SCH was associated with a higher rate of all-cause mortality (incidence rate ratio, 1.82; 95% CI, 1.18-2.83; P = .02). Conclusions: Patients with SCH have higher operative mortality, prolonged hospital LOS, and increased renal complications after cardiac surgery. Achieving and maintaining a euthyroid state prior to and after cardiac surgery procedures might improve outcomes in these patients.

Impact of Incomplete Revascularization on Long-term Survival Based on Revascularization Strategy.

BACKGROUND: This study investigated the impact of complete revascularization (CR) and incomplete revascularization (IR) on long-term survival in patients undergoing isolated coronary artery bypass grafting (CABG) using multiple arterial graft (MAGs) or a single artery with saphenous vein grafts (SAGs). METHODS: Between January 2006 and December 2020, 12,625 patients underwent CABG and were divided into 4 groups: MAG CR (n = 1066), MAG IR (n = 286), SAG CR (n = 8360), and SAG IR (n = 2913). Inverse probability of treatment weighting based on the generalized propensity score was used to minimize imbalance between the groups. RESULTS: In the weighted cohort, median follow-up time was 8.35 years (interquartile range, 5.01-11.6 years). MAG CR was associated with similar long-term survival compared with MAG IR (hazard ratio [HR], 0.79; 95% CI, 0.60-1.03; P = .084). SAG CR was associated with improved long-term survival compared with SAG IR (HR, 0.67; 95% CI, 0.52-0.84; P = .01). MAG CR was associated with better long-term survival compared with SAG CR (HR, 0.45; 95% CI, 0.35-0.57; P < .001). Moreover, MAG IR was protective compared with SAG IR (HR, 0.62; 95% CI, 0.45-0.85; P = .033). Additional analysis was performed comparing perfect CR vs imperfect CR vs IR in MAG and SAG patients, separately. In the weighted sample of MAG, there were no differences in the long-term survival between perfect CR, imperfect CR, and IR. However, in the weighted sample of the SAG cohort, SAG perfect CR was associated with improved survival compared with SAG imperfect CR (HR, 0.81; 95% CI, 0.0.72-0.92; P = .001). Whereas, SAG perfect and imperfect CR were both associated with improved survival compared with SAG IR (HR, 0.51; 95% CI, 0.0.35-0.87; P = .006 and HR, 0.72; 95% CI, 0.64-0.82; P < .001), respectively. CONCLUSIONS: MAG CR is associated with better survival compared with SAG CR. If IR is inevitable, patients with MAG IR had better long-term survival compared with patients receiving SAG IR. Moreover, similar long-term survival is observed whether perfect CR, imperfect CR, or IR is achieved in the MAG population but not in SAG patients.