Clinical Trial Diversity, Equity, and Inclusion: Roadmap of the Cardiothoracic Surgical Trials Network.

BACKGROUND: There is a recognized lack of diversity among patients enrolled in cardiovascular interventional and surgical trials. Diverse patient representation in clinical trials is necessary to enhance generalizability of findings, which may lead to better outcomes across broader populations. The Cardiothoracic Surgical Trials Network (CTSN) recently developed a plan of action to increase diversity among participating investigators and trial participants and is the focus of this review. METHODS: A review of literature and enrollment data from CTSN trials was conducted. RESULTS: CTSN completed more than a dozen major clinical trials (2008-2022), enrolling >4000 patients, of whom 30% were women, 11% were non-White, and 5.6% were Hispanic. CTSN also completed trials of hospitalized patients with coronavirus disease 2019, wherein enrollment was more diverse, with 42% women, and 58% were Asian, Black, Hispanic, or from another underrepresented racial group. The discrepancy in diversity of enrollment between cardiac surgery trials and coronavirus disease trials highlights the need for a more comprehensive understanding of (1) the prevalence of underlying disease requiring cardiac interventions across broad populations, (2) differences in access to care and referral for cardiac surgery, and (3) barriers to enrollment in cardiac surgery trials. CONCLUSIONS: Committed to diversity, CTSN's multifaceted action plan includes developing site-specific enrollment targets, collecting social determinants of health data, understanding reasons for nonparticipation, recruiting sites that serve diverse populations, emphasizing greater diversity among clinical trial teams, and implicit bias training. The CTSN will prospectively assess how these interventions influence enrollment as we work to ensure trial participants are more representative of the communities we serve.

Racial/Ethnic Disparities in Aortic Valve Replacement Among Medicare Beneficiaries in the United States, 2012-2019.

PURPOSE: There are concerns that transcatheter or surgical aortic valve replacement (TAVR/SAVR) procedures are preferentially available to White patients. Our objective was to examine differences in utilization of aortic valve replacement and outcomes by race/ethnicity in the US for patients with aortic stenosis. METHODS: We performed a serial cross-sectional cohort study of 299,976 Medicare beneficiaries hospitalized with principal diagnosis of aortic stenosis between 2012 and 2019 stratified by self-reported race/ethnicity (Black, Hispanic, Asian, Native American, and White). Outcomes included aortic valve replacement rates within 6 months of index hospitalization and associated procedural outcomes, including 30-day readmission, 30-day and 1-year mortality. RESULTS: Within 6 months of an index admission for aortic stenosis, 86.8% (122,457 SAVR; 138,026 TAVR) patients underwent aortic valve replacement. Overall, compared with White people, Black (HR 0.87 [0.85-0.89]), Hispanic (0.92 [0.88-0.96]), and Asian (0.95 [0.91-0.99]) people were less likely to receive aortic valve replacement. Among patients who were admitted emergently/urgently, White patients (41.1%, 95% CI, 40.7-41.4) had a significantly higher aortic valve replacement rate compared with Black (29.6%, 95% CI, 28.3-30.9), Hispanic (36.6%, 95% CI, 34.0-39.3), and Asian patients (35.4%, 95% CI, 32.3-38.9). Aortic valve replacement rates increased annually for all race/ethnicities. There were no significant differences in 30-day or 1-year mortality by race/ethnicity. CONCLUSIONS: Aortic valve replacement rates within 6 months of aortic stenosis admission are lower for Black, Hispanic, and Asian people compared to White people. These race-related differences in aortic stenosis treatment reflect complex issues in diagnosis and management, warranting a comprehensive reassessment of the entire care spectrum for disadvantaged populations.

Heart transplantation in patients from socioeconomically distressed communities.

BACKGROUND: Studies examining heart transplantation disparities have focused on individual factors such as race or insurance status. We characterized the impact of a composite community socioeconomic disadvantage index on heart transplantation outcomes. METHODS: From the Scientific Registry of Transplant Recipients (SRTR), we identified 49,340 primary, isolated adult heart transplant candidates and 32,494 recipients (2005-2020). Zip code-level socioeconomic disadvantage was characterized using the Distressed Community Index (DCI: 0-most prosperous, 100-most distressed) based on education, poverty, unemployment, housing vacancies, median income, and business growth. Patients from distressed communities (DCI ≥ 80) were compared to all others. RESULTS: Patients from distressed communities were more often non-white, less educated, and had public insurance (all p < 0.01). Distressed patients were more likely to require ventricular assist devices at listing (29.4 vs 27.1%) and before transplant (44.8 vs 42.0%, both p < 0.001), and they underwent transplants at lower-volume centers (23 vs 26 cases/year, p < 0.01). Distressed patients had higher 1-year waitlist mortality or deterioration (12.3% [95% confidence interval (CI) 11.6-13.0] vs 10.9% [95% CI 10.5-11.3]) and inferior 5-year survival (75.3% [95% CI 74.0-76.5] vs 79.5% [95% CI 79.0-80.0]) (both p < 0.001). After adjustment, living in a distressed community was independently associated with an increased risk of waitlist mortality or deterioration hazard ratio (HR 1.10, 95% CI 1.02-1.18) and post-transplant mortality (HR 1.13, 95% CI 1.06-1.20). CONCLUSIONS: Patients from socioeconomically distressed communities have worse waitlist and post-transplant mortality. These findings should not be used to limit access to heart transplantation, but rather highlight the need for further studies to elucidate mechanisms underlying the impact of community-level socioeconomic disparity.

Racial Disparities in Failure to Rescue after Pediatric Heart Surgeries in the US.

OBJECTIVE: To identify the trend in failure to rescue (FTR) and risk factors contributing to racial disparities in FTR after pediatric heart surgery using contemporary nationwide data. STUDY DESIGN: We identified 85 267 congenital heart surgeries in patients <18 years of age from 2009 to 2019 using the Kid's Inpatient Database. The primary outcome was FTR. A mixed-effect logistic regression model with hospital random intercept was used to identify independent predictors of FTR. RESULTS: Among 36 753 surgeries with postoperative complications, the FTR was 7.3%. The FTR decreased from 7.4% in 2009 to 6.3% in 2019 (P = .02). FTR was higher among Black than White children for all years. The FTR was higher among girls (7.2%) vs boys (6.6%), children aged <1 (9.6%) vs 12-17 years (2.4%), and those of Black (8.5%) vs White race (5.9%) (all P < .05). Black race was associated with a higher FTR odds (OR, 1.40; 95% CI, 1.20-1.65) after adjusting for demographics, medical complexity, nonelective admission, and hospital surgical volume. Higher hospital volume was associated with a lower odds of FTR for all racial groups, but fewer Black (19.7%) vs White (31%) children underwent surgery at high surgical volume hospitals (P < .001). If Black children were operated on in the same hospitals as White children, the racial differences in FTR would decrease by 47.3%. CONCLUSIONS: Racial disparities exist in FTR after pediatric heart surgery in the US. The racial differences in the location of care may account for almost half the disparities in FTR.

Lung transplantation outcomes in patients from socioeconomically distressed communities.

BACKGROUND: Previous studies have demonstrated racial and gender disparities in lung allocation, but contemporary data regarding socioeconomic disparities in post-transplant outcomes are lacking. We evaluated the impact of a composite socioeconomic disadvantage index on post-transplant outcomes. METHODS: The Scientific Registry of Transplant Recipients identified 27,763 adult patients undergoing isolated primary lung transplantation between 2005 and 2020. Zip code-level socioeconomic distress was characterized using the Distressed Communities Index (DCI: 0-no distress, 100-severe distress) based on education level, poverty, unemployment, housing vacancies, median income, and business growth, and patients were stratified into high (DCI ≥60) or low (DCI <60) distressed groups. RESULTS: Recipients from high-distress communities (n = 8006, 28.8%) were younger (59years [interquartile range {IQR} 50-64] vs 61years [IQR 52-66]), less often white (73 vs 85%), less likely to have a college degree (45 vs 59%), and more likely to have public insurance (57 vs 49%, all p < 0.001) compared to those from low-distress communities. Additionally, high-distress recipients were more likely to have group A diagnoses (32 vs 27%) and undergo bilateral lung transplants (72.4 vs 69.3%, all p < 0.001). Post-transplant survival at 5years was 55.7% (95% confidence interval [CI]: 54.4-56.9) in high-distress recipients and 58.2% (95% CI: 57.4-58.9) in low-distress recipients (p = 0.003). After adjustment, high distress level was independently associated with an increased risk of 5-year mortality (hazard ratio:1.09, 95% CI:1.04-1.15). CONCLUSIONS: Recipients from distressed communities are at increased mortality risk following lung transplantation. Efforts should be focused on increased resource allocation and further study to better understand factors which may mitigate this disparity.

Socioeconomic disparities in midterm outcomes after repair for degenerative mitral regurgitation.

OBJECTIVE: The influence of socioeconomic disparities on survival after mitral repair is poorly defined. We examined the association between socioeconomic disadvantage and midterm outcomes of repair in Medicare beneficiaries with degenerative mitral regurgitation. METHODS: US Centers for Medicare and Medicaid Services data were used to identify 10,322 patients undergoing isolated first-time repair for degenerative mitral regurgitation between 2012 and 2019. Zip code-level socioeconomic disadvantage was dichotomized with the Distressed Communities Index, which incorporates education level, poverty, unemployment, housing security, median income, and business growth; those with Distressed Communities Index score ≥80 were classified as distressed. The primary outcome was survival, censored at 3 years. Secondary outcomes included cumulative incidences of heart failure readmission, mitral reintervention, and stroke. RESULTS: Of the 10,322 patients undergoing degenerative mitral repair, 9.7% (n = 1003) came from distressed communities. Patients from distressed communities underwent surgery at lower volume centers (11 vs 16 cases/year) and traveled further for surgical care (40 vs 17 miles) (both P values < .001). At 3 years, unadjusted survival (85.4%; 95% CI, 82.9%-87.5% vs 89.7%; 95% CI, 89.0%-90.4%) and cumulative incidence of heart failure readmission (11.5%; 95% CI, 9.6%-13.7% vs 7.4%; 95% CI, 6.9%-8.0%) were worse in patients from distressed communities (all P values < .001), whereas mitral reintervention rates were similar (2.7%; 95% CI, 1.8%-4.0% vs 2.8%; 95% CI, 2.5%-3.2%; P = .75). After adjustment, community distress was independently associated with 3-year mortality (hazard ratio, 1.21; 95% CI, 1.01-1.46) and heart failure readmissions (hazard ratio, 1.28; 95% CI, 1.04-1.58). CONCLUSIONS: Community-level socioeconomic distress is associated with worse outcomes in degenerative mitral repair among Medicare beneficiaries.

Trainee experience on ischemic times and outcomes following orthotopic heart transplantation.

OBJECTIVE: This study was designed to evaluate the association of surgical training on outcomes following orthotopic heart transplantation in all levels of cardiothoracic surgery fellows. METHODS: A retrospective cohort analysis was performed on all heart transplants at a single institution from 2011 to 2020. Transplants performed using organ preservation systems (n = 10) or with significant missing data were excluded (n = 37), resulting in 154 transplants performed by faculty surgeons and 799 total transplants performed by first-year Accreditation Council for Graduate Medical Education fellows (n = 73), second-year Accreditation Council for Graduate Medical Education fellows (n = 124), or non-Accreditation Council for Graduate Medical Education fellows (n = 602) in a transplantation and mechanical circulatory support fellowship. Primary outcome was warm ischemic time analyzed by year of fellowship. Additional secondary outcomes included 30-day mortality, primary graft dysfunction, reoperation for bleeding, and 5-year survival. Median follow-up was 3 years (interquartile range [IQR], 1.0-5.5 years) and 100% complete. RESULTS: The median number of transplants performed was 30 (IQR, 19.5-51.8) during the study period performed by 22 trainees. Baseline transplant characteristics performed were similar amongst the trainee years, although the first-year Accreditation Council for Graduate Medical Education fellows approached significantly fewer re-do transplants (1.4% vs 8.1% and 4.3%; P = .07). Warm ischemic time was lower in the first-year fellows (49 minutes; IQR, 42-63 minutes) versus second-year fellows (56.5 minutes; IQR, 45.5-69 minutes) and mechanical circulatory support/transplant fellows (56 minutes; IQR, 46-67 minutes) (P = .028). Crossclamp time was also lower in the first-year fellows than in second-year and mechanical circulatory support/transplant fellows, respectively (79 minutes; IQR, 65-100 minutes vs 147 minutes; IQR, 125-176 minutes and 143 minutes; IQR, 119-175 minutes) (P = .008). Secondary outcomes, including 30-day mortality (4.1% [n = 3] vs 2.4% [n = 3] vs 2.7% [n = 16]; P = .76), primary graft dysfunction (5.5% [n = 4] vs 4.0% [n = 5] vs 4.3% [n = 26]; P = .88), reoperation for bleeding (2.7% [n = 2] vs 4.8% [n = 6] vs 4.2% [n = 25]; P = .78), and 5-year survival (82.2%; 95% CI, 66.7%-84.9% vs 77.3%; 95% CI, 66.7%-84.9% vs 79.3%; 95% CI, 74.9%-83.1%; P = .84) were comparable in all groups. CONCLUSIONS: This cohort of nearly 800 operations demonstrates that orthotopic heart transplantation may be performed by cardiac fellowship trainees all levels of training with acceptable short- and long-term outcomes.

The Association of Socioeconomic Factors With Outcomes for Coronary Artery Bypass Surgery.

BACKGROUND: Numerous studies have identified the associations of socioeconomic factors with outcomes of cardiac procedures. The majority have focused on easily measured factors like sex, race, and insurance status, or on socioeconomic characteristics of patients' 5-digit zip codes. The impact of more granular census-derived socioeconomic information on outcomes has rarely been studied. METHODS: The independent impact of the Area Deprivation Index (ADI) on short-term mortality and readmissions was tested on patients undergoing isolated coronary artery bypass grafting (CABG) surgery in New York by using it in logistic regression models in conjunction with patient risk factors and typical disparities measures (race, ethnicity, payer). Changes in hospitals' risk-adjusted outcomes and outlier status with the addition of socioeconomic measures were also tested. RESULTS: After adjusting for numerous patient characteristics, patients in the fourth and fifth highest ADI quintiles (most deprived) were more likely to experience in-hospital/30-day mortality after CABG surgery (adjusted odds ratio [AOR] 1.54, 95% confidence interval [CI] 1.08, 2.20; and AOR 1.50, 95% CI 1.02, 2.21), respectively. ADI was not associated with readmissions, but African Americans (AOR 1.49, 95% CI 1.18, 1.87), Hispanics (AOR 1.33, 95% CI 1.06, 1.65) and Medicaid patients (AOR 1.34, 95% CI 1.09, 1.64) were more likely to be readmitted. CONCLUSIONS: Patients with high ADIs are more likely to experience short-term mortality after CABG surgery. African Americans, Hispanics, and Medicaid patients are more likely to experience 30-day readmissions. This information should be taken into account when monitoring patients to reduce adverse events following surgery, and more studies related to ADI are needed to fully understand its implications.

The cost-effectiveness of transcatheter aortic valve replacement in low surgical risk patients with severe aortic stenosis.

AIMS: The economic value of transcatheter aortic valve replacement (TAVR) in low surgical risk patients with severe, symptomatic aortic stenosis is not known. Our objective was to determine the cost-effectiveness of balloon-expandable TAVR and self-expandable TAVR relative to surgical aortic valve replacement (SAVR) in low-risk patients. METHODS AND RESULTS: A fully probabilistic Markov cohort model was constructed to estimate differences in costs and effectiveness [quality-adjusted life years (QALYs)] over the patient's life-time time from the third-party payer's perspective. Clinical outcomes modelled were alive/well (no complications), permanent stroke, ≥moderate paravalvular leak, new pacemaker, rehospitalization, and death. A network meta-analysis of the PARTNER 3 and Evolut Low Risk trial was performed to compare balloon-expandable TAVR, self-expandable TAVR, and SAVR for the efficacy inputs. Incremental-cost effectiveness ratios (ICER) were calculated. The total life-time costs in the balloon-expandable TAVR, self-expandable-TAVR, and SAVR arms were $37 330 ± 4724, $39 660 ± 4862, and $34 583 ± 6731, respectively, and total life-time QALYs gained were 9.15 ± 3.23, 9.13 ± 3.23, and 9.05 ± 3.20, respectively. The ICERs for balloon-expandable TAVR and self-expandable TAVR against SAVR were $27 196/QALY and $59 641/QALY, respectively. Balloon-expandable TAVR was less costly and more effective than self-expandable TAVR. There was substantial uncertainty, with 53% and 58% of model iterations showing balloon-expandable TAVR to be the preferred option at willingness-to-pay thresholds of $50 000/QALY and $100 000/QALY, respectively. CONCLUSION: Compared with SAVR, TAVR, particularly with balloon-expandable prostheses may be a cost-effective option for patients with severe aortic stenosis at low surgical risk.

The Cost of Innovation and Evidence in Cardiac Surgery.

This review summarizes a systematic analysis of 216 randomized trials of cardiovascular interventions performed during 2008-2019, according to the source of trial funding. The systematic analysis showed that on average the results of each trial would change significance if only 5 patients experienced different outcomes. Industry-sponsored trials were more likely to use composite endpoints, noninferiority designs, and twice as likely as nonindustry trials to report results favoring the device arm. Over 80% of industry trials used reporting strategies or "spin" suggesting the device arm was advantageous versus fewer than half of non-industry trials. The review discusses the implications of these findings.

Characteristics of Contemporary Randomized Clinical Trials and Their Association With the Trial Funding Source in Invasive Cardiovascular Interventions.

Importance: Changes in evidence-based practice and guideline recommendations depend on high-quality randomized clinical trials (RCTs). Commercial device and pharmaceutical manufacturers are frequently involved in the funding, design, conduct, and reporting of trials, the implications of which have not been recently analyzed. Objective: To evaluate the design, outcomes, and reporting of contemporary randomized clinical trials of invasive cardiovascular interventions and their association with the funding source. Design, Setting, and Participants: This cross-sectional study analyzed published RCTs between January 1, 2008, to May 31, 2019. The trials included those involving coronary, vascular and structural interventional cardiology, and vascular and cardiac surgical procedures. Main Outcomes and Measures: We assessed (1) trial characteristics, (2) finding of a statistically significant difference in the primary end point favoring the experimental intervention, (3) reporting of implied treatment advantage in trials without significant differences in primary end point, (4) existence of major discrepancies between registered and published primary outcomes, (5) number of patients whose outcomes would need to switch from a nonevent to an event to convert a significant difference in primary end point to nonsignificant, and (6) association with funding source. Results: Of the 216 RCTs analyzed, 115 (53.2%) reported having commercial sponsorship. Most trials had 80% power to detect an estimated treatment effect of 30%, and 128 trials (59.3%) used composite primary end points. The median (interquartile range [IQR]) sample size was 502 (204-1702) patients, and the median (IQR) follow-up duration was 12 (1.0-14.4) months. Overall, 123 trials (57.0%) reported a statistically significant difference in the primary outcome favoring the experimental intervention; reporting strategies that implied an advantage were identified in 55 (65.5%) of 84 trials that reported nonsignificant differences. Commercial sponsorship was associated with a statistically significantly greater likelihood of favorable outcomes reporting (exponent of regression coefficient ß, 2.80; 95% CI, 1.09-7.18; P = .03) and with the reporting of findings that are inconsistent with the trial results. Discrepancies between the registered and published primary outcomes were found in 82 trials (38.0%), without differences in trial sponsorship. A median (IQR) number of 5 (2.8-12.5) patients experiencing a different outcome would have change statistically significant results to nonsignificant. Commercial sponsorship was associated with a greater number of patients (exponent of regression coefficient ß, 1.29; 95% CI, 1.00-1.66; P = .04). Conclusions and Relevance: These results suggest that contemporary RCTs of invasive cardiovascular interventions are relatively small and fragile, have short follow-up, and have limited power to detect large treatment effects. Commercial support appeared to be associated with differences in trial design, results, and reporting.

Does payer status impact clinical outcomes after cardiac surgery? A propensity analysis.

BACKGROUND: Medicaid patients bear proportionately greater financial responsibility for the cost of outpatient care and medication than non-Medicaid patients. We hypothesized that this difference in provision of continuing care would be associated with adverse clinical outcomes after cardiac surgery. MATERIALS AND METHODS: In a retrospective cohort analysis, 5056 consecutive adult patients undergoing cardiac surgery at a single institution between 2005 and 2010 were divided according to payer status. Propensity scores were calculated using 16 preoperative and demographic variables for each patient, and 461 1:1 propensity score-matched pairs were analyzed. Patient socioeconomic position was determined using aggregate data derived from zip codes. The main outcome measures were early mortality, postoperative complications, and patient survival. RESULTS: In multivariate analysis, Medicaid was found to be an independent predictor of worse survival after cardiac surgery (hazard ratio [HR], 2.1; 95% confidence interval [CI], 1.2-3.7; P = .01). No significant difference was observed in operative mortality in the 2 groups. After propensity score matching and controlling for socioeconomic position, the only independent predictors of worse midterm survival were an ejection fraction = 30% (HR, 1.7; 95% CI, 1.1-2.7; P = .02) and a higher logistic EuroSCORE (HR, 1.03; 95% CI, 1.0-1.1; P = .02). CONCLUSIONS: Comorbidity and lower socioeconomic status appear to be more important predictors of late mortality after cardiac surgery than payer status, which does not have a significant impact on survival.

Frailty: the missing element in predicting operative mortality.

Although age is an extensively documented independent risk factor for mortality, morbidity and decreased quality of life after cardiac surgery, it has also been demonstrated that excellent outcomes can be obtained after cardiac surgery in very elderly patients. The disparity between chronological and biological age that underlies these findings forms the focus of this review, which examines recent studies aiming to refine pre-operative risk stratification tools by using assessments of frailty and functional status.

Does previous percutaneous coronary stenting compromise the long-term efficacy of subsequent coronary artery bypass surgery? A microsimulation study.

BACKGROUND: This study aims to compare long-term survival and health-related quality of life in patients undergoing coronary artery bypass surgery with and without previous coronary stenting. METHODS: Markov microsimulation was used to model long-term survival and quality of life after surgical revascularization using data from referenced sources. Probabilistic sensitivity analysis was used to investigate the effect of uncertainty associated with the model parameters on the microsimulation results. RESULTS: Percutaneous coronary stenting was found to significantly decrease the effectiveness of coronary surgery. The model suggests that after a single stenting procedure ten-year survival was reduced by 3.3% (SD 0.7%), from 79.9% (SD 1.3%) to 76.6% (SD 1.4%). Similarly, after multiple stenting procedures ten-year survival was reduced by 3.5% (SD 0.7%) to 76.4% (SD 1.4%). Over a ten-year period a single stenting procedure reduced the quality adjusted life year (QALY) payoff by 0.25 QALY (SD 0.11 QALY) and multiple stenting procedures reduced the QALY payoff by 0.27 QALY (SD 0.08 QALY). CONCLUSIONS: This study suggests that patients who undergo surgical bypass after stenting have worse long-term outcomes than patients who undergo surgical revascularization without previous percutaneous intervention. The pathophysiological mechanisms for this are not fully understood and must be further investigated. The findings of this study suggest that the timing of surgical bypass in relation to percutaneous intervention is important. This may have significant implications for clinical practice, suggesting that greater emphasis should be placed on selecting the optimum initial revascularization strategy.

Excellent results of contemporary coronary artery bypass grafting with systematic application of modern perioperative strategies.

BACKGROUND: The patient population referred for coronary artery bypass grafting (CABG) has become more challenging. The surgical population is aging and patients present with significant preoperative comorbidities. This worsening risk profile has led to the development of operative techniques (off-pump CABG) and perioperative measures (epi-aortic scanning, intensive insulin therapy) to preserve the quality of care following CABG. The aim of this study was to determine the outcome of contemporary CABG following the implementation of the above measures in our practice. METHODS: We retrospectively analyzed prospectively collected data of 2725 patients undergoing CABG between 01/1998 and 12/2005 (mean age, 65 +/- 11 years; 843 [31%] female; mean ejection fraction, 45% +/- 14%). Outcome measures included hospital mortality, postoperative complications, and long-term survival and independent predictors of outcome. Subgroup analyses were performed for 2 study periods (1998-2002 versus 2003-2005) where the above measures were implemented and for patients undergoing conventional versus off-pump CABG. RESULTS: When comparing the 2 study periods, we observed a substantial worsening of the risk profile with an increased EuroSCORE predicted mortality from 6.4% +/- 6.8% to 7.0% +/- 7.8% (P = .028). During the same period, operative mortality decreased from 2.4% to 0.7% (P < .001). This reduction in mortality was also observed in diabetic patients (3.1% versus 1.0%, P = .021) and those with low ejection fraction (4% versus 2.6%, P = not significant). Off-pump procedures were performed with an increasing frequency in high-risk patients in whom we obtained excellent results. Finally, we observed a reduction of postoperative complications including respiratory failure (P = .013), gastrointestinal complications (P = .017), and stroke (P = .094). Independent predictors of mortality included renal failure (OR = 5.7), peripheral vascular disease (OR = 2.9), intra-aortic balloon pump (OR = 4.8), reoperation (OR = 3.3), and hypertension (OR = 2.3). CONCLUSION: Despite a worsening case mix, contemporary CABG can be performed with excellent results (operative mortality < 1%). Off-pump CABG performed in very high-risk patients obtains results similar to those of the general CABG population. Diabetes and ejection fraction were not independent predictors of early outcome. In our experience, these excellent outcomes were achieved by adopting an operative approach using modern perioperative management (epi-aortic scanning, intensive insulin therapy) and surgical techniques (off-pump CABG) based on individual patients.