The Asian system for cardiac operative risk evaluation for predicting mortality after isolated coronary artery bypass graft surgery (ASCORE-C).

OBJECTIVE: The mortality of coronary artery bypass graft surgery (CABG) in Asian patients predicted by Western population-based risk models is not ideal. We aimed to develop a risk scoring system based on a multiracial Asian patient population to predict early-stage mortality. METHODS: A total of 2495 patients who underwent isolated CABG in Singapore from 2009 to 2015 were included to develop a regional scoring system: the regional Asian System for Cardiac Operative Risk Evaluation in CABG (ASCORE-C). Predictors were identified via a stepwise multiple logistic regression to construct models for 30-day, 90-day, and 1-year cumulative mortality prediction. The optimal cut-offs of ASCORE-C risk strata were determined by the multiway χ2 and Interaction Detection decision tree. The performance of ASCORE-C was compared with European System for Cardiac Operative Risk Evaluation score (EuroSCORE) II and Society of Thoracic Surgeons (STS) score by observed/estimated mortality ratio. RESULTS: The observed postoperative 30-day, 90-day, and 1-year cumulative mortality following isolated CABG were 2.6%, 3.3%, and 4.6%, respectively. The ASCORE-C to predict these three events were constructed with age (>65 years), Malay ethnicity, congestive heart failure, abnormal heart rhythm, aortic atherosclerosis, estimated glomerular filtration rate, peripheral vascular disease, critical preoperative status, and emergency surgery. Tested by three different validation datasets, receiver operating characteristic curve of ASCORE-C model prediction performed well with the Hosmer-Lemeshow test. The ASCORE-C was found to have better predictive accuracy than EuroSCORE II and STS score in CABG mortality prediction, especially for the high-risk patients. CONCLUSION: The ASCORE-C system is reliable for early-stage CABG mortality prediction in a multiracial Asian population.

Impact of preoperative fractional flow reserve on arterial bypass graft anastomotic function: the IMPAG trial.

AIMS: Visual estimation is the most commonly used method to evaluate the degree of coronary artery stenosis prior to coronary artery bypass grafting. In interventional cardiology, the use of fractional flow reserve (FFR) to guide revascularization decisions has become routine. We investigated whether the preoperative FFR measurement of coronary lesions is associated with anastomosis function 6 months after surgical revascularization using a multiarterial grafting strategy. METHODS AND RESULTS: In this prospective double-blind study, 67 patients were enrolled from two institutions in Europe and Canada. From these patients, 199 coronary lesions were assessed visually and with FFR at the time of the preoperative angiogram. All patients received coronary revascularization using multiple arterial grafts. A post-operative 6-month angiogram was performed to assess anastomosis functionality using a described angiographic method. The primary outcome was the association between preoperative FFR values and anastomosis function 6 months after surgery. Preoperative FFR was significantly associated with 6-months anastomotic function for all conduits and for all targets (P < 0.001). An FFR value of ≤0.78 was associated with an anastomotic occlusion rate of 3%. CONCLUSION: We found a significant association between the preoperative FFR measurement of the target vessel and the anastomotic functionality at 6 months, with a cut-off of 0.78. Integration of FFR measurement into the preoperative diagnostic workup before multiarterial coronary surgical revascularization leads to improved anastomotic graft function. CLINICAL TRIALS. GOV IDENTIFIER: NCT02527044.

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.

Comparison of meta-analytical estimates of outcomes after Alfieri or neochordal repair in isolated anterior mitral prolapse.

OBJECTIVES: Repair of the isolated degenerative anterior mitral leaflet has been considered more challenging and associated with compromised durability compared with isolated posterior leaflet in major series. Implantation of neochordae or Alfieri edge-to-edge is the most employed repair technique for isolated anterior repair currently, but little data exist comparing their relative durability. We sought to investigate this issue with this meta-analysis. METHODS: A literature search was performed (Ovid MEDLINE, Ovid Embase and The Cochrane Library). The primary outcome was the incidence rate (IR) of reoperation, the secondary outcomes were recurrent moderately severe/severe mitral regurgitation (MR), in-hospital/30-day reoperation and mortality and follow-up mortality. A random-effect model was used. Leave-one-out, subgroup analysis (Alfieri versus neochordae) and meta-regression were done. RESULTS: Seventeen studies (including 1358 patients) were included. At a weighted mean follow-up of 5.56 ± 3.31 years, the IR for reoperation was 14.45 event per 1000 person-year and significantly lower in Alfieri than neochordae repair (9.40 vs 18.61, P = 0.04) on subgroup analysis. The IR of follow-up moderately severe/severe MR was 19.89 event per 1000 person-year and significantly lower in Alfieri than neochordae repair (10.68 and 28.63, P = 0.01). In a sensitivity analysis comparing homogenous studies, a significant difference in the recurrence of regurgitation in favour of the Alfieri approach remained. There were no differences in operative outcomes or survival. There were significant associations between increased incidence of late reoperation and New York Heart Association class III/IV and associated coronary artery bypass graft procedure for whole cohort. CONCLUSIONS: Alfieri repair may be associated with a lower incidence of recurrent MR compared with neochordae-based repair in the setting of isolated degenerative anterior mitral pathology. This is the first such meta-analysis and further inquiry into this area is needed.

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.

Challenges in outlier surgeon assessment in the era of public reporting.

OBJECTIVE: To assess the effect of various evaluation and reporting strategies in determining outlier surgeons, defined by having worse-than-expected mortality after cardiac surgery. METHODS: Our study included 33 394 isolated coronary artery bypass graft (CABG) procedures performed by 136 surgeons and 12 172 surgical aortic valve replacement (SAVR) procedures performed by 113 surgeons between 2010 and 2014. Three current methodologies based on the framework of comparing observed and expected (O/E ratio) mortality, with different distributional assumptions, were examined. We further assessed the consistency of outliers detected by these three methods and the impact of using different time windows and aggregating data of CABG and SAVR procedures. RESULTS: The three methods were consistent and detected same outliers, with the least conservative method detecting additional outliers (outliers detected for methods 1, 2 and 3: CABG 3 (2.2%), 2 (1.5%) and 8 (5.9%); SAVR 1 (0.9%), 0 (0.0%) and 11 (9.7%)). When numbers of cases recorded were low and events were rare, the two more conservative methods were unlikely to detect outliers unless the O/E ratios were extremely high. However, these two methods were more consistent in detecting the same surgeons as outliers across different time windows for assessment. Of the surgeons who performed both CABG and SAVR, none was an outlier for both procedures when assessed separately. Aggregating data from CABG and SAVR may lead to results to be dominated by the procedure that had a higher caseload. CONCLUSIONS: The choices of outlier assessment method, time window for assessment and data aggregation have an intertwined impact on detecting outlier surgeons, often representing different value assumptions toward patient protection and provider penalty. It is desirable to use different methods as sensitivity analyses, avoid aggregating procedures and avoid rare-event endpoints if possible.