Superior Outcomes of Dual-Arterial Coronary Artery Bypass Grafting Are Maintained in the Veterans Health Administration.

INTRODUCTION: Controversy surrounds the long-term clinical benefit of coronary artery bypass grafting (CABG) using dual arterial grafts (DAGs) compared to single arterial grafts (SAGs). We investigated outcomes of DAG, using single internal thoracic artery and radial artery (DAG-RA) or bilateral internal thoracic artery grafts (DAG-BITA), compared to SAG, using the left internal thoracic artery and saphenous vein grafts, in the U.S. Veterans Health Administration (VA). METHODS: We conducted a cross-sectional study of U.S. Veterans undergoing isolated on-pump CABG between 2005 and 2015 at 44 VA medical centers. The primary composite outcome was first occurrence of a major adverse cardiac and cerebrovascular event (MACCE), comprised of death from any cause, myocardial infarction, stroke, or repeat revascularization. RESULTS: Among 25,969 Veterans undergoing isolated CABG, 1261 (4.9%) underwent DAG (66.8% DAG-RA and 33.2% DAG-BITA). Over a 5-y follow-up, DAG was associated with lower rates of all-cause death (adjusted hazard ratio [AHR] 0.70, 95% confidence interval [CI] 0.58-0.85), MACCE (AHR 0.80, 95% CI 0.71-0.91), and stroke (AHR 0.74, 95% CI 0.57-0.96) versus SAG. DAG-BITA was associated with lower rates of all-cause death (AHR 0.52, 95% CI 0.35-0.77) and MACCE (AHR 0.66, 95% CI 0.51-0.84) than SAG, while DAG-RA was associated with lower rates of all-cause death (AHR 0.79, 95% CI 0.64-0.99). CONCLUSIONS: In the VA, DAG was associated with improved long-term MACCE outcomes compared to SAG. These results suggest that the practice of DAG in the VA benefits Veterans and should be promoted further.

Perioperative risks associated with administration of andexanet alfa during emergency cardiac surgery with circulatory arrest.

This case report describes the perioperative course of a patient undergoing emergency repair of acute type A thoracic aortic dissection. Andexanet alfa was administered intraoperatively to obtain a dry operative field for right axillary artery exposure and cannulation. Andexanet alfa-induced heparin resistance resulted in cardiopulmonary bypass circuit and pericardial thrombosis requiring more than 400,000 units of unfractionated heparin and antithrombin III to overcome. Postoperatively, excessive chest tube output was observed secondary to protracted heparin rebound requiring continuous dosing of protamine. This case demonstrates the significant challenging perioperative, not just intraoperative, hazards associated with intraoperative andexanet alfa use during emergency cardiac surgery with cardiopulmonary bypass.

A Novel, Multi-Modal, Intraoperative Cognitive Workload Assessment of Cardiac Surgery Team Members.

OBJECTIVE: We characterized cognitive workload (CWL) of cardiac surgery team members in a real-world setting during CABG using providers' heart rate variability (HRV) data as a surrogate measure of CWL. METHODS: HRV was collected from the surgeon, anesthesiologist, perfusionist, and scrub nurse. Audio/video was recorded during isolated, nonemergency CABG surgeries (N=27). Eight surgical phases were annotated by trained researchers and HRV was calculated for each phase. RESULTS: Significant differences in CWL were observed within a given role across surgical phases. Results are reported as (predicted probability (95% CI)). CWL was significantly higher for anesthesiologists during "Preparation and Induction" (0.57, (0.42, 0.71)) and "Anastomoses" (0.44, (0.30, 0.58)) compared to other phases, while the same held for nurses during "Opening" (0.51, 95 (0.37, 0.65)) and "Post-operative" (0.68, (0.42, 0.86)) phases. Additional significant differences were observed between roles within a given surgical phase. For example, surgeons had significantly higher CWL during "Anastomoses" (0.81, (0.69, 0.89)) compared to all other roles while the same was true of perfusionists during "Opening" (0.79, (0.66, 0.88)) and "Pre-bypass Preparation" (0.50, (0.36, 0.64)) phases. CONCLUSIONS: Our innovative analysis demonstrates that CWL fluctuates across surgical procedures by role and phase, which may reflect the distribution of primary tasks. This corroborates earlier findings from self-report measures. Data suggest that team-wide, peak CWL during a phase decreases from early phases of surgery through initiating bypass, rises during anastomosis, and decreases when terminating bypass. Knowledge of these trends could contribute to adopting behaviors to enhance team dynamics and performance.

Deep Learning Analysis of Surgical Video Recordings to Assess Nontechnical Skills.

Importance: Assessing nontechnical skills in operating rooms (ORs) is crucial for enhancing surgical performance and patient safety. However, automated and real-time evaluation of these skills remains challenging. Objective: To explore the feasibility of using motion features extracted from surgical video recordings to automatically assess nontechnical skills during cardiac surgical procedures. Design, Setting, and Participants: This cross-sectional study used video recordings of cardiac surgical procedures at a tertiary academic US hospital collected from January 2021 through May 2022. The OpenPose library was used to analyze videos to extract body pose estimations of team members and compute various team motion features. The Non-Technical Skills for Surgeons (NOTSS) assessment tool was employed for rating the OR team's nontechnical skills by 3 expert raters. Main Outcomes and Measures: NOTSS overall score, with motion features extracted from surgical videos as measures. Results: A total of 30 complete cardiac surgery procedures were included: 26 (86.6%) were on-pump coronary artery bypass graft procedures and 4 (13.4%) were aortic valve replacement or repair procedures. All patients were male, and the mean (SD) age was 72 (6.3) years. All surgical teams were composed of 4 key roles (attending surgeon, attending anesthesiologist, primary perfusionist, and scrub nurse) with additional supporting roles. NOTSS scores correlated significantly with trajectory (r = 0.51, P = .005), acceleration (r = 0.48, P = .008), and entropy (r = -0.52, P = .004) of team displacement. Multiple linear regression, adjusted for patient factors, showed average team trajectory (adjusted R2 = 0.335; coefficient, 10.51 [95% CI, 8.81-12.21]; P = .004) and team displacement entropy (adjusted R2 = 0.304; coefficient, -12.64 [95% CI, -20.54 to -4.74]; P = .003) were associated with NOTSS scores. Conclusions and Relevance: This study suggests a significant link between OR team movements and nontechnical skills ratings by NOTSS during cardiac surgical procedures, suggesting automated surgical video analysis could enhance nontechnical skills assessment. Further investigation across different hospitals and specialties is necessary to validate these findings.

Performance of left internal thoracic artery-left anterior descending artery anastomosis by residents versus attendings and coronary artery bypass grafting outcomes.

OBJECTIVES: Performance of a technically sound left internal thoracic artery to left anterior descending artery (LITA-LAD) anastomosis during coronary artery bypass grafting (CABG) is critically important. We used prospectively collected data from the multicentre, randomized REGROUP (Randomized Endograft Vein Perspective) trial to investigate CABG outcomes based on whether a resident or an attending surgeon performed the LITA-LAD anastomosis. METHODS: This was a post hoc subanalysis of the REGROUP trial, which randomized veterans undergoing isolated on-pump CABG to endoscopic versus open vein harvest from 2014 through 2017. The primary end point was major cardiac adverse events, defined as the composite of all-cause deaths, nonfatal myocardial infarctions or repeat revascularizations. RESULTS: Among 1,084 patients, 344 (31.8%) LITA-LAD anastomoses were performed by residents and 740 (68.2%), by attending surgeons. Residents (compared to attendings) operated on fewer patients with high tercile SYNTAX scores (22.1% vs 37.4%, P < 0.001), performed fewer multiarterial CABGs (5.2% vs 14.6%, P < 0.001) and performed more anastomoses to distal targets with diameters > 2.0 mm (19.0% vs 10.9%, P < 0.001) and non-calcified landing zones (25.1% vs 21.6%, P < 0.001). During a median observation time of 4.7 years (interquartile range 3.84-5.45), major cardiac adverse events occurred in 77 patients (22.4%) in the group treated by residents and 169 patients (22.8%) in the group treated by attendings (unadjusted HR 1.00; 95% confidence interval, 0.76-1.33; P = 0.99). Outcomes persisted on adjusted analyses. CONCLUSIONS: Based on this REGROUP trial subanalysis, under careful supervision and with appropriate patient selection, LITA-LAD anastomoses performed by the residents yielded clinical outcomes similar to those of the attendings.

Distinguishing Clinical From Statistical Significances in Contemporary Comparative Effectiveness Research.

OBJECTIVE: To determine the prevalence of clinical significance reporting in contemporary comparative effectiveness research (CER). BACKGROUND: In CER, a statistically significant difference between study groups may or may not be clinically significant. Misinterpreting statistically significant results could lead to inappropriate recommendations that increase health care costs and treatment toxicity. METHODS: CER studies from 2022 issues of the Annals of Surgery , Journal of the American Medical Association , Journal of Clinical Oncology , Journal of Surgical Research , and Journal of the American College of Surgeons were systematically reviewed by 2 different investigators. The primary outcome of interest was whether the authors specified what they considered to be a clinically significant difference in the "Methods." RESULTS: Of 307 reviewed studies, 162 were clinical trials and 145 were observational studies. Authors specified what they considered to be a clinically significant difference in 26 studies (8.5%). Clinical significance was defined using clinically validated standards in 25 studies and subjectively in 1 study. Seven studies (2.3%) recommended a change in clinical decision-making, all with primary outcomes achieving statistical significance. Five (71.4%) of these studies did not have clinical significance defined in their methods. In randomized controlled trials with statistically significant results, sample size was inversely correlated with effect size ( r = -0.30, P = 0.038). CONCLUSIONS: In contemporary CER, most authors do not specify what they consider to be a clinically significant difference in study outcome. Most studies recommending a change in clinical decision-making did so based on statistical significance alone, and clinical significance was usually defined with clinically validated standards.

Complete Coronary Revascularization and Outcomes in Patients Who Underwent Coronary Artery Bypass Grafting: Insights from The REGROUP Trial.

There is growing evidence in support of coronary complete revascularization (CR). Nonetheless, there is no universally accepted definition of CR in patients who undergo coronary bypass grafting surgery (CABG). We sought to investigate the outcomes of CR, defined as surgical revascularization of any territory supplied by a suitable coronary artery with ≥50% stenosis. We performed a preplanned subanalysis in the Randomized Trial of Endoscopic or Open Saphenous Vein Graft Harvesting (REGROUP) clinical trial cohort. Of 1,147 patients who underwent CABG, 810 (70.6%) received CR. The primary outcome was a composite of major adverse cardiac events (MACEs), including death from any cause, nonfatal myocardial infarction, or repeat revascularization over a median 4.7 years of follow-up. MACE occurred in 175 patients (21.6%) in the CR group and 86 patients (25.5%) in the incomplete revascularization (IR) group (hazard ratio [HR] 0.87, 95% confidence interval [CI] 0.67 to 1.13, p = 0.29). A total of 97 patients (12.0%) in the CR group and 48 patients (14.2%) in the IR group died (HR 0.93, 95% CI 0.65 to 1.32, p = 0.67); nonfatal myocardial infarction occurred in 49 patients (6.0%) in the CR group and 30 patients (8.9%) in the IR group (HR 0.76, 95% CI 0.48 to 1.2, p = 0.24), and repeat revascularization occurred in 62 patients (7.7%) in the CR group and 39 patients (11.6%) in the IR group (HR 0.64; 95% CI 0.42 to 0.95, p = 0.027). In conclusion, in patients with a great burden of co-morbidities who underwent CABG in the REGROUP trial over a median follow-up period of a median 4.7 years, CR was associated with similar MACE rates but a reduced risk of repeat revascularization. Longer-term follow-up is warranted.

Impact of Oral Anticoagulation on Clinical Outcomes in Postoperative Atrial Fibrillation.

INTRODUCTION: The impact of postoperative oral anticoagulation (OAC) with warfarin on postoperative atrial fibrillation (POAF) after coronary artery bypass grafting (CABG) was the focus of this examination of patients from the randomized endo-vein graft prospective (REGROUP) Trial. MATERIAL AND METHODS: REGROUP was a prospective randomized Veterans Affairs cooperative study comparing endoscopic versus open vein harvest in elective CABG patients (March 2014-April 2017) at 16 Veterans Affairs facilities. This study compared new-onset POAF patients who were treated with warfarin versus no-warfarin. Outcomes included stroke during active follow-up and a major adverse cardiac event composite of mortality, acute myocardial infarction, and repeat revascularization during active and passive follow-up. RESULTS: Of the 316/1103 (28.6%) of REGROUP patients who developed new-onset POAF, 45 patients were excluded - mainly for preoperative warfarin use. Of the remaining 269 patients, 85 received OAC with warfarin (OAC group); 184 did not (no-OAC group). Stroke rates during active follow-up (32 [IQR 24-38] mo) were 3.5% OAC group versus 5.4% no-OAC group (P = 0.76); major adverse cardiac eventrates were 20% OAC versus 11.4% no-OAC (P = 0.06). On longer follow-up of (median 4.61 [IQR 3.9-5.1] y), discharge OAC use was associated with all-cause mortality after adjusting for Society of Thoracic Surgeons mortality risk (20.0% versus 11.4% no-OAC use; HR = 2.00, 95% CI: 1.05-3.81, P = 0.035). CONCLUSIONS: REGROUP patients with POAF treated with OAC had similar stroke and higher mortality rates versus no-OAC patients. Further investigation of the risk-benefit ratio of OAC in post-CABG patients and which POAF patient subgroups might derive the most benefit with anticoagulation appears warranted.

Using Digital Biomarkers for Objective Assessment of Perfusionists' Workload and Acute Stress During Cardiac Surgery.

The cardiac operating room (OR) is a high-risk, high-stakes environment inserted into a complex socio-technical healthcare system. During cardiopulmonary bypass (CPB), the most critical phase of cardiac surgery, the perfusionist has a crucial role within the interprofessional OR team, being responsible for optimizing patient perfusion while coordinating other tasks with the surgeon, anesthesiologist, and nurses. The aim of this study was to investigate objective digital biomarkers of perfusionists' workload and stress derived from heart rate variability (HRV) metrics captured via a wearable physiological sensor in a real cardiac OR. We explored the relationships between several HRV parameters and validated self-report measures of surgical task workload (SURG-TLX) and acute stress (STAI-SF), as well as surgical processes and outcome measures. We found that the frequency-domain HRV parameter HF relative power - FFT (%) presented the strongest association with task workload (correlation coefficient: -0.491, p-value: 0.003). We also found that the time-domain HRV parameter RMSSD (ms) presented the strongest correlation with perfusionists' acute stress (correlation coefficient: -0.489, p-value: 0.005). A few workload and stress biomarkers were also associated with bypass time and patient length of stay in the hospital. The findings from this study will inform future research regarding which HRV-based biomarkers are best suited for the development of cognitive support systems capable of monitoring surgical workload and stress in real time.

An Open-Source, Interoperable Architecture for Generating Real-Time Surgical Team Cognitive Alerts from Heart-Rate Variability Monitoring.

Clinical alarm and decision support systems that lack clinical context may create non-actionable nuisance alarms that are not clinically relevant and can cause distractions during the most difficult moments of a surgery. We present a novel, interoperable, real-time system for adding contextual awareness to clinical systems by monitoring the heart-rate variability (HRV) of clinical team members. We designed an architecture for real-time capture, analysis, and presentation of HRV data from multiple clinicians and implemented this architecture as an application and device interfaces on the open-source OpenICE interoperability platform. In this work, we extend OpenICE with new capabilities to support the needs of the context-aware OR including a modularized data pipeline for simultaneously processing real-time electrocardiographic (ECG) waveforms from multiple clinicians to create estimates of their individual cognitive load. The system is built with standardized interfaces that allow for free interchange of software and hardware components including sensor devices, ECG filtering and beat detection algorithms, HRV metric calculations, and individual and team alerts based on changes in metrics. By integrating contextual cues and team member state into a unified process model, we believe future clinical applications will be able to emulate some of these behaviors to provide context-aware information to improve the safety and quality of surgical interventions.

Public reporting for coronary artery bypass graft surgery: The quest for the optimal scorecard.

OBJECTIVE: A number of publicly available rating algorithms are used to assess hospital performance in coronary artery bypass grafting (CABG). However, concerns remain that these algorithms fail to correlate with each other and inadequately capture the case complexity of individual center practices. METHODS: Composite star ratings for isolated CABG from the Society of Thoracic Surgeons public reporting database were extracted for 2018-2019. U.S. News & World Report Best Hospitals was used to extract CABG ratings as well as overall cardiology and heart surgery ranking, and the Centers for Medicare & Medicaid Services Hospital Compare was used to extract CABG volume and 30-day mortality. Spearman correlation coefficients were used to assess possible relationships. Expert opinion on risk adjustment and program evaluation was incorporated. RESULTS: Correlations between Society of Thoracic Surgeons star rating and U.S. News & World Report overall ranking in cardiology and heart surgery (r = 0.15) and Centers for Medicare & Medicaid Services 30-day mortality (r = -0.27) were poor. Society of Thoracic Surgeons star rating correlated weakly with U.S. News & World Report CABG ratings (r = 0.33) and with Centers for Medicare & Medicaid Services CABG volume (r = 0.32), whereas the latter 2 correlated moderately (r = 0.52) with each other. Of the 75 centers with accredited cardiac surgery training programs, 13 (17%) did not participate in Society of Thoracic Surgeons public reporting. Important gaps were identified in risk assessment, and potential solutions are proposed. CONCLUSIONS: Correlations between current CABG public reporting systems are weak. Further work is needed to refine and standardize CABG rating systems to more adequately capture the scope and complexity of an individual center's clinical practice and to better inform patients.

A Coding Framework for Usability Evaluation of Digital Health Technologies.

Several studies have reported low adherence and high resistance from clinicians to adopt digital health technologies into clinical practice, particularly the use of computer-based clinical decision support systems. Poor usability and lack of integration with the clinical workflow have been identified as primary issues. Few guidelines exist on how to analyze the collected data associated with the usability of digital health technologies. In this study, we aimed to develop a coding framework for the systematic evaluation of users' feedback generated during focus groups and interview sessions with clinicians, underpinned by fundamental usability principles and design components. This codebook also included a coding category to capture the user's clinical role associated with each specific piece of feedback, providing a better understanding of role-specific challenges and perspectives, as well as the level of shared understanding across the multiple clinical roles. Furthermore, a voting system was created to quantitatively inform modifications of the digital system based on usability data. As a use case, we applied this method to an electronic cognitive aid designed to improve coordination and communication in the cardiac operating room, showing that this framework is feasible and useful not only to better understand suboptimal usability aspects, but also to recommend relevant modifications in the design and development of the system from different perspectives, including clinical, technical, and usability teams. The framework described herein may be applied in other highly complex clinical settings, in which digital health systems may play an important role in improving patient care and enhancing patient safety.

Association Between Operating Room Noise and Team Cognitive Workload in Cardiac Surgery.

Excessive intra-operative noise in cardiac surgery has the potential to serve as source of distraction and additional cognitive workload for the surgical team, and may interfere with optimal performance. The separation from bypass phase is a technically complex phase of surgery, making it highly susceptible to communication breakdowns due to high cognitive demands and requiring tightly coupled team coordination. The objective of this study was to investigate team cognitive workload levels and communication in relation to intra-operative time periods representative of infrequent vs. frequent peaks in ambient noise. Compared to 5-minute segments with no peaks in noise at all, segments with the highest percentage of noise peaks (≥10%) were significantly associated with higher team members' heart rate before, during, and after noise segments analyzed. These noisier segments were also associated with a significantly higher level of case-irrelevant communication events. These data suggest that case-irrelevant conversations associated with a greater degree of excessive peaks in noise may be associated with team workload levels, warranting further investigation into efforts to standardize communication during critical surgical phases.

Assessing Team Situational Awareness in the Operating Room via Computer Vision.

Situational awareness (SA) at both individual and team levels, plays a critical role in the operating room (OR). During the pre-incision time-out, the entire OR team comes together to deploy the surgical safety checklist (SSC). Worldwide, the implementation of the SSC has been shown to reduce intraoperative complications and mortality among surgical patients. In this study, we investigated the feasibility of applying computer vision analysis on surgical videos to extract team motion metrics that could differentiate teams with good SA from those with poor SA during the pre-incision time-out. We used a validated observation-based tool to assess SA, and a computer vision software to measure body position and motion patterns in the OR. Our findings showed that it is feasible to extract surgical team motion metrics captured via off-the-shelf OR cameras. Entropy as a measure of the level of team organization was able to distinguish surgical teams with good and poor SA. These findings corroborate existing studies showing that computer vision-based motion metrics have the potential to integrate traditional observation-based performance assessments in the OR.

Costs of Endoscopic vs Open Vein Harvesting for Coronary Artery Bypass Grafting: A Secondary Analysis of the REGROUP Trial.

Importance: Value-based purchasing creates pressure to examine whether newer technologies and care processes, including new surgical techniques, yield any economic advantage. Objective: To compare health care costs and utilization between participants randomized to receive endoscopic vein harvesting (EVH) or open vein harvesting (OVH) during a coronary artery bypass grafting (CABG) procedure. Design, Setting, and Participants: This secondary economic analysis was conducted alongside the 16-site Randomized Endo-Vein Graft Prospective (REGROUP) clinical trial funded by the Department of Veterans Affairs (VA) Cooperative Studies Program. Adults scheduled for urgent or elective bypass involving a vein graft were eligible. The first participant was enrolled in September 2013, with most sites completing enrollment by March 2014. The last participant was enrolled in April 2017. A total of 1150 participants were randomized, with 574 participants receiving OVH and 576 receiving EVH. For this secondary analysis, cost and utilization data were extracted through September 30, 2020. Participants were linked to administrative data in the VA Corporate Data Warehouse and activity-based cost data starting with the index procedure. Interventions: EVH vs OVH, with comparisons based on intention to treat. Main Outcomes and Measures: Discharge costs for the index procedure as well as follow-up costs (including intended and unintended events; mean [SD] follow-up time, 33.0 [19.9] months) were analyzed, with results from different statistical models compared to test for robustness (ie, lack of variation across models). All costs represented care provided or paid by the VA, standardized to 2020 US dollars. Results: Among 1150 participants, the mean (SD) age was 66.4 (6.9) years; most participants (1144 [99.5%] were male. With regard to race and ethnicity, 6 participants (0.5%) self-reported as American Indian or Alaska Native, 10 (0.9%) as Asian or Pacific Islander, 91 (7.9%) as Black, 62 (5.4%) as Hispanic, 974 (84.7%) as non-Hispanic White, and 6 (0.5%) as other race and/or ethnicity; data were missing for 1 participant (0.1%). The unadjusted mean (SD) costs for the index CABG procedure were $76 607 ($43 883) among patients who received EVH and $75 368 ($45 900) among those who received OVH, including facility costs, insurance costs, and physician-related costs (commonly referred to as provider costs in Centers for Medicare and Medicaid and insurance data). No significant differences were found in follow-up costs; per 90-day follow-up period, EVH was associated with a mean (SE) added cost of $302 ($225) per patient. The results were highly robust to the statistical model. Conclusions and Relevance: In this study, EVH was not associated with a reduction in costs for the index CABG procedure or follow-up care. Therefore, the choice to provide EVH may be based on surgeon and patient preferences. Trial Registration: ClinicalTrials.gov Identifier: NCT01850082.