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.

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.

Postoperative Atrial Fibrillation After Surgical Aortic Valve Replacement: Amiodarone and Warfarin Use.

INTRODUCTION: The association between amiodarone treatment for postoperative atrial fibrillation (POAF) after surgical aortic valve replacement (SAVR) and both the return to normal sinus rhythm (NSR) and anticoagulation use at discharge has not been extensively studied. METHODS: We retrospectively identified all patients who underwent biological SAVR with or without concomitant coronary artery bypass grafting (CABG) at a Veterans Affairs Medical Center (2005-2015). We reviewed new-onset POAF, amiodarone use, return to NSR, and anticoagulation use with warfarin. Discharge rhythm and warfarin administration were compared among patients with POAF who were treated with amiodarone and patients who did not receive amiodarone. RESULTS: Of the 395 patients (186 AVR/coronary artery bypass grafting; 209 AVR) studied, POAF developed in 191 patients (48.0%); 80.1% (153/191) of these patients received amiodarone. Among patients treated with amiodarone, 70.6% (108/153) were in SR at the time of discharge versus 65.8% (25/38) of POAF patients who were not treated with amiodarone (P = 0.57). Among amiodarone-treated patients, 30.7% (47/153) were discharged with warfarin; among patients not treated with amiodarone, 31.6% (12/38) were discharged with warfarin (P = 0.92). Among amiodarone-treated patients discharged in NSR, 89.9% (97/108 patients) were not discharged with warfarin; among patients not treated with amiodarone who were discharged in NSR, 92% (23/25) were not discharged with warfarin (P = 0.74). CONCLUSIONS: POAF after SAVR appears common. Although amiodarone is often used for POAF patients, its use does not appear to be associated with surgeons' decision to anticoagulate patients. Surgeons' preferences for using rhythm control and antithrombotic therapy for POAF after SAVR warrant further exploration.

Randomized Trial of Endoscopic or Open Vein-Graft Harvesting for Coronary-Artery Bypass.

BACKGROUND: The saphenous-vein graft is the most common conduit for coronary-artery bypass grafting (CABG). The influence of the vein-graft harvesting technique on long-term clinical outcomes has not been well characterized. METHODS: We randomly assigned patients undergoing CABG at 16 Veterans Affairs cardiac surgery centers to either open or endoscopic vein-graft harvesting. The primary outcome was a composite of major adverse cardiac events, including death from any cause, nonfatal myocardial infarction, and repeat revascularization. Leg-wound complications were also evaluated. RESULTS: A total of 1150 patients underwent randomization. Over a median follow-up of 2.78 years, the primary outcome occurred in 89 patients (15.5%) in the open-harvest group and 80 patients (13.9%) in the endoscopic-harvest group (hazard ratio, 1.12; 95% confidence interval [CI], 0.83 to 1.51; P=0.47). A total of 46 patients (8.0%) in the open-harvest group and 37 patients (6.4%) in the endoscopic-harvest group died (hazard ratio, 1.25; 95% CI, 0.81 to 1.92); myocardial infarctions occurred in 34 patients (5.9%) in the open-harvest group and 27 patients (4.7%) in the endoscopic-harvest group (hazard ratio, 1.27; 95% CI, 0.77 to 2.11), and revascularization occurred in 35 patients (6.1%) in the open-harvest group and 31 patients (5.4%) in the endoscopic-harvest group (hazard ratio, 1.14; 95% CI, 0.70 to 1.85). Leg-wound infections occurred in 18 patients (3.1%) in the open-harvest group and in 8 patients (1.4%) in the endoscopic-harvest group (relative risk, 2.26; 95% CI, 0.99 to 5.15). CONCLUSIONS: Among patients undergoing CABG, we did not find a significant difference between open vein-graft harvesting and endoscopic vein-graft harvesting in the risk of major adverse cardiac events. (Funded by the Cooperative Studies Program, Office of Research and Development, Department of Veterans Affairs; REGROUP ClinicalTrials.gov number, NCT01850082 .).

Health-related quality of life impacts upon 5-year survival after coronary artery bypass surgery.

BACKGROUND: Poor preoperative health-related quality of life (HRQoL) has been associated with reduced short-term survival after coronary artery bypass graft (CABG) surgery; however, its impact on long-term mortality is unknown. This study's objective was to determine if baseline HRQoL status predicts 5-year post-CABG mortality. METHODS: This prespecified, randomized on/off bypass follow-up study (ROOBY-FS) subanalysis compared baseline patient characteristics and HRQoL scores, obtained from the Seattle Angina Questionnaire (SAQ) and Veterans RAND Short Form-36 (VR-36), between 5-year post-CABG survivors and nonsurvivors. Standardized subscores were calculated for each questionnaire. Multivariable logistic regression assessed whether HRQoL survey subcomponents independently predicted 5-year mortality (p ≤ .05). RESULTS: Of the 2203 ROOBY-FS enrollees, 2104 (95.5%) completed baseline surveys. Significant differences between 5-year post-CABG deaths (n = 286) and survivors (n = 1818) included age, history of chronic obstructive pulmonary disease, stroke, peripheral vascular disease, renal dysfunction, diabetes, lower left ventricular ejection fraction, atrial fibrillation, depression, non-White race/ethnicity, lower education status, and off-pump CABG. Adjusting for these factors, baseline VR-36 physical component summary score (p = .01), VR-36 mental component summary score (p < .001), and SAQ physical limitation score (p = .003) were all associated with 5-year all-cause mortality. CONCLUSIONS: Pre-CABG HRQoL scores may provide clinically relevant prognostic information beyond traditional risk models and prove useful for patient-provider shared decision-making and enhancing pre-CABG informed consent.

Analysis of Dynamic Changes in Cognitive Workload During Cardiac Surgery Perfusionists' Interactions With the Cardiopulmonary Bypass Pump.

OBJECTIVE: This novel preliminary study sought to capture dynamic changes in heart rate variability (HRV) as a proxy for cognitive workload among perfusionists while operating the cardiopulmonary bypass (CPB) pump during real-life cardiac surgery. BACKGROUND: Estimations of operators' cognitive workload states in naturalistic settings have been derived using noninvasive psychophysiological measures. Effective CPB pump operation by perfusionists is critical in maintaining the patient's homeostasis during open-heart surgery. Investigation into dynamic cognitive workload fluctuations, and their relationship with performance, is lacking in the literature. METHOD: HRV and self-reported cognitive workload were collected from three Board-certified cardiac perfusionists (N = 23 cases). Five HRV components were analyzed in consecutive nonoverlapping 1-min windows from skin incision through sternal closure. Cases were annotated according to predetermined phases: prebypass, three phases during bypass, and postbypass. Values from all 1min time windows within each phase were averaged. RESULTS: Cognitive workload was at its highest during the time between initiating bypass and clamping the aorta (preclamp phase during bypass), and decreased over the course of the bypass period. CONCLUSION: We identified dynamic, temporal fluctuations in HRV among perfusionists during cardiac surgery corresponding to subjective reports of cognitive workload. Not only does cognitive workload differ for perfusionists during bypass compared with pre- and postbypass phases, but differences in HRV were also detected within the three bypass phases. APPLICATION: These preliminary findings suggest the preclamp phase of CPB pump interaction corresponds to higher cognitive workload, which may point to an area warranting further exploration using passive measurement.

Five-Year Outcomes after On-Pump and Off-Pump Coronary-Artery Bypass.

BACKGROUND: Coronary-artery bypass grafting (CABG) surgery may be performed either with cardiopulmonary bypass (on pump) or without cardiopulmonary bypass (off pump). We report the 5-year clinical outcomes in patients who had been included in the Veterans Affairs trial of on-pump versus off-pump CABG. METHODS: From February 2002 through June 2007, we randomly assigned 2203 patients at 18 medical centers to undergo either on-pump or off-pump CABG, with 1-year assessments completed by May 2008. The two primary 5-year outcomes were death from any cause and a composite outcome of major adverse cardiovascular events, defined as death from any cause, repeat revascularization (CABG or percutaneous coronary intervention), or nonfatal myocardial infarction. Secondary 5-year outcomes included death from cardiac causes, repeat revascularization, and nonfatal myocardial infarction. Primary outcomes were assessed at a P value of 0.05 or less, and secondary outcomes at a P value of 0.01 or less. RESULTS: The rate of death at 5 years was 15.2% in the off-pump group versus 11.9% in the on-pump group (relative risk, 1.28; 95% confidence interval [CI], 1.03 to 1.58; P=0.02). The rate of major adverse cardiovascular events at 5 years was 31.0% in the off-pump group versus 27.1% in the on-pump group (relative risk, 1.14; 95% CI, 1.00 to 1.30; P=0.046). For the 5-year secondary outcomes, no significant differences were observed: for nonfatal myocardial infarction, the rate was 12.1% in the off-pump group and 9.6% in the on-pump group (P=0.05); for death from cardiac causes, the rate was 6.3% and 5.3%, respectively (P=0.29); for repeat revascularization, the rate was 13.1% and 11.9%, respectively (P=0.39); and for repeat CABG, the rate was 1.4% and 0.5%, respectively (P=0.02). CONCLUSIONS: In this randomized trial, off-pump CABG led to lower rates of 5-year survival and event-free survival than on-pump CABG. (Funded by the Department of Veterans Affairs Office of Research and Development Cooperative Studies Program and others; ROOBY-FS ClinicalTrials.gov number, NCT01924442 .).

Epiaortic Ultrasound for Assessment of Intraluminal Atheroma; Insights from the REGROUP Trial.

OBJECTIVES: To assess the use of epiaortic ultrasound in contemporary cardiac surgery, as well as its impact on surgical cannulation strategy and cerebrovascular events. DESIGN: Epiaortic ultrasound data was prospectively collected in the Randomized Endovein Graft Prospective (REGROUP) trial (VA Cooperative Studies Program #588, ClinicalTrials.gov, NCT01850082), which randomized 1,150 coronary artery bypass graft patients between 2014 and 2017 to endoscopic or open-vein graft harvest. SETTING: Sixteen cardiac surgery programs within the Veterans Affairs Healthcare System with expertise at performing endoscopic vein-graft harvesting. PARTICIPANTS: Veterans Affairs patients, greater than 18 years of age, undergoing elective or urgent coronary artery bypass grafting with cardiopulmonary bypass and cardioplegic arrest with at least one planned saphenous vein graft were eligible for enrollment. INTERVENTIONS: Epiaortic ultrasound was performed by the surgeon using a high frequency (>7 MHz) ultrasound transducer. Two-dimensional images of the ascending aorta in multiple planes were acquired before aortic cannulation and cross-clamping. MEASUREMENTS AND MAIN RESULTS: Epiaortic ultrasound was performed in 34.1% (269 of 790) of patients in REGROUP. Among these patients, simple intraluminal atheroma was observed in 21.9% (59 269), and complex intraluminal atheroma comprised 2.2% (6 of 269). The aortic cannulation or cross-clamp strategy was modified based on these findings in 7.1% of cases (19 of 269). There was no difference in stroke between patients who underwent epiaortic ultrasound and those who did not (1.9% v 1.2% p = 0.523). CONCLUSIONS: Despite current guidelines recommending routine use of epiaortic ultrasound (IIa/B) to reduce the risk of stroke in cardiac surgery, in this contemporary trial, use remains infrequent, with significant site-to-site variability.

Preoperative factors associated with worsening in health-related quality of life following coronary artery bypass grafting in the Randomized On/Off Bypass (ROOBY) trial.

For advanced coronary disease, coronary artery bypass graft (CABG) surgery generally improves patients' symptoms and long-term survival. Unfortunately, some patients experience worse health-related quality of life (HRQL) after CABG. The objective of this study is to report the frequency and risk factors associated with 1-year post-CABG HRQL deterioration. METHODS: From 2002 to 2007, 2203 "Randomized On/Off Bypass" (ROOBY) trial patients randomly received either off-pump or on-pump CABG at 18 VA medical centers. Subjects completed both baseline and 1-year Seattle Angina Questionnaire (SAQ) and the Veterans Rand 36 (VR-36) questionnaires to assess HRQL. Using previously published criteria, the rates of clinically significant changes were determined for the SAQ [angina frequency (AF), physical limitation (PL), and quality of life (QoL)] and VR36 [mental component score (MCS) and physical component score (PCS)] subscales. Multivariate regression models were then used to identify pre-CABG patient characteristics associated with worsened 1-year HRQL status for each subscale. RESULTS: Over 80% of patients had an improvement or no change in SAQ and VR-36 subscale scores 1 year after CABG. The HRQL scale-specific deterioration rates were 4.5% SAQ-AF, 16.8% SAQ-PL, 4.9% SAQ-QoL, 19.4% VR36-MCS, and 13.5% VR36-PCS. Predictors of 1-year HRQL deterioration were diabetes and smoking for the SAQ-AF; diabetes, chronic obstructive pulmonary disease (COPD), and peripheral vascular disease (PVD) for SAQ-PL; COPD and depression for the SAQ-QoL; diabetes for VR36-PCS, and history of stroke and depression for VR36-MCS. The baseline score was an independent predictor for worsening in all the subscales studied. CONCLUSIONS: Among VA patients, less than 20% experienced worse HRQL 1 year after CABG. For patients with low symptom burden at baseline, diabetes, smoking, depression, PVD, COPD, and a prior stroke, clinicians should be more cautious in pre-CABG counseling as to their anticipated HRQL improvements.

Concordance between administrative data and clinical review for mortality in the randomized on/off bypass follow-up study (ROOBY-FS).

BACKGROUND: The optimal methodology to identify cardiac versus non-cardiac cause of death following cardiac surgery has not been determined. METHODS: The Randomized On/Off Bypass Trial was a multicenter, randomized, controlled clinical trial of 2203 patients (February 2002-May 2008) comparing 1-year cardiac outcomes between off-pump and on-pump bypass surgery. In 2013, the Veterans Affairs (VA) Cooperative Studies Program funded a follow-up study to assess 5-year outcomes including mortality. Deaths were identified and confirmed using the National Death Index (NDI), VA Vital Status file, and medical records. An Endpoints Committee (EC) reviewed patient medical records and classified each cause of death as cardiac, non-cardiac, or unknown. Using pre-determined ICD-10 codes, NDI death certificates were independently used to classify deaths as cardiac or non-cardiac. Cause of death was compared between the NDI and EC classifications and concordance measured, using Kappa statistics. RESULTS: Of the 297 5-year deaths identified by the NDI and/or VA vital status file and confirmed by the EC, 219 had adequate patient records for EC cause of death determination. The EC adjudicated 141 of these deaths as non-cardiac and 78 as cardiac, while the NDI classified 150 as non-cardiac and 69 as cardiac; agreement was 77.6% (kappa 0.500; P < 0.001). CONCLUSIONS: Since concordance between EC and NDI cause of death classifications was only moderate, caution should be exercised in relying exclusively on NDI data to determine cause of death. A hybrid approach, integrating multiple information sources, may provide the most accurate approach to classifying cause of death.

Travel distance and outcomes after surgical aortic valve among veterans.

OBJECTIVE: To investigate the association between travel distance and postoperative length of stay (LOS) and discharge disposition among veterans undergoing surgical aortic valve replacement (SAVR). DATA SOURCES/STUDY SETTING: We performed a retrospective cohort study of patients undergoing SAVR, with or without coronary artery bypass grafting (CABG) at VA Boston Healthcare (January 1, 2005-December 31, 2015). STUDY DESIGN: Postoperative LOS and discharge disposition were compared for SAVR patients based on travel distance to the facility: <100 miles or ≥100 miles. Multivariable regression was performed to ascertain factors associated with LOS and home discharge. DATA COLLECTION/EXTRACTION METHODS: Data were collected via chart review. All patients undergoing SAVR at our institution who primarily resided within the defined region were included. PRINCIPAL FINDINGS: Of 597 patients studied, 327 patients underwent isolated SAVR; 270 patients underwent SAVR/CABG. Overall median (IQR) distance between the patient's residence and the hospital was 49.95 miles (27.41-129.94 miles); 190 patients (32%) resided further than 100 miles away. There were no differences in the proportion of patients with diabetes, hypertension, chronic obstructive pulmonary disease (COPD), cerebrovascular disease, atrial fibrillation, or prior myocardial infarction between groups. Overall LOS (IQR) was 9 (7-13) days and did not differ between groups (p = 0.18). The proportion of patients discharged home was higher among patients who resided more than 100 miles from the hospital (71% vs. 58%, p = 0.01). On multivariable analysis, residing further than 100 miles from the hospital was independently associated with home discharge (OR = 1.64, 95% CI: 1.09-2.48). Travel distance was not associated with LOS. CONCLUSIONS: Based on our institutional experience, potential concerns of longer hospital stay or discharge to other inpatient facilities for geographically distanced patients undergoing SAVR do not appear supported. Continued examination of the drivers underlying the marked shift of veterans to the private sector appears warranted.

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.

Ten-Year Outcomes of Off-Pump vs On-Pump Coronary Artery Bypass Grafting in the Department of Veterans Affairs: A Randomized Clinical Trial.

IMPORTANCE: The long-term benefits of off-pump ("beating heart") vs on-pump coronary artery bypass grafting (CABG) remain controversial. OBJECTIVE: To evaluate the 10-year outcomes and costs of off-pump vs on-pump CABG in the Department of Veterans Affairs (VA) Randomized On/Off Bypass (ROOBY) trial. DESIGN, SETTING, AND PARTICIPANTS: From February 27, 2002, to May 7, 2007, 2203 veterans in the ROOBY trial were randomly assigned to off-pump or on-pump CABG procedures at 18 participating VA medical centers. Per protocol, the veterans were observed for 10 years; the 10-year, post-CABG clinical outcomes and costs were assessed via centralized abstraction of electronic medical records combined with merges to VA and non-VA databases. With the use of an intention-to-treat approach, analyses were performed from May 7, 2017, to December 9, 2021. INTERVENTIONS: On-pump and off-pump CABG procedures. MAIN OUTCOMES AND MEASURES: The 10-year coprimary end points included all-cause death and a composite end point identifying patients who had died or had undergone subsequent revascularization (ie, percutaneous coronary intervention [PCI] or repeated CABG); these 2 end points were measured dichotomously and as time-to-event variables (ie, time to death and time to composite end points). Secondary 10-year end points included PCIs, repeated CABG procedures, changes in cardiac symptoms, and 2018-adjusted VA estimated costs. Changes from baseline to 10 years in post-CABG, clinically relevant cardiac symptoms were evaluated for New York Heart Association functional class, Canadian Cardiovascular Society angina class, and atrial fibrillation. Outcome differences were adjudicated by an end points committee. Given that pre-CABG risks were balanced, the protocol-driven primary and secondary hypotheses directly compared 10-year treatment-related effects. RESULTS: A total of 1104 patients (1097 men [99.4%]; mean [SD] age, 63.0 [8.5] years) were enrolled in the off-pump group, and 1099 patients (1092 men [99.5%]; mean [SD] age, 62.5 [8.5] years) were enrolled in the on-pump group. The 10-year death rates were 34.2% (n = 378) for the off-pump group and 31.1% (n = 342) for the on-pump group (relative risk, 1.05; 95% CI, 0.99-1.11; P = .12). The median time to composite end point for the off-pump group (4.6 years; IQR, 1.4-7.5 years) was approximately 4.3 months shorter than that for the on-pump group (5.0 years; IQR, 1.8-7.9 years; P = .03). No significant 10-year treatment-related differences were documented for any other primary or secondary end points. After the removal of conversions, sensitivity analyses reconfirmed these findings. CONCLUSIONS AND RELEVANCE: No off-pump CABG advantages were found for 10-year death or revascularization end points; the time to composite end point was lower in the off-pump group than in the on-pump group. For veterans, in the absence of on-pump contraindications, a case cannot be made for supplanting the traditional on-pump CABG technique with an off-pump approach. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01924442.

Coronary Artery Bypass Grafting Transit Time Flow Measurement: Graft Patency and Clinical Outcomes.

BACKGROUND: This subanalysis of the Randomized On-Off Bypass (ROOBY) trial examined transit time flow measurement (TTFM) use and its impact on graft patency and long-term clinical outcomes after coronary artery bypass graft surgery. METHODS: Use of TTFM for ROOBY centers and surgeons was assessed. Comparative patient outcomes based on TTFM use included 1-year graft patency and 1-year and 5-year major adverse cardiac events: all-cause mortality, nonfatal myocardial infarction, and revascularization (percutaneous coronary intervention or repeat coronary artery bypass graft surgery). RESULTS: Transit time flow measurement was used in 1067 patients (TTFM group) and not used in 501 patients (non-TTFM group); of the TTFM group, median percentage TTFM use was 79% (interquartile range, 41% to 98%) among 18 Veterans Affairs Medical Centers, and 74% (interquartile range, 13% to 98%) among 48 surgeons. Patients were comparable in age (63 ± 8.5 years TTFM vs 62 ± 8 years non-TTFM, P = .30) and estimated 30-day mortality risk (1.8 ± 1.7 TTFM vs 1.9 non-TTFM, P = .53). One-year FitzGibbon A patency was 83% (1600 of 1988 grafts) for TTFM assessed grafts and 78% (629 of 803) for non-TTFM assessed grafts (P < .01). Fewer TTFM patients had an occluded graft (29%, vs 38% non-TTFM; P = .01). Comparing TTFM patients with non-TTFM patients, 5-year major adverse cardiac event rates were 30% vs 25% (P = .06). Individual component rates were 14% vs 11% for death (P = .06), 12% vs 8.8% for myocardial infarction (P = .07), and 13% vs 12% for revascularization (P = .62). CONCLUSIONS: The association of TTFM use with graft patency and clinical outcome is uncertain. Future randomized studies that account for patient risk factors and practice variation would help address this knowledge gap.

New-onset postoperative atrial fibrillation impact on 5-year clinical outcomes and costs.

OBJECTIVE: The impact of new-onset postoperative atrial fibrillation (POAF) following coronary artery bypass grafting (CABG) surgery on long-term clinical outcomes and costs is not known. This subanalysis of the Veterans Affairs "Randomized On/Off Bypass Follow-up Study" compared 5-year outcomes and costs between patients with and without POAF. METHODS: Of the 2203 veterans in the study, 100 with pre-CABG atrial fibrillation (93) or missing data (7) were excluded (4.8%). Unadjusted and risk-adjusted outcomes were compared between new-onset POAF (n = 551) and patients without POAF (n = 1552). Five-year clinical outcomes included mortality, major adverse cardiovascular events (MACE, comprising mortality, repeat revascularization, and myocardial infarction), MACE subcomponents, stroke, and costs. A stringent P value of ≤.01 was required to identify statistical significance. RESULTS: Patients with POAF were older and had more complex comorbidities. Unadjusted 5-year all-cause mortality was 16.3% POAF versus 11.9% no-POAF, P = .008. Unadjusted cardiac-mortality was 7.4% versus 4.8%, P = .022. There were no differences between groups in any other unadjusted outcomes including MACE or stroke. After risk adjustment, there were no significant differences between groups in 5-year all-cause mortality (POAF odds ratio, 1.19; 99% confidence interval, 0.81-1.75) or cardiac mortality (odds ratio, 1.51, 99% confidence interval, 0.88-2.60). Adjusted first-year post-CABG costs were $15,300 greater for patients with POAF, but 2- through 5-year costs were similar. CONCLUSIONS: No 5-year risk-adjusted outcome differences were found between patients with and without POAF after CABG. Although first-year costs were greater in patients with POAF, this difference did not persist in subsequent years.

Incidence and Prognostic Impact of Incomplete Revascularization Documented by Coronary Angiography 1 Year After Coronary Artery Bypass Grafting.

Complete revascularization (CR) at the time of coronary artery bypass graft (CABG) surgery improves long-term cardiac outcomes. No studies have previously reported angiographically confirmed CR rates post-CABG. This study's aim was to assess the impact upon long-term outcomes of CR versus incomplete revascularization (IR), confirmed by coronary angiography 1 year after CABG. Randomized On/Off Bypass Study patients who returned for protocol-specified 1-year post-CABG coronary angiograms were included. Patients with a widely patent graft supplying the major diseased artery within each diseased coronary territory were considered to have CR. Outcomes were all-cause mortality and major adverse cardiovascular events (MACE; all-cause mortality, nonfatal myocardial infarction, repeat revascularization) over the 4 years after angiography. Of the 1,276 patients, 756 (59%) had CR and 520 (41%) had IR. MACE was 13% CR versus 26% IR, p <0.001. This difference was driven by fewer repeat revascularizations (5% CR vs 18% IR; p <0.001). There were no differences in mortality (7.1% CR vs 8.1% IR, p = 0.13) or myocardial infarction (4% in both). Adjusted multivariable models confirmed CR was associated with reduced MACE (odds ratio 0.44, 95% confidence interval 0.33 to 0.58, p <0.01), but had no impact on mortality. In conclusion, CR confirmed by post-CABG angiography was associated with improved MACE but not mortality. Repeat revascularization of patients with IR, driven by knowledge of the research angiography results, may have ameliorated potential mortality differences.

Clinical and Angiographic Predictors of Patient-Reported Angina 1 Year After Coronary Artery Bypass Graft Surgery.

BACKGROUND: Studies of the relationship between patient self-reported angina symptoms using the Seattle Angina Questionnaire (SAQ) and angiographic findings after coronary artery bypass grafting surgery (CABG) are lacking. Nested within a randomized controlled trial, this prospective observational cohort comparison study aimed to assess which clinical characteristics and angiographic findings are associated with self-reported angina 1 year after CABG. METHODS AND RESULTS: Patients from the ROOBY trial (Randomized On/Off Bypass) with protocol-specified 1-year post-CABG coronary angiography and SAQ assessments were included (n=1258). Patients reporting no angina (62.3%) within 4 weeks before the 1-year post-CABG study visit on the SAQ angina frequency domain were compared with patients reporting angina (37.7%). Multivariable modeling identified clinical variables and angiographic findings associated with angina. Sequential univariate and multivariable modeling found the following demographic and clinical factors were associated with angina after CABG: younger age, worse preoperative SAQ angina frequency score, smoking, diabetes mellitus, and pre-CABG depression. The only 1-year angiographic finding significantly associated with angina was incomplete revascularization of the left anterior descending (LAD) territory. Graft occlusions, incomplete revascularization of non-LAD territories, and ≥70% lesions in nonrevascularized native coronary arteries were not correlated with the presence or absence of angina. Further, only 30.6% of subjects reporting angina at 1 year had a residual major coronary artery stenosis of ≥70%. CONCLUSIONS: Self-reported angina 1 year after CABG is associated with younger age, worse baseline SAQ angina frequency score, smoking, diabetes mellitus, and depression. The only angiographic finding associated with angina was a poorly revascularized LAD territory. These results may help guide physicians when counseling patients on expected improvements in angina symptoms and in making decisions regarding the need for coronary angiography after CABG. Whether intensive treatment of these comorbidities improves post-CABG angina symptoms requires further study. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00032630.

Off-Pump Versus On-Pump Impact: Diabetic Patient 5-Year Coronary Artery Bypass Clinical Outcomes.

BACKGROUND: For diabetic patients who require coronary artery bypass graft (CABG) operation, controversy persists whether an off-pump or an on-pump approach may be advantageous. This US-based, multicenter, randomized, controlled trial, Department of Veterans Affairs Randomization On versus Off Bypass Follow-up Study, compared diabetic patients' 5-year clinical outcomes for off-pump versus on-pump procedures. METHODS: From 2002 to 2008, 835 medically treated (ie, oral hypoglycemic agent or insulin) diabetic patients underwent either off-pump (n = 402) or on-pump (n = 433) CABG. Five-year primary end points included all-cause death and major adverse cardiovascular events (MACE; composite included all-cause death, myocardial infarction, or repeat revascularization). Secondary 5-year end points included cardiac death and MACE-related components. With baseline risk factors balanced, outcomes were evaluated by using a p value less than or equal to 0.01; nonsignificant trends were reported for p values greater than 0.01 and less than or equal to 0.15. RESULTS: Five-year all-cause death rates were 20.2% off pump versus 14.1% on pump (p = 0.0198). No differences were seen in MACE (32.6% off-pump approach versus 28.6% on-pump approach, p = 0.216), repeat revascularization (12.4% off-pump approach versus 11.8% on-pump approach, p = 0.770), and nonfatal myocardial infarction (12.7% off-pump approach versus 10.4% on-pump approach, p = 0.299). Cardiac death trended worse with off-pump CABG (9.0%) than with on-pump CABG (6.25%, p = 0.137). Sensitivity analyses that removed conversions confirmed these findings. CONCLUSIONS: With a 6.1% absolute difference, a strong trend toward improved 5-year survival was observed with on-pump CABG for medically treated diabetic patients. No off-pump advantage was found for any 5-year end points. A future clinical trial now appears warranted to rigorously compare off-pump versus on-pump longer term outcomes for diabetic patients.

Costs Five Years After Off-Pump or On-Pump Coronary Artery Bypass Surgery.

BACKGROUND: Coronary artery bypass grafting (CABG) is a common surgical treatment for ischemic heart disease. Little is known about the long-term costs of conducting the surgery on-pump or off-pump. METHODS: As part of the Randomized On/Off Bypass follow-up study, we followed 2,203 participants randomized to on-pump (n = 1,099) and off-pump (n = 1,104) CABG for 5 years using Department of Veterans Affairs and Medicare administrative data. We examined annual costs through 5 years, standardized to 2016 dollars, using multivariate regression models, controlling for site and baseline patient factors. RESULTS: In the first year, including the CABG surgery, annual average costs were $66,599 (SE, $1,946) for the on-pump group and $70,552 (SE, $1,954) for the off-pump group. In years 2 to 5, average costs ranged from $15,000 to $20,000 per year. There was no significant difference between on-pump and off-pump across the 5 years. We explored differences among high-risk subgroups (diabetes, chronic obstructive pulmonary disease, peripheral vascular disease, cerebrovascular disease, renal dysfunction, ejection fraction < 35%, over age 70 years), and found no treatment assignment by time interactions, except for a nonsignificant trend in patients with diabetes. CONCLUSIONS: At 5 years, the average costs of off-pump and on-pump CABG patients did not statistically differ. Costs do not favor one approach and the decision should be based on clinical risks, especially in subgroups. Future research is warranted to examine post-CABG costs and outcomes for diabetic patients over time.

Antithrombotic Strategies After Bioprosthetic Aortic Valve Replacement: A Systematic Review.

BACKGROUND: The optimal antithrombotic regimen after bioprosthetic aortic valve replacement (bAVR) is unclear. We conducted a systematic review of various anticoagulation strategies following surgical or transcatheter bAVR (TAVR). METHODS: We searched Medline, PubMed, Embase, Evidence-Based Medicine Reviews, and gray literature through June 2017 for controlled clinical trials and cohort studies that directly compared different antithrombotic strategies in nonpregnant adults who had undergone bAVR. We assessed risk of bias and graded the strength of the evidence using established methods. RESULTS: Of 4,554 titles reviewed, 6 clinical trials and 13 cohort studies met inclusion criteria. We found moderate-strength evidence that mortality, thromboembolic events, and bleeding rates are similar between aspirin and warfarin after surgical bAVR. Observational data suggest lower mortality and thromboembolic events with aspirin combined with warfarin compared with aspirin alone after surgical bAVR, but the effect size is small and the combination is associated with a substantial increase in bleeding risk. We found insufficient evidence for all other treatment comparisons in surgical bAVR. In TAVR patients, we found moderate-strength evidence that mortality, stroke, and major cardiac events are similar between dual antiplatelet therapy and aspirin alone, though a nonsignificantly lower rate of bleeding occurred with aspirin alone. CONCLUSIONS: Treatment with warfarin or aspirin leads to similar outcomes after surgical bAVR. Combining aspirin with warfarin may lead to a small decrease in thromboembolism and mortality, but is accompanied by increased bleeding. For TAVR patients, aspirin is equivalent to dual antiplatelet therapy for reducing thromboembolism and mortality, with a possible decrease in bleeding.