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.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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.
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.
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.
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.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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.
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).
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).
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.
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Background Observational studies have documented an off-pump over on-pump advantage for high-risk patients, including diabetic patients. Randomized trials have not confirmed this advantage. The VA ...Randomization On Versus Off Bypass (ROOBY) trial randomly assigned 2,203 coronary artery bypass graft surgery (CABG) patients at 18 sites to either on-pump (n = 1,099) or off-pump (n = 1,104) procedures. An a priori ROOBY aim was to evaluate treatment impact on diabetic patients. Methods Actively treated diabetic patients (n = 835, receiving oral hypoglycemic or insulin medications) received off-pump CABG (n = 402) or on-pump CABG (n = 433). The primary ROOBY trial endpoints were a short-term composite (30-day operative death or major complications) and a 1-year composite (death, nonfatal acute myocardial infarction, or repeat revascularization). Secondary ROOBY endpoints included 1-year all-cause death, 1-year graft patency, 1-year changes from baseline in neurocognitive status and health-related quality of life, and costs. Results Diabetic patients' risk factors at baseline were balanced across treatments. For diabetic patients, the primary short-term composite outcome rate showed a worse trend for off-pump (8.0%) than on-pump (3.9%, p = 0.013), with no difference in the 1-year primary composite outcome or 1-year death rate. One-year patency was 83.1% off-pump versus 88.4% on-pump ( p = 0.004). No differences were found in neurocognitive, health-related quality of life, discharge cost, and 1-year cumulative cost. Conclusions Concordant with the ROOBY trial's overall findings, off-pump CABG yielded no advantage over on-pump CABG for actively treated diabetic patients. The 1-year graft patency was lower and the short-term composite trended higher for off-pump CABG, with no other significant outcome or cost differences.
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.
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.
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.
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.
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.
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.
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.
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.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
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.
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BFBNIB, DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, UILJ, UKNU, UL, UM, UPUK
Abstract Objective Controversy exists regarding ideal approaches in teaching residents complex and/or new surgical techniques in part because consequences on patient outcomes are largely unknown. ...This study compared patient outcomes for cases in which residents (rather than attending surgeons) performed most of the distal anastomoses as primary surgeons, during on- and off-pump coronary artery bypass grafting (CABG). Methods This preapproved substudy of the Randomized On/Off Bypass (ROOBY) trial compared clinical outcomes and 1-year graft patency for cases in which residents versus attending surgeons were the primary operator. Comparisons were made between on-pump and off-pump techniques. Results From July 2003 through May 2007, a total of 1272 ROOBY nonemergent CABG patients were randomized at 16 Veterans Affairs centers where residents were active participants. Residents were the primary surgeon (ie, performed ≥50% of the distal anastomoses) more frequently in on-pump (77.9%) than in off-pump (67.4%) cases. Between these 2 techniques, no were found differences in baseline patient characteristics; short-term and 1-year morbidity and mortality rates were no different for residents versus attendings in CABG cases. FitzGibbon A graft patency rates were similar for resident versus attendings completed distal anastomoses for on-pump (83.0% vs 82.4%) compared with off-pump (77.2% vs 76.6%) procedures. Conclusions In the ROOBY trial, short-term and 1-year patient outcomes and graft patency rates did not differ between resident and attending surgeons, demonstrating that with appropriate patient selection and resident supervision, residents can perform advanced, novel surgical techniques with outcomes similar to those of attending surgeons.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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.
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NUK, OILJ, SAZU, UKNU, UL, UM, UPUK
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).
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.
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.
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.
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