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A review of the recent randomized control trial evidence of the use of recombinant factor VIIa (rFVIIa) in massive bleeding. rFVIIa is a recombinant genetically engineered clotting factor that has been used for the management of haemophilia patients with inhibitors. There has been increasing use in patients with massive bleeding, even when there is no underlying coagulation disorder present. In November 2006, the Canadian National Advisory Committee on Blood and Blood Products engaged in a consultation and review process with several leading Canadian experts to review and discuss the current evidence up to November 2006. There is little evidence to support the routine use of rFVIIa in massive bleeding on review of 13 randomized controlled trials. rFVIIa should only be considered as part of a transfusion policy framework for massive bleeding after all other transfusion and supportive measures are considered. An example of a policy framework is presented. [ABSTRACT FROM AUTHOR]

Background: Differences in quality of life (QoL) after coronary artery bypass grafting (CABG) compared with percutaneous coronary intervention (PCI) are not well characterized. We aimed to compare the short- and long-term effects of CABG versus PCI on QoL., Methods and Results: We performed a systematic review and meta-analysis of randomized controlled trials comparing CABG versus PCI using the Seattle Angina Questionnaire (SAQ)-Angina Frequency, SAQ-QoL, SAQ-Physical Limitations, EuroQoL-5D, and Short-Form Questionnaire. We calculated mean changes within each group from baseline to 1, 6, 12, and 36 to 60 months (latest follow-up) and the weighted mean differences between groups using inverse-variance methods. A total of 10 760 patients were enrolled in 5 trials. From baseline to 12 months and 36 to 60 months, the mean change in SAQ-Angina Frequency was >22 points (95% CI, 21.0-25.6) after both PCI and CABG. The mean difference in SAQ-Angina Frequency was similar between procedures at 1 month and at 36 to 60 months but favored CABG at 12 months (1.97 [95% CI, 0.68-3.26]). SAQ-QoL favored PCI at 1 month (-2.92 [95% CI, -4.66 to -1.18]) and CABG at 6 (2.50 [95% CI, 1.02-3.97]), 12 (3.30 [95% CI, 1.78-4.82]), and 36 to 60 months (3.17 [95% CI, 0.54 5.80). SAQ-Physical Limitations (-12.61 [95% CI, -16.16 to -9.06]) and EuroQoL-5D (-0.07 [95% CI, -0.08 to -0.07) favored PCI at 1 month. Short-Form Questionnaire-Physical Component favored CABG at 12 months (1.18 [95% CI, 0.46-1.90])., Conclusions: Both PCI and CABG improved long-term disease-specific and generic QoL.

Background: It is unknown if the presence of saphenous vein grafting (SVG) adversely affects late survival following coronary surgery with multiple arterial grafting (MAG) versus single arterial grafting., Methods and Results: A retrospective, observational, multicenter cohort study from 2001 to 2020 was conducted using the Australian and New Zealand Society of Cardiac and Thoracic Surgeons Database linked to the National Death Index. Patients undergoing primary isolated coronary artery bypass grafting with ≥2 grafts were included, and exclusions were patients aged <18 years, reoperations, concomitant or previous cardiac surgery, and the absence of arterial grafting. Demographics, comorbidities, medication, and operative configurations were propensity score matched between cohorts. The primary outcome was all-cause late death. Of 59 689 eligible patients, 35 113 were MAG (58.8%), and 24 576 were single arterial grafting (41.2%). Of the MAG cohort, 17 055 (48.6%) patients did not receive supplementary SVG (total arterial revascularization). Matching separately generated 22 764 patient pairs for MAG versus single arterial grafting, and 11 137 patient pairs for MAG with total arterial revascularization versus MAG with ≥1 supplementary vein grafts. At a median follow-up duration of 5.0 years postoperatively, the mortality rate was significantly lower for MAG than single arterial grafting (hazard ratio [HR], 0.79 [95% CI, 0.76-0.83]; P <0.001). The stratified MAG analysis found that MAG with total arterial revascularization had a lower risk of late death (HR, 0.85 [95% CI, 0.80-0.91]; P <0.001) compared with MAG with ≥1 supplementary vein grafts. Sensitivity analyses produced consistent outcomes as the primary analysis. Following adjustment for the presence of SVG in the Cox model, the survival advantage of incremental number of arteries was lost., Conclusions: Multiple arterial grafting has significantly improved long-term survival compared with single arterial grafting. A further incremental survival benefit exists when no SVG is used.

Background We tested the potential of the Secondary Manifestations of Arterial Disease (SMART2) risk score for use in patients undergoing coronary artery bypass grafting. Methods and Results We conducted an external validation of the SMART2 score in a racially diverse high-risk national cohort (2010-2019) that underwent isolated coronary artery bypass grafting. We calculated the preoperative SMART2 score and modeled the 5-year major adverse cardiovascular event (cardiovascular mortality+myocardial infarction+stroke) incidence. We evaluated SMART2 score discrimination at 5 years using c-statistic and calibration with observed/expected ratio and calibration plots. We analyzed the potential clinical benefit using decision curves. We repeated these analyses in clinical subgroups, diabetes, chronic kidney disease, and polyvascular disease, and separately in White and Black patients. In 27 443 (mean age, 65 years; 10% Black individuals) US veterans undergoing coronary artery bypass grafting (2010-2019) nationwide, the 5-year major adverse cardiovascular event rate was 25%; 27% patients were in high predicted risk (>30% 5-year major adverse cardiovascular events). SMART2 score discrimination (c-statistic: 64) was comparable to the original study (c-statistic: 67) and was best in patients with chronic kidney disease (c-statistic: 66). However, it underpredicted major adverse cardiovascular event rates in the whole cohort (observed/expected ratio, 1.45) as well as in all studied subgroups. The SMART2 score performed better in White than Black patients. On decision curve analysis, the SMART2 score provides a net benefit over a wide range of risk thresholds. Conclusions The SMART2 model performs well in a racially diverse coronary artery bypass grafting cohort, with better predictive capabilities at the upper range of baseline risk, and can therefore be used to guide secondary preventive pharmacotherapy.

Background Several randomized trials have compared the patency of coronary artery bypass conduits. All of the published studies, however, have performed pairwise comparisons and a comprehensive evaluation of the patency rates of all conduits has yet to be published. We set out to investigate the angiographic patency rates of all conduits used in coronary bypass surgery by performing a network meta-analysis of the current available randomized evidence. Methods and Results A systematic literature search was conducted for randomized controlled trials comparing the angiographic patency rate of the conventionally harvested saphenous vein, the no-touch saphenous vein, the radial artery (RA), the right internal thoracic artery, or the gastroepiploic artery. The primary outcome was graft occlusion. A total of 4160 studies were retrieved of which 14 were included with 3651 grafts analyzed. The weighted mean angiographic follow-up was 5.1 years. Compared with the conventionally harvested saphenous vein, both the RA (incidence rate ratio [IRR] 0.54; 95% CI, 0.35-0.82) and the no-touch saphenous vein (IRR 0.55; 95% CI, 0.39-0.78) were associated with lower graft occlusion. The RA ranked as the best conduit (rank score for RA 0.87 versus 0.85 for no-touch saphenous vein, 0.23 for right internal thoracic artery, 0.29 for gastroepiploic artery, and 0.25 for the conventionally harvested saphenous vein). Conclusions Compared with the conventionally harvested saphenous vein, only the RA and no-touch saphenous vein grafts are associated with significantly lower graft occlusion rates. The RA ranks as the best conduit. Registration URL: https://www.crd.york.ac.uk/prospero; Unique identifier: CRD42020164492.

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 χ 2 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., (© 2020 Wiley Periodicals LLC.)

Background Current cardiac surgery guidelines give Class I and II recommendations to valve-sparing root replacement over the Bentall procedure, mitral valve (MV) repair over replacement, and multiple arterial grafting with bilateral internal thoracic artery based on observational evidence. We evaluated the robustness of the observational studies supporting these recommendations using the E value, an index of unmeasured confounding. Methods and Results Observational studies cited in the guidelines and in the 3 largest meta-analyses comparing the procedures were evaluated for statistically significant effect measures. Two E values were calculated: 1 for the effect-size estimate and 1 for the lower limit of the 95% CI. Thirty-one observational studies were identified, and E values were computed for 75 effect estimates. The observed effect estimates for improved clinical outcomes with valve-sparing root replacement versus the Bentall procedure, MV repair versus replacement, and grafting with bilateral internal thoracic artery versus single internal thoracic artery could be explained by an unmeasured confounder that was associated with both the treatment and outcome by a risk ratio of more than 16.77, 4.32, and 3.14, respectively. For MV repair versus replacement and grafting with bilateral internal thoracic artery versus single internal thoracic artery, the average E values were lower than the effect sizes of the other measured confounders in 33.3% and 60.9% of the studies, respectively. For valve-sparing root replacement versus the Bentall procedure, no study reported effect sizes for associations of other covariates with outcomes. Conclusions The E values for observational evidence supporting the use of valve-sparing root replacement, MV repair, and grafting with bilateral internal thoracic artery over the Bentall procedure, MV replacement, and grafting with single internal thoracic artery are relatively low. This suggests that small-to-moderate unmeasured confounding could explain most of the observed associations for these procedures.

Background: When transcatheter aortic valve replacement (TAVR) was first approved by the Food and Drug Administration in October 2011, it was an innovative treatment with limited accessibility. However, over the past few years, TAVR has become standard of care in patients with aortic stenosis. The effect of socioeconomic status (SES) on this transition of use of TAVR is unknown., Method: Using the New York state department Statewide Planning and Research Cooperative System database, we compared baseline patient characteristics and facilities in low-income areas and high-income areas. Trends in residential SES of patients undergoing TAVR were examined over time and assessed with a Poisson regression and Cochran Armitage trend tests., Result: From October 2011 and 2012 to December 2016, we found that the numbers of TAVR procedures performed among patients from both low (187-1150 in 2016, P < .001) and high (227-1160, P < .001) income areas increased over time. The proportion of TAVR procedures performed in patients from low-income areas increased over time, while those in high-income areas decreased (from 45.2% in 2011 and 2012 to 49.8% in 2016 for low-income and from 54.8%-50.2% for high-income, P = .009)., Conclusion: In the case of TAVR in New York State, when the innovative treatment was introduced in the clinical practice, there were initial SES-based disparities in access to the procedure. However, these disparities resolved over time, probably due to the broader diffusion of the technique., (© 2019 Wiley Periodicals, Inc.)

Background Although it is traditionally regarded as a single entity, perioperative stroke comprises 2 separate phenomena (early/intraoperative and delayed/postoperative stroke). We aimed to systematically evaluate incidence, risk factors, and clinical outcome of early and delayed stroke after cardiac surgery. Methods and Results A systematic review ( MEDLINE , EMBASE , Cochrane Library) was performed to identify all articles reporting early (on awakening from anesthesia) and delayed (after normal awakening from anesthesia) stroke after cardiac surgery. End points were pooled event rates of stroke and operative mortality and incident rate of late mortality. Thirty-six articles were included (174 969 patients). The pooled event rate for early stroke was 0.98% (95% CI 0.79% to 1.23%) and was 0.93% for delayed stoke (95% CI 0.77% to 1.11%; P=0.68). The pooled event rate of operative mortality was 28.8% (95% CI 17.6% to 43.4%) for early and 17.9% (95% CI 14.0% to 22.7%) for delayed stroke, compared with 2.4% (95% CI 1.9% to 3.1%) for patients without stroke ( P<0.001 for early versus delayed, and for perioperative stroke, early stroke, and delayed stroke versus no stroke). At a mean follow-up of 8.25 years, the incident rate of late mortality was 11.7% (95% CI 7.5% to 18.3%) for early and 9.4% (95% CI 5.9% to 14.9%) for delayed stroke, compared with 3.4% (95% CI 2.4% to 4.8%) in patients with no stroke. Meta-regression demonstrated that off-pump was inversely associated with early stroke (β=-0.009, P=0.01), whereas previous stroke (β=0.02, P<0.001) was associated with delayed stroke. Conclusions Early and delayed stroke after cardiac surgery have different risk factors and impacts on operative mortality as well as on long-term survival.

From November 1989 to December 1994, we performed 2264 bypass procedures. Data were collected prospectively. The population was divided into three subgroups: group 1 = single internal mammary artery (IMA) +/- veins (n = 1584); group 2 = veins only (n = 503); and group 3 = two or more arterial conduits +/- veins (n = 177). Patients who received only saphenous vein conduits (group 2) were significantly older (66.7 +/- 8.9 years) than either group 1 (60.3 +/- 8.3 years) or group 3 (51.6 +/- 9.2 years). Furthermore, this cohort group had the highest percentage of females (28.6%), urgent cases (43.5%), preoperative myocardial infarction (MI) (18.5%), and redo surgery (5.4%). In contrast, patients who received two or more arterial conduits were 94.9% male, and had the lowest incidence of urgent cases (18.1%) and redo surgery (0.5%). Mortality was 1.4% in group 1 and 3.2% in group 2; there were no deaths in group 3. Furthermore, group 2 patients had the highest incidence of perioperative MI (6.6%), low output syndrome (22.1%), intra-aortic balloon pump (IABP) assist (6.2%), and stroke (2.7%). By multivariate logistic regression analysis (odds ratio in parentheses), redo surgery (7.92), preoperative IABP (5.53), poor LV function (4.01), renal impairment (3.94), and advanced age (2.12) were all predictors of operative mortality. When mortality and morbidity (death, infarction, low output syndrome, IABP assist) were combined, regression analysis revealed that in addition to the above variables, female gender and cold cardioplegia were also independent predictors of combined mortality and morbidity. Resource utilization was determined for the three patient groups. There was concern that the increased technical demands of multiple arterial grafting along with longer periods of aortic occlusion and pump times may lead to increased complications and prolonged hospital stay. However, we found that group 3 had the lowest ventilation time, intensive care unit stay, and hospital stay. The results no doubt were influenced by case selection. Whether or not this approach to revascularization will increase long-term survival and freedom from reoperation will require further study.