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Objectives: The authors aimed to investigate the impact of severe bleeding and use of red blood cell (RBC) transfusion on the development of postoperative stroke after surgical (SAVR) and transcatheter aortic valve replacement (TAVR), taken from the FinnValve registry., Design: Nationwide, retrospective observational study., Setting: Five Finnish university hospitals participated in the registry., Participants: A total of 6,463 patients who underwent SAVR (n = 4,333) or TAVR (n = 2,130)., Interventions: Patients who underwent TAVR or SAVR with a bioprosthesis with or without coronary revascularization., Measurements and Main Results: The incidence of postoperative stroke after SAVR was 3.8%. In multivariate analysis, the number of transfused RBC units (odds ratio [OR], 1.098; 95% confidence interval [CI], 1.064-1.133) was one of the independent predictors of postoperative stroke. The incidence of stroke increased, along with the severity of perioperative bleeding, according to the European Coronary Artery Bypass Grafting (E-CABG) bleeding grades were as follows: grade 0, 2.2% (reference group); grade 1, 3.4% (adjusted OR, 1.841; 95% CI, 1.105-3.066); grade 2, 5.5% (adjusted OR, 3.282; 95% CI, 1.948-5.529); and grade 3, 14.8% (adjusted OR, 7.103; 95% CI, 3.612-13.966). The incidence of postoperative stroke after TAVR was 2.5%. The number of transfused RBC units was an independent predictor of stroke after TAVR (adjusted OR, 1.155; 95% CI, 1.058-1.261). The incidence of postoperative stroke increased, along with the severity of perioperative bleeding, as stratified by the E-CABG bleeding grades: E-CABG grade 0, 1.7%; grade 1, 5.3% (adjusted OR, 1.270; 95% CI, 0.532-3.035); grade 2, 10.0% (adjusted OR, 2.898; 95% CI, 1.101-7.627); and grade 3, 30.0% (adjusted OR, 10.706; 95% CI, 2.389-47.987)., Conclusions: Perioperative bleeding requiring RBC transfusion and/or reoperation for intrathoracic bleeding is associated with an increased risk of postoperative stroke after SAVR and TAVR. Patient blood management and meticulous preprocedural planning and operative technique aiming to avoid significant perioperative bleeding may reduce the risk of cerebrovascular complications., Competing Interests: Declaration of Competing Interest K.E. Juhani Airaksinen reports research grants from The Finnish Foundation for Cardiovascular Research; the status of speaker for Bayer, Pfizer, and Boehringer-Ingelheim; and status as a member in the advisory boards for Bayer, Pfizer, Astra-Zeneca. Other authors have no conflict of interests to declare., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: The impact of patient-prosthesis mismatch (PPM) on long-term outcome after surgical aortic valve replacement (SAVR) is controversial. We sought to investigate the incidence of PPM and its impact on survival and reinterventions in a Finnish nationwide cohort., Methods: In the context of the nationwide FinnValve registry, we identified 4097 patients who underwent SAVR with a stented bioprosthesis with or without myocardial revascularization. The indexed effective orifice areas (EOAs) of surgical bioprostheses were calculated using literature-derived EOAs. PPM was graded as moderate (EOA 0.65-0.85 cm 2 /m 2 ) or severe (EOA ≤0.65 cm 2 /m 2 )., Results: The incidence of PPM was 46.0%. PPM was moderate in 38.8% (n = 1579) patients and severe in 7.2% (n = 297) patients. Time-trend analysis showed that the proportion of PPM decreased significantly from 74% in 2009 to 18% in 2017 (P < .01). Severe PPM was associated with increased 5-year all-cause mortality (adjusted hazard ratio [HR], 1.72; 95% confidence interval [CI], 1.07-2.76; P = .02). Severe PPM was not associated with an increased risk of repeat AVR (adjusted HR, 5.90; 95% CI, 0.95-36.5; P = .06). In a subanalysis of patients greater than or equal to 70 years of age, in comparison with no PPM, any PPM (adjusted HR, 1.23; 95% CI, 1.05-1.45; P = .01) and severe PPM (HR, 1.53; 95% CI, 1.17-2.00; P < 0.01) were associated with increased risk of 5-year mortality., Conclusions: Severe PPM after SAVR had a negative impact on survival. This study demonstrated that the effects of PPM should not be overlooked in elderly undergoing SAVR., (Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The data on acute kidney injury (AKI) in patients without chronic kidney disease (CKD) after transcatheter aortic valve replacement (TAVR) are limited. The study sought to compare the incidence of AKI and its impact on 5-year mortality after TAVR and surgical aortic valve replacement (SAVR) in patients without CKD., Methods: This registry included data from 6463 consecutive patients who underwent TAVR or SAVR. CKD was defined as estimated glomerular filtration rate <60 mL/min/1.73 m 2 . AKI was defined according to the Kidney Disease Improving Global Outcomes criteria. For sensitivity analysis, propensity-score matching between TAVR and SAVR was performed., Results: The study included 4555 consecutive patients (TAVR, n = 1215 and SAVR, n = 3340) without CKD. Propensity-score matching identified 542 pairs. Patients who underwent TAVR had a significantly lower incidence of AKI in comparison to those who underwent SAVR (unmatched 4.7% vs 16.4%, P < 0.001, multivariable analysis: odds ratio, 0.29, 95% confidence interval [CI], 0.20-0.41; matched 5.9% vs 19.0%, P < 0.001). Patients with AKI had significantly increased 5-year mortality compared with those without AKI (unmatched 36.0% vs 19.1%, log-rank P < 0.001; matched 36.3% vs 24.0%, log-rank P < 0.001). The adjusted hazard ratios for 5-year mortality were 1.58 (95% CI, 1.20-2.08) for AKI grade 1, 3.27 (95% CI, 2.09-5.06) for grade 2, and 4.82 (95% CI, 2.93-8.04) for grade 3., Conclusions: TAVR in patients without CKD was associated with a significantly less frequent incidence of AKI compared with SAVR. AKI significantly increased the risk of 5-year mortality after either TAVR or SAVR, and increasing severity of AKI was incrementally associated with 5-year mortality., (Copyright © 2020 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: Recent surgical bovine pericardial prostheses are widely used despite limited data on their long-term durability., Methods: This is a comparative analysis of the outcome of the Trifecta (Abbott, Abbott Park, IL) and Perimount Magna Ease (Edwards, Lifesciences Corp, Irvine, CA) bioprostheses from the FinnValve registry, a Finnish nationwide database including patients with aortic stenosis who underwent transcatheter or surgical aortic valve replacement with a bioprosthesis between 2008 and 2017., Results: Overall 2216 patients (mean age, 74.1 ± 6.7 years; age <65 years, 8.9%; mean follow-up, 3.8 ± 2.1 years) received the Trifecta (851 patients) or the Perimount Magna Ease (1365 patients) bioprostheses. The rates of late mortality and prosthetic valve endocarditis were comparable in the study cohorts. At 7 years the Trifecta cohort had a significantly higher risk of repeat aortic valve replacement for structural valve failure (3.3% vs 0%; adjusted subdistribution hazard ratio, 2.224; 95% confidence interval, 1.044-4.737), repeat aortic valve replacement for any cause (3.6% vs 0.4%; adjusted subdistribution hazard ratio, 3.210; 95% confidence interval, 1.286-8.013), and repeat aortic valve replacement and/or prosthetic valve endocarditis (4.1% vs 0.9%; adjusted subdistribution hazard ratio, 3.210; 95% confidence interval, 1.286-8.013) compared with the Perimount Magna Ease cohort. Among 772 propensity score-matched pairs, at 7 years the Trifecta cohort had a higher risk of repeat aortic valve replacement for structural valve failure (5.7% vs 0%, P = .009)., Conclusions: The Trifecta aortic bioprosthesis is associated with a higher occurrence of repeat aortic valve replacement for structural valve failure compared with the Perimount Magna Ease bioprosthesis. Further comparative studies with echocardiographic data on structural valve deterioration and longer follow-up are needed to confirm these findings., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: There is limited information on the longer-term outcome after transcatheter aortic valve replacement (TAVR) with new-generation prostheses compared to surgical aortic valve replacement (SAVR). The aim of this study was to compare the mid-term outcomes after TAVR with Sapien 3 and SAVR with Perimount Magna Ease bioprostheses for severe aortic stenosis., Methods: In a retrospective study, we included patients who underwent transfemoral TAVR with Sapien 3 or SAVR with Perimount Magna Ease bioprosthesis between January 2008 and October 2017 from the nationwide FinnValve registry. Propensity score matching was performed to adjust for differences in the baseline characteristics. The Kaplan-Meir method was used to estimate late mortality., Results: A total of 2000 patients were included (689 in the TAVR cohort and 1311 in the SAVR cohort). Propensity score matching resulted in 308 pairs (STS score, TAVR 3.5 ± 2.2% vs. SAVR 3.5 ± 2.8%, p = 0.918). In-hospital mortality was 3.6% after SAVR and 1.3% after TAVR (p = 0.092). Stroke, acute kidney injury, bleeding and atrial fibrillation were significantly more frequent after SAVR, but higher rate of vascular complications was observed after TAVR. The cumulative incidence of permanent pacemaker implantation at 4 years was 13.9% in the TAVR group and 6.9% in the SAVR group (p = 0.0004). At 4-years, all-cause mortality was 20.6% for SAVR and 25.9% for TAVR (p = 0.910). Four-year rates of coronary revascularization, prosthetic valve endocarditis and repeat aortic valve intervention were similar between matched cohorts., Conclusions: The Sapien 3 bioprosthesis achieves comparable midterm outcomes to a surgical bioprosthesis with proven durability such as the Perimount Magna Ease. However, the Sapien 3 bioprosthesis was associated with better early outcome., Trial Registration: ClinicalTrials.gov Identifier: NCT03385915 .

Objective: To develop a risk score for deep sternal wound infection (DSWI) after isolated coronary artery bypass grafting (CABG)., Design: Multicenter, prospective study., Setting: Tertiary-care referral hospitals., Participants: The study included 7,352 patients from the European multicenter coronary artery bypass grafting (E-CABG) registry., Intervention: Isolated CABG., Methods: An additive risk score (the E-CABG DSWI score) was estimated from the derivation data set (66.7% of patients), and its performance was assessed in the validation data set (33.3% of patients)., Results: DSWI occurred in 181 (2.5%) patients and increased 1-year mortality (adjusted hazard ratio, 4.275; 95% confidence interval [CI], 2.804-6.517). Female gender (odds ratio [OR], 1.804; 95% CI, 1.161-2.802), body mass index ≥30 kg/m2 (OR, 1.729; 95% CI, 1.166-2.562), glomerular filtration rate <45 mL/min/1.73 m2 (OR, 2.410; 95% CI, 1.413-4.111), diabetes (OR, 1.741; 95% CI, 1.178-2.573), pulmonary disease (OR, 1.935; 95% CI, 1.178-3.180), atrial fibrillation (OR, 1.854; 95% CI, 1.096-3.138), critical preoperative state (OR, 2.196; 95% CI, 1.209-3.891), and bilateral internal mammary artery grafting (OR, 2.088; 95% CI, 1.422-3.066) were predictors of DSWI (derivation data set). An additive risk score was calculated by assigning 1 point to each of these independent risk factors for DSWI. In the validation data set, the rate of DSWI increased along with the E-CABG DSWI scores (score of 0, 1.0%; score of 1, 1.8%; score of 2, 2.2%; score of 3, 6.9%; score ≥4: 12.1%; P < .0001). Net reclassification improvement, integrated discrimination improvement, and decision curve analysis showed that the E-CABG DSWI score performed better than other risk scores., Conclusions: DSWI is associated with poor outcome after CABG, and its risk can be stratified using the E-CABG DSWI score., Trial Registration: clinicaltrials.gov identifier: NCT02319083.

Background: The aim of this study was to investigate the impact of anatomical site status and major vascular complication (MVC) severity on the outcome of transfemoral transcatheter aortic valve replacement (TF-TAVR). Methods and Results: The FinnValve registry enrolled consecutive TAVR patients from 2008 to 2017. MVC was divided into 2 groups: non-access site-related MVC (i.e., MVC in aorta, aortic valve annulus or left ventricle); and access site-related MVC (i.e., MVC in iliac or femoral arteries). Severity of access site-related MVC was measured as units of red blood cell (RBC) transfusion. Of 1,842 patients who underwent TF-TAVR, 174 had MVC (9.4%; non-access site related, n=29; access site related, n=145). Patients with MVC had a significantly higher 3-year mortality than those without MVC (40.8% vs. 24.3%; HR, 2.01; 95% CI: 1.16-3.62). Adjusted 3-year mortality risk was significantly increased in the non-access site-related MVC group (mortality, 77.8%; HR, 4.30; 95% CI: 2.63-7.02), but not in the access site-related MVC group (mortality, 32.6%; HR, 1.38; 95% CI: 0.86-2.15). In the access site-related MVC group, only those with RBC transfusion ≥4 units had a significantly increased 3-year mortality risk (mortality, 51.8%; HR, 2.18; 95% CI: 1.19-3.89). Conclusions: In patients undergoing TF-TAVR, MVC was associated with an increased 3-year mortality risk, incrementally correlating with anatomical site and bleeding severity., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2020, THE JAPANESE CIRCULATION SOCIETY.)

Increasing data support transcatheter aortic valve implantation (TAVI) as a valid option over surgical aortic valve replacement (SAVR) in the treatment for severe aortic stenosis (AS) also in patients with low operative risk. However, limited data exist on the outcome of TAVI and SAVR in low-risk patients without coronary artery disease (CAD). The FinnValve registry included data on 6463 patients who underwent TAVI or SAVR with bioprosthesis between 2008 and 2017. Herein, we evaluated the outcome of low operative risk as defined by STS-PROM score <3% and absence of CAD, previous stroke and other relevant co-morbidities. Only patients who underwent TAVI with third-generation prostheses and SAVR with Perimount Magna Ease or Trifecta prostheses were included in this analysis. The primary endpoints were 30-day and 3-year all-cause mortality. Overall, 1,006 patients (175 TAVI patients and 831 SAVR patients) met the inclusion criteria of this analysis. Propensity score matching resulted in 140 pairs with similar baseline characteristics. Among these matched pairs, 30-day mortality was 2.1% in both TAVI and SAVR cohorts (p = 1.00) and 3-year mortality was 17.0% after TAVI and 14.6% after SAVR (p = 0.805). Lower rates of bleeding and atrial fibrillation, and shorter hospital stay were observed after TAVI. The need of new permanent pacemaker implantation and the incidence of early stroke did not differ between groups. In conclusion, TAVI using third-generation prostheses achieved similar early and mid-term survival compared with SAVR in low-risk patients without CAD., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Patients with severe aortic stenosis and heart failure have poor prognosis, and their outcomes may be suboptimal even after transcatheter (TAVR) and surgical aortic valve replacement (SAVR)., Methods: This is an analysis of the nationwide FinnValve registry, which included patients who underwent primary TAVR or SAVR with a bioprothesis for aortic stenosis. We evaluated the outcome of patients with acute heart failure (AHF) within 60 days prior to TAVR or SAVR., Results: The prevalence of recent AHF was 11.4% (484 of 4241 patients) in the SAVR cohort and 11.3% (210 of 1855 patients) in the TAVR cohort. In the SAVR cohort, AHF was associated with lower 30-day survival (91.3% vs 97.0%; adjusted odds ratio 1.801, 95% confidence interval [CI] 1.125-2.882) and 5-year survival (64.0% vs 81.2%; adjusted hazard ratio 1.482, 95% CI 1.207-1.821). SAVR patients with AHF had higher risk of major bleeding, need of mechanical circulatory support, acute kidney injury, prolonged hospital stay, and composite end-point (30-day mortality, stroke and/or acute kidney injury). Patients with AHF had a trend toward lower 30-day survival (crude rates 95.2% vs 97.9%; adjusted odds ratio 2.028, 95% CI 0.908-4.529) as well as significantly lower 5-year survival (crude rates 45.3% vs 58.5%; adjusted hazard ratio 1.530, 95% CI 1.185-1.976) also after TAVR. AHF increased the risk of acute kidney injury, prolonged hospital stay, and composite end-point after TAVR., Conclusions: Recent AHF is associated with increased risk of mortality and morbidity after SAVR and TAVR. These findings suggest that aortic stenosis patients should be referred for invasive treatment before the development of clinically evident heart failure., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Recent studies suggested that prothrombin complex concentrate (PCC) might be more effective than fresh frozen plasma (FFP) to reduce red blood cell (RBC) transfusion requirement after cardiac surgery., Methods: This is a comparative analysis of 416 patients who received FFP postoperatively and 119 patients who received PCC with or without FFP after isolated coronary artery bypass grafting (CABG)., Results: Mixed-effects regression analyses adjusted for multiple covariates and participating centres showed that PCC significantly decreased RBC transfusion (67.2% vs. 87.5%, adjusted OR 0.319, 95%CI 0.136-0.752) and platelet transfusion requirements (11.8% vs. 45.2%, adjusted OR 0.238, 95%CI 0.097-0.566) compared with FFP. The PCC cohort received a mean of 2.7±3.7 (median, 2.0, IQR 4) units of RBC and the FFP cohort received a mean of 4.9±6.3 (median, 3.0, IQR 4) units of RBC (adjusted coefficient, -1.926, 95%CI -3.357-0.494). The use of PCC increased the risk of KDIGO (Kidney Disease: Improving Global Outcomes) acute kidney injury (41.4% vs. 28.2%, adjusted OR 2.300, 1.203-4.400), but not of KDIGO acute kidney injury stage 3 (6.0% vs. 8.0%, OR 0.850, 95%CI 0.258-2.796) when compared with the FFP cohort., Conclusions: These results suggest that the use of PCC compared with FFP may reduce the need of blood transfusion after CABG., (Copyright © 2018 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.)

Objective: To investigate the prognostic impact of red blood cell (RBC) transfusion on the outcome after transfemoral transcatheter aortic valve replacement (TAVR)., Design: Nationwide, retrospective multicenter study., Setting: Five University Hospitals., Participants: The nationwide FinnValve registry included data from 2,130 patients who underwent TAVR for aortic stenosis from 2008 to 2017. After excluding patients who underwent TAVR through nontransfemoral accesses, 1,818 patients were selected for this analysis., Intervention: TAVR with or without coronary revascularization., Measurements and Main Results: RBCs were transfused in 293 patients (16.1%). Time-trend analysis showed that the rates of RBC transfusion decreased significantly from 27.5% in 2012 to 10.0% in 2017 (p < 0.0001). Among 281 propensity score matched pairs, RBC transfusion was associated with higher 30-day mortality (7.1% v 0%, p < 0.0001), late mortality (at 5-year, 59.1% v 43.3%, p = 0.008), as well as increased risk of acute kidney injury (17.0% v 4.4%, p < 0.0001), renal replacement therapy (3.6% v 0.4, p < 0.0001) and prolonged hospital stay (mean, 8.5 v 4.7 days, p < 0.0001) compared with patients who did not receive blood transfusion. In the overall series, the risk of adverse events increased significantly with the increasing amount of transfused RBC units and when operation for excessive bleeding was necessary. Consistently with these findings, postoperative hemoglobin drop and nadir level were associated with higher early and late mortality., Conclusions: Patients who received blood transfusion after TAVR had an increased risk of early and late adverse events. These adverse effects were particularly evident with increasing amount of RBC transfusion and operations for excessive bleeding., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Aims: The aim of this study was to compare the risk of prosthetic valve endocarditis (PVE) in patients with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR)., Methods and Results: The FinnValve registry included data from 6,463 consecutive patients who underwent TAVR (n=2,130) or SAVR (n=4,333) with a bioprosthesis from 2008 to 2017. PVE was defined according to the modified Duke criteria. In this study, the incidence of PVE was 3.4/1,000 person-years after TAVR, and 2.9/1,000 person-years after SAVR. In competing risk analysis there was no significant difference in the risk of PVE between patients with TAVR and SAVR over an eight-year observational period. Male gender (HR 1.73, 95% CI: 1.04-2.89) and deep sternal wound infection or vascular access-site infection (HR 5.45, 95% CI: 2.24-13.2) were positively associated with PVE, but not type of procedure (HR 1.09, 95% CI: 0.59-2.01) in multivariate analysis. The mortality rate was 37.7% at one month and increased to 52.5% at one year. Surgical treatment was independently associated with decreased in-hospital mortality (HR 0.34, 95% CI: 0.21-0.61)., Conclusions: PVE is rare, and its risk is similar after TAVR and SAVR. ClinicalTrials.gov Identifier: NCT03385915. https://clinicaltrials.gov/ct2/show/NCT03385915.

Importance: Transcatheter aortic valve replacement (TAVR) has been shown to be a valid alternative to surgical aortic valve replacement (SAVR) in patients at high operative risk with severe aortic stenosis (AS). However, the evidence of the benefits and harms of TAVR in patients at low operative risk is still scarce., Objective: To compare the short-term and midterm outcomes after TAVR and SAVR in low-risk patients with AS., Design, Setting, and Participants: This retrospective comparative effectiveness cohort study used data from the Nationwide Finnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis of patients at low operative risk who underwent TAVR or SAVR with a bioprosthesis for severe AS from January 1, 2008, to November 30, 2017. Low operative risk was defined as a Society of Thoracic Surgeons Predicted Risk of Mortality score less than 3% without other comorbidities of clinical relevance. One-to-one propensity score matching was performed to adjust for baseline covariates between the TAVR and SAVR cohorts., Exposures: Primary TAVR or SAVR with a bioprosthesis for AS with or without associated coronary revascularization., Main Outcomes and Measures: The primary outcomes were 30-day and 3-year survival., Results: Overall, 2841 patients (mean [SD] age, 74.0 [6.2] years; 1560 [54.9%] men) fulfilled the inclusion criteria and were included in the analysis; TAVR was performed in 325 patients and SAVR in 2516 patients. Propensity score matching produced 304 pairs with similar baseline characteristics. Third-generation devices were used in 263 patients (86.5%) who underwent TAVR. Among these matched pairs, 30-day mortality was 1.3% after TAVR and 3.6% after SAVR (P = .12). Three-year survival was similar in the study cohorts (TAVR, 85.7%; SAVR, 87.7%; P = .45). Interaction tests found no differences in terms of 3-year survival between the study cohorts in patients younger than vs older than 80 years or in patients who received recent aortic valve prostheses vs those who did not., Conclusions and Relevance: Transcatheter aortic valve replacement using mostly third-generation devices achieved similar short- and mid-term survival compared with SAVR in low-risk patients. Further studies are needed to assess the long-term durability of TAVR prostheses before extending their use to low-risk patients.

Background: We evaluated perioperative bleeding after coronary artery bypass grafting (CABG) in patients preoperatively treated with ticagrelor or clopidogrel, stratified by discontinuation of these P2Y 12 inhibitors., Methods: All patients from the prospective, European Multicenter Registry on Coronary Artery Bypass Grafting (E-CABG) treated with ticagrelor or clopidogrel undergoing isolated primary CABG were eligible. The primary outcome measure was severe or massive bleeding defined according to the Universal Definition of Perioperative Bleeding, stratified by P2Y 12 inhibitor discontinuation. Secondary outcome measures included four additional definitions of major bleeding. Propensity score matching was performed to adjust for differences in preoperative and perioperative covariates., Results: Of 2,311 patients who were included, 1,293 (55.9%) received clopidogrel and 1,018 (44.1%) ticagrelor preoperatively. Mean time between discontinuation and the operation was 4.5 ± 3.2 days for clopidogrel and 4.9 ± 3.0 days for ticagrelor. In the propensity score-matched cohort, ticagrelor-treated patients had a higher incidence of major bleeding according to Universal Definition of Perioperative Bleeding when ticagrelor was discontinued 0 to 2 days compared with 3 days before the operation (16.0% vs 2.7%, p = 0.003). Clopidogrel-treated patients had a higher incidence of major bleeding according to the Universal Definition of Perioperative Bleeding when clopidogrel was discontinued 0 to 3 days compared with 4 to 5 days before the operation (15.6% vs 8.3%, p = 0.031)., Conclusions: In patients receiving ticagrelor 2 days before CABG and in those receiving clopidogrel 3 days before CABG, there was an increased rate of severe bleeding. Postponing nonemergent CABG for at least 3 days after discontinuation of ticagrelor and 4 days after clopidogrel should be considered., (Copyright © 2019 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Aim: We investigated the outcomes of transcatheter (TAVR) and surgical aortic valve replacement (SAVR) in Finland during the last decade. Methods: The nationwide FinnValve registry included data from 6463 patients who underwent TAVR or SAVR with a bioprosthesis for aortic stenosis from 2008 to 2017. Results: The annual number of treated patients increased three-fold during the study period. Thirty-day mortality declined from 4.8% to 1.2% for TAVR ( p  = .011) and from 4.1% to 1.8% for SAVR ( p  = .048). Two-year survival improved from 71.4% to 83.9% for TAVR ( p  < .001) and from 87.2% to 91.6% for SAVR ( p  = .006). During the study period, a significant reduction in moderate-to-severe paravalvular regurgitation was observed among TAVR patients and a reduction of the rate of acute kidney injury was observed among both SAVR and TAVR patients. Similarly, the rate of red blood cell transfusion and severe bleeding decreased significantly among SAVR and TAVR patients. Hospital stay declined from 10.4 ± 8.4 to 3.7 ± 3.4 days after TAVR ( p  < .001) and from 9.0 ± 5.9 to 7.8 ± 5.1 days after SAVR ( p  < .001). Conclusions: In Finland, the introduction of TAVR has led to an increase in the invasive treatment of severe aortic stenosis, which was accompanied by improved early outcomes after both SAVR and TAVR. Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT03385915 Key Messages This study demonstrated that the introduction of transcatheter aortic valve replacement has led to its widespread use as an invasive treatment for severe aortic stenosis. Early and 2-year survival after transcatheter and surgical aortic valve replacement has improved during past decade. Transcatheter aortic valve replacement has fulfilled its previously unmet clinical needs and has surpassed surgical aortic valve replacement as the most common invasive treatment for aortic stenosis.

The perioperative bleeding risk in patients receiving fondaparinux versus low-molecular weight heparin before coronary artery bypass grafting has not been reported. We evaluated perioperative coronary artery bypass grafting-related bleeding in patients with acute coronary syndrome preoperatively treated with fondaparinux or low-molecular weight heparin. All patients with acute coronary syndrome from the prospective, European multicenter registry on coronary artery bypass grafting preoperatively treated with fondaparinux or low-molecular weight heparin undergoing isolated primary CABG were eligible. The primary outcome measure was severe or massive bleeding defined according to the Universal Definition of Perioperative Bleeding stratified by P2Y 12 inhibitor discontinuation. Secondary outcome measures included 3 additional definitions of major bleeding used in cardiac surgery trials. Propensity score matching was performed to adjust for differences in pre- and perioperative covariates. 1,525 patients were included, of whom 276 (18.1%) received fondaparinux and 1,249 (81.9%) low-molecular weight heparin preoperatively. In the propensity score-matched cohort (245 pairs), the risk of major bleeding according to the universal definition of perioperative bleeding severe or massive bleeding (11.8 vs 9.0%, p = 0.285) and the 3 other major bleeding definitions was similar between the fondaparinux and low-molecular weight heparin cohorts. In conclusion, preoperative treatment with fondaparinux compared with low-molecular weight heparin was associated with similar incidence of perioperative bleeding in patients with acute coronary syndrome who underwent coronary artery bypass grafting., (Copyright © 2018. Published by Elsevier Inc.)

The impact of thrombocytopenia on postoperative bleeding and other major adverse events after cardiac surgery is unclear. This issue was investigated in a series of patients who underwent isolated coronary artery bypass grafting (CABG) from the prospective, multicenter E-CABG registry. Preoperative thrombocytopenia was defined as preoperative platelet count <150 × 10 9 /L and it was considered moderate-severe when preoperative platelet count was <100 × 10 9 /L. Multilevel mixed-effects regression analysis was performed to adjust the effect of thrombocytopenia on outcomes for baseline and operative covariates as well as for interinstitutional differences in patient-blood management. Among 7189 patients included in this analysis, 599 (8.3%) had preoperative thrombocytopenia. Patient with preoperative thrombocytopenia had an increased chest drainage output at 12 h (mean, 519 vs. 456 mL, adjusted coeff. 39, 95%CI 18-60) and rates of severe-massive bleeding (Universal Definition of Perioperative Bleeding (UDPB) severity grades 3-4: 12.7% vs. 8.1%, adjusted OR 1.47, 95%CI 1.11-1.93; E-CABG bleeding severity grades 2-3: 10.4% vs. 6.1%, adjusted OR 1.78, 95%CI 1.30-2.43). Thrombocytopenia was associated with an increased risk of hospital/30-day death (3.2% vs. 1.9%, adjusted OR 2.02, 95%CI 1.20-3.42), 1-year death (5.7% vs. 3.4%, adjusted HR 1.68, 95%CI 1.16-2.44), deep sternal wound infection (3.5% vs. 2.4%, adjusted OR 1.65, 95%CI 1.02-2.66), acute kidney injury (28.1% vs. 22.2%, OR 1.45, 1.18-1.78), and prolonged stay in the intensive care unit (mean, 3.6 vs 2.8 days, adjusted coeff. 0.74, 95%CI 0.40-1.09). Similar results were observed in a subset of patients with moderate-severe thrombocytopenia (51 patients, 0.7%). In particular, these patients had a markedly higher rate of acute kidney injury (40%, adjusted OR, 1.94, 95%CI 1.05-3.57), resternotomy for bleeding (7.8%, adjusted OR 3.49, 95%CI 1.20-10.21), and severe-massive bleeding (UDPB severity grades 3-4: 23.5%, adjusted OR 3.08, 95%CI 1.52-6.22; E-CABG bleeding severity grades 2-3: 23.5%, adjusted OR 4.43, 95%CI 2.15-9.15) compared to patients with normal preoperative platelet count. Mild preoperative thrombocytopenia is associated with increased risk of severe-massive bleeding, mortality, and other major adverse events after CABG. Such risks are markedly increased in patients with moderate-severe preoperative thrombocytopenia.

Objectives: The aim of this study was to assess the impact of frailty on the outcome after coronary artery bypass grafting (CABG) and whether it may improve the predictive ability of European System for Cardiac Operative Risk Evaluation (EuroSCORE II)., Methods: The Clinical Frailty Scale (CFS) was assessed preoperatively in patients undergoing isolated CABG from the multicentre E-CABG registry, and patients were stratified into 3 classes: scores 1-2, scores 3-4 and scores 5-7., Results: Of the 6156 patients enrolled, 39.2% had CFS scores 1-2, 57.6% scores 3-4, and 3.2% scores 5-7. Logistic regression adjusted for multiple covariates showed that the CFS was an independent predictor of hospital/30-day mortality [CFS scores 3-4, odds ratio (OR) 3.95, 95% confidence interval (CI) 2.19-7.14; CFS scores 5-7, OR 5.90, 95% CI 2.67-13.05] and resulted in an Integrated Improvement Index of 1.3 (P < 0.001) and a Net Reclassification Index of 55.6 (P < 0.001) for prediction of hospital/30-day mortality. Adding the CFS classes to EuroSCORE II resulted in an Integrated Improvement Index of 0.9 (P < 0.001) and Net Reclassification Index of 59.6 (P < 0.001) for prediction of hospital/30-day mortality with a significantly larger area under the receiver operating characteristics curve (0.809 vs 0.781, P = 0.028). The CFS was an independent predictor of mid-term mortality [CFS scores 3-4, hazard ratio (HR) 2.05, 95% CI 1.43-2.85; CFS scores 5-7, HR 3.05, 95% CI 1.83-5.06]., Conclusions: The CFS predicted early- and mid-term mortality in patients undergoing isolated CABG. Further studies are needed to evaluate whether frailty may improve the estimation of the operative risk of patients undergoing adult cardiac surgery., Clinicaltrials.gov Number: NCT02319083.

Objective: The aim of this study was to pool data on the proportion and prognostic impact of sources of bleeding in patients requiring re-exploration after adult cardiac surgery., Design: Systematic review of the literature and meta-analysis., Setting: Multistitutional study., Measurements and Main Results: A literature review was performed to identify studies published since 1990 evaluating the outcome after reoperation for bleeding or tamponade after adult cardiac surgery. Eighteen studies including 5,1497 patients fulfilled the selection criteria. Reoperation for bleeding/tamponade was performed in 2,455 patients (4.6%; 95% confidence interval [CI] 3.9%-5.2%, I 2 92%). These had a significantly higher risk of in-hospital/30-day mortality compared with patients not reoperated for bleeding (pooled rates: 9.3% v 2.3%; risk ratio 3.30; 95% CI 2.52-4.32; I 2 47%; 8 studies; 25,463 patients). Surgical sites of bleeding were identified in 65.7% of cases (95% CI 58.3%-73.2%; I 2 94%), cardiac site bleeding in 40.9% of cases (95% CI 29.7%-52.0%; I 2 94%), and mediastinal/sternum site bleeding in 27.0% of cases (95% CI 16.8%-37.3%; I 2 94%). The main sites of bleeding were the body of the graft (20.2%), the sternum (17.0%), vascular sutures (12.5%), the internal mammary artery harvest site (13.0%), and anastomoses (9.9%). In metaregression, surgical site bleeding was associated with a lower risk of in-hospital/30-day mortality compared with diffuse bleeding (p = 0.003)., Conclusions: Surgical site bleeding is identified in two-thirds of patients undergoing re-exploration after adult cardiac surgery. Meticulous surgical technique and systematic intraoperative checking of potential surgical sites of bleeding at the time of the original cardiac surgery may reduce the risk of such a severe complication., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objective: This study was planned to pool existing data on outcome and to evaluate the efficacy of postcardiotomy venoarterial extracorporeal membrane oxygenation (VA-ECMO) in adult patients., Design: Systematic review of the literature and meta-analysis., Setting: Multi-institutional study., Participants: Adult patients with acute heart failure immediately after cardiac surgery., Interventions: VA-ECMO after cardiac surgery. Studies evaluating only heart transplant patients were excluded from this analysis., Measurements and Main Results: A literature search was performed to identify studies published since 2000. Thirty-one studies reported on 2,986 patients (mean age, 58.1 years) who required postcardiotomy VA-ECMO. The weaning rate from VA-ECMO was 59.5% and hospital survival was 36.1% (95% CI 31.5-40.8). The pooled rate of reoperation for bleeding was 42.9%, major neurological event 11.3%, lower limb ischemia 10.8%, deep sternal wound infection/mediastinitis 14.7%, and renal replacement therapy 47.1%. The pooled mean number of transfused red blood cell units was 17.7 (95% CI 13.3-22.1). The mean stay in the intensive care unit was 13.3 days (95% CI 10.2-16.4). Survivors were significantly younger (mean, 55.7 v 63.6 years, p = 0.015) and their blood lactate level before starting VA-ECMO was lower (mean, 7.7 v 10.7 mmol/L, p = 0.028) than patients who died. One-year survival rate was 30.9% (95% CI 24.3-37.5)., Conclusions: Pooled data showed that VA-ECMO may salvage one-third of patients unresponsive to any other resuscitative treatment after adult cardiac surgery., (Copyright © 2017 Elsevier Inc. All rights reserved.)

The aim of this study was to evaluate the impact of blood transfusion on bloodstream infections. This study included 2764 patients who underwent isolated coronary artery bypass grafting. Blood cultures were drawn in 27.9% of patients and were positive in 3.5% of them. Blood transfusion before blood cultures were drawn (4.7% vs 1.2%, odds ratio 3.75, 95% confidence interval 1.11-12.67) and deep sternal wound infection/mediastinitis (20.0% vs 2.8%, odds ratio 7.43, 95% confidence interval 2.72-20.32) were independent predictors of a positive postoperative blood culture. Positive blood culture increased the risk of 5-year mortality (among patients with blood cultures drawn: 44.7% vs 19.6%, adjusted hazard ratio 2.10, 95% confidence interval 1.18-3.71). Exposure to blood products may increase the risk of bloodstream infection after cardiac surgery. Positive blood cultures after coronary artery bypass grafting are associated with poor late survival. These findings require validation in prospective studies., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: The evidence of the benefits of using venoarterial extracorporeal membrane oxygenation (VA-ECMO) after coronary artery bypass grafting (CABG) is scarce., Methods: We analyzed the outcomes of patients who received VA-ECMO therapy due to cardiac or respiratory failure after isolated CABG in 12 centers between 2005 and 2016. Patients treated preoperatively with ECMO were excluded from this study., Results: VA-ECMO was employed in 148 patients after CABG for median of 5.0days (mean, 6.4, SD 5.6days). In-hospital mortality was 64.2%. Pooled in-hospital mortality was 65.9% without significant heterogeneity between the centers (I 2 8.6%). The proportion of VA-ECMO in each center did not affect in-hospital mortality (p=0.861). No patients underwent heart transplantation and six patients received a left ventricular assist device. Logistic regression showed that creatinine clearance (p=0.004, OR 0.98, 95% CI 0.97-0.99), pulmonary disease (p=0.018, OR 4.42, 95% CI 1.29-15.15) and pre-VA-ECMO blood lactate (p=0.015, OR 1.10, 95% CI 1.02-1.18) were independent baseline predictors of in-hospital mortality. One-, 2-, and 3-year survival was 31.0%, 27.9%, and 26.1%, respectively., Conclusions: One third of patients with need for VA-ECMO after CABG survive to discharge. In view of the burden of resources associated with VA-ECMO treatment and the limited number of patients surviving to discharge, further studies are needed to identify patients who may benefit the most from this treatment., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Purpose: To investigate the impact of minor perioperative bleeding requiring transfusion of 1-2 red blood cell (RBC) units on the outcome after coronary artery bypass grafting (CABG)., Methods: Sixteen cardiac surgical centers contributed to the prospective European CABG registry (E-CABG). 1014 patients receiving 1-2 RBC units during or after isolated CABG were compared to 2264 patients not receiving RBCs., Results: In 827 propensity score matched pairs, transfusion of 1-2 RBC units did not affect the risk of in-hospital/30-day death (p=0.523) or stroke (p=0.804). However, RBC transfusion was associated with an increased risk of acute kidney injury (p=0.008), sternal wound infection (p=0.001), postoperative use of antibiotics (p=0.001), prolonged use of inotropes (p<0.0001), use of intra-aortic balloon pump (p=0.012), length of intensive care unit stay (p<0.0001) and length of in-hospital stay (p<0.0001). Matched paired analysis excluding pre- and postoperative critical hemodynamic conditions showed that RBC transfusion was associated with an increased risk of major complications except in-hospital/30-day death., Conclusion: Minor perioperative bleeding and subsequent transfusion of 1-2 RBC units did not affect the risk of early death, but increased the risk of other major adverse events. Minimizing perioperative bleeding and prevention of even low-volume RBC transfusion may improve the outcome after CABG., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Preoperative anemia is associated with increased morbidity and mortality after cardiac surgery. Since anemia is ultimately treated with red blood cell transfusions, we investigated the independent impact of anemia and transfusion on the outcome after coronary artery bypass grafting (CABG)., Methods: This study included 2761 consecutive patients who underwent isolated CABG. Anemia was defined as hemoglobin <12.0 g/dL in women and <13.0 g/dL in men. The main outcomes were 30-day and late mortality., Results: Patients with preoperative anemia had an increased prevalence of significant comorbidities and were associated with higher unadjusted risk of early and late adverse events. Propensity score matching resulted in 560 pairs with similar baseline and operative characteristics. In these matched pairs, anemic patients had an increased risk of late all-cause death (P = 0.047) and acute kidney injury (P < 0.0001). However, when adjusted for the severity of perioperative bleeding, preoperative anemia was not associated with an increased mortality risk (HR 1.10, 95% CI 0.86-1.39). Instead, this regression model showed that the European CABG registry (E-CABG) bleeding classification was an independent predictor of late mortality (compared to grade 0: grade 1, HR 1.93, 95% CI 1.37-2.73, grade 2, HR 2.19, 95% CI 1.50-3.18, grade 3, HR 5.59, 95% CI 3.34-9.39, P < 0.0001)., Conclusions: When adjusted for important baseline characteristics and operative factors as well as for the severity of perioperative bleeding and the amount of transfused blood products, anemia was not associated with an increased risk of adverse events. Increased exposure to blood transfusion among anemic patients may be the determinant of their poorer late survival.

Objectives: Incomplete drainage of blood from around the heart and lungs can lead to retained blood syndrome (RBS) after cardiac surgery. The aim of this study was to assess the incidence of and the outcome after procedures for RBS in patients undergoing isolated coronary artery bypass grafting (CABG)., Methods: A total of 2764 consecutive patients who underwent isolated CABG from 2006 to 2013 were investigated retrospectively. Patients undergoing any procedure for RBS were compared with patients who did not undergo any procedure for RBS. Multivariate analyses were performed to assess the impact of procedures for RBS on the early outcome., Results: A total of 254 patients (9.2%) required at least one procedure for RBS. Multivariate analysis showed that RBS requiring a procedure for blood removal was associated with significantly increased 30-day mortality [8.3% vs 2.7%, odds ratio (OR) 2.11, 95% confidence interval (95% CI) 1.15-3.86] rates. Procedures for RBS were independent predictors of the need for postoperative antibiotics (51.6% vs 32.1%, OR 2.08, 95% CI 1.58-2.74), deep sternal wound infection/mediastinitis (6.7% vs 2.2%, OR 3.12, 95% CI 1.72-5.66), Kidney Disease: Improving Global Outcomes acute kidney injury (32.7% vs 15.3%, OR 2.50, 95% CI 1.81-3.46), length of stay in the intensive care unit (mean 8.3 vs 2.0 days, beta 1.74, 95% CI 1.45-2.04) and composite major adverse events (21.3% vs 6.9%, OR 3.24, 95% CI 2.24-4.64). These findings were also confirmed in a subgroup of patients with no pre- or postoperative unstable haemodynamic conditions., Conclusion: RBS requiring any procedure for blood removal from pericardial and pleural spaces is associated with an increased risk of severe complications after isolated CABG., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Purpose: To evaluate the impact of transfusion on the development of stroke after cardiovascular interventions., Methods: A literature search was performed to identify comparative studies on the impact of blood transfusion on the occurrence of stroke after adult cardiac surgery and interventional cardiology procedures., Results: Twenty-four studies compared the outcome of 80 283 patients who received and 2 260 709 patients who did not receive blood transfusion after cardiovascular interventions. Pooled analysis showed that transfused patients had a higher risk of postoperative stroke (2.1% vs 0.9%; P < .001; risk ratio [RR], 2.563; 95% confidence interval [CI], 1.615-4.069; I 2 = 94%) compared with patient who did not receive blood transfusion. The leave-one-out analysis confirmed the consistency of the overall series (RR ranged from 2.367 [95% CI, 1.978-2.834] to 2.676 [95% CI, 1.679-4.265]). Transfusion was associated with increased risk of stroke after either interventional cardiology interventions (3.2% vs 1.1%; RR, 3.325; 95% CI, 1.579-7.004) or cardiac surgery (1.9% vs 0.8%; RR, 2.260; 95% CI, 1.845-2.769). Generic inverse variance analysis of 11 studies reporting adjusted odds ratios for baseline characteristics showed that transfusion after cardiovascular interventions was an independent predictor of stroke (RR, 1.53; 95% CI, 1.10-2.14; I 2 = 0%)., Conclusion: Blood transfusion is associated with a significantly increased risk of postoperative stroke in patients undergoing cardiovascular interventions., Registration: The present meta-analysis is registered in PROSPERO, code CRD42016046426., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Perioperative bleeding is a determinant of poor outcome in patients undergoing coronary artery bypass grafting (CABG), but there is a lack of adequate stratification of its severity. The ability of the European registry of Coronary Artery Bypass Grafting (E-CABG), Universal Definition of Perioperative Bleeding (UDPB), Study of Platelet Inhibition and Patient Outcomes (PLATO), Clopidogrel and Aspirin Optimal Dose Usage to Reduce Recurrent Events-Seventh Organization to Assess Strategies in Ischemic Syndromes (CURRENT-OASIS 7), Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q Wave Coronary Events (ESSENCE), and SafeTy and Efficacy of Enoxaparin in Percutaneous coronary intervention patients, an internationaL randomized Evaluation (STEEPLE) bleeding classifications to predict early mortality, stroke, acute kidney injury (AKI) stage 3, and deep sternal wound infection/mediastinitis was investigated in 3,730 patients from the prospective, multicentre E-CABG registry. Increasing grades of the E-CABG, UDPB, PLATO, and CURRENT-OASIS 7 classifications were associated with increasing risks of early mortality, had similar receiver-operating characteristic area under the curves (>0.7), and were predictive also when adjusted for EuroSCORE II. The E-CABG and UDPB classifications had satisfactory area under the curves (>0.6) in predicting stroke, AKI stage 3, and deep sternal wound infection/mediastinitis even when adjusted for EuroSCORE II. The PLATO and CURRENT-OASIS 7 classifications had similar predictive ability for stroke and AKI stage 3 as confirmed by multivariate analysis adjusted for EuroSCORE II but showed inferior ability in predicting severe wound infection compared to the E-CABG and UDPB classifications. The STEEPLE and ESSENCE classifications had a poor ability of predicting all these adverse events. Decision curve analysis showed a benefit of the E-CABG bleeding classification over the other classifications in predicting all adverse events. In conclusion, the E-CABG, UDPB, PLATO, and CURRENT-OASIS 7 bleeding classifications have a satisfactory ability in predicting adverse events after CABG. Decision curve analysis showed that the E-CABG bleeding classification had the best predictive performance., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Severe perioperative bleeding after coronary artery bypass grafting (CABG) is associated with poor outcome. An additive score for prediction of severe bleeding was derived (n=2494) and validated (n=1250) in patients from the E-CABG registry. Severe bleeding was defined as E-CABG bleeding grades 2-3 (transfusion of >4 units of red blood cells or reoperation for bleeding). The overall incidence of severe bleeding was 6.4 %. Preoperative anaemia (3 points), female gender (2 points), eGFR <45 ml/min/1.73 m 2 (3 points), potent antiplatelet drugs discontinued less than five days (2 points), critical preoperative state (5 points), acute coronary syndrome (2 points), use of low-molecular-weight heparin/fondaparinux/unfractionated heparin (1 point) were independent predictors of severe bleeding. The WILL-BLEED score was associated with increasing rates of severe bleeding in both the derivation and validation cohorts (scores 0-3: 2.9 % vs 3.4 %; scores 4-6: 6.8 % vs 7.5 %; scores>6: 24.6 % vs 24.2 %, both p<0.0001). The WILL-BLEED score had a better discriminatory ability (AUC 0.725) for prediction of severe bleeding compared to the ACTION (AUC 0.671), CRUSADE (AUC 0.642), Papworth (AUC 0.605), TRUST (AUC 0.660) and TRACK (AUC 0.640) bleeding scores. The net reclassification index and integrated discrimination improvement using the WILL-BLEED score as opposed to the other bleeding scores were significant (p<0.0001). The decision curve analysis demonstrated a net benefit with the WILL-BLEED score compared to the other bleeding scores. In conclusion, the WILL-BLEED risk score is a simple risk stratification method which allows the identification of patients at high risk of severe bleeding after CABG.

Background: Excessive bleeding and blood transfusion are associated with adverse outcome after cardiac surgery, but their mechanistic effects are difficult to disentangle in patients with increased operative risk. This study aimed to evaluate the incidence and prognostic impact of bleeding and transfusion of blood products in low-risk patients undergoing coronary artery bypass grafting (CABG)., Study Design and Methods: Sixteen tertiary European centers of cardiac surgery contributed to the prospective European registry of CABG (E-CABG). The severity of bleeding was defined by the E-CABG bleeding severity classification and universal definition of perioperative bleeding (UDPB) classification., Results: Of 1213 patients with EuroSCORE II of less than 2% (mean, 1.1 ± 0.4%), 18.5% suffered from mild bleeding (E-CABG bleeding Grade 1) and 3.4% experienced severe bleeding (E-CABG bleeding Grade 2-3). Similarly, 19.7% had UDPB Class 2 and 5.9% had UDPB Classes 3 and 4. Mild and severe bleeding defined by the E-CABG and UDPB classifications were associated with an increased risk of several adverse events as adjusted by multiple covariates. The risk of death, stroke, and acute kidney injury was particularly increased in patients with severe bleeding., Conclusion: Severe bleeding is rather uncommon in low-risk patients undergoing CABG, but it is associated with an increased risk of major adverse events. Prevention of excessive perioperative bleeding and patient blood management may improve the outcome of cardiac surgery also in low-risk patients., (© 2016 AABB.)

Background: Glycated hemoglobin (HbA1c) is a suspected risk factor for sternal wound infection (SWI) after CABG., Methods and results: Data on preoperative HbA1c and SWI were available in 2,130 patients undergoing isolated CABG from the prospective E-CABG registry. SWI occurred in 114 (5.4%). Baseline HbA1c was significantly higher in patients with SWI (mean, 54±17 vs. 45±13 mmol/mol, P<0.0001). This difference was also observed in patients without a diagnosis of diabetes (P=0.027), in insulin-dependent diabetic (P=0.023) and non-insulin-dependent diabetic patients (P=0.034). In the overall series, HbA1c >70 mmol/mol (NGSP units, 8.6%) was associated with the highest risk of SWI (20.6% vs. 4.6%; adjusted OR, 5.01; 95% CI: 2.47-10.15). When dichotomized according to the cut-off 53 mmol/mol (NGSP units, 7.0%) as suggested both for diagnosis and optimal glycemic control of diabetes, HbA1c was associated with increased risk of SWI in the overall series (10.6% vs. 3.9%; adjusted OR, 2.09; 95% CI: 1.24-3.52), in diabetic patients (11.7% vs. 5.1%; adjusted OR, 2.69; 95% CI: 1.38-5.25), in patients undergoing elective surgery (9.9% vs. 2.7%; adjusted OR, 2.09; 95% CI: 1.24-3.52) and in patients with bilateral mammary artery grafts (13.7% vs. 4.8%; adjusted OR, 2.35; 95% CI: 1.17-4.69)., Conclusions: Screening for HbA1c before CABG may identify untreated diabetic patients, as well as diabetic patients with suboptimal glycemic control, at high risk of SWI.

Importance: The optimal timing of discontinuation of ticagrelor before cardiac surgery is controversial., Objective: To evaluate the safety of preoperative use of ticagrelor with or without aspirin in patients with acute coronary syndromes (ACS) undergoing isolated coronary artery bypass grafting (CABG) compared with aspirin alone., Design, Setting, and Participants: This prospective, multicenter clinical trial was performed at 15 European centers of cardiac surgery. Participants were patients with ACS undergoing isolated CABG from the European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG) registry between January and September 2015., Exposures: Before surgery, patients received ticagrelor with or without aspirin or aspirin alone., Main Outcomes and Measures: Severe bleeding as defined by the Universal Definition of Perioperative Bleeding (UDPB) and E-CABG bleeding classification criteria. A propensity score-matched analysis was performed to adjust for differences in baseline and operative covariates., Results: Of 2482 patients from the E-CABG registry, the study cohort included 786 (31.7%) consecutive patients with ACS (mean [SD] age, 67.1 [9.3] years; range, 32-88 years), and 132 (16.8%) were female. One-to-one propensity score matching provided 215 pairs, whose baseline and operative covariates had a standardized difference of less than 10%. Preoperative use of ticagrelor was associated with a similar risk of bleeding according to the UDPB and E-CABG bleeding classifications, but the incidence of platelet transfusion was higher in the ticagrelor group (13.5% [29 of 215] vs 6.0% [13 of 215]). Compared with those receiving aspirin alone, continuing ticagrelor up to the time of surgery or discontinuing its use less than 2 days before surgery was associated with a higher risk of platelet transfusion (22.7% [5 of 22] vs 6.4% [12 of 187]) and E-CABG bleeding grades 2 and 3 (18.2% [4 of 22] vs 5.9% [11 of 187]) and tended to have an increased risk of UDPB grades 3 and 4 (22.7% [5 of 22] vs 9.6% [18 of 187]). Among patients in whom antiplatelet drug use was discontinued at least 2 days before surgery, the incidence of platelet transfusion was 12.4% (24 of 193) in the ticagrelor group and 3.6% (1 of 28) in the aspirin-alone group., Conclusions and Relevance: In propensity score-matched analyses among patients with ACS undergoing CABG, the use of preoperative ticagrelor with or without aspirin compared with aspirin alone was associated with more platelet transfusion but similar degree of bleeding; in patients receiving ticagrelor 1 day before or up until surgery, there was an increased rate of severe bleeding.

Background: The objective was to evaluate the early outcome after adult cardiac surgery in Jehovah's Witnesses (JWs) compared with controls not refusing blood transfusions., Study Design and Methods: A literature review was performed through PubMed, Scopus, and Google Scholar to identify any comparative study evaluating the outcome of JWs and patients not refusing blood transfusion after adult cardiac surgery., Results: Six studies comparing the outcome of 564 JWs and 903 controls fulfilled the inclusion criteria of this study. All series included a matched control cohort. Baseline characteristics of these two cohorts were similar, but JWs had higher hemoglobin (Hb) levels as reported in three studies. Pooled analysis of postoperative outcomes showed that JWs had higher postoperative levels of Hb (data from four studies: mean, 11.5 g/L vs. 9.8 g/L; p < 0.001) and significantly less postoperative blood loss (mean, 402 mL vs. 826 mL; p < 0.001) compared to controls. JWs and controls had similar early outcome. However, JWs had a nonsignificant trend toward decreased early mortality (2.6% vs. 3.6%; p = 0.318), reoperation for bleeding (3.2% vs. 4.7%; p = 0.070), atrial fibrillation (9.9% vs. 14.3%; p = 0.056), stroke (2.2% vs. 3.1%; p = 0.439), myocardial infarction (0.4% vs. 1.4%; p = 0.203), and length of stay in the intensive care unit (1.5 days vs. 2.0 days; p = 0.081)., Conclusion: JWs undergoing adult cardiac surgery have a nonsignificant trend toward better early outcome than controls receiving or not blood transfusions. The suboptimal quality of available studies prevents conclusive results on the possible benefits of a transfusion-free strategy in patients not refusing blood transfusion., (© 2016 AABB.)

Introduction: This study was planned to investigate the impact of severe bleeding and blood transfusion on the development of stroke after coronary surgery., Methods: This cohort study includes 2357 patients undergoing isolated CABG from the prospective European Coronary Artery Bypass Grafting (E-CABG) registry. Severity of bleeding was categorized according to the Universal Definition of Perioperative Bleeding (UDPB), E-CABG and PLATO definitions., Results: Thirty patients (1.3%) suffered postoperative stroke. The amount of transfused red blood cell (RBC) (OR 1.10, 95%CI 1.03-1.18), preoperative use of unfractioned heparin (OR 4.49, 95%CI 1.91-10.60), emergency operation (OR 3.97, 95%CI 1.47-10.74), diseased ascending aorta (OR 4.62, 95%CI 1.37-15.65) and use of cardiopulmonary bypass (p = 0.043, OR 4.85, 95%CI 1.05-22.36) were independent predictors of postoperative stroke. Adjusted analysis showed that UDPB classes 3-4 (crude rate: 3.6% vs. 1.0%; adjusted OR 2.66, 95%CI 1.05-6.73), E-CABG bleeding grades 2-3 (crudes rate: 6.3% vs. 0.9%; adjusted OR 5.91, 95%CI 2.43-14.36), and PLATO life-threatening bleeding (crude rate: 2.5% vs. 0.6%, adjusted OR 3.70, 95%CI 1.59-8.64) were associated with an increased risk of stroke compared with no or moderate bleeding., Conclusions: Bleeding and blood transfusion are associated with an increased risk of stroke after CABG, which is highest in patients with severe bleeding., (Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.)

Objective: The authors aimed to validate the European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG) classification of postoperative complications in patients undergoing coronary artery bypass grafting (CABG)., Design: Retrospective, observational study., Setting: University hospital., Participants: A total of 2,764 patients with severe coronary artery disease. Complete baseline, operative, and postoperative data were available for patients who underwent isolated CABG., Interventions: Isolated CABG., Measurements and Main Results: The E-CABG complication classification was used to stratify the severity and prognostic impact of adverse postoperative events. Primary outcome endpoints were 30-day, 90-day, and long-term all-cause mortality. The secondary outcome endpoints was the length of intensive care unit stay. Both the E-CABG complication grades and additive score were predictive of 30-day (area under the receiver operating characteristics curve 0.866, 95% confidence interval [CI] 0.829-0.903; and 0.876; 95% CI 0.844-0.908, respectively) and 90-day (area under the receiver operating characteristics curve 0.850, 95% CI 0.812-0.887; and 0.863, 95% CI 0.829-0.897, respectively) all-cause mortality. The complication grades were independent predictors of increased mortality at actuarial (log-rank: p<0.0001) and adjusted analysis (p<0.0001; grade 1: hazard ratio [HR] 1.757, 95% CI 1.111-2.778; grade 2: HR 2.704, 95% CI 1.664-4.394; grade 3: HR 5.081, 95% CI 3.148-8.201). When patients who died within 30 days were excluded from the analysis, this grading method still was associated with late mortality (p<0.0001). The grading method (p<0.0001) and the additive score (rho, 0.514; p<0.0001) were predictive of the length of intensive care unit stay., Conclusions: The E-CABG postoperative complication classification seems to be a promising tool for stratifying the severity and prognostic impact of postoperative complications in patients undergoing cardiac surgery., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Salvage coronary artery bypass grafting (CABG) is often performed for cardiogenic shock on compassionate basis without clinical data justifying this aggressive approach. The aim of this study was to analyze early and intermediate outcomes after salvage CABG. We retrospectively reviewed the data of 85 patients who underwent salvage CABG at 11 European cardiac surgery centers. Salvage CABG was defined according to the EuroSCORE criteria, that is, a procedure performed in patients requiring cardiopulmonary resuscitation (external cardiac massage) en route to the operating theater or before induction of anesthesia. A percutaneous coronary intervention procedure preceded salvage CABG in 55 patients (64.7%). Thirty patients (35.3%) died during the inhospital stay. The mean EuroSCORE II was 32.0% and the observed-to-expected ratio was 1.08. Salvage CABG was associated with high rates of postoperative stroke (9.4%), resternotomy for bleeding (23.5%), resternotomy for hemodynamic instability (15.3%), dialysis (18.8%), severe gastrointestinal complications (12.9%), and deep sternal wound infection (10.6%). Survival at 1, 3, and 5 years was 58.6%, 49.8%, and 40.9%, respectively. Twenty patients (23.5%) were postoperatively treated with extracorporeal membrane oxygenation (ECMO). The rates of adverse events after ECMO were particularly high (stroke 40%, resternotomy for bleeding 60%, dialysis 35%, gastrointestinal complications 30%, and deep sternal wound infection 30%). Of patients treated with ECMO, 8 (40%) survived to discharge, and 1-year survival was 29.2%. Salvage CABG is associated with high risk of immediate mortality and severe adverse events. However, the observed immediate and intermediate outcome justify coronary surgery in these critically ill patients. A number of these patients are currently treated by ECMO, and its results are encouraging., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objective: To examine the effect of blood products on the occurrence of stroke after coronary artery surgery., Design: Institutional retrospective analysis., Setting: University hospital., Participants: One thousand three hundred fourteen patients undergoing coronary artery surgery., Interventions: Off-pump coronary artery bypass grafting (OPCAB). Epiaortic ultrasound was performed in all patients., Measurements and Main Results: Complete pre-, intra- and postoperative data including the number of transfused blood products as well as the timing, type, and course of stroke were available in all patients. Postoperative stroke occurred in 23 patients (1.8%). Logistic regression identified transfusion of platelets (3.6% v 1.1%, p = 0.003, OR 3.34, 95%CI 1.46-7.67) and diseased ascending aorta (3.0% v 1.2%, p = 0.022, OR 2.64, 95% CI 1.15-6.06) as independent predictors of stroke. When these variables were adjusted for CHA2DS2VASc (p = 0.005, OR 1.44, 95% CI 1.12-1.86), only transfusion of platelets (p = 0.012, OR 2.91, 95% CI 1.26-6.70) was associated with stroke. Neither nadir hematocrit on the day of surgery nor nadir hematocrit during the perioperative period was an independent predictor of stroke. Chi-squared automatic interaction detection analysis identified solvent/detergent-treated plasma (Octaplas; Octapharma AG, Lachen, Switzerland) units >2 and platelet units >4 along with diseased ascending aorta as independent predictors of stroke. The stroke rate was 8.9% in patients receiving >2 units of Octaplas and having a diseased ascending aorta. In patients receiving ≤2 units of Octaplas, the stroke rate was as high as 3.8% in patients receiving >4 units of platelets., Conclusions: The results of this study indicated that atherosclerosis of the ascending aorta as well as transfusion of platelets and/or Octaplas were independent predictors of stroke after OPCAB., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: The impact of transfusion of aged red blood cells (RBCs) on the outcome after coronary artery bypass grafting (CABG) is controversial. This issue has been investigated in the present study., Materials and Methods: Data on perioperative blood transfusion, storage time of RBCs, and adverse events were available for 819 consecutive patients who underwent isolated CABG and received two to four units of RBCs. The maximum RBC storage time was 35 d., Results: Repeated-measure test showed that transfusion of all RBC units >14 d and at least one RBC unit >14 d was associated with similar postoperative C-reactive protein (P = 0.245 and P = 0.103, respectively) or creatinine levels (P = 0.414 and P = 0.259, respectively) compared with newer RBC units. Propensity score-adjusted analysis showed similar immediate and late outcome in patients receiving only newer RBCs compared with those who received only older RBCs. Similar findings were observed in patients receiving only newer RBCs compared with patients who received at least one unit of older RBCs. Logistic and proportional hazards analyses adjusted for the number of RBC units showed that the median storage duration of RBCs was not associated with either any of the immediate outcome end points or late mortality., Conclusions: These findings suggest that, when the maximum RBC storage time is 35 d, the duration of storage of transfused RBCs does not affect the immediate and late outcome of patients with moderate bleeding after CABG., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Clinical evidence in coronary surgery is usually derived from retrospective, single institutional series. This may introduce significant biases in the analysis of critical issues in the treatment of these patients. In order to avoid such methodological limitations, we planned a European multicenter, prospective study on coronary artery bypass grafting, the E-CABG registry., Design: The E-CABG registry is a multicenter study and its data are prospectively collected from 13 centers of cardiac surgery in university and community hospitals located in six European countries (England, Italy, Finland, France, Germany, Sweden). Data on major and minor immediate postoperative adverse events will be collected. Data on late all-cause mortality, stroke, myocardial infarction and repeat revascularization will be collected during a 10-year follow-up period. These investigators provided a score from 0 to 10 for any major postoperative adverse events and their rounded medians were used to stratify the severity of these complications in four grades. The sum of these scores for each complication/intervention occurring after coronary artery bypass grafting will be used as an additive score for further stratification of the prognostic importance of these events., Discussion: The E-CABG registry is expected to provide valuable data for identification of risk factors and treatment strategies associated with suboptimal outcome. These information may improve the safety and durability of coronary artery bypass grafting. The proposed classification of postoperative complications may become a valuable research tool to stratify the impact of such complications on the outcome of these patients and evaluate the burden of resources needed for their treatment., Clinical Trials Number: NCT02319083.

Objectives: We evaluated the clinical significance and identified the predictors of the universal definition of perioperative bleeding (UDPB) classes in patients undergoing isolated coronary artery bypass grafting (CABG)., Methods: Data on antithrombotic medication, perioperative bleeding, blood transfusion, and adverse events were available for 2764 patients who had undergone isolated CABG., Results: The Papworth risk score correlated significantly with the UDPB classes (rate of UDPB class 3-4 and Papworth risk score of 0, 12.1%; 1, 23.9%; 2, 37.5%; and 3, 45.0%; P<.0001). Ordinal regression showed that increased age, female sex, low body mass index, low estimated glomerular filtration rate, low hemoglobin, dialysis, urgent or emergency operation, critical status, on-pump surgery, potent antiplatelet drug pause of <5 days, and warfarin pause of <2 days were independent predictors of high UDPB classes. These risk factors also predicted UDPB classes 3-4 in logistic regression analysis. Increasing UDPB classes were associated with an increased risk of in-hospital mortality (P=.002), stroke (P=.023), low cardiac output (P<.0001), prolonged use of inotropes (P<.0001), renal replacement therapy (P<.0001), length of stay in the intensive care unit (P<.0001), and late mortality (P<.0001) as assessed by multilevel propensity score-adjusted analysis. Similar findings were observed in the propensity score-adjusted analysis for the most severe grades of perioperative bleeding (ie, UDPB class 3-4)., Conclusions: High UDPB classes were associated with significantly poorer immediate and late outcomes. The UDPB classification seems to be a valuable research tool to estimate the severity of bleeding and its prognostic impact affect after coronary surgery., (Copyright © 2014 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Increased troponin levels after coronary artery bypass surgery are associated with increased risk of early and late mortality. We hypothesized that perioperative blood transfusion is associated with increased postoperative troponin release., Methods: Complete data on perioperative blood transfusion and troponin I were available for 140 patients who underwent isolated, elective off-pump coronary artery bypass graft surgery., Results: Linear regression analysis showed that red blood cell (RBC) transfusion (p=0.007) was an independent predictor of troponin I levels on the first postoperative day. The RBC transfusion was associated with a high risk of type V myocardial infarction as indicated by troponin I levels greater than 6.6 μg/L on the first postoperative day (9 of 58 patients [15.5%] versus 1 of 82 patients [1.2%], p=0.002; adjusted analysis odds ratio 14.878, 95% confidence interval: 1.829 to 121.033). This finding did not change when hemoglobin and hematocrit nadirs were included in the analysis. Repeated-measure test showed that any blood product transfusion (p=0.040), any blood product transfusion on the operation day (p=0.025), any RBC transfusion (p=0.014), and RBC transfusion on the operation day (p=0.026) were associated with increased postoperative troponin I release. These findings persisted even after adjusting for hemoglobin and hematocrit nadirs., Conclusions: Red blood cell transfusion is associated with increased troponin I release after elective off-pump coronary artery bypass graft surgery independently of hemoglobin and hematocrit nadirs. These findings suggest that prevention of major bleeding requiring blood transfusion may be cardioprotective during coronary surgery. Further studies are needed to verify whether troponin release is affected simply by RBC transfusion or by unstable hemodynamic conditions in presence of mild and severe anemia., (Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)