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Thromboembolic events, particularly strokes, remain a major complication of transcatheter aortic valve replacement (TAVR). Embolic protection devices have failed to show significant clinical benefit in large randomized clinical trials. Aortic wall thrombus (AWT) is often observed on multidetector computed tomography during TAVR work-up, but its prognostic significance is uncertain. This study sought to evaluate the association between the presence of AWT and the incidence of thromboembolic outcomes in patients undergoing transfemoral (TF) TAVR for severe aortic stenosis. This was a prospective cohort study of consecutive patients who underwent TF TAVR for severe aortic stenosis between January 2011 and April 2022. A dedicated scale (range: 0-10) was qualitatively used to assess AWT. The primary outcome was a composite of procedural thromboembolic events defined as ischemic stroke, blue toe syndrome, bowel ischemia, or other solid organ infarction. The secondary endpoints were ischemic strokes and procedural death. Of the 641 patients included, severe AWT (score ≥8) was identified in 73 (11.4%). The presence of severe AWT was strongly associated with an increase in the primary outcome (OR: 8.48; 95% CI: 3.36-21.40; P < 0.001). This relationship persisted following multivariable analysis, which adjusted for comorbidities and procedural characteristics. The presence of severe AWT was also found to be associated with an increased incidence of stroke and procedural death (OR: 5.66; 95% CI: 2.00-15.30; P = 0.002 and OR: 4.66; 95% CI: 1.80-11.30; P = 0.002, respectively). The presence of severe AWT on preprocedural multidetector computed tomography is strongly associated with thromboembolic complications including stroke and mortality after TF TAVR. [Display omitted] [ABSTRACT FROM AUTHOR]

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Background: Unfractionated heparin has been the standard anticoagulant used immediately after mechanical heart valve replacement (MHVR). The purpose of this study was to assess a postoperative anticoagulation protocol with low-molecular-weight heparin (LMWH) immediately after MHVR without the use of unfractionated heparin or anti-factor Xa monitoring. Methods: We performed a prospective, single-center, observational study of 1,063 consecutive patients undergoing elective MHVR with postoperative LMWH anticoagulation treatment. The exclusion criteria were as follows: renal failure, intraaortic balloon counterpulsation, critical perioperative state, or a recent neurologic event. The postoperative anticoagulation protocol used subcutaneous enoxaparin as a bridging anticoagulant treatment beginning on the first postoperative day and continuing until vitamin K antagonist treatment was fully effective. Patients were followed for 6 weeks. The primary endpoints were the incidence of thromboembolic or major bleeding events. Results: Eleven (1%) thromboembolic events occurred. Ten of these events were transient or permanent strokes. Major bleeding events occurred in 44 patients (4.1%), 7 of which were observed before the enoxaparin treatment period. At the time of discharge, 570 patients (53.6%) were no longer receiving LMWH treatment due to achieving the target international normalized ratio. The mean length of hospital stay was 8.5 ± 2.9 days. There were no deaths during the 6-week follow-up period. Conclusions: In our highly selected population, after MHVR, postoperative anticoagulation using LMWH is associated with a low rate of thromboembolic and major bleeding events. This large observational study demonstrates that the use of LMWH as an anticoagulant is effective and safe after MHVR. [Copyright &y& Elsevier]

Objective: The objective of this study was to create a novel animal model to foster the future development of interventional techniques for a cavocaval connection that mimics a Fontan completion. Methods: Ten sheep were studied. All had the superior vena cava–right atrium junction closed using a polytetrafluoroethylene membrane. A valveless Gore-Tex conduit connecting the terminal portion of the superior vena cava to the right atrium was used to bypass the polytetrafluoroethylene occlusion and to allow normal venous drainage through the right atrium. Radio-opaque nitinol rings were placed around the inferior vena cava near its entry in the right atrium to allow better fluoroscopic visualization and to enhance stent stability during transcatheter cavocaval connection. Results: The first 3 animals died during the learning curve as a result of technical issues. The subsequent 7 surviving sheep showed good flow dynamics on cardiac catheterization. Transcatheter cavocaval connection was performed successfully performed in 6 sheep at 0 to 9 months after the initial surgery. Sacrifice was done electively in all animals at 1 to 9 months per protocol. One animal was euthanized early because of an untreatable infection. One sheep was observed as a control without a transcatheter cavocaval connection and was sacrificed at 12 months. Conclusions: A novel, chronic ovine model to foster development of transcatheter techniques for cavocaval connection to mimic a Fontan completion was created. The successful model is easily reproducible after a short learning curve and shows good survival. [Copyright &y& Elsevier]

Background: To date, no instrument to assess morbidity in congenital cardiac surgery has been validated. In the Aristotle system, morbidity is accounted for by a subjective assessment of length of intensive care unit stay. A previously published Morbidity Index (MI), still in development, has been derived from objective data. The present study aims to assess the feasibility and utility of the MI at a single institution and its association with the Aristotle Comprehensive Complexity (ACC) score. Methods: Patients undergoing congenital cardiac surgery at our institution were enrolled retrospectively. The MI was calculated from the nonweighted sum of its components. The ability of the ACC to predict the components was estimated. Results: The MI increased more than length of stay across procedures with increasing complexity. Renal failure requiring long-term dialysis was not observed. A requirement for temporary dialysis, which is not an MI component, correlated well with the MI (r = 0.51, p < 0.001). The ACC was a good predictor for most components of the MI: length of intensive care unit stay 3 days or more, time to extubation, postoperative extracorporeal assistance, and, for temporary dialysis, with areas under the receiver operating characteristics curve of 0.67 (0.65, 0.70), 0.71 (0.68, 0.74) , 0.84 (0.75, 0.91), and 0.83 (0.77, 0.87) respectively. Conclusions: Implementation of the MI in the Aristotle system will improve prediction of complications and long lengths of stay, making it a better morbidity indicator than length of intensive care unit stay. Requirement for temporary dialysis may be considered as an MI component. [Copyright &y& Elsevier]

Background: The Aristotle Comprehensive Complexity (ACC) and the Risk Adjustment in Congenital Heart Surgery (RACHS-1) scores have been proposed for complexity adjustment in the analysis of outcome after congenital heart surgery. Previous studies found RACHS-1 to be a better predictor of outcome than the Aristotle Basic Complexity score. We compared the ability to predict operative mortality and morbidity between ACC, the latest update of the Aristotle method and RACHS-1. Morbidity was assessed by length of intensive care unit stay. Methods: We retrospectively enrolled patients undergoing congenital heart surgery. We modeled each score as a continuous variable, mortality as a binary variable, and length of stay as a censored variable. We compared performance between mortality and morbidity models using likelihood ratio tests for nested models and paired concordance statistics. Results: Among all 1,384 patients enrolled, 30-day mortality rate was 3.5% and median length of intensive care unit stay was 3 days. Both scores strongly related to mortality, but ACC made better prediction than RACHS-1; c-indexes 0.87 (0.84, 0.91) vs 0.75 (0.65, 0.82). Both scores related to overall length of stay only during the first postoperative week, but ACC made better predictions than RACHS-1; U statistic = 0.22, p < 0.001. No significant difference was noted after adjusting RACHS-1 models on age, prematurity, and major extracardiac abnormalities. Conclusions: The ACC was a better predictor of operative mortality and length of intensive care unit stay than RACHS-1. In order to achieve similar performance, regression models including RACHS-1 need to be further adjusted on age, prematurity, and major extracardiac abnormalities. [ABSTRACT FROM AUTHOR]

Background: The Aristotle Comprehensive Complexity (ACC) score has been proposed for complexity adjustment in the analysis of outcome after congenital heart surgery. The score is the sum of the Aristotle Basic Complexity score, largely used but poorly related to mortality and morbidity, and of the Comprehensive Complexity items accounting for comorbidities and procedure-specific and anatomic variability. This study aims to demonstrate the ability of the ACC score to predict 30-day mortality and morbidity assessed by the length of the intensive care unit (ICU) stay. Methods: We retrospectively enrolled patients undergoing congenital heart surgery in our institution. We modeled the ACC score as a continuous variable, mortality as a binary variable, and length of ICU stay as a censored variable. For each mortality and morbidity model we performed internal validation by bootstrapping and assessed overall performance by R 2, calibration by the calibration slope, and discrimination by the c index. Results: Among all 1,454 patients enrolled, 30-day mortality rate was 3.4% and median length of ICU stay was 3 days. The ACC score strongly related to mortality, but related to length of ICU stay only during the first postoperative week. For the mortality model, R 2 = 0.24, calibration slope = 0.98, c index = 0.86, and 95% confidence interval was 0.82 to 0.91. For the morbidity model, R 2 = 0.094, calibration slope = 0.94, c index = 0.64, and 95% confidence interval was 0.62 to 0.66. Conclusions: The ACC score predicts 30-day mortality and length of ICU stay during the first postoperative week. The score is an adequate tool for complexity adjustment in the analysis of outcome after congenital heart surgery. [ABSTRACT FROM AUTHOR]

Obesity is suggested to reduce postoperative bleeding in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) but perioperative hemostasis variations have not been studied. Therefore, we investigated the effects of severe obesity (body mass index [BMI] ≥35kg/m2) on chest tube output (CTO) and hemostasis in patients undergoing cardiac surgery with CPB.Materials and Methods We prospectively investigated 2799 consecutive patients who underwent coronary and/or valve surgery using CPB between 2008 and 2012. 204 patients (7.3%) presented a severe obesity. Results In the severe obesity group, the 6-h and 24-h CTO were significantly reduced by -21.8% and -14.8% respectively (P<0.0001) compared with the control group. A significant reduction of the mean number of red blood cell units transfused at 24h was observed in the severe obesity groups (P=0.01). On admission to the intensive care unit, a significant increase of platelet count (+9.2%; P<0.0001), fibrinogen level (+12.2%; P<0.0001) and prothrombin time (+4.1%; P<0.01) and a significant decrease of the activated partial thromboplastin time (-4.2%; P<0.01) were observed in the severe obesity group compared with the control group. In multivariate analysis, severe obesity was significantly associated to a decreased risk of excessive bleeding (24-h CTO >90th percentile; Odds ratio: 0.37, 95% CI: 0.17 to 0.82). No significant differences were observed regarding postoperative thromboembolic events between the two groups. Conclusions Severe obesity is associated with a prothrombotic postoperative state that leads to a reduction of postoperative blood loss in patients undergoing cardiac surgery with CPB. [ABSTRACT FROM AUTHOR]

Evidence regarding the behavior of fibrinogen levels and the relation between fibrinogen levels and postoperative bleeding is limited in cardiac surgery under cardiopulmonary bypass (CPB). To evaluate perioperative fibrinogen levels as a predictor of postoperative bleeding in patients undergoing cardiac surgery with CPB.Materials and Methods In this prospective, single-center, observational cohort study of 1956 patients following cardiac surgery with CPB, fibrinogen level was measured perioperatively. Excessive bleeding group was defined as patients with a 24-h chest tube output (CTO) exceeded the 90th percentile of distribution. Results The median 24-h CTO was 728.6±431.1ml. A total of 189 patients (9.7%) were identified as having excessive bleeding. At admission to the intensive care (Day 0), the fibrinogen levels were 2.5±0.8g/l and 2.1±0.8g/l in the control and excessive bleeding groups, respectively (P<0.0001). The fibrinogen level on Day 0 was significantly correlated with the 24-h CTO (rho=-0.237; P<0.0001). Multivariate analysis demonstrated that the fibrinogen level at Day 0 was the best perioperative standard laboratory test to predict excessive bleeding (P=0.0001; odds ratio, 0.5), whereas preoperative fibrinogen level was not a predictor. Using receiver operating characteristics curve analyses, the best Day 0 fibrinogen level cutoff to predict postoperative bleeding was 2.2g/l. Conclusions In this large prospective study, the fibrinogen level upon admission to the intensive care unit after CPB predicted the risk of postoperative bleeding. Our data add to the concern regarding the fibrinogen level threshold that might require fibrinogen concentrate infusion to reduce postoperative blood loss. [ABSTRACT FROM AUTHOR]