Postoperative Atrial Fibrillation Prediction by Left Atrial Size in Coronary Artery Bypass Grafting and Five-Year Survival Outcome.

Background: Postoperative Atrial Fibrillation (POAF) is a common complication in cardiac surgery. Despite its multifactorial origin, the left atrial (LA) size is closely linked to POAF, raising the question of a valid cut-off value and its impact on the long-term outcome. Methods: Patients without a history of AF who underwent coronary artery bypass grafting between 2014 and 2016 were selected for this retrospective study. LA size was preoperatively assessed using the left atrial anterior-posterior diameter (LAAPd). Correlation and logistic regression analyses were performed, following a receiver-operating characteristic (ROC) analysis. Propensity score matching (PSM) was applied to ensure group comparability, followed by a comparison analysis regarding the primary endpoint of POAF and the secondary endpoints of all-cause mortality and stroke during a five-year follow-up. Results: A total of 933 patients were enrolled in the study eventually revealing a significant correlation between LAAPd and POAF (cor = 0.09, p < 0.01). A cut-off point of 38.5 mm was identified, resulting in groups with 366 patients each after PSM. Overall, patients with a dilated LA presented a significantly higher rate of POAF (22.3% vs. 30.4%, p = 0.02). In a five-year follow-up, a slightly higher rate of all-cause mortality (9.8% vs. 13.7%, HR 1.4 [0.92-2.29], p = 0.10) was observed, but there was no difference in the occurrence of strokes (3.6% vs. 3.3%, p = 0.87). Conclusions: An LAAPd of >38.5 mm was found to be an independent predictor of POAF after coronary artery bypass grafting and resulted in a non-significant tendency towards a worse outcome regarding all-cause mortality in a five-year follow-up.

Off-pump coronary artery bypass grafting with clampless aortic anastomosis devices: Aortic sealing devices versus automated anastomosis punching.

Objectives: Clampless aortic anastomosis devices aim to lower stroke risk in off-pump coronary artery bypass grafting. Two main strategies for clampless anastomosis devices emerged with automated anastomosis punching and aortic sealing devices, prompting the question of perioperative outcome differences. Methods: All consecutive patients undergoing elective off-pump coronary artery bypass grafting with a clampless aortic anastomosis device between September 2014 and December 2021 in 2 centers were retrospectively included. Cohorts were divided by the use of an automated anastomosis punching device or an aortic sealing device to achieve proximal anastomosis on the ascending aorta. To reach group comparability propensity score matching was performed. The primary end point was defined as a composite of all-cause mortality, stroke and rethoracotomy. Secondary end points were perioperative outcome parameters. Results: A total of 3703 patients were enrolled of whom 575 and 3128 were included in the automated anastomosis punching and the aortic sealing device group, respectively. By propensity score matching a total of 1150 patients were included with 575 in each group. The primary composite endpoint showed no significant difference with 6.3% versus 5.9% events (odds ratio, 0.9; 95% confidence interval, 0.58-1.53, P = .81). All-cause mortality (P = .36), stroke (P = .81), and rethoracotomy (P = .89) also exhibit no disparity. Operation time was significantly longer in the aortic sealing device cohort with 220.0 ± 50.8 minutes and 204.6 ± 53.8 minutes (P < .01). Conclusions: Clampless aortic anastomosis strategies aortic sealing device and automated anastomosis punching did not differ in perioperative outcome parameters, whereas the implementation of aortic sealing devices were associated with a prolonged operation time without inducing any inferior clinical outcome.

Five-year-outcome of new-onset perioperative atrial fibrillation after left atrial appendage amputation concomitant with cardiac surgery.

BACKGROUND: Recent data demonstrated the benefit of left atrial appendage (LAA)-amputation in patients with atrial fibrillation (AF). However, the long-term impact of LAA-amputation for patients with new-onset perioperative atrial fibrillation (POAF) is still unknown. METHODS: Patients with no history of AF undergoing coronary artery bypass grafting by off-pump technique (OPCAB) between 2014 and 2016 were retrospectively examined. Cohorts were divided by the concomitant execution of LAA-amputation. Propensity score (PS) matching was applied by all available baseline characteristics. The composite of all-cause mortality, stroke and rehospitalization in patients with POAF and patients maintaining sinus rhythm posed as the primary endpoint. RESULTS: A total of 1522 patients were enrolled, of whom 1208 and 243 were included in the control and the LAA-amputation group, respectively and were matched to 243 patients in each group. In total, patients with POAF without LAA-amputation showed a significantly higher rate of the composite endpoint (17.3% vs 32.1%, p = 0.007). However, patients with LAA-amputation showed no significant difference in the composite endpoint (23.2% vs 26.7%, p = 0.57). The significantly higher occurrence of the composite endpoint was driven by all-cause mortality (p = 0.005) and rehospitalization (p = 0.029). Subgroup analysis revealed a CHA2DS2-VASc-score of ≥ 3 to be associated with the high rate of the primary endpoint (p = 0.004). CONCLUSION: POAF is associated with a higher rate of the combined endpoint of all-cause mortality, stroke and rehospitalization. The composite endpoint in patients with LAA-amputation concomitant with OPCAB surgery developing new-onset POAF in a 5-year follow-up was not increased compared to a control cohort maintaining sinus rhythm. Five-year outcome of patients with POAF and LAA-amputation; 95% CI, 95% confidence interval, CPR, cardiopulmonary resuscitation, ECLS, extracorporeal life support, HR, hazard ratio, IABP, intra-aortic balloon pump, LAA, left atrial appendage, OPCAB, off-pump coronary artery bypass grafting, PAPs, systolic pulmonary artery pressure, SR, sinus rhythm, VT, ventricular tachycardia.

Statin loading before coronary artery bypass grafting: a randomized trial.

AIMS: Evidence suggests that a high-dose statin loading before a percutaneous coronary revascularization improves outcomes in patients receiving long-term statins. This study aimed to analyse the effects of such an additional statin therapy before surgical revascularization. METHODS AND RESULTS: This investigator-initiated, randomized, double-blind, and placebo-controlled trial was conducted from November 2012 to April 2019 at 14 centres in Germany. Adult patients (n = 2635) with a long-term statin treatment (≥30 days) who were scheduled for isolated coronary artery bypass grafting (CABG) were randomly assigned to receive a statin-loading therapy or placebo at 12 and 2 h prior to surgery using a web-based system. The primary outcome of major adverse cardiac and cerebrovascular events (MACCE) was a composite consisting of all-cause mortality, myocardial infarction (MI), and a cerebrovascular event occuring within 30 days after surgery. Key secondary endpoints included a composite of cardiac death and MI, myocardial injury, and death within 12 months. Non-statistically relevant differences were found in the modified intention-to-treat analysis (2406 patients; 1203 per group) between the statin (13.9%) and placebo groups (14.9%) for the primary outcome [odds ratio (OR) 0.93, 95% confidence interval (CI) 0.74-1.18; P = 0.562] or any of its individual components. Secondary endpoints including cardiac death and MI (12.1% vs. 13.5%; OR 0.88, 95% CI 0.69-1.12; P = 0.300), the area under the troponin T-release curve (median 0.398 vs. 0.394 ng/ml, P = 0.333), and death at 12 months (3.1% vs. 2.9%; P = 0.825) were comparable between treatment arms. CONCLUSION: Additional statin loading before CABG failed to reduce the rate of MACCE occuring within 30 days of surgery.

Left atrial appendage amputation concomitant with cardiac surgery in patients with sinus rhythm.

OBJECTIVES: Since recent data demonstrated the benefit of the amputation of the left atrial appendage (LAA) in patients with atrial fibrillation, the long-term impact of LAA amputation on stroke rate and mortality in patients with no history of atrial fibrillation is still unknown. METHODS: Patients with no history of atrial fibrillation who underwent coronary artery bypass grafting by the off-pump technique between 2014 and 2016 were examined retrospectively. Cohorts were divided by the concomitant execution of LAA amputation, and propensity score matching was applied by baseline characteristics. The stroke rate in a 5-year follow-up served as the primary end point. Secondary end points were the mortality rate and rehospitalization in the same time span. RESULTS: A total of 1,522 patients were enrolled, of whom 1,267 and 255 were included in the control group and in the LAA amputation group, respectively. These were matched to 243 patients in each group. In total, patients with an LAA amputation showed a significantly lower rate of stroke in a 5-year follow-up [7.0% vs 2.9%, hazard ratio, 0.41; 95% confidence interval (0.17; 0.98), p = 0.045]. However, there was no difference in all-cause mortality (P = 0.23) or rehospitalizations (P = 0.68). Subgroup analysis revealed LAA amputation in patients with a CHA2DS2VASc [congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female)] score of ≥3 to be associated with a reduction of stroke [9.4% vs 3.1%, hazard ratio, 0.33; 95% confidence interval [0.12; 0.92], P = 0.034]. CONCLUSIONS: LAA amputation concomitant with cardiac surgery reduces the stroke rate in patients with no history of atrial fibrillation and a high CHA2DS2VASc score (≥3) in a 5-year follow-up.

Impact of Left Atrial Appendage Amputation on Left Atrial Morphology and Rhythm after Off-Pump CABG.

OBJECTIVES: Left atrial appendage (LAA) amputation concomitant to coronary artery bypass grafting (CABG) has become an increasingly performed technique in patients with atrial fibrillation (AF) or with sinus rhythm and a CHA2DS2-VASc score ≥2. However, LAA amputation has come under suspicion to cause postoperative atrial fibrillation (POAF) due to left atrial (LA) dilation. This study aims to assess this assumption in patients undergoing CABG in off-pump technique with and without amputation of the LAA. METHODS: Patients who underwent isolated CABG in off-pump technique without history of AF were retrospectively examined. Cohorts were divided according to the concomitant execution of LAA amputation. LA volume was measured by transthoracic echocardiography and rhythm was analyzed by electrocardiography, medication protocol, and visit documentation. Propensity score (PS) matching was performed based on 20 preoperative risk variables to correct for selection bias. RESULTS: A total of 1,522 patients were enrolled, with 1,267 in the control group and 255 in the LAA amputation group. Occurrence of POAF was compared in 243 PS-matched patient pairs. Neither the unmatched cohort (odds ratio [OR] 0.82; 95% confidence interval or CI [0.61; 1.11], p = 0.19) nor the PS-matched cohort (OR 0.94; 95% CI [0.62; 1.41], p = 0.75) showed significant differences in POAF occurrence. Subgroup analysis of sex, use of ß-blockers, pulmonary disease, ejection fraction, and CHA2DS2-VASc-Score also showed no tendencies. LA volume did not change significantly (p = 0.18, 95% CI [-0.29; 1.51]). CONCLUSION: Surgical amputation of the LAA concomitant to CABG did not lead to LA dilation and has no significant impact on the occurrence of POAF.

Surgical technique for acute retrograde type A aortic dissection after zone 2 TEVAR for complicated type B dissection in a 63-year-old patient.

Patients suffering retrograde type A aortic dissection after TEVAR for type B dissection are at higher risk of mortality than their spontanous counterparts and the kind of optimal therapy remains obscure. We present a case of successful open surgical repair where distal open anastomosis was accomplished by cutting off the un-covered stent portion and suturing a vascular prosthesis to the dissected distal aortic arch including the covered stent part. The clinical course was regular. Immediate and radical repair in the aortic arch may be the adequate response in such instances.

Risk-adjusted analysis of long-term outcomes after on- versus off-pump coronary artery bypass grafting.

OBJECTIVES: Recent data suggested that off-pump coronary artery bypass (OPCAB) may carry a higher risk for mortality in the long term when compared to on-pump coronary artery bypass (ONCAB). We, therefore, compared long-term survival and morbidity in patients undergoing ONCAB versus OPCAB in a large single-centre cohort. METHODS: A total of 8981 patients undergoing isolated elective/urgent coronary artery bypass grafting between January 2009 and December 2019 were analysed. Patients were stratified into 2 groups (OPCAB n = 6649/ONCAB n = 2332). The primary end point was all-cause mortality. Secondary endpoints included repeat revascularization, stroke and myocardial infarction. To adjust for potential selection bias, 1:1 nearest neighbour propensity score (PS) matching was performed resulting in 1857 matched pairs. Moreover, sensitivity analysis was applied in the entire study cohort using multivariable- and PS-adjusted Cox regression analysis. RESULTS: In the PS-matched cohort, 10-year mortality was similar between study groups [OPCAB 36.4% vs ONCAB 35.8%: hazard ratio (HR) 0.99, 95% confidence interval (CI) 0.87-1.12; P = 0.84]. While 10-year outcomes of secondary endpoints did not differ significantly, risk of stroke (OPCAB 1.50% vs ONCAB 2.8%: HR 0.51, 95% CI 0.32-0.83; P = 0.006) and mortality (OPCAB 3.1% vs ONCAB 4.8%: HR 0.65, 95% CI 0.47-0.91; P = 0.011) at 1 year was lower in the OPCAB group. In the multivariable- and the PS-adjusted model, mortality at 10 years was not significantly different (OPCAB 34.1% vs ONCAB 35.7%: HR 0.97, 95% CI 0.87-1.08; P = 0.59 and HR 1.01, 95% CI 0.90-1.13; P = 0.91, respectively). CONCLUSIONS: Data do not provide evidence that elective/urgent OPCAB is associated with significantly higher risks of mortality, repeat revascularization, or myocardial infarction during late follow-up when compared to ONCAB. Patients undergoing OPCAB may benefit from reduced risks of stroke and mortality within the first year postoperatively.

Dissection of the Left Coronary Artery after Surgical Aortic Valve Replacement.

Our report presents a 73-year-old female patient with severe aortic stenosis who was admitted to our department for a surgical aortic valve replacement. After an uneventful surgery, a worsening low cardiac output syndrome with signs of myocardial ischemia occurred. Immediate angiography revealed a diffuse left coronary dissection starting from the ostium extending to the periphery of the left coronary system. The diffuse nature of the dissection ruled interventional management out and thus has been treated with urgent coronary bypass surgery. However, after an antecedent favorable course, the patient died 2 months later due to pneumonia resulting in septic shock.

Circulating antibodies against age-modified proteins in patients with coronary atherosclerosis.

Advanced glycation endproducts (AGEs) are formed in a series of non-enzymatic reactions between reducing sugars and the amino groups of proteins and accumulate during aging, diabetes mellitus, chronic kidney disease and other chronic diseases. Accumulation of AGE-modifications alters protein structure and function, transforming these molecules into potential targets of the immune system, presumably triggering the production of autoantibodies against AGEs. In this study, we detected autoantibodies against AGE-modified proteins with ELISA in plasma samples of 91 patients with documented coronary artery disease (CAD), who underwent coronary artery bypass grafting (CABG) surgery. Patients with high levels of autoantibodies had a higher body mass index (BMI 28.6 vs 27.1 kg/m2; p = 0.046), were more likely to suffer from chronic obstructive pulmonary disease (COPD 30% vs 9.8%; p = 0.018), and more likely to need dialysis after the surgery (10% vs 0%; p = 0.037). Our findings show a weak link between the levels of autoantibodies against AGEs and diabetes mellitus (DM 44% vs 24.4%; p = 0.05). In a small subpopulation of patients, antibodies against native bovine serum albumin (BSA) were detected. A growing body of research explores the potential role of antibodies against AGE-modified proteins in pathogenesis of different chronic diseases; our data confirms the presence of AGE-autoantibodies in patients with CAD and that in parallel to the AGEs themselves, they may have a potential role in concomitant clinical conditions in patients undergoing CABG surgery. Further research is necessary to verify the molecular role of these antibodies in different pathological conditions.

Off-pump Revascularization with Bilateral versus Single Mammary Arteries-A Propensity Score-Matched Analysis.

BACKGROUND: Coronary artery bypass grafting is the first-line therapy for severe multivessel coronary artery disease. We aimed to investigate the clinical outcome in patients undergoing isolated off-pump surgery with the single or bilateral internal mammary artery (SIMA or BIMA) approach. METHODS: We performed a propensity score-matched analysis in 1,852 consecutive patients, aged 50 to 70 years, who underwent myocardial revascularization at our institution between July 2009 and August 2016. Primary end point was the probability of survival. RESULTS: Mean follow-up was 36.3 (range: 0.1-89.6) months. The probability of survival in the SIMA and BIMA groups was 98.6 and 99.0% at year 1, 92.0 and 92.5% at year 5, and 85.6 and 81.6% at year 7, respectively, with a hazard ratio (HR) of mortality for the BIMA group versus the SIMA group of 0.98 (95% confidence interval[CI]: 0.64-1.52; p = 0.94). There was evidence for interaction between diabetes and study group on mortality risk (HR = 2.59, 95% CI: 1.07-6.23; p = 0.034). Freedom from mediastinitis/wound infection was higher in the SIMA group than in the BIMA group (99.5 and 96.9%, respectively; HR of an event = 6.39, 95% CI: 2.88-14.18; p < 0.001). The corresponding values in the subgroups of diabetic patients were 98.6 and 90.9%, respectively (HR = 6.45, 95% CI: 2.24-18.58; p = 0.001). Mediastinitis/wound infection was associated with increased mortality risk (HR = 2.96, 95% CI: 1.29-6.78; p = 0.010). CONCLUSION: Overall, our data indicate similar probability of survival up to a maximum follow-up of 7 years by off-pump surgery with the SIMA or BIMA approach. However, in diabetic patients, the clinical outcome indicates caution regarding the use of the BIMA approach.

Transcatheter Aortic Valve Implantation in Patients With Pre-Existing Mechanical Mitral Valve Prostheses.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) has become standard therapy for aortic stenosis patients with intermediate or high operative risk. Treatment of patients with pre-existing mechanical mitral valve replacement (MVR) is challenging due to possible interference between the TAVI prosthesis and MVR. We present our single-center experience with this special patient cohort. METHODS: A total of 1960 patients underwent TAVI at our institution between 2009 and March 2018; of these, 16 patients had pre-existing mechanical MVR. Device success and adverse events were analyzed according to the Valve Academic Research Consortium (VARC)-2 criteria. Patients were followed for at least 12 months. RESULTS: Mean patient age was 81.5 ± 4.4 years. The patients had a mean logistic EuroScore of 37.1 ± 13.5% and STS score of 7.1 ± 3.2%. Successful valve deployment was achieved in all patients, peri-interventional stroke rate was 0.0%, and permanent pacemaker was implanted in 2 patients (12.5%). Two patients experienced major complications, with blockage of the MVR disc in 1 patient and annulus rupture in 1 patient. Hence, 30-day mortality was 12.5% and 1-year mortality was 25.0%. CONCLUSION: TAVI in patients with mechanical MVR is challenging and requires careful preparation and choice of TAVI device. Repositionable and retrievable devices seem to be a safer option.

Incidence and outcome of peri-procedural transcatheter heart valve embolization and migration: the TRAVEL registry (TranscatheteR HeArt Valve EmboLization and Migration).

AIMS: Peri-procedural transcatheter valve embolization and migration (TVEM) is a rare but potentially devastating complication of transcatheter aortic valve implantation (TAVI). We sought to assess the incidence, causes, and outcome of TVEM in a large multicentre cohort. METHODS AND RESULTS: We recorded cases of peri-procedural TVEM in patients undergoing TAVI between January 2010 and December 2017 from 26 international sites. Peri-procedural TVEM occurred in 273/29 636 (0.92%) TAVI cases (age 80.8 ± 7.3 years; 53.8% female), of which 217 were to the ascending aorta and 56 to the left ventricle. The use of self-expanding or first-generation prostheses and presence of a bicuspid aortic valve were independent predictors of TVEM. Bail-out measures included repositioning attempts using snares or miscellaneous tools (41.0%), multiple valve implantations (83.2%), and conversion to surgery (19.0%). Using 1:4-propensity matching, we identified a cohort of 235 patients with TVEM (TVEMPS) and 932 patients without TVEM (non-TVEMPS). In the matched cohort, all-cause mortality was higher in TVEMPS than in non-TVEMPS at 30 days (18.6% vs. 4.9%; P < 0.001) and after 1 year (30.5% vs. 16.6%; P < 0.001). Major stroke was more frequent in TVEMPS at 30 days (10.6% vs. 2.8%; P < 0.001), but not at 1 year (4.6% vs. 1.9%; P = 0.17). The need for emergent cardiopulmonary support, major stroke at 30 days, and acute kidney injury Stages 2 and 3 increased the risk of 1-year mortality, whereas a better renal function at baseline was protective. CONCLUSION: Transcatheter valve embolization and migration occurred in approximately 1% and was associated with increased morbidity and mortality.

Outcomes of left main revascularization in patients with acute coronary syndromes and stable ischemic heart disease: Analysis from the EXCEL trial.

BACKGROUND: Prompt revascularization is often required in acute coronary syndromes (ACS), whereas stable ischemic heart disease (SIHD) may allow for more measured procedural planning. Whether the acuity of presentation preferentially affects outcomes after coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) in patients with left main coronary artery disease (LMCAD) is unknown. We investigated whether the acuity of presentation discriminated patients who derived a differential benefit from PCI versus CABG in the randomized Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial. METHODS: We used multivariable Cox models to assess the interaction between the acuity of presentation, type of revascularization and outcomes in patients with low or intermediate SYNTAX scores enrolled in EXCEL. RESULTS: At baseline, 1151 patients (60.7%) presented with SIHD and 746 patients (39.3%) presented with an ACS. The acuity of presentation was not associated with the primary endpoint of all-cause death, MI, or stroke at 3 years (multivariable adjusted hazard ratio [HR] 0.94; 95% CI 0.70-1.26, P = .64). The primary endpoint rate was similar in patients assigned to PCI versus CABG whether they presented with SIHD (adjusted HR 1.04; 95% CI 0.73-1.48]) or with ACS (HR 0.82; 95% CI 0.54-1.26) (Pinteraction = .34). CONCLUSIONS: The acuity of presentation did not predict outcomes in patients with LMCAD undergoing revascularization, nor did it discriminate patients who derive greater event-free survival from PCI versus CABG.

Five-Year Outcome After Off-Pump or On-Pump Coronary Artery Bypass Grafting in Elderly Patients.

BACKGROUND: The 30-day and 1-year follow-up analysis of the GOPCABE trial (German Off-Pump Coronary Artery Bypass Grafting in Elderly Patients) revealed no significant difference in the composite end point consisting of death, stroke, myocardial infarction, new renal replacement therapy, or repeat revascularization. The 5-year follow-up data of this trial are reported here. METHODS: From June 2008 to September 2011, a total of 2539 patients aged ≥75 years were randomly assigned to undergo off-pump or on-pump coronary artery bypass grafting (CABG) at 12 centers in Germany. The primary outcome was all-cause mortality at 5 years. The secondary 5-year outcomes were a composite of death, myocardial infarction, and repeat revascularization. Furthermore, the impact of complete versus incomplete revascularization was assessed. RESULTS: After a median follow-up of 5 years, 361 patients (31%) assigned to off-pump CABG and 352 patients (30%) assigned to on-pump CABG had died (hazard ratio off-pump/on-pump CABG, 1.03; 95% CI, 0.89-1.19; P=0.71). The composite outcome of death, myocardial infarction, and repeat revascularization occurred in 397 (34%) after off-pump and in 389 (33%) after on-pump CABG (hazard ratio, 1.03; 95% CI, 0.89-1.18; P=0.704). Incomplete revascularization occurred in 403 (34%) patients randomly assigned to off-pump and 354 (29%) patients randomly assigned to on-pump CABG ( P<0.001). Five-year survival rates were 72% (95% CI, 67-76) with incomplete versus 76% (95% CI, 74-80) with complete revascularization (log-rank test: P=0.02) after off-pump CABG and 72% (95% CI, 67-76) versus 77% (95% CI, 74-80) after on-pump CABG (log-rank test: P=0.03), respectively. Cox regression analysis revealed a hazard ratio incomplete/complete revascularization of 1.19 (95% CI, 1.01-1.39; P=0.04). CONCLUSIONS: In elderly patients ≥75 years of age, the 5-year survival rates and the combined outcome of death, myocardial infarction, and repeat revascularization, as well, were similar after on-pump and off-pump CABG. Incomplete revascularization was associated with a lower 5-year survival rate, irrespective of the type of surgery. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00719667.

Risk factors for adverse outcomes after left ventricular assist device implantation and extracorporeal cardiopulmonary resuscitation.

Left ventricular assist device implantation following extracorporeal cardiopulmonary resuscitation has been associated with ambivalent results. In a series of patients who underwent left ventricular assist device implantation after extracorporeal cardiopulmonary resuscitation, we investigated whether the outcome can be predicted by preoperative risk factors or established risk scores. Primary endpoint was a composite of mortality and severe neurological disabling over 1 year of follow-up. To assess predictors of the primary endpoint, we performed univariate and multivariable Cox regression analyses. Of the 40 patients included, 24 patients (60%) experienced the primary endpoint. Renal replacement therapy and the Vasoactive-Inotropic Score were independently associated regarding the primary endpoint with a hazard ratio for renal replacement therapy of 2.50 (95% confidence interval: 1.09-5.70; P = 0.021) and for the Vasoactive-Inotropic Score of 1.02 per unit (95% confidence interval: 1.00-1.03; P = 0.040). The risk of experiencing an unfavorable outcome during follow-up in patients with a Vasoactive-Inotropic Score of 20 who needed renal replacement therapy or did not need renal replacement therapy was 78% and 54%, respectively. Our data indicate that a decision to implant a left ventricular assist device in patients requiring renal replacement therapy and revealing a high Vasoactive-Inotropic Score after extracorporeal cardiopulmonary resuscitation should be reached with caution.

Vitamin D supplementation does not prevent the testosterone decline in males with advanced heart failure: the EVITA trial.

PURPOSE: Observational studies indicate a positive association between circulating 25-hydroxyvitamin D (25OHD) and testosterone (T) concentrations. Because low 25OHD concentrations and T deficiency are considered to be a generalized phenomenon in patients with advanced heart failure (HF), we aimed to investigate whether vitamin D supplementation has beneficial effects on T indices in these patients. METHODS: In a pre-specified secondary analysis of the EVITA (effect of vitamin D on mortality in heart failure) randomized controlled trial, we analyzed in male subjects with 25OHD concentrations < 75 nmol/L the effect of a daily vitamin D3 supplement of 4000 IU for 3 years (n = 71) vs. placebo (n = 62) on total T (TT), sex hormone-binding globulin (SHBG), free T (fT), and bioactive T (BAT). We assessed changes from baseline until study termination and between-group differences at study termination. RESULTS: 25OHD increased in the placebo group from 36.6 nmol/L by 9.2 nmol/L (95% CI 3.2-15.1 nmol/L; P = 0.003) and in the vitamin D group from 36.5 nmol/L by 63.9 nmol/L (95% CI 52.6-75.3 nmol/L; P < 0.001), with a significant between-group difference at study termination (P < 0.001). TT and SHBG concentrations did not change significantly, neither in the placebo group nor in the vitamin D group (P = 0.845-0.082), but concentrations of fT and BAT declined significantly in both groups (P = 0.025-0.008). At study termination, there were no between-group differences in TT (P = 0.612), SHBG (P = 0.393), fT (P = 0.861), or BAT (P = 0.960). CONCLUSIONS: In male patients with advanced HF and low 25OHD concentrations, a daily vitamin D3 supplement of 4000 IU for 3 years did not prevent the decline in testosterone indices.