Sleep apnea in patients undergoing coronary artery bypass grafting: Impact on perioperative outcomes.

Sleep-disordered breathing is common in patients with coronary artery disease undergoing coronary artery bypass grafting. Sleep-disordered breathing is associated with increased perioperative morbidity, arrhythmias (e.g. atrial fibrillation) and mortality. This study investigated the impact of sleep-disordered breathing on the postoperative course after coronary artery bypass grafting, including development of atrial fibrillation. This prospective single-centre cohort study included adults undergoing coronary artery bypass grafting. All were screened for sleep-disordered breathing (polygraphy) and atrial fibrillation (electrocardiogram) preoperatively; those with known sleep-disordered breathing or atrial fibrillation were excluded. Endpoints included new-onset atrial fibrillation, duration of mechanical ventilation, time in the intensive care unit, and postoperative infection. Regression analysis was performed to identify associations between sleep-disordered breathing and these outcomes. A total of 508 participants were included (80% male, median age 68 years). The prevalence of any (apnea-hypopnea index ≥ 5 per hr), moderate (apnea-hypopnea index = 15-30 per hr) and severe (apnea-hypopnea index > 30 per hr) sleep-disordered breathing was 52.9%, 9.3% and 10.2%, respectively. All-cause 30-day mortality was 0.98%. After adjustment for age and sex, severe sleep-disordered breathing was associated with longer respiratory ventilation support (crude odds ratio [95% confidence interval] 5.28 [2.18-12.77]; p < 0.001) and higher postoperative infection rates (crude odds ratio 3.32 [1.45-7.58]; p < 0.005), but not new-onset atrial fibrillation or mortality. New-onset atrial fibrillation was significantly associated with postoperative infection and prolonged hospital stay. The significant associations between sleep-disordered breathing and several adverse outcomes after coronary artery bypass grafting support the need for preoperative sleep-disordered breathing screening in individuals undergoing cardiac surgery.

The Efficacy and Safety of a Low-Dose Tranexamic Acid Bolus-Only Protocol Compared with the Moderate-Dose Protocol in Valvular Heart Surgery.

In 873 propensity score-matched pairs of patients undergoing valvular heart surgery, we compared a "moderate dose" of tranexamic acid (TXA) protocol (group 1; median TXA dose: 24 mg/kg body weight) with a 1.5-g "bolus-only" protocol (group 2; median TXA dose: 19 mg/kg body weight). The number of transfused patients was higher in group 2 than in group 1 (74.5 vs 66.0%, p < 0.001), as was the number of transfused red blood cell concentrates (p = 0.001). The risks of re-exploration and convulsive seizures were similar between groups (p > 0.50). Data indicate an impaired efficacy following the "bolus-only" protocol, without a significant safety improvement.

Early and Late Results after Surgical Mitral Valve Repair: A High-Volume Center Experience.

BACKGROUND: Surgical mitral valve repair is the gold standard treatment of severe primary mitral regurgitation (MR). In the light of rapidly evolving percutaneous technologies, current surgical outcome data are essential to support heart-team-based decision-making. METHODS: This retrospective, high-volume, single-center study analyzed in 1779 patients with primary MR early morbidity and mortality, postoperative valve function, and long-term survival after mitral valve (MV) repair. Surgeries were performed between 2009 and 2022. Surgical approaches included full sternotomy (FS) and right-sided minithoracotomy (minimally invasive cardiac [MIC] surgery). RESULTS: Of the surgeries (mean age: 59.9 [standard deviation:11.4] years; 71.5% males), 85.6% (n = 1,527) were minithoracotomies. Concomitant procedures were performed in 849 patients (47.7%), including tricuspid valve and/or atrial septal defect repair, cryoablation, and atrial appendage closure. The majority of patients did not need erythrocyte concentrates. Mediastinitis and rethoracotomy for bleeding rates were 0.1 and 4.3%, respectively. Reoperation before discharge for failed repair was necessary in 12 patients (0.7%). Freedom from more than moderate MR was > 99%. Thirty-day mortality was 0.2% and did not differ significantly between groups (p = 0.37). Median follow-up was 48.2 months with a completeness of 95.9%. Long-term survival was similar between groups (p = 0.21). In the FS and MIC groups, 1-, 5-, and 10-year survival rates were 98.8 and 98.8%, 92.9 and 94.4%, and 87.4 and 83.1%, respectively. CONCLUSION: MV surgery, both minimally invasive and via sternotomy, is associated with high repair rates, excellent perioperative outcomes, and long-term survival. Data underscore the effectiveness of surgical repair in managing MR, even in the era of advancing interventional techniques.

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.

Cytokine Hemoadsorption During Cardiac Surgery Versus Standard Surgical Care for Infective Endocarditis (REMOVE): Results From a Multicenter Randomized Controlled Trial.

BACKGROUND: Cardiac surgery often represents the only treatment option in patients with infective endocarditis (IE). However, IE surgery may lead to a sudden release of inflammatory mediators, which is associated with postoperative organ dysfunction. We investigated the effect of hemoadsorption during IE surgery on postoperative organ dysfunction. METHODS: This multicenter, randomized, nonblinded, controlled trial assigned patients undergoing cardiac surgery for IE to hemoadsorption (integration of CytoSorb to cardiopulmonary bypass) or control. The primary outcome (change in sequential organ failure assessment score [ΔSOFA]) was defined as the difference between the mean total postoperative SOFA score, calculated maximally to the 9th postoperative day, and the basal SOFA score. The analysis was by modified intention to treat. A predefined intergroup comparison was performed using a linear mixed model for ΔSOFA including surgeon and baseline SOFA score as fixed effect covariates and with the surgical center as random effect. The SOFA score assesses dysfunction in 6 organ systems, each scored from 0 to 4. Higher scores indicate worsening dysfunction. Secondary outcomes were 30-day mortality, duration of mechanical ventilation, and vasopressor and renal replacement therapy. Cytokines were measured in the first 50 patients. RESULTS: Between January 17, 2018, and January 31, 2020, a total of 288 patients were randomly assigned to hemoadsorption (n=142) or control (n=146). Four patients in the hemoadsorption and 2 in the control group were excluded because they did not undergo surgery. The primary outcome, ΔSOFA, did not differ between the hemoadsorption and the control group (1.79±3.75 and 1.93±3.53, respectively; 95% CI, -1.30 to 0.83; P=0.6766). Mortality at 30 days (21% hemoadsorption versus 22% control; P=0.782), duration of mechanical ventilation, and vasopressor and renal replacement therapy did not differ between groups. Levels of interleukin-1ß and interleukin-18 at the end of integration of hemoadsorption to cardiopulmonary bypass were significantly lower in the hemoadsorption than in the control group. CONCLUSIONS: This randomized trial failed to demonstrate a reduction in postoperative organ dysfunction through intraoperative hemoadsorption in patients undergoing cardiac surgery for IE. Although hemoadsorption reduced plasma cytokines at the end of cardiopulmonary bypass, there was no difference in any of the clinically relevant outcome measures. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03266302.

High Efficacy and Low Early Mortality in High-Volume Center Tricuspid Valve Surgery.

BACKGROUND: Isolated tricuspid valve surgery has been associated with early mortality rates of up to 10%. With rapidly emerging interventional catheter-based options, the question arises whether current technical and perioperative protocols in cardiac surgery translate into lower than previously expected mortality rates, especially when looking at data from high-volume centers. METHODS: We performed a retrospective single-center analysis in 369 patients undergoing isolated tricuspid valve repair (n = 256) or replacement (n = 113) between 2009 and 2021. Surgical approaches included full sternotomy, as well as right-sided minithoracotomy. According to a recently introduced clinical risk score, patients were divided into scoring groups, and observed (O) versus expected (E) early mortality were compared. Pre- and postoperative tricuspid valve function was also analyzed. RESULTS: Overall, 30-day mortality was 4.1%, ranging from 0% (scoring group 0-1 points) to 8.7% (scoring group ≥ 10 points), which was substantially lower than the expected early mortality (2% in the lowest to 34% in the highest scoring group). Preoperative tricuspid regurgitation was severe in 71.3% (n = 263), moderate to severe in 14.9% (n = 55), and mild or less in 6.5% (n = 24). The corresponding postoperative values were 0% (n = 0), 1.4% (n = 5), and 81.6% (n = 301). CONCLUSION: Our high-volume center data indicate substantially lower than predicted 30-day mortality in different cardiac surgical risk scoring groups. The majority of patients had zero to minimal residual tricuspid valve insufficiency postoperatively. Randomized controlled trials are needed to compare tricuspid valve functional results and long-term outcomes of surgical versus interventional procedures in patients undergoing isolated tricuspid valve procedures.

Papillary Muscle Heads Focalization for Functional Mitral Regurgitation with Severe Tethering.

We performed "Papillary muscle heads focalization" for three patients with severe functional mitral regurgitation with severe leaflet tethering (coaptation distance ≥1 cm and/or posterior leaflet angle ≥45 degrees). All separated papillary muscle heads were sutured together and both the anterolateral and posteromedial papillary muscles were reconstructed as single head papillary muscles. The stitches are positioned to adjust the levels of mitral leaflet tips, concerning the length of the marginal chordae connected to each head. A downsized annuloplasty is performed concomitantly. At discharge, no patient showed moderate/severe mitral regurgitation. Their coaptation lengths were 7.1, 8.5, and 8.3 mm.

Tranexamic Acid and the Risk of Delirium after Off-Pump Surgery.

We investigated whether in patients undergoing off-pump coronary artery bypass grafting surgery a single bolus of 1 g tranexamic acid (TXA) impacts the risk of postoperative delirium using the propensity score matching approach. In 2,757 pairs, the risk of delirium was 4.2% (TXA group) and 5.0% (non-TXA group), with a relative risk in the TXA versus the non-TXA group of 0.83 (95% confidence interval: 0.65-1.07; p = 0.16). There was no significant interaction between TXA administration and renal function on the risk of delirium (p = 0.12). Data indicate that a single bolus of 1 g TXA does not increase the risk of delirium in patients undergoing off-pump surgery.

The HeartWare Ventricular Assist Device (HVAD): A Single Institutional 10-Year Experience.

OBJECTIVES: The aim of this study was to analyze our 10-year experience with the HVAD in a real-world scenario in a high-volume German heart center. METHODS: We retrospectively analyzed outcomes of adults (≥18 years) with terminal heart failure (HF), who underwent HVAD implantation for durable LVAD therapy in our center between October 2009 and March 2020. Primary and secondary end points were all-cause death after implantation and LVAD-associated complications, respectively. We focused the distinct analyses on risk profiles at the time of implantation and implant strategies, i.e., bridge-to-transplant (BTT) or destination therapy (DT). RESULTS: A total of 510 patients were included, with 229 and 281 individuals in Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) level 1 (45%) and 2 to 4, respectively. Median follow-up was 26 months (IQR: 5-54 months). Overall survival at 1, 3, and 5 years after HVAD implantation was 66% (95% CI; 61.7-70%), 49.4% (95% CI; 44.9-53.8%), and 37.4% (95% CI; 32.8-42%), not censored for LVAD exchange, LVAD explantation, or heart transplantation. INTERMACS level 1 and peri-operative temporary right heart assistance were independent risk factors for survival. Survival was best in BTT patients undergoing heart transplantation at any time during follow-up. The INTERMACS level at time of HVAD implantation did not affect survival after heart transplantation. Freedom from the combined end point of any device-associated severe complication and death was 44.5% (95% CI; 40-48.8%) at 1-year after implantation. CONCLUSION: The HVAD is a reliable pump for durable mechanical circulatory support even in high-risk patients. Still, heart transplantation outperforms durable MCS therapy for a superior long-term survival.

Secondary aortic valve replacement in continuous flow left ventricular assist device therapy.

The purpose of the study was to investigate the outcome of secondary surgical aortic valve replacement (sSAVR) in patients with severe aortic regurgitation (AR) in the context of ventricular assist device (VAD) therapy. From 2009 to 2020, 792 patients underwent cf-LVAD implantation [HVAD (Medtronic, USA), n = 585, and HM 3 (Abbott, USA), n = 207]. All cf-LVAD patients with severe AR requiring secondary AVR were enrolled in this study. A total of six patients (median, 40 years, IQR; 34-61 years, 50% male) underwent secondary surgical aortic valve replacement (sSAVR) after cf-LVAD implantation. Median time of previous LVAD support was 26 months (IQR: 21-29 months). Two patients required additional tricuspid valve repair (TVR) and one patient underwent SAVR after failed TAVR. Four patients needed temporary right ventricular assist device (RVAD) with a median of 30 days (IQR; 29-33 days). Three patients were bridged to urgent heart transplantation due to persevering right heart failure, whereas two destination therapy (DT) candidates survived without any associated complications. An additional DT patient died of pneumonia 1 month after sSAVR. Secondary surgical aortic valve replacement in ongoing LVAD patients is an advanced procedure for a complex cohort. In our series, sSAVR was safely performed and effective, but involved a high-risk for subsequent right heart failure, requiring urgent heart transplantation. In LVAD patients with severe AR requiring treatment where TAVR is not feasible, sSAVR can be evaluated as salvage option for bridge to transplant patients or selected destination therapy candidates.

Patients with ventricular assist device and cerebral entrapment-Supporting skullcap reimplantation.

Effects of cranioplasty (CP) and skullcap reimplantation after decompressive craniectomy (DC) for cerebral hemorrhage or malignant brain infarction in patients with left ventricular assist device (LVAD) support as bridge to transplantation has not been surveyed yet. The aim of this study was to evaluate outcome and management after CP when aiming for transplantation. Data were collected from our prospective institutional database including all patients undergoing LVAD implantation between 2010 and 2019. Six patients needed CP procedures and were included. Our analysis focused on postoperative outcome, survival, and facilitation of heart transplantation. Study endpoints included also all-cause mortality. From a total of 1010 LVAD implantations during analysis period in our center, six bridge-to-transplantation LVAD patients [median age at LVAD implantation: 32.5 years (IQR: 24.8-39.5 years); four male, HVAD, n = 3; HM II, n = 1; HM 3, n = 2] underwent CP with imminent entrapment secondary to cerebral hemorrhage or malignant infarction. Primary heart failure etiology was myocarditis (n = 2), dilated (n = 2), or ischemic (n = 2). Median INTERMACS class was 1.5 (IQR; 1.0-2.8). Median time on LVAD support to DC procedure was 33 months (IQR: 16-48 months). The indication for DC was intraparenchymal hemorrhage (n = 4), subdural hematoma (n = 1), and malignant middle cerebral artery infarction (n = 1). After a median time of 4 months (IQR: 3.3-4.0 months, range; 2.0-10 months) post DC procedure, CP was subsequently performed without profound neurologic disabilities in all patients. After median time of 26 months (IQR: 21-42 months) follow-up, three patients successfully received heart transplantation, one patient could undergo LVAD explantation for myocardial recovery, and the remaining two patients are still on the list awaiting heart transplantation. CP procedure with skullcap reimplantation is feasible and can be safely performed in LVAD patients, which subsequently may even be eligible for heart transplantation with beneficial prognosis.

Identification of characteristics, risk factors, and predictors of recurrent LVAD thrombosis: conditions in HeartWare devices.

BACKGROUND: Redictors of repetitive left-ventricular assist device (LVAD)-thrombosis have not been studied yet. METHODS: We identified predictors of recurrent LVAD thrombosis in HeartWare (HVAD) patients in a long-term study from 2010 until 2020. We included all patients with two or more thrombolysis treatments for repetitive HVAD thrombosis and effectiveness of thrombolytic therapy was defined as freedom from stroke, death, another HVAD thrombosis, or surgical device exchange within 30 days after the event. Study endpoints also include all-cause mortality and heart transplantation. RESULTS: A total of 534 HVAD implantations have been screened, and 73 patients (13.7%) developed first HVAD thrombosis after a median of 10 months (IQR; 6-21 months). 46 of these patients had effective thrombolysis in 71.7% (n = 33/46). After a median of 14 months (IQR 4-32 months) follow-up, 17 patients (51.5%) had developed a second HVAD thrombosis and all were treated with t-PA therapy again, resulting in effectiveness in 76.5% (n = 13/17). The four patients with ineffective t-PA therapy underwent subsequent surgical HVAD exchange. Multiple Cox regression model analysis revealed time interval between HVAD implantation and first thrombosis as an independent risk factor of recurrent thrombosis (HR, 0.93, 95% CI 0.87-0.99, p = 0.031). Kaplan-Meier analysis at 3 year follow-up showed no significant difference in overall survival for recurrent vs non-recurrent thrombosis groups (log-rank test, p = 0.959). CONCLUSION: Recurrent HVAD thrombosis mostly appears within 12 months after first thrombosis. Systemic t-PA therapy for recurrent pump thrombosis seems safe, achieving comparable effectiveness rates to initial t-PA therapy. Survival does not differ between patients with or without recurrent HVAD thrombosis.

Associations of preoperative stroke and tranexamic acid administration with convulsive seizures in valvular open-heart surgery.

In cardiac surgery, use of the antifibrinolytic agent tranexamic acid (TXA) and acute perioperative stroke are both associated with convulsive seizures. We hypothesized that an older (preoperative) stroke increases the risk of TXA-associated seizures as well. To test this hypothesis, we retrospectively analyzed data from 16,110 patients who had undergone open-heart valvular surgery at our institution between 2009 and 2020. The dosing of TXA was moderate. Use of TXA and a history of stroke were both independently associated with convulsive seizure with an adjusted odds ratio (OR) of 2.40 (95%CI: 1.71-3.37) and 1.79 (95%CI: 1.27-2.54), respectively. Compared to patients without TXA administration, the adjusted OR of experiencing a seizure in TXA patients without a history of stroke was 2.44 (95%CI: 1.71-3.46) and in patients receiving TXA with a history of stroke 4.30 (95%CI: 2.65-6.99). However, there was no significant interaction between TXA use and preoperative stroke on convulsive seizures (P = 0.77). Compared to patients without seizure, for patients with seizure, the inverse probability-weighted ORs of in-hospital mortality and 30-day mortality were 3.58 (95%CI: 2.20-5.83) and 4.04 (95%CI: 2.34-6.98), respectively. We conclude that, in patients undergoing open-heart surgery, a history of stroke is independently associated with convulsive seizures but is not a contraindication for TXA use.

First interventional exchange of a left transvenous phrenic nerve stimulation lead from the novel remede system.

The remede system is a novel fully implantable transvenous phrenic nerve stimulation (TPNS) device developed to treat central sleep apnea. No information is published on how to explant or replace its leads. An eighty-one year-old had a fractured lead and we removed it over a wire. However, unbreachable resistances occurred with a new lead deployed over the enclosed wire and interventional endovascular techniques were performed to reimplant a new fully functioning system. This first report demonstrates TPNS lead exchange is possible but can be challenging. Interventional maneuvers and techniques, including balloon angioplasty, can facilitate this procedure.

Derivation and Validation of a Novel Right-Sided Heart Failure Model After Implantation of Continuous Flow Left Ventricular Assist Devices: The EUROMACS (European Registry for Patients with Mechanical Circulatory Support) Right-Sided Heart Failure Risk Score.

BACKGROUND: The aim of the study was to derive and validate a novel risk score for early right-sided heart failure (RHF) after left ventricular assist device implantation. METHODS: The EUROMACS (European Registry for Patients with Mechanical Circulatory Support) was used to identify adult patients undergoing continuous-flow left ventricular assist device implantation with mainstream devices. Eligible patients (n=2988) were randomly divided into derivation (n=2000) and validation (n=988) cohorts. The primary outcome was early (<30 days) severe postoperative RHF, defined as receiving short- or long-term right-sided circulatory support, continuous inotropic support for ≥14 days, or nitric oxide ventilation for ≥48 hours. The secondary outcome was all-cause mortality and length of stay in the intensive care unit. Covariates found to be associated with RHF (exploratory univariate P<0.10) were entered into a multivariable logistic regression model. A risk score was then generated using the relative magnitude of the exponential regression model coefficients of independent predictors at the last step after checking for collinearity, likelihood ratio test, c index, and clinical weight at each step. RESULTS: A 9.5-point risk score incorporating 5 variables (Interagency Registry for Mechanically Assisted Circulatory Support class, use of multiple inotropes, severe right ventricular dysfunction on echocardiography, ratio of right atrial/pulmonary capillary wedge pressure, hemoglobin) was created. The mean scores in the derivation and validation cohorts were 2.7±1.9 and 2.6±2.0, respectively (P=0.32). RHF in the derivation cohort occurred in 433 patients (21.7%) after left ventricular assist device implantation and was associated with a lower 1-year (53% versus 71%; P<0.001) and 2-year (45% versus 58%; P<0.001) survival compared with patients without RHF. RHF risk ranged from 11% (low risk score 0-2) to 43.1% (high risk score >4; P<0.0001). Median intensive care unit stay was 7 days (interquartile range, 4-15 days) versus 24 days (interquartile range, 14-38 days) in patients without versus with RHF, respectively (P<0.001). The c index of the composite score was 0.70 in the derivation and 0.67 in the validation cohort. The EUROMACS-RHF risk score outperformed (P<0.0001) previously published scores and known individual echocardiographic and hemodynamic markers of RHF. CONCLUSIONS: This novel EUROMACS-RHF risk score outperformed currently known risk scores and clinical predictors of early postoperative RHF. This novel score may be useful for tailored risk-based clinical assessment and management of patients with advanced HF evaluated for ventricular assist device therapy.

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.

Daily Supplementation with 4000 IU Vitamin D3 for Three Years Does Not Modify Cardiovascular Risk Markers in Patients with Advanced Heart Failure: The Effect of Vitamin D on Mortality in Heart Failure Trial.

BACKGROUND/AIMS: We aimed to investigate the effect of a moderately high vitamin D dose on lipid parameters and biochemical markers of vascular calcification (VC) in patients with established cardiovascular disease. METHODS: We included in this pre-specified secondary analysis of a randomized controlled trial 161 patients with advanced heart failure and 25-hydroxyvitamin D (25OHD) concentrations < 75 nmol/L (vitamin D group: n = 80; placebo group: n = 81), who received a daily vitamin D3 supplement of 4,000 IU for 3 years. We assessed between-group differences of the lipid parameters total-cholesterol, high-density lipoprotein-cholesterol, low-density lipoprotein-cholesterol, and triglycerides, and the VC markers fetuin-A and non-phosphorylated undercarboxylated matrix gla protein (MGP) at study termination, with adjustment for baseline values. RESULTS: Lipid parameters, the percentage of patients with dyslipoproteinemia, and VC markers did not differ significantly between groups at study termination (p values: 0.395-0.939). Likewise, vitamin D achieved no significant treatment effect on these markers in subgroup analyses in patients with 25OHD concentrations < 30 nmol/L, nonusers of lipid-lowering drugs, or diabetic patients (p values: 0.245-0.998). CONCLUSION: Our data indicate that vitamin D does not improve the lipid profile and does not influence the calcification inhibitors fetuin-A and non-phosphorylated undercarboxylated MGP in patients with advanced heart failure.

No Significant Association Between the Transfusion of Small Volumes of Leukocyte-Depleted Red Blood Cells and Mortality Over 7 Years of Follow-up in Patients Undergoing Cardiac Surgery: A Propensity Score Matched Analysis.

BACKGROUND: The impact of red blood cell (RBC) transfusion on long-term clinical outcome is controversial. METHODS: We prospectively recorded follow-up data of 6124 cardiac surgical patients who received no transfusion (RBC- group) or 1-2 units of leukocyte-depleted RBC (RBC+ group) at our institution. The primary end point was overall mortality up to 7 years after cardiac surgery; secondary end point was coronary artery revascularization during follow-up. To correct for nonrandomized group assignment, propensity score (PS) matching was performed. A subgroup analysis was also performed in patients with preoperative anemia. RESULTS: PS matching was possible in 4118 patients. During a mean follow-up of 4.05 years (range, 0.0-7.3 years), 140 patients (14.6%) died in the RBC- group and 173 (17.2%) died in the RBC+ group. The hazard ratio for the RBC+ group versus the RBC- group was 1.00 (95% confidence interval, 0.79-1.25; P = .969). The number of revascularizations was 96 (9.9%) and 125 (10.6%), respectively, with a hazard ratio of 1.21 (95% confidence interval, 0.92-1.58; P = .166) for the RBC+ group. Preoperative anemia was not a risk factor for postoperative mortality, even when patients were transfused. CONCLUSIONS: This PS-matched analysis does not provide evidence for an association of the transfusion of small volumes of leukocyte-depleted RBCs with an increased postoperative mortality in cardiac surgical patients. Moreover, preoperative anemia could not be identified as a risk factor for increased postoperative mortality.

Effect of vitamin D on all-cause mortality in heart failure (EVITA): a 3-year randomized clinical trial with 4000 IU vitamin D daily.

AIMS: Circulating 25-hydroxyvitamin D (25OHD) levels <75 nmol/L are associated with a nonlinear increase in mortality risk. Such 25OHD levels are common in heart failure (HF). We therefore examined whether oral vitamin D supplementation reduces mortality in patients with advanced HF. METHODS AND RESULTS: Four hundred HF patients with 25OHD levels <75 nmol/L were randomized to receive 4000 IU vitamin D daily or matching placebo for 3 years. Primary endpoint was all-cause mortality. Key secondary outcome measures included hospitalization, resuscitation, mechanical circulatory support (MCS) implant, high urgent listing for heart transplantation, heart transplantation, and hypercalcaemia. Initial 25OHD levels were on average <40 nmol/L, remained around 40 nmol/L in patients assigned to placebo and plateaued around 100 nmol/L in patients assigned to vitamin D. Mortality was not different in patients receiving vitamin D (19.6%; n = 39) or placebo (17.9%; n = 36) with a hazard ratio (HR) of 1.09 [95% confidence interval (CI): 0.69-1.71; P = 0.726]. The need for MCS implant was however greater in patients assigned to vitamin D (15.4%, n = 28) vs. placebo [9.0%, n = 15; HR: 1.96 (95% CI: 1.04-3.66); P = 0.031]. Other secondary clinical endpoints were similar between groups. The incidence of hypercalcaemia was 6.2% (n = 10) and 3.1% (n = 5) in patients receiving vitamin D or placebo (P = 0.192). CONCLUSION: A daily vitamin D dose of 4000 IU did not reduce mortality in patients with advanced HF but was associated with a greater need for MCS implants. Data indicate caution regarding long-term supplementation with moderately high vitamin D doses. TRIAL REGISTRATION INFORMATION: clinicaltrials.gov Idenitfier: NCT01326650.

German Heart Surgery Report 2016: The Annual Updated Registry of the German Society for Thoracic and Cardiovascular Surgery.

Based on a long-standing voluntary registry founded by the German Society for Thoracic and Cardiovascular Surgery (GSTCVS), well-defined data of all cardiac, thoracic, and vascular surgery procedures performed in 78 German heart surgery departments during the year 2016 are analyzed. In 2016, a total of 103,128 heart surgery procedures (implantable defibrillator, pacemaker, and extracardiac procedures excluded) were submitted to the registry. Approximately 15.7% of the patients were at least 80 years of age, resulting in an increase of 0.9% compared with the data of 2015. For 37,614 isolated coronary artery bypass grafting procedures (relationship on-/off-pump 4.4:1), an unadjusted in-hospital mortality of 2.9% was observed. Concerning the 33,451 isolated heart valve procedures (including 11,701 catheter-based procedures), the unadjusted in-hospital mortality was 4.3%. This annual updated registry of the GSTCVS represents voluntary public reporting by accumulating actual information for nearly all heart surgical procedures in Germany, describes advancements in heart medicine, and is a basis for internal and external quality assurances for all participants. In addition, the registry demonstrates that the provision of cardiac surgery in Germany is appropriate and patients are treated nationwide at all times.