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.

Effect of High-Dose Selenium on Postoperative Organ Dysfunction and Mortality in Cardiac Surgery Patients: The SUSTAIN CSX Randomized Clinical Trial.

Importance: Selenium contributes to antioxidative, anti-inflammatory, and immunomodulatory pathways, which may improve outcomes in patients at high risk of organ dysfunctions after cardiac surgery. Objective: To assess the ability of high-dose intravenous sodium selenite treatment to reduce postoperative organ dysfunction and mortality in cardiac surgery patients. Design, Setting, and Participants: This multicenter, randomized, double-blind, placebo-controlled trial took place at 23 sites in Germany and Canada from January 2015 to January 2021. Adult cardiac surgery patients with a European System for Cardiac Operative Risk Evaluation II score-predicted mortality of 5% or more or planned combined surgical procedures were randomized. Interventions: Patients were randomly assigned (1:1) by a web-based system to receive either perioperative intravenous high-dose selenium supplementation of 2000 µg/L of sodium selenite prior to cardiopulmonary bypass, 2000 µg/L immediately postoperatively, and 1000 µg/L each day in intensive care for a maximum of 10 days or placebo. Main Outcomes and Measures: The primary end point was a composite of the numbers of days alive and free from organ dysfunction during the first 30 days following cardiac surgery. Results: A total of 1416 adult cardiac surgery patients were analyzed (mean [SD] age, 68.2 [10.4] years; 1043 [74.8%] male). The median (IQR) predicted 30-day mortality by European System for Cardiac Operative Risk Evaluation II score was 8.7% (5.6%-14.9%), and most patients had combined coronary revascularization and valvular procedures. Selenium did not increase the number of persistent organ dysfunction-free and alive days over the first 30 postoperative days (median [IQR], 29 [28-30] vs 29 [28-30]; P = .45). The 30-day mortality rates were 4.2% in the selenium and 5.0% in the placebo group (odds ratio, 0.82; 95% CI, 0.50-1.36; P = .44). Safety outcomes did not differ between the groups. Conclusions and Relevance: In high-risk cardiac surgery patients, perioperative administration of high-dose intravenous sodium selenite did not reduce morbidity or mortality. The present data do not support the routine perioperative use of selenium for patients undergoing cardiac surgery. Trial Registration: ClinicalTrials.gov Identifier: NCT02002247.

Redo heart transplantation in a high-risk patient due to severe aortic regurgitation and accompanying right ventricular failure after LVAD implantation and temporary RVAD support.

BACKGROUND: We report a 62-year-old patient who received redo-orthotopic heart transplantation due to worsening severe aortic regurgitation after 19 months of continuous flow left ventricular assist device  (LVAD) (cf-LVAD) and temporary right ventricular assist device (RVAD) support for 1 month. CASE REPORT: The patient received a heartware LVAD (heartware ventricular assist device) and annuloplasty of the tricuspid valve due to end-stage heart failure (as a consequence of dilated cardiomyopathy) and severe tricuspid regurgitation in addition to right-sided extracorporeal membrane oxygenation (ECMO) implantation. Postoperatively due to the inability to wean the implanted ECMO, a temporary RVAD was implanted after which the patient's condition improved so that it had been explanted later and the patient was discharged after 9 months. In immediate postoperative echo, minimal aortic regurgitation was noted but in the follow-up transthoracic echocardiograms, there was a gradual increase in the severity of aortic regurgitation with worsening both right and left ventricular functions. Transcatheter aortic valve implantation was not an option due to unfavorable anatomical issues. That's why the patient was listed for urgent heart transplantation, performed 19 months after the LVAD implantation. The postoperative course was complicated due to acute renal failure. After recompensation, dialysis, and intensive physiotherapy, the patient could be discharged home after 3 months. CONCLUSION: Severe aortic regurgitation is a recognizable complication after cf-LVAD implantation which in our case was managed successfully with orthotopic heart transplantation in this high-risk patient.

Coronary Artery Bypass Graft Surgery in Patients With Acute Coronary Syndromes After Primary Percutaneous Coronary Intervention: A Current Report From the North-Rhine Westphalia Surgical Myocardial Infarction Registry.

Background Coronary artery bypass grafting has remained an important treatment option for acute coronary syndromes, particularly in patients (1) with ongoing ischemia and large areas of jeopardized myocardium, if percutaneous coronary intervention (PCI) cannot be performed; (2) following successful PCI of the culprit lesion with further indication for coronary artery bypass grafting; and (3) where PCI is incomplete, not sufficient, or failed. Methods and Results We aimed to analyze coronary artery bypass grafting outcome following prior PCI in acute coronary syndromes from the North-Rhine-Westphalia surgical myocardial infarction registry comprising 2616 patients. Primary end points were in-hospital all-cause mortality and major adverse cardio-cerebral event. Patients were 68±11 years of age, had 3-vessel and left main-stem disease in 80.4% and 45.3%, presenting a logistic EuroSCORE of 15.1% in unstable angina, 20.3% in non-ST-segment-elevation myocardial infarction, and 23.5% in ST-segment-elevation myocardial infarction. A history of PCI was present in 36.2% and PCI was performed within 24 hours before surgery in 5.2% in unstable angina, 5.9% in non-ST-segment-elevation myocardial infarction, and 16.1% in ST-segment-elevation myocardial infarction. PCI failed in 5.3% in unstable angina, 6.8% in non-ST-segment-elevation myocardial infarction and 17.2% in ST-segment-elevation myocardial infarction, and 28.8% of patients presented with cardiogenic shock. In-hospital mortality without PCI was 7.4%, but increased to 8.7% with prior PCI >24 hours, 14.5% with prior PCI <24 hours, and 14.1% with failed PCI (P<0.003). The in-hospital major adverse cardio-cerebral event rate was 16.4% without PCI, but 17.4% with prior PCI >24 hours, 25.6% with prior PCI <24 hours, and 41.3% with failed PCI (P=0.014). Multivariable logistic regression analysis showed prior PCI (P=0.039), as well as failed PCI (P=0.001) to be predictors for in-hospital all-cause mortality and major adverse cardio-cerebral event. Conclusions In the current PCI era, immediately prior or failed PCI before coronary artery bypass grafting in acute coronary syndromes is associated with high perioperative risk, cardiogenic shock, and increased morbidity and mortality.

Preoperative Statin Therapy for Atrial Fibrillation and Renal Failure after Cardiac Surgery.

BACKGROUND: Performing cardiac surgery in patients with cardiovascular risk factors incorporates a steady risk for the development of postoperative complications. Perioperative statin intake was associated with an improvement of perioperative outcomes in these patients. However, the European Association for Cardio-Thoracic Surgery guidelines regarding the perioperative statin treatment were changed recently due to large studies reporting about relevant adverse effects related to statin therapy. METHODS: All relevant databases were searched including the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and the metaRegister of Controlled Trials. Various registries were screened (National Research Register, the ClinicalTrials.gov, and gray literature) with search on online conference indices of relevant scientific meetings. No language restrictions were applied. RESULTS: We identified 10 randomized controlled studies summarizing 3,468 participants undergoing various kinds of cardiac surgical procedures. All included studies presented with marked differences regarding study design. Pooled analysis indicated that statin pretreatment was associated with a formally reduced incidence of postoperative atrial fibrillation (AF) (odds ratio [OR] 0.63, 95% confidence interval [CI] 0.39-1.00; p = 0.05) but with an increased incidence of renal failure (OR 1.20, 95% CI 1.01-1.44; p = 0.04) compared with control. Substantial heterogeneity was observed among studies reporting about AF. CONCLUSION: Current but sparse evidence reveals that statin pretreatment is associated with a higher rate of postoperative renal failure compared with control therapy but is ineffective to substantially reduce postoperative AF. Given the relevant heterogeneity among included studies, statin pretreatment cannot be generally recommended.

Long-Term Outcomes after Thoracic Endovascular Aortic Repair Using Chimney Grafts for Aortic Arch Pathologies: 10 Years of Single-Center Experience.

BACKGROUND: This study reports the early- and long-term outcomes of the thoracic endovascular aortic repair using the Chimney-Graft technique (ChTEVAR) for the treatment of aortic arch pathologies. METHODS: From January 2010 to December 2019, patients who underwent aortic ChTEVAR technique in our institution were included. Early, mid, and long-term outcomes in this group of patients were evaluated. Patient follow-up data were obtained by imaging follow-up that are routinely performed after 3-6 months following initial surgery and then at yearly intervals. RESULTS: Aortic arch repair with a ChTEVAR was performed in 54 patients. The 30-day mortality was 18.5% (n = 10). All-cause 30-day mortality was higher in the subgroup of patients operated urgently (33% vs. 14%) without a significant difference (P = 0.141). Permanent neurological deficit (PND) was observed in 15% (8/54 patients); stroke in 11% (6/54), and paraplegia 4% (2/54). During follow-up the primary and primary-assisted chimney-graft patency was 96.8% and 97.8%, respectively. The multivariate analysis identified the age >70 years and the aortic diameter as independent risk factors for elevated mortality during the follow-up (P = 0.015 and 0.001, respectively). The PND was an independent predictor for 30-day mortality (P = 0.014, hazard ratio 13.5, 95% confidence interval 1.7-106.6). CONCLUSIONS: The ChTEVAR has noninferior results to other open and endovascular aortic arch repair methods with an acceptable long-term survival especially in elective procedures.

Rapid Deployment Aortic Valve Replacement with the Perceval S and Intuity Elite.

BACKGROUND: Rapid deployment aortic valve replacement (RDAVR) has emerged as an alternative to conventional aortic valve replacement. This single-center study retrospectively analyzed clinical outcomes and hemodynamic performance of the Perceval S (LivaNova) and Intuity Elite (Edwards LifeSciences) rapid deployment valves (RDVs) in a propensity score matched patient cohort. METHODS: A total of 372 consecutive patients with symptomatic aortic valve stenosis underwent RDAVR between 2012 and 2018 at our institution. The Intuity Elite (INT group) and Perceval S (PER group) were implanted in 251 and 121 patients, respectively. After 1:1 propensity score matching for relevant preoperative comorbidities, 107 patient pairs were compared with respect to relevant perioperative data including hemodynamic parameter, postoperative pacemaker implantation, and 30-day all-cause mortality. RESULTS: Propensity score matching resulted in balanced characteristics between groups. Cardiopulmonary bypass and aortic cross-clamp time did not differ between groups, but more patients in the INT group received coronary artery bypass grafting compared with the PER group (56 vs. 42%; p = 0.055). Thirty-day mortality (4.7 vs. 2.2%) and need for permanent pacemaker implantation (7 versus 4.4%) were comparable between the INT and PER groups for isolated AVR and also for combined procedures, respectively. Cerebrovascular events showed comparable low rates for both RDVs (INT group [1.9%] vs. PER group [2.8%]). Indexed effective orifice area was higher in the INT group (0.90 vs. 0.82 cm2/m2) and coupled to a lower peak (17 ± 7 vs. 22 ± 8) and mean (10 ± 5 vs. 12 ± 4) pressure gradients compared with the PER group. CONCLUSIONS: Our propensity score analysis in AVR patients showed good hemodynamic characteristics with comparable 30-day mortality rate and complications rates for both investigated RDVs.

Single-center experience with the frozen elephant trunk procedure in 111 patients with complex aortic disease.

BACKGROUND: The frozen elephant trunk (FET) technique is increasingly used for the treatment of acute and chronic aortic arch disease. This study reports our single center experience with the FET technique in patients with complex aortic disease. METHODS: Between 2009 and 2019, 111 consecutive patients underwent aortic arch surgery in our institution using the FET technique for acute type A dissection (AAD group; n=75) or non-acute type A dissection (non-AAD group; n=36; 10 patients with chronic type A dissection; 26 patients with aneurysm), respectively. Relevant perioperative data, including 30-day mortality and neurological complications, were retrospectively obtained from our electronic patient's records, including follow-up (FU) data of outpatient clinical visits and computed tomography (CT). RESULTS: Thirty-day mortality in the entire FET cohort was 16.2% (AAD 18.7% vs. non-AAD 11.1%; n=0.414). Severe brain injury was the leading cause of death in AAD patients (12.0% vs. 0% non-AAD; P=0.030). Overall permanent stroke and spinal cord injury was 12.6% and 3.6%. Four patients in the AAD group developed paraplegia and permanent stroke rate was significantly higher in AAD compared to non-AAD patients (17.3% vs. 2.8%; P=0.034). One, 3- and 5-year survival rates were 78.7%±4.0%, 72.2%±4.8%, and 64.3%±6.8% for the total cohort; survival at 1-, 3- and 5-year was 76.7%±5.0%, 71.0%±6.1%, and 64.5%±8.3% for the AAD cohort compared to 83.1%±6.3%, 75.0%±7.9% and 66.7% for non-AAD patients (P=0.579), respectively. CONCLUSIONS: Our single-center experience confirms good early and mid-term survival after the FET procedure in patients presenting with AAD, CAD and aneurysm. Future efforts should focus on reduction of severe neurological complication.

Surgical revascularization for acute coronary syndromes: a report from the North Rhine-Westphalia surgical myocardial infarction registry.

OBJECTIVES: The aim of this was to analyse current outcomes in patients referred to coronary artery bypass grafting (CABG) for acute coronary syndromes (ACSs), including ST-elevation or non-ST-elevation ACS (non-ST-segment elevation myocardial infarction) or unstable angina. METHODS: Patients (n = 2432) undergoing CABG for ACS between January 2010 and December 2017 were prospectively entered into a surgical myocardial infarction registry in North Rhine-Westphalia, Germany. Key end points were in-hospital all-cause mortality (IHM) and major adverse cardio-cerebral events (MACCE). Predictors for IHM and MACCE were analysed by multivariable logistic regression. RESULTS: Patients (78% males) were referred for CABG for unstable angina (25%), non-ST-segment elevation myocardial infarction (50%), and ST-segment elevation myocardial infarction (25%). The mean patient age was 68 ± 11 years, logistic EuroSCORE was 19 ± 18% and three-vessel and left main stem diseases were diagnosed in 81% and 45% of patients, respectively. On-pump CABG with cardiac arrest or beating heart was performed in 92% and 2%, respectively, with only 6% off-pump surgery and 6% multiple arterial revascularization (3.1 ± 1.0 grafts, 93% left internal thoracic artery). Emergency CABG was performed in 23% of patients (42% in ST-segment elevation myocardial infarction; P < 0.001). The total IHM and MACCE rates were 8.1% and 17.5% and were highest in ST-segment elevation myocardial infarction patients with 12.6% and 28.5%, respectively (P < 0.001). Key predictors for IHM and MACCE were female gender, elevated troponin, left ventricular ejection fraction, inotropic support, logistic EuroSCORE, cardiopulmonary bypass and aortic clamp time and the need for emergency CABG. CONCLUSIONS: Surgical myocardial revascularization in patients with ACS is still linked to substantial in-hospital mortality. Emergency CABG for patients with ACS was associated with poorer outcomes.