Technical considerations and sizing of external annuloplasty in the Ross procedure.

Pure aortic regurgitation and dilation of aortic annulus are the most significant risk factors for the failure of pulmonary autograft after the Ross procedure. Aortic annuloplasty has a positive effect on the durability of the autograft. Previously, we described a technique for external annuloplasty with dedicated CORONEO ring. In the present manuscript, we suggest the sizing of annuloplasty based on the diameter of pulmonary autograft annulus.

Study protocol of a phase 2, randomised, placebo-controlled, double-blind, adaptive, parallel group clinical study to evaluate the efficacy and safety of recombinant alpha-1-microglobulin in subjects at high risk for acute kidney injury following open-chest cardiac surgery (AKITA trial).

INTRODUCTION: Acute kidney injury (AKI) is a common complication after cardiac surgery (CS) and is associated with adverse short-term and long-term outcomes. Alpha-1-microglobulin (A1M) is a circulating glycoprotein with antioxidant, heme binding and mitochondrial-protective mechanisms. RMC-035 is a modified, more soluble, variant of A1M and has been proposed as a novel targeted therapeutic protein to prevent CS-associated AKI (CS-AKI). RMC-035 was considered safe and generally well tolerated when evaluated in four clinical phase 1 studies. METHODS AND ANALYSIS: This is a phase 2, randomised, double-blind, adaptive design, parallel group clinical study that evaluates RMC-035 compared with placebo in approximately 268 cardiac surgical patients at high risk for CS-AKI. RMC-035 is administered as an intravenous infusion. In total, five doses will be given. Dosing is based on presurgery estimated glomerular filtration rate (eGFR), and will be either 1.3 or 0.65 mg/kg.The primary study objective is to evaluate whether RMC-035 reduces the incidence of postoperative AKI, and key secondary objectives are to evaluate whether RMC-035 improves postoperative renal function compared with placebo. A blinded interim analysis with potential sample size reassessment is planned once 134 randomised subjects have completed dosing. An independent data monitoring committee will evaluate safety and efficacy data at prespecified intervals throughout the trial. The study is a global multicentre study at approximately 30 sites. ETHICS AND DISSEMINATION: The trial was approved by the joint ethics committee of the physician chamber Westfalen-Lippe and the University of Münster (code '2021-778 f-A') and subsequently approved by the responsible ethics committees/relevant institutional review boards for the participating sites. The study is conducted in accordance with Good Clinical Practice, the Declaration of Helsinki and other applicable regulations. Results of this study will be published in a peer-reviewed scientific journal. TRIAL REGISTRATION NUMBER: NCT05126303.

Midterm outcomes of mini-invasive surgical and hybrid ablation of atrial fibrillation.

BACKGROUND: We evaluated the feasibility and effectiveness of thoracoscopic and a staged surgical and transcatheter ablation technique to treat stand-alone atrial fibrillation (AF). METHODS: . Between 2009 and 2016, a cohort of 65 patients underwent bilateral totally thoracoscopic ablation of symptomatic paroxysmal AF (n=30; 46%), persistent AF (n=18; 28%) or long-standing persistent AF (n=17; 26%) followed by catheter ablation in case of AF recurrence. Surgical box lesion procedure included bilateral pulmonary vein and left atrial posterior wall ablation using irrigated bipolar radiofrequency with documentation of conduction block. RESULTS: There were no intra- or peri-operative ablation-related complications. There was no operative mortality, no myocardial infarction, and no stroke. Skin-to-skin procedure time was 120.5 ± 22.0 min and the postoperative average length of stay was 8.1 ± 3.0 days. At discharge, 60 patients (92%) were in sinus rhythm. Median follow-up time was 866 days (IQR, 612-1185 days). One-year success rate after surgical procedure was 78% (off antiarrhythmic drugs). Eleven patients (17%) underwent catheter re-ablation. Sixty (92%) patients were free of atrial fibrillation after hybrid ablation (on demand) at 1 year follow up after the last ablation. The success at 24-months was achieved in 96% (paroxysmal) and 78% (persistent) patients. At the last follow-up control, 69% patients discontinued oral anticoagulant therapy. CONCLUSIONS: . Combination of mini-invasive surgical and endocardial treatment (two-stage hybrid procedure) is a safe and effective method for the treatment of isolated (lone) AF. This procedure provided good midterm outcomes.

Ubiquinol-10/lipids ratios in consecutive patients with different angiographic findings.

OBJECTIVE: Information concerning un-supplemented plasma concentrations of ubiquinol-10 in coronary artery disease patients is still controversial. The aim of this study is to determine the levels of plasma ubiquinol-10 and ratios of ubiquinol-10 to plasma lipids in consecutive patients with different angiographic findings. SUBJECTS AND METHODS: Thirty-six consecutive patients who underwent coronary angiography were split in two groups with different atherosclerotic changes. These patients were un-supplemented with antioxidants and were not treated by lipid-lowering medication. We have measured a plasma level of ubiquinol-10 using high-performance liquid chromatography with coulometric detection. Conventional plasma lipids, markers of oxidative stress and other widely accepted risk factors of atherosclerosis have been determined too. RESULTS: Plasma ubiquinol-10 to low-density lipoprotein cholesterol (LDL-C) ratios in patients with different angiographic findings have been found as 180+/-69 and 132+/-43, respectively (p=0.020). The ubiquinol-10/LDL-C ratio was significantly lower in angiographically positive patients. There were also significant differences in ubiquinol-10 per total cholesterol (109+/-47 and 80+/-26, respectively; p=0.031), per triglycerides (426+/-191 and 237+/-86, respectively; p=0.002) and per the sum of triglycerides and total cholesterol (86+/-35 and 61+/-20, respectively; p=0.013). CONCLUSIONS: There have not been found any significant differences between levels of widely accepted risk factors for genesis and progress of atherosclerotic changes in these two groups of patients. Only the level of triglycerides and the total cholesterol minus high-density lipoprotein cholesterol/high-density lipoprotein cholesterol ratio were significantly higher in patients with stenosis. This ratio correlated with the ubiquinol-10/LDL-C ratio, which was significantly lower in patients with stenosis. Our results indicate that the ratio of ubiquinol-10/LDL-C is likely to be a risk factor for atherogenesis.