Rationale and design of the ELEANOR trial early aortic valve surgery versus watchful waiting strategy in severe asymptomatic aortic regurgitation, ACRONYM: ELEANOR.

Background: The optimal treatment of patients with severe symptomatic aortic regurgitation (AR) is state-of-the-art surgery. Asymptomatic patients with advanced left ventricular (LV) dilatation and/or impaired ejection fraction should undergo surgical treatment, but there is no guidelines consensus on cut-off values for this recommendation. Multimodality imaging has brought new tools for the accurate selection of asymptomatic patients at risk of early clinical deterioration, however, prospective and randomized data are pending. Cardiac magnetic resonance (CMR)-derived AR quantification along with LV remodeling assessment appears to be the most accurate tool for a selection of such patients at risk. Trial design: The objective of our prospective and multicenter study is to determine whether patients at risk of early clinical deterioration as per CMR assessment will benefit from early surgical treatment. The study is designed as a superiority trial to demonstrate that early surgical treatment is safe and more effective than the standard treatment. A total of 217 asymptomatic patients with severe AR, but without current guidelines-based surgical indication, will be enrolled across all centers. We expect 24 % of patients identified as high clinical risk and therefore eligible for 1:1 randomization to early surgical treatment within 3 months or a watchful waiting strategy. Follow-up will be annual. We expect a complete restoration of LV size and function along with improved quality of life and physical performance in a short-term follow-up of 12 months. The primary endpoint will be a composite safety and efficacy with all criteria mandatory: 15 % or larger reduction of baseline CMR-derived LV end-diastolic volume index, LV ejection fraction >50 %, and no major adverse cardiovascular events. The annual follow-up will continue for a minimum of 4 years until the required number of endpoints is achieved to show a statistically significant difference in cardiovascular morbidity and mortality in early surgically treated patients. Conclusion: The ELEANOR trial is the first multicenter randomized controlled study to compare early surgical treatment with a watchful waiting strategy in asymptomatic patients with chronic severe AR at high risk of early clinical deterioration as per CMR assessment but without guidelines-based indications for surgical treatment.

Mid-term success rate of single stage hybrid ablation of persistent and long-term persistent atrial fibrillation.

INTRODUCTION: Single stage thoracoscopic radiofrequency ablation (RFA) is a treatment method for persistent and long-term persistent atrial fibrillation (AF) offering the possibility for patients otherwise inconsolable by conventional catheter RFA. We present a pilot group of patients after the introduction of the new method at our clinical center. Patients group: A total of 52 patients aged 61.82 ± 9.7 years underwent single stage hybrid ablation (thoracoscopic isolation of pulmonary veins and box lesion followed by catheter verification of the surgical procedure effectivness) for symptomatic persistent and long-term persistent AF with significantly dilated left atrium 57.9 ± 11.0mm in the period September 2016-March 2019. RESULTS: The median duration of the procedure was 232 minutes and the median duration of hospitalization was 10 days. At discharge, 52 patients (100%) had sinus rhythm. 48 of 52 patients (92.3%) had a 6-month follow-up. 41 of 48 (85.4%) and 38 of 44 (86.4%) of patients were AF free at 3-month and 6-month follow-up, respectively. Acute complications were: one left atrial perforation resolved successfully by suture and one transient ischaemic attack without permanent sequelae. Late complications involved one massive pulmonary embolization and an atrioesophageal fistula. There was no periprocedural myocardial infarction or stroke with permanent sequelae. CONCLUSION: Hybrid thoracoscopic-catheter ablation performed during one procedure is an effective and relatively safe mini-invasive method of treatment for long-term persistent atrial fibrillation.

Danon disease is an underdiagnosed cause of advanced heart failure in young female patients: a LAMP2 flow cytometric study.

AIMS: Danon disease (DD) is a rare X-linked disorder caused by mutations in the lysosomal-associated membrane protein type 2 gene (LAMP2). DD is difficult to distinguish from other causes of dilated or hypertrophic cardiomyopathy (HCM) in female patients. As DD female patients regularly progress into advanced heart failure (AHF) aged 20-40 years, their early identification is critical to improve patient survival and facilitate genetic counselling. In this study, we evaluated the prevalence of DD among female patients with non-ischemic cardiomyopathy, who reached AHF and were younger than 40 years. METHODS AND RESULTS: The study cohort comprised 60 female patients: 47 (78%) heart transplant recipients, 2 (3%) patients treated with ventricular assist device, and 11 (18%) patients undergoing pre-transplant assessment. Aetiology of the cardiomyopathy was known in 15 patients (including two DD patients). LAMP2 expression in peripheral white blood cells (WBC) was tested by flow cytometry (FC) in the remaining 45 female patients. Whole exome sequencing was used as an alternative independent testing method to FC. Five additional female DD patients (two with different novel LAMP2 mutations) were identified by FC. The total prevalence of DD in this cohort was 12%. HCM phenotype (57% vs. 9%, * P = 0.022) and delta waves identified by electrocardiography (43% vs. 0%, ** P = 0.002) were significantly more frequent in DD female patients. CONCLUSIONS: Danon disease is an underdiagnosed cause of AHF in young female patients. LAMP2 expression testing in peripheral WBCs by FC can be used as an effective screening/diagnostic tool to identify DD in this patient population.

Minimally Invasive Aortic Valve Replacement with Sutureless Valves: Results From an International Prospective Registry.

OBJECTIVE: To report the early and mid-term results of patients who underwent minimally invasive aortic valve replacement (MI-AVR) with a sutureless prosthesis from an international prospective registry. METHODS: Between March 2011 and September 2018, among 957 patients included in the prospective observational SURE-AVR (Sorin Universal REgistry on Aortic Valve Replacement) registry, 480 patients underwent MI-AVR with self-expandable Perceval aortic bioprosthesis (LivaNova PLC, London, UK) in 29 international institutions through either minithoracotomy (n = 266) or ministernotomy (n = 214). Postoperative, follow-up, and echocardiographic outcomes were analyzed for all patients. RESULTS: Patient age was 76.1 ± 7.1 years; 64.4% were female. Median EuroSCORE I was 7.9% (interquartile range [IQR], 4.8 to 10.9). Median cardiopulmonary bypass and cross-clamp times were 81 minutes (IQR 64 to 100) and 51 minutes (IQR 40 to 63). First successful implantation was achieved in 97.9% of cases. Two in-hospital deaths occurred, 1 for noncardiovascular causes and 1 following a disabling stroke. In the early (≤30 days) period, stroke rate was 1.4%. Three early explants were reported: 2 due to nonstructural valve dysfunction (NSVD) and 1 for malpositioning. One mild and 1 moderate paravalvular leak were reported. In 16 patients (3.3%) pacemaker implantation was needed. Mean follow-up was 2.4 years (maximum = 7 years). During follow-up 5 explants were reported, 3 due to endocarditis and 2 due to NSVD. Follow-up stroke rate was 2.5%. Three structural valve deteriorations not requiring reintervention were reported. Five-year survival was 91.45%. CONCLUSIONS: In this large prospective international registry, MI-AVR with Perceval valve confirmed to be safe, reproducible, and effective in an intermediate-risk population, providing excellent clinical recovery both in early and mid-term follow-up.

[Surgical treatment of aortic root aneurysm: comparison of Bentall procedure and David reimplantation of aortic valve]. / Chirurgická lécba aneuryzmatu aortálního korene: srovnání Bentallovy operace a reimplantace aortální chlopne podle Davida.

INTRODUCTION: The aortic root aneurysm is associated with a more frequent occurrence of aortic dissection and development of aortic regurgitation. The aim of this study was to compare outcomes of composite graft replacement and valve sparing root replacement in treating aortic root aneurysms. METHODS: From January 2006 to December 2015 a total of 137 patients (mean age 46.3 ± 14.5, range 16-65) underwent elective surgery for aortic root aneurysm without valvular structural defects. Replacement by mechanical composite graft (Bentall procedure) has been performed in 46 patients while 91 patients underwent valve sparing root replacement (David procedure). The mean length of follow-up has been 77 months. RESULTS: There was no operative death. Overall 9 patients died during follow-up. Five patients were after Bentall procedure and 4 were after reimplantation of aortic valve. Thromboembolic and bleeding complications were observed in 7 patients, 5 of them were after Bentall surgery and 2 after reimplantation of the aortic valve. Five patients after reimplantation of aortic valve underwent reoperation. Four of these patients had aortic valve replacement and in 1 case aortic homograft was implanted. CONCLUSION: Bentall procedure used to be the standard treatment for patients with aortic root aneurysms. During the past two decades, aortic valve sparing procedure has gained widespread use to reduce thromboembolic and bleeding complications.Key words: aortic root aneurysm - composite graft replacement - valve-sparing root replacement.