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.

Left atrial appendage occlusion: Percutaneous and surgical approaches in everyday practice.

Prophylactic left atrial appendage occlusion has been suggested as a means of reducing cardioembolism risk in patients with atrial fibrillation. Its clinical benefits have been discussed together with potential endocrine or hemodynamic adverse effects, with conflicting conclusions. We aimed to provide a thorough overview of the current literature and a recommendation for daily clinical decision-making. A comprehensive Medline search through PubMed was conducted to search for relevant articles, which were further filtered using the title and abstract. Sixty-five articles were selected as relevant to the topic. Concomitant left atrial appendage occlusion during cardiac surgery for other reasons is effective in terms of thromboembolism risk reduction in patients with a history of atrial fibrillation and higher CHA2DS2-VASc scores. Surgical occlusion is safe, and epicardial closure techniques are preferred. Thoracoscopic and transcatheter techniques are also feasible, and the individual treatment choice must be tailored to the patient. The concerns about endocrine imbalance or risk of heart failure after occlusion are not supported by evidence. Current evidence is conflicting with regard to hemodynamic consequences of appendage occlusion.

Multiparametric Strategy to Predict Early Disease Decompensation in Asymptomatic Severe Aortic Regurgitation.

BACKGROUND: Use of the current echocardiography-based indications for aortic regurgitation (AR) surgery might result in late valve replacement at the stage of irreversible myocardial damage. Therefore, we aimed to identify simple models combining multiple echocardiography or magnetic resonance imaging (MRI)-derived indices and natriuretic peptides (BNP [brain natriuretic peptide] or NT-proBNP [N-terminnal pro-B type natriuretic peptide]) to predict early disease decompensation in asymptomatic severe AR. METHODS: This prospective and multicenter study included asymptomatic patients with severe AR, preserved left ventricular ejection fraction (>50%), and sinus rhythm. The echocardiography and MRI images were analyzed centrally in the CoreLab. The study end point was the onset of indication for aortic valve surgery as per current guidelines. RESULTS: The derivative cohort consisted of 127 asymptomatic patients (age 45±14 years, 84% males) with 41 (32%) end points during a median follow-up of 1375 (interquartile range, 1041-1783) days. In multivariable Cox regression analysis, age, BNP, 3-dimensional vena contracta area, MRI left ventricular end-diastolic volume index, regurgitant volume, and a fraction were identified as independent predictors of end point (all P<0.05). However, a combined model including one parameter of AR assessment (MRI regurgitant volume or regurgitant fraction or 3-dimensional vena contracta area), 1 parameter of left ventricular remodeling (MRI left ventricular end-diastolic volume index or echocardiography 2-dimensional global longitudinal strain or E wave), and BNP showed significantly higher predictive accuracy (area under the curve, 0.74-0.81) than any parameter alone (area under the curve, 0.61-0.72). These findings were confirmed in the validation cohort (n=100 patients, 38 end points). CONCLUSIONS: In asymptomatic severe AR, multimodality and multiparametric model combining 2 imaging indices with natriuretic peptides, showed high accuracy to identify early disease decompensation. Further prospective studies are warranted to explore the clinical benefit of implementing these models to guide patient management. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02910349.

Severe left ventricular dyssynchrony is associated with poor prognosis in patients with moderate systolic heart failure undergoing coronary artery bypass grafting.

OBJECTIVES: The objective of the present study was to assess the relationship between the presence of left ventricular (LV) dyssynchrony and clinical outcome in patients with moderate systolic heart failure undergoing coronary artery bypass graft (CABG) surgery. BACKGROUND: The presence of LV dyssynchrony is associated with poor prognosis in patients with LV dysfunction. METHODS: The study consisted of 215 consecutive patients with ischemic cardiomyopathy and dyspnea (age 65 +/- 9 years, 81% male) undergoing CABG. Dyssynchrony was calculated by tissue Doppler imaging from regional time intervals in basal LV segments before and 1 month after CABG. Myocardial viability was assessed using single-photon emission computed tomography (SPECT) before CABG. RESULTS: Twenty-five patients (11.6%) died within 30 days (in-hospital mortality) of CABG. The presence of pre-CABG dyssynchrony > or =119 ms had the highest predictive accuracy for in-hospital mortality, with a sensitivity of 84% and a specificity of 71%. During the median follow-up period of 359 days (interquartile range 219 to 561), an additional 19 patients (10.3%) died and 34 patients (18.5%) were hospitalized for worsening heart failure. At Cox regression analysis, post-CABG dyssynchrony > or =72 ms and > or =5 viable segments were identified as independent predictors of clinical events, with a hazard ratio (HR) of 5.02, 95% confidence interval (CI) 2.57 to 10.02 (p < 0.001), and an HR of 0.63, 95% CI 0.55 to 0.75 (p < 0.001), respectively. Patients without post-CABG dyssynchrony and with viable myocardium had excellent prognosis compared with patients with severe post-CABG dyssynchrony and nonviable myocardium (event rate 3% vs. 64%; p < 0.001). CONCLUSIONS: The presence of severe LV dyssynchrony is associated with poor clinical outcomes despite revascularization. These results advocate a routine assessment of both LV dyssynchrony and viability to predict outcome in systolic heart failure patients undergoing CABG surgery.