Background There is a lack of evidence regarding the benefits of β-blocker treatment after invasively managed acute myocardial infarction (MI) without reduced left ventricular ejection fraction (LVEF). Methods and results TREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fraction (REBOOT) trial is a pragmatic, controlled, prospective, randomized, open-label blinded endpoint (PROBE design) clinical trial testing the benefits of β-blocker maintenance therapy in patients discharged after MI with or without ST-segment elevation. Patients eligible for participation are those managed invasively during index hospitalization (coronary angiography), with LVEF >40%, and no history of heart failure (HF). At discharge, patients will be randomized 1:1 to β-blocker therapy (agent and dose according to treating physician) or no β-blocker therapy. The primary endpoint is a composite of all-cause death, nonfatal reinfarction, or HF hospitalization over a median follow-up period of 2.75 years (minimum 2 years, maximum 3 years). Key secondary endpoints include the incidence of the individual components of the primary composite endpoint, the incidence of cardiac death, and incidence of malignant ventricular arrhythmias or resuscitated cardiac arrest. The primary endpoint will be analyzed according to the intention-to-treat principle. Conclusion The REBOOT trial will provide robust evidence to guide the prescription of β-blockers to patients discharged after MI without reduced LVEF.

ObjectivesMitraClip is an established therapy for patients with mitral regurgitation (MR) that are considered of high-risk or inoperable. However, late bleeding events (BE) after hospital discharge and their impact on prognosis in this cohort of patients have been poorly investigated. Our purpose is to address the incidence, related factors and clinical implications of BE after hospital discharge in patients treated with MitraClip.MethodsProspective registry of all consecutive patients (n = 80) who underwent MitraClip implantation in our Institution between June 2014 and December 2017. BE were defined according to MVARC definitions. A combined clinical end-point including admission for heart failure (HF) and all-cause mortality was established to analyze prognostic implications of BE.ResultsDuring a median follow up of 523.5 days, 41 BE were reported in 21 patients. Atrial fibrillation (AF, HR 4.54, CI95% 1.20–17.10) and combined antithrombotic therapy at discharge (HR 3.52, CI95% 1.03–11.34) were independently associated with BE. In the study period, 15 (18.8%) patients died, 20 (25%) were admitted for HF and 29 (36.3%) presented the combined end-point. After multivariable adjustment BE remained independently associated with an adverse outcome (HR 3.80, CI 95% 1.66–8.72). In the subgroup of patients with AF, HAS-BLED score was higher among subjects with BE (3.1 ± 1.3 vs 2.1 ± 0.9, p = 0.003). HAS-BLED score had a significant discrimination power for the occurrence BE (AUC: 0.677 [0.507–0.848]) in this subgroup.ConclusionsBE are common after MitraClip and are associated with an impaired outcome. Strategies to reduce bleeding events are paramount in this cohort of patients.

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Background Recent studies have shown that the extent of extravalvular (extra-aortic valve) cardiac damage in patients with severe aortic stenosis (AS) have important prognostic implications for clinical outcomes after aortic valve replacement (AVR). Aims The aim of the present study is to evaluate the prognostic impact of a defined staging classification (“Généreux Staging Classification”) (GSC) characterizing the extent of extravalvular cardiac damage in patients with severe AS undergoing percutaneous transcatheter aortic valve implantation (TAVI). Methods A total of 102 consecutive patients, admitted in our institution between 2011–2017, with severe AS (echo-defined by peak aortic velocity, mean transvalvular gradient or aortic valve area) and symptoms related to AS (dyspnea, heart failure, angina or syncope) undergoing TAVI, were included. These patients were pooled and classified according to the presence or absence of cardiac damage as detected by echocardiography prior to TAVI, regarding the GSC: no extravalvular cardiac damage (Stage 0), left ventricular damage (Stage 1), left atrial or mitral valve damage (Stage 2), pulmonary vasculature or tricuspid valve damage (Stage 3), or right ventricular damage (Stage 4). Two-year outcomes were compared using Kaplan– Meier techniques and multivariable Cox proportional hazards models were used to identify 2-year predictors of mortality. Results Out of 102 patients, 57 were male (55.9%). Mean age was 83.46±4.23 years. 2 patients (2.1%) were classified as Stage 0; 20 patients (20.3%) as Stage 1; 55 patients (54.2%) as Stage 2; 22 (21.6%) as Stage 3; and 3 patients (2.9%) as Stage 4. Two-year mortality was 0.0% in Stage 0, 5.0% in Stage 1, 5.5% in Stage 2, and 44.0% in Stages 3–4. After multivariable and univariate analysis, stage of cardiac damage was independently associated as predictor for all-cause mortality at 2-years, after TAVI (HR 2.8 [1.3±6.2], p<0.01). There were not another identificable predictors of 2-years death (age, sex, hypertension [78.5% of total patients], dislipemia [64.7%], diabetes [30.3%], smoking [78.5%], O2-chronic obstructive pulmonary disease [27.5% of total patients], renal insufficiency [78.5%], previous coronary artery disease [37.3%], peak aortic velocity, mean transvalvular gradient, and aortic valve area). Conclusions Given the strong association demonstrated in this study between advanced staging of cardiac damage and worse clinical outcomes after TAVI in short-middle term survival, consideration of the GSC in patients with severe AS in future recommendations for risk stratification might be useful. Two-year all-cause death in TAVI by GSC. Funding Acknowledgement Type of funding source: None