Recommendations for prophylactic implantable cardioverter defibrillator (ICD) implantation in asymptomatic heart failure patients with a reduced left ventricular ejection fraction (LVEF) differ between guidelines. Evidence on the risk of appropriate device therapy (ADT) and death in New York Heart Association (NYHA) class I patients is scarce. Aim of this study is to evaluate ADT and mortality in NYHA-I primary prevention ICD patients with a LVEF ≤35%. A retrospective cohort was studied, including 572 patients with LVEF ≤35% who received a prophylactic ICD with or without resynchronization therapy (CRT-D). To evaluate the incidence of ADT and mortality, NYHA-I was compared with NYHA-II-III using Cox regression analysis. During a follow-up of 4.1 § 2.4 years, 33% of the NYHA-I patients received ADT compared with 20% of the NYHA-II-III patients (hazard ratio 1.5, 95% confidence interval 1.04 to 2.31, p = 0.03). No differences in mortality were observed (hazard ratio 0.70, 95% confidence interval 0.49 to 1.07, p = 0.10). Additional analyses showed no difference in time to ADT excluding CRT patients (ICD-NYHA-I patients vs ICD-NYHA-II-III patients, p = 0.17) and comparing ischemic and nonischemic cardiomyopathy NYHA-I patients (p = 0.13). Multivariable Cox regression analyses showed that NYHA class was the strongest independent predictor of ADT. In conclusion, primary prevention NYHA-I ICD patients showed a higher incidence of ADT compared with NYHA-II-III ICD patients. These results strongly suggest that primary prevention NYHA-I patients with a LVEF ≤35% are likely to benefit from ICD therapy and should not be excluded from a potentially life-saving therapy.

IntroductionThe effectiveness of rotator cuff tear repair surgery is influenced by multiple patient-related, pathology-centred and technical factors, which is thought to contribute to the reported retear rates between 17% and 94%. Adequate patient selection is thought to be essential in reaching satisfactory results. However, no clear consensus has been reached on which factors are most predictive of successful surgery. A clinical decision tool that encompassed all aspects is still to be made. Artificial intelligence (AI) and machine learning algorithms use complex self-learning models that can be used to make patient-specific decision-making tools. The aim of this study is to develop and train an algorithm that can be used as an online available clinical prediction tool, to predict the risk of retear in patients undergoing rotator cuff repair.Methods and analysisThis is a retrospective, multicentre, cohort study using pooled individual patient data from multiple studies of patients who have undergone rotator cuff repair and were evaluated by advanced imaging for healing at a minimum of 6 months after surgery. This study consists of two parts. Part one: collecting all potential factors that might influence retear risks from retrospective multicentre data, aiming to include more than 1000 patients worldwide. Part two: combining all influencing factors into a model that can clinically be used as a prediction tool using machine learning.Ethics and disseminationFor safe multicentre data exchange and analysis, our Machine Learning Consortium adheres to the WHO regulation ‘Policy on Use and Sharing of Data Collected by WHO in Member States Outside the Context of Public Health Emergencies’. The study results will be disseminated through publication in a peer-reviewed journal. Institutional Review Board approval does not apply to the current study protocol.

Purpose/introductionOver the last decades, there has been increasing interest in biological stimulation or bioaugmentation after rotator cuff repair. So far, there is no consensus on the appropriate composition of biologicals or which patients would benefit most, and moreover, these biologicals are often expensive. However, there are other, non-pharmacological strategies that are also believed to achieve biological stimulation. This randomised controlled trial evaluates the possible cumulative effect of pragmatic application of cryobiomodulation, photobiomodulation and electrobiomodulation—collectively called biomodulation—on the bone-to-tendon healing process after rotator cuff repair.MethodsIn this randomised, controlled proof of concept study, 146 patients undergoing arthroscopic repair of a full thickness posterosuperior or anterosuperior rotator cuff tear will be 1:1 randomly assigned to either a control group or to the additional biomodulation protocol group. The adjuvant biomodulation protocol consists of seven self-applicable therapies and will be administered during the first 6 weeks after surgery. Primary outcome will be healing of the rotator cuff as evaluated by the Sugaya classification on MRI at 1-year postoperatively.Ethics and disseminationThis study has been accepted by the National Ethical Review Board CPP Sud-Est IV in France and has been registered at Clinicaltrials.gov. The results of this study will be published in a peer-reviewed journal.Trial registration numberNCT04618484.