Transcatheter aortic valve implantation (TAVI) has become the standard of care for elderly patients with aortic stenosis. International guidelines recommend that TAVI should be performed only in centers with on-site cardiac surgery (CS). However, rapidly evolving TAVI technology and increasing operator expertise have significantly reduced peri-procedural complications, including those requiring rescue surgery, which occur in less than 0.5% of cases. Furthermore, only a minority of major complications are treated with CS, and the outcomes remain unfavorable. TAVI in centers without CS could represent a solution to reduce waiting times and ensure continuity of care for fragile patients. “TAVI at Home” is a single-arm prospective interventional study. According to sample size calculations based on literature data, the study aims to enroll a total of 200 patients, beginning with a run-in phase of 20 patients to establish safety. The primary endpoint is 30-day all-cause mortality. Secondary endpoints include technical success and the evaluation of single complications 30 days after the procedure. Hospitals without CS that are eligible to perform TAVI must have a high volume of coronary percutaneous interventions, operators with established TAVI experience, collaboration with vascular surgeons, and regular Heart Team meetings to ensure rigorous patient selection.

BACKGROUND: The universal definition of percutaneous coronary intervention (PCI)–related myocardial infarction (MI) has been substantially updated over the years, including an increase in the biomarker threshold (from 3 to 5 times the upper reference limit) and the introduction of ancillary criteria such as ischemic symptoms and electrocardiographic or angiographic complication. The impact of these changes in patients with acute coronary syndrome (ACS) remains incompletely understood. The objective of this study was to compare prognostic implications of evolving universal definitions of PCI-MI in a large cohort of patients with ACS from the MATRIX trial (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX). METHODS: Among 6724 patients undergoing PCI in the MATRIX trial, PCI-MI was prospectively adjudicated by the second, third and fourth universal definition of MI (UDMI). The 2 co-primary end points were all-cause and cardiovascular death (from 24 hours to 1 year after PCI) in patients with non–ST-segment–elevation ACS. Hazard ratios and 95% CIs were generated for primary and secondary end points with the use of Cox proportional hazards time-to-event analyses for each MI definition. RESULTS: PCI-MI occurred in 590 patients (9%) with the second UDMI, 193 (3%) with the third UDMI, and 182 (3%) with the fourth UDMI applied in the overall ACS population. Among patients with non–ST-segment–elevation ACS, the corresponding figures were 15%, 5%, and 5%. Only PCI-MI defined by the fourth UDMI in patients with non–ST-segment–elevation ACS was associated with increased risks of all-cause (hazard ratio, 2.08 [95% CI, 1.00–4.30]; P =0.048) and cardiovascular (hazard ratio, 2.62 [95% CI, 1.03–6.65]; P =0.043) death. In patients with ST-segment–elevation myocardial infarction, PCI-MI was uncommon (1% to 4% depending on the working definition) and was not associated with increased mortality. In the absence of objective ancillary criteria (electrocardiographic and angiographic complications), isolated troponin elevations up to 20 times the upper reference limit were not associated with increased mortality risk. CONCLUSIONS: PCI-MI defined according to the fourth UDMI was associated with increased risks of 1-year mortality only in patients with non–ST-segment–elevation ACS. These data support the evolution of the universal definition of PCI-MI. REGISTRATION: URL: http://www.clinicaltrials.gov ; Unique identifier: NCT01433627.

Sudden death guidelines make emphasis on the need to identify the etihiology of the arrest in survived patients or in their family members. If cardio–pulmonary resuscitation techniques are almost standardized throughout the world, the intra– and post–hospital treatment of the patient changes in the different centers and countries. The local discrepancies related to the survival rate of the patients can instead be considered as an indirect index of the good network in the management of the victims. Given the impossibility of carrying out randomized, controlled and prospective studies, registries represent the only alternative system for collecting and analyzing data in this area. The SCARe (Sudden Cardiac Arrest Registry) project – unique for being multidisciplinary – represents the most effective system for carrying out an epidemiological investigation, optimizing the treatment of patients affected by cardiac arrest, creating collaborations and integrations between hospitals and the territory, identifying diagnostic pathways for study of family members, monitoring the efficiency of the work performed. 646 interventions for "code blue" (out–of–hospital cardiac arrest) carried out in the Province of Rimini from 2019 to 2021 were analysed. There were 318 patients less than 75 yrs old, with a median age of 63 years: only 24% of the victims presented with a shockable rhythm, in 98% of them with ventricular fibrillation; autopulse was used in 20%; 217 patiente died out from hospital, 5 in the emergency room. Of the remaining 72% was hospitalized in Intensive Care, 28% in CCU or Emergency Medicine. A multi–specialist database can evaluate the adherence to the guidelines and the methods of approach of the different professional figures to the patient. Data analysis will allow to increase the survival rate of patients.

In many countries, patients’ access to transcatheter aortic valve implantation (TAVI) is limited by reimbursement issues or delayed admission to heart valve centers, thus increasing the risk of adverse events in wait-listed patients. The TAVI AT HOME (TAH) is a single-arm, multicenter study aiming to evaluate the safety and efficacy of transfemoral TAVI performed at centers without on-site cardiac surgery by expert operators. The primary endpoint is 30-day all-cause mortality. This study focuses on the run-in phase of the registry, which was required by the ethics committee to perform an interim safety analysis. The outcome of 20 TAH patients enrolled at three Italian centers from May 2023 to May 2024 was compared to 41 TAVI cases included in the permanent local registry, matching the TAH inclusion/exclusion criteria. The two groups had similar baseline characteristics. Significantly more patients in the TAH group were deemed at prohibitive risk (85.0% vs. 56.1%; p = 0.026) but had similar surgical risk scores. A self-expanding device was used in most cases (60.7%). Technical success did not differ between groups (95.0% in the TAH vs. 85.4%, p = 0.409). No deaths at 30 days (primary endpoint) were observed. The 1-year survival rate did not differ between groups. After interim data analysis, the ethics committee authorized the completion of the TAH enrollment and extension to other centers. The TAH approach might represent an alternative model to allow timely access to TAVI without compromising safety and effectiveness.