REC Interventional Cardiology最新文献

Despite the 2017 update to European medical device regulation and its entry into force in 2021, many doubts persist about its real-world application in medical device (MD) research in Spain. The development of MDs requires collaboration among numerous stakeholders, including researchers, ethics committees, notified bodies, the Spanish Agency of Medicines and Medical Devices, manufacturers, and other involved parties-all of whom have had to adapt to the new regulatory framework. This has required a significant effort and consumption of resources to understand and apply the different clinical practice guidelines to unify protocols in MD research and ensure the safety and efficacy profile of these products. Although challenges remain, the adoption of this legislation has fostered collaboration among stakeholders, enabling progress and a better understanding of the new obstacles it presents. The aim of this review is to define, in a practical way, the content of this regulation and expose the perspectives of the different actors involved in the development of MD.

Introduction and objectives: Although transcatheter aortic valve implantation (TAVI) is the first-line therapy for aortic stenosis (AS), its benefit could be lower (or even disappear) in frail patients. Physical exercise and nutritional support programs are recommended to address frailty. Data on the application of telemedicine strategies in this context is scarce. The objective of this study is to analyze, in older patients with AS undergoing TAVI, the effect of a telematic intervention on the reversal of frailty vs standard of care.

Methods: We will be conducting a randomized multicenter study including patients aged ≥ 75 years with severe AS (mean aortic gradient > 40 mmHg, or aortic valve area < 0.8 8 cm² on echocardiogram) with baseline frailty criteria (Short Physical Performance Battery [SPPB ] < 10 and FRAIL scale ≥ 3) undergoing TAVI. Prior to discharge, patients will be randomized to a) a telematic intervention within the first 3 months (nutritional support plus supervised physical exercise plus health education); or b) standard of care. The primary endpoint will be the percentage of patients with frailty reversal (SPPB ≥ 10) at 3 months. The estimated sample size is 206 patients (103 in each arm).

Conclusions: The hypothesis of this study is that telematic intervention will allow a higher percentage of frailty reversal at 3 months vs standard of care after TAVI. The results of this study may provide novel information on this approach to frail patients with AS undergoing TAVI.ClinicalTrials.gov registered trial (NCT06742970).

Introduction and objectives: The Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC) and the Interventional Working Group of the Spanish Society of Pediatric Cardiology (GTH-SECPCC) present their 2023 annual activity report.

Methods: Participation was open to all Spanish centers with cath labs and interventional programs for congenital heart disease. Data was collected online and analyzed by an external company, and members from the ACI-SEC and the GTH-SECPCC.

Results: A total of 19 centers participated (15 public and 4 private). Interventional data on adult congenital diseases was contributed to the Registry of Hemodynamics and Interventional Cardiology of the ACI-SEC in 2023 by another 114 hospitals and, then, added to the analysis. A total of 1127 diagnostic studies (1.2% less than 2022) and 3856 interventional cardiac catheterizations (53.7% more than 2022) were registered, 2439 of which (65%) were performed on patients older than 18 years. The most widely performed procedures were foramen ovale closure (1498 cases), atrial septal defect closure (700 cases), transcatheter closure of the patent ductus arteriosus (344 cases) and aortic coarctation (221 cases). The most significant volume increment of cases was associated with ventricular septal defect closure (181%), foramen ovale closure (87%), and aortic coarctation (75%). Interventional procedures were considered successful in 98.3% of the cases, with rates of major procedural complication and in-hospital mortality of 1% and 0.05%, respectively.

Conclusions: We present the fourth Spanish cardiac catheterization in congenital heart diseases registry with data from 2023. We observed a significant rise in interventional procedures, notably ventricular septal defect and patent foramen ovale closures. Most interventional techniques continue to demonstrate excellent safety and efficacy outcomes.