Systematic fluoroscopic and electrical assessment of implantable cardioverter-defibrillator patients implanted with silicone-polyurethane copolymer (Optim™) coated leads.

AIMS: Serious concerns have been recently raised about the reliability of the silicone-polyurethane copolymer (Optim™) lead insulation system. We sought to identify insulation defects and Optim-lead failures by systematic fluoroscopic and electrical assessment in a prospectively defined cohort of implantable cardioverter-defibrillator (ICD) patients. METHODS AND RESULTS: Between July 2007 and December 2011, 234 patients were implanted with 413 optim-coated leads as part of an ICD system at a single centre. Fluoroscopic screening with high-resolution cine-fluoroscopy at 30 frames per second was offered to all patients. In addition, the electrical integrity of all implanted leads was assessed. Durata, Riata ST Optim, and low-voltage Optim leads were implanted in 199, 26, and 188 cases, respectively. During a total follow-up of 10 036 lead-months, there were 7 Optim-lead failures (defined as electrical malfunction resulting in lead replacement) and 31 deaths; no cases of electrical noises were encountered. The overall incidence of lead failure was 1.2 vs. 0.3 per 100 lead-years, for high- and low-voltage leads, respectively (P = 0.1). One hundred fifty-one patients agreed to undergo fluoroscopy screening; none of the 264 analysed Optim leads were found to have any fluoroscopically visible structural defects after an average of 31 months post-implant. CONCLUSION: This study represents the first systematic screening of Optim-coated leads in a large unselected cohort of ICD patients. Over a 5-year period few lead failures were observed and normal fluoroscopic appearance was present in all patients.

Transcatheter aortic valve implantation for severe regurgitation in native and degenerated bioprosthetic aortic valves.

OBJECTIVES: We evaluated transcatheter aortic valve Implantation (TAVI) in high-risk patients with severe aortic regurgitation (AR) in native or degenerated bioprosthetic valves. BACKGROUND: TAVI has emerged as a viable treatment modality for severe aortic stenosis in inoperable or high-risk patients. The use of TAVI for treatment of severe AR has remained largely unexplored. METHODS: Eight patients (age 79.6 years ± 5.75 years) with severe AR underwent TAVI at six tertiary hospitals between April 2010 and May 2011. All patients were considered to be at prohibitive risk for surgical aortic valve replacement (SAVR).TAVI with the nitinol based Core Valve bioprosthesis (CRS) (Medtronic) was performed in all patients. RESULTS: Transfemoral access was used in all cases. Procedural success was obtained in all cases without any intraprocedural complications. There was no in hospital or 30-day mortality. There were no cases of atrioventricular blocks requiring permanent pacemaker implantation. At a mean follow up of 15.5 ± 15 months; all patients had improvement in New York Heart Association functional class. Follow up echocardiography revealed improved or stable left ventricular ejection fraction and optimal device function in all cases. CONCLUSIONS: TAVI with the CRS bioprosthesis is feasible and effective in appropriately selected cases of severe aortic regurgitation in native and bioprosthetic aortic valves.

Italian Cardiological Guidelines (COCIS) for Competitive Sport Eligibility in athletes with heart disease: update 2020.

Since 1989, SIC Sport and a FMSI, in partnership with leading Italian Cardiological Scientific Associations (ANCE, ANMCO and SIC) have produced Cardiological Guidelines for Completive Sports Eligibility for athletes with heart disease (COCIS -- 1989, 1995, 2003, 2009 and 2017). The English version of the Italian Cardiological Guidelines for Competitive Sports Eligibility for athletes with heart disease was published in 2013 in this Journal. This publication is an update with respect to the document previously published in English in 2013. It includes the principal innovations that have emerged over recent years, and is divided into five main chapters: arrhythmias, ion channel disorders, congenital heart diseases, acquired valve diseases, cardiomyopathies, myocarditis and pericarditis and ischemic heart disease. Wherever no new data have been introduced with respect to the 2013 publication, please refer to the previous version. This document is intended to complement recent European and American guidelines but an important difference should be noted. The European and American guidelines indicate good practice for people engaging in physical activity at various levels, not only at the competitive level. In contrast, the COCIS guidelines refer specifically to competitive athletes in various sports including those with high cardiovascular stress. This explains why Italian guidelines are more restrictive than European and USA ones. COCIS guidelines address 'sports doctors' who, in Italy, must certify fitness to participate in competitive sports. In Italy, this certificate is essential for participating in any competition.

Percutaneous closure of patent foramen ovale with Atriasept II device in nickel allergic patients.

There are concerns about percutaneous closure of patent foramen ovale (PFO) using nitinol-alloys devices in patients with nickel hypersensitivity. We describe our experience with Atriasept II (Cardia Eagan, Minnesota, USA) used in four patients with known nickel allergy. No intraprocedural or in-hospital adverse events occurred. The follow-up was negative for allergic manifestations, without complications, as assessed by echocardiography. Because of the risk of adverse outcomes in nickel-allergic patients, devices with higher biocompatibility, low-profile, and low nickel content should be preferred in cases of known hypersensitivity. Atriasept II, containing less metallic material, appears to be a safe option in allergic patients undergoing PFO closure.