Moving transcatheter valve intervention towards atrioventricular (AV) valves implies increasing complexity. Some of the knowledge that has been generated during the development of mitral devices can be applied to the tricuspid valve (TV). A deep understanding of the peculiar anatomy of the TV and of the right heart chambers, with differences and similarities between the two AV valves, is fundamental to overcoming the specific challenges related to transcatheter TV therapies. The aim of this report is to explore similarities and differences between the mitral and tricuspid valve apparatus, and their interventional implications.
as stent thrombosis. The Biolimus A9™ eluting stent platform (BES) releases biolimus from an abluminal biodegradable polymer, fully absorbed after 6-9 months. The LEADERS trial assessed the safety and efficacy of BES with an established stent platform releasing sirolimus from a durable polymer (SES) in a large scale, all-comers, noninferiority trial. We report the 5 year follow-up and final report of the LEADERS study. Methods: LEADERS is a multi-center, randomized, assessor-blind, non-inferiority trial performed at 10 European sites in an all-comers, "real world" patient population. A total of 1,707 patients were enrolled and randomized 1:1 to BES or SES. The primary endpoint was MACE (a composite of cardiac death, MI, or clinically-indicated TVR) at 9 months. Secondary endpoints include death, cardiac death, MI, ST (ARC defined), TLR and TVR. All patients are followed up to 5 years. Results: 1707 patients were allocated to BES (857) and SES (850) patients. At 4 years, there was a clinical follow-up rate of over 96%, at which time the risk of MACE was lower in patients treated with BES than in those treated with SES (18.7% vs. 22.6%: p ϭ 0.050). The RR of definite ST was 0.62 (pϭ0.09), which was largely attributed to a lower risk of very late definite ST between years 1 and 4 in the BES compared to the SES group (RR 0.20, pϭ0.004) demonstrating 80% relative risk reduction. An analysis of the correlation between MACE and definite stent thrombosis events showed that the benefit in favor of BES in terms of MACE was largely driven by a lower risk of MACE associated with definite VLST beyond the first year of follow-up.The 5-year analysis of LEADERS trial is ongoing. Conclusions: Biodegradable polymer BES are non-inferior to durable polymer SES, and by reducing the risk of cardiac events associated with VLST, might improve long-term clinical outcomes. LEADERS final 5-year follow-up results will be reported for the 1st time during this presentation.
Background: This is an investigation of complete arterial coronary artery bypass grafting (CACABG) using bilateral internal mammary arteries (IMA) and the T-graft technique either on- or off-pump as a routine approach to treat coronary artery disease. Methods: Between January 2000 and December 2012, 3,445 patients underwent on-pump (n = 2,216) or off-pump (n = 1,229) CACABG. A 30-day follow-up was performed prospectively, a long-term follow-up by a questionnaire, and coronary angiography in selected patients. Results: End points at 30 days were death, myocardial infarction, stroke, repeat revascularization, renal replacement, reoperation, sternal wound infection and atrial fibrillation. FitzGibbon A patency rates were 89.8 vs. 91.4% (p = 0.464) with consecutive percutaneous coronary intervention in the grafted area of 1.8 vs. 1.1% (p = 0.693) on- vs. off-pump, and no reoperation in the grafted area in both groups. Conclusion: CACABG by use of skeletonized bilateral IMA with the T-graft technique performed either on- or off-pump is a safe and effective approach.
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