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Background Durable polymers used for first-generation drug-eluting stents (DES) potentially contribute to persistent inflammation and late DES thrombosis. We report the first real-life human experience with the rapamycin-eluting biodegradable polymer-coated Rapstrom stent. Methods All consecutive patients with single de novo native coronary stenosis (<30 mm and between 2.5 and 4.0 mm) were enrolled. Major adverse cardiac events (MACE) at 1 year (cardiac death, myocardial infarction [Q and non-Q], or ischemia-driven target lesion revascularization) were the primary end-point. Results A total of 123 patients were enrolled. The stent was implanted without complications in all patients, and no MACE were recorded at 30 days. At 12-month follow-up 9 patients (7.3%) experienced a MACE and 4 (3.2%) required a target lesion revascularization, while 1 (1%) stent thrombosis was recorded. A planned angiographic follow-up (FU) was performed in 73 patients (59%) at 9.4 ± 2.6 months following the index procedure. In-stent late loss was 0.16 ± 0.09 mm, and in-segment late loss was 0.18 ± 0.8 mm. Conclusion The Rapstrom biodegradable polymer rapamycin-eluting stent appeared safe and efficacious in this first real-life human experience, due to a low late lumen loss. Larger randomized studies are required to confirm these preliminary results. (J Interven Cardiol 2014;27:373-380) [ABSTRACT FROM AUTHOR]

The balloon expandable Myval transcatheter heart valve (THV) showed encouraging results regarding residual aortic regurgitation (AR) from multiple observational studies. The newly designed Myval Octacor has been introduced recently, aiming for a reduction in AR and improved performance. The focus of this study is to report the incidence of AR using the validated quantitative Videodensitometry angiography technology (qLVOT-AR%) in the first in human use of the Myval Octacor THV system. We report on the first in human use of the Myval Octacor THV system in 125 patients in 18 Indian centres. Independent retrospective analysis of the final aortograms following implantation of the Myval Octacor was performed using the CAAS-A-Valve software. AR is reported as a regurgitation fraction. The previously validated cutoff values have been used to identify ≥moderate AR (RF% >17%), mild (6% < RF% ≤17%), and none or trace AR (RF% ≤ 6%). Final aortogram was analysable for 103 patients (84.4%) among the 122 available aortograms. 64 (62%) patients, had tricuspid aortic valve (TAV), 38 (37%) with bicuspid AV (BAV), and one with unicuspid AV. The median absolute RF% was 2% [1, 6], moderate or more AR incidence was 1.9%, mild AR in 20.4%, and none or trace AR in 77.7%. The two cases with RF% >17% were in the BAV group. The initial results of Myval Octacor using quantitative angiography-derived regurgitation fraction demonstrated a favourable outcome regarding residual AR, possibly due to improved device design. Results must be confirmed in a larger randomised study, including other imaging modalities. • The new BE Myval Octacor THV shows changes in cell design to minimise over-shortening of the device. • The improved internal and external skirt design shows improvement in the incidence of residual AR. • In comparison to the First Myval iteration, Myval Octacor shows a significant reduction of moderate or more AR. • A reduction of mild AR with a shift to none/trace AR was observed when AR was assessed using quantitative technology. [ABSTRACT FROM AUTHOR]