Safety and effectiveness of the novel Myval Octacor transcatheter heart valve in severe, symptomatic aortic valve stenosis - A real-world Indian experience (The OCTACOR India Study).

PURPOSE: To evaluate the safety and effectiveness of the novel, next-generation Myval Octacor - Transcatheter Heart Valve (THV) in patients with severe, symptomatic, native aortic stenosis (AS). METHODS: This multicenter, real-world observational registry included 123 patients with severe symptomatic AS, across 16 Indian centers who underwent treatment with the novel Myval Octacor THV. Study endpoints included all-cause mortality, all stroke, acute kidney injury (AKI), major vascular complications, moderate or severe paravalvular leakage (PVL) and new permanent pacemaker implantation (PPI) until 30 days follow-up. RESULTS: Of the 123 patients (average age 70.07 ± 8.33 years), 37.4 % (n = 46) were female and 39.84 % presented with bicuspid valves. The technical success rate of the procedure was 100 % and the device success rate at 30 days was 98.4 %. At 30 days (n = 123) after the procedure, the overall mortality was 1.6 %. AKI occurred in 1.6 % of patients and there was no incidence of stroke, bleeding (types 3 and 4), and major vascular complications. In an analysis of 31 patients whose echocardiographic parameters were available across all timepoints, there were significant improvements in the mean pressure gradient (54.31 ± 18.19 mmHg vs. 10.42 ± 4.24 mmHg; p < 0.0001) and effective orifice area (0.66 ± 0.21 cm2 vs. 1.80 ± 0.44 cm2; p < 0.0001) from baseline to the 30-day follow-up. None of the patients experienced severe PVL, while moderate PVL was observed in two patients (1.6 %). CONCLUSIONS: Early outcomes of the next-generation, novel Myval Octacor THV proved its safety and effectiveness in the treatment of severe AS.

EMPIRE (Escorts Multiple ProNova Implantation Registry) Study: Evaluating the ProNova SES in De Novo Coronary Artery Lesions.

BACKGROUND: The main limitation of percutaneous coronary intervention (PCI) with bare metal stents was the increased incidence of instant restenosis. The introduction of drug-eluting stents has decreased the rate of restenosis. Various DESs, using different drugs and stent designs, are now being used in interventional cardiology worldwide. The EMPIRE study was conducted to evaluate the safety and efficacy of the slow-release sirolimus-eluting ProNova stent in de novo coronary artery lesions in patients with single- or multi-vessel disease. METHODS AND RESULTS- A total of 300 patients, enrolled in a single-centre registry, were successfully implanted with ProNova, a sirolimus-eluting stent (SES). They were followed up clinically, first at 30 days and then six months after the procedure for parameters like death, target vessel failure, documented myocardial infarction (MI) and restenosis. Assessment of binary restenosis was done angiographically at six months. The primary success rate of stent implantation was 100%, the percentage of acute major adverse cardiac events (MACE) being 0% and 2% at 30 days and six months, respectively. Angiographic restenosis was documented in 12.6% of the patients enrolled in the study. CONCLUSION: The ProNova stent was found to be safe and effective in this trial.