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.

Angiographic quantification of aortic regurgitation following myval octacor implantation; independent core lab adjudication.

BACKGROUND: 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. OBJECTIVES: 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. METHODOLOGY: 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%). RESULTS: 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. CONCLUSION: 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.

Depression, anxiety, and quality of life after percuataneous coronary interventions.

Coronary artery disease (CAD) is the leading cause of morbidity and mortality in the world. However, some fascinating advances in the field of cardiology have not only added years to people's life but life to years as well. Percutaneous coronary intervention (PCI), commonly known as coronary angioplasty is a nonsurgical procedure used to treat stenotic coronary arteries. In recent years, PCI has become the preferred modality of treatment for occluded coronary arteries. However, there has been growing interest in the quality of life (QOL) issues for those who undergo such procedures. Depression, anxiety, vital exhaustion, hostility, anger, and acute mental stress have been evaluated as risk factors for the development and progression of CAD. Further, they also have strong bearing toward recovery from an acute coronary event. The current article discusses the role of depression, anxiety, and QOL of patients undergoing PCI.

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.

Use of PercuSurge in primary angioplasty.

Thrombus load and its subsequent distal embolization causing slow flow makes primary angioplasty a challenging task. Although data is scanty, these complications may be potentially mitigated by use of distal protection devices. We report 6 cases of PercuSurge distal protection device-assisted primary angioplasty. All lesions were stented with patients achieving brisk TIMI 3 flow; none of the patients had in-hospital major adverse cardiac events. The strategy of PercuSurge Guardwire-assisted primary angioplasty seems encouraging in improving successful outcome in this subset of patients.