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)

• Published in: Cardiovascular revascularization medicine 2024-06, Vol.63, p.1-7
• Main Authors: Jose, John, Mandalay, Asishkumar, Cholenahally, Manjunath N., Khandenahally, Ravindranath S., Budnur, Srinivas C., Parekh, Maulik, Rao, Ravinder S., Seth, Ashok, Chandra, Praveen, Kapoor, Rajneesh, Agarwal, Praveer, Mathur, Atul, Kumar, Vijay, Kanchanahalli, Sadananda S., Mullasari, Ajith S., Subban, Vijayakumar, Khanolkar, Uday B., Mehrotra, Sanjay, Chopra, Manik, Jain, Rajendra K., Mehta, Haresh, Gupta, Rahul, Kumar, Viveka, Raghuraman, Bagirath, Shastri, Naman, Elzomor, Hesham, Soliman, Osama, Gunasekaran, Sengottuvelu
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Aortic Valve - diagnostic imaging; Aortic Valve - physiopathology; Aortic Valve - surgery; Aortic Valve Stenosis - diagnostic imaging; Aortic Valve Stenosis - mortality; Aortic Valve Stenosis - physiopathology; Aortic Valve Stenosis - surgery; Female; Heart Valve Prosthesis; Hemodynamics; Humans; India; Male; Middle Aged; Myval Octacor THV; Paravalvular leakage; Postoperative Complications; Prosthesis Design; Recovery of Function; Registries; Retrospective Studies; Risk Factors; Severity of Illness Index; Symptomatic severe native aortic valve stenosis; Time Factors; Transcatheter aortic valve implantation; Transcatheter Aortic Valve Replacement - adverse effects; Transcatheter Aortic Valve Replacement - instrumentation; Transcatheter Aortic Valve Replacement - mortality; Treatment Outcome
• ISSN: 1553-8389; 1878-0938; 1878-0938
• DOI: 10.1016/j.carrev.2024.01.016

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). 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. 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