1. 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).
- Author
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Jose J, Mandalay A, Cholenahally MN, Khandenahally RS, Budnur SC, Parekh M, Rao RS, Seth A, Chandra P, Kapoor R, Agarwal P, Mathur A, Kumar V, Kanchanahalli SS, Mullasari AS, Subban V, Khanolkar UB, Mehrotra S, Chopra M, Jain RK, Mehta H, Gupta R, Kumar V, Raghuraman B, Shastri N, Elzomor H, Soliman O, and Gunasekaran S
- Subjects
- Humans, Female, Male, Treatment Outcome, Aged, India, Time Factors, Aged, 80 and over, Middle Aged, Risk Factors, Recovery of Function, Postoperative Complications, Retrospective Studies, Hemodynamics, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Aortic Valve Stenosis mortality, Aortic Valve Stenosis physiopathology, Registries, Heart Valve Prosthesis, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement instrumentation, Transcatheter Aortic Valve Replacement mortality, Prosthesis Design, Severity of Illness Index, Aortic Valve diagnostic imaging, Aortic Valve surgery, Aortic Valve physiopathology
- Abstract
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 cm
2 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., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Sengottuvelu Gunasekaran reports a relationship with Meril Life Sciences Pvt. Ltd. that includes: consulting or advisory. John Jose, Ashok Seth, Ravinder S. Rao & Haresh Mehta reports a relationship with Meril Life Sciences Pvt. Ltd. that includes: consulting or advisory. Other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Inc.)- Published
- 2024
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