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)

John Jose; Asishkumar Mandalay; Manjunath N Cholenahally; Ravindranath S Khandenahally; Srinivas C Budnur; Maulik Parekh; Ravinder S Rao; Ashok Seth; Praveen Chandra; Rajneesh Kapoor; Praveer Agarwal; Atul Mathur; Vijay Kumar; Sadananda S Kanchanahalli; Ajith S Mullasari; Vijayakumar Subban; Uday B Khanolkar; Sanjay Mehrotra; Manik Chopra; Rajendra K Jain; Haresh Mehta; Rahul Gupta; Viveka Kumar; Bagirath Raghuraman; Naman Shastri; Hesham Elzomor; Osama Soliman; Sengottuvelu Gunasekaran

doi:10.1016/j.carrev.2024.01.016

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)

John Jose, Asishkumar Mandalay, Manjunath N Cholenahally, Ravindranath S Khandenahally, Srinivas C Budnur, Maulik Parekh, Ravinder S Rao, Ashok Seth, Praveen Chandra, Rajneesh Kapoor, Praveer Agarwal, Atul Mathur, Vijay Kumar, Sadananda S Kanchanahalli, Ajith S Mullasari, Vijayakumar Subban, Uday B Khanolkar, Sanjay Mehrotra, Manik Chopra, Rajendra K JainHaresh Mehta, Rahul Gupta, Viveka Kumar, Bagirath Raghuraman, Naman Shastri, Hesham Elzomor, Osama Soliman, Sengottuvelu Gunasekaran

Research output: Contribution to a Journal (Peer & Non Peer) › Article › peer-review

8 Citations (Scopus)

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 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.

Original language	English
Pages (from-to)	1-7
Number of pages	7
Journal	Cardiovascular Revascularization Medicine
Volume	63
DOIs	https://doi.org/10.1016/j.carrev.2024.01.016
Publication status	Published - Jun 2024

Keywords

Humans
Female
Male
Aortic Valve Stenosis/diagnostic imaging
Treatment Outcome
Aged
India
Registries
Heart Valve Prosthesis
Transcatheter Aortic Valve Replacement/adverse effects
Prosthesis Design
Time Factors
Severity of Illness Index
Aged, 80 and over
Middle Aged
Aortic Valve/diagnostic imaging
Risk Factors
Recovery of Function
Postoperative Complications
Retrospective Studies
Hemodynamics

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.carrev.2024.01.016

Cite this

Jose, J., Mandalay, A., Cholenahally, M. N., Khandenahally, R. S., Budnur, S. C., Parekh, M., Rao, R. S., Seth, A., Chandra, P., Kapoor, R., Agarwal, P., Mathur, A., Kumar, V., Kanchanahalli, S. S., Mullasari, A. S., Subban, V., Khanolkar, U. B., Mehrotra, S., Chopra, M., ... Gunasekaran, S. (2024). 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). Cardiovascular Revascularization Medicine, 63, 1-7. https://doi.org/10.1016/j.carrev.2024.01.016

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title = "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)",

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 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.",

keywords = "Humans, Female, Male, Aortic Valve Stenosis/diagnostic imaging, Treatment Outcome, Aged, India, Registries, Heart Valve Prosthesis, Transcatheter Aortic Valve Replacement/adverse effects, Prosthesis Design, Time Factors, Severity of Illness Index, Aged, 80 and over, Middle Aged, Aortic Valve/diagnostic imaging, Risk Factors, Recovery of Function, Postoperative Complications, Retrospective Studies, Hemodynamics",

author = "John Jose and Asishkumar Mandalay and Cholenahally, \{Manjunath N\} and Khandenahally, \{Ravindranath S\} and Budnur, \{Srinivas C\} and Maulik Parekh and Rao, \{Ravinder S\} and Ashok Seth and Praveen Chandra and Rajneesh Kapoor and Praveer Agarwal and Atul Mathur and Vijay Kumar and Kanchanahalli, \{Sadananda S\} and Mullasari, \{Ajith S\} and Vijayakumar Subban and Khanolkar, \{Uday B\} and Sanjay Mehrotra and Manik Chopra and Jain, \{Rajendra K\} and Haresh Mehta and Rahul Gupta and Viveka Kumar and Bagirath Raghuraman and Naman Shastri and Hesham Elzomor and Osama Soliman and Sengottuvelu Gunasekaran",

note = "Copyright {\textcopyright} 2024. Published by Elsevier Inc.",

year = "2024",

month = jun,

doi = "10.1016/j.carrev.2024.01.016",

language = "English",

volume = "63",

pages = "1--7",

journal = "Cardiovascular Revascularization Medicine",

issn = "1553-8389",

publisher = "Elsevier Inc.",

}

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 & Gunasekaran, S 2024, '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)', Cardiovascular Revascularization Medicine, vol. 63, pp. 1-7. https://doi.org/10.1016/j.carrev.2024.01.016

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). / Jose, John; Mandalay, Asishkumar; Cholenahally, Manjunath N et al.
In: Cardiovascular Revascularization Medicine, Vol. 63, 06.2024, p. 1-7.

Research output: Contribution to a Journal (Peer & Non Peer) › Article › peer-review

TY - JOUR

T1 - 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)

AU - Jose, John

AU - Mandalay, Asishkumar

AU - Cholenahally, Manjunath N

AU - Khandenahally, Ravindranath S

AU - Budnur, Srinivas C

AU - Parekh, Maulik

AU - Rao, Ravinder S

AU - Seth, Ashok

AU - Chandra, Praveen

AU - Kapoor, Rajneesh

AU - Agarwal, Praveer

AU - Mathur, Atul

AU - Kumar, Vijay

AU - Kanchanahalli, Sadananda S

AU - Mullasari, Ajith S

AU - Subban, Vijayakumar

AU - Khanolkar, Uday B

AU - Mehrotra, Sanjay

AU - Chopra, Manik

AU - Jain, Rajendra K

AU - Mehta, Haresh

AU - Gupta, Rahul

AU - Kumar, Viveka

AU - Raghuraman, Bagirath

AU - Shastri, Naman

AU - Elzomor, Hesham

AU - Soliman, Osama

AU - Gunasekaran, Sengottuvelu

PY - 2024/6

Y1 - 2024/6

N2 - 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.

AB - 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.

KW - Humans

KW - Female

KW - Male

KW - Aortic Valve Stenosis/diagnostic imaging

KW - Treatment Outcome

KW - Aged

KW - India

KW - Registries

KW - Heart Valve Prosthesis

KW - Transcatheter Aortic Valve Replacement/adverse effects

KW - Prosthesis Design

KW - Time Factors

KW - Severity of Illness Index

KW - Aged, 80 and over

KW - Middle Aged

KW - Aortic Valve/diagnostic imaging

KW - Risk Factors

KW - Recovery of Function

KW - Postoperative Complications

KW - Retrospective Studies

KW - Hemodynamics

U2 - 10.1016/j.carrev.2024.01.016

DO - 10.1016/j.carrev.2024.01.016

M3 - Article

C2 - 38423848

SN - 1553-8389

VL - 63

SP - 1

EP - 7

JO - Cardiovascular Revascularization Medicine

JF - Cardiovascular Revascularization Medicine

ER -

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)

Abstract

Keywords

UN SDGs

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