Transcatheter transseptal treatment of patients with severe mitral regurgitation using an atrial fixation mitral valve replacement technology.

AltaValve Mitral Regurgitation Mitral valve TMVR Transfemoral Transseptal Valve replacement

Journal

Cardiovascular revascularization medicine : including molecular interventions
ISSN: 1878-0938
Titre abrégé: Cardiovasc Revasc Med
Pays: United States
ID NLM: 101238551

Informations de publication

Date de publication:
15 Jul 2023
Historique:
received: 11 05 2023
revised: 13 07 2023
accepted: 13 07 2023
medline: 3 8 2023
pubmed: 3 8 2023
entrez: 2 8 2023
Statut: aheadofprint

Résumé

Mitral regurgitation (MR) is the most common valvular heart disease worldwide with a 5-year mortality rate of 50 % with medical therapy alone. Several transcatheter mitral valve replacement (TMVR) devices are being investigated in clinical trials. Early evidence has demonstrated clinical benefits with a reduction in heart failure symptoms, low rates of residual MR, and reverse remodeling of the left ventricle (LV) over time. However, high anatomical screen failure rates limit its applicability. The primary reasons for the anatomical screen failure are risk of LV outflow tract obstruction, large mitral valve annulus size, and the presence of mitral annular calcification. Our clinical experiences using an atrial only fixation TMVR technology delivered via a transfemoral-transseptal approach is described. Three consecutive patients with severe functional MR underwent TMVR implantation using an atrial only fixation technology and a low-profile transseptal delivery system. Technical success was achieved in 100 % of the patients with a clinically significant reduction in MR. Longer-term follow-up (up to 6-months) has demonstrated a sustained reduction in MR and significant improvement in quality of life for all patients. Longer-term outcomes in our patients showed persistent reduction in MR, sustained implant performance, and notable improvements in NYHA Class and quality of life. There were no major adverse events. Follow-up CT data showed no evidence of device-related thrombosis, with stable valve position and integrity. The atrial fixation TMVR technology may have benefits in preserving the dynamics of the native mitral valve annulus thereby reducing the overall risk of LVOT obstruction. We present a single-center experience of three consecutive patients with severe functional MR treated with the AltaValve using a low-profile transseptal delivery system. A clinically significant reduction in mitral regurgitation was achieved in all patients, and longer-term follow-up has demonstrated sustained clinical benefits.

Sections du résumé

BACKGROUND BACKGROUND
Mitral regurgitation (MR) is the most common valvular heart disease worldwide with a 5-year mortality rate of 50 % with medical therapy alone. Several transcatheter mitral valve replacement (TMVR) devices are being investigated in clinical trials. Early evidence has demonstrated clinical benefits with a reduction in heart failure symptoms, low rates of residual MR, and reverse remodeling of the left ventricle (LV) over time. However, high anatomical screen failure rates limit its applicability. The primary reasons for the anatomical screen failure are risk of LV outflow tract obstruction, large mitral valve annulus size, and the presence of mitral annular calcification. Our clinical experiences using an atrial only fixation TMVR technology delivered via a transfemoral-transseptal approach is described.
METHODS METHODS
Three consecutive patients with severe functional MR underwent TMVR implantation using an atrial only fixation technology and a low-profile transseptal delivery system.
RESULTS RESULTS
Technical success was achieved in 100 % of the patients with a clinically significant reduction in MR. Longer-term follow-up (up to 6-months) has demonstrated a sustained reduction in MR and significant improvement in quality of life for all patients.
CONCLUSIONS CONCLUSIONS
Longer-term outcomes in our patients showed persistent reduction in MR, sustained implant performance, and notable improvements in NYHA Class and quality of life. There were no major adverse events. Follow-up CT data showed no evidence of device-related thrombosis, with stable valve position and integrity. The atrial fixation TMVR technology may have benefits in preserving the dynamics of the native mitral valve annulus thereby reducing the overall risk of LVOT obstruction.
SHORT ABSTRACT UNASSIGNED
We present a single-center experience of three consecutive patients with severe functional MR treated with the AltaValve using a low-profile transseptal delivery system. A clinically significant reduction in mitral regurgitation was achieved in all patients, and longer-term follow-up has demonstrated sustained clinical benefits.

Identifiants

pubmed: 37532604
pii: S1553-8389(23)00703-0
doi: 10.1016/j.carrev.2023.07.006
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:

Auteurs

Vlasis Ninios (V)

Department of Cardiology, Interbalkan European Medical Center, Thessaloniki, Greece. Electronic address: vninios@gmail.com.

Ilias Ninios (I)

Department of Cardiology, Interbalkan European Medical Center, Thessaloniki, Greece.

Lauren S Ranard (LS)

Columbia University Irving Medical Center, Columbia Structural Heart and Valve Center, New York, NY.

Torsten P Vahl (TP)

Columbia University Irving Medical Center, Columbia Structural Heart and Valve Center, New York, NY.

Krzysztof Wróbel (K)

Department of Cardiac Surgery, Warsaw Medicover Hospital, Warsaw, Poland; Lazarski University, Warsaw Poland.

Classifications MeSH