Implantation of Personalized, Biocompatible Mitral Annuloplasty Rings: Feasibility Study in an Animal Model

Overview

Journal Interact Cardiovasc Thorac Surg

Publisher Oxford University Press

Specialties Cardiology & Vascular Diseases
General Surgery
Pulmonary Medicine

Date 2013 Jan 5

PMID 23287589

Citations 8

Authors

Simon H Sundermann

Michael Gessat

Nikola Cesarovic

Thomas Frauenfelder

Patric Biaggi

Dominique Bettex

Volkmar Falk

Stephan Jacobs

Affiliations

Soon will be listed here.

Abstract

Objectives: Implantation of an annuloplasty ring is an essential component of a durable mitral valve repair. Currently available off-the-shelf rings still do not cover all the variations in mitral annulus anatomy and pathology from subject to subject. Computed tomography (CT) and echo imaging allow for 3-D segmentation of the mitral valve and mitral annulus. The concept of tailored annuloplasty rings has been proposed although, to date, no surgically applicable implementation of patient-specific annuloplasty rings has been seen. The objective of this trial was to prove the concept of surgical implantation of a model-guided, personalized mitral annuloplasty ring, manufactured based on individual CT-scan models.

Methods: ECG-gated CT angiography was performed in six healthy pigs under general anaesthesia. Based on the individual shape of the mitral annulus in systole, a customized solid ring with integrated suturing holes was designed and manufactured from a biocompatible titanium alloy by a rapid process using laser melting. The ring was implanted three days later and valve function was assessed by intraoperative echocardiography. The macroscopic annulus-annuloplasty match was assessed after heart explantation.

Results: CT angiography provided good enough image quality in all animals to allow for segmentation of the mitral annulus. The individually tailored mitral rings were manufactured and successfully implanted in all pigs. In 50%, a perfect matching of the implanted ring and the mitral annulus was achieved. In one animal, a slight deviation of the ring shape from the circumference was seen postoperatively. The rings implanted in the first two animals were significantly oversized but the deviation did not affect valve competence.

Conclusions: CT image quality and accuracy of the dimensions of the mitral annulus were sufficient for digital modelling and rapid manufacturing of mitral rings. Implantation of individually tailored annuloplasty rings is feasible.

Citing Articles

DynaRing: A Patient-Specific Mitral Annuloplasty Ring With Selective Stiffness Segments.

Frishman S, Kight A, Pirozzi I, Maddineni S, Imbrie-Moore A, Karachiwalla Z J Med Device. 2022; 16(3):031009.

PMID: 35646225 PMC: 9125864. DOI: 10.1115/1.4054445.

Personalized Interventions: A Reality in the Next 20 Years or Pie in the Sky.

Salavitabar A, Armstrong A Pediatr Cardiol. 2020; 41(3):486-502.

PMID: 32198592 DOI: 10.1007/s00246-020-02303-4.

Stereolithography for Personalized Left Atrial Appendage Occluders.

Robinson S, Aubin C, Wallin T, Gharaie S, Xu P, Wang K Adv Mater Technol. 2019; 3(12).

PMID: 31803824 PMC: 6892588. DOI: 10.1002/admt.201800233.

Computed tomography for planning and postoperative imaging of transvenous mitral annuloplasty: first experience in an animal model.

Sundermann S, Gordic S, Manka R, Cesarovic N, Falk V, Maisano F Int J Cardiovasc Imaging. 2014; 31(1):135-42.

PMID: 25119889 DOI: 10.1007/s10554-014-0516-7.

Sizing the mitral annulus in healthy subjects and patients with mitral regurgitation: 2D versus 3D measurements from cardiac CT.

Gordic S, Nguyen-Kim T, Manka R, Sundermann S, Frauenfelder T, Maisano F Int J Cardiovasc Imaging. 2013; 30(2):389-98.

PMID: 24306054 DOI: 10.1007/s10554-013-0341-4.

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