Preclinical cardiac perforation reduction in leadless pacing: An update to the Micra leadless pacemaker delivery system.
Micra
catheter
leadless pacemaker
perforation
Journal
Pacing and clinical electrophysiology : PACE
ISSN: 1540-8159
Titre abrégé: Pacing Clin Electrophysiol
Pays: United States
ID NLM: 7803944
Informations de publication
Date de publication:
09 2023
09 2023
Historique:
revised:
13
06
2023
received:
10
02
2023
accepted:
20
06
2023
medline:
8
9
2023
pubmed:
10
7
2023
entrez:
10
7
2023
Statut:
ppublish
Résumé
Leadless pacemakers have been developed to avoid some of the complications that are associated transvenous pacemakers. Pericardial effusion is a rare complication of leadless pacemaker implantation, which may result from perforation of the delivery catheter. In this study, we describe preclinical perforation performance of an updated Micra delivery catheter. To assess preclinical perforation performance of the updated delivery catheter, three analyses were performed. First, Finite Element Analysis (FEA) computational modeling was performed to estimate the target tissue stress during Micra delivery catheter tenting. Second, benchtop perforation forces of ovine tissue were recorded for the original and updated delivery catheters. Finally, a Monte-Carlo simulation combining human cadaveric Micra implant forces and human ventricular tissue perforation properties was performed to estimate clinical perforation performance. FEA modeling demonstrated a 66% reduction in target tissue stress when using the updated Micra delivery catheter (6.2 vs. 2.2 psi, Original vs. Updated Micra delivery catheter). Updated Micra delivery catheters required 20% more force to perforate porcine ventricular tissues in benchtop testing (μ This study, using computer modelling and benchtop experimentation, has indicated that increased surface area and rounding of the updated Micra catheter tip significantly improves preclinical perforation performance. It will be important to evaluate the impact of these catheter design changes with robust registry data.
Sections du résumé
BACKGROUND
Leadless pacemakers have been developed to avoid some of the complications that are associated transvenous pacemakers. Pericardial effusion is a rare complication of leadless pacemaker implantation, which may result from perforation of the delivery catheter. In this study, we describe preclinical perforation performance of an updated Micra delivery catheter.
METHODS
To assess preclinical perforation performance of the updated delivery catheter, three analyses were performed. First, Finite Element Analysis (FEA) computational modeling was performed to estimate the target tissue stress during Micra delivery catheter tenting. Second, benchtop perforation forces of ovine tissue were recorded for the original and updated delivery catheters. Finally, a Monte-Carlo simulation combining human cadaveric Micra implant forces and human ventricular tissue perforation properties was performed to estimate clinical perforation performance.
RESULTS
FEA modeling demonstrated a 66% reduction in target tissue stress when using the updated Micra delivery catheter (6.2 vs. 2.2 psi, Original vs. Updated Micra delivery catheter). Updated Micra delivery catheters required 20% more force to perforate porcine ventricular tissues in benchtop testing (μ
CONCLUSIONS
This study, using computer modelling and benchtop experimentation, has indicated that increased surface area and rounding of the updated Micra catheter tip significantly improves preclinical perforation performance. It will be important to evaluate the impact of these catheter design changes with robust registry data.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1085-1091Informations de copyright
© 2023 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.
Références
Reynolds D, Duray GZ, Omar R, et al. A leadless intracardiac transcatheter pacing system. N Engl J Med. 2016;374:533-541. doi:10.1056/NEJMoa1511643
Garg A, Koneru JN, Fagan DH, et al. Morbidity and mortality in patients precluded for transvenous pacemaker implantation: experience with a leadless pacemaker. Heart Rhythm. 2020;17:2056-2063. doi:10.1016/j.hrthm.2020.07.035
El-Chami MF, Al-Samadi F, Clementy N, et al. Updated performance of the Micra transcatheter pacemaker in the real-world setting: a comparison to the investigational study and a transvenous historical control. Heart Rhythm. 2018;15:1800-1807. doi:10.1016/j.hrthm.2018.08.005
Vamos M, Erath JW, Benz AP, Bari Z, Duray GZ, Hohnloser SH. Incidence of cardiac perforation with conventional and with leadless pacemaker systems: a systematic review and meta-analysis. J Cardiovasc Electrophysiol. 2017;28:336-346. doi:10.1111/jce.13140
Piccini JP, Cunnane R, Steffel J, et al. Development and validation of a risk score for predicting pericardial effusion in patients undergoing leadless pacemaker implantation: experience with the Micra transcatheter pacemaker. Europace. 2022;24:1119-1126. doi:10.1093/europace/euab315
Eggen MD, Grubac V, Bonner MD. Design and evaluation of a Novel fixation mechanism for a transcatheter pacemaker. IEEE Trans Biomed Eng. 2015;62:2316-2323.
Garweg C, Vandenberk B, Foulon S, Haemers P, Ector J, Willems R. Leadless pacing with Micra TPS: a comparison between right ventricular outflow tract, mid-septal, and apical implant sites. J Cardiovasc Electrophysiol. 2019;30:2002-2011. doi:10.1111/jce.14083
Zucchelli G, Tolve S, Barletta V, et al. Comparison between leadless and transvenous single-chamber pacemaker therapy in a referral centre for lead extraction. J Interv Card Electrophysiol. 2021;61:395-404. doi:10.1007/s10840-020-00832-9
Bongiorni MG, Della Tommasina V, Barletta V, et al. Feasibility and long-term effectiveness of a non-apical Micra pacemaker implantation in a referral centre for lead extraction. EP Eur. 2018;21:114-120. doi:10.1093/europace/euy116
Togashi I, Sato T, Hoshida K, Soejima K. Subclinical cardiac perforation caused by a Micra™ leadless pacemaker. J Arrhythmia. 2018;34:326-328. doi:10.1002/joa3.12052
Tan NY, Madhavan M, Greason KL, Cha YM. The subtle tine: asymptomatic Micra perforation incidentally discovered during cardiac surgery. J Cardiovasc Electrophysiol. 2023;34:229-230. doi:10.1111/jce.15653
Roberts PR, Clementy N, Al Samadi F, et al. A leadless pacemaker in the real-world setting: the Micra transcatheter pacing system post-approval registry. Heart Rhythm. 2017;14:1375-1379. doi:10.1016/j.hrthm.2017.05.017