Preclinical safety and electrical performance of novel atrial leadless pacemaker with dual-helix fixation

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023884%3A_____%2F22%3A00009412" target="_blank" >RIV/00023884:_____/22:00009412 - isvavai.cz</a>

Result on the web

<a href="https://www-sciencedirect-com.ezproxy.lib.cas.cz/science/article/abs/pii/S1547527122000364?via%3Dihub" target="_blank" >https://www-sciencedirect-com.ezproxy.lib.cas.cz/science/article/abs/pii/S1547527122000364?via%3Dihub</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.hrthm.2022.01.021" target="_blank" >10.1016/j.hrthm.2022.01.021</a>

Result language

angličtina

Original language name

Preclinical safety and electrical performance of novel atrial leadless pacemaker with dual-helix fixation

Original language description

BACKGROUND Complications associated with transvenous pacemakers, specifically those involving the lead or subcutaneous pocket, may be avoided with leadless pacemakers (LPs). The safety and efficacy of single-chamber right ventricular LPs have been demonstrated, but their right atrium (RA) use poses new design constraints. OBJECTIVES The purpose of this study was to evaluate the implant success, electrical performance, and safety of a novel RA LP design in benchtop and preclinical studies. METHODS A new LP was designed with a dual-helix fixation mechanism specific to the RA anatomy. A 12-week preclinical ovine study was conducted to evaluate implant success, electrical performance, mechanical stability, and safety in vivo, with supporting benchtop measurements to quantify the mechanical forces needed for device retrieval and dislodgment. RESULTS LPs were successfully implanted in all 10 ovine subjects with no complications. The pacing capture threshold improved significantly over time from implant to week 12 (1.1 +/- 0.7 V vs 0.4 +/- 0.2 V, P = .008). Sensing amplitudes and pacing impedances were stable from implant to week 12 (4.8 +/- 1.8 mV vs 6.0 +/- 1.9 mV, P = .160; and 393 +/- 77 Omega vs 398 +/- 65 Omega, P = .922, respectively). Gross pathology and microscopic histology revealed no adverse interactions and no evidence of device dislodgment or clinically significant myocardial perforation. Benchtop ex vivo porcine atrial tissue measurements revealed greater pull forces required to dislodge the LP vs transvenous active fixation lead (0.42 +/- 0.18 lbf vs 0.29 +/- 0.08 lbf, P = .020), and greater rotational forces required for deliberate extraction (0.28 +/- 0.04 lbf vs 0.14 +/- 0.07 lbf, P <.001). CONCLUSION The novel atrial LP demonstrated successful implantation, with acceptable electrical performance, mechanical stability, and safety in a 12-week preclinical study.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30201 - Cardiac and Cardiovascular systems

Project

—

Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2022

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Heart Rhythm

ISSN

1547-5271

e-ISSN

—

Volume of the periodical

19

Issue of the periodical within the volume

5

Country of publishing house

US - UNITED STATES

Number of pages

6

Pages from-to

776-781

UT code for WoS article

000800525300016

EID of the result in the Scopus database

2-s2.0-85124236445