Percutaneous Retrieval of Implanted Leadless Pacemakers Feasibility at 2.5 Years Post-Implantation in an in Vivo Ovine Model

Kód výsledku v IS VaVaI

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Výsledek na webu

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DOI - Digital Object Identifier

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Jazyk výsledku

angličtina

Název v původním jazyce

Percutaneous Retrieval of Implanted Leadless Pacemakers Feasibility at 2.5 Years Post-Implantation in an in Vivo Ovine Model

Popis výsledku v původním jazyce

Objectives: This in vivo ovine study describes the feasibility and safety of retrieving implanted leadless pacemakers (LPs). Background: Although LPs have been shown to be removable soon after implantation, there are no data on the feasibility of removing chronically implanted LPs. Methods This study was performed in 2 phases. In the mid-term cohort, 10 chronically (5.3 months) implanted animals underwent retrieval, followed by: 1) immediate necropsy in 5; and 2) in the remaining 5, reimplantation of a new LP followed by necropsy at 6 weeks. In the long-term cohort, 8 additional sheep underwent retrieval at 2.3 0.1 years followed by necropsy. Retrieval was performed using either a single or triple loop snare. All 18 LPs (100%) were successfully retrieved. The time from retrieval catheter insertion to retrieval was 2:35 01:11 and 3:04 01:13 minutes in the mid-term and long-term study groups, respectively. Results: There were no significant differences in retrieval times using either snare. Intracardiac echocardiography was used pre- and post-retrieval to confirm the absence of pericardial effusion in all 8 sheep. On necropsy, there was no evidence of pericardial bleeding or perforation. Only minor tissue disruption and hemorrhage was noted at the implant site after retrieval. Histology demonstrated fibrous connective tissue at the contact sites of endocardium and LP can and at the helix. There was no evidence of pulmonary thromboembolism. Conclusions We demonstrate the feasibility and safety of percutaneous, catheter-based retrieval in chronic LP implants of a maximum duration of approximately 2.5 years.

Název v anglickém jazyce

Percutaneous Retrieval of Implanted Leadless Pacemakers Feasibility at 2.5 Years Post-Implantation in an in Vivo Ovine Model

Popis výsledku anglicky

Objectives: This in vivo ovine study describes the feasibility and safety of retrieving implanted leadless pacemakers (LPs). Background: Although LPs have been shown to be removable soon after implantation, there are no data on the feasibility of removing chronically implanted LPs. Methods This study was performed in 2 phases. In the mid-term cohort, 10 chronically (5.3 months) implanted animals underwent retrieval, followed by: 1) immediate necropsy in 5; and 2) in the remaining 5, reimplantation of a new LP followed by necropsy at 6 weeks. In the long-term cohort, 8 additional sheep underwent retrieval at 2.3 0.1 years followed by necropsy. Retrieval was performed using either a single or triple loop snare. All 18 LPs (100%) were successfully retrieved. The time from retrieval catheter insertion to retrieval was 2:35 01:11 and 3:04 01:13 minutes in the mid-term and long-term study groups, respectively. Results: There were no significant differences in retrieval times using either snare. Intracardiac echocardiography was used pre- and post-retrieval to confirm the absence of pericardial effusion in all 8 sheep. On necropsy, there was no evidence of pericardial bleeding or perforation. Only minor tissue disruption and hemorrhage was noted at the implant site after retrieval. Histology demonstrated fibrous connective tissue at the contact sites of endocardium and LP can and at the helix. There was no evidence of pulmonary thromboembolism. Conclusions We demonstrate the feasibility and safety of percutaneous, catheter-based retrieval in chronic LP implants of a maximum duration of approximately 2.5 years.

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FA - Kardiovaskulární nemoci včetně kardiochirurgie

OECD FORD obor

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Projekt

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Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2015

Kód důvěrnosti údajů

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

Název periodika

Journal of the American College of Cardiology: Clinical Electrophysiology

ISSN

2405-500X

e-ISSN

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Svazek periodika

1

Číslo periodika v rámci svazku

6

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

8

Strana od-do

563-570

Kód UT WoS článku

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EID výsledku v databázi Scopus

2-s2.0-84951983665