Intracardiac Echocardiography-Guided Left Atrial Appendage Closure With a Novel Foam-Based Conformable Device: Safety and 1-Year Outcomes

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023884%3A_____%2F22%3A00009435" target="_blank" >RIV/00023884:_____/22:00009435 - isvavai.cz</a>

Výsledek na webu

<a href="https://www-sciencedirect-com.ezproxy.lib.cas.cz/science/article/abs/pii/S2405500X21008537?via%3Dihub" target="_blank" >https://www-sciencedirect-com.ezproxy.lib.cas.cz/science/article/abs/pii/S2405500X21008537?via%3Dihub</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.jacep.2021.10.001" target="_blank" >10.1016/j.jacep.2021.10.001</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Intracardiac Echocardiography-Guided Left Atrial Appendage Closure With a Novel Foam-Based Conformable Device: Safety and 1-Year Outcomes

Popis výsledku v původním jazyce

OBJECTIVES This is a first report of the safety and 1-year outcomes of left atrial appendage closure (LAAC) using a novel foam-based conformable device, guided by intracardiac echocardiography (ICE). BACKGROUND Limitations of current transcatheter LAAC devices include the need for precise coaxial delivery into the left atrial appendage (LAA), potential for traumatic implantation, incomplete LAA seal, and device-related thrombus. METHODS The device (Conformal Left Atrial Appendage Seal, Conformal Medical Inc) is a self-expanding occluder consisting of a cylindrical nitinol endoskeleton with low-profile anchor barbs around the midpoint, covered with a porous foam cup. In a prospective single-center series, under conscious sedation, the device was delivered under fluoroscopic and ICE guidance. After positioning, a transesophageal echocardiography probe was placed to confirm ICE findings before device release. After closure, dual antiplatelet therapy was administered for 6 months. Follow-up imaging was planned for 45 days and 6 and 12 months. RESULTS A total of 15 patients (age 71.3 +/- 10.8 years, 33% men, CHA2DS2-VASc 4.1 +/- 1.7, HAS-BLED 3.4 +/- 1.4) underwent LAAC, 100% successfully. There were no procedure/device-related complications requiring intervention. Asymptomatic pericardial effusion occurred in 2 patients. The 45-day, 6-month, and 12-month follow-up imaging in 11, 9, and 13 patients, respectively, revealed adequate LAA seal (leak #5 mm) in all patients; device-related thrombus was detected in 1 patient at 6 months. Over 1-year follow-up, there were no ischemic strokes and 1 minor bleed. Nonprocedure-/device-related death occurred in 2 patients. CONCLUSIONS This first report indicates that LAAC with the conformable implant guided by ICE imaging is feasible with encouraging 1-year clinical outcomes. (C) 2022 Published by Elsevier on behalf of the American College of Cardiology Foundation.

Název v anglickém jazyce

Intracardiac Echocardiography-Guided Left Atrial Appendage Closure With a Novel Foam-Based Conformable Device: Safety and 1-Year Outcomes

Popis výsledku anglicky

OBJECTIVES This is a first report of the safety and 1-year outcomes of left atrial appendage closure (LAAC) using a novel foam-based conformable device, guided by intracardiac echocardiography (ICE). BACKGROUND Limitations of current transcatheter LAAC devices include the need for precise coaxial delivery into the left atrial appendage (LAA), potential for traumatic implantation, incomplete LAA seal, and device-related thrombus. METHODS The device (Conformal Left Atrial Appendage Seal, Conformal Medical Inc) is a self-expanding occluder consisting of a cylindrical nitinol endoskeleton with low-profile anchor barbs around the midpoint, covered with a porous foam cup. In a prospective single-center series, under conscious sedation, the device was delivered under fluoroscopic and ICE guidance. After positioning, a transesophageal echocardiography probe was placed to confirm ICE findings before device release. After closure, dual antiplatelet therapy was administered for 6 months. Follow-up imaging was planned for 45 days and 6 and 12 months. RESULTS A total of 15 patients (age 71.3 +/- 10.8 years, 33% men, CHA2DS2-VASc 4.1 +/- 1.7, HAS-BLED 3.4 +/- 1.4) underwent LAAC, 100% successfully. There were no procedure/device-related complications requiring intervention. Asymptomatic pericardial effusion occurred in 2 patients. The 45-day, 6-month, and 12-month follow-up imaging in 11, 9, and 13 patients, respectively, revealed adequate LAA seal (leak #5 mm) in all patients; device-related thrombus was detected in 1 patient at 6 months. Over 1-year follow-up, there were no ischemic strokes and 1 minor bleed. Nonprocedure-/device-related death occurred in 2 patients. CONCLUSIONS This first report indicates that LAAC with the conformable implant guided by ICE imaging is feasible with encouraging 1-year clinical outcomes. (C) 2022 Published by Elsevier on behalf of the American College of Cardiology Foundation.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30105 - Physiology (including cytology)

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2022

Kód důvěrnosti údajů

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

Název periodika

JACC: Clinical Electrophysiology

ISSN

2405-500X

e-ISSN

—

Svazek periodika

8

Číslo periodika v rámci svazku

2

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

11

Strana od-do

197-207

Kód UT WoS článku

000760853000009

EID výsledku v databázi Scopus

2-s2.0-85124463496