Preclinical assessment of a modified Occlutech left atrial appendage closure device in a canine model

Jung Sun Kim, Seul Gee Lee, Sung Kyung Bong, Se Il Park, Sung Yu Hong, Sanghoon Shin, ChiYoung Shim, Geu Ru Hong, Donghoon Choi, Yangsoo Jang, Jai Wun Park

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background LAA occlusion has a similar stroke prevention efficacy compared to anticoagulation treatment for non-valvular atrial fibrillation. Objective The objective of this study was to assess the feasibility and safety of a modified Occlutech® left atrial appendage (LAA) closure device in a canine model. Methods The device was implanted in 10 dogs (33 ± 1 kg) using fluoroscopy and transesophageal echocardiography (TEE) guidance. The modified Occlutech® LAA occlusion device was compared with the current version, the Watchman device, and the Amplazter cardiac plug (ACP). LAA occlusion and anchoring to the LAA were evaluated. All dogs were assessed using angiography, TEE, and a gross anatomy examination. Results The 10 LAA occlusion devices were to be implanted into 10 dogs (5 modified Occlutech devices, 3 current version of Occlutech devices, 1 Watchman, and 1 ACP). LAA implantation was not performed in one dog due to transeptal puncture failure. The three current version of Occlutech devices were embolized immediately after implantation, so three modified devices of the same size were implanted securely without embolization. The mean implant size was 20.1 ± 2.0 mm. The devices chosen were a mean of 23.3 ± 10.6% larger than the measured landing zone diameters. Post-implant angiography and TEE revealed well-positioned devices without pericardial effusion or impingement on surrounding structures. Conclusions The results of this acute animal study suggested that a modified Occlutech® LAA occlusion device was feasible and had greater anchoring performance in canines. Additional large clinical studies are needed to evaluate safety and efficacy.

Original languageEnglish
Pages (from-to)413-418
Number of pages6
JournalInternational Journal of Cardiology
Volume221
DOIs
Publication statusPublished - 2016 Oct 15

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Atrial Appendage
Canidae
Equipment and Supplies
Transesophageal Echocardiography
Dogs
Angiography
Safety
Pericardial Effusion
Fluoroscopy
Punctures
Atrial Fibrillation
Anatomy

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Kim, Jung Sun ; Lee, Seul Gee ; Bong, Sung Kyung ; Park, Se Il ; Hong, Sung Yu ; Shin, Sanghoon ; Shim, ChiYoung ; Hong, Geu Ru ; Choi, Donghoon ; Jang, Yangsoo ; Park, Jai Wun. / Preclinical assessment of a modified Occlutech left atrial appendage closure device in a canine model. In: International Journal of Cardiology. 2016 ; Vol. 221. pp. 413-418.
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title = "Preclinical assessment of a modified Occlutech left atrial appendage closure device in a canine model",
abstract = "Background LAA occlusion has a similar stroke prevention efficacy compared to anticoagulation treatment for non-valvular atrial fibrillation. Objective The objective of this study was to assess the feasibility and safety of a modified Occlutech{\circledR} left atrial appendage (LAA) closure device in a canine model. Methods The device was implanted in 10 dogs (33 ± 1 kg) using fluoroscopy and transesophageal echocardiography (TEE) guidance. The modified Occlutech{\circledR} LAA occlusion device was compared with the current version, the Watchman device, and the Amplazter cardiac plug (ACP). LAA occlusion and anchoring to the LAA were evaluated. All dogs were assessed using angiography, TEE, and a gross anatomy examination. Results The 10 LAA occlusion devices were to be implanted into 10 dogs (5 modified Occlutech devices, 3 current version of Occlutech devices, 1 Watchman, and 1 ACP). LAA implantation was not performed in one dog due to transeptal puncture failure. The three current version of Occlutech devices were embolized immediately after implantation, so three modified devices of the same size were implanted securely without embolization. The mean implant size was 20.1 ± 2.0 mm. The devices chosen were a mean of 23.3 ± 10.6{\%} larger than the measured landing zone diameters. Post-implant angiography and TEE revealed well-positioned devices without pericardial effusion or impingement on surrounding structures. Conclusions The results of this acute animal study suggested that a modified Occlutech{\circledR} LAA occlusion device was feasible and had greater anchoring performance in canines. Additional large clinical studies are needed to evaluate safety and efficacy.",
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Preclinical assessment of a modified Occlutech left atrial appendage closure device in a canine model. / Kim, Jung Sun; Lee, Seul Gee; Bong, Sung Kyung; Park, Se Il; Hong, Sung Yu; Shin, Sanghoon; Shim, ChiYoung; Hong, Geu Ru; Choi, Donghoon; Jang, Yangsoo; Park, Jai Wun.

In: International Journal of Cardiology, Vol. 221, 15.10.2016, p. 413-418.

Research output: Contribution to journalArticle

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T1 - Preclinical assessment of a modified Occlutech left atrial appendage closure device in a canine model

AU - Kim, Jung Sun

AU - Lee, Seul Gee

AU - Bong, Sung Kyung

AU - Park, Se Il

AU - Hong, Sung Yu

AU - Shin, Sanghoon

AU - Shim, ChiYoung

AU - Hong, Geu Ru

AU - Choi, Donghoon

AU - Jang, Yangsoo

AU - Park, Jai Wun

PY - 2016/10/15

Y1 - 2016/10/15

N2 - Background LAA occlusion has a similar stroke prevention efficacy compared to anticoagulation treatment for non-valvular atrial fibrillation. Objective The objective of this study was to assess the feasibility and safety of a modified Occlutech® left atrial appendage (LAA) closure device in a canine model. Methods The device was implanted in 10 dogs (33 ± 1 kg) using fluoroscopy and transesophageal echocardiography (TEE) guidance. The modified Occlutech® LAA occlusion device was compared with the current version, the Watchman device, and the Amplazter cardiac plug (ACP). LAA occlusion and anchoring to the LAA were evaluated. All dogs were assessed using angiography, TEE, and a gross anatomy examination. Results The 10 LAA occlusion devices were to be implanted into 10 dogs (5 modified Occlutech devices, 3 current version of Occlutech devices, 1 Watchman, and 1 ACP). LAA implantation was not performed in one dog due to transeptal puncture failure. The three current version of Occlutech devices were embolized immediately after implantation, so three modified devices of the same size were implanted securely without embolization. The mean implant size was 20.1 ± 2.0 mm. The devices chosen were a mean of 23.3 ± 10.6% larger than the measured landing zone diameters. Post-implant angiography and TEE revealed well-positioned devices without pericardial effusion or impingement on surrounding structures. Conclusions The results of this acute animal study suggested that a modified Occlutech® LAA occlusion device was feasible and had greater anchoring performance in canines. Additional large clinical studies are needed to evaluate safety and efficacy.

AB - Background LAA occlusion has a similar stroke prevention efficacy compared to anticoagulation treatment for non-valvular atrial fibrillation. Objective The objective of this study was to assess the feasibility and safety of a modified Occlutech® left atrial appendage (LAA) closure device in a canine model. Methods The device was implanted in 10 dogs (33 ± 1 kg) using fluoroscopy and transesophageal echocardiography (TEE) guidance. The modified Occlutech® LAA occlusion device was compared with the current version, the Watchman device, and the Amplazter cardiac plug (ACP). LAA occlusion and anchoring to the LAA were evaluated. All dogs were assessed using angiography, TEE, and a gross anatomy examination. Results The 10 LAA occlusion devices were to be implanted into 10 dogs (5 modified Occlutech devices, 3 current version of Occlutech devices, 1 Watchman, and 1 ACP). LAA implantation was not performed in one dog due to transeptal puncture failure. The three current version of Occlutech devices were embolized immediately after implantation, so three modified devices of the same size were implanted securely without embolization. The mean implant size was 20.1 ± 2.0 mm. The devices chosen were a mean of 23.3 ± 10.6% larger than the measured landing zone diameters. Post-implant angiography and TEE revealed well-positioned devices without pericardial effusion or impingement on surrounding structures. Conclusions The results of this acute animal study suggested that a modified Occlutech® LAA occlusion device was feasible and had greater anchoring performance in canines. Additional large clinical studies are needed to evaluate safety and efficacy.

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