Jianwen Li1, Wen-Bo Hou1, Ming-Kun Cao1, Wen-Xiu Zhou1, Yan Wang1, Yi Fang1, Chao Zhou1, Yu-Xia Yin1, Egon S Toft2, Hai-Jun Zhang1,3,4. 1. R&D Department, National United Engineering Laboratory for Biomedical Material Modification, Dezhou, China. 2. Medical and Health Sciences, Qatar University, Doha, Qatar. 3. Institute of Interventional & Vascular Surgery, Tenth People's Hospital of Tongji University, Shanghai, China. 4. Medical College, Aalborg University, Alborg, Denmark.
Abstract
BACKGROUND AND OBJECTIVES: The success rate of leadless cardiac pacemaker (LP) retrieval remains a major concern for this disruptive technology. The present paper performed a systematic review of the safety and feasibility of the retrieval of LPs. METHODS: Primary publications that performed LP retrieval were collected and included five animal experiments and two worldwide retrieval experiences in human. The procedural details, such as indication, days post implantation, extraction success rate, and complications, were described. The present paper analyzed factors affecting the retrieval and management of the nonfunctional devices. RESULTS: Retrieval animal models was possible at least up to 2.5 years post implantation, and data from humans suggest that removal of a device that was implanted longer (eg, 4 years and 9 months for Nanostim; 4 years for Micra) could be performed within a reasonable safety profile. The fixed mechanism, implant site, and encapsulation of the LP systems may affect the retrieval process. CONCLUSIONS: A high success rate in the relatively chronic retrieval of LPs was demonstrated, which promotes the extensive use of these devices in the treatment arrhythmia in the future.
BACKGROUND AND OBJECTIVES: The success rate of leadless cardiac pacemaker (LP) retrieval remains a major concern for this disruptive technology. The present paper performed a systematic review of the safety and feasibility of the retrieval of LPs. METHODS: Primary publications that performed LP retrieval were collected and included five animal experiments and two worldwide retrieval experiences in human. The procedural details, such as indication, days post implantation, extraction success rate, and complications, were described. The present paper analyzed factors affecting the retrieval and management of the nonfunctional devices. RESULTS: Retrieval animal models was possible at least up to 2.5 years post implantation, and data from humans suggest that removal of a device that was implanted longer (eg, 4 years and 9 months for Nanostim; 4 years for Micra) could be performed within a reasonable safety profile. The fixed mechanism, implant site, and encapsulation of the LP systems may affect the retrieval process. CONCLUSIONS: A high success rate in the relatively chronic retrieval of LPs was demonstrated, which promotes the extensive use of these devices in the treatment arrhythmia in the future.