TY - JOUR
T1 - First-in-Human Chronic Implant Experience of the Substernal Extravascular Implantable Cardioverter-Defibrillator
AU - Crozier, Ian
AU - Haqqani, Haris
AU - Kotschet, Emily
AU - Shaw, David
AU - Prabhu, Anil
AU - Roubos, Nicholas
AU - Alison, Jeffrey
AU - Melton, Iain
AU - Denman, Russell
AU - Lin, Tina
AU - Almeida, Aubrey
AU - Portway, Bridget
AU - Sawchuk, Robert
AU - Thompson, Amy
AU - Sherfesee, Lou
AU - Liang, Samuel
AU - Lentz, Linnea
AU - DeGroot, Paul
AU - Cheng, Alan
AU - O'Donnell, David
N1 - Funding Information:
This work was sponsored in its entirety by Medtronic. Dr. Crozier is a consultant for and has received research support and fellowship support from Medtronic; and has received grants from Boston Scientific. Dr. O’Donnell is a consultant for Medtronic and Abbott. Dr. Haqqani is a consultant for Medtronic, Abbott, and Boston Scientific. Drs. Kotschet and Shaw are consultants for Medtronic. Dr. Denman has received grants from Medtronic and Boston Scientific. Ms. Portway, Mr. Sawchuk, Ms. Thompson, Dr. Sherfesee, Mr. Liang, Dr. Lentz, Mr. DeGroot, and Dr. Cheng are employees of Medtronic. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2020 The Authors
PY - 2020/11
Y1 - 2020/11
N2 - Objectives: The aim of this study was to evaluate the safety and performance of an extravascular (EV) implantable cardioverter-defibrillator (ICD). Background: Limitations of existing transvenous and subcutaneous ICD systems include lead reliability and morbidity issues associated with ICD lead implantation in the vasculature or lack of pacing therapies (e.g., antitachycardia pacing) in subcutaneous systems. The EV defibrillator uses a novel substernal lead placement to address these limitations. Methods: This was a prospective, nonrandomized, chronic pilot study conducted at 4 centers in Australia and New Zealand. Participants were 21 patients referred for ICD implantation. Patients received EV ICD systems. Data collection included major systemic and procedural adverse events, defibrillation testing at implantation, and sensing and pacing thresholds. Results: Among 20 patients who underwent successful implantation, the median defibrillation threshold was 15 J, and 90% passed defibrillation testing with a ≥10-J safety margin. Mean R-wave amplitude was 3.4 ± 2.0 mV, mean ventricular fibrillation amplitude was 2.8 ± 1.7 mV, and pacing was successful in 95% at ≤10 V. There were no intraprocedural complications. Two patients have undergone elective chronic system removal since hospital discharge. In the 15 patients presently implanted, the systems are stable in long-term follow-up. Conclusions: This first-in-human evaluation of an EV ICD demonstrated the feasibility of substernal lead placement, defibrillation, and pacing with a chronically implanted system. There were no acute major complications, and pacing, defibrillation, and sensing performance at implantation were successful in most patients. (Extravascular ICD Pilot Study [EV ICD]; NCT03608670)
AB - Objectives: The aim of this study was to evaluate the safety and performance of an extravascular (EV) implantable cardioverter-defibrillator (ICD). Background: Limitations of existing transvenous and subcutaneous ICD systems include lead reliability and morbidity issues associated with ICD lead implantation in the vasculature or lack of pacing therapies (e.g., antitachycardia pacing) in subcutaneous systems. The EV defibrillator uses a novel substernal lead placement to address these limitations. Methods: This was a prospective, nonrandomized, chronic pilot study conducted at 4 centers in Australia and New Zealand. Participants were 21 patients referred for ICD implantation. Patients received EV ICD systems. Data collection included major systemic and procedural adverse events, defibrillation testing at implantation, and sensing and pacing thresholds. Results: Among 20 patients who underwent successful implantation, the median defibrillation threshold was 15 J, and 90% passed defibrillation testing with a ≥10-J safety margin. Mean R-wave amplitude was 3.4 ± 2.0 mV, mean ventricular fibrillation amplitude was 2.8 ± 1.7 mV, and pacing was successful in 95% at ≤10 V. There were no intraprocedural complications. Two patients have undergone elective chronic system removal since hospital discharge. In the 15 patients presently implanted, the systems are stable in long-term follow-up. Conclusions: This first-in-human evaluation of an EV ICD demonstrated the feasibility of substernal lead placement, defibrillation, and pacing with a chronically implanted system. There were no acute major complications, and pacing, defibrillation, and sensing performance at implantation were successful in most patients. (Extravascular ICD Pilot Study [EV ICD]; NCT03608670)
KW - ICD
KW - anterior mediastinum
KW - defibrillation
KW - extravascular
KW - substernal
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U2 - 10.1016/j.jacep.2020.05.029
DO - 10.1016/j.jacep.2020.05.029
M3 - Article
C2 - 33213813
AN - SCOPUS:85090485963
SN - 2405-500X
VL - 6
SP - 1525
EP - 1536
JO - JACC: Clinical Electrophysiology
JF - JACC: Clinical Electrophysiology
IS - 12
ER -