TY - JOUR
T1 - Initial Experience With Intercostal Insertion of an Extravascular ICD Lead Compatible With Existing Pulse Generators
AU - Burke, Martin C.
AU - Knops, Reinoud E.
AU - Reddy, Vivek
AU - Aasbo, Johan
AU - Husby, Michael
AU - Marcovecchio, Alan
AU - O'Connor, Mark
AU - Sanghera, Rick
AU - Scheck, Don
AU - Pepplinkhuizen, Shari
AU - Ebner, Adrian
N1 - Funding Information: M.C. Burke has received honoraria and research grants from Boston Scientific and AtaCor Medical as well as owns equity in AtaCor Medical. Drs Knops and Reddy have received honoraria and research grants from Boston Scientific and Medtronic, consult for Abbott, Boston Scientific, and AtaCor Medical and hold equity in AtaCor Medical. J. Aasbo have received honoraria and research grants from Boston Scientific and AtaCor Medical. M. Husby, A. Marcovecchio, M. O’Connor, R. Sanghera, and D. Scheck are employees and shareholders of AtaCor Medical. Dr Ebner has received research grants from AtaCor Medical. Funding Information: The studies reported here were funded by AtaCor Medical Inc. Publisher Copyright: © 2023 Lippincott Williams and Wilkins. All rights reserved.
PY - 2023/8/1
Y1 - 2023/8/1
N2 - BACKGROUND: This study assessed safety and feasibility of a novel extravascular implantable cardioverter defibrillator (ICD) lead when inserted anteriorly through a rib space and connected to various commercially available ICD pulse generators (PGs) placed in either a left mid-axillary or left pectoral pocket. Currently available or investigational, extravascular-ICDs include a subcutaneous or subxiphoid lead connected to customized extravascular-ICD PGs. METHODS: This novel extravascular-ICD (AtaCor Medical Inc, San Clemente, CA) employs a unique intercostal implant technique and is designed to function with commercial DF-4 ICD PGs. In this nonrandomized, single-center, acute study, 36 de novo or replacement ICD (transvenous ICD) patients enrolled to receive a concomitant extravascular-ICD lead inserted through an intercostal space along the left parasternal margin. extravascular-ICD leads were connected to DF-4 compatible ICD PGs positioned in either a left mid-axillary or pectoral pocket for acute sensing and defibrillation testing. Defibrillation testing started at 30 Joules (J) and stepped up or down in 5 to 10 joule increments depending on the success and limitations of the generator used. RESULTS: Successful acute defibrillation using ≤35 J was noted in 100% of left mid-axillary PG subjects (n=27, mean 16.3±8.6 J) and 83% of left pectoral PG subjects (n=6, mean 21.0±8.4 J). Furthermore, 24 of 27 (89%) of patients tested with a left, mid-axillary intermuscular PG had successful VF conversion with defibrillation energies at least 10 J below the maximum delivered output of the device. All evaluable episodes (n=93) were automatically sensed, detected, and shocked. No serious device-related intraoperative adverse events were observed. CONCLUSIONS: This first-in-human study documented the safe and reliable placement of a novel extravascular ICD lead with effective sensing and defibrillation of induced ventricular fibrillation using commercial DF-4 ICD PGs.
AB - BACKGROUND: This study assessed safety and feasibility of a novel extravascular implantable cardioverter defibrillator (ICD) lead when inserted anteriorly through a rib space and connected to various commercially available ICD pulse generators (PGs) placed in either a left mid-axillary or left pectoral pocket. Currently available or investigational, extravascular-ICDs include a subcutaneous or subxiphoid lead connected to customized extravascular-ICD PGs. METHODS: This novel extravascular-ICD (AtaCor Medical Inc, San Clemente, CA) employs a unique intercostal implant technique and is designed to function with commercial DF-4 ICD PGs. In this nonrandomized, single-center, acute study, 36 de novo or replacement ICD (transvenous ICD) patients enrolled to receive a concomitant extravascular-ICD lead inserted through an intercostal space along the left parasternal margin. extravascular-ICD leads were connected to DF-4 compatible ICD PGs positioned in either a left mid-axillary or pectoral pocket for acute sensing and defibrillation testing. Defibrillation testing started at 30 Joules (J) and stepped up or down in 5 to 10 joule increments depending on the success and limitations of the generator used. RESULTS: Successful acute defibrillation using ≤35 J was noted in 100% of left mid-axillary PG subjects (n=27, mean 16.3±8.6 J) and 83% of left pectoral PG subjects (n=6, mean 21.0±8.4 J). Furthermore, 24 of 27 (89%) of patients tested with a left, mid-axillary intermuscular PG had successful VF conversion with defibrillation energies at least 10 J below the maximum delivered output of the device. All evaluable episodes (n=93) were automatically sensed, detected, and shocked. No serious device-related intraoperative adverse events were observed. CONCLUSIONS: This first-in-human study documented the safe and reliable placement of a novel extravascular ICD lead with effective sensing and defibrillation of induced ventricular fibrillation using commercial DF-4 ICD PGs.
KW - anterior mediastinum
KW - defibrillation
KW - extravascular
KW - intercostal
KW - ventricular fibrillation
UR - http://www.scopus.com/inward/record.url?scp=85168065748&partnerID=8YFLogxK
U2 - https://doi.org/10.1161/CIRCEP.123.011922
DO - https://doi.org/10.1161/CIRCEP.123.011922
M3 - Article
C2 - 37582163
SN - 1941-3149
VL - 16
SP - 421
EP - 432
JO - Circulation. Arrhythmia and electrophysiology
JF - Circulation. Arrhythmia and electrophysiology
IS - 8
ER -