Key result
Novel extravascular ICD lead achieves 100% acute defibrillation success with a left mid-axillary generator.
Why the study?
Current extravascular ICDs require customized pulse generators; whether a novel extravascular ICD lead inserted via an intercostal space is safe and feasible when connected to commercially available pulse generators was unknown.
Does an extravascular ICD lead inserted via an intercostal approach and connected to existing pulse generators safely and effectively sense and defibrillate in patients requiring an ICD?
Does an extravascular ICD lead inserted via an intercostal approach and connected to existing pulse generators safely and effectively sense and defibrillate in patients requiring an ICD?
A novel extravascular ICD lead placed via an anterior intercostal approach and connected to commercial pulse generators demonstrated safe and effective acute sensing and defibrillation.
Early feasibility of novel anterior rib-space extravascular ICD lead is suggested; prospective trials needed before clinical adoption.
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.
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Burke et al. (2023) studied Patients scheduled to undergo de novo or replacement ICD procedures (n=36). Extravascular ICD lead (AtaCor Medical Inc) connected to commercial DF-4 ICD PGs was evaluated on Successful acute defibrillation using ≤35 J. The novel extravascular ICD lead achieved successful acute defibrillation using ≤35 J in 100% of patients with a left mid-axillary pulse generator and 83% of patients with a left pectoral pulse generator.
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