Efficacy and Safety of an Extravascular Implantable Cardioverter–Defibrillator

Friedman, Paul A.; Murgatroyd, Francis; Boersma, Lucas V.A.; Manlucu, Jaimie; O’Donnell, David; Knight, Bradley P.; Clémenty, Nicolas; Leclercq, Christophe; Amin, Anish K.; Merkely, Béla; Birgersdotter‐Green, Ulrika; Chan, Joseph Yat‐Sun; Biffi, Mauro; Knops, Reinoud E.; Engel, Gregory S.; Carvajal, Ignacio; Epstein, Laurence M.; Sagi, Venkata; Johansen, Jens Brock; Sterliński, Maciej; Steinwender, Clemens; Hounshell, Troy; Abben, Richard; Thompson, Amy; Wiggenhorn, Christopher; Willey, Sarah; Crozier, Ian

doi:10.1056/nejmoa2206485

Cited by 77 publications

(64 citation statements)

References 39 publications

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“…Recently, the first results of the EV-ICD CE/investigational device exemption trial reported the outcomes of 299 patients that received a fully implanted device. 32 After FU for at least 6 months for all patients, the 2 predefined primary endpoints were both met. The efficacy of the defibrillation testing for induced VAs was 98.7%, which well exceeded the 84% target that was set based on prior TV-ICD and S-ICD trial outcomes.…”

Section: The Substernal Ev-icd Strategymentioning

confidence: 99%

Evolution of extravascular implantable cardioverter-defibrillator therapy for ventricular arrhythmias

Römers¹,

Dijk²,

Boersma³

2023

Heart Rhythm O2

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Section: The Substernal Ev-icd Strategymentioning

confidence: 99%

Evolution of extravascular implantable cardioverter-defibrillator therapy for ventricular arrhythmias

Römers¹,

Dijk²,

Boersma³

2023

Heart Rhythm O2

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“…Other EVDs that have been developed and are currently being studied clinically are: extravascular ICD (EV-ICD), an ICD with a substernal epicardial lead; modular cardiac rhythm management (mCRM) system, consisting of an S-ICD and LP that can wirelessly communicate to provide anti-tachycardia pacing; and dual-chamber LP, consisting of right atrial and right ventricular LPs that communicate wirelessly. Only preclinical or short-term data on these devices are available [14][15][16]. At this rate of development, many new EVDs will be available for clinical studies in the next decade.…”

Section: The Era Of Extravascular Devicesmentioning

confidence: 99%

“…This emphasises the popularity of EVDs in the Netherlands, and possibly, additional information about these devices can be collected retrospectively. Dutch hospitals have been involved in many of the early EVD studies, and presently, clinical studies with the mCRM system and dual-chamber LP are led by a Dutch hospital [14,[17][18][19][20]. Hence, combining Dutch data on EVDs will provide a unique opportunity to describe long-term safety and efficacy.…”

Section: Dutch National Evd Registrymentioning

confidence: 99%

NL-EVDR: Netherlands—ExtraVascular Device Registry

et al. 2023

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Cardiac implantable electronic device (CIED) therapy is an essential element in treating cardiac arrhythmias. Despite their benefits, conventional transvenous CIEDs are associated with a significant risk of mainly pocket- and lead-related complications. To overcome these complications, extravascular devices (EVDs), such as the subcutaneous implantable cardioverter-defibrillator and intracardiac leadless pacemaker, have been developed. In the near future, several other innovative EVDs will become available. However, it is difficult to evaluate EVDs in large studies because of high costs, lack of long-term follow-up, imprecise data or selected patient populations. To improve evaluation of these technologies, real-world, large-scale, long-term data are of utmost importance. A Dutch registry-based study seems to be a unique possibility for this goal due to early involvement of Dutch hospitals in novel CIEDs and an existing quality control infrastructure, the Netherlands Heart Registration (NHR). Therefore, we will soon start the Netherlands—ExtraVascular Device Registry (NL-EVDR), a Dutch nationwide registry with long-term follow-up of EVDs. The NL-EVDR will be incorporated in NHR’s device registry. Additional EVD-specific variables will be collected both retrospectively and prospectively. Hence, combining Dutch EVD data will provide highly relevant information on safety and efficacy. As a first step, a pilot project has started in selected centres in October 2022 to optimise data collection.

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“…21,22,23 To that end, substernal EV-ICD leads (Medtronic Inc, Minneapolis, MN) have been developed. Crozier et al 24 reported successful substernal implantation in 299 of 316 subjects (95%) with no procedural complications observed. Shock termination of induced ventricular arrhythmias was successful in 298 of 302 subjects (98.7%) when connected to a custom EV-ICD pulse generator (Medtronic, Inc, Minneapolis, MN) placed into a left posterior-lateral pocket.…”

Section: Introductionmentioning

confidence: 98%

Initial Experience with Intercostal Insertion of an Extravascular ICD Lead Compatible with Existing Pulse Generators

Burke

Knops

Reddy

et al. 2023

Preprint

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Structured Abstract Objectives This study assessed safety and feasibility of a novel extravascular (EV) 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. Background Currently available or investigational, EV-ICDs include a subcutaneous or subxiphoid lead connected to customized EV-ICD PGs. This novel EV-ICD (AtaCor Medical, Inc, San Clemente, CA) employs a unique intercostal implant technique and is designed to function with commercial DF-4 ICD PGs. Methods In this non-randomized, single-center, acute study, 36 de novo or replacement transvenous (TV) ICD patients enrolled to receive a concomitant EV-ICD lead inserted through an intercostal space along the left parasternal margin. EV-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 down in 10 J increments following conversion success and stepped up in 5 J increments following conversion failure. 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). 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 safe and reliable placement of a novel extravascular ICD lead with effective sensing and defibrillation of induced ventricular fibrillation using commercial DF-4 ICD pulse generators.

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Efficacy and Safety of an Extravascular Implantable Cardioverter–Defibrillator

Cited by 77 publications

References 39 publications

Evolution of extravascular implantable cardioverter-defibrillator therapy for ventricular arrhythmias

Evolution of extravascular implantable cardioverter-defibrillator therapy for ventricular arrhythmias

NL-EVDR: Netherlands—ExtraVascular Device Registry

Initial Experience with Intercostal Insertion of an Extravascular ICD Lead Compatible with Existing Pulse Generators

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