First-in-Human Chronic Implant Experience of the Substernal Extravascular Implantable Cardioverter-Defibrillator

Crozier, Ian; Haqqani, Haris M.; Kotschet, Emily; Shaw, David D.; Prabhu, Ashwin; Roubos, Nicholas; Alison, J.; Melton, Iain; Denman, R.; Lin, Tina; Almeida, Aubrey; Portway, Bridget; Sawchuk, Robert; Thompson, Amy; Sherfesee, Lou; Liang, Samuel; Lentz, Linnea; DeGroot, Paul; Cheng, Alan; O’Donnell, David

doi:10.1016/j.jacep.2020.05.029

Cited by 34 publications

(61 citation statements)

References 27 publications

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“…Recently a dedicated substernal defibrillator system has been developed and feasibility studies demonstrated successful defibrillation in adult patients with shock energies comparable to transvenous devices and substantially lower than subcutaneous ICDs 64 allowing for smaller generator sizes. First-In-Human pilot studies yielded encouraging results 65 , 66 and also proved feasibility of appropriate R-wave sensing and pacing capture from the substernal space allowing for complementary anti-tachycardia pacing and bradycardia protection 67 .…”

Section: Extravascular Implantable Cardioverter-defibrillator Configu...mentioning

confidence: 91%

Non-traditional implantable cardioverter-defibrillator configurations and insertion techniques: a review of contemporary options

Tonko

Rinaldi

2021

EP Europace

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Implantable cardioverter-defibrillators (ICDs) have revolutionized the treatment of acquired or inherited cardiac diseases associated with a high risk of sudden cardiac death due to ventricular tachyarrhythmias. Contemporary ICD devices offer reliable arrhythmia detection and discrimination algorithms and deliver highly efficient tachytherapies. Percutaneously inserted transvenous defibrillator coils with pectoral generator placement are the first-line approach in the majority of adults due to their extensively documented clinical benefit and efficiency with comparably low periprocedural implantation risks as well as the option of providing pain-free tachycardia treatment via anti-tachycardia pacing (ATP), concomitant bradycardiaprotection, and incorporation in a cardiac resynchronization therapy if indicated. Yet, expanding ICD indications particularly among younger and more complex patient groups as well as the increasingly evident long-term consequences and complications associated with intravascular lead placements promoted the development of alternative ICD configurations. Most established in daily clinical practice is the subcutaneous ICD but other innovative extravascular approaches like epicardial, pericardial, extra-pleural, and most recently substernal defibrillator coil placements have been introduced as well to overcome shortcomings associated with traditional devices and allow for individualized treatment strategies tailored to the patients characteristics and needs. The review aims to provide practical solutions for common complications encountered with transvenous ICD systems including restricted venous access, high defibrillation/fibrillation thresholds (DFTs), and recurrent device infections. We summarize the contemporary options for non-traditional extravascular ICD configurations outlining indications, advantages, and disadvantages.

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Section: Extravascular Implantable Cardioverter-defibrillator Configu...mentioning

confidence: 91%

Non-traditional implantable cardioverter-defibrillator configurations and insertion techniques: a review of contemporary options

Tonko

Rinaldi

2021

EP Europace

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“…[ 49 ] The other concept is an ICD with an extravascular yet substernal lead that has shown promising results for successful pacing and defibrillation. [ 50 ]…”

Section: Complicationsmentioning

confidence: 99%

The Subcutaneous ICD: A Review of the UNTOUCHED and PRAETORIAN Trials

Karimianpour

John

Gold

2021

Arrhythm Electrophysiol Rev

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The ICD is an important part of the treatment and prevention of sudden cardiac death in many high-risk populations. Traditional transvenous ICDs (TV-ICDs) are associated with certain short- and long- term risks. The subcutaneous ICD (S-ICD) was developed in order to avoid these risks and complications. However, this system is associated with its own set of limitations and complications. First, patient selection is important, as S-ICDs do not provide pacing therapy currently. Second, pre-procedural screening is important to minimise T wave and myopotential oversensing. Finally, until recently, the S-ICD was primarily used in younger patients with fewer co-morbidities and less structural heart disease, limiting the general applicability of the device. S-ICDs achieve excellent rates of arrhythmia conversion and have demonstrated noninferiority to TV-ICDs in terms of complication rates in real-world studies. The objective of this review is to discuss the latest literature, including the UNTOUCHED and PRAETORIAN trials, and to address the risk of inappropriate shocks.

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“…[10][11][12][13] A complete understanding of extravascular lead extraction is thus still emerging for SQ-ICD and is required for EV ICD.Recently reported experience with the SQ-ICD demonstrated the ability to explant the subcutaneous lead in 96.9% of patients after a median implant duration of 9.3 months (range: 5.4-17.5 months); among 32 patients analyzed, simple traction was successful in 19 F I G U R E 5 Histology examination. Representative EV ICD mature tissue capsule histology from 1 year (top panel, lead removed from tissue leaving a void (*)) showing minimal inflammation and from 2 years (bottom panel, with lead cross-section remaining in tissue) showing mild, focal inflammation.…”

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confidence: 99%

Three‐year extraction experience of a novel substernal extravascular defibrillation lead in sheep

Thompson

Marshall

Lentz

et al. 2022

Pacing Clinical Electrophis

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Background:The extravascular implantable cardioverter-defibrillator (EV ICD) with lead implantation in the substernal space may provide an alternative to transvenous and subcutaneous systems. This is the first-reported chronic extraction experience for EV ICD leads. The aim of the study is to evaluate the chronic encapsulation and extractability of EV ICD leads.Methods: Two EV ICD leads and one transvenous lead were implanted in each of 24 mature sheep. A subset of animals was evaluated yearly for histology and lead extractability. Extractions were performed using simple traction or extraction tools.Histology evaluated the encapsulating tissue.Results: At 1 year, extraction was performed successfully for two of five EV ICD leads with traction alone using ≤3.1 kg-force (kgf) and the remainder extracted successfully with extraction tools; no transvenous leads were removed with traction alone. At 2 years, no EV ICD or transvenous leads were extracted with traction alone, while at 3 years, one of eight EV ICD leads and two of four transvenous leads were extracted with traction (0.8 and ≤2.3 kgf, respectively). There was one observation of hemopericardium resulting in tamponade with EV ICD extraction but without injury to cardiovascular structures and related to the unique implant tract. Among transvenous leads, inversion of the ventricle with loss of cardiac output resulted in abandonment of traction for two animals.Conclusions: Chronic extraction of EV ICD leads from the substernal space was successfully performed using traction and simple tools through 3 years in sheep with one observation of hemopericardium that did not originate from cardiovascular injury.

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First-in-Human Chronic Implant Experience of the Substernal Extravascular Implantable Cardioverter-Defibrillator

Cited by 34 publications

References 27 publications

Non-traditional implantable cardioverter-defibrillator configurations and insertion techniques: a review of contemporary options

Non-traditional implantable cardioverter-defibrillator configurations and insertion techniques: a review of contemporary options

The Subcutaneous ICD: A Review of the UNTOUCHED and PRAETORIAN Trials

Three‐year extraction experience of a novel substernal extravascular defibrillation lead in sheep

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