Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): Clinical characteristics and perioperative results

Boersma, Lucas V.A.; El‐Chami, Mikhael F.; Bongiorni, Maria Grazia; Burke, Martin C.; Knops, Reinoud E.; Aasbo, Johan D.; Lambiase, Pier D.; Deharo, Jean Claude; Russo, Andrea M.; Dinerman, Jay L.; Shaik, Naushad; Barr, Craig; Carter, Nathan; Appl, Ursula; Brisben, Amy J.; Steín, Kenneth M.; Gold, Michael R.

doi:10.1016/j.hrthm.2019.04.048

Cited by 54 publications

(50 citation statements)

References 23 publications

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“…The S‐ICD appears well suited for patients with LVAD for several reasons. The S‐ICD is extravascular which likely explains the absence of reported bacteremia 1,3,4,6,7 which, in patients with LVAD, can be particularly life threatening. In addition, the prolonged duration from sensing to therapy delivery with the S‐ICD is ideal for patients with LVAD, where delayed therapy is preferred 8 …”

Section: Introductionmentioning

confidence: 99%

Electromagnetic interference from left ventricular assist devices in patients with subcutaneous implantable cardioverter‐defibrillators

Ishida

Payne

Field

et al. 2020

Cardiovasc electrophysiol

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Introduction: Interactions of left ventricular assist devices (LVADs) with transvenous implantable cardioverter-defibrillator systems (ICDs) have been widely reported. However, less is known regarding the impact of electromagnetic interference (EMI) from LVADs on subcutaneous ICD function.Methods and Results: A comprehensive literature search was performed on PubMed, Cochrane central registry, and Google Scholar using the search terms "subcutaneous implantable cardioverter-defibrillator and left ventricular assist devices," "electromagnetic interference, LVAD, and subcutaneous ICD," "EMI and S-ICD," and "inappropriate shocks, LVAD, and ICD." Demographic and programming data were extracted from the reports and authors as needed. A total of seven cases of EMI in LVAD patients with subcutaneous ICD (S-ICD) devices were found. In addition three previously unreported cases from our center were included. All cases involved either a heartware ventricular assist device or HeartMate III LVAD with a pre-existing S-ICD. In all patients, both the primary and secondary vectors had inappropriate sensing due to EMI. Three patients were reprogramed to the alternate vector with appropriate sensing. The S-ICD was either inactivated or replaced with a transvenous device in six patients. A single patient was left sensing in the alternate vector. There were no reports of inability to interrogate S-ICD systems in patients with LVADs. Conclusion:The risk of inappropriate shocks from LVADs should be considered in pre-existing patients with S-ICD, particularly when the heartware ventricular assist device or HeartMate III LVAD device is present. Reprogramming of the sensing vector can occasionally avoid this issue but often the S-ICD needs to be inactivated. K E Y W O R D S electromagnetic interference, inappropriate shock, left ventricular assist device, oversensing, subcutaneous implantable cardioverter-defibrillator

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Section: Introductionmentioning

confidence: 99%

Electromagnetic interference from left ventricular assist devices in patients with subcutaneous implantable cardioverter‐defibrillators

Ishida

Payne

Field

et al. 2020

Cardiovasc electrophysiol

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“…Another single centre study showed that the first shock during DFT was successful in just 75% and argues that DFT is still necessary for S-ICD implants [30]. However, these results do not comply with the first published studies about S-ICD safety, which showed a high conversion success rate of DFT during S-ICD implants, varying from 98.7-100% [31][32][33][34]. Tab.…”

Section: Omission Of Dft In S-icd Implantsmentioning

confidence: 88%

Defibrillation testing during implantation of the subcutaneous implantable cardioverter-defibrillator: a necessary standard or becoming redundant?

2020

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Since the publication of the SIMPLE and NORDIC trials, defibrillation testing (DFT) is rarely performed during routine implantation of transvenous implantable cardioverter-defibrillators (ICD). However, the results of these trials cannot be extrapolated to the later introduced subcutaneous ICD (S-ICD) and a class I recommendation to perform DFT during the implantation of these devices remains in the current guidelines. Due to the high conversion success rate of DFT on one hand, and the risk of complications on the other, a significant number of physicians omit DFT in S-ICD recipients. Several retrospective analyses have assessed the safety of the omission of DFT and report contradicting results and recommendations. It is known that implant position, as well as device factors and patient characteristics, influence defibrillation success. A better comprehension of these factors and their relationship could lead to more reliable and safer alternatives to DFT. An ongoing randomised clinical trial, which is expected to end in 2023, is the first study to implement a method that assesses implant position to identify patients who are likely to fail their DFT.

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“…5 The American Heart Association guidelines 4 recommend sICDs for patients without proper venous access or at high risk of CDRIE. Boersma et al 56 reported low periprocedural complication rates, with 99.6% successfully implanted devices and high defibrillation efficacy (99.2% during defibrillation testing) among 1,116 patients who had undergone sICD implantation as primary prevention of SCD. In another study, Boersma et al 57 indicated a low risk of infection in sICD recipients, even in individuals with a history of CDRIE and explanted transvenous ICDs.…”

Section: Subcutaneous Cardioverter-defibrillatormentioning

confidence: 99%

<p>Cardiac Electronic Devices: Future Directions and Challenges</p>

Kotalczyk¹,

Kalarus²,

Wright³

et al. 2020

MDER

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Cardiovascular implantable electronic devices (CIEDs) are essential management options for patients with brady-and tachyarrhythmias or heart failure with concomitant optimal pharmacotherapy. Despite increasing technological advances, there are still gaps in the management of CIED patients, eg, the growing number of lead-and pocket-related longterm complications, including cardiac device-related infective endocarditis, requires the greatest care. Likewise, patients with CIEDs should be monitored remotely as a part of a comprehensive, holistic management approach. In addition, novel technologies used in smartwatches may be a convenient tool for long-term atrial fibrillation (AF) screening, especially in high-risk populations. Early detection of AF may reduce the risk of stroke and other AF-related complications. The objective of this review article was to provide an overview of novel technologies in cardiac rhythm-management devices and future challenges related to CIEDs.

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Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): Clinical characteristics and perioperative results

Cited by 54 publications

References 23 publications

Electromagnetic interference from left ventricular assist devices in patients with subcutaneous implantable cardioverter‐defibrillators

Electromagnetic interference from left ventricular assist devices in patients with subcutaneous implantable cardioverter‐defibrillators

Defibrillation testing during implantation of the subcutaneous implantable cardioverter-defibrillator: a necessary standard or becoming redundant?

<p>Cardiac Electronic Devices: Future Directions and Challenges</p>

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