TY - JOUR
T1 - Comprehensive analysis of substernal lead removal
T2 - experience from EV ICD Pilot, Pivotal, and Continued Access Studies
AU - Sagi, Venkata
AU - Murgatroyd, Francis
AU - Boersma, Lucas V.A.
AU - Manlucu, Jaimie
AU - Knight, Bradley P.
AU - Leclercq, Christophe
AU - Amin, Anish
AU - Birgersdotter-Green, Ulrika Maria
AU - Chan, Joseph Yat Sun
AU - Roukoz, Henri
AU - Biffi, Mauro
AU - Haqqani, Haris
AU - Denman, Russell
AU - Wiggenhorn, Christopher
AU - Holmes, Thomas R.
AU - Lulic, Thomas
AU - Friedman, Paul
AU - Crozier, Ian
N1 - Publisher Copyright:
© 2024 The Author(s). Published by Oxford University Press on behalf of the European Society of Cardiology.
PY - 2024/9/1
Y1 - 2024/9/1
N2 - Aims: The extravascular implantable cardioverter-defibrillator (EV ICD) has been shown to be safe and effective for patients at risk of sudden cardiac death, but little is known about EV ICD lead removal in humans. This analysis aimed to characterize the EV ICD lead removal experience thus far. Methods and results: This was a retrospective analysis of lead removals from the EV ICD Pilot, Pivotal, and Continued Access Studies. Patients with a successful EV ICD implant who underwent lead removal were included. The main objective was lead removal success. Ancillary objectives included characterizing technique used, procedure complications, and reimplantation status. An EV ICD system was successfully implanted in 347 patients across the 3 studies (25.9% female; 53.4 ± 13.3 years; left ventricular ejection fraction: 39.7 ± 15.9). Of these patients, 29 (8.4%) underwent lead removal with a mean lead dwell time of 12.6 ± 14.3 months (0.2-58.4). The main reason for lead removal was lead dislodgement (n = 9, 31.0%). Lead removal was successful in 27/29 (93.1%) cases [100% (19/19) success rate <1 year and 80% (8/10) success rate >1 year post-implant]. Simple traction was used in 22/26 (84.6%) and extraction tools in 4/26 (15.4%) successful cases where technique was known. No complications were reported for any of the removal procedures. All 11 EV ICD reimplant attempts were successful. Conclusion: Complete removal of the EV ICD lead was successful in 93.1% of cases, and simple traction was sufficient in most instances. Based on these results, lead removal from the substernal space was safe and achievable up to 3 years post-implant.
AB - Aims: The extravascular implantable cardioverter-defibrillator (EV ICD) has been shown to be safe and effective for patients at risk of sudden cardiac death, but little is known about EV ICD lead removal in humans. This analysis aimed to characterize the EV ICD lead removal experience thus far. Methods and results: This was a retrospective analysis of lead removals from the EV ICD Pilot, Pivotal, and Continued Access Studies. Patients with a successful EV ICD implant who underwent lead removal were included. The main objective was lead removal success. Ancillary objectives included characterizing technique used, procedure complications, and reimplantation status. An EV ICD system was successfully implanted in 347 patients across the 3 studies (25.9% female; 53.4 ± 13.3 years; left ventricular ejection fraction: 39.7 ± 15.9). Of these patients, 29 (8.4%) underwent lead removal with a mean lead dwell time of 12.6 ± 14.3 months (0.2-58.4). The main reason for lead removal was lead dislodgement (n = 9, 31.0%). Lead removal was successful in 27/29 (93.1%) cases [100% (19/19) success rate <1 year and 80% (8/10) success rate >1 year post-implant]. Simple traction was used in 22/26 (84.6%) and extraction tools in 4/26 (15.4%) successful cases where technique was known. No complications were reported for any of the removal procedures. All 11 EV ICD reimplant attempts were successful. Conclusion: Complete removal of the EV ICD lead was successful in 93.1% of cases, and simple traction was sufficient in most instances. Based on these results, lead removal from the substernal space was safe and achievable up to 3 years post-implant.
KW - Explant
KW - Extraction
KW - Extravascular ICD
KW - Lead removal
KW - Substernal
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U2 - 10.1093/europace/euae225
DO - 10.1093/europace/euae225
M3 - Article
C2 - 39210643
AN - SCOPUS:85204819600
SN - 1099-5129
VL - 26
JO - Europace
JF - Europace
IS - 9
M1 - euae225
ER -