Long-term complications in patients implanted with subcutaneous implantable cardioverter-defibrillators: Real-world data from the extended ELISIR experience

Alessio Gasperetti; Marco Schiavone; Matteo Ziacchi; Julia Vogler; Alexander Breitenstein; Mikael Laredo; Pietro Palmisano; Danilo Ricciardi; Gianfranco Mitacchione; Paolo Compagnucci; Antonio Bisignani; Andrea Angeletti; Michela Casella; Francesco Picarelli; Thomas Fink; Lukas Kaiser; Samer Hakmi; Leonardò Calò; Carlo Pignalberi; Luca Santini; Carlo Lavalle; Ennio Pisanò; Iacopo Olivotto; Claudio Tondo; Antonio Curnis; Antonio Dello Russo; Nicolas Badenco; Jan Steffel; Charles J. Love; Roland Tilz; Giovanni Forleo; Mauro Biffi

doi:10.1016/j.hrthm.2021.07.008

Long-term complications in patients implanted with subcutaneous implantable cardioverter-defibrillators: Real-world data from the extended ELISIR experience

Alessio Gasperetti^*, Marco Schiavone, Matteo Ziacchi, Julia Vogler, Alexander Breitenstein, Mikael Laredo, Pietro Palmisano, Danilo Ricciardi, Gianfranco Mitacchione, Paolo Compagnucci, Antonio Bisignani, Andrea Angeletti, Michela Casella, Francesco Picarelli, Thomas Fink, Lukas Kaiser, Samer Hakmi, Leonardò Calò, Carlo Pignalberi, Luca SantiniCarlo Lavalle, Ennio Pisanò, Iacopo Olivotto, Claudio Tondo, Antonio Curnis, Antonio Dello Russo, Nicolas Badenco, Jan Steffel, Charles J. Love, Roland Tilz, Giovanni Forleo, Mauro Biffi

^*Corresponding author for this work

Clinic of Internal Medicine II - Cardiology

42 Citations (Scopus)

Abstract

Background: Recently, the Food and Drug Administration issued a recall for the subcutaneous implantable cardioverter-defibrillator (S-ICD) because of the possibility of lead ruptures and accelerated battery depletion. Objective: The aim of this study was to evaluate device-related complications over time in a large real-world multicenter S-ICD cohort. Methods: Patients implanted with an S-ICD from January 2015 to June 2020 were enrolled from a 19-institution European registry (Experience from the Long-term Italian S-ICD registry [ELISIR]; ClinicalTrials.gov identifier NCT0473876). Device-related complication rates over follow-up were collected. Last follow-up of patients was performed after the Boston Scientific recall issue. Results: A total of 1254 patients (median age 52.0 [interquartile range 41.0–62.2] years; 973 (77.6%) men; 387 (30.9%) ischemic) was enrolled. Over a follow-up of 23.2 (12.8–37.8) months, complications were observed in 117 patients (9.3%) for a total of 127 device-related complications (23.6% managed conservatively and 76.4% required reintervention). Twenty-seven patients (2.2%) had unanticipated generator replacement after 3.6 (3.3–3.9) years, while 4 (0.3%) had lead rupture. Body mass index (hazard ratio [HR] 1.063 [95% confidence interval 1.028–1.100]; P <.001), chronic kidney disease (HR 1.960 [1.191–3.225]; P =.008), and oral anticoagulation (HR 1.437 [1.010–2.045]; P =.043) were associated with an increase in overall complications, whereas older age (HR 0.980 [0.967–0.994]; P =.007) and procedure performed in high-volume centers (HR 0.463 [0.300–0.715]; P =.001) were protective factors. Conclusion: The overall complication rate over 23.2 months of follow-up in a multicenter S-ICD cohort was 9.3%. Early unanticipated device battery depletions occurred in 2.2% of patients, while lead fracture was observed in 0.3%, which is in line with the expected rates reported by Boston Scientific.

Original language	English
Journal	Heart Rhythm
Volume	18
Issue number	12
Pages (from-to)	2050-2058
Number of pages	9
ISSN	1547-5271
DOIs	https://doi.org/10.1016/j.hrthm.2021.07.008
Publication status	Published - 12.2021

Funding

Funding sources: The authors have no funding sources to disclose. Disclosures: Dr Santini is a consultant for Boston Scientific. Dr Tondo is a member of Boston Scientific advisory board. Dr Steffel has received consultancy and/or speaker fees and grant support through his institution from Boston Scientific. The rest of the authors report no conflicts of interest.

Research Areas and Centers

Centers: Cardiological Center Luebeck (UHZL)

DFG Research Classification Scheme

2.22-12 Cardiology, Angiology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.hrthm.2021.07.008

Cite this

Gasperetti, A., Schiavone, M., Ziacchi, M., Vogler, J., Breitenstein, A., Laredo, M., Palmisano, P., Ricciardi, D., Mitacchione, G., Compagnucci, P., Bisignani, A., Angeletti, A., Casella, M., Picarelli, F., Fink, T., Kaiser, L., Hakmi, S., Calò, L., Pignalberi, C., ... Biffi, M. (2021). Long-term complications in patients implanted with subcutaneous implantable cardioverter-defibrillators: Real-world data from the extended ELISIR experience. Heart Rhythm, 18(12), 2050-2058. https://doi.org/10.1016/j.hrthm.2021.07.008

@article{3ce69730f2a34b938f14c1dc557ceb08,

title = "Long-term complications in patients implanted with subcutaneous implantable cardioverter-defibrillators: Real-world data from the extended ELISIR experience",

abstract = "Background: Recently, the Food and Drug Administration issued a recall for the subcutaneous implantable cardioverter-defibrillator (S-ICD) because of the possibility of lead ruptures and accelerated battery depletion. Objective: The aim of this study was to evaluate device-related complications over time in a large real-world multicenter S-ICD cohort. Methods: Patients implanted with an S-ICD from January 2015 to June 2020 were enrolled from a 19-institution European registry (Experience from the Long-term Italian S-ICD registry [ELISIR]; ClinicalTrials.gov identifier NCT0473876). Device-related complication rates over follow-up were collected. Last follow-up of patients was performed after the Boston Scientific recall issue. Results: A total of 1254 patients (median age 52.0 [interquartile range 41.0–62.2] years; 973 (77.6\%) men; 387 (30.9\%) ischemic) was enrolled. Over a follow-up of 23.2 (12.8–37.8) months, complications were observed in 117 patients (9.3\%) for a total of 127 device-related complications (23.6\% managed conservatively and 76.4\% required reintervention). Twenty-seven patients (2.2\%) had unanticipated generator replacement after 3.6 (3.3–3.9) years, while 4 (0.3\%) had lead rupture. Body mass index (hazard ratio [HR] 1.063 [95\% confidence interval 1.028–1.100]; P <.001), chronic kidney disease (HR 1.960 [1.191–3.225]; P =.008), and oral anticoagulation (HR 1.437 [1.010–2.045]; P =.043) were associated with an increase in overall complications, whereas older age (HR 0.980 [0.967–0.994]; P =.007) and procedure performed in high-volume centers (HR 0.463 [0.300–0.715]; P =.001) were protective factors. Conclusion: The overall complication rate over 23.2 months of follow-up in a multicenter S-ICD cohort was 9.3\%. Early unanticipated device battery depletions occurred in 2.2\% of patients, while lead fracture was observed in 0.3\%, which is in line with the expected rates reported by Boston Scientific.",

author = "Alessio Gasperetti and Marco Schiavone and Matteo Ziacchi and Julia Vogler and Alexander Breitenstein and Mikael Laredo and Pietro Palmisano and Danilo Ricciardi and Gianfranco Mitacchione and Paolo Compagnucci and Antonio Bisignani and Andrea Angeletti and Michela Casella and Francesco Picarelli and Thomas Fink and Lukas Kaiser and Samer Hakmi and Leonard{\`o} Cal{\`o} and Carlo Pignalberi and Luca Santini and Carlo Lavalle and Ennio Pisan{\`o} and Iacopo Olivotto and Claudio Tondo and Antonio Curnis and \{Dello Russo\}, Antonio and Nicolas Badenco and Jan Steffel and Love, \{Charles J.\} and Roland Tilz and Giovanni Forleo and Mauro Biffi",

note = "Publisher Copyright: {\textcopyright} 2021 Heart Rhythm Society",

year = "2021",

month = dec,

doi = "10.1016/j.hrthm.2021.07.008",

language = "English",

volume = "18",

pages = "2050--2058",

journal = "Heart Rhythm",

issn = "1547-5271",

publisher = "Elsevier B.V.",

number = "12",

}

Gasperetti, A, Schiavone, M, Ziacchi, M, Vogler, J, Breitenstein, A, Laredo, M, Palmisano, P, Ricciardi, D, Mitacchione, G, Compagnucci, P, Bisignani, A, Angeletti, A, Casella, M, Picarelli, F, Fink, T, Kaiser, L, Hakmi, S, Calò, L, Pignalberi, C, Santini, L, Lavalle, C, Pisanò, E, Olivotto, I, Tondo, C, Curnis, A, Dello Russo, A, Badenco, N, Steffel, J, Love, CJ, Tilz, R, Forleo, G & Biffi, M 2021, 'Long-term complications in patients implanted with subcutaneous implantable cardioverter-defibrillators: Real-world data from the extended ELISIR experience', Heart Rhythm, vol. 18, no. 12, pp. 2050-2058. https://doi.org/10.1016/j.hrthm.2021.07.008

TY - JOUR

T1 - Long-term complications in patients implanted with subcutaneous implantable cardioverter-defibrillators

T2 - Real-world data from the extended ELISIR experience

AU - Gasperetti, Alessio

AU - Schiavone, Marco

AU - Ziacchi, Matteo

AU - Vogler, Julia

AU - Breitenstein, Alexander

AU - Laredo, Mikael

AU - Palmisano, Pietro

AU - Ricciardi, Danilo

AU - Mitacchione, Gianfranco

AU - Compagnucci, Paolo

AU - Bisignani, Antonio

AU - Angeletti, Andrea

AU - Casella, Michela

AU - Picarelli, Francesco

AU - Fink, Thomas

AU - Kaiser, Lukas

AU - Hakmi, Samer

AU - Calò, Leonardò

AU - Pignalberi, Carlo

AU - Santini, Luca

AU - Lavalle, Carlo

AU - Pisanò, Ennio

AU - Olivotto, Iacopo

AU - Tondo, Claudio

AU - Curnis, Antonio

AU - Dello Russo, Antonio

AU - Badenco, Nicolas

AU - Steffel, Jan

AU - Love, Charles J.

AU - Tilz, Roland

AU - Forleo, Giovanni

AU - Biffi, Mauro

PY - 2021/12

Y1 - 2021/12

N2 - Background: Recently, the Food and Drug Administration issued a recall for the subcutaneous implantable cardioverter-defibrillator (S-ICD) because of the possibility of lead ruptures and accelerated battery depletion. Objective: The aim of this study was to evaluate device-related complications over time in a large real-world multicenter S-ICD cohort. Methods: Patients implanted with an S-ICD from January 2015 to June 2020 were enrolled from a 19-institution European registry (Experience from the Long-term Italian S-ICD registry [ELISIR]; ClinicalTrials.gov identifier NCT0473876). Device-related complication rates over follow-up were collected. Last follow-up of patients was performed after the Boston Scientific recall issue. Results: A total of 1254 patients (median age 52.0 [interquartile range 41.0–62.2] years; 973 (77.6%) men; 387 (30.9%) ischemic) was enrolled. Over a follow-up of 23.2 (12.8–37.8) months, complications were observed in 117 patients (9.3%) for a total of 127 device-related complications (23.6% managed conservatively and 76.4% required reintervention). Twenty-seven patients (2.2%) had unanticipated generator replacement after 3.6 (3.3–3.9) years, while 4 (0.3%) had lead rupture. Body mass index (hazard ratio [HR] 1.063 [95% confidence interval 1.028–1.100]; P <.001), chronic kidney disease (HR 1.960 [1.191–3.225]; P =.008), and oral anticoagulation (HR 1.437 [1.010–2.045]; P =.043) were associated with an increase in overall complications, whereas older age (HR 0.980 [0.967–0.994]; P =.007) and procedure performed in high-volume centers (HR 0.463 [0.300–0.715]; P =.001) were protective factors. Conclusion: The overall complication rate over 23.2 months of follow-up in a multicenter S-ICD cohort was 9.3%. Early unanticipated device battery depletions occurred in 2.2% of patients, while lead fracture was observed in 0.3%, which is in line with the expected rates reported by Boston Scientific.

AB - Background: Recently, the Food and Drug Administration issued a recall for the subcutaneous implantable cardioverter-defibrillator (S-ICD) because of the possibility of lead ruptures and accelerated battery depletion. Objective: The aim of this study was to evaluate device-related complications over time in a large real-world multicenter S-ICD cohort. Methods: Patients implanted with an S-ICD from January 2015 to June 2020 were enrolled from a 19-institution European registry (Experience from the Long-term Italian S-ICD registry [ELISIR]; ClinicalTrials.gov identifier NCT0473876). Device-related complication rates over follow-up were collected. Last follow-up of patients was performed after the Boston Scientific recall issue. Results: A total of 1254 patients (median age 52.0 [interquartile range 41.0–62.2] years; 973 (77.6%) men; 387 (30.9%) ischemic) was enrolled. Over a follow-up of 23.2 (12.8–37.8) months, complications were observed in 117 patients (9.3%) for a total of 127 device-related complications (23.6% managed conservatively and 76.4% required reintervention). Twenty-seven patients (2.2%) had unanticipated generator replacement after 3.6 (3.3–3.9) years, while 4 (0.3%) had lead rupture. Body mass index (hazard ratio [HR] 1.063 [95% confidence interval 1.028–1.100]; P <.001), chronic kidney disease (HR 1.960 [1.191–3.225]; P =.008), and oral anticoagulation (HR 1.437 [1.010–2.045]; P =.043) were associated with an increase in overall complications, whereas older age (HR 0.980 [0.967–0.994]; P =.007) and procedure performed in high-volume centers (HR 0.463 [0.300–0.715]; P =.001) were protective factors. Conclusion: The overall complication rate over 23.2 months of follow-up in a multicenter S-ICD cohort was 9.3%. Early unanticipated device battery depletions occurred in 2.2% of patients, while lead fracture was observed in 0.3%, which is in line with the expected rates reported by Boston Scientific.

UR - https://www.scopus.com/pages/publications/85112050058

U2 - 10.1016/j.hrthm.2021.07.008

DO - 10.1016/j.hrthm.2021.07.008

M3 - Journal articles

C2 - 34271173

AN - SCOPUS:85112050058

SN - 1547-5271

VL - 18

SP - 2050

EP - 2058

JO - Heart Rhythm

JF - Heart Rhythm

IS - 12

ER -

Long-term complications in patients implanted with subcutaneous implantable cardioverter-defibrillators: Real-world data from the extended ELISIR experience

Abstract

Funding

Research Areas and Centers

DFG Research Classification Scheme

UN SDGs

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