TY - JOUR
T1 - Pain after subcutaneous implantable cardioverter-defibrillator implantation
T2 - A secondary analysis of the PRAETORIAN-DFT trial
AU - de Veld, Jolien A.
AU - Smeding, Lonneke
AU - el-Chami, Mikhael F.
AU - Marquie, Christelle
AU - Nordbeck, Peter
AU - Quast, Anne-Floor B. E.
AU - Tilz, Roland R.
AU - Brouwer, Tom F.
AU - Lambiase, Pier D.
AU - Cassidy, Christopher J.
AU - Boersma, Lucas V. A.
AU - Burke, Martin C.
AU - Pepplinkhuizen, Shari
AU - Dijkshoorn, Leonard A.
AU - de Weger, Anouk
AU - Manyam, Harish
AU - Probst, Vincent
AU - Betts, Timothy R.
AU - Bijsterveld, Nick R.
AU - Defaye, Pascal
AU - Elders, Jan
AU - Golovchiner, Gregory
AU - de Jong, Jonas S. S. G.
AU - Lewis, Nigel
AU - Marijon, Eloi
AU - Martin, Claire A.
AU - Miller, Marc A.
AU - Shaik, Naushad A.
AU - van der Stuijt, Willeke
AU - Kuschyk, J. rgen
AU - Olde Nordkamp, Louise.R. A.
AU - Arya, Anita
AU - Borger van der Burg, Alida E.
AU - Boveda, Serge
AU - Glikson, Michael
AU - Kaiser, Lukas
AU - Maass, Alexander H.
AU - van Woerkens, L. on J. P. M.
AU - Zaidi, Amir
AU - Wilde, Arthur A. M.
AU - Knops, Reinoud E.
N1 - Publisher Copyright:
© 2025 Heart Rhythm Society
PY - 2025/6
Y1 - 2025/6
N2 - Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) overcomes transvenous lead-related complications. Its extrathoracic design results in a generator twice the size of transvenous ICDs. Objective: We investigated pain after S-ICD implantation and explore predictors for severe pain. Methods: The PRAETORIAN-DFT (PRospective randomized compArative trial of subcutanEous implanTable cardiOverter-defibrillatoR ImplANtation with and without DeFibrillation Testing) trial included 965 patients undergoing S-ICD implantation in 37 centers across Europe, the United States, and Israel. Pain was assessed using the numeric rating scale (NRS), ranging from no pain to unbearable pain. The NRS was measured before implantation, and 1 to 4 hours, 5 to 7 hours, 1 day, and 1 to 4 months after implantation. Two questions about implantation experience were asked at follow-up. Logistic regression analysis was used to identify predictors. Implanting physicians were asked their expectations on pain experience. Results: In the PRAETORIAN-DFT trial, 24% was female, mean age was 54 ± 14 years and 45% had ischemic cardiomyopathy. The median NRS within 1 day after implantation was 4. Pain was most frequently experienced at the pocket. There were 262 (29%) of 918 patients who reported severe pain (NRS ≥7) within 1 day after implantation. Predictors for severe pain were female sex (adjusted odds ratio [aOR] 2.23, P < .001), procedure duration >48 minutes (aOR 1.84, P < .001), and severe pain at baseline (aOR 3.97, P = .026). Additionally, female sex was a predictor for disappointment in pain perception during and after implantation. Physician anticipated NRS and location corresponded with reported pain, and females were expected to have more pain by 4 of 24 physicians. Conclusion: In the period surrounding S-ICD implantation, attention should be paid to analgesia and expectation management in patients with longer procedure duration, severe pre-existing pain, and especially female sex.
AB - Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) overcomes transvenous lead-related complications. Its extrathoracic design results in a generator twice the size of transvenous ICDs. Objective: We investigated pain after S-ICD implantation and explore predictors for severe pain. Methods: The PRAETORIAN-DFT (PRospective randomized compArative trial of subcutanEous implanTable cardiOverter-defibrillatoR ImplANtation with and without DeFibrillation Testing) trial included 965 patients undergoing S-ICD implantation in 37 centers across Europe, the United States, and Israel. Pain was assessed using the numeric rating scale (NRS), ranging from no pain to unbearable pain. The NRS was measured before implantation, and 1 to 4 hours, 5 to 7 hours, 1 day, and 1 to 4 months after implantation. Two questions about implantation experience were asked at follow-up. Logistic regression analysis was used to identify predictors. Implanting physicians were asked their expectations on pain experience. Results: In the PRAETORIAN-DFT trial, 24% was female, mean age was 54 ± 14 years and 45% had ischemic cardiomyopathy. The median NRS within 1 day after implantation was 4. Pain was most frequently experienced at the pocket. There were 262 (29%) of 918 patients who reported severe pain (NRS ≥7) within 1 day after implantation. Predictors for severe pain were female sex (adjusted odds ratio [aOR] 2.23, P < .001), procedure duration >48 minutes (aOR 1.84, P < .001), and severe pain at baseline (aOR 3.97, P = .026). Additionally, female sex was a predictor for disappointment in pain perception during and after implantation. Physician anticipated NRS and location corresponded with reported pain, and females were expected to have more pain by 4 of 24 physicians. Conclusion: In the period surrounding S-ICD implantation, attention should be paid to analgesia and expectation management in patients with longer procedure duration, severe pre-existing pain, and especially female sex.
KW - Anesthesia
KW - Implantation
KW - Pain
KW - Sex
KW - Subcutaneous ICD
UR - https://www.scopus.com/pages/publications/105003179214
U2 - 10.1016/j.hroo.2025.03.011
DO - 10.1016/j.hroo.2025.03.011
M3 - Article
C2 - 40717858
SN - 2666-5018
VL - 6
SP - 799
EP - 807
JO - Heart rhythm O2
JF - Heart rhythm O2
IS - 6
ER -