Медицинская библиотека · Heart rhythm O2 · 2025

Pain after subcutaneous implantable cardioverter-defibrillator implantation: A secondary analysis of the PRAETORIAN-DFT trial.

de Veld Jolien A, Smeding Lonneke, El-Chami Mikhael F, Marquie Christelle, Nordbeck Peter, Quast Anne-Floor B E, Tilz Roland R, Brouwer Tom F, Lambiase Pier D, Cassidy Christopher J, Boersma Lucas V A, Burke Martin C, Pepplinkhuizen Shari, Dijkshoorn Leonard A, de Weger Anouk, Manyam Harish, Probst Vincent, Betts Timothy R, Bijsterveld Nick R, Defaye Pascal, Elders Jan, Golovchiner Gregory, de Jong Jonas S S G, Lewis Nigel, Marijon Eloi, Martin Claire A, Miller Marc A, Shaik Naushad A, van der Stuijt Willeke, Kuschyk Jürgen, Olde Nordkamp Louise R A, Arya Anita, Borger van der Burg Alida E, Boveda Serge, Glikson Michael, Kaiser Lukas, Maass Alexander H, van Woerkens Léon J P M, Zaidi Amir, Wilde Arthur A M, Knops Reinoud E

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Аннотация

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.

Для цитирования: de Veld Jolien A, Smeding Lonneke, El-Chami Mikhael F, Marquie Christelle, Nordbeck Peter, Quast Anne-Floor B E, Tilz Roland R, Brouwer Tom F, Lambiase Pier D, Cassidy Christopher J, Boersma Lucas V A, Burke Martin C, Pepplinkhuizen Shari, Dijkshoorn Leonard A, de Weger Anouk, Manyam Harish, Probst Vincent, Betts Timothy R, Bijsterveld Nick R, Defaye Pascal, Elders Jan, Golovchiner Gregory, de Jong Jonas S S G, Lewis Nigel, Marijon Eloi, Martin Claire A, Miller Marc A, Shaik Naushad A, van der Stuijt Willeke, Kuschyk Jürgen, Olde Nordkamp Louise R A, Arya Anita, Borger van der Burg Alida E, Boveda Serge, Glikson Michael, Kaiser Lukas, Maass Alexander H, van Woerkens Léon J P M, Zaidi Amir, Wilde Arthur A M, Knops Reinoud E. Pain after subcutaneous implantable cardioverter-defibrillator implantation: A secondary analysis of the PRAETORIAN-DFT trial.. Heart rhythm O2. 2025. DOI: 10.1016/j.hroo.2025.03.011.

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