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

IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Heart Rhythm O2 Pub Date : 2025-06-01 DOI:10.1016/j.hroo.2025.03.011

Jolien A. de Veld MD , Lonneke Smeding PhD , Mikhael F. El-Chami MD, FHRS , Christelle Marquie MD , Peter Nordbeck MD , Anne-Floor B.E. Quast MD, PhD , Roland R. Tilz MD, PhD, FHRS , Tom F. Brouwer MD, PhD , Pier D. Lambiase BCH, BM, MBChB, PhD, FHRS , Christopher J. Cassidy MD , Lucas V.A. Boersma MD, PhD , Martin C. Burke DO , Shari Pepplinkhuizen MD , Leonard A. Dijkshoorn MD , Anouk de Weger MSc , Harish Manyam MD , Vincent Probst MD, PhD , Timothy R. Betts MD , Nick R. Bijsterveld MD, PhD , Pascal Defaye MD , Reinoud E. Knops MD, PhD, FESC

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Abstract

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.

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皮下植入式心律转复除颤器植入后疼痛：PRAETORIAN-DFT试验的二次分析

皮下植入式心律转复除颤器（S-ICD）克服了经静脉铅相关并发症。它的胸外设计使其产生器的大小是经静脉icd的两倍。目的观察S-ICD植入后的疼痛情况，探讨重度疼痛的预测因素。方法PRAETORIAN-DFT（前瞻性随机比较试验，皮下植入性心律转复除颤器植入与不除颤试验）试验包括欧洲、美国和以色列37个中心的965例接受S-ICD植入的患者。使用数字评定量表（NRS）评估疼痛，范围从无疼痛到无法忍受的疼痛。分别于着床前、着床后1 ~ 4小时、5 ~ 7小时、1天、1 ~ 4个月测定NRS。随访时询问2个关于植入经验的问题。采用Logistic回归分析确定预测因子。植入医生被问及他们对疼痛体验的期望。结果PRAETORIAN-DFT试验中，24%为女性，平均年龄54±14岁，45%为缺血性心肌病。植入后1天内的中位NRS为4。最常感到疼痛的是口袋。918例患者中有262例（29%）报告植入后1天内出现严重疼痛（NRS≥7）。重度疼痛的预测因子为女性(校正优势比[aOR] 2.23, P <；.001)，手术时间>；48分钟(aOR 1.84, P <；0.001)，基线时疼痛严重（aOR 3.97, P = 0.026）。此外，女性性别是植入期间和植入后疼痛感知失望的预测因素。医生预期的NRS和位置与报告的疼痛相对应，24位医生中有4位预计女性会有更多的疼痛。结论S-ICD植入术期间，对于手术时间较长、既往疼痛严重的患者，尤其是女性患者，应注意镇痛和预期管理。

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