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

TL;DR

This study examines pain after subcutaneous implantable cardioverter-defibrillator implantation and identifies risk factors for severe pain.

Contribution

The study identifies female sex, longer procedure duration, and pre-existing pain as predictors of severe post-implantation pain.

Findings

29% of patients reported severe pain (NRS ≥7) within one day after implantation.

Female sex was a significant predictor of severe pain and disappointment in pain perception.

Procedure duration over 48 minutes and pre-existing severe pain also predicted severe post-implantation pain.

Abstract

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.

We investigated pain after S-ICD implantation and explore predictors for severe pain.

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.

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.

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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