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

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.

Keywords: Anesthesia; Implantation; Pain; Sex; Subcutaneous ICD.

Graphical abstract

Figure 1

Flowchart of questionnaire completion. Number of patients who completed the questionnaire at 5 different time points. hrs = hours.

Figure 2

(A) Absolute pain score at different time points. The x indicates the mean score. The box indicates the interquartile range, with the inner line indicating the median. The error bars indicate the range, and outliers are presented as dots. (B) Change in pain scores from baseline. Change in pain score corrected for the baseline pain score. The zero value represents the value of pain at baseline. The x indicates the mean change score. The box indicates the interquartile range, with the inner line indicating the median. The error bars indicate the range, outliers are presented as dots. A sensitivity analysis excluding patients with a pain score other than zero at baseline showed comparable results.

Figure 3

Pain areas. (A) Pain areas as presented in questionnaire. The 4 boxes indicate the areas in which patients could report pain. If patients experienced pain in other areas, this was indicated as “other.” (B) Pain areas reported at different time points. The area that was indicated as painful most frequently was the anterior side of the generator pocket, at the incision. This is most likely due to the large incision and generator, and the fact that the generator is sutured to the thoracic muscles.