Two-versus three-incision techniques for subcutaneous implantable cardioverter-defibrillator implantation: insights from the HONEST registry
L Donisi, F Kerkouri, M Badoz, R Guarcia, W Aoudjeghout, V Probst, C Marquie, P Defaye, S Boveda, E MarijonAbstract
Background
The subcutaneous implantable cardioverter-defibrillator (S-ICD) is widely adopted for sudden cardiac death prevention. The original three-incision technique has been replaced by a simplified two-incision approach. The extent to which the number of incisions interfere with outcomes at long term has not been evaluated so far.
Purpose
To compare clinical outcomes between two- and three-incision S-ICD implantation techniques through a nationwide cohort with 5-year outcomes.
Methods
The HONEST (coHOrte fraNçaise des dEfibrillateurs Sous cuTanés) cohort prospectively enrolled all patients implanted with an S-ICD (EMBLEM™) in France between 2012 and 2019 across the 150 accredited centres. Five-year clinical endpoints were centrally adjudicated. Analyses were adjusted for potential confounders using multivariable Cox regression and inverse probability weighting (IPW) based on propensity scores. Sensitivity analyses accounted for calendar year, to control for learning-curve and technological effects, were performed.
Results
Among 4 924 patients, 504 (10.2 %) received the three-incision and 4 420 (89.8 %) the two-incision technique. The use of the two-incision approach increased markedly, reaching 97.4 % by 2019. At baseline, three-incision patients were younger, had higher left-ventricular ejection fraction, and more frequently received first-generation devices under general anaesthesia. During follow-up (4.8 vs. 4.5 years/100 PY, p < 0.001), crude incidence rates were comparable for overall complications, while inappropriate shocks (1.73 vs. 1.08 events/100 PY, p < 0.001) and local complications (0.94 vs. 0.48 events/100 PY, p < 0.001) were more frequent in the three-incision group. After adjusting for potential confounders, including the year of implantation, the difference in inappropriate shock rates was no longer significant, while overall complication rates remained similar across techniques. In contrast, the three-incision approach was independently associated with a higher incidence of local complications (aHR 1.58, 95 % CI 1.09–2.30; p = 0.016), particularly infections (aHR 1.80; p = 0.048) and poor wound healing (aHR 2.36; p = 0.014). Complications requiring reintervention were also more frequent in three incisions group (aHR 1.52; 95 % CI 1.02–2.33; p = 0.047), especially those related to inappropriate shocks (aHR 2.03; 95 % CI 1.10–3.74; p = 0.023) and local complications (aHR 1.70, 95 % CI 1.03-2.82; p = 0.039). Lead-related events, including lead dislodgement and lead fracture, did not differ significantly between techniques.
Conclusion
In this nationwide real-world cohort, the simplified two-incision technique achieved comparable long-term safety while substantially reducing local complications and reinterventions. These findings support its adoption as the standard surgical approach for S-ICD implantation.Graphical Abstract