Subcutaneous or transvenous defibrillators during long-term follow-up: which one results in less complications?
Implantable cardioverter-defibrillators (ICDs) are devices implanted in patients who have an increased risk of life-threatening arrhythmia or cardiac arrest (CA). In these cases, the ICD can deliver a shock to restore the normal heart rhythm. The conventional transvenous ICD (TV-ICD) has a lead implanted in the heart through the blood vessels. This lead enables the ICD to deliver pacing, which consists of small electric pulses that can keep the heart from contracting when the heart rate is too low. The same lead can also potentially stop a fast regular rhythm from the ventricles by temporarily take over the rhythm through pacing. However, a lead in the heart also carries a risk of complications, such as bacteria entering the bloodstream in case of an infection or broken leads. More recently, the subcutaneous ICD (S-ICD) was developed, which is implanted outside the vessels under the skin. This provides a suitable alternative for patients who do not require pacing. Due to the novelty of this S-ICD, it was unknown if this device has a lower or higher risk of complications during long-term follow-up.
In this study, we sought to investigate if the S-ICD has a lower risk of complications compared with the TV-ICD during a follow-up of eight years. To investigate this, we used data from 849 patients who were implanted with either an S-ICD (426 patients) or TV-ICD (423 patients). These patients were followed in 39 different hospitals in Europe and the US. We found that there was no difference between the two ICDs in the overall complication rate. However, the complications that occurred in the TV-ICD patients were more severe as they more often resulted in an intervention such as an additional operation. Besides this, the patients in the TV-ICD group had a higher risk of complications related to the lead. We therefore propose that the S-ICD should be considered for all patients who have an ICD indication but who do not require pacing. At the other hand, for all patients who require pacing, the TV-ICD is the better option despite the known complications.
Olde Nordkamp LRA, de Veld JA, Ghani A, Kuschyk J, Bonnemeier H, Bode K, Boersma LVA, de Weger A, de Jong JSSG, Jansen WPJ, Alings M, Bijsterveld N, El-Chami MF, Beukema RJ, Vernooy K, Philbert BT, Neuzil P, Nordbeck P, van Opstal JM, Allaart CP, Wright DJ, Knaut M, Betts TR, Whinnett ZI, Lambiase PD, de Groot JR, Chicos AB, Nemirovsky D, Kääb S, Mittal S, Borger van der Burg AE, Dijkshoorn LA, Pepplinkhuizen S, van der Stuijt W, Dizon JM, Miller MA, Behr ER, Burke MC, Kooiman K, Quast ABE, Brouwer TF, Wilde AAM, Smeding L, Knops RE; PRAETORIAN-XL Investigators. Device-related Complications in Transvenous Versus Subcutaneous Defibrillator Therapy During Long-term Follow-up: the PRAETORIAN-XL Trial. Circulation. 2025 Apr 25. doi: 10.1161/CIRCULATIONAHA.125.074576. Epub ahead of print. PMID: 40279654
Prepared by Louise Olde Nordkamp and Ruth Biller