January 24, 2016
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Subcutaneous ICD viable option after transvenous ICD extraction

In a new study, patients reimplanted with a subcutaneous implantable cardioverter defibrillator after the explantation of a transvenous implantable cardioverter defibrillator had low rates of complications and mortality.

Lucas Boersma, MD, PhD, FESC

Lucas Boersma

In this retrospective analysis, Lucas Boersma, MD, PhD, of St. Antonius Ziekenhuis in Nieuwegein, the Netherlands, and colleagues analyzed data from the S-ICD IDE study and EFFORTLESS S-ICD registry to compare mortality rates, as well as intraoperative and postoperative complication rates, in patients who received a subcutaneous ICD implantation after transvenous ICD extraction vs. patients who received a subcutaneous ICD as their initial ICD implant.

The researchers divided 866 patients into three groups: those implanted with the subcutaneous ICD after transvenous ICD extraction for system-related infection (n = 75), those implanted after transvenous ICD extraction for other reasons (n = 44) and those with no prior ICD (n = 747).

Patients previously explanted for transvenous ICD infection were older (P = .01), more likely to have received the ICD for secondary prevention (P < .001) and had the highest percentage of comorbidities. Besides infection, other reasons for the explantation of the transvenous ICD included transvenous lead failure or advisory alerts. The mean follow-up was 651 days.

According to the findings, all-cause mortality (3.2%) was low for all three groups. No patient deaths occurred in the cohort reimplanted with a subcutaneous ICD after transvenous ICD explantation for reasons other than infection. Five deaths (6.7%) were reported in the transvenous ICD cohort extracted for infection. In the cohort in which patients had no prior transvenous ICD, 23 deaths (3.1%) occurred. Major infection rates were low for all groups.

Boersma and colleagues also reported that the number of patients with system- or procedural-related complications was not significantly higher in the cohort whose transvenous ICD explantation was due to infection (10.7%) than those implanted after transvenous ICD extraction for other reasons (6.8%) and patients with no prior ICD (9.6%). One patient (1.3%) from the cohort of patients who received a subcutaneous ICD after transvenous ICD explantation due to infection developed a new infection that required antibiotics and subsequent explantation. Twelve (1.6%) patients with no prior ICD and two (4.5%) of the patients whose transvenous ICD were explanted for other reasons also developed infections.

The researchers concluded that the subcutaneous ICD “is a suitable alternative for [transvenous ICD] patients whose devices are explanted for any reason.”

While subcutaneous ICDs are not suitable for every patient, Boersma estimates that about 50% of patients receiving an ICD now could have a subcutaneous ICD as the first option.

“Leads inside the heart are a big problem. In the long run, a lot can happen to these leads and the patients. One in four patients with systemic infection may die. We may avoid [some of these complications] by using a subcutaneous ICD, which isn’t associated with the same risks,” he told Cardiology Today. by Tracey Romero

Disclosure: The S-ICD IDE study and EFFORTLESS S-ICD registry are sponsored by a subsidiary of Boston Scientific. Boersma reports receiving consultant fees from Boston Scientific and Medtronic and speaking fees from Biotronik, Boston Scientific and Medtronic. Please see the full study for a list of all other researchers’ relevant financial disclosures.