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Subcutaneous defibrillator successfully converted all ventricular fibrillation events

Issue: June 2011

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Heart Rhythm Society 32nd Annual Scientific Sessions

SAN FRANCISCO — An entirely subcutaneous defibrillator was able to successfully convert 100% of the episodes of ventricular fibrillation in a cohort of almost 100 patients, which represents the largest patient cohort to date implanted with the device.

The 98 participants in the study were pooled from three centers in the Netherlands: Erasmus Medical Center (n=32), Academic Medical Center (n=37) and St. Antonius Hospital (n=29). Each received a subcutaneous implantable cardiac defibrillator (S-ICD) that included a subcutaneous pulse generator and lead, and delivered a shock of 80 J, which Lara Dabiri Abkenari, MD, electrophysiology fellow and PhD candidate, Erasmus Medical Center, Rotterdam, the Netherlands, and study researcher, said led to the device being larger than traditional defibrillators.

Overall, a primary prevention indication was present in 63% of patients. Among the causes of cardiac disease were ischemic cardiomyopathy (41%), idiopathic ventricular fibrillation (28%), non-ischemic dilated cardiomyopathy (14%) and Brugada syndrome (7%).

During a median follow-up of 9 months, both sensitivity and conversion efficacy of ventricular fibrillation were 100%. Overall, 34 spontaneous ventricular arrhythmias were correctly detected and 23 arrhythmic episodes were treated. Inappropriate shocks were reported in 8 patients, while infection (n=5), mitigation or dislodgments (n=3) and hematoma (n=3) were the other main complications found.

According to Abkenari in her presentation, limitations for the study included lack of information of lead integrity over time, the unknown risks with box changes, the learning curve as well as the newness of the device.

In spite of the complications and limitations, Abkenari said, “We believe that S-ICD is a viable alternative option to standard transvenous ICD systems .” – by Brian Ellis

For more information:

• Abkenari L. AB01-4. Presented at: Heart Rhythm Society 32nd Annual Scientific Sessions; May 4-7, 2011; San Francisco.

The subcutaneous defibrillator is not a released product in some geographies … but it is a potentially disruptive innovation. It’s a very exciting technique.

On the other hand, we have to look at what new technologies do in the way of total morbidity reduction. We can’t be trading off one great feature for more morbidity. We saw a 5% infection rate with the S-ICD. One of my hopes was that we were going to see less infection with the S-ICD. There is nothing saying we can’t solve this problem, but when we come up with answers we better look towards reducing total morbidity.

– Bruce L. Wilkoff, MD
Director, Cardiac Pacing, Cleveland Clinic, Cleveland
Cardiology Today Editorial Board

Disclosures: Drs. Abkenari and Wilkoff reported no relevant financial disclosures.

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