Poster Points To Lower Complications For Boston’s S-ICD® System Vs Transvenous ICD Leads

Boston Scientific Corporation is trumpeting a poster presentation at this week’s EHRA EuroPace 2013 in Athens. Data suggests the company’s subcutaneous ICD (S-ICD®)  System shows a significant reduction in major lead-related complications when compared with both single (VVI) and dual chamber(DDD) transvenous implantable defibrillator (TV-ICD) systems.

Background

TV-ICDs require a lead to be connected to the heart to sense and defibrillate, whereas the S-ICD System utilizes an electrode that sits just under the skin, leaving the heart and vasculature untouched.

The authors of this new poster presentation analysed the rate of surgical complications in S-ICD over one thousand patients as reported in the Boston Scientific EFFORTLESS S-ICD international postmarket registry compared to a nationwide cohort of first VVI and DDD TV-ICD implantations derived from the Danish ICD Register.

Results showed a significantly lower rate of major lead complications for the S-ICD System (1.4 percent) when compared with VVI TV-ICDs (4.3 percent), (p<0.05), and DDD TV-ICDs (5.4 percent), (p<0.01)

Furthermore there were fewer surgical complications for the S-ICD System (7.9 percent) when compared with conventional TV-ICDs (11.5 percent), (p=0.06). There was reportedly no difference in the rate of pocket revision or major hematoma.

The poster and subsequent press release come on the back of the UK’s NICE watchdog issuing guidance supporting the use of the S-ICD system.

Investigator comments

“The benefits of the S-ICD System leaving the heart and vasculature untouched are becoming more evident,” said Dr. Johansen. “These are very exciting outcomes, since implanting an S-ICD System is relatively new compared with implanting transvenous ICDs. Having supportive outcomes in the acute phase is incredibly important and I am optimistic about the potential benefits the S-ICD System may have in the long term.”

On the NICE guidance, Trudie Lobban MBE, founder and chief executive of the Arrhythmia Alliance, the heart rhythm charity said; “This is very positive news for patients requiring protection against sudden cardiac death and ventricular arrhythmias.”

Andrew Grace, M.D., consultant cardiologist at Papworth Hospital, Cambridge, United Kingdom said; “The NICE interventional procedure guidance on the insertion of theS-ICD System is a welcome step in the development of this new therapy. The guidance complements the growing evidence supporting its application in a larger patient pool.”

Regulatory status

The S-ICD System has been available in European countries since July 2009 and was approved in the United States by the Food and Drug Administration in September 2012.

Source: Boston Scientific Corporation, PR Newswire