Sorin Announces New Data from ICD Trial

Denver, Colo.-based Sorin Group, a company that focuses on technology for the treatment of cardiovascular diseases, has announced new data from its Option study that demonstrates patients with Sorin dual-chamber implantable cardioverter defibrillators (ICDs) experienced a significantly lower incidence of inappropriate shocks compared with patients with standard single-chamber devices (4.3 percent vs. 10.3 percent). The study also found no difference in mortality from any cause between the two groups.

A total of 462 patients at 54 centers in Europe and North America were enrolled in the study. Patients were randomized to either dual-chamber or standard single-chamber ICD therapy. Study endpoints were the occurrence of appropriate and inappropriate shocks and all-cause mortality. Median follow up was over two years. The Option study results were presented as a late-breaking clinical trial at the Heart Rhythm Society’s 2013 Annual Scientific Meeting in Denver from May 8-11.

The Option study demonstrates the benefits of Sorin dual-chamber ICD therapy. Sorin dual-chamber ICDs feature the Parad+ arrhythmia discrimination algorithm which, according to a 2007 study, reduces the number of inappropriate shocks; and the Safer pacing mode which, according to a 2012 study, minimizes unnecessary ventricular pacing. Excessive right ventricular pacing has been associated with dual chamber pacing and has been shown to increase heart failure and atrial fibrillation.

“This is very good news for patients,” said Christof Kolb, M.D., of the Deutsches Herzzentrum in Munich, Germany, and principal study investigator “We have known for a long time that inappropriate shocks were associated with poor quality of life and adverse outcomes. The findings demonstrate that patients can rest assured that their Sorin ICD is correctly monitoring their heart and delivering only the therapy that is needed.”

While ICDs deliver lifesaving therapy to patients at risk of sudden cardiac arrest, Sorin’s concern is that inappropriate shocks still occur too frequently and negatively impact patients’ quality of life. ICDs are available in single and dual-chamber models and use differing methods to detect a patient’s arrhythmias and treat them with antitachycardia therapies; both types of ICDs can provide rescue shocks. According to Sorin, many physicians consider that dual-chamber ICDs provide superior antitachycardia therapy compared with single-chamber devices, but long-term data is lacking.

“The results of the Option study fill an evidence gap,” said Dan Dan, M.D., of the Piedmont Heart Institute in Atlanta, Ga. “We always thought that dual-chamber ICDs which preserve the natural cardiac conduction, were a better choice for our patients. This has been proven in this well-designed study.”
“Sorin is committed to developing technologically advanced devices that provide smart therapies that are both lifesaving and beneficial to physicians and patients alike,” added Stefano Di Lullo, president of the cardiac rhythm management business unit at Sorin Group. “We continue to invest in advancing knowledge about cardiac rhythm disorders and will support clinical trials that provide the strongest possible evidence supporting our therapies.”