Patients with Sorin Group (BIT:SRN) dual-chamber implantable cardioverter defibrillators had significantly fewer inappropriate shocks than patients with standard single-chamber devices, according to new clinical data.
Option study data, presented at the Heart Rhythm Society’s annual meeting in Denver last week, also showed that there was no difference in all-cause mortality between the 2 groups, Sorin noted.
The Italian medical device company’s ICDs are available in single- and dual-chamber models and use different methods to detect a patient’s arrhythmias and treat them with anti-tachycardia therapies. While both types of ICDs can provide rescue shocks, many physicians believe that dual-chamber ICDs provide superior antitachycardia therapy compared with single-chamber devices, but long-term data were lacking.
"The results of the Option study fill an evidence gap," Dr. Dan Dan of the Piedmont Heart Institute in Atlanta, Ga., said in a statement. "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."
Unfortunately, although ICDs deliver lifesaving therapy to patients at risk of sudden cardiac arrest, "inappropriate shocks still occur too frequently and negatively impact patients’ quality of life," Sorin notes in a press release. Also, excessive right ventricular pacing has been associated with dual chamber pacing and has been shown to increase heart failure and atrial fibrillation.
Option data "is very good news for patients," principal study investigator Dr. Christof Kolb of the Deutsches Herzzentrum in Munich, Germany said in a statement. "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."
A total of 462 patients at 54 centers in Europe and North America were enrolled in Option, with a 2-year median follow-up. 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.
Sorin noted that its dual-chamber ICDs feature the Parad arrhythmia discrimination algorithm, which reduces the number of inappropriate shocks, and the Safe pacing mode, which minimizes unnecessary ventricular pacing.