Fresh off gaining approval for a next-generation implantable cardioverter defibrillator, St. Jude Medical ($STJ) is working hard to prove that the implants are viable over many years for certain classes of heart failure patients. The Minnesota device company released a substantial follow-up study May 10 at the Heart Rhythm Society conference in Boston to prove its point, which it says showed that ICDs helped boost survival rates for patients with moderate heart failure for at least 11 years after their implants.
Specifically, St. Jude was able to follow the status for 91% of the original 2,521 patients that took part in the company's original SCD-HeFT trial, as part of an official 10-year follow-up study. And the average follow-up period went 11-plus years for survivors. According to the company, the absolute 12-year mortality rate for patients with the ICD implant was 5% lower than patients originally randomized to the placebo group, even though a number of the control group patients got their ICDs at the end of the initial trial. Also paralleling the initial study, patients with New York Heart Association Class II heart failure lived longer still than those with Class III heart failure that didn't have cardiac resynchronization therapy during the trial. Patients also did well if their heart failure was caused by impaired coronary artery blood flow.
The original study, which also included sponsorship from archrival Medtronic ($MDT) and Wyeth Ayerst, showed that patients with ICDs fared better than the control group, based on an average 5-year follow-up of patients. For the control group, patients received ideal drug treatment alone. Another variation compared the use of a specific drug (amiodarone) to manage irregular heartbeats to the control group. And it mattered, because the initial study helped persuade the Centers for Medicare & Medicaid Services to approve covering ICD implants for patients with both Class II and III heart failure (which is why St. Jude's rivals would also sponsor the study).
So what does this revelation of ICD survival rates accomplish? It shows that ICDs are viable and provide real, long-term benefits for heart failure patients who aren't too far gone with their condition. Interestingly, it also deflects attention from continued scrutiny over St. Jude's defective Riata defibrillator leads, which have since been recalled and pulled from the market because of defects. The company has heavily pushed its next-generation Durata leads as much safer. As MassDevice, MedCity News and others have reported, an apparently independent researcher, oddly enough, backed those claims during a separate presentation at the HRS conference.
Meanwhile, the long-term data regarding the benefit of ICD implants just might add some significant market fuel to the company's tiny Ellipse ICD, which gained FDA approval just this week.
- here's the release
- read MassDevice's take
- check out MedCity News' coverage