SAN FRANCISCO – St. Jude Medical’s Durata and Riata ST Optim defibrillator leads performed comparably to Medtronic’s Sprint Quattro out to 7 years in a Veterans Affairs analysis of almost 18,000 patients in the VA National Cardiac Device Surveillance Program.
The “highly satisfactory electrical survival” of the Optim leads, at least until year 5, should be of some reassurance to cardiologists, especially since the findings come from the VA, not a device company, investigator Seema Pursnani, MD, said.
The investigators combined Durata and Riata ST Optim leads together in their analysis, since they are similar; both are 7 Fr leads with St. Jude’s silicone/polyurethane Optim coating. After a mean follow-up of 3.4 years in 4,091 Durata patients and 351 Riata ST Optim patients, there were 26 electrical lead failures, which translated to 0.17% failures per device-year.
The investigators compared those results with Medtronic’s Sprint Quattro, which “is sort of a gold standard. It’s been around for quite a long time, and people have confidence in it,” said Dr. Pursnani. After a mean follow-up of 3.8 years in 13,254 patients, there were 57 failures, translating to 0.11% failures per device-year.
Seven-year lead survival was 97.7% with St. Jude’s products, and 98.9% with Medtronic’s. Although the difference was not statistically significant, “we need a little more follow-up to see why the curves are diverging at years 6 and 7,” said Dr. Pursnani, a cardiologist at the San Francisco Veterans Affairs Medical Center when the study was done, but now with the Kaiser Permanente San Leandro (Calif.) Medical Center.
There’s been lingering concern about St. Jude leads ever since the recall of earlier versions of Riata – with silicone-only insulation – in 2011 because of lead abrasion and subsequent safety problems. Optim was developed to address the issue.
“One of the most common modes of lead failure that we saw” with all three leads “was a rise in the pace-sense conductor impedance from the baseline impedance. Sometimes, there is nonphysiologic noise that can also be a sign of early failure,” she said.
There was no industry funding for the work, and the investigators have no disclosures.