It has been more than 2 years since St. Jude Medical’s (NYSE:STJ) Riata lead recall dominated the headlines coming out of the Heart Rhythm Society’s annual conference. Although the leads haven’t been available for years, they were not forgotten at this year’s meeting, the Heart Rhythm Society’s 35th Annual Scientific Sessions.
Several researchers presented new data on the recalled leads and others examined St. Jude’s new lead technology for signs of the problems that brought down Riata, problems that continue to loom large for patients still implanted with the new-recalled devices.
Yet lingering concerns about the high-profile recall and the hullabaloo that followed haven’t pushed St. Jude out as a serious contender in cardiac leads. Although the troubled Riata was the subject of several sessions and posters during this year’s conference, high praise for the company’s next-generation leads may have won a few hearts.
Some groups of researchers at this year’s Heart Rhythm Society conference continued to struggle with how to care for patients still implanted with the defunct Riata leads, which connect implanted defibrillators to patients’ hearts.
St. Jude pulled the leads off of the shelves in 2010 after finding that some of the internal conductors had worn through their insulation, a failure that could result in patients receiving unwanted shocks.
The issue remained fairly quiet until St. Jude warned in November 2011 that the Riata leads appeared to fail more frequently than previously reported. That report lead to an FDA recall with a Class I label, reserved for product defects with a potential risk of serious injury or death. St. Jude said at the time that 2 patients died and another suffered a serious injury when surgeons attempted to extract the leads. Another patient died and a 5th was seriously injured, both with compromised Riata leads, but the "externalized conductors" were not found to be responsible, St. Jude added.
The hubbub had died down by the time this year’s Heart Rhythm Society members convened in San Francisco, but the conference docket included nearly 20 presentations, poster sessions and debates on rates of lead failure and best ways to manage patients.
One small study examined ongoing surveillance for patients with the Riata leads, finding that of 42 patients that underwent 2 episodes of surveillance fluoroscopy 1 year apart, 19% had "new or worsening conductor externalization on repeat imaging."
"We feel that [patients] have a continued degree of externalization as time goes by," lead author Dr. Sandeep Goyal told MassDevice.com. "Based on this limited set of data, it’s plausible that most of these leads will eventually have externalization as time goes by."
Goyal added that further studies of serial fluoroscopy are necessary to corroborate his team’s findings.
Another study led by Dr. Xinran Zhao found that among 163 patients followed at an average of 6.5 years about 8% had "lead failure or fracture with insulation defect," 5 instances of which occurred before the 5-year mark.
"Insulation defects of lead is especially higher after 5 years," the authors wrote. "That implies a very careful and strict follow-up on the long run."
While a slew of researchers examined surveillance and extraction methods for patients with Riata leads, others had high praise for St. Jude’s next generation of leads insulated with a proprietary Optim coating. St. Jude has been working for years to insulate its next-gen leads from the flap over Riata, which included some public blows between lead rival lead-makers.
"I think what St. Jude realized for credibility in the community, they needed an outside organization to look at their data," Dr. John Cairns, who led a McMaster University Population Health Institute study on Optim-coated leads, told MassDevice.com
Cairns and a team of researchers examined 5 years’ worth of data from St. Jude’s registries, looking for rates of failure in St. Jude’s next-generation leads. The researchers found low rates of mechanical failure and no reports of externalized conductors at 5 years. Cairns cited 1 known known instance of externalization in Optim-coated leads, but that event didn’t appear in the St. Jude surveillance data used in the Population Health Institute report.
"[Optim-coated leads] are very different from the earlier series, the so-called Riata lead that didn’t have the new insulation on it," lead author Cairns said. "At face value they look similar to the latest generation of Medtronic (NYSE:MDT) leads and the latest generation of Boston Scientific (NYSE:BSX) leads."
Another study led by Dr. David Hayes found no externalized conductors and no cases of electrical dysfunction in St. Jude’s Durata leads at an average of 3.9 years following implantation.
A study conducted by the VA Medical Center in San Francisco found "highly satisfactory" freedom from all-cause electrical failures up to 5 year for St. Jude’s Optim coated Riata ST and Durata leads.
"We’re very pleased that at HRS 2014, data from 3rd-party sponsored studies as well as our robust post-market surveillance continues to show that Durata lead performance meets expectations by all measures and that the overall accumulation of data continues to demonstrate Durata’s excellent safety and reliability," St. Jude spokeswoman Rachel Ellingson told us.