The Sprint Fidelis implantable cardioverter-defibrillator (ICD) lead was recalled in 2007 after a high fracture rate was found, but understanding how to best manage patients who are implanted with these leads remains controversial. Performing device removal during elective surgery for a generator change could prove cost-effective and reduce risk for these patients, according to a study presented during a poster session May 9 at the 33rd annual scientific sessions of the Heart Rhythm Society (HRS).
More than 100,000 Sprint Fidelis leads remain in patients in the U.S. Lead failures remain a hot topic in cardiology after recent recalls including the Sprint Fidelis (Medtronic) and Riata (St. Jude) leads. Fracture rates still remain a concern. In fact, these reach 3 percent per year, according to the study author; Five years out, it reaches 15 percent.
The majority of the Sprint Fidelis lead implantations took place between 2004 and 2007, prior to the recall in October 2007. “Many of these patients are now reaching a time when they will need their device generator changed because their battery is running low,” Jamil Bashir, MD, of the division of cardiovascular surgery at the University of British Columbia in Vancouver, B.C., told Cardiovascular Business.
In the current study, Bashir and colleagues used five-year data from two centers in British Columbia to analyze the costs of elective or urgent lead procedures based on whether the patient presented with lead dysfunction. During the time span, 346 Sprint Fidelis leads were placed in 342 patients.The researchers reported 47 fractures; nearly 80 patients were operated on.
Recently, the American Heart Association and Canadian Heart Rhythm Society recommended that clinicians do not “prophylactically deal with the lead,” Bashir said. “What that means is that these patients are going forward with a lead that is recalled and at this stage you are getting into areas of competing risk."
These competing risks include complications when revising a lead during a generator change or the risk of the lead failing down the road. “This is a difficult process for clinicians to figure out,” Bashir added.
To help, Bashir et al used costs as a surrogate measure.
The researchers found that elective procedures that revise the lead during a generator change are much cheaper than those of a patient experiencing a lead fracture. In fact, these costs almost doubled. During the study, 46 urgent procedures and 34 elective procedures were evaluated. The average costs for lead fracture cases were double that of an elective procedure to revise the lead, $32,869 vs. $15,212, respectively.
“We created a model to look at whether you aggressively went after revising the leads electively [to see] whether you save money or whether it was cost-effective, and it was,” Bashir added.
The incremental cost-effectiveness ratio (ICER) calculated from the Markov model was reported to be $7,187 per failure avoided.
“In a population that still has a significant number of these leads in place and the patients are coming in for a generator change, we think these leads should be dealt with at the time of the generator change when they are already having a surgery,” he added.
The time when patients already are undergoing surgery for generator placement may be the safest and most cost-effective opportunity to perform lead revision rather than waiting for them to fracture.
“The crux of that is that the fracture rate is so high that it justifies this,” he said. “If you have a low fracture rate, then there is no need to do that.” Dealing with the lead electively when there are high fracture rates saves money in the long run.
“This solves two problems: it’s cheaper and the patient isn’t walking around with a recalled lead,” he said.
However, Bashir cautioned that these operations should only be performed in experienced centers by experienced operators in the properly indicated patients. “If you have an 85-year-old sitting in a nursing home, doing this wouldn’t make sense,” he said.