Fidelis Leads: What to Do at the Time of Generator Change?

A 30-year-old man with a history of a dilated nonischemic cardiomyopathy, status post implantation of a single-chamber ICD eight years ago for primary prevention of sudden death, has reached the elective replacement indicator (ERI) for his device. He has never had an appropriate defibrillator therapy, but his ejection fraction is still 20%. The problem? He has a Sprint Fidelis ICD lead.

How should this patient be managed? Should the generator simply be replaced, or should the lead be revised at the time of generator replacement? If the lead is revised, should the old lead be capped and abandoned or extracted? What are the risks and the benefits?

Because these clinical decisions related to recalled defibrillator leads can be challenging and given the major risks of extraction, the financial implications of these choices are rarely considered or discussed. A recent Canadian study, however, has tried to address the issue of cost-effectiveness as related to the management of the Fidelis lead.¹ The authors compared the costs of a “wait and see” approach to a “proactive” strategy of lead revision at the time of generator change. They used actual cost data from 341 patients who received a Fidelis lead and underwent lead revision at the time of a generator change to create a probabilistic Markov model, in which a proactive management strategy was compared to a “wait and see” strategy. Patients under age 60 years and felt to be low risk were offered extraction rather than abandonment at the time of the procedure. They found that when an extraction was performed for a fractured lead, the cost was $31K compared to $18K when the extraction was done electively, and that the length of stay was three times longer. The incremental cost-effectiveness ratio of proactive lead revision versus a recommended monitoring strategy was $12,779 per lead failure avoided. The proactive strategy also resulted in 21 fewer failures per 100 patients treated.

The cost to the health care system of managing the Fidelis lead recall is staggering. The five-year cost of the Medtronic Sprint Fidelis lead recall to Medicare alone has been estimated to be $287,000,000.² There are several considerations, however, when taking care of these patients that are not directly related to cost. First, a proactive approach should only be pursued at centers that, as the authors of the Bashir study point out, are experienced and have established results. Another important consideration when the decision is made to revise the lead is whether to remove the old lead or abandon it. The Bashir study does not specifically address this issue. Finally, the recommendation for patients must be individualized. There are some patients who have so many comorbidities that they might be better off with a simple generator change. In fact, there may even be some patients who have such a poor life expectancy that they should be advised to not even have the generator replaced. A study this year by Kramer et al using the NCDR ICD Registry data found that more than 40% of patients who undergo defibrillator generator replacement are dead within five years, and that age, atrial fibrillation, heart failure, and noncardiac comorbidities are associated with increased mortality.³ Despite these caveats, the Bashir study is important and supports a proactive approach to the management of patients with a Fidelis lead, from both a clinical and a financial basis.

References

1. Bashir J, Cowan S, Raymakers A, et al. A cost-effectiveness analysis of a proactive management strategy for the Sprint Fidelis recall: A probabilistic decision analysis model. Heart Rhythm. 2013;10:1761-1767.
2. Mehrotra AK, Knight BP, Smelley MP, et al. Medtronic Sprint Fidelis lead recall - determining the initial 5-year management cost to Medicare. Heart Rhythm. 2011;8:1192-1197.
3. Kramer DB, Kennedy KF, Spertus JA, et al. Mortality risk following replacement implantable cardioverter-defibrillator implantation at end of battery life: Results from the NCDR. Heart Rhythm. 2014;11:216-221.