Safe to Leave Recalled Sprint Fidelis ICD Leads in Place? Debate Continues

Sprint Fidelis implantable cardioverter-defibrillator (ICD) leads, which were placed under an advisory and recalled more than a decade ago due to an elevated risk of fracture, can be safely left in place when patients go back for a subsequent device surgery, data from a single center’s experience suggest.

A strategy of lead abandonment—leaving the Sprint Fidelis leads in the body while implanting a new lead—was adopted by physicians at the University of Ottawa Heart Institute in Canada, and among 213 patients treated this way, 10 (4.7%) had a procedural complication and three (1.4%) later had a device infection that required extraction of the system. There were no deaths through an average of more than 4.5 years of follow-up.

“We wanted to share our experience, because we believe that most of these patients will not require the extraction procedure that could put them at high risk for adverse events,” Mouhannad Sadek, MD (University of Ottawa Heart Institute), one of the senior authors of the paper, told TCTMD.

Though some patients will still need to have their leads extracted, the more conservative approach of lead abandonment should probably be the first choice offered, he said.

“The doctor can offer this to the patient without feeling guilty or worrying about at least medium-term outcomes,” Sadek said. “If you have a patient who is older and with comorbidities and you are worried about the risk of device extraction, lead abandonment is a very safe strategy in the medium term.”

Commenting for TCTMD, Mikhael El-Chami, MD (Emory University Hospital Midtown, Atlanta, GA), wouldn’t go as far as to suggest that lead abandonment should be offered as the first option to patients. Arguments in favor of immediate extraction are that even though the procedure carries acute risks, it avoids the presence of multiple leads in the future, he explained, noting that prior research suggests that if there is an infection down the road, having multiple leads in place can complicate needed extractions and increase risk. On the flip side, a strategy of implanting new leads without removing the old ones avoids the upfront risks of extraction.

It’s best to tailor the approach to each individual case using shared decision-making, taking into consideration a patient’s preferences, life expectancy, age, comorbidities, and other characteristics, El-Chami said. In a younger patient who potentially has decades left to live and who is likely to require multiple battery replacements over time, for example, it’s worth taking the small risk of extraction in order to avoid problems with having multiple leads in the future, he said. But in an older patient with more comorbidities, a more conservative approach is warranted.

El-Chami noted that even though the investigators in this study routinely adopted the more conservative strategy, they, too, were tailoring to a certain extent. He pointed out that the four patients who underwent immediate extraction were relatively young, ranging in age from 29 to 58.

Overall, El-Chami indicated that these new data will not change how he’ll practice moving forward. “I think this paper will just add to the controversies that exist in this field.”

Controversy Lingers

Sprint Fidelis ICD leads (Medtronic) were placed under advisory in October 2007 because of an increased risk of conductor failure, an action deemed a Class I recall by the US Food and Drug Administration. Medtronic stopped distributing the leads and had physicians return any unused product. As for what to do about patients who already had the leads implanted, recommendations from Medtronic state that in cases of a lead fracture, a new high-voltage lead should be implanted with or without extraction of the original lead. No action is recommended when there are no signs of lead fracture.

I think this paper will just add to the controversies that exist in this field. Mikhael El-Chami

But debate continues in the electrophysiology community about what to do for patients who already had these leads implanted, and practice varies. Some cases are managed by immediate extraction of the Sprint Fidelis lead with implantation of a new lead, others are managed by implantation of a new lead without extraction of the old lead (abandonment), and still others are managed without any intervention at all.

The team from Ottawa adopted the preferred strategy of lead abandonment after the Sprint Fidelis leads were recalled. When patients with these leads show up for surgery for a device upgrade or lead fracture or in response to an elective replacement indicator, they speak with their physician about the options. The recommended approach for most patients is to leave the old leads in the body. Patients who have a heightened risk of superior vena cava obstruction, however, are recommended to have the Sprint Fidelis leads extracted and new leads implanted.

For the current study, published online August 28, 2019, ahead of print in JACC: Clinical Electrophysiology, Sadek, along with lead author Wael Alqarawi, MD (University of Ottawa Heart Institute), and colleagues, looked at the results of their approach among 520 patients who underwent Sprint Fidelis dual-coil lead implantation between December 2003 and October 2007. Follow-up lasted an average of 55 months.

Of those, 233 (45%) did not present for device surgery after the recall. The rest of the patients did, mostly in response to the elective replacement indicator (60%), followed by lead fracture or impending fracture (23%) and a need for an upgrade to cardiac resynchronization therapy (17%).

Among the group of patients presenting for device surgery, 70 patients did not undergo lead replacement and 217 did. The researchers focused on that latter subset of patients, of whom all but four accepted a strategy of lead abandonment.

Procedural complications in patients who opted to leave their Sprint Fidelis lead in place while receiving a new lead included six RV lead dislodgements and one case each of coronary sinus lead dislodgement, pneumothorax, perforation, and a dislodged segment of Terumo wire. Four patients—including three who developed device infection—eventually had their leads extracted an average of 3.5 years after the initial replacement. There were no complications associated with those extractions.

There were no complications associated with extraction in the four patients who were treated with immediate removal of the Sprint Fidelis leads and replacement with new leads.

Long-term Outcomes Unknown

El-Chami said the proportion of patients managed with a strategy of lead abandonment versus extraction in this study is likely higher than in his own practice, where 10% to 20% of patients have their leads extracted.

The main message is that “if you decide to manage these patients with a conservative approach, then over an intermediate follow-up of 3 to 5 years, the risk of abandoning the lead is not high. The big question in my mind is what is the risk beyond 3 years or 4 years,” he said, noting that the uncertainty about long-term outcomes drives the use of extraction in some cases.

“Although longer follow-up duration is desirable,” the authors acknowledge in their paper, “this study represents the longest follow-up of abandoned leads published. This data adds to existing literature that informs our decisions in managing patients needing lead replacement.”

Sadek said one could argue that over 10 or 20 years of follow-up, having an abandoned lead in the body could lead to problems such as worsening valve function or infected leads. Therefore, he said his team is interested in continuing to follow this cohort to see what the outcomes look like in another 5 years, and perhaps even longer.