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Management of Recalled ICD Leads
Abstract & Commentary
By John P. DiMarco, MD, PhD
Source: Parkash R, et al. Complications associated with revision of sprint fidelis leads: Report from the Canadian Heart Rhythm Society Device Advisory Committee. Circulation. 2010; 121: 2384-2387.
The Medtronic Sprint-Fidelis ICD-lead family is associated with an increased risk for lead fracture. Given the known risks of elective ICD lead revisions or extractions, a consensus has not been reached on how to manage patients with these leads. In this paper, the Canadian Heart Rhythm Society Device Advisory Committee reports the results of a survey of 25 Canadian centers that includes follow-up data on 6,237 Sprint-Fidelis leads implanted between July 2004 and October 2007.
As of June 1, 2009, there were 310 Sprint-Fidelis lead failures (4.97%) over an estimated 40 months of follow-up. An additional 159 Sprint-Fidelis leads were revised electively or semi-electively for other reasons. Reasons for revision, other than manifest lead failure, included pacemaker dependence, elective revision at the time of a pulse generator change or upgrade, infection, and lead dislodgment. Of the 469 leads that were revised, a new defibrillation lead was inserted in 433 cases, whereas in 25 cases, only a pace/sense lead was added. The Sprint-Fidelis lead was extracted in 248 cases. In 163 cases (66%), only manual traction was required. A laser sheath-extraction approach was required in 82 cases, and in three cases nonpowered extraction tools were used. In an additional 51 patients, manual extraction was attempted but, when this was unsuccessful, the lead was abandoned in situ. Among the 469 leads that were revised, there were 68 complications, for an overall rate of 14.5%. There were 34 major complications (7.25%). These included: death (2), cardiac arrest (2), superior vena cava tear requiring urgent surgery (1), and 29 less severe complications that required reoperation, including infection (9), hematoma (4), and lead dislodgement or set screw problem (15).
In addition, minor complications occurred in 34 cases (7.25%). These complications included three pneumothoraces, two cases of congestive heart failure, two left-upper extremity venous thromboses, 19 incisional infections, seven small hematomas, and two other unrelated complications.
The authors conclude that the risk of complications associated with Sprint-Fidelis lead revision or removal is significant. Careful consideration of patient characteristics and local experience with lead revision is vital before attempts are made to revise this lead.
The best strategy for management of ICD or pacemaker leads that have a higher than normal risk of lead failure is often uncertain. As shown here, the risk of even an elective lead revision in a stable patient can be substantial and may be considerably greater than the risk of complications associated with lead malfunction itself. In the case of the Sprint-Fidelis lead, it also is difficult to predict what the final shape of the long-term survival curve for this lead will be. Some authors have reported an accelerated rate of lead failure, whereas other reports describe a failure rate that is relatively stable over time.
In our laboratory, we base decisions about management of 6,949 leads on several individual patient characteristics. In general, we have not electively reoperated to revise the lead if there is no other indication for reopening the pocket. At the time of an elective generator change or re-upgrade, we have not been revising the lead in the majority of cases. In select cases, particularly young patients who are likely to have a need for an ICD lead that stretches for decades, we revise the lead after having a thorough discussion of the risks and benefits of lead revision with the patient. Almost all of our patients are followed with remote monitoring and have the lead-integrity alert system in their ICD activated. If a failure occurs, we usually try to extract the lead unless the patient is thought to be at an unusually high risk for complications with the extraction. Given the risk of complications with purely elective lead revision, we feel this conservative approach is most appropriate. However, we continue to follow the Sprint-Fidelis lead-survival curves closely. If an accelerating trend for lead failure is identified and confirmed, we are likely to become more aggressive at lead revision in the patients we follow. At the present time, however, it appears the risks of elective lead revision outweigh the potential benefits for the majority of our patients.