Intravascular Extraction of Problematic or Infected Permanent Pacemaker Leads: 1994–1996

Abstract

Of the 400,000-500,000 permanent pacemaker leads implanted worldwide each year, around 10% may eventually fail or become infected, becoming potential candidates for removal. Intravascular techniques for removing problematic or infected leads evolved over a 5-year period (1989-1993). This article analyzes results from January 1994 through April 1996, a period during which techniques were fairly stable. Extraction of 3,540 leads from 2,338 patients was attempted at 226 centers. Indications were: infection (27%), nonfunctional or incompatible leads (25%), Accufix or Encore leads (46%), or other causes (2%). Patients were 64+/-17 years of age (range 5-96); 59% were men, 41% women. Leads were implanted 47+/-41 months (maximum 26 years), in the atrium (53%), ventricle (46%), or SVC (1%). Extraction was attempted via the implant vein using locking stylets and dilator sheaths, and/or transfemorally using snares, retrieval baskets, and sheaths. Complete removal was achieved for 93% of leads, partial for 5%, and 2% were not removed. Risk of incomplete or failed extraction increased with implant duration (P<0.0001), less experienced physicians (P<0.0001), ventricular leads (P<0.005), noninfected patients (P<0.0005), and younger patients (P<0.0001). Major complications were reported for 1.4% of patients (<1% at centers with >300 cases), minor for 1.7%. Risk of complications increased with number of leads removed (P<0.005) and with less experienced physicians (P<0.005); risk of major complications was higher for women (P<0.01). Given physician experience, appropriate precautions, and appropriate patient selection, contemporary lead removal techniques allow success with low complication rates.

Device Pocket Scar Predicts Transvenous Lead Extraction Difficulty

“…Predictors of TLE difficulty have been evaluated in several prior single and multicenter studies. 5,[16][17][18] Many variables previously identified as predictors of TLE difficulty were confirmed in this study, including implant duration 3,5,[16][17][18] and the number of leads extracted. 13 In contrast to prior studies, both local and systemic infection were associated with more severe pocket scar and increased TLE difficulty.…”

“…13 In contrast to prior studies, both local and systemic infection were associated with more severe pocket scar and increased TLE difficulty. 5 The observed association between more severe pocket scar and infection is plausible given the pathologic changes that occur with infection including inflammation and granulation. Although this study was underpowered to detect relationship between major complications and pocket scar severity due to the small number of events, it is worth noting that the only major complication occurred in a patient with severe pocket severity and calcification within the pocket.…”

“…Reported major complication and mortality rates with TLE vary widely across studies, ranging from 0.4% to 7.3%. [3][4][5][6][7][8] The difficulty and risk of TLE of CIED is predominantly related to the body's foreign body response to the endovascular leads. The response begins immediately after implantation with thrombus development along the lead(s).…”

Management of Cardiac Electronic Device Infections: Challenges and Outcomes

“…31 System extraction is associated with a small risk of major complications, particularly vascular lacerations causing haemothorax and death. 32,70,[79][80][81][82] Extraction-related mortality rates are 0.1-0.8 % in large experienced centres. 70,83 In one large, single-centre study, including more than 5,000 lead extractions, 43 % of which were due to infection, risk of major complications was 1.8 %, and minor complications 3.6 %.…”

Percutaneous removal of transvenous pacemaker leads using an extraction device

“…Byrd et al reported that the risk of failure or partial removal doubled for every 3 years of implant duration. 7 The Heart Rhythm Society expert consensus for transvenous lead extraction defines complete success of the procedure as the removal of all targeted leads and all lead material from the vascular space without occurrence of any permanently disabling complication or procedure-related death. Clinical success was defined as the removal of all targeted leads and lead material from the vascular space or retention of a small portion of the lead (<4 cm) when the residual part did not increase the risk of perforation, embolic events, or perpetuation of infection, in the absence of complications.…”