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Heart and Vessels

, Volume 33, Issue 10, pp 1245–1250 | Cite as

Differences in laser lead extraction of infected vs. non-infected leads

  • Simon Pecha
  • Liesa Castro
  • Julia Vogler
  • Matthias Linder
  • Nils Gosau
  • Stephan Willems
  • Hermann Reichenspurner
  • Samer Hakmi
Original Article

Abstract

We investigated the effect of systemic infection or lead endocarditis on the complexity and the success of laser lead extraction (LLE) procedures. Medical records of all patients undergoing LLE between January 2012 and March 2017 were screened with regard to information on systemic infection or lead endocarditis. We treated 184 patients using high-frequency 80 Hz laser sheaths in patients with lead implant duration of ≥ 12 months. Indications for lead extraction were systemic infection and lead endocarditis in 52 cases (28.3%), local infection in 74 cases (40.2%), lead dysfunction in 37 cases (20.1%) and other indications in 21 cases (11.4%). 386 leads were scheduled for LLE: 235 (60.9%) pacing, 105 (27.2%) ICD and 46 (11.9%) CS leads. The mean time from initial lead implantation (systemic infection 96.8 ± 74.7 months vs. 102.1 ± 82.6 non-infected: months; p = 0.4155) and ratio of ICD leads (26.8 vs. 27.4%; p = 0.3411) did not differ significantly between the two groups. Complete procedural success was significantly higher in the systemic infection group (100 vs. 94.7%; p = 0.0077). The mean laser treatment (60.2 ± 48.7 vs. 72.4 ± 61.5 s; p = 0.2038) was numerically lower in the infection group, while fluoroscopy time (9.3 ± 7.6 vs. 12.8 ± 10.3 min; p = 0.0275) was significantly lower in this group. Minor and major complications were low in both groups and did not reveal any statistically significant difference (infected group: one minor complication; pocket hematoma, non-infected: three major complications; emergent sternotomy due to pericardial tamponade). No extraction related mortality was observed. The presence of systemic infection or lead endocarditis in LLE procedures allows for higher complete procedural success. When compared with LLE of non-infected leads, the infected leads require less laser and fluoroscopy times. Due to the scarcity of minor and major complications in general, no statistical significance was found in that regard.

Keywords

Laser lead extraction Lead endocarditis CIED infections Pacemaker infection 

Introduction

In recent years, the implantation rates of chronically implanted pacemaker (PM), implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy (CRT) devices have increased markedly [1, 2]. Therefore, in this context, there have been a rising number of complications in patients with cardiac implantable electronic devices (CIED) [3, 4, 5]. Especially, CIED infections can lead to severe device-related complications [6]. A two-step strategy starting with complete device and lead removal followed by re-implantation is recommended for all patients with local or systemic infections (Class I) [7, 8]. Complete device and lead removal is associated with improved survival [5, 6, 7, 9]. The efficacy and safety of laser lead extraction (LLE) of chronically implanted ICD, CRT and PM leads have been demonstrated in previous studies [10, 11, 12, 13, 14].

However, little is known about the impact of systemic infection on the procedural success and complication rates of laser lead extraction.

The aim of our study was to examine the differences in laser lead extraction (LLE) in patients with systemic infection or lead endocarditis compared with patients receiving LLE for local infections or non-infectious indications.

Materials and methods

Between January 2012 and March 2017, 184 patients underwent LLE at our center using the Glide Light 80 Hz laser Sheath (Spectranetics Corporation, Colorado Springs, Co, USA). The study was in accordance with the ethical standards of the Declaration of Helsinki from 1964 and its later amendments. All patients gave their written informed consent. Patients were retrospectively screened for systemic infections or lead vegetations and these results were compared to patients with local infections or non-infectious indications.

Definitions

(1) Local and (2) systemic infections were defined in accordance with the Heart Rhythm Society Expert Consensus document from 2009 [8]:
  1. 1.

    Presence of local inflammation signs such as pocket abscess, device/lead erosion, skin adherence or chronic draining sinus without clinically evident involvement of the transvenous portion of the lead system.

     
  2. 2.

    Valvular endocarditis with or without definite involvement of the leads, occult Gram-positive bacteremia or sepsis.

     

Other indications for lead extraction were lead dysfunction, venous occlusion, system upgrade, need of MRI-compatible device and tricuspid regurgitation.

Outcomes and complications were as well determined according to the 2009 Heart Rhythm Society Expert Consensus document on transvenous lead extraction [8].

Diagnosis and treatment

All patients underwent transesophageal echocardiography (TEE). In patients with systemic or local infections, multiple blood culture samples were obtained. Additional swab cultures of the pulse generator pocket were obtained in patients with local infections. We initiated a prolonged course of intravenous antibiotic treatment according to resistograms. All non-pacemaker-dependent patients who underwent ICD/CRT removal were prescribed a wearable cardioverter defibrillator (LifeVest, ZOLL, Pittsburgh, PA, USA) for the bridging period. Pacemaker-dependent patients underwent also a two-step procedure using transcutaneous implanted temporary pacing leads. When confirmed by C-reactive protein (CRP) value, leucocyte counts and negative blood culture samples that infection had vanished, a new CIED was implanted on the contralateral side.

Removal techniques

All procedures were performed in a hybrid operating room with patients under general anesthesia and all patients were prepared for emergent sternotomy with cardiopulmonary bypass circuit standby. For intraprocedural monitoring, we used transesophageal echocardiography in all cases.

According to our standard approach, we used the Glide light 80 Hz laser sheaths (Spectranetics Corporation, Colorado Springs, Co, USA) to extract the targeted leads. LLE was performed as previously described by our group [11, 12]. In few cases, due to aggressive calcifications, we employed rotating mechanical dilator sheaths such as TightRail™ (Spectranetics Corporation, Colorado Springs, Co, USA) and Evolution® RL (COOK Medical Inc, Bloomington, IN, USA). In case of additional perioperative fractured leads due to prior extraction attempts, we crossed over to a femoral approach using different snares as a last step of the transvenous lead extraction procedure.

Statistical analysis

We performed a retrospective review of the medical records from patients who underwent LLE at our center. All relevant data were collected in an electronic database and were analyzed with SPSS statistical software version 21 (IBM SPSS Statistics for Windows, Version 24.0., Armonk, NY: IBM Corp.).

Continuous variables are expressed as mean ± standard deviation and categorical variables are displayed as numbers and percentages. Two-tailed Student’s T test was used to investigate statistically significant differences between the two groups.

Results

Patients

The mean patient age was 66.1 ± 13.5 (17.9–90.7) years, 72.8% were male. 52 (28.3%) patients underwent LLE showing systemic infection or lead endocarditis, whereas 132 (71.7%) patients were treated due to pocket infection (40.2%), lead dysfunction (20.1%) or other non-infectious indications (11.4%). Except the number of patients with diabetes which was higher in the systemic infected group, there were no significant differences regarding baseline patient characteristics. The patient characteristics are shown in Table 1.
Table 1

Baseline and clinical characteristics

Patients

Infected (n = 52)

Non-infected (n = 132)

p value

Demographics

 Age, years

67.7 ± 11.03

64.4 ± 16.02

0.1226

 Male gender, n (%)

33 (63.5)

101 (76.5)

0.3799

 Ejection fraction < 30%, n (%)

13 (25)

33 (25)

0.8262

 Prior cardiac surgery, n (%)

7 (13.5)

38 (28.8)

0.0668

Medical history, n (%)

 Arterial hypertension

39 (75)

83 (62.9)

0.0923

 Coronary artery disease

22 (42.3)

57 (43.2)

0.2152

 Diabetes mellitus

22 (42.3)

36 (27.3)

0.0092

Continuous variables are expressed as mean ± standard deviation and categorical variables by values and percentages

Bold represents a statistically significant p value. p values < 0.05 were considered as statistically significant

Lead characteristics

A total of 386 leads were treated, including 123 leads in the infected group and 263 leads in the non-infected group. The mean time from initial lead implantation (infected 96.8 ± 74.7 months vs. non-infected 102.1 ± 82.6 months; p = 0.0221) and ratio of ICD leads (26.8 vs. 27.4%; p = 0.0341) did not differ significantly between the two groups. Lead characteristics are displayed in Table 2.
Table 2

Lead characteristics

Number of treated RV leads

Infected (n = 123)

Non-infected (n = 263)

p value

Mean time from implantation, months

96.8 ± 74.7

102.1 ± 82.6

0.4155

Leads, n (%)

 Pacing leads

76 (61.8)

159 (60.4)

0.9461

 ICD leads

33 (26.8)

72 (27.4)

0.3411

 CS leads

14 (11.4)

32 (12.2)

0.8679

Continuous variables are expressed as mean ± standard deviation and categorical variables by values and percentages

ICD implantable cardioverter defibrillator, CS coronary sinus

Procedural data

The mean procedural time (98.1 ± 68.5 min vs. 102.5 ± 51.2 s; p value 0.6991) and mean laser treatment time (60.2 ± 48.7 vs. 72.4 ± 61.5 s; p value 0.2038) were numerically lower in the infected group. The fluoroscopy time (9.3 ± 7.6 vs. 12.8 ± 10.3 min; p value 0.0275) was even significantly lower in the infected group. Additional mechanical or femoral extraction tools were only applied in 3 cases in the group of patients with systemic infection or lead endocarditis and in 9 cases in the non-infected group (5.7 vs 6.8%; p value 0.5185).

Outcome and complications

Complete procedural success was significantly higher among patients with systemic infection than in the non-infected group (100 vs. 94.7%; p = 0.0077). Minor and major complications were low in both groups and did not reveal any significant difference. One case of a relevant pocket hematoma that had to be treated surgically was observed in both groups (1.9% infected group vs 0.8% non-infected group; p value 0.4865). Major complications occurred only in the non-infected group; three patients underwent emergent sternotomy for pericardial tamponade in the non-infected group (0 vs 2.3%; p value 0.5598). None of the patients died due to procedure-related complications, whereas 4 patients in the systemic infection group died in hospital before discharge due to septic complications. The outcome and complications are shown in Table 3.
Table 3

Outcome and complications

 

Infected (n = 52)

Non-infected (n = 132)

p value

Outcome, n (%)

 Complete procedural success

52 (100)

125 (94.7)

0.0077

 Procedure-related death

0

0

1.000

 In-hospital mortality

4 (7.7)

0

0.0059

Complications, n (%)

 Pocket hematoma

1 (1.9)

1 (0.8)

0.4865

 Sternotomy (pericardial tamponade)

0

3 (2.3)

0.5598

Categorical variables are expressed by values and percentages

Bold represents a statistically significant p value. p values < 0.05 were considered as statistically significant

Discussion

In this study, we have shown that laser lead extraction of pacemaker and ICD leads is safe and effective in patients with systemic as well as non-systemic infection. Procedural success rate was significantly higher in the group of patients with systemic compared to those with non-systemic infection. Furthermore, in the systemic infection group, shorter laser treatment and fluoroscopy times were needed. Regarding minor and major complications, there was no statistically significant difference between the groups.

In patients with local as well as systemic infection, the removal of the device and all lead material is recommended in the guidelines (Class I) [8]. Lead extraction has been shown to reduce mortality in patients with CIED infection. In a study by Le et al., lead removal reduced the related mortality sevenfold, compared to patients with CIED infection without lead removal [15, 16]. Additionally, the timing of lead removal is essential. Lead extraction within 3 days after diagnosis of CIED infection significantly reduced in-hospital mortality in a study by Viganego et al. [17]. Furthermore, time until a CIED infection is diagnosed is one of the crucial issues. Patients having already a lead-associated sepsis experience a rather high mortality, even if an uncomplicated lead extraction is performed [16].

The intraprocedural mortality rate in patients with systemic lead infection is comparable to those with local infection only. However, in systemic infection cases, there is a higher risk for subsequent in-hospital mortality due to sepsis-associated complications. In our patient cohort, there was no in-hospital mortality in the local infection group, but a mortality rate of 7.6% in the systemic infection group. Those septic patients are prone to multi-organ failure and often need specialized treatment including prolonged intensive care unit stay. Especially, CRT responders with CIED infection are at high risk for clinical deterioration after lead extraction. The loss of biventricular pacing, in combination with the sepsis, can lead to immediate hemodynamic compromise. Here, antibiotic treatment, in combination with exceeded medical hemodynamic support, can be necessary.

After transvenous cardiac device implantation, activation of different immunogenic mechanisms and endothelialization contribute to fibrotic encapsulation of the leads [18]. The lead adhesions usually increase over time and young patients tend to develop fibrotic adhesions at an earlier stage of time compared to elderly patients [19]. To date, there are only a small number of studies comparing the extraction of infected and non-infected leads. In a study by Huang et al., the extraction of superfluous leads was compared to the extraction of infected leads. In contrast to our results, Huang et al. found a higher success rate for extraction of superfluous leads. (97 vs. 92%; p = 0.05). However, in their study, the superfluous leads had been implanted for a significantly shorter time, when compared with infected leads (53 vs. 81 months; p < 0.001) [20]. Furthermore, 57% of the superfluous leads were removed by simple traction only. As the time from initial lead implantation is a known risk factor for difficulty in lead extraction, this parameter might have influenced their results. When looking at major procedural complications, there was no statistically significant difference between both groups. This finding, in combination with a low overall complication rate, is in line with our results and shows that the laser lead extraction of infected as well as non-infected leads can be performed safely and effectively.

In a study by Bracke et al., using a multivariate logistic regression analysis to identify predictors for successful lead extraction in 83 patients, the presence of a lead infection was a statistically significant predictor for extraction success [21].

Similar results have been published by Byrd et al. in a multicenter lead removal study including 2338 patients and 3540 leads [20]. Here, patients with non-infected leads had a significantly lower procedural success rate when compared with infected patients. In line with our study, the procedural complication rate was not different between patients with and without infection in this study. Byrd et al. have reported that in their experience, infected leads tended to be easier to remove, but that this trend was not universal and some infected leads were difficult to remove. However, in this study there was no differentiation between local and systemic infection. Therefore, it is not possible to evaluate if the higher success rate is associated with infection cases in general or only with systemic infection cases.

The exact mechanism for the higher procedural success rate in patients with infected leads remains unclear. In cases of systemic infection, the lead adhesions might be loosened up by the bacteremia and inflammatory reaction. This could be one of the reasons for the higher procedural success rate in those patients. Comparable to surgical cases of valvular endocarditis, where a loosening of the valvular apparatus and surrounding tissue due to inflammatory processes can be observed, in cases of systemic lead infection, similar mechanisms might contribute to less aggressive adhesions allowing for easier lead extraction.

A further explanation could be that the surgeon has a stronger intention to remove all lead material in infected cases, compared to the extraction of superfluous leads or other cases with less strong indications.

Conclusion

The presence of a systemic infection or lead endocarditis in patients undergoing LLE procedures allows for higher complete procedural success rate. When compared with extraction of non-systemic infected leads, the infected leads require less laser treatment and fluoroscopy times. No statistically significant differences were observed in minor as well as major complication rates. No intraprocedural mortality was observed in any of the patients. However, in the group of patients with systemic lead infection, 4 patients without intraoperative complications died from septic shock during hospital stay.

Notes

Funding

No funding was received for this study.

Compliance with ethical standards

Conflict of interest

Samer Hakmi is a Proctor of Spectranetics Corp.

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Copyright information

© Springer Japan KK, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Department of Cardiovascular SurgeryUniversity Heart Center HamburgHamburgGermany
  2. 2.Department of Cardiology, ElectrophysiologyUniversity Heart Center HamburgHamburgGermany

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