Safety and Efficacy of Transvenous Lead Extraction With a High-Frequency Excimer Laser　― A Single Center Experience ―

Abstract

Background: Transvenous lead extractions have been performed using 40-Hz laser sheaths. Recently, a new 80-Hz laser sheath became available, but only a few reports have compared the effectiveness of the 40- and 80-Hz laser sheaths.

Methods and Results: This study included 215 patients. Lead extractions using only laser sheaths were analyzed. The clinical characteristics, extraction parameters, and extraction tools were evaluated. The procedures were performed with 40-Hz sheaths in 150 patients (group 1: 270 leads) and 80-Hz sheaths in 65 (group 2: 99 leads). No statistically significant differences were observed in the clinical parameters except for sex. The mean implant duration was 95.3±86.0 and 78.2±56.8 months in groups 1 and 2, respectively (P=0.07). The respective mean laser time and number of laser pulses were 48.5±52.1 and 48.1±56.1 s (P=0.96) and 2,035.0±2,384.0 and 3,955.1±2,339.3 pulses (P<0.0001). Complete removal was achieved for 97.4% of the leads and in 98.0% in both groups (P=0.38). Major complications occurred in 2.0% and 3.1% of the patients in groups 1 and 2, respectively (P=0.94).

Conclusions: Transvenous lead extraction using high-frequency laser sheaths was as highly successful as with low-frequency laser sheaths in Japanese patients.

Over the past few decades, the rate of cardiac implantable electronic device implantations has been increasing with the aging of the general population and expansion of the indications. Inevitably, there is an increasing demand for lead extractions. The incidence of lead extractions has been increasing concurrently, and in recent years, it has even exceeded the increase in implantations.¹

Fibrotic attachments that develop between chronically implanted leads and the venous, valvular and cardiac structures are the major obstacles to safe and consistent lead extraction. To overcome this issue, excimer laser sheaths (40 Hz) have been introduced for use in the current lead extraction procedures. Fibrous adhesions are disrupted by a circumferential laser beam applied to the tip of a specialized sheath telescoped over the lead of interest. However, the extraction of chronically implanted leads remains a difficult procedure associated with risks of morbidity and mortality. Recently, 80-Hz high-frequency laser sheaths have become available. Theoretically, these sheaths deliver twice as many pulses per second.² Mechanical force has been suggested to be a major cause of complications during the procedures. However, few reports have compared 40- and 80-Hz laser sheaths, particularly in Japan.

Therefore, the purpose of this study was to compare the safety and efficacy of the low- and high-frequency laser sheaths for lead extractions in Japanese institutions.

Methods

Study Patients

A total of 418 leads in 215 patients were extracted transvenously, mainly using an excimer laser sheath, from May 2013 through April 2018 at Tokyo Medical and Dental University Hospital. In total, 122 patients were implanted with pacemakers, 64 of which were implantable cardioverter-defibrillator (ICDs) and 29 cardiac resynchronization therapy defibrillator/pacemakers (CRT-D/Ps). A low-frequency sheath (40 Hz) was used in 150 patients between May 2013 and April 2017 (group 1) and a high-frequency sheath (80 Hz) in 65 patients between April 2017 and April 2018 (group 2). The clinical history, extracted lead, extraction indications, laser time, number of laser pulses, and extraction tools were recorded and analyzed retrospectively. With respect to the extraction parameters, 369 leads that had been extracted using only laser sheaths were analyzed.

The definition of a device infection and classification of the indication of the procedure were submitted to the latest Expert Consensus Statement published by the Heart Rhythm Society.³ All patients gave their written informed consent and the study was approved by the Ethical Committee of Tokyo Medical and Dental University Hospital.

Lead Extraction Procedure

The procedures were performed in the cardiac catheterization laboratory or operating room under general or venous anesthesia according to the patient’s condition. Careful monitoring with both surface ECGs and invasive arterial blood pressure monitoring was performed. Transesophageal or intracardiac echocardiography was also performed. Cardiac surgical back-up and stand-by percutaneous cardiopulmonary support were provided.

The lead extraction procedure has been described in detail.^4–6 Briefly, the lead was prepared by inserting a locking stylet (LLD, Spectranetics, Colorado Springs, CO, USA) into the inner coil lumen when possible. A suture was then tied onto the insulation and the locking stylet, after which the laser sheath was advanced over the lead. A laser application was performed at the binding sites and the laser sheath was gradually advanced from one binding site to another until it reached the tip of the lead. Once abutting the myocardium, a combination of traction and counter-traction was performed and the lead was freed. A laser generator (CVX-300 Excimer laser system, Spectranetics) with a lower-frequency pulsed sheath (SLS^TM II, Spectranetics) emitting a 308-nm wavelength at a repetition rate of up to 40 Hz was used in patients who underwent laser lead extraction from May 2013 to April 2017. In April 2017, a high-frequency pulsed laser sheath (GlideLight^TM, Spectranetics) emitting 308-nm wavelength laser pulses with a repetition rate of up to 80 Hz was introduced.

In cases in which a laser sheath could not be advanced at the binding site, we upgraded the size of the laser sheath or switched to a non-laser system; viz., telescoping polypropylene mechanical dilator sheath, stainless steel dilator sheath, Needle’s Eye snare (Cook Medical Inc., Bloomington, IN, USA), or Amplatz Goose Neck Snares (Medtronic, Minneapolis, MN, USA).

Extraction Outcomes

The definitions published in the 2017 Heart Rhythm Society’s consensus statement³ on transvenous lead extractions were used to judge complete removals, partial removals, failures, and complications. Major complications were defined as “any of the outcomes related to the procedure that were life threatening or resulted in death” or “any unexpected events that caused a persistent or significant disability or any events that required a significant surgical intervention to prevent.”

Statistical Analysis

The patient parameters were analyzed with the chi-square test, or contingency table analysis. A Fisher’s exact test was used for a 2×2 analysis. The analyses were conducted using Stat-View 5.0 software (SAS Institute Cary, NC, USA). Continuous variables are expressed as the mean±SD. All tests were 2-tailed and P<0.05 indicated statistical significance.

Results

Baseline Characteristics

We analyzed 215 patients (152 men [70%], mean age 67.1±15.0 years) who underwent a transvenous lead extraction. The baseline patient characteristics are shown in Table 1. There was no statistically significant difference between groups 1 and 2 for any of the clinical parameters except for sex. The mean body mass index was 22.2±3.5. The mean left ventricular ejection fraction was 54.4±15.4%. The lead characteristics and indications for the procedures in each group are listed in Table 2. No statistically significant differences were observed for implantation duration of the leads, lead characteristics, or indications for the procedure. The mean implant duration was 90.7±79.6 months (longest=379 months). The indication for the procedure was class I in 153 patients (device-related infections in 151 and superior vena cava syndrome in 2), class IIa in 12 (chronic pain in 2, vascular issue in 6, and >4 leads on one side in 4 patients) and class IIb in 50 (lead failures in 32, advisory leads in 8, tricuspid regurgitation in 3, and upgrades in 7 patients).

Table 1. Summary Data of the Baseline Characteristics of the Study Patients

	Group 1 (LF laser sheath)	Group 2 (HF laser sheath)	P value
No. of patients	150	65
Male (%)	100 (65.4)	52 (80.0)	<0.05
Age	67.3±13.9	66.5±17.2	0.71
Body mass index	22.3±3.5	22.0±3.4	0.61
Ejection fraction (%)	53.9±15.9	55.4±14.7	0.51
BNP (pg/mL)	254.6±491.3	249.2±316.5	0.94
Serum creatinine (mg/dL)	1.2±1.3	1.4±1.5	0.32
Hypertension (%)	62 (41.3)	25 (38.5)	0.69

Data are mean±SD (%). BNP, B-type natriuretic peptide; HF, high-frequency; LF, low-frequency; NS, not significant.

Table 2. Lead Characteristics

	Group 1 (LF laser sheath)	Group 2 (HF laser sheath)	P value
No. of leads	270	99
Implant duration (month)	95.3±86.0	78.2±56.8	0.07
Lead characteristics
RA (%)	93 (34.4)	29 (29.3)	0.38
RV (pacemaker, %)	99 (36.7)	31 (31.3)
VDD pacing (%)	7 (2.6)	5 (5.1)
LV (%)	16 (5.9)	8 (8.1)
ICD (%)	55 (20.4)	26 (26.3)
Indication of extraction
Class I	106	47	0.54
Class IIa	7	5
Class IIb	37	13

ICD, implantable cardioverter-defibrillator; LV, left ventricle; RA, right atrium; RV, right ventricle. Other abbreviations as in Table 1.

Lead Extraction Procedure

A total of 1–5 leads were removed in each patient, and a total of 418 leads were extracted; 61 leads were extracted by manual traction, 251 leads were extracted using a low-frequency laser sheath and 106 were extracted using a high- frequency laser sheath; 38 leads required a non-laser system. Therefore, 369 leads extracted using only laser sheaths were analyzed. The positions of the leads were the right atrium (n=122), coronary sinus (n=24), and right ventricle (n=223), including 81 ICDs and 12 leads with VDD pacing including 1 VDD-ICD lead. There was no statistically significant difference in the lead characteristics between groups 1 and 2 (Table 2). The mean implant duration was 90.7±79.6 months; the implant duration was 95.3±86.0 months in group 1 and 78.2±56.8 months in group 2 (P=0.07). No statistically significant difference was observed in the indications for the extraction procedure (Table 2).

The procedural results are shown in Table 3. The total laser pulses per lead in group 2 were greater than those in group 1 (P<0.0001), but no significant difference was observed in the duration of the laser application per lead. Complete removal was achieved in 360 leads (97.6%), whereas partial removal was achieved in 5 (1.2%) and failure occurred in 4 (1.1%). The procedural results were similar between the 2 groups. In all cases of partial removal, only the tip of the lead remained in the myocardium without causing any complications and the desired clinical outcome could be achieved. A non-laser system was required in 8.7% of the patients in group 1 and in 10.1% in group 2.

Table 3. Outcomes and Complications of the Procedure

	Group 1 (LF laser sheath)	Group 2 (HF laser sheath)	P value
Laser duration/lead (s)	48.5±52.1	48.1±56.1	0.96
Laser pulses/lead (n)	2,035.0±2,384.0	3,955.0±2,339.3	<0.0001
Result
Complete removal (%)	263 (97.4)	97 (98.0)	0.38
Partial removal (%)	4 (1.5)	0 (0)
Failure (%)	3 (1.1)	2 (2.0)
Major complications (%)	3 (2.0)	2 (3.1)	0.94

HF, high-frequency; LF, low-frequency.

Major Complications

Major complications occurred in 5 patients (2.3%) and the complication rate was similar between the 2 groups (Table 3). The details are shown in Table 4. A laceration of the superior vena cava wall occurred in 1 patient in group 2. Fortunately, no after-effects remained following urgent surgical hemostasis. Cardiac tamponade occurred in 3 patients (2 in group 1 and 1 in group 2). Surgical hemostasis was required in 2 of 3 patients. The first case of tamponade occurred in a 62-year-old patient with an infected dual-chamber ICD 122 months after implantation. Just after extraction of the atrial lead positioned in the right atrial appendage followed by successful extraction of the ICD lead, the patient’s atrial blood pressure suddenly fell and a pericardial effusion was detected using intracardiac echocardiography (ICE). The second case of tamponade occurred in a 69-year-old patient with an infected dual-chamber pacemaker 79 months after implantation. ICE demonstrated cardiac tamponade just after extraction of the atrial lead, which was situated in the right atrial appendage. Shock of an undefined etiology occurred after discontinuation of the extraction procedure because of breakage of the target lead in the remaining patient in group 1.

Table 4. Complications

Complication	Type of laser sheath	Result	Description
Tamponade	40-Hz	Thoracotomy	Cardiac tamponade occurred just after extraction of the non- retractable active fixation atrial lead (implant duration: 122 months)
Shock of undefined etiology	40-Hz	Percutaneous cardiopulmonary support	Shock occurred after discontinuation of the extraction procedure because of breakage of the ventricular lead (implant duration: 396 months)
Tamponade	40-Hz	Pericardiocentesis	Cardiac tamponade occurred during extraction of the passive fixation ventricular lead (implant duration: 122 months)
Tamponade	80-Hz	Thoracotomy	Cardiac tamponade occurred just after extraction of the passive fixation atrial lead (implant duration: 79 months)
SVC laceration	80-Hz	Thoracotomy	Cardiac tamponade caused by an SVC laceration occurred during extraction of the passive fixation ICD lead (implant duration: 101 months)

ICD, implantable cardioverter-defibrillator; SVC, superior vena cava.

Discussion

This study compared the clinical results of lead extraction procedures using a low-frequency laser sheath (group 1) and high-frequency laser sheath (group 2). The results revealed no statistically significant differences in the success rates and complication rates between the 2 groups.

Over the past few decades, the number of lead extraction procedures for the management of cardiac rhythm device leads has been increasing yearly. Common indications for extraction include infections, vascular issues, lead-lead interactions, non-functional leads, and advisory leads. Leads with a long duration of implantation characteristically develop fibrous attachments to the surrounding structures, such as the vascular wall, cardiac structures, or valvular tissue, and require specialized extraction techniques. Excimer laser technology is commonly used in current lead extraction procedures. The excimer laser system with a 40-Hz (SLS II) frequency became available in 2010 and the 80-Hz laser (GlideLight) in 2017 in Japan. In the PLEXES trial, the complete removal rate with the 40-Hz laser sheath was 94%; however, a considerable number of major complications (2.0%) occurred.⁷ High-frequency laser sheaths (80-Hz) are thought to disintegrate human tissue more effectively, but also have the potential to cause more extraction-related complications.

Few reports have investigated the use of 80-Hz laser sheaths for lead extractions. To the best of our knowledge, only 3 papers from 2 groups have been published (Table 5). An initial experience of 112 patients was published by Tanawuttiwat et al in 2014,⁸ and a second study of 38 patients treated with GlideLight laser sheaths was reported by Hakumi et al.⁹ In 2017, the same group (this time authored by Pecha et al) published their experiences of using the GlideLight laser sheath in 151 patients.¹⁰ In the study by Tanawuttiwat et al,⁸ the complete removal rate and major complication rate for the 40-Hz sheath were 100% and 1.6%, respectively, compared with 100% and 0.9%, respectively, for the 80-Hz sheath. The complete removal rate and major complication rate for the 80-Hz sheath in Pecha et al’s report were 97.6% and 1.3%, respectively. In our study, complete removal was achieved for 97.4% of the leads in group 1 and for 98.0% in group 2. Furthermore, the major complication rates were 2.0% and 3.1%, respectively, in the 2 groups. These data suggested 2 issues. First, the 40- and 80-Hz laser sheaths gave almost equivalent beneficial results. Second, the complication rate for the 2 types of sheaths was comparable. These data concurred with those from the previous 3 studies.

Table 5. Summary of Previous Studies

	Tanawuttiwat et al8	Hakmi et al9	Pecha et al10	Yoshitake et al
No. of leads	427	76	292	369
Implant duration (months)	68.5±59.5	96±58.3	98.0±65.2	90.7±79.6
Complete removal (%)	100	94.8	97.6	97.6
Major complication (%)	1.4	2.6	1.3	2.3
Low-frequency (40 Hz)
Laser duration/lead (s)	75.42±258.68			48.5±52.1
Laser pulses/lead (n)	2,356.82±3,417.53			2,035.0±2,384.0
High-frequency (80 Hz)
Laser duration/lead (s)	23.39±24.86	68.8±61.6	67.5±71.3	48.1±56.1
Laser pulses/lead (n)	1,585.31±1,656.36	5,281.2±4,560.8	5,130±6,592	3,955.0±2,339.3

Continuous variables are shown as mean±SD.

Interestingly, in 2 of the 5 cases of major complications, tamponade occurred just after the extraction of a passive fixation or non-retractable active fixation atrial lead situated inside the right atrial appendage. This suggests careful handling is required in this situation.

The duration of the laser application per lead was 48.5±52.1 and 48.1±56.1 s in groups 1 and 2, respectively (P=0.96). Furthermore, the pulses of the laser applications per lead were 2,035.0±2,384.0 and 3,955.0±2,339.3 in groups 1 and 2, respectively (P<0.0001). Theoretically, the 80-Hz laser sheath delivers twice as many pulses per second and allows for the same advancement inside the vessel with half the force.² There has been only 1 report directly comparing these parameters of low- and high-frequency laser sheaths (Table 5). As such, Tanawuttiwat et al observed significantly shorter laser treatment times in their 80-Hz laser sheath group. However, in our cohort, the duration of the laser applications in the 2 groups was similar and the number of pulses in the laser applications in group 2 were almost twice that of group 1. This was inconsistent with the theoretical hypothesis. The mean lead age in Tanawuttiwat et al’s study was 68.5±59.5 months. Furthermore, our mean lead age was 90.7±79.6 months. Roux et al reported that a longer time from implantation independently predicted procedural failure.¹¹ Moreover, postmortem analyses of long-term pacing leads have revealed that the fibrotic response may extend along the entire lead and complicate its removal from adherent surrounding structures.¹² We speculate that a strong fibrotic response related to longer lead age might be the basis for this inconsistency. In the present study, with respect to the leads with an implant duration of less than 5 years (Table 6), the duration of the laser applications per lead was 30.7±32.6 s and 25.7±22.2 s in groups 1 and 2, respectively (P=0.51). Furthermore, the number of pulses of the laser application per lead were 1,226.7±1,176.5 and 1,854.1±1,817.8, respectively for groups 1 and 2 (P=0.08). These parameters demonstrated a similar tendency to Tanawuttiwat et al’s study. Furthermore, those parameters finally supported our speculation.

Table 6. Lead Characteristics and Outcome of the Procedures in Patients With Implant Duration <5 Years

	Group 1 (LF laser sheath)	Group 2 (HF laser sheath)	P value
No. of leads	90	22
Implant duration (months)	27.8±15.4	26.7±17.1	0.76
Lead characteristics
RA	34	6
RV	29	9
LV	5	0
ICD	22	7
Laser duration/lead (s)	30.7±32.6	25.7±22.2	0.52
Laser pulses/lead (n)	1,226.7±1,176.5	1,854.1±1,817.8	0.08
Results
Complete removal	90/90	22/22
Major complications	0	0

Continuous variables are shown as mean±SD. Abbreviations as in Tables 1,2.

Tanawuttiwat et al⁸ and Pecha et al¹⁰ reported that major complications occurred in 1.4% and 1.3% of patients, respectively. In the present study, major complications occurred in 2.3% of the cohort as a whole. The LExICon study¹³ reported that a body mass index <25 was an indicator of a major procedural adverse event. The mean body mass index in the present study was 22.2±3.5. The lower body mass index values in this cohort might account for the procedure-related major complications observed. Once major complications requiring urgent surgical or endovascular maneuvers occur, the in-hospital mortality increases to almost 40%.¹⁴ Therefore, careful handling is required, especially with the use of a high-frequency laser sheath.

Study Limitations

First, the number of patients studied was small. Second, the patient background of the 2 groups was heterogeneous. Third, the results represented a retrospective analysis from a single center. Therefore, these data and the outcomes may not be replicated in the general population.

Conclusions

At our center, transvenous lead extractions using high-frequency laser sheaths appeared to be highly successful. Furthermore, the major complication rate was 3.1%. These findings suggested that the high-frequency (80-Hz) laser sheath provided equally beneficial results when compared with use of the low-frequency (40-Hz) laser sheath in Japanese patients.

Disclosures

M.G., and K.H. have received speaker’s honoraria from Medtronic, Johnson and Johnson, and St. Jude Medical. S.M. and Y.T. have received endowments from Medtronic, Win International, Japan Lifeline, and Boston Scientific. The remaining authors have no relevant conflicts of interest to disclose.

Grants / Acknowledgements

None.

References

• 1.   Voigt A, Shalaby A, Saba S. Continued rise in rates of cardiovascular implantable electronic device infections in the United States: Temporal trends and causative insights. Pacing Clin Electrophysiol 2010; 33: 414–419.
• 2.   Spectranetics. Glidelight^TM laser sheath. http://www.spectranetics.com/solutions/lead-management/glidelight-laser-sheath/ (accessed August 28, 2018).
• 3.   Kusumoto FM, Schoenfeld MH, Wilkoff BL, Berul CI, Birgersdotter-Green UM, Carrillo R, et al. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm 2017; 14: e503–e551.
• 4.   Goya M, Nagashima M, Hiroshima K, Hayashi K, Makihara Y, Fukunaga M, et al. Lead extractions in patients with cardiac implantable electronic device infections: Single center experience. J Arrhythmia 2016; 32: 308–312.
• 5.   Fukunaga M, Goya M, Nagashima M, Hiroshima K, Yamada T, An Y, et al. Identification of causative organism in cardiac implantable electronic device infections. J Cardiol 2017; 70: 411–415.
• 6.   Goya M, Nagashima M, Hiroshima K, Hayashi K, Makihara Y, Fukunaga M, et al. Transvenous extraction of advisory implantable cardioverter defibrillator leads with a relatively long implant duration. J Cardiol 2018; 72: 316–320.
• 7.   Wilkoff BL, Byrd CL, Love CJ, Hayes DL, Sellers D, Schaerf B, et al. Pacemaker lead extraction with the laser sheath: Results of the pacing lead extraction with the Excimer Sheath (PLEXES) trial. J Am Coll Cardiol 1999; 33: 1671–1676.
• 8.   Tanawuttiwat T, Gallego D, Carrillo RG. Lead extraction experience with high frequency Excimer laser. Pacing Clin Electrophysiol 2014; 37: 1120–1128.
• 9.   Hakmi S, Pecha S, Sill B, Reiter B, Willems S, Aydin MA, et al. Initial experience of pacemaker and implantable cardioverter defibrillator lead extraction with the new GlideLight 80 Hz laser sheaths. Interact CardioVasc Thorac Surg 2014; 18: 56–60.
• 10.   Pecha S, Linder M, Gosau N, Castro L, Vogler J, Willems S, et al. Lead extraction with high frequency laser sheaths: A single-centre experience. Eur J Cardio-Thorac Surg 2017; 51: 902–905.
• 11.   Roux JF, Page P, Dubuc M, Thibault B, Guerra PG, Magle L, et al. Lase lead extraction: Predictors of success and complication. Pacing Clin Electrophysiol 2007; 30: 214–220.
• 12.   Candinas R, Duru F, Schneider J, Luscher TF, Stokes K. Postmortem analysis of encapsulation around long-term ventricular endocardial pacing leads. Mayo Clin Proc 1999; 74: 120–125.
• 13.   Wazni O, Epstein LM, Carrillo RG, Love C, Adler SW, Riggio DW, et al. Lead extraction in the contemporary setting: The LExICon Study. An observational retrospective study of consecutive laser lead extraction. J Am Coll Cardiol 2010; 55: 579–586.
• 14.   Brunner MP, Cronin EM, Wazni O, Baranowski B, Saliba WI, et al. Outcomes of patients requiring emergent surgical of endovascular intervention for catastrophic complications during transvenous lead extraction. Heart Rhythm 2014; 11: 419–425.