How adequate are the current methods of lead extraction? A review of the efficiency and safety of transvenous lead extraction methods

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1 Europace (2015) 17, doi: /europace/euu378 REVIEW How adequate are the current methods of lead extraction? A review of the efficiency and safety of transvenous lead extraction methods Maurits S. Buiten, Aafke C. van der Heijden, Martin J. Schalij, and Lieselot van Erven* Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands Received 21 August 2014; accepted after revision 2 December 2014; online publish-ahead-of-print 16 February 2015 Currently several extraction tools are available in order to allow safe and successful transvenous lead extraction (TLE) of pacemaker and ICD leads; however, no directives exist to guide physicians in their choice of extraction tools and approaches. To aim of the current review is to provide an overview of the success and complication rates of different extraction methods and tools available. A comprehensive search of all published literature was conducted in the databases of PubMed, Embase, Web of Science, and Central. Included papers were original articles describing a specific method of TLE and the corresponding success rates of at least 50 patients. Fifty-three studies were included; the majority (56%) utilized 2 (1-4) different venous extraction approaches (subclavian and femoral), the median number of extraction tools used was 3 (1-6). A stepwise approach was utilized in the majority of the studies, starting with simple traction which resulted in successful TLE in 7 85% of the leads. When applicable the procedure was continued with non-powered tools resulting in a successful extraction of 34 87% leads. Subsequently, powered tools were applied whereby success rates further increased to %. The final step in TLE was usually utilized by femoral snare leading to an overall TLE success rate of %. The median procedure-related mortality and major complication described were,respectively, 0% (0 3%) and 1% (0 7%) per patient. In conclusion, a stepwise extraction approachcan result in aclinical successful TLE in up to 100% of the leads with a relatively low risk of procedure-related mortality and complications Keywords Transvenous lead extractions Cardiac implantable devices Extraction tools Introduction The implantation rate of devices such as pacemakers (PMs) and implantable cardioverter-defibrillators (ICDs), with or without cardiac resynchronization therapy (CRT) options has significantly increased over the last decades, 1 3 leading to a rising number of failed leads, device infections, and lead or device recalls. As a consequence, the need for PM and/or ICD lead extractions is increasing. 4 Currently, a vast number of extraction tools are available in order to allow a successful extraction of the PM and ICD leads, and there are numerous studies describing and comparing the different extraction tools, methods, and approaches. 5 However to date, no directives exist to guide physicians in their choice of extraction tool or approach and all extractionists have their own preferred methods. 5 Given the differences in study designs, operators experience, patient, and lead characteristics, comparison of the various transvenous lead extraction (TLE) methods is faulty. The aim of the current review is to provide an overview of the success and complication rates of different extraction methods currently available. Furthermore, the success and failure rates of different stepwise TLE approaches are summarized. Methods Literature research A comprehensive search of all published literature was conducted in the databases of PubMed, Embase, Web of Science, and the Cochrane central register of controlled trials (Central). The search was performed using the following search terms: implantable cardioverterdefibrillators, cardiac resynchronization therapy, PM, pacing, defibrillating or percutaneous, and lead extraction or lead removal. The search was limited to English literature and focused on clinical reports and studies published until the 26th of March Two reviewers (M.B. and A.H.) screened all available reports independently. Disagreements were resolved by the two reviewers after studying the report in detail together. Selection criteria The primary selection of the papers was based on the screening of titles and abstracts for potential relevance. All remaining reports were studied thoroughly and papers were included if the specific method of TLE and the corresponding success rates were described. Exclusion criteria * Corresponding author. Tel: , Fax: address: l.van_erven@lumc.nl Maurits S. Buiten and Aafke C. van der Heijden contributed equally to this manuscript. Published on behalf of the European Society of Cardiology. All rights reserved. & The Author For permissions please journals.permissions@oup.com.

2 690 M.S. Buiten et al. were: papers describing,50 patients; reviews; letters; editorials; and case reports. As a consequence, the current review describes the results of original articles and randomized trials. One exception was made for an editorial that provided novel, and extensive data on a very large cohort of device patients. 6 Design review and definitions Success and complication rates of TLE were described per method of extraction. In line with the Heart Rhythm Society (HRS) consensus document, lead extraction methods were divided into extractions using: 5 Simple traction (non-locking stylets and fixation screw retraction clips) Non-powered extraction tools (locking stylets and mechanical dilator sheaths) Powered extraction tools (laser sheaths, electrosurgical dissection sheaths, and rotating threaded tip sheaths). The primary endpoints of the review were clinical success of the TLE procedure, TLE procedure-related death, and major and minorcomplications. These endpoints were all described as stated by the HRS consensus document. Therefore, a part of the referenced studies required recalculation of the reported events; as a consequence, numbers and percentages of the current review may differ from the results reported in the reference study. Clinical outcomes and complications of the different TLE methods were classified as follows: Clinical success: removal of all targeted leads and lead material fromthevascularspace,orretentionofasmallleadfragmentas long as it does not negatively impact the outcome goals of the procedure. Clinical success was not achieved in case permanently disabling (major) complications or procedure-related death occurred. Procedure-related death: death directly related to the TLE procedure. Major complications: any procedure-related event, which is life threatening, results in death, causes persistent disabilities, or requires surgical intervention. Minor complications: any procedure-related event that is undesired and requires medical intervention or minor procedural intervention without resulting in persistent significant disabilities. Complications were classified based on the HRS consensus document, except that tricuspid valve damage leading to (worsening of) valve insufficiency, but not requiring surgical intervention, was added to the minor complications. 5 Finally, since the extraction of ICD leads with defibrillator coils and left ventricular (LV) leads from the coronary sinus (CS) are associated with additional concerns regarding the safety, the results per lead type were discussed separately. Statistical analysis Categorical data are presented as number (N) and percentage. An overview of these categorical data is presented as range from minimal up to maximum reported rates, with a corresponding grouped median. Continuous data are expressed as mean and standard deviation. Results of the references studies were maintained as reported except when results were not in line with the HRS consensus document. Recalculation of reported results was only performed when major complications were not taken into account for the determination of true clinical success. No comparison requiring further statistical analysis of the referenced studies was performed. Citations identified by PubMed n = 499 Full text articles assessed n =108 Results Studies included n =53 Selected studies Excluded (n = 404): 1. <50 included patients (n = 112) 2. Endpoint not reported (n =171) 3. Surgical lead extraction (n = 3) 4. Not an original article (n = 114) 5. Animal research (n =3) 6. Non-English (n =1) Additional citations: 1. Identified by embase, Web of science, Central (n = 12) 2. Other (n =1) Excluded (n =54): 1. <50 included patients (n =8) 2. Endpoint not reported (n =36) 3. Not an original article (n =1) 4. Non-English (n =1) 5. Results of recalled leads (n =6) 6. Other (n =3) Figure 1 Flowchart describing literature research and study selection. As illustrated in Figure 1, the literature search in PubMed yielded 499 results. Of these, 112 papers had insufficient patient numbers (N, 50), in 171 the endpoint was not reported, 3 reported results of surgical lead extraction, 114 had an incompatible study design, 3 reported results of an animal study, and 1 was not written in English. The search in Embase, Web of Science, and Central yielded 12 additional reports. Of the remaining 107 results, full-text articles were read thoroughly. An additional 54 papers were excluded, of which 8 had insufficient patient numbers, 36 did not report endpoints for any specific extraction method, 1 had an incompatible study design, 6 were papers reporting results of recalled leads, 2 papers described results that had already been described in another included paper, and 1 full-text article was not accessible. One additional study was added, despite being published 7 days after the original literature search date, since it was deemed to be of high importance. 7 The current review therefore includes 53 studies. Of all reported studies, the majority (56%) utilized 2 (1 4) different venous approaches (subclavian and femoral), and the median number of extraction tools described per study was 3 (1 6). An overview of the assumed clinical success and complication rates per extraction method of these studies is provided in Figure 2.

3 The efficiency and safety of transvenous lead extraction methods 691 Complications (%) Clinical success (%) Simple traction % Simple traction 44% Locking stylet 71% 97% Mechanical Femoral dilator snare The firstattempt to extractatransvenous PM or ICD lead is usually by performing simple traction. This technique of applying traction to the lead combined with the use of tools typically supplied for lead implantation (non-locking stylets, fixation screw retraction clips) is particularly successful in leads with a relative short dwell time. 8 Table 1 provides an overview of 25 studies describing the results of simple manual traction for lead extraction. 6,8 31 In all studies, simple traction was performed as a first attempt to remove the lead. Studies using locking stylets to assist the simple traction were excluded. The success rate of TLE by simple traction ranged from 9 to 31% (19%) of patients (N ¼ 288), and 7 to 85% (28%) of leads (N ¼ 3432). 6,8 26,28 31 Notable is the wide variability in the success rate of simple traction between the different studies. This might partially be explained by differences in lead age in the included studies, which ranged from 1.1 to 17.1 years. Likewise, differences in lead properties and extraction indications may have played a part. Exceptionally high success rates of the simple traction TLE procedure were observed in two single-centre studies by Maytin et al. 28 and de Bie et al. 8 (78 85%). Maytin et al. 28 reported on leads with a relative short dwell time (1.1 years). To date, only de Bie et al. 8 reported the results of TLE with a specific focus on simple traction. In a cohort of 279 patients, successful TLE using simple traction was achieved in 85% (N ¼ 377) of the leads after a mean lead implant time of 2.6 years. The authors state that since it is not well defined when a simple traction procedure failed and at what point cross-over to 95% 87% Laser sheath *** EDS Evolution Clinical success Mortality Major complications Minor complications Figure 2 Clinical outcomes of different extraction methods. Clinical success rate is reported per lead and complication rate is reported per patient. The percentages represent the mean success rate. EDS, Electrosurgical dissection sheath. ***Clinical success or complication rates were not reported for this extraction method. another extraction method should be considered, their success rate of simple traction might be high. Furthermore, they state that all lead extractions were performed by physicians with extensive experience in manual lead extraction. In the remaining studies, 7 46% (27%) of leads were successfully extracted using simple traction only (N ¼ 2868). No simple traction procedure-related deaths were reported in the 3769 patients in whom simple traction was performed. 10,12 14,16,17,19 22,24,25 However, major complications occurred in 0 1.3% (N ¼ 4). 8,10,14,16,18,24 Three cases of cardiac avulsion requiring surgical intervention were described by de Bie et al. 8 (N ¼ 2; 0.7%) and Mathur et al. 16 (N ¼ 1; 1.3%). In addition, Atallah et al. 14 reported one (0.7%) major complication from TLE by simple traction in children and young adults, in a multicentre study including 24 centers. The type of complication, however, was not described in this study. Finally, two of the most recent studies that performed TLE in 374 patients did not observe any major complications. 10,24 Minor complications owing to TLE by simple traction were only reported by de Bie et al., 8 who observed 4.7% minor complications (seven patients with haematomas requiring reoperation for drainage, five patients with migrated lead fragments without sequelae, and one patient with a pneumothorax). Non-powered traction tools Over time leads become adherent to either myocardium or vascular walls in varying degrees, due to encapsulating fibrotic tissue at contact

4 692 M.S. Buiten et al. Table 1 Overview of lead extractions performed by simple manual traction Author Year Centres Patients Leads Lead age, Successful extractions a Complications years Per patient, Per lead, N (%) Death, Major, Minor, N (%) N (%) N (%) N (%)... Colavita /86 (7%) b 0 (0%) Bracke /145 (25%) b Saad /161 (24%) b Mathur /145 (19%) 0 (0%) 1 (1%) Camboni /53 (32%) b 0 (0%) Bongiorni /2062 (14%) b Agarwal /456 (25%) b Kennergren /1032 (29%) b 0 (0%) Calvagna /518 (22%) b 0 (0%) Cecchin /203 (29%) b 0 (0%) Kratz /365 (9%) b Maytin /239 (78%) 0 (0%) 0 (0%) 0 (0%) Le /325 (31%) b Henrikson /67 (31%) b 0 (0%) 0 (0%) Pichlmaier /155 (18%) b Williams /406 (20%) b 0 (0%) Geselle /259 (40%) b 0 (0%) Maytin /1951 (36%) b 0 (0%) de Bie /445 (85%) 0 (0%) 2 (1%) 13 (5%) Mazzone /208 (11%) b Kutarski /1563 (12%) b Epstein /2274 (27%) b Atallah /143 (46%) 0 (0%) 1 (1%) Bracke /476 (29%) b 0 (0%) 0 (0%) Kohut /156 (45%) b 0 (0%) 0 (0%) 0 (0%) Categorical variables are expressed by N (%) and continuous variable by mean. N, number. a Successful extractions are either reported per lead (preferably) or per patient. b Major complications were not taken into account for the determination of true clinical success rates. sites. Thus, when applying traction to chronically implanted leads, force will be distributed over all fibrotic binding sites and weakened at the distal end of the lead. Non-powered tools are developed to direct the force of traction to the length or at the distal end of the lead (locking stylets), or to disrupt and dilate the encapsulating fibrotic tissue (mechanical dilator sheaths). Locking stylets Locking stylets are specialized tools designed to slide into the lumen of a lead and are advanced to the tip of the lead where they are locked into position. Table 2 provides an overview of eight studies describing the present experience with locking stylets for TLE. 11,13,22,25,26,29,31,32 In 1996, Alt et al. 32 were the first to describe TLE results using the locking stylet specifically, in a large study population (N. 50). In seven study centres, lead extractions were performed with primary use of locking stylets after a mean lead dwell time of 4.6 years. Clinical success was achieved in 93% of the leads (N ¼ 140) without the occurrence of procedure-related death or major complications. Two (2%) minor complications occurred (one haematoma requiring reoperation and one migrated lead fragment without sequelae). 32 Although the initial success rate of TLE using locking stylets seems fairly high, in 12% of the cases the lead was partially retained and further removed using a femoral snare-loop catheter. These results reflect TLE before the introduction of more advanced (powered) extraction tools. In more recent studies extractionists might have crossed over to another TLE method sooner, potentially decreasing the risk of lead fracture and complications. Subsequent studies reported their experience with locking stylets as part of a stepwise extraction approach, and the use of a locking stylet was only preceded by simple traction, as demonstrated in Table 2. 11,13,22,25,26,29,31 In these single-centre studies, the mean lead age was years. The TLE success rate after the use of both simple traction and locking stylets ranged from 22 to 85% (43%) of patients (N ¼ 631) and from 34 to 62% (36%) of leads (N ¼ 266). 11,13,22,25,26,29,31 No procedure-related deaths due to TLE using locking stylets were reported. Unfortunately, none of these studies accurately

5 Table 2 Overview of lead extractions performed by non-powered extraction tools Author Year Centres Patients Leads Lead Failed Successful extraction a Complications Total successful extractions age, previous steps by stepwise approach a years Per patient, N Per lead, N (%) Death, Major, Minor, Per patient, Per lead, (%) N (%) N (%) N (%) N (%) N (%)... Locking stylet Alt /150 (93%) 0 (0%) 0 (0%) 2 (2%) Bracke ST 13/109 (12%) b 49 (34%) Cecchin ST 11/109 (10%) b 0 (0%) 56 (36%) Kratz ST 47/333 (14%) b 79 (22%) Le ST 173/223 (78%) b 275 (85%) Geselle ST 58/160 (37%) b 0 (0%) 161 (62%) Williams ST 121/324 (37%) 0 (0%) 203 (50%) Mazzone ST 51/185 (28%) b 0 (0%) 74 (36%) Dilator sheath Bongiorni ST 1514/1777 (85%) 1799 (87%) Cecchin ST,LS 20/98 (20%) b 76 (54%) Kratz ST,LS 50/222 (23%) 81% c Mazzone ST,LS 11/134 (8%) 0 (0%) 85 (41%) Femoral needle eye snare Bordachar /51 (96%) 0 (0%) 1 (2%) 2 (4%) Bracke ST 334/340 (98%) 0 (0%) 2 (1%) 0 (0%) 470 (99%) Byrd ST,LS,NPS 33/33 (100%) 0 (0%) 0 (0%) 0 (0%) 115 (100%) Bracke ST,LS,PS 5/5 (100%) b 141 (97%) Bracke ST,LS,PS 5/5 (100%) 0 (0%) 0 (0%) 0 (0%) 75 (91%) Kennergren ST,PS 8/8 (100%) b 369 (96%) Scott ST,LS,PS 2/5 (40%) b 0 (0%) 69 (93%) Kratz ST,LS,NPS,PS 30/32 (94%) 0 (0%) 362 (99%) Maytin ST, LS,NPS,PS 67/67 (100%) b 1939 (99%) Mazzone ST,LS 18/21 (86%) 0 (0%) 205 (99%) Bongiorni ST,NPS 28/85 (33%) 1827 (89%) Categorical variables are expressed by N (%) and continuous variable by mean. N, number; ST, simple traction; LS, locking stylet; NPS, non-powered sheath (mechanical dilator sheath). a Successful extractions are either reported per lead (preferably) or per patient. b Major complications were not taken into account for the determination of true clinical success rates. c Estimated percentage. The efficiency and safety of transvenous lead extraction methods 693

6 694 M.S. Buiten et al. reported the occurrence of complications due to the use of locking stylets in a stepwise approach for TLE. Mechanical dilator sheaths A common third step in the stepwise approach of lead extraction is the use of a mechanical dilator sheath. This sheath, available in different materials (i.e. polypropylene, Teflonw or stainless steel), is advanced along the lead to disrupt and dilate the encapsulating fibrotic attachments. Bongiorni et al. 27 described the use of a dilator sheath after a failed attempt of simple traction. In 1193 patients, the use of a dilator sheath led to successful TLE in 85% of the leads (N ¼ 1514) aftera mean lead dwell time of 5.8 years. Three other single-centre studies specifically described the experience with mechanical dilator sheaths after unsuccessful TLE attempts using simple traction and locking stylets. 13,26,31 After a mean lead dwell time of 7 years, Cecchin et al. 13 reported that 20% of the leads were successfully extracted using dilator sheaths (N ¼ 20), resulting in a total success after simple traction, locking stylet, and mechanical sheath use of 54% (N ¼ 76). The remaining two studies described that in 8 23% (16%) of the patients (N ¼ 61) leads were extracted using a mechanical dilator sheath after failed previous steps. 26 Neither the implant duration of the leads nor complications related to mechanical dilator sheaths were described. 26,31 Mazzone et al. 31 reported no deaths related to the mechanical dilator sheath extraction procedure. Femoral snare A transfemoral approach is helpful when access or extraction via the implanting vein is impossible, or when the leads are fractured or cut. The needle s eye snare is the most frequently used tool for lead extractions via the transfemoral approach. Usually, the femoral snare is the last step in TLE. Eleven studies described their experience with femoral snares or lassos (Table 2). Two of these studies described their results using the needle s eye snare for lead extraction after a failed attempt of simple traction via the implanting vein; thus as second method in the stepwise approach. 10,33 In the first study by Bordachar et al., 33 the use of the needle s eye snare for TLE resulted in a clinical success in 96% of patients (N ¼ 49; mean lead age 12.5 years). There were no procedure-related deaths reported, major complications occurred in 2% (one patient with atrial rupture), and minor complications in 3.9% (one patient with pericardial effusion and one patient with tricuspid regurgitation). Bracke et al. 10 reported the results of the transfemoral approach in a large cohort of patients, and the mean dwell time of the leads was 7.6 years. After simple traction had failed, 98% of the remaining leads (N ¼ 334) were successfully extracted using the needle s eye snare. There were no procedure-related deaths, the occurrence of major complications was 0.6% (two patients with cardiac avulsion requiring surgical intervention), and no minor complications occurred. In eight studies, the extraction attempt using femoral snares or lassos was preceded by simple traction, the use of non-powered 11,21,26,31,34 37 tools, and/or powered tools. Only Kennergren et al. 35 described a multi-centre experience including 14 centres that after the usage of the femoral snare, successful extractions were achieved in 96% of the leads. Leads had been implanted years; clinical success of TLE by femoral snares was achieved in 86 94% of patients (N ¼ 48) and % (90%) of leads (N ¼ 120). This resulted in a total of successful extraction after the stepwise approach in 91 99% (95%) of patients (N ¼ 2445) and % (98%) of leads (N ¼ 830). In a large single-centre study by Bongiorni et al., 27 the TLE approach using simple traction, dilator sheaths, and/or a femoral snare was successful in 89% of the leads (N ¼ 1827). However, extraction of the remaining leads was attempted via a transjugular approach, resulting in a total success rate of 99% (N ¼ 2032). Powered traction tools Whereas non-powered sheaths use blunt dissection, powered extraction sheaths use an energy source to disrupt adhesions between the lead and the endothelial or endocardial wall. Powered sheaths include laser sheaths, electrosurgical dissection sheaths, and rotating threaded tip sheaths. Powered traction tools are usually applied when simple traction, while non-powered traction tools fail in a stepwise approach. Laser sheaths The excimer laser sheath slides over the implanted lead and utilizes a cool pulsed ultraviolet laser to vaporize adhesions that come into contact with the tip of the sheath. Since the penetration depth of the laser is only 100 mm, the vascular wall is not damaged by the sheath as it is advanced over the lead. In 1999, the laser sheath was first shown to have significant added value in TLE in the PLEXES trial (including nine centres) that demonstrated an increase of 30% in extraction rate in patients randomized for laser sheath extraction compared with manual traction and dilator sheath alone. 38 A decade later, the LExICon study retrospectively analysed 2405 laser-assisted lead extractions with the laser sheath as the primary tool for extraction, showing that laser sheath extractions were quite successful (clinical success 98%, 1416 leads, and 13 study centres). 39 The largest multicentre study on the use of laser sheaths to date was performed by Byrd et al. 40 in nine centres, describing 2561 laser-assisted extractions registered during a 1-year period in the USA and demonstrating a clinical success rate of 93% (N ¼ 2382). Between 1999 and 2013, 23 clinical studies published the success rate of laser-assisted lead extractions in cohorts.50 patients (Table 3). 11,18,19,28,31,33 36,38 51 The included studies consisted of three different approaches. First, studies in which patients underwent laser sheath extraction as the primary tool with a clinical success in 93 95% (94%) of patients (N ¼ 359) or 92 98% (95%) of leads (N ¼ 3921; lead age years). 33,38,40,41,47,50 Secondly, studies including patients after a failed extraction attempt using manual traction or non-powered extraction tools. 35,36,39,42,44,45,48,51 These studies showed clinical success in 93 98% (96%) of patients (N ¼ 2078) or 92 97% (95%) of leads (N ¼ 919; lead age years). Thirdly, patients who underwent laser sheath extraction as part of a stepwise approach, including initial manual traction and non-powered traction tools. 11,18,19,28,31,34,43,46,49 These studies demonstrated clinical success after stepwise approach in 85 96% (94%) of patients (N ¼ 471) and % (95%) of leads (N ¼ 2488; lead age years).

7 Table 3 Overview of lead extractions performed by powered extraction tools Author Year Centres Patients Leads Lead age, Failed Successful extraction a Complications Total successful extractions years previous steps by stepwise approach a... Per patient, Per lead, N (%) Death, Major Minor Per patient, Per lead, N (%) N (%) N (%) N (%) N (%) N (%)... Laser sheath Wilkoff None 1 (1%) 3 (2%) 2 (1%) 236 (97%) Epstein None 7 (1%) 32 (3%) b 1176 (92%) Byrd None 10 (1%) 31 (2%) 24 (1%) 2382 (93%) Gaca None 3 (3%) 4 (4%) 104 (93%) Bordachar None 2 (1%) 6 (2%) 2 (1%) 255 (95%) Sohal ,7 None 0 (0%) 2 (3%) 4 (6%) 127 (98%) Kennergren ST c 0 (0%) 0 (0%) 1 (1%) 170 (95%) Ghosh ST, LS c 0 (0%) 0 (0%) 6 (8%) 140 (97%) Kennergren ST c 0 (0%) 10 (3%) 4 (1%) 361 (94%) d Roux ST c 1 (1%) 5 (3%) 7 (4%) 248 (92%) d Scott ST c 0 (0%) 0 (0%) 0 (0%) 40 (93%) Wazni ST c 4 (0%) 15 (1%) 11 (1%) 1416 (98%) Rodriguez ST c 1 (0%) 6 (1%) b 22 (4%) 489 (97%) Wang ST c 1 (1%) 6 (4%) 8 (6%) 133 (95%) Moon ST, LS 107/111 (96%) 0 (0%) 225 (98%) d Bracke ST, LS 87/96 (91%) 136 (94%) d Bracke ST, LS 43/55 (78%) 2 (2%) 6 (7%) 0 (0%) 70 (85%) Jones ST, LS 694/757 (92%) 0 (0%) 2 (0%) 911 (93%) d Agarwal ST 156/159 (98%) 203 (96%) Kennergren ST, NPS 610/615 (99%) 978 (95%) d Maytin ST 51/52 (98%) 0 (0%) 0 (0%) 238 (100%) Viganego ST, LS, NPS 33/33 (100%) d 0 (0%) 50 (96%) Mazzone ST, ST+LS, NPS 67/73 (92%) 0 (0%) 2 (1%) 4 (3%) 148 (93%) Electrosurgical dissection sheath Neuzil ST c 0 (0%) 83 (99%) Scott ST c 0 (0%) 1 (3%) 0 (0%) 26 (84%) Cecchin ST, LS, NPS 61/78 (78%) 0 (0%) 151 (74%) d Continued The efficiency and safety of transvenous lead extraction methods 695

8 696 M.S. Buiten et al. Table 3 Continued Successful extraction a Complications Total successful extractions by stepwise approach a Failed previous steps Author Year Centres Patients Leads Lead age, years Per patient, Per lead, N (%) Death, Major Minor Per patient, Per lead, N (%) N (%) N (%) N (%) N (%) N (%)... Evolution Oto ST, LS c 0 (0%) 1 (2%) 2 (3%) 58 (88%) d Mazzone ST, ST+LS, NPS 35/48 (73%) 0 (0%) 1 (1%) 3 (2%) 119 (88%) Categorical variables are expressed by N (%) and continuous variable by mean. N, Number; ST, simple traction; LS, locking stylet; NPS, non-powered sheath (mechanical dilator sheath). a Successful extractions are either reported per lead (preferably) or per patient. b Complications were not further specified. c Patients with successful extraction using ST or LS were excluded from this study. d Major complications were not taken into account for the determination of true clinical success rates. Complications were reported specifically for laser sheath extractions in 20 studies. The described 28,31,33 36,38 42,44 48,50,51 procedure-related mortality was 0 2.7% (N ¼ 32), with major complications in 0 7.3% (N ¼ 130) and minor complications in 0 8.0% (N ¼ 95). The most common major complications were cardiac avulsion (0 7.3%, N ¼ 53) and vascular avulsion (0 3.6%, N ¼ 37). High complication (7.3%, N ¼ 6) and mortality rates (2.4%, N ¼ 2) were reported by Bracke et al. 34 The authors stated that first-generation laser sheaths might have been less flexible than the current model and that overconfidence in the laser sheath might have caused these high complication rates. 34 Lack of a cardiothoracic surgeon present in the operating room during laser-assisted lead extraction was described as a reason for the high incidence of mortality (2.7%, N ¼ 3) by Gaca et al. 47 Except for these two studies, procedure-related mortality showed an upper range of 0.8% and the highest reported major complication rate of laser sheath extraction was 4.3%. The most common minor complications were haematoma (0 2.9%, N ¼ 15) and arm swelling (0 5.3%, N ¼ 11). Electrosurgical dissection sheath The electrosurgical dissection sheath (EDS) utilizes radiofrequency energy, similar to the cautery tool used in surgery, to cut through fibrous tissue. Two electrodes are exposed at the tip of the sheath, which allows linear dissection of adhesions comparable to a cautery tool. As opposed to the laser sheath, the EDS permits localized application of energy instead of circumferential dissection. There are three large single-centre studies that described the performance of EDS in TLE, with an average lead age of years (Table 3). 13,36,52 Neuzil et al. 52 randomized 120 patients for primary EDS-assisted extraction vs. dilator sheath extraction and demonstrated a clinical success rate of 99% (83 out of 84 leads). Scott et al. 36 compared EDS extractions with laser sheath extractions and showed clinical success in 84% of patients (N ¼ 26), without prior manual traction. Cecchin et al. 13 reported their experience of 203 lead extractions in paediatric patients and patients with congenital heart disease using a stepwise approach with manual traction, nonpowered tools, and EDS. A total of 35 leads were abandoned after manual traction failed. 13 The clinical success after stepwise approach was 74% (N ¼ 151; median age 7.0 years). The EDS was successful in extracting the lead in 61 out of 78 attempts (78%). This somewhat low success rate might be explained by the complexity of this paediatric patient population suffering from congenital heart disease. Complication rates were described in all three studies that investigated extraction procedures utilizing EDS. 13,36,52 Unfortunately, only one of these studies specifically described complications associated with the use of EDS. Scott et al. 36 observed one case of cardiac tamponade in the EDS group requiring surgery (3% of patients). No procedure-related deaths were reported in any of the three studies. Whereas laser lead extraction has been extensively described in the literature, relatively limited data exists on EDS. More data describing the success rate of EDS and especially the complications associated with of EDS are needed. Rotating threaded tip sheaths The most recent addition to the equipment of the lead extractionist is a hand powered rotating threaded tip sheath. This sheath is attached

9 The efficiency and safety of transvenous lead extraction methods 697 to a handle which controls the rotation of a threaded screw mechanism at the tip of the sheath causing it to bore through adhesions around the lead. The Evolutionw is currently the only rotating threaded tip sheath available and it has been advocated as especially advantageous in disrupting calcified fibrosis. 53 Since its introduction in 2009, there have been a few studies reporting on the experience of the rotating threaded tip sheath with only two single-centre studies large enough to be included in the present review (Table 3). 31,54 Oto et al. 54 reported on their experience in 66 patients who underwent lead extraction with the Evolution tool, after failed manual traction. The complete success rate attributed to the Evolution tool was 88%, with an average lead age of 7.1 years. Mazzone et al. described the use of the Evolution tool in a stepwise approach with successful extraction after manual traction, non-powered sheaths, and the Evolution tool in 88% of patients (N ¼ 119). The Evolution tool was successful in 35 of the 48 attempts (73%). Lead age was not reported in this study. Major complications occurred in % of patients (N ¼ 2), with vascular tear requiring surgery in both patients. 31,54 Minor complications occurred in % of patients (N ¼ 5), with haematoma being the most common ( of patients, N ¼ 2). 31,54 As with EDS, more data are necessary to provide insight in the clinical success rate and complication rates of TLEs using rotating threaded tip sheaths. Extraction methods per lead type Pacemaker (pace/sense) vs. implantable cardioverter-defibrillators (high voltage) leads The shock coils of high-voltage ICD leads allow fibrous ingrowth, resulting in dense vascular and myocardial adhesions. 6 Therefore, ICD leads might offer an additional challenge and could have an increased risk of complications, as compared with regular PM leads. Only 5 of the 43 included studies described the success rates of PM leads specifically (Table 4). 10,19,22,37,52 All studies reported singlecentre experience. The success rate of PM lead extraction described in these studies was % (99%). Only two studies reported a lead age ( years), while no complications or mortality rates were reported. 19,37 Implantable cardioverter-defibrillator lead extractions have been described in nine studies with a complete success rate of % (99%) of leads or % (96%) of patients. 6,7,14,17,19,22,35,52,54 Average lead age was years. Four studies specifically investigated defibrillator leads. 6,7,14,17 Camboni et al. 17 reported non-lethal complications in 15.1% of patients (N ¼ 8), including (but not specified) pneumothorax, haematothorax, pericardial effusion, pocket haematoma, and wound infection. In a multi-centre study (N ¼ 9), Epstein et al. 6 observed major complications in 0.8% of their population (N ¼ 18), including cardiac avulsion (N ¼ 10), vascular avulsion (N ¼ 3), and respiratory failure (N ¼ 1). In another multi-centre study (N ¼ 24), Atallah et al. 14 demonstrated complications in 4% of patients (N ¼ 5) associated with ICD lead extraction. This included three vascular tears, one moderate tricuspid regurgitation, and one complication was not specified. 14 Bongiorni et al. 7 observed no major complications in their large single-centre study experience. In 13 patients (2.4%), however, a minor complication occurred. Mortality associated with ICD lead extraction was 0 0.1% in seven studies, with death observed only in a single patient in a single study. 6,7,14,17,22,52,54 Left ventricular lead extraction Extraction of LV leads from the afferent, epicardial branches of the CS is not comparable with the extraction of traditional endocardially positioned right ventricular (RV) and right atrial (RA) leads. There are concerns regarding perforation of the tortuous and fragile CS and complications in the often frail CRT recipients. Currently, four large single-centre studies specifically describe LV lead extraction, with a reported clinical success rate in 97 99% (98%) of patients (N ¼ 371) or 98% of leads (N ¼ 122), using a stepwise approach including simple traction, non-powered 25,55 57 sheaths, powered sheaths, and femoral snares (Table 4). Notably, all four studies reported a relatively high percentage of LV leads extracted using simple traction [70 93%, (84%) of leads, N ¼ 406]. This observation might be explained by the relatively short implantation duration of the leads (1.5 3 years). Positioning of extraction tools inside the CS was rarely needed (N ¼ 6), and mostly involved Medtronic Starfix leads (N ¼ 3), which is reported to be difficult to extract. 25,56 Three singlecentre studies describing LV lead extraction as part of a larger cohort report a clinical success in % of leads after a stepwise approach (N ¼ 117). 8,10,22 Procedure-related death occurred in one patient (0.9%) in one study ,55 57 The complication rate was described in four studies. Vascular tear with tamponade was reported in % of the patients (N ¼ 4) Further major complications were respiratory failure (N ¼ 1, 0.6%) and an infected haematoma requiring system extraction (N ¼ 1, 1.7%). 25,56 Minor complications were reported in % of the cases (N ¼ 33). The most frequently reported complication was bleeding, which occurred in % of the 23,46 48 patients (N ¼ 21). Discussion Since the first report on lead extraction procedures in 1968, several hundreds of extractionists have shared their experience with TLE. 58 The more remarkable it is that even after almost half a decade of experience with TLE, there is still no standard approach for transvenous extraction of PM and/or ICD leads. In 2009, the HRS consensus document provided an overview of the available equipment and conditions to be met for TLE, but no recommendations were given on the choice of extraction tool or when to cross-over to another tool. 5 Obviously, there are many factors influencing the success and complication rate of TLE besides the type of extraction tool or approach used. Factors influencing the outcome of lead extraction procedures are lead implantation duration, lead tip location (RA, RV, or CS), lead properties (presence of defibrillator coils, active or passive leads, and insulation material), TLE indication (infectious or non-infectious) patient anatomy, and, undoubtedly, the experience of the physician performing the TLE. 6,45 In addition, the degree of fibrosis and the location and strength of adhesions vary between patients independent of implant duration. In other words,

10 698 Table 4 Overview of lead extractions per lead type Author Year Centres Patients Leads Lead age, Procedural success, stepwise per lead Complications Total successful extractions years by stepwise approach a ST (1LS) NPS PS Femoral Death, Major, Minor, Per patient, N Per lead, (%) N (%) N (%) (%) N (%)... PM lead extraction Byrd /101 (82%) 33/33 (100%) 0 (0%) 0 (0%) 0 (0%) 115 (100%) Neuzil /70 (86%) 78/79 (99%) 0 (0%) 141 (98%) Kennergren (99%) Geselle /75 (85%) 46/48 (96%) 57/67 (85%) 0 (0%) 184 (97%) Bracke /440 (26%) 320/440 (73%) 434 (99%) ICD lead extraction Kennergren /50 (90%) 45 (90%) Neuzil /7 (57%) 11/12 (92%) 0 (0%) 15 (88%) Camboni /53 (32%) 36/53 (68%) 0 (0%) 53 (100%) Kennergren (100%) Oto /49 (92%) 4/49 (8%) 0 (0%) 49 (100%) Geselle /16 (100%) 11/11 (100%) 28/28 (100%) 0 (0%) 55 (100%) Epstein /2274 (27%) 409/2274 (18%) 1251/2274 (55%) 1 (0%) 18 (1%) 2182 (99%) Atallah /132 (50%) 31/132 (24%) 35/132 (27%) 0 (0%) 4 (3%) 1 (1%) 124 (98%) Bongiorni /582 (6%) 484/582 (83%) 58/582 (10%) b 0 (0%) 0 (0%) 13 (2%) 577 (99%) CS lead extraction Williams /60 (90%) 5/60 (8%) 0 (0%) 1 (2%) 3 (5%) 57 (97%) Di Cori /147 (70%) 39/147 (27%) 4/147 (3%) 0 (0%) 1 (1%) 4 (3%) 143 (99%) Sheldon /125 (93%) 6/125 (5%) 2/125 (2%) 1 (1%) 2 (2%) 13 (11%) 122 (98%) Rickard /173 (77%) 40/173 (23%) 0 (0%) 2 (1%) 13 (8%) 171 (99%) Geselle /14 (79%) 1/14 (21%) 0 (0%) 12 (86%) de Bie /67 (98%) 1/67 (2%) 67 (100%) Bracke /36 (61%) 14/36 (39%) 36 (100%) Categorical variables are expressed by N (%) and continuous variable by mean. N, Number; ST, simple traction; LS, locking stylet; NPS, non-powered sheath (mechanical dilator sheath); PS, powered sheath; PM, pacemaker; ICD, implantable cardioverter-defibrillator; CS, coronary sinus. a Successful extractions are either reported per lead (preferably) or per patient. b Combined jugular femoral approach in this particular study. M.S. Buiten et al.

11 The efficiency and safety of transvenous lead extraction methods 699 every TLE procedure poses specific impediments, hampering comparison of the various studies and the composition of recommendations. Therefore, it is not surprising that different physicians have developed different preferences in their use of extraction tools and extraction approaches in specific situations. The most important drawback of these variations in approaches is, however, that no benchmark exists for the success or complication rate of TLE. As a consequence, it is difficult for physicians to criticize and improve their own results. In the majority of the referenced studies, a stepwise TLE approach was utilized starting with simple traction, resulting in successful extraction in 7 85% of leads. When applicable, the TLE procedure was continued by using non-powered tools (locking stylet or dilator sheath) after which 34 87% of the leads was successfully extracted. When still unsuccessful, extraction was attempted by using powered tools (laser or EDS), and the success rate of this approach was %. In the majority of the cases, the final step of the TLE procedure was via femoral snare leading to a success of %. The current review demonstrates that such a stepwise extraction approach can result in safe and successful extraction in up to 100% of patients, regardless of the specific extraction tool used. These results are surprisingly good with relatively few complications. However, the complications that do occur are often life threatening, necessitating acute (surgical) intervention. In the referenced studies, the course of 129 of all major complications was explicitly described. In 106 (82%) patients acute surgical intervention was required, of which 80 (75%) patients survived. This emphasizes that adequate surgical backup is of great importance and significantly reduces perioperative mortality. The diversity of tools, techniques, and approaches used today mirrors the fact that the ideal method of TLE still needs to be developed. Due to the wide range of possible hurdles that can be encountered during TLE, however, a supreme tool, technique, or approach might not exist. Thus, the use of the various tools for TLE is not mutually exclusive but synergistic. Although the majority of the reported studies utilized an approach using consecutive extraction techniques, initially via subclavian venous access, some groups describe a method in which a single extraction tool was used via multiple venous access approaches (subclavian, femoral, and jugular). The advantage of the latter method is that only one extraction tool needs to be mastered. In the near future, the results of the ELECTRA registry will providedataonleadextractioninapproximately80european medical centers. 59 Reports on such extensive experience will be valuable to further improve the practice of TLE and although the development of directives may be a bridge too far, it may lead to development of recommendations regarding extraction approaches and the timing of cross-over to the next extraction tool. This review was limited by the fact that tools of the same category are not identical (i.e. various types and brands of locking stylets, mechanical sheaths, and laser sheaths exists). Furthermore, due to the heterogeneity in the referenced studies, efficacy and safety of the different tools could not be compared. The authors of this review attempted to include all important experiences regarding TLEs currently available, by performing a broad search in all relevant databases. However, it is still possible that some studies have been omitted in the present manuscript. Conclusion This systematic review on success and safety of the different TLE methods demonstrates that a stepwise extraction approach can result in a clinical successful TLE in up to 100% of the leads with a relatively low risk of procedure-related mortality and complications. The future of lead extraction would benefit from recommendations regarding extraction approaches and the timing of cross-over to a different extraction method in order to further improve success rates and prevent unnecessary complications. Conflict of interest: The Department of Cardiology received unrestricted research grants from Biotronik, Boston Scientific, GE Healthcare, Medtronic and St. Jude Medical. References 1. 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