Overcoming the current issues surrounding device

Expert Review of Medical Devices

ISSN: 1743-4440 (Print) 1745-2422 (Online) Journal homepage: http://www.tandfonline.com/loi/ierd20

Overcoming the current issues surrounding device leads: reducing the complications during extraction Maria Grazia Bongiorni, Luca Segreti , Andrea Di Cori, Giulio Zucchelli, Luca Paperini, Stefano Viani & Ezio Soldati To cite this article: Maria Grazia Bongiorni, Luca Segreti , Andrea Di Cori, Giulio Zucchelli, Luca Paperini, Stefano Viani & Ezio Soldati (2017) Overcoming the current issues surrounding device leads: reducing the complications during extraction, Expert Review of Medical Devices, 14:6, 469-480, DOI: 10.1080/17434440.2017.1332990 To link to this article: http://dx.doi.org/10.1080/17434440.2017.1332990

Accepted author version posted online: 18 May 2017. Published online: 31 May 2017. Submit your article to this journal

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Date: 10 June 2017, At: 16:14

EXPERT REVIEW OF MEDICAL DEVICES, 2017 VOL. 14, NO. 6, 469–480 https://doi.org/10.1080/17434440.2017.1332990

REVIEW

Overcoming the current issues surrounding device leads: reducing the complications during extraction Maria Grazia Bongiorni, Luca Segreti

, Andrea Di Cori, Giulio Zucchelli, Luca Paperini, Stefano Viani and Ezio Soldati

Second Division of Cardiovascular Diseases, Cardiac and Thoracic Department, New Santa Chiara Hospital, University of Pisa, Pisa, Italy ABSTRACT

ARTICLE HISTORY

Introduction: The implantation rate of cardiac implantable electronic devices has consistently increased in the last 20 years, as have the related complication rates. The most relevant issue is the removal of pacing and implantable cardioverter defibrillator (ICD) leads, which a few months after implantation tend to develop intravascular fibrosis, often making extraction a challenging and risky procedure. Areas covered: The transvenous lead extraction (TLE) scenario is constantly evolving. TLE is a key procedure in lead management strategies. Many efforts have been made to develop new TLE approaches and techniques allowing a safe and effective procedure for patients. The increasing rate of cardiac implantable electronic device (CIED) implantations and of CIED related complications highlight the importance of TLE. Lead related- and patient-related factors may change the future of extractions. We review the current status of TLE, focusing on the strategies available to perform the optimal procedure in the right patient and reducing procedure related complications. Expert commentary: Understanding the importance of an accurate TLE risk stratification is mandatory to optimize the procedural risk-to-benefits ratio. The use of adequate tools, techniques and approaches, and appropriate training are cornerstones for the achievement of safer procedures.

Received 4 April 2017 Accepted 17 May 2017

1. Introduction In recent years, the number of cardiac implantable electronic device (CIED) complications has steadily increased due to the growing of annual devices implantations, more complex devices and procedures, higher-risk patients, lead malfunctions and recalls [1–4]. Transvenous lead extraction (TLE) is the gold standard in the treatment of CIED-related infective complications and is often required in the management of lead malfunction. From the beginning of lead extraction in the 1980s, techniques have developed from simple traction to counter-traction using locking stylets and mechanical or powered sheaths to disrupt or dissect lead adherences. The leads were approached via the superior veins but femoral and jugular approaches were also described [5]. In the last 15 years, there have been a high number of reports of single and multicenter experiences, a few registries and one randomized multicenter trial [6]. The North American Society of Pacing and Electrophysiology (NASPE) in 2000, the Heart Rhythm Society (HRS) in 2009, and the European Heart Rhythm Association (EHRA) in 2012 published recommendations on TLE with well-defined indications and definitions allowing accurate estimation of success and complication rates [7–9]. A European survey administrated by EHRA in 2012 provided a snapshot of the clinical practices and physicians’ attitudes toward TLE in Europe, also highlighting that TLE

CONTACT Luca Segreti 2, 56124, Pisa, Italy

[email protected]

© 2017 Informa UK Limited, trading as Taylor & Francis Group

KEYWORDS

Transvenous lead extraction; complications; device leads

was still under developed across European countries regarding appropriate indications, tools, techniques, success rates and complications [10,11]. Finally, the ELECTRa (European Lead Extraction Controlled) Registry was the first and largest European Registry of consecutive patients undergoing TLE procedures, conducted to reflect the reallife experience of 73 centers in 19 European countries [12].

2. TLE procedure and trends: news of the world Expanding indications for cardiac implantable electrophysiological devices (CIEDs) have led to an increasing number of implanted leads. Moreover, in the last years, increasing patient comorbidities and increased life expectancy contribute to the increased need for lead extraction. At the moment, an estimated 30.000 device leads are extracted annually worldwide [13]. Since TLE procedures are going to further increase in the next future, a safer approach is advisable. The goal of extraction techniques of chronic pacemaker and defibrillator leads is to present an approach that is successful in extracting all leads and minimizes or eliminates complications. Fibrosis occurs predominantly on areas of lead that contact the vascular endothelium or endocardium (like the venous entry site, the superior vena cava, and the lead tip) and may be affected by clinical (patient-related) and technical (device-related) factors [14]. Patient related factors, like age (young patient show often a massive fibrotic reaction) and anatomy, are, by definition, ‘non-modifiable.’ The best we can do is to implant properly, the right device in the

Second Division of Cardiovascular Diseases, New Santa Chiara Hospital, University of Pisa, Via Paradisa

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right patient. Lead characteristics consistently affects reactive fibrosis [15]. In the last 20 years, designs are largely improved. Active fixation mechanisms [16], tip steroid eluting technologies [17], new insulators [18], isodiametric designs, and single covered coil technologies [19–21], all demonstrated to reduce inflammation and fibrosis, facilitating TLE. Despite all potential improvements in prothesis design and technology, transvenous endocardial lead continues to be the source of many implantation complications and TLE risk. New pacing and defibrillating systems have been introduced in order to leave the vessels and the heart completely or partially ‘untouched’) [22]. Among the methods for lead extraction, use of a laser extraction technique has become common place not only for cardiac surgeons, but also for electrophysiologists, sometimes without surgical backup. Although laser-assisted extraction is highly efficacious, it is an independent predictor of major morbidity among lead extraction techniques. A meta-analysis of the last 15 years of experience in lead extraction was recently published (6). 62 studies on transvenous lead extraction were evaluated and 13,000 patients (69% men, mean age 64 y) with 20,000 leads (pacing 79%, ICD 17%, CS 4%) enrolled. Infection was the leading indication of extraction (55%). In the overall population, complete removal was 94%, major complications 1.7%, and death rate 0.3%. The meta-regression analysis identified the following variables associated with worst outcome: patient age, presence of leads in situ for more than 1 year, presence of device infection, and use of laser sheath. In particular, the use of laser sheath was associated with increased risk of major complications or death among the entire population (p = 0.029) despite being associated with higher technical success of extraction (p = 0.003). In presence of infection, where a greater push for complete extraction is obviously searched, a greater technical success is obtained with mechanical extraction, while the laser approach seems to carry more complications. Possible explanations for the higher incidence of complications associated with laser extractions: (a) a decrease in venous wall stiffness after lasing, which creates a tunnel around the extracted lead: this is both related to laser action and to the larger size of the sheath adopted (12–16 Fr); (b) The delivery of a fixed amount of energy by the laser sheath irrespective of the tenacity of binding sites without any feedback about the force applied by the operator. The results demonstrate fairly low concomitant morbidity and mortality, yet the focus should remain on further minimizing the risk profile of the procedure.

preparation of the patient, the delivery of anesthesia, and opening and closing the incision. – Post-procedural complication: Any event related to the procedure that occurs or becomes evident within 30 days following the intra-procedural period. Extraction events are classified as major complications, minor complications, or observations, according to their severity, as described below. Examples of classifications using these definitions are shown in Table 1. The definitions for level of severity are: – Major complication: Any of the outcomes related to the procedure which is life threatening or results in death. In addition, any unexpected event that causes persistent or significant disability, or any event that requires significant surgical intervention to prevent any of outcomes listed above. – Minor complication: Any undesired event related to the procedure that requires medical intervention or minor procedural intervention to remedy, and does not limit persistently or significantly the patient’s function, nor does it threaten life or cause death. Several factors have been associated with a more difficult and subsequently more challenging and dangerous lead extraction procedures (Table 2). One of the most important factors that makes the lead extraction more difficult is the longer time from implantation [23,24]. After many years from implantation, fibrous adhesions around the lead can become hard and sometimes calcified, which make the extraction extremely difficult and can require an alternative approach.

Table 1. CLASSIFICATION OF COMPLICATIONS. Classification Major complication

Examples 1. Death 2. Cardiac avulsion or tear requiring thoracotomy, pericardiocentesis, chest tube, or surgical repair 3. Vascular avulsion or tear (requiring thoracotomy, pericardiocentesis, chest tube, or surgical repair) 4. Pulmonary embolism requiring surgical intervention 5. Respiratory arrest or anesthesia-related complication leading to prolongation of hospitalization 6. Stroke 7. Pacing system-related infection of a previously noninfected site

Minor complication

1. Pericardial effusion not requiring pericardiocentesis or surgical intervention 2. Hemothorax not requiring a chest tube 3. Hematoma at the surgical site requiring reoperation for drainage 4. Arm swelling or thrombosis of implant veins resulting in medical intervention 5. Vascular repair near the implant site or venous entry site 6. Hemodynamically significant air embolism 7. Migrated lead fragment without sequelae 8. Blood transfusion related to blood loss during surgery 9. Pneumothorax requiring a chest tube 10. Pulmonary embolism not requiring surgical intervention

3. TLE complications: the game According to guidelines, either the recording of all complications or the correct definition of complications is crucial for quality assessment and quality improvement. The definition and assessment of complications requires both a time frame and a level of severity. The standard methodology used to classify surgical complications is by the time of occurrence. The definitions for time frames are: – Intra-procedural complication: Any event related to the performance of a procedure that occurs or becomes evident from the time the patient enters the operating room until the time the patient leaves the operating room. This includes complications related to the

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Table 2. Lead extraction: factors associated with higher procedural risk (modified from [9]). Factor Body mass index Sex Congenital heart disease Comorbidities Venous status Number of leads Implantation time Fixation mechanism Lead bodygeometry ICD lead Special/Damaged leads Volume’s center Operator’s experience Tools, technique, approaches

Criteria 90th PCTL) both at univariate and multivariate analysis. A receiver-operating characteristic analysis showed an area under the curve of 0.81. A LED score greater than 10 could predict fluoroscopy time above 90th PCTL with a sensitivity of 78.3% and a specificity of 76.7%. In the work by Fu et al. [59], a total of 1,378 leads (mean lead age 57.6 ± 58.8 months) were removed from 652 (age 64 ± 17 years, M 68%) patients undergoing 702 procedures. In total, 44% of leads required laser-assisted extraction. Overall lead duration and an implantable ICD lead were associated with the need for laser extraction and procedure failure. Longer lead duration was associated with major complications (overall 1.9%). High-risk patients (with a > 10-year-old pacing or a > 5-year-old ICD lead) had significantly higher major events than moderate-risk (with pacing lead 1–10 years old or ICD lead 1–5 years old) and low-risk (any lead < 1-year-old) patients (5.3%, 1.2%, and 0%, respectively; P < 0.001).

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5. SVC-RA junction: hot space All extractors are afraid of the SVC-RA junction, and it remains one the most site prone to injury. During laser extraction procedures, injuries in this region were responsible for 36% of all vascular tears [60]. Since the pericardial reflections extends only partially up onto the SVC, a tear in this region can cause undiagnosed pleural or mediastinal bleeds and not a pericardial effusion (that is more simple to diagnose). Stiff laser sheaths use and dual coil ICD leads extraction can be associated with this kind of complication [19]. However, since often complications in these anatomical regions are not predicable, a number of hybrid procedures have been developed. These have included novel methods like direct visualization of the SVC-RA junction by a limited local thoracotomy or thoracoscopy [61–63] and retrograde laser use via right atriotomy [64]. The hybrid approach, with minithoracotomy or thoracoscopy, is feasible and it might increase the safety in the most challenging TLE procedures: the minimally invasive surgical intervention allows for continuous monitoring of the critical cardiac structures and prompt treatment of potential complications. However, since definitive data on these techniques are lacking, no routine recommendation on their use can be done. Despite the high success rate obtained with all extraction tools, techniques and approaches, TLE procedures may still result in deaths and cardiovascular injuries due to venous tears and myocardial perforations [13,19]. A study evaluating catastrophic complications occurring during transvenous lead extraction, demonstrated 25 cases (0.8%) over a 16-year period that required emergent surgical or endovascular intervention [60]. Laceration of the right atrium, superior vena cava (SVC), or innominate vein was responsible for the majority (64%) of deaths and injuries. Tears in the SVC usually prompt sudden hemodynamic compromise associated with high mortality and generally necessitate immediate surgical intervention. Though tears are rare, when they do happen the rapid blood loss can be difficult to manage. Recently, different tools, designed to mitigate such as complications, the Bridge Occlusion Balloon (Spectranetics

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Corporation, Colorado Springs) and the CODA Endovascular Occlusion Balloon (Cook Medical, Bloomington, Indiana) were recently developed: the devices are intended to reduce blood loss during a SVC tear. If an SVC tear occurs, the occlusion balloons deploys in less than 2 min, occludes the tear and stems 90% of the blood loss for at least 30 min. Moreover, the use of endovascular stent grafting to repair superior vena cava laceration and control hemorrhage has been successfully demonstrated through several case reports as an alternative to open surgical repair [65].

6. Mechanical sheaths and the internal transjugular approach: a kind of magic Peculiarities of our extraction technique, previously described [52], are represented by: (1) normal stylet insertion, easy to remove in case of crossover to a different approach, (2) special knot, that does not increase the diameter of the lead, (3) the use of single polypropylene sheath, with the inner diameter very close to the diameter of the lead, advanced with rotational movements, (4) the internal jugular approach. As a matter of fact, our approach consists in adherence dilatation using a single polypropylene sheath with a normal stylet inside the lead. This approach is, in our opinion, not dangerous, because the sheath penetrates the space between the lead and the adherences. When traction on the sutures is maintained, the lead decreases its circumference and is possible to separate it from the adherences enough to allow sheath penetration. When dilatation is correctly performed, adherences break and remain attached to the vascular wall, with no risk of complications. This is very important at the SVC level (Figure 1). If adherences are calcified, the single sheath technique is often successful, but rotational movement must be performed for a considerable length of time while the right hand feels for rupture of the calcium. In ICD leads, dilatation of coil adherence is possible, although very often

Figure 1. Clockwise and counterclockwise single-sheath movement: (a) before entering the adherence and (b) inside it at the superior vena cava level. At this point, correctly performing the dilatation, the adherence breaks and remains attached to the wall, with no risk of complications. During dilation, smooth traction on the suture(s) is performed to maintain strain on the lead and thus use it as a rail. Reproduced from [66] with permission of Springer.

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using a larger sheath is necessary to avoid coil disruption. When dilating coil adherence, sheath progression is visible at fluoroscopy at each turn. While maintaining strain on the lead and after checking stylet insertion to the lead tip, rotational advancement of the sheath is continued under fluoroscopic, ECG, and blood pressure monitoring. Once the distal binding site around the base of lead tip is disrupted, the lead comes out abruptly and enters the sheath. Sheath advancement, tunneling, and tip dislodgement are illustrated in Figure 2. The internal jugular venous approach is used (1) in case of an unsuccessful approach from the venous entry site, (2) as a first choice in the presence of free-floating leads with attached tip. Difficult sheath advancement and lead damage during extraction procedure, and free-floating leads are situation that can potentially negatively affect lead extraction procedure outcome. Standard solution can be represented by: lead traction, upsize the dilator, switch to a powered mechanical sheaths or to a femoral approach. All of the previous situations were associated with possible complications (Table 3). The internal transjugular approach can be the definitive solution in all of these situations. In our experience when, despite the use of a larger sheath, advancement of the sheath was stopped at any site of adherence for 5 min, or when dilatation was judged too risky, the internal transjugular approach was considered. In brief, a tip-deflecting wire was advanced via the femoral vein and the lead was grasped at the level of the right atrium or superior vena cava, distally to the site where dilatation had been stopped. Slight traction was applied in order to assess the possibility of slipping the lead and making it free floating. When the lead could not be slipped through, the possibility of grasping it proximally to the site of adherence and making it free floating was checked. After removal of the stylet and the suture, the lead was made free floating by applying traction from femoral vein by means of the tip-deflecting wire. The right internal jugular vein was then percutaneously cannulated by means of an 11 French introducer. A Lasso (Osypka GmbH) was advanced through the jugular vein, the proximal end of the lead was captured as close as possible to its end, and the lead was retrieved through the jugular vein and exposed. The exposed lead was then extracted by means of a percutaneous procedure that

Table 3. Critical points during pacing and implantable cardioverter defibrillator (ICD) lead removal. Critical point & problems

Standard approach limitations

Difficult sheath advancement – Use of larger sheaths precluded – Difficult dilatation, power ineffective – Narrow costo-clavicular – No rail effect Space – Tight & calcified binding sites – Hard turns in lead course Lead damage – Damage or loss of the insulation – Damage of the inner coil – Damage of the ICD coil – Cables externalization

– Obstacle to traction & dilatation with further damage – Stylet stops early – Snow-plowing effect – Snow-plowing effect

Free-floating leads

– Venous entry site approach impossible – Femoral extraction techniques may be irreversible – Femoral approach ineffective for dilatation

– Leads are free floating

uses the same tools as for a venous entry approach procedure using mechanical dilators (Figure 3). In case of free-floating leads, when the length of the lead cannot allow its exposure, the Lasso can be conveniently used as an extension of the lead itself, and dilatation performed by a dilating sheath previously inserted over Lasso’s body. In Figure 4 consecutive steps of the internal transjugular approach (ITA) in case of free-floating leads with anchored tips were reported. The results and complications of extraction procedure techniques using our approach is reported in Figure 5. A summary of traction, sheaths and approaches for transvenous lead extraction is reported in Table 4.

7. Electra registry: made in heaven The European Lead Extraction ConTRolled Registry (ELECTRa) [67] was the largest prospective registry of consecutive TLE procedures conducted by the European Heart Rhythm Association (EHRA). It was conducted in order to identify the safety and efficacy of the current practice of TLE. The primary end point was TLE safety defined by predischarge major procedure-related complications including

Figure 2. Clockwise and counterclockwise single-sheath movement: (a) before entering the adherence and (b) inside it at the apex of the right ventricle. Once the distal binding site around the base of the tip is disrupted (by tunnelling and tip dislodgement), the lead comes out abruptly and (c) enters into the sheath. Reproduced from [66] with permission of Springer.

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Figure 3. Consecutive steps of the internal transjugular approach (ITA) in case of crossover from the venous entry approach (VEA). (A) A tip deflecting wire is advanced via the femoral vein in order to assess the possibility to grasp the lead and to move it. (B) Once the lead has been grasped, it is pulled down in the inferior vena cava and slipped through the binding site; a Lasso, introduced through the internal jugular vein, is advanced near the proximal end of the lead. (C) The lead is caught by the Lasso, pulled up and exposed through the jugular vein. (D) Dilatation using a dilating sheath is performed. See the text for further details. TDW: tip deflecting wire. Reproduced from [50] with permission.

Figure 4. Consecutive steps of the internal transjugular approach (ITA) in case of free-floating leads with anchored tips. (A) A tip deflecting wire is advanced via the femoral vein in order to assess the possibility to grasp the lead and to move it. (B) Once the lead has been grasped, it is pulled down in the inferior vena cava; a Lasso, introduced through the internal jugular vein, is advanced near the proximal end of the lead. (C) The lead is caught by the lasso and then pulled up and exposed through the jugular vein. (D) Dilatation using a dilating sheath is performed. See the text for further details. TDW: tip deflecting wire; FF: free-floating lead. Reproduced from [52] with permission.

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Figure 5. Lead Extraction in Pisa: Outcome and Approaches (4554 leads – 2478 patients).

Table 4. Traction,sheaths, and approaches for transvenous lead extraction Success rate TRACTION

SHEATHS

APPROACHES

Traction with simple stylet

32% [50]

Complication rate 1.3% [50]

Traction with locking stylet

47 [50]

Not reported [50]

Mechanical sheaths

92.83% [6]

1.19% [6]

Mechanical powered sheaths

Few data

Few data

Laser sheaths

93.54% [6] §

3.04% [6] §

Venous entry site

71–95% [50], tools depending

Depends on tools

Internal jugular Femoral

98% [51] 97% [50] §

0.6% [51] 2% [50] §

Advantages & disadvantages Gentle traction is used in all TLE procedures Traction is less effective with standard stylet, but Crossover to different approaches is simpler Locking stylet increases tensile properties of the leads Failure & complication if excessive traction Crossover to different approaches not always possible More Operator dependent More tactile feedback (binding sites) Requires alternative approaches in 10% Cheaper In the middle between mechanical & laser sheaths Less operator dependent Less tactile feedback (binding sites) Rarely requires alternative approaches More expensive First choice approach for exposed leads Effective in the majority of cases Ineffective if hard turns in lead course See Table 3 Valuable approach for intravascular leads Ineffective for dilatation Often requires excessive traction on the leads Irreversible approach if improperly used New reversible tools are more expensive

§ Laser Sheaths & Femoral Routes were associated with a higher rate of complications and clinical failure in the ELECTRa [67] Registry.

death. Secondary end points included clinical and radiological success and overall complication rates. Outcomes were compared between low versus high volume centers (LoV 10 years (OR 3.54), with the use of powered sheaths (OR 2.4) and a femoral approach (OR 3.60). Predictors of clinical failure included: low volume centers (OR 2.23), female gender (OR 1.81), 3 or more leads targeted for extraction (OR 2.47), a lead dwell time >10 years (OR 4.0), the use of powered sheaths (OR 1.89), and a femoral approach (OR 3.93). Predictors of increased all-cause mortality during hospitalization were: extraction in a low volume center (OR 2.02), age >68 years (OR 2.42), NYHA Class III/IV (OR 4.08), and systemic infection (OR 4.93). The finding that older and sicker patients

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Table 5. Large published works in lead extraction outcomes and complications. ELECTRa (57)

LExICon (27)

Brunner (51)

PATIENTS CHARACTERISTICS – Patients, n

3555

1449

2999

– Age, years

66.8 ± 15.6

63.4 ± 17.1

67.2 (55.2–76.2)

– Male gender, n (%)

2566 (72.2)

1041 (71.8)

2093 (69.8)

– Ejection Fraction, %

45.5 ± 14.7

37.7 ± 16.6

35.0 (25.0–55.0)

– Coronary artery disease, n (%)

1396 (39.6)

728 (50.2)

1604 (53.5)

– Diabetes mellitus, n (%)

782 (22.1)

403 (28.1)

730 (24.3)

– NYHA Class III/IV, n (%)

495 (32%)

145 (41.6%)

607 (20.2)

– Infection, n (%) (systemic, local)

1872 (52.8) (19 33)

825 (56.9) (29 28)

1281 (42.7)

– Lead malfunction or abandoned

1439 (40.4)

547 (37.7)

1522 (50.7)

244 (6.8)

77 (5.3)

186 (6.2)

INDICATION FOR EXTRACTION

– Other LEAD CHARACTERISTICS – Leads, n

6493

2405

5521

– PM leads, n (%)

4917 (75.7)

1684 (70.0)

4137 (74.9)

– ICD leads, n (%)

1576 (24.3)

703 (29.3)

1384 (25.1)

0 (0)

18 (0.7)

0 (0)

5.0 (2.0–9.0)

6.8

4.7 (2.4–8.3)

– Right ventricle

3587 (55.2)

1528 (63.5)

3287 (59.5)

– Right atrium

2219 (34.2)

769 (32.0)

1865 (33.8)

– Coronary venous system

547 (8.4)

70 (2.9)

263 (4.8)

– Other or unknown locations

140 (2.2)

38 (1.6)

106 (1.9)

– Unknown leads, n (%) – Implant duration, median, years(IQR) – Location

PROCEDURAL OUTCOMES – Complete procedural success, n (%)

6212 (95.7)

2322 (96.5)

2853 (95.1)

– Partial procedural success, n (%)

184 (2.8)

56 (2.3)

113 (3.8)

– Failure, n (%)

97 (1.5)

27 (1.1)

33 (1.1)

– Clinical success, n (%)

3395 (96.7)

1416 (97.7)

2966 (98.9)

– Powered sheaths, n (%)

1757 (27.0)

2045 (100)

2369 (72.7)

– Mechanical sheaths, n (%)

2359 (36.3)

0 (0)

441 (14.7)

– Length of procedure min, median(IQR)

83 (57–120)

NA

135 (100–185)

9 (4–17)

NA

11.5 (5.7–21.6)

– Total MAEs, n (%)

95 (2.7)

63 (4.0)

115 (3.8)

– MAEs procedure related, n (%)

58 (1.7)

24 (1.4)

54 (1.8)

– Cardiac or vascular tear, n (%)

48 (1.4)

15 (1.0)

32 (1.1)

– Total Deaths, n (%)

50 (1.4)

27 (1.86)

67 (2.2)

– Deaths, procedure related, n (%)

17 (0.5)

4 (0.28)

6 (0.20)

– Fluoroscopy time, median(IQR) COMPLICATIONS

had an increased all cause mortality, independent of the procedure highlights the challenge of the clinical management of these patients especially after the TLE procedure. The finding of a higher all cause in-hospital major complications and death rate in LoV vs. HiV centers (4.1 vs. 2.4%, p = 0.01 and 2.5 vs. 1.2%, p = 0.008, respectively) suggests that the outcome of TLE is not only confined to the TLE procedure per se but is dependent on multiple patient factors and comorbidities that require an advanced and high skilled multidisciplinary team management that may only be facilitated in HiV centers. In the event of major complications

occurring after the procedure, patients may often be saved, if complications are recognized and treated promptly. A comparison of lead extraction outcomes and complications, in ELECTRa (57), LExICon (27), and Brunner’s paper [68], is reported in Table 4.

8. Reducing the complications during extraction: the miracle A multidisciplinary ‘heart team’ approach (electrophysiologists and cardiac surgeons) in an environment with appropriate

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training of the supporting staff for early detection and adequate management of complications associated with TLR appears to be more important than the solely the experience of the primary operator [8]. Transvenous lead extraction is not always straightforward, and extra precautions, with additional preoperative and intraoperative evaluations, should be taken in patients who are likely to present a difficult procedure. A comprehensive understanding of anatomic relationships and potential complications can minimize adverse outcomes with this complex procedure. Lead extraction requires training and experience to consistently deliver safe and effective care. Procedures must only be performed at centers with accredited cardiac surgery and cardiac catheterization programs. A cardiothoracic surgeon must be physically on site and capable of initiating an emergent procedure promptly. Lead extraction procedures should be preferably performed in hybrid rooms, with all the advantages and facilities of either electrophysiological rooms (high-quality fluoroscopy) or the operating theater (prompt and quick sternotomy). Physicians wishing to perform TLE procedures should be properly trained in extraction techniques and management of complications. Therefore, recommendations are based on these limited data as well as data available for other intravascular procedures. These studies demonstrated the steepest decline in complications over the first 30 cases, with a further continuous decline up to 400 cases [16,69,70]. As recently confirmed, small centers have a lower success rate with higher cumulative procedural MAE compared to high volume ones [27,71]. As stated by international societies, centers should carefully consider their learning curve and extraction volume, when decided to perform this procedure. Regarding extractors, as one can never predict the ease of extraction in any given individual, strong considerations should be given to starting with less challenging cases. Given the acknowledged learning curve for this procedure, a staged approach should be used when starting an extraction program. Finally, outcomes data are necessary to assess performance. A quality-oriented database should be maintained at each institution to document procedure outcomes. New approaches such as simulator training, proctorship, and fellow program are recommended to enhance proficiency [9]. A simulator program could seem to be the most effective way to provide practical experience in the different techniques and handling of extraction tools [72].

9. Expert commentary TLE is the gold standard in the treatment of CIED-related infective complications and is often required in the management of lead malfunction. At the moment, an estimated 30,000 device leads are extracted annually worldwide [13]. Since TLE procedures are going to further increase in the next future, a safer approach is advisable. TLE complications may be observed during or after the procedure with a various level of severity. Pocket hematoma, vascular damage, cardiac tamponade, pulmonary embolism are only the most common described complications and, if not managed, potentially fatal. Lead-related factor and patient-related factor affect consistently the procedural risk stratification. Appropriate TLE

indication is the first step. The second one is to perform the procedure in an appropriate center, with large TLE procedural volumes and back-up cardiac surgery. Finally, training has to be performed to have a complete learning curve in the use of technology to extract and manage complications. Several factors have been associated with a more difficult and subsequently more challenging and dangerous lead extraction procedures. At present, the best way to reduce complication and increase safety is prevention. Extracting the right patient, in the best location, using the appropriate technique/ approach, by an experienced team is recommended.

10. Five-year view Is it possible to reduce the complications rate during extraction? The first step is to optimize the risk benefits ratio of TLE procedures. Identification of predictors of complexity or complication is essential so as to improve TLE practice and skillness. The second step is to develop new TLE tools, making extraction more effective but no dangerous. The last one is to be prepared to manage complication during and after extraction. When a complication occurs, time is limited. Be ready means to save a life. New patient stabilization tools are now available, to save time, allowing a life-saving surgical procedure. At present, new electrical devices have been introduced. Subcutaneous ICD and leadless pacemaker may delivery therapy untouching the heart. They appear effective and reliable, with less risks for the patient when are implanted and when are removed. Unfortunately, pacing and defibrillating modalities are still limited. Until then, TLE procedures will continue to be necessary to remove endocardial leads and should be considered in centers of excellence with dedicated teams and concentrated volumes.

Key issues ● CIEDs indications, implantations and complications are rising. ● TLE is the gold standard in the treatment of CIEDs complications. ● TLE is proven to be safe and effective, but major complications are ever around the corner. ● Prevention is the best way to reduce TLE complications. ● Prevention include: TLE risk stratification, appropriate tool and technique selection, optimal location, skilled and experienced TLE team.

Funding This paper was not funded.

Declaration of interest M.G. Bongiorni reports grants from Boston Scientific, Medtronic, St Jude Medical and Biosense Webster. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

EXPERT REVIEW OF MEDICAL DEVICES

ORCID Luca Segreti

http://orcid.org/0000-0002-1421-9033

References Papers of special note have been highlighted as either of interest (•) or of considerable interest (••) to readers. 1. Greenspon AJ, Patel JD, Lau E, et al. Trends in permanent pacemaker implantation in the United States from 1993 to 2009: increasing complexity of patients and procedures. J Am Coll Cardiol. 2012;60:1540–1545. • Interesting epidemiological analysis focusing on trend in devices implantation. 2. Brignole M, Auricchio A, Baron-Esquivias G, et al. ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J. 2013;34:2281–2329. 3. Poole JE, Gleva MJ, Mela T, et al. Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures results from the REPLACE registry. Circulation. 2010;122:1553–1561. 4. Maytin M, Epstein LM. The challenges of transvenous lead extraction. Heart. 2011;97:425–434. 5. Byrd CL, Wilkoff BL, Love CJ, et al. Clinical study of the laser sheath for lead extraction: the total experience in the United States. Pacing Clin Electrophysiol. 2002;25:804–808.. • TLE using laser sheaths 6. Diemberger I, Mazzotti A, Giulia MB, et al. From lead management to implanted patient management: systematic review and metaanalysis of the last 15 years of experience in lead extraction. Expert Rev Med Devices. 2013;10:551–573. 7. Love CJ, Wilkoff BL, Byrd CL, et al. Recommendations for extraction of chronically implanted transvenous pacing and defibrillator leads: indications, facilities, training. North American Society of Pacing and Electrophysiology Lead Extraction Conference Faculty. Pacing Clin Electrophysiol. 2000;23:544–551. 8. Wilkoff BL, Love CJ, Byrd CL, et al. Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management. Heart Rhythm. 2009;6:1085– 1104. •• (Guidelines in TLE) The most important available consensus document on TLE. 9. Deharo JC, Bongiorni MG, Rozkovec A, et al. Pathways for training and accreditation for transvenous lead extraction: a European Heart Rhythm Association position paper. Europace. 2012;14: 124–134. •• (Guidelines in TLE) 10. Bongiorni MG, Blomström-Lundqvist C, Kennergren C, et al. Current practice in transvenous lead extraction: a European Heart Rhythm Association EP Network Survey. Europace. 2012;14:783–786. 11. Bongiorni MG, Marinskis G, Lip GY, et al. European centres diagnose, treat, and prevent CIED infections: results of an European Heart Rhythm Association survey. Europace. 2012;14:1666–1669. 12. Bongiorni MG, Romano SL, Kennergren, et al. ELECTRa (European Lead Extraction ConTRolled) Registry—shedding light on transvenous lead extraction real-world practice in Europe. Herzschrittmacherther Elektrophysiol. 2013;24:171–175. 13. Hauser RG, Katsiyiannis WT, Gornick CC, et al. Deaths and cardiovascular injuries due to device-assisted implantable cardioverterdefibrillator and pace- maker lead extraction. Europace. 2010;12:395–401. 14. Segreti L, di Cori A, Zucchelli G, et al. A questionable indication for ICD extraction after successful VT ablation. Jafib. 2015;7:53–61. 15. Mond HG, Grenz D. Implantable transvenous pacing leads: the shape of things to come. Pacing Clin Electrophysiol. 2004;27(6 Pt 2):887–893.

479

16. Smith HJ, Fearnot NE, Byrd CL, et al. Five-years experience with intravascular lead extraction. U.S. Lead Extraction Database. Pacing Clin Electrophysiol. 1994;17(11Pt 2):2016–2020. 17. Mond HG, Stokes KB. The electrode-tissue interface: the revolutionary role of steroid elution. Pacing Clin. Electrophysiol. 1992;15(1):95–107. 18. Di Cori A, Bongiorni MG, Zucchelli G, et al. Short-term extraction profile of cardiac pacing leads with hybrid silicone-polyurethane insulator: a pilot study. Int J Cardiol. 2013;168(4):4432–4433. 19. Epstein LM, Love CJ, Wilkoff BL, et al. Superior vena cava defibrillator coils make transvenous lead extraction more challenging and riskier. J Am Coll Cardiol. 2013;61(9):987–989. 20. Di Cori A, Bongiorni MG, Zucchelli G, et al. Transvenous extraction performance of expanded polytetrafluoroethylene covered ICD leads in comparison to traditional ICD leads in humans. Pacing Clin Electrophysiol. 2010;33(11):1376–1378. 21. Kohut AR, Grammes J, Schulze CM, et al. Percutaneous extraction of ePTFE-coated ICD leads: a single center comparative experience. Pacing Clin Electrophysiol. 2013;36(4):444–450. 22. Bongiorni MG, Di Cori A, Segreti L, et al. Where is the future of cardiac lead extraction heading? Expert Rev Cardiovasc Ther. 2016 Oct;14(10):1197–1203. 23. Jones SO 4th, Eckart RE, Albert CM, et al. Large, single-center, single-operator experience with transvenous lead extraction: outcomes and changing indications. Heart Rhythm. 2008;5:520–525. 24. Di Cori A, Bongiorni MG, Soldati E. Learning while extracting: ‘pacing’ lessons from the world of lead extraction. Expert Rev Cardiovasc Ther. 2013 Oct;11(10):1275–1276. • Editorial explaining the importance of knowing the lead structure to implant it properly and to prevent complications. 25. Bongiorni MG, Segreti L, Di Cori A, et al. Safety and efficacy of internal transjugular approach for transvenous extraction of implantable cardioverter defibrillator leads. Europace. 2014;16(9):1356–1362. •• Understanding the role of jugular approach in lead removal. 26. Pérez Baztarrica G, Gariglio L, Salvaggio F, et al. Transvenous extraction of pacemaker leads in infective endocarditis with vegetations ≥20 mm: our experience. Clin Cardiol. 2012 Apr;35(4): 244–249. 27. Wazni O, Epstein LM, Carrillo RG, et al. Lead extraction in the contemporary setting: the lexicon study: an observational retrospective study of consecutive laser lead extractions. J Am Coll Cardiol. 2010;55:579–586. 28. Byrd CL, Wilkoff BL, Love CJ, et al. Intravascular extraction of problematic or infected permanent pacemaker leads: 1994-1996. U.S. Extraction database, med institute. Pacing Clin Electrophysiol. 1999;22:1348–1357. 29. Franceschi F, Thuny F, Giorgi R, et al. Incidence, risk factors, and outcome of traumatic tricuspid regurgitation after percutaneous ventricular lead removal. J Am Coll Cardiol. 2009;53:2168–2174. 30. Pierce M, Pratap B, Pamidimukala C, et al. Female gender, laser sheath use and operator skill drive the success and complication rates of cardiac device lead extraction: an acap registry analysis. J Am Coll Cardiol. 2014;63:A381. 31. Klug D, Vaksmann G, Jarwe M, et al. Pacemaker lead infection in young patients. Pacing Clin Electrophysiol. 2003;26:1489–1493. 32. Cecchin F, Atallah J, Walsh EP, et al. Lead extraction in pediatric and congenital heart disease patients. Circ Arrhythm Electrophysiol. 2010 Oct;3(5):437–444. 33. Hamid S, Arujuna A, Ginks M, et al. Pacemaker and defibrillator lead extraction: predictors of mortality during follow-up. Pacing Clin Electrophysiol. 2010;33:209–216. 34. Kennergren C, Bjurman C, Wiklund R, et al. A single-centre experience of over one thousand lead extractions. Europace. 2009;11:612–617. 35. Love CJ, Smith MC. Extraction of pacing leads: overview of current techniques. J Cardiovasc Electrophysiol. 2006;17:1257–1261. 36. Figa FH, McCrindle BW, Bigras JL, et al. Risk factors for venous obstruction in children with transvenous pacing leads. Pacing Clin Electrophysiol. 1997;20:1902–1909. 37. Fischer A, Love B, Hansalia R, et al. Transfemoral snaring and stabilization of pacemaker and defibrillator leads to maintain

480

M. G. BONGIORNI ET AL.

38.

39.

40.

41. 42. 43.

44.

45.

46.

•• 47.

48.

49.

50.

51.

52.

•• 53.

54.

55.

vascular access during lead extraction. Pacing Clin Electrophysiol. 2009;32:336–339. Gula LJ, Ames A, Woodburn A, et al. Central venous occlusion is not an obstacle to device upgrade with the assistance of laser extraction. Pacing Clin Electrophysiol. 2005;28:661–666. Bracke F, Meijer A, van Gelder B. Extraction of pacemaker and implantable cardioverter defibrillator leads: patient and lead characteristics in relation to the requirement of extraction tools. Pacing Clin Electrophysiol. 2002;25:1037–1040. Agarwal SK, Kamireddy S, Nemec J, et al. Predictors of complications of endovascular chronic lead extractions from pacemakers and defibrillators: a single-operator experience. J Cardiovasc Electrophysiol. 2009;20:171–175. Field ME, Jones SO, Epstein LM. How to select patients for lead extraction. Heart Rhythm. 2007;4:978–985. Gula LJ, Krahn AD, Yee R, et al. Arrhythmia device lead extraction: factors that necessitate laser assistance. Can J Cardiol. 2008;24:767–770. Henrikson CA, Zhang K, Brinker JA. A survey of the practice of lead extraction in the United States. Pacing Clin Electrophysiol. 2010;33:721–726. Saad EB, Saliba WI, Schweikert RA, et al. Nonthoracotomy implantable defibrillator lead extraction: results and com- parison with extraction of pacemaker leads. Pacing Clin Electrophysiol. 2003;26:1944–1950. Segreti L, Di Cori A, Soldati E, et al. Major predictors of fibrous adherences in transvenous implantable cardioverter-defibrillator lead extraction. Heart Rhythm. 2014;11(12):2196–2201. Bongiorni MG, Di Cori A, Segreti L, et al. Transvenous extraction profile of Riata leads: procedural outcomes and technical complexity of mechanical removal. Heart Rhythm. 2015;12(3):580–587. Single high volume center experience on a challenging lead (RIATA) to extract Bongiorni MG, Di Cori A, Zucchelli G, et al. A modified transvenous single mechanical dilatation technique to remove a chron- ically implanted active-fixation coronary sinus pacing lead. Pacing Clin Electrophysiol. 2011;34:e66– 9. Kay GN, Brinker JA, Kawanishi DT, et al. Risks of spontaneous injury and extraction of an active fixation pacemaker lead: report of the Accufix Multicenter Clinical Study and Worldwide Registry. Circulation. 1999;100:2344–2352. Deshmukh A, Patel N, Noseworthy PA, et al. Trends in utilization and adverse outcomes associated with transvenous lead removal in the United States. Circulation. 2015. DOI:10.1161/ CIRCULATIONAHA.114.013801. Buiten MS, van der Heijden AC, Schalij MJ, et al. How adequate are the current methods of lead extraction? A review of the efficiency and safety of transvenous lead extraction methods. Europace. 2015 May;17(5):689–700. Bongiorni MG, ed. Transvenous lead extraction: from simple traction on to the internal transjugular approach. Springer Verlag Italia; 2011. p. 1– 180. Bongiorni MG, Soldati E, Zucchelli G, et al. Transvenous removal of pacing and implantable cardiac defibrillating leads using single sheath mechanical dilatation and multiple venous approaches: high success rate and safety in more than 2000 leads. Eur Heart J. 2008 Dec;29(23):2886–2893. Large tertiary center experience in lead extraction using mechanical sheaths. Di Cori A, Bongiorni MG, Zucchelli G, et al. Large, single-center experience in transvenous coronary sinus lead extraction: procedural outcomes and predictors for mechanical dilatation. Pacing Clin Electrophysiol. 2012 Feb;35(2):215–222. Crossley GH, Sorrentino RA, Exner DV, et al. Extraction of chronically implanted coronary sinus leads active fixation vs passive fixation leads. Heart Rhythm. 2016 Jun;13(6):1253–1259. Rordorf R, Canevese F, Vicentini A, et al. Delayed ICD lead cardiac perforation: comparison of small versus standard-diameter leads

56.

57.

58.

59.

60.

61.

62.

63.

64.

65.

66.

67.

68.

•• 69.

70. 71.

72.

implanted in a single center. Pacing Clin Electrophysiol. 2011 Apr;34(4):475–483. Ruttmann E, Hangler HB, Kilo J, et al. Transvenous pacemaker lead removal is safe and effective even in large vegetations: an analysis of 53 cases of pacemaker lead endocarditis. Pacing Clin Electrophysiol. 2006;29:231–236. Habib G, Lancellotti P, Antunes MJ, et al. 2015 ESC guidelines for the management of infective endocarditis: the Task Force for the Management of Infective Endocarditis of the European Society of Cardiology (ESC). Endorsed by: European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Nuclear Medicine (EANM). Eur Heart J. 2015 Nov 21;36 (44):3075–3128. Bontempi L, Vassanelli F, Cerini M, et al. Predicting the difficulty of a lead extraction procedure: the LED index. J Cardiovasc Med (Hagerstown). 2014 Aug;15(8):668–673. Fu HX, Huang XM, Zhong LI, et al. Outcomes and complications of lead removal: can we establish a risk stratification schema for a collaborative and effective approach? Pacing Clin Electrophysiol. 2015 Dec;38(12):1439–1447. Brunner MP, Cronin EM, Wazni O, et al. Outcomes of patients requiring emergent surgical or endovascular intervention for catastrophic complications during transvenous lead extraction. Heart Rhythm. 2014;11:419–425. Goyal SK, Ellis CR, Ball SK, et al. High-risk lead removal by planned sequential transvenous laser extraction and minimally invasive right thoracotomy. J Cardiovasc Electrophysiol. 2014;25:617–621. Koneru JN, Ellenbogen KA. High-risk lead extraction using a hybrid approach: the blade and the lightsaber. J Cardiovasc Electrophysiol. 2014;25:622–623. Bontempi L, Vassanelli F, Cerini M, et al. Hybrid minimally invasive approach for transvenous lead extraction: a feasible technique in high-risk patients. J Cardiovasc Electrophysiol. 2017;28 (4):466–473. Rodriguez Y, Garisto JD, Carrillo RG. A novel retrograde laser extraction technique using a transatrial approach: an alternative for complex lead extractions. Circ Arrhythm Electrophysiol. 2011;4:501–505. Lou X, Brunner MP, Wilkoff BL, et al. Successful stent implantation for superior vena cava injury during transvenous lead extraction. Heartrhythm Case Reports. 2015;1:394–396. Bongiorni MG. Personal technique and experience: the Pisa approach. Transvenous Lead Extraction. Springer Verlag Italia; 2011;83–96. Bongiorni MG, Kennergren C, Butter C, et al. The European Lead Extraction ConTRolled (ELECTRa) study: a European Heart Rhythm Association (EHRA) registry of transvenous lead extraction outcomes. Eur Heart J. 2017 Mar 23. doi: 10.1093/eurheartj/ ehx080. Brunner MP, Cronin EM, Duarte VE, et al. Clinical predictors of adverse patient outcomes in an experience of more than 5000 chronic endovascular pacemaker and defibrillator lead extractions. Heart Rhythm. 2014 May;11(5):799–805. Large tertiary center experience in lead extraction using powered sheaths. Bracke FA, Meijer A, van Gelder B. Learning curve characteristics of pacing lead extraction with a laser sheath. Pacing Clin Electrophysiol. 1998;21:2309–2313. Ghosh N, Yee R, Klein G, et al. Laser lead extraction. Is there a learning curve. Pacing Clin Electrophysiol. 2005;28:180–184. Neuzil P, Taborsky M, Rezek Z, et al. Pacemaker and ICD lead extraction with electrosurgical dissection sheaths and standard transvenous extraction systems: results of a randomized trial. Europace. 2007;9:98–104. Maytin M, Daily TP, Carillo RG. Virtual reality lead extraction as a method for training new physicians: a pilot study. Pacing Clin Electrophysiol. 2015 Mar;38(3):319–325.