Author's Accepted Manuscript

Major Predictors of Fibrous Adherences in Trans-venous ICD Lead Extraction

Luca Segreti MD, Andrea Di Cori MD, Ezio SoldatiMD, Giulio Zucchelli MD, PhD, Stefano Viani MD,Luca Paperini MD, Raffaele De Lucia MD, GiovanniColuccia MD, Sergio Valsecchi PhD, Maria GraziaBongiorni MD, FESC

PII: S1547-5271(14)00865-0DOI: http://dx.doi.org/10.1016/j.hrthm.2014.08.011Reference: HRTHM5896

To appear in: Heart Rhythm

Cite this article as: Luca Segreti MD, Andrea Di Cori MD, Ezio Soldati MD, GiulioZucchelli MD, PhD, Stefano Viani MD, Luca Paperini MD, Raffaele De Lucia MD,Giovanni Coluccia MD, Sergio Valsecchi PhD, Maria Grazia Bongiorni MD, FESC,Major Predictors of Fibrous Adherences in Transvenous ICD Lead Extraction, HeartRhythm, http://dx.doi.org/10.1016/j.hrthm.2014.08.011

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Major Predictors of Fibrous Adherences in Transvenous ICD Lead Extraction

Luca Segreti,a MD; Andrea Di Cori,

a MD; Ezio Soldati,

a MD; Giulio Zucchelli,

a MD, PhD; Stefano

Viani,a MD; Luca Paperini,

a MD; Raffaele De Lucia,

a MD; Giovanni Coluccia,

a MD; Sergio

Valsecchi,b PhD; Maria Grazia Bongiorni,

a MD, FESC

a Second Cardiology Division, Cardiothoracic and Vascular Department, University Hospital of

Pisa, Pisa, Italy; b

Boston Scientific Italy, Milan, Italy

Short title: ICD Lead Extraction and Fibrous Adherences

Word count: 4231.

Funding Sources: None to declare.

Disclosure: Sergio Valsecchi is an employee of Boston Scientific. No other potential conflict of

interest to declare.

Correspondence to:

Luca Segreti, MD,

Second Cardiology Division

Cardiothoracic and Vascular Department

University Hospital of Pisa

via Paradisa, 2 - 56100 Pisa, Italy

Tel. 0039050993043| Fax. 0039050992362 | e-mail: lucasegreti@gmail.com

2

ABSTRACT

Background: Percutaneous removal of implantable defibrillator (ICD) leads is a difficult procedure,

as the consequence of the massive fibrous tissue growth along the lead.

Objective: Aim of the study was to describe the occurrence and location of fibrous adherences in

ICD lead extraction, and to identify potential predictors among patient and lead characteristics.

Methods: We studied 637 consecutive patients who underwent transvenous extraction of 678 ICD

leads from 1997 to 2013.

Results: Procedural success rate was 99%, without major complications. Areas of adherence were

found in the subclavian vein (78%), the innominate vein (65%), the superior vena cava (66%) and

the heart (73%). Dwell-time, passive fixation and dual-coil lead design were independently

associated with adherences. Dual-coil lead design was associated with adherences in the innominate

vein and in the superior vena cava, while coil treatment (like expandable polytetrafluoroethylene-

coated or medical adhesive back-filled strategies) prevented adherences. Passive fixation

mechanism was associated with adherences in the heart.

Conclusion: ICD leads, after long dwell-time, are affected by fibrous adherences uniformly

distributed along the lead course. Lead features represent major predictors of the phenomenon. A

careful lead selection is recommended at implantation to prevent adherences. Similarly, a lead-

related risk stratification is mandatory before transvenous extraction procedure.

Keywords: Implantable defibrillator; Lead; Extraction; Adherence; Internal Jugular Vein.

List of abbreviations:

ICD: implantable cardioverter defibrillator; MT: manual traction; MD: mechanical dilatation; SD:

standard deviation; OR: odds ratio; CI: confidence interval.

3

INTRODUCTION

In recent years, the growth of implantable defibrillator (ICD) implantations has led to an increase in

ICD removal procedures for lead failure or infection (1). Although safe and effective, transvenous

lead extraction continues to be a challenging procedure (2,3). Fibrous ingrowth, the main obstacle

to lead removal (4), may vary from patient to patient, affecting complexity, duration and outcomes

of the procedure. Some factors have been suggested to increase the fibrous reaction, but until today

no data have been systematically collected to describe rate, location and predictors of fibrous

adherences in patients with ICD leads.

Aim of the study was to analyze data collected in patients who underwent transvenous ICD lead

extraction in our center and to describe, from a procedural standpoint, the occurrence and the

location of fibrous adherences, and the potential predicting value of patient and lead characteristics.

METHODS

Patient Population and Procedure

We included and analyzed all consecutive patients who underwent a transvenous ICD lead

extraction in our center from January 1997 to December 2012. In accordance with the guiding

principles of the Declaration of Helsinki about studies involving humans, all the patients gave

informed consent to the procedure and to personal data collection and the study was approved by

the Institutional Committee on Human Research at our Institution.

The extraction procedure has been previously described (5,6). After device removal, the leads were

examined visually and by means of fluoroscopy in their intravascular segment; the proximal end

was then clipped and a standard stylet was inserted into the lead. Lead extraction was attempted by

means of gentle manual traction (MT).

If this proved unsuccessful, we crossed to mechanical dilatation (MD) with a single-sheath (i.e.

non-telescopic) technique. This involved inserting and advancing multisized dilators (Cook

4

Intravascular Inc., Leechburg, PA, USA) through the venous entry-site, as first choice, or through

the right internal jugular vein, if required (5,6).

Lead extraction time was defined as the time from the start of MT to complete lead removal.

Procedural outcomes (i.e. success and complications) were defined according to previously

published guidelines (7,8).

Definition of Fibrous Adherence Sites

As previously described (9-11), we adopted an indirect procedural model to assess the presence and

the location of fibrous sites. The presence of at least one site of fibrotic adherence was defined in

case of ineffective MT (i.e. necessity to cross to MD). The location of fibrotic tissue was defined by

an expert operator, who evaluated the difficulty in sheath advancement during MD. When the

sheath advancement required more than 1 minute of MD at one site, that site was defined as a local

area of fibrotic tissue. Regarding the number of sites, we identified 4 intravascular adherence sites

(subclavian vein, innominate vein, superior vena cava, cardiac chambers) on the basis of the

relationship between cardiac leads and anatomical landmarks, detectable with the postero-anterior

projection at fluoroscopy.

The following radiologic landmarks definitions were used (12-14):

- Subclavian venous district: from the first rib-clavicular joint to the ipsilateral sterno-

clavicular joint.

- Innominate venous district: from the left to the right sterno-clavicular joint.

- Superior Vena Cava district: from an horizontal plane passing through the upper margin of

the aortic arch to an horizontal plane passing through the upper margin of the right heart

contour (i.e. right lateral border of the right atrium).

- Cardiac Chambers District: from an horizontal plane passing through the upper margin of

the right heart contour to an horizontal plane passing through the upper margin of the left

emi-diaphragm. (Figure 1).

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Statistical Analysis

Descriptive statistics are reported as means standard deviation (SD) for normally distributed

continuous variables, or medians with ranges in the case of skewed distribution. Categorical data

are expressed as percentages, and differences in proportions were compared by means of a Chi-

square analysis or Fisher’s exact test, as appropriate.

Univariate binary logistic regression analysis was utilized to evaluate the relationship between the

presence of adherence requiring mechanical dilatation and patient and lead characteristics. All

variables displaying statistical significance, i.e. p value < 0.05, underwent multivariate binary

logistic regression analysis. A p value <0.05 was considered significant for all tests. Statistical

analyses were performed by means of SYSTAT 12.0 (Systat software Inc., Chicago, USA)

software.

RESULTS

Patient population and extracted leads

From January 1997 to December 2013, 637 consecutive patients required transvenous removal of

678 ICD leads. The majority of ICD leads were passively fixed (69%), had 2 coils (78%), were

silicone-insulated and had a multi-lumen design. In the majority (74%) of our patients the clinical

indication for the removal procedure was infection.

In addition to ICD leads, 369 atrial, 221 coronary sinus and 89 ventricular pacing leads had to be

removed from our patients. The median number of cardiac leads to be removed from each patient

was 2, ranging from 1 to 7.

Patient characteristics are summarized in Table 1 and the characteristics of the leads extracted are

reported in Table 2.

6

Procedural Outcomes

MT was effective in 44 leads (6%). To remove the remaining 634 leads, MD was attempted through

the venous entry-site and was effective in 555 cases (82%). Seventy-eight of the 79 leads that could

not be successfully extracted through the venous entry-site approach were finally approached via

the internal jugular vein, successful extraction being achieved in 73 cases (94%). The final

procedural success rate was 99% (672 out of 678). The median extraction time was 8 min, ranging

from 1 to 210 min.

Six leads (0.9%) could not be transvenously removed: they were abandoned in situ with no

sequelae, or the patient was referred to the cardiac surgeon for open-chest extraction, according to

the indication.

There were no major complications associated with lead extraction. Minor complications were

reported in 25 patients (4%).

Fibrous Adherences Assessment: rate and location

Fibrous adherences were found in 593 patients (94%). The average number of adherences was

2.8±1.2 per patient. Areas of adherence were documented in all sites, with a statistically higher

prevalence in the subclavian vein and in the heart (p<0.001) [subclavian vein (78%), innominate

vein (65%), superior vena cava (66%) and heart (73%)] (Figure 2).

Univariate and multivariate analyses of clinical and lead-related factors were performed to identify

predictors of fibrous adherences at any site and at each specific intravascular site.

At multivariate logistic regression analysis, dwell time (odds ratio [OR] 1.10 , 95% confidence

interval [CI] 1.06 – 1.14; P <0.001), passive fixation (OR 3.25 , 95% CI 1.41 – 7.53; P = 0.006)

and dual coil lead design (OR 2.94, 95% CI 1.27 – 6.78; P = 0.011) were independent predictors of

fibrous adherence (Table 3).

Dual-coil design predicted adherences in the innominate vein (OR 3.93, 95% CI 2.47 –6.23; P

<0.001) and in the superior vena cava (OR 3.52, 95% CI 2.15 – 5.74; P <0.001), and the passive

7

fixation mechanism was associated with adherences in the heart (OR 1.72, 95% CI 1.11 – 2.65; P

=0.015). The coil treatment (expandable polytetrafluoroethylene-coated or medical adhesive back-

filled coils) was associated with a low rate of adherences in the superior vena cava (OR 1.75, 95%

CI 1.04 – 2.93; P = 0.035) and in the heart (OR 2.11, 95% CI 1.25 – 3.57; P = 0.005) (Figure 2, 3

and 4).

Results of Univariate and Multivariate analysis are shown in Table 3.

Location and rate of fibrous adherences are shown in Figure 2, 3 and 4.

DISCUSSION

A comprehensive knowledge of adherence location is the key point of a safe and effective

transvenous procedure. The aim of MD is dissecting all lead-related adherences from the venous

entry site to the tip and complications are commonly observed as the result of vascular or cardiac

damage during dilatation. In the past, adherence rate and location have been described for standard

pacing leads, and some predictors were identified (5,9,15).

This was the first large single-center experience systematically describing location, rate and

predictors of adherence in more than 600 patients with ICD leads. Our analysis confirmed the

peculiar post-implantation behavior of ICD leads. Compared to standard pacing leads, they show a

similar time-dependent fibrous ingrowth, but with a larger involvement of the lead course (16).

In agreement with previous experiences (17-21), we found that dwell-time was independently

associated with the use of mechanical dilatation. Moreover, some structural lead features seem to

promote the formation of adherence at specific locations. In this study, a major predictor of

adherence turned out to be the dual coil technology (22) (Table 3). The coils of ICD leads have been

shown to induce an extensive growth of scar tissue, which surrounds and entraps the lead, and

requires complex extraction procedures (23). Nonetheless, a dual coil design predicted a risk of

adherence at the level of innominate vein and superior vena cava (Figure 2) and only the presence

of a coil treatment (like expandable polytetrafluoroethylene-coated or medical adhesive back-filled

8

strategies) was protective (Table 3, Figure 5), confirming the findings of previous studies

(11,24,25).

As shown in a recent multicenter study (26), the presence of a superior vena cava coil is associated

with significantly higher complication rates, and transvenous extraction of dual-coil ICD leads is

2.6 times more difficult than that of single-coil leads and is more frequently associated with the use

of powered sheaths and with higher complication rates. A complication in these vascular districts

can lead to serious consequences that may not be mitigated by emergency surgery (27).

The second independent predictor of adherence related to the fixation mechanism. As previously

described (28), tines were often associated with MD. In particular, isodiametric active fixation leads

seemed to prevent adherences inside the ventricles, and were more easily and completely removed

by MT (Table 3, Figure 4).

All these peculiar lead features (non isodiametric structure, dual coil, lack of coil treatment, passive

fixation mechanism), with a typical model of response to injury, cause a progressive time-

dependent tissue ingrowth. This explains the extent of fibrosis (94% of patients with a mean of

2.8±1.2 adhesion sites per patient), specifically associated with older ICD lead models. Although

early experiences demonstrated the feasibility of transvenous ICD lead extraction (14, 29-36), these

leads have always been considered more difficult to extract, because of their larger size, aggressive

fibrosis around the coils (19), and their non-isodiametric structure (especially of older models) (37-

39). In the Pacing Lead Surveillance Study in Europe (PLESSE), transvenous ICD lead extraction

was associated with a 12% risk of major complications, while the risk of major complications

associated with pacing lead extraction was 1.7% (40). Additional multicenter experiences have

documented potential major complications, such as death (at a rate of 0.28-0.8%), emergency

cardiac surgery (1-2%) and cardiac perforations (1-4%) (18,32). Although some clinical factors ,

like BMI and renal insufficiency, were recently suggested to be predictors of all-cause mortality

within 30 days of transvenous extraction, (41) in our experience no significant correlation were

9

found with adherences rate and location, suggesting a potential unfavorable predictive role

independent from procedural standpoints, like adherences and related necessity of MD.

Identification of adherence predictors has major implications. It may improve and facilitate risk

stratification of transvenous ICD lead removal. In addition, it could promote prevention, stimulating

the production of new lead technologies to reduce the impact of post-implantation tissue ingrowth.

At the present time, the use of single-covered coil lead with active fixation constitutes the first

strategy to reduce lead related fibrosis.

Study limitations

As the present study is a retrospective review, all the potential limitations of retrospective analyses

should be taken into account when interpreting its results. Moreover, although large, the present

series represents a single-center experience. Thus, the present results cannot be generalized beyond

the specific technique adopted in our institution and described in this paper. Finally, fibrous

adherence sites were identified indirectly from a procedural perspective. Gross examination and

histopathology of the extracted leads was beyond the intentions of the present study.

CONCLUSION

Very few ICD leads can be successfully removed by simple MT, and dilatation is often required.

Fibrous ingrowth on these leads is extensive, and may encapsulate the entire intravascular path up

to cardiac chambers. Structural lead features seem associated with adherence formation, enhancing

the response to injury in a time dependent fashion. A careful lead selection is recommended at

implantation to prevent intravenous adherences. Similarly, a lead related risk stratification is

mandatory before a transvenous extraction procedure.

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ACKNOWLEDGMENTS

The authors are indebted to their nurses Michela Favaro, Cristina Giannessi, Giampietro Ercoli,

Mascia Sarti, Susy Bardelli, and Patrizio Lazzerini for their excellent support in the management of

patients in the cath lab and operating room.

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CLINICAL PERSPECTIVES

Percutaneous removal of implantable defibrillator (ICD) leads is a difficult procedure, as the

consequence of the massive fibrous tissue growth along the lead. In this series of 678 ICD leads

extracted from 1997 to 2013 in our center, we analyzed the rate, location and predictors of fibrous

adherences. We found that very few ICD leads can be successfully removed by simple manual

traction, because of extensive fibrous ingrowth encapsulating the entire intravascular lead path up to

cardiac chambers. Dwell-time was independently associated with adhesions, together with lead

features, such as passive fixation or dual-coil lead design. Nonetheless, coil treatment (like

expandable polytetrafluoroethylene-coated or medical adhesive back-filled strategies) prevented

adherences. The present findings allow a risk stratification before transvenous extraction procedure.

Moreover, they strengthen the importance of a careful lead selection at implantation to prevent

intravenous adherences, and seem to suggest the adoption of ICD leads with specific characteristics

only after careful evaluation of the expected benefits and possible risks.

17

FIGURE LEGENDS

Figure 1

Overview of the anatomical landmarks in the postero-anterior fluoroscopic view, in a patient with a

dual chamber ICD. Red dotted lines illustrate the three horizontal planes passing through the upper

margin of the aortic arch (A), through the upper margin of the right heart contour (B) and through

the upper margin of the left emi-diaphragm (C). Continuous red lines illustrate the rib-clavicular

joints (a), the sterno-clavicular joints (b) and the aortic arch (c). Finally, the yellow lines show the

final obtained upper venous anatomy with the corresponding sites (subclavian, innominate, superior

vena cava, right cardiac chambers). For description see text.

Figure 2.

Location and rate of fibrous adherences in the overall population (IV = innominate vein, SV =

subclavian vein, SVC = superior vena cava).

Figure 3.

Overall Adherences rate and location with comparison between single and dual coil ICD lead

groups. Dual coil leads showed a statistically higher significant rate of adherences at the IV and

SVC sites (p<0.001) (IV = innominate vein, SV = subclavian vein, SVC = superior vena cava).

Figure 4.

Overall Adherences rate and location with comparison between active and passive fixation ICD

lead groups. Passive fixation leads showed a statistically higher significant rate of adherences at the

Heart site (p<0.001) (IV = innominate vein, SV = subclavian vein, SVC = superior vena cava).

18

Figure 5.

Overall Adherences rate and location with comparison between treated and untreated coil ICD lead

groups. Untreated coil leads showed a statistically significant higher rate of adherences at the SVC

site (p<0.001) (IV = innominate vein, SV = subclavian vein, SVC = superior vena cava).

19

20

21

22

23

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Table 1. Patient Population.

Patients n = 637

Male gender, n (%) 539 (85)

Age, years 62±15

Body mass index, Kg/m2 25.9±3.9

Creatinine, mg/dl 1.3±0.6

Coronary artery disease, n (%) 312 (49)

Primary prevention ICD indication, n (%) 306 (48)

Previous cardiac surgery, n (%) 153 (24)

Time from implant, months 48±36

Implanted device, n (%)

- Single-chamber ICD

- Dual-chamber ICD

- Biventricular ICD

236 (37)

180 (28)

221 (35)

Cardiac leads per patient 2 [1 – 7]

Indication for removal, n (%)

- Local infection

- Sepsis

- Lead failure

- Other

315 (49)

158 (25)

154 (24)

10 (2)

25

Table 2. Extracted ICD leads.

ICD Lead Characteristic n = 678

Coil:

- Single

- Dual

- Unknown

135

531

12

Size:

- ≤ 7 Fr

- 8-9 Fr

- ≥ 10 Fr

- Unknown

114

380

152

32

Coil treatment:

- ePTFBE

- MABF

- No treatment

80

46

552

Fixation:

- Active

- Passive

- Unknown

214

468

4

Insulation:

- Silicone

- Polyurethane

- Optim

- Unknown

568

32

46

32

Design:

- Multi-lumen

- Coaxial

- Unknown

613

33

32

ePTFBE = expandable polytetrafluoroethylene-coated coil;

MABF = medical adhesive back-filled coil

26

Table 3. Univariate and multivariate analyses of factors predicting the presence of fibrous

adherences.

Univariate Analysis Multivariate Analysis

OR (95% CI) p OR (95% CI) p

Male gender 0.81 (0.36-1.80) 0.617 - -

Age 0.99 (0.97-1.01) 0.632 - -

Body mass index 1.02 (0.92-1.14) 0.636 - -

Creatinine 1.00 (0.49-2.01) 0.994 - -

Previous cardiac surgery 1.06 (0.41-2.70) 0.899 - -

Time from implant 1.10 (1.06-1.14) <0.001 1.10 (1.06-1.14) <0.001

Number of cardiac leads 0.80 (0.60-1.07) 0.139 - -

Removal for infection 1.24 (0.63- 2.43) 0.532 - -

Passive fixation 6.01 (3.07-11.74) <0.001 3.25 (1.41-7.53) 0.006

Lead size 1.55 (1.15-2.09) 0.001 1.15 (0.77-1.72) 0.480

Dual coil 4.50 (2.41-8.41) <0.001 2.94 (1.27-6.78) 0.011

No ePTFBE/MABF 5.80 (3.07-10.96) <0.001 1.82 (0.79-4.19) 0.156

Subclavian access 1.19 (0.55-2.54) 0.661 - -

Right-sided implantation 0.23 (0.10-0.51) 0.001 0.66 (0.22-1.98) 0.460

OR = Odds Ratio; CI = Confidence Interval; ePTFBE = expandable

polytetrafluoroethylene-coated coil; MABF = medical adhesive back-filled coil