Author + information
- Received March 21, 2016
- Revision received May 16, 2016
- Accepted June 27, 2016
- Published online September 7, 2016.
- Ayman A. Hussein, MD,
- Khaldoun G. Tarakji, MD, MPH,
- David O. Martin, MD, MPH,
- Abhishek Gadre, MD,
- Thomas Fraser, MD,
- Alice Kim, MD,
- Michael P. Brunner, MD,
- Amr F. Barakat, MD,
- Walid I. Saliba, MD,
- Mohamed Kanj, MD,
- Bryan Baranowski, MD,
- Daniel Cantillon, MD,
- Mark Niebauer, MD,
- Thomas Callahan, MD,
- Thomas Dresing, MD,
- Bruce D. Lindsay, MD,
- Steven Gordon, MD,
- Bruce L. Wilkoff, MD and
- Oussama M. Wazni, MD∗ ()
- ↵∗Reprint requests and correspondence:
Dr. Oussama M. Wazni, Cardiac Pacing and Electrophysiology, Department of Cardiovascular Medicine/J2-2, 9500 Euclid Avenue, Cleveland, Ohio 44195.
Objectives The study sought to assess the impact of previously abandoned leads on the clinical management of cardiac device infections, notably transvenous lead extraction and subsequent clinical course.
Background The population of patients with cardiac implantable electronic devices continues to grow with a disproportionate increase in device infections, which are invariably life threatening. A potentially complicating issue is the widely practiced strategy of device lead abandonment at the time of system revision, change, or upgrade, which is affecting an increasing number of patients.
Methods The study assessed the impact of previously abandoned leads in a prospectively maintained registry of consecutive patients undergoing percutaneous extraction of infected cardiac devices at the Cleveland Clinic between August 1996 and September 2012. The primary clinical endpoint was complete procedural and clinical success defined as the successful removal of the device and all lead material from the vascular space, in the absence of a major complication.
Results Of 1,386 patients with infected cardiac devices, 323 (23.3%) had previously abandoned leads. Failure to achieve the primary endpoint occurred more frequently in patients with abandoned leads (13.0% vs. 3.7%; p < 0.0001). This was primarily due to retention of lead material (11.5% vs. 2.9%; p < 0.0001), which was associated with poor clinical outcomes including higher rates of 1-month mortality (7.4% vs. 3.5% in those without lead remnants). Lead extraction procedures in patients with previously abandoned leads were longer (p < 0.0001), with longer fluoroscopy times (p < 0.0001), and more likely to require specialized extraction tools (94.4% vs. 81.8%; p < 0.0001) or adjunctive rescue femoral workstations (14.9% vs. 2.9%; p < 0.0001). Procedural complications occurred more frequently in patients with previously abandoned leads (11.5% vs. 5.6%; p = 0.0003), which was true for both major (3.7% vs. 1.4%; p = 0.009) and minor complications (7.7% vs. 4.4%; p = 0.02).
Conclusions Previously abandoned leads complicate the management of cardiac device infections, leading to worse clinical outcomes.
The population of patients with cardiac implantable electronic devices (CIEDs) has grown over the course of the past 2 decades (1). More than 300,000 patients have been receiving new CIED implants every year in the United States alone (2). The population of patients with CIEDs is growing due to the expanding indications for their use and improved longevity of patients with heart disease and comorbid conditions. As such, more patients are requiring CIED pocket interventions for system changes, revisions, or upgrades. These interventions are occurring more frequently in patients’ lifetimes and are known risk factors for infection.
In conjunction with the increasing rate of new device implantation and revisions, there has been a disproportionate increase in device infections (2–5), which carry a risk of death up to 66%, and this risk is decreased to about 18% with antibiotics and complete extraction (1,6–8).
A potentially complicating issue is the practice of lead abandonment that takes place at the time of CIED system change, revision, or upgrade. An increasing number of patients with CIED infections present with previously abandoned leads. It is likely that this number will continue to rise given the widely practiced strategy of lead abandonment in an ever-growing population of patients with CIEDs. The practice of lead abandonment remains controversial (1,9–13). Although it avoids the acute risk of lead extraction, such strategy ultimately leads to higher burden of leads and may carry risks, but data regarding this issue remain limited (14). In clinical practice, many patients may eventually require extraction for complications related to lead abandonment (15–19).
We hypothesized that the practice of lead abandonment complicates the clinical management of CIED infections, notably transvenous lead extraction (TLE) and subsequent clinical course. In patients with CIED infections, complete removal of leads and lead material is standard of care and carries a class Ia recommendation in management guidelines (5). Abandoned leads by definition have longer dwell times with more leads in place, both of which may be associated with more complex extractions and higher complication rates.
All 1,386 consecutive patients undergoing TLE of infected CIEDs at the Cleveland Clinic between August 1996 and September 2012 were included in this study. Device infection was defined as either pocket or endovascular infection. Patients with pocket infections manifested signs and symptoms of local infection or erosion at the device site with or without systemic symptoms and without bacteremia or vegetations. Patients with endovascular infections were those who had systemic signs and symptoms of infection, bacteremia, and in most patients echocardiographic findings consistent with vegetations. A cardiac electrophysiologist and an infectious disease specialist from the cardiac device infection service evaluated all patients and agreed on a consensus regarding the need for device and lead extraction. The clinical features, characteristics, and presentation of device infection were entered into a prospectively maintained data registry.
Most patients underwent lead extraction in the electrophysiology laboratories while under general anesthesia or moderate to deep sedation, depending on patient factors and physician preference. A cardiothoracic surgeon was on site and available for immediate emergency sternotomy or thoracotomy, as needed. Rooms were equipped with all necessary surgical equipment for immediate surgical intervention with the exception of cardiopulmonary bypass equipment, which was readily available as needed with a perfusionist. In all patients, invasive hemodynamic monitoring and central venous access were obtained. In pacemaker-dependent patients, a temporary pacemaker was placed, usually via the femoral vein.
During lead extraction, the major principles adhered to were as follows: control of the entire lead body, advancement of extraction sheath with appropriate traction, counterpressure, dissection or lysis of fibrotic adherences when needed, and countertraction at the tip of the lead. Locking stylets were used to control the conductor coil down to the tip of the lead and a suture tied at the insulation usually bound the lead’s outer insulation and conductor together. A stepwise approach to extractions is usually followed. Simple traction or traction on a locking stylet with insulation-bound suture is attempted initially. If these attempts are not sufficient, powered sheaths are then used. These included the initial generation, SLS II, and GlideLight Laser Sheaths (Spectranetics, Colorado Springs, Colorado), the Evolution mechanical dilator sheath (Cook Medical, Bloomington, Indiana), or occasionally the Perfecta electrosurgical dissection sheath (Cook Medical). The choice of the primary sheath for extraction was up to the electrophysiologist performing the procedure. In some instances, mechanical sheaths, snares, or a femoral workstation (often as a rescue) were needed for a complete successful extraction.
All patients were monitored for complications related to the procedure at the time of extraction, during their hospital stay, and at scheduled follow-up with their electrophysiologist 6 to 8 weeks after the procedure.
Primary clinical endpoint and complications
The primary endpoint of the extraction procedures was clinical and complete procedural success, defined in concordance with the published guidelines (1) as the successful removal of all targeted leads and all lead material from the vascular space, in the absence of a major or a permanently disabling complication or procedure-related death. Given that this cohort included only patients with CIED infections in whom a complete extraction is required, any retention of leads or lead material was considered as clinical failure of the extraction procedure.
The complications of TLE procedures were also defined in concordance with the published guidelines (1), with major complications being those that were life threatening, resulted in significant or permanent disability or death, or required surgical intervention and minor complications being those that required medical or minor procedural interventions.
All statistical analyses were performed by using JMP pro version 10.0 (SAS Institute, Cary, North Carolina). Continuous variables are presented as mean ± SD or median (interquartile range [IQR]), as appropriate. The chi-square test was employed for comparison of proportions. For continuous variables, the Student t test or the nonparametric Wilcoxon rank sum test were used as appropriate. A 2-sided p value <0.05 was considered statistically significant.
All 1,386 consecutive patients who underwent TLE for CIED infection at the Cleveland Clinic between August 1996 and September 2012 were included. The study population was categorized into 2 groups on the basis of whether patients had previously abandoned leads (n = 323, Group 1) or not (n = 1,063, Group 2).
The baseline characteristics of the 2 groups are summarized in Table 1. Group 1 patients were older (69.6 ± 13.6 years of age vs. 67.8 ± 15.4 years of age; p = 0.04) and more likely to have an established diagnosis of sinus node dysfunction (57% vs. 41.5%; p < 0.0001) or complete heart block (32.2% vs. 17.8%). There were otherwise no other significant differences in baseline clinical characteristics between the Groups (Table 1) (p = NS).
The initial clinical presentation was device pocket infection or endovascular infection in 67.8% and 32.2% in Group 1, respectively (vs. 58.0% and 42.0% in Group 2; p = 0.02). Despite the higher prevalence of pocket infections, more patients in Group 1 had evidence of vegetations with transthoracic (12.4% vs. 7.2%; p = 0.02) or transesophageal (30.8% vs. 22.3%; p = 0.02) echocardiograms. Vegetations on the leads were found in 27.0% of Group 1 patients versus 16.9% in Group 2 (p = 0.002). When present, vegetations were larger in Group 1 patients (5 [IQR: 1 to 12] mm vs. 1 [IQR: 1 to 7] mm; p = 0.0003).
Extraction procedures, outcomes and complications
All leads were targeted for extraction in all patients. The lead data according to the study groups are summarized in Table 2. There were a total of 1,010 leads in Group 1 and 2,133 leads in Group 2. As expected, patients in Group 1 had a higher lead burden (median 3 [IQR: 3 to 4] leads) compared with those in Group 2 (median 2 [IQR: 2 to 2] leads; p < 0.0001). The leads in place were more likely to be pacer leads (83.4% vs. 73.1%) than defibrillator leads (16.6% vs. 26.9%; p < 0.0001) in Group 1. There were no differences in terms of lead location between the Groups (p = NS) (Table 2), but Group 1 patients had much older leads in place. One patient in Group 1 and 6 patients in Group 2 had subcutaneous array or coils in place. The median age of leads in Group 1 was 2,291 (IQR: 761 to 3,946) days versus 1,549 (IQR: 750 to 2,721) days (p < 0.0001). This was also true for the age of oldest lead in place and the combined age of leads per patient (Table 2) (p < 0.0001 for both).
In Group 1, 425 abandoned leads were extracted in 323 patients. The number of abandoned leads in place was 1 in 233 patients, 2 in 81 patients, 3 in 6 patients, and 4 in 3 patients. The median age of previously abandoned leads was 3,641 (IQR: 2,491 to 5,632) days. Most of the abandoned leads were pacer leads (n = 378) and the remaining were defibrillator leads (n = 47). The location of abandoned leads was right ventricular (n = 298), right atrial (n = 125), or coronary sinus (n = 2).
The procedural profiles and outcomes of TLEs in patients with and without previously abandoned leads are summarized in Table 3. When compared to procedures without abandoned leads in place, those that involved extraction of previously abandoned leads were significantly longer (170 [IQR: 130 to 220] min vs. 115 [IQR: 85 to 155] min; p < 0.0001) with longer fluoroscopy times (13.2 [IQR: 7.7 to 24.8] min vs. 6.6 [IQR: 3.2 to 13] min; p < 0.0001). Specialized extraction tools were required more frequently in Group 1 patients (94.4% vs. 81.8%; p < 0.0001). This was true for locking stylets, Laser sheaths, mechanical dilator sheaths, and snares (Table 3). More patients in Group 1 required adjunctive rescue femoral workstations (14.9% vs. 2.9%; p < 0.0001). Of those who required femoral workstations in Group 1, there were 6 patients with previously abandoned intravascular remnants of leads but complete procedural success was achieved in all 6 of them with no complications. Of note, subcutaneous arrays or coils (n = 7) were successfully extracted with manual traction but required additional incisions in all but 1 patient.
Retention of lead material due to inability to completely remove all lead material from the vascular space was much more likely in Group 1 (11.5% vs. 2.9% of patients; p < 0.0001) (Figure 1). As far as procedural complications are concerned, Group 1 patients were more likely to experience complications during TLEs (11.5% vs. 5.6%; p = 0.0007). This was true for both major (3.7% vs. 1.4%; p = 0.01) and minor complications (7.7% vs. 4.4%; p = 0.02). These complications are detailed in Table 4.
Failure to achieve the primary endpoint was more likely in Group 1 compared with Group 2 (13.0% vs. 3.7%; p < 0.0001). To assess whether the outcomes are different between patients with or without abandoned leads but with a similar total number of endovascular leads in place, we conducted a sensitivity analysis in patients with a total of 2 or 3 endovascular leads in place, which were the numbers at which the populations of patients with or without abandoned leads overlapped. All but 1 patient with 1 lead in place belonged to the group without abandoned leads and all but 9 patients with 4 or more endovascular leads belonged to the group with abandoned leads. The sensitivity analysis confirmed the observations made in the overall population (Online Table 1).
As far as the microbiological data are concerned, cultures of the extracted lead tips were more likely to yield positive pathogen growth in Group 1 patients (73.7% vs. 61.2%; p = 0.003).
Lead material retention and subsequent clinical course
Retention of lead material was associated with poor clinical outcomes. The 1-month mortality was higher in patients who had retained lead material (7.4% vs. 3.5% in those without retained lead material). Additionally, 16.2% of patients with lead material retention required open heart surgery to remove lead remnants and 41.2% required long term suppressive antibiotics (>6 months) due to concerns of incomplete eradication of the infection.
In a large population with CIED infections, the presence of abandoned leads complicated the management of these patients. Importantly, this issue affected 1 in every 4 patients with CIED infection. The primary clinical challenge in patients with previously abandoned leads included complex TLE and failure to achieve complete removal of leads and lead material from the vascular space, which is required for complete eradication of the infection. The extraction procedures in patients with abandoned leads were associated with higher rates of complications, both major and minor. Furthermore, lead material retention occurred more frequently in patients with previously abandoned leads, which translated into poor clinical outcomes including higher rates of 1-month mortality and the need for open-heart surgery to remove lead remnants, or long-term suppressive antibiotics.
To our knowledge, this is the first study to assess the impact of previously abandoned leads on the management of CIED infections. This subject is of interest due to the fact that lead abandonment at the time of system revisions or upgrades is widely practiced with continued controversy regarding management of superfluous leads. This is further amplified by the growing numbers of patients who will eventually need upgrades and revisions. If abandonment is the prevailing strategy, this problem will only increase. Similarly, the risk of a CIED infection, a time-dependent variable that is also increased by device pocket interventions, will likely follow a similar trend and the rates of CIED infections will probably continue to increase at a disproportionately higher rate than newly implanted CIEDs (3,4). Published data suggest that the practice of lead abandonment carries risks but the impact of abandoned leads on CIED infections management has not been studied (14,15). Importantly, CIED infections carry a risk of death up to 66% if left untreated and this risk is decreased to about 18% with antibiotics and complete extraction (1,6–8). The eradication of infection requires removal of the devices and all lead material and carries a class Ia recommendation in the guidelines (1,6–8). The present study demonstrates that the clinical goal of the extraction procedures, which is the elimination of all infected material, could not be achieved in a significantly large proportion of patients with previously abandoned leads, which complicated subsequent clinical decisions. These included referral for additional surgical extraction and longer periods of antibiotic use. Indeed, lead retention was associated with worse clinical outcomes.
The complexity of TLE in patients with previously abandoned leads and the lower success rates are a manifestation of longer implantation duration, a significant burden of intravascular or intracardiac lead-to-endothelium adhesions, and lead-on-lead binding (1,20–24). Therefore, these risks cannot be ignored when a decision is made to abandon leads in light of the current findings and the fact that many patients may require extraction for complications related to lead abandonment (15–19). However, the study did not allow assessment of trends in lead abandonment over time or the actual incidence rates of infection after lead abandonment. This is primarily due to the fact that we favor lead extraction over abandonment in our own practice when possible. Furthermore, a large proportion of patients undergoing extraction at our center are referred from other centers and as such the denominator population is unknown. Decisions to abandon or extract superfluous leads need to be made on a case-by-case basis after discussion with the patient of both risks of extraction or abandonment and accounting for patients' age, lead burden, type of lead, and comorbid conditions, among others. Nonetheless, a recently published report (25) showed that the extraction of noninfected superfluous leads is feasible and successful, and has lower complication rates compared with extraction of infected leads, which supports the practice of lead extraction at time of system revisions or upgrade. However, there are limited data in the literature regarding the risks of lead abandonment (15–19,26–31), and clinical decision making remains difficult.
The study has the inherent limitations of observational studies but the data included in this report are derived from a prospectively maintained data registry. The topic addressed in this study is very unlikely to be addressed in a randomized trial and cannot address the controversy of lead extraction or abandonment at the time of system revision or upgrade. However, the study presents evidence that the practice of lead abandonment complicates the overall management of CIED infections with lower TLEs success, higher complication rates, and higher clinical failure rates. Finally, the study reflects the experience of a large-volume tertiary care center with experienced providers in TLEs, and the overall failure and complication rates might underestimate their real-life occurrence, as reported in a recent analysis of the Nationwide Inpatient Sample (32). Furthermore, the overall extraction experience over 16 years may not be generalizable to current-day practice. Although, we have favored lead extraction in our practice versus lead abandonment at the time of system revision or upgrade, decisions are made on a case-by-case basis. Lead extraction procedures remain complex interventions with inherent risks (32) and those risks need to be weighed against the risks of lead abandonment and to account for patient's age and comorbid conditions, but most importantly for operator's and center's experience in lead extractions with consideration of referral to experienced centers as applicable.
Previously abandoned CIED leads complicate the overall management of patients with cardiac device infections. Vegetations on CIED leads were more common and larger in patients with previously abandoned leads compared with those without abandoned leads. Importantly, previously abandoned leads in our study were associated with more complex extraction procedures, worse clinical outcomes, lower success, and higher complication rates. The study highlights the importance of resisting the expedient clinical decision of abandoning leads at the time of CIED system change, revision, and upgrade. Any discussion with patients about the risks of extracting redundant leads versus lead abandonment should account for the added complexity of managing possible future CIED infections.
COMPETENCY IN MEDICAL KNOWLEDGE: The practice of lead abandonment complicates the management of cardiac device infections. Future risks need to be discussed with patients before lead abandonment.
TRANSLATIONAL OUTLOOK: A large prospective registry or clinical trial of lead abandonment or extraction would be needed to further assess the risks of either strategy.
For a supplemental table, please see the online version of this article.
Dr. Tarakji has received speaker/consulting honoraria from Medtronic. Dr. Callahan has served as a consultant for Biotronik. Dr. Dresing has received speaker honoraria and grant support. Dr. Wilkoff has received honoraria from Medtronic, St. Jude Medical, and Convatec; has served as a consultant for Medtronic, St. Jude Medical, and Spectranetics; has received royalties and research support from Medtronic. Dr. Wazni has received speaker fees from Spectranetics. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Abbreviations and Acronyms
- cardiac implantable electronic device
- interquartile range
- transvenous lead extraction
- Received March 21, 2016.
- Revision received May 16, 2016.
- Accepted June 27, 2016.
- American College of Cardiology Foundation
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