Ann Thorac Surg 2010;89:44-50. doi:10.1016/j.athoracsur.2009.10.025
© 2010 The Society of Thoracic Surgeons
Original Articles: Adult Cardiac
A 15-Year Experience With Permanent Pacemaker and Defibrillator Lead and Patch Extractions
Alexander Rusanov, MD,
Henry M. Spotnitz, MD*
Department of Surgery, Columbia University Medical Center, New York, New York
Accepted for publication October 12, 2009.
* Address correspondence to Dr Spotnitz, Department of Surgery, Columbia University Medical Center, 622 W 168th St, New York, NY, 10032 (Email: hms2{at}columbia.edu).
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Abstract
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Background: The value of extraction of infected or hazardous epicardial and endocardial pacemaker and internal cardioverter defibrillator (ICD) leads is well established. Recent reviews including all leads and patches are lacking. This review describes experience with open and percutaneous techniques, including all lead types and indications.
Methods: With Institutional Review Board approval, we reviewed charts of all adults and children undergoing extraction of permanent pacemaker and ICD leads and patches by a single operator between 1993 and 2008.
Results: Overall, 145 leads and 7 patches were removed from 79 patients. Dwell time averaged 56.2 months. The commonest indications for extraction were infection (73.4%) or risk of lead fracture (20.3%). Most leads (84.2%) were extracted percutaneously. Removal was complete for 131 leads (86.2%) and partial in 14. Incomplete lead removal was rarely associated with clinical complications. Minor complications occurred in 6 patients (7.6%) and major complications occurred in 3 (3.8%). The major complication rate was 16.7% for the open group and 1.5% in the percutaneous group.
Conclusions: Pacemaker and ICD infections generally respond to antibiotics, complete hardware removal, and a hardware free interval. However, these principles cannot always be invoked, and the risk of complications is likely to increase when hardware cannot be completely removed or when a hardware-free interval is unsafe or inadvisable. Percutaneous lead extraction is superior to open extraction in terms of safety and comfort, but epicardial extraction techniques remain critically important in selected patients.
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Introduction
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The implantation rates for cardiac pacemakers and internal cardioverter defibrillators (ICDs) have been rapidly increasing in the past several decades [1]. Improved technologies and techniques have made transvenous implantation possible, obviating the need for sternotomy or thoracotomy, with their associated risks. Recent trials demonstrating benefits of ICD and cardiac resynchronization therapy (CRT) [2–4] have increased the number of devices implanted.
Concomitantly, lead-related complications, including infections and mechanical and electrical failures, have increased the frequency of lead extraction. The frequency of lead infections has also risen faster than expected based solely on the number of implanted leads [5].
Leads are extracted with percutaneous or open techniques. Percutaneous extractions are accomplished with simple traction or with the aid of locking stylets, snares, retrieval baskets, telescoping sheaths, and ablative (laser or radiofrequency) sheaths. Open extractions are performed through a thoracotomy or sternotomy, with or without cardiopulmonary bypass. Previous reviews of this topic have focused on experiences with one of the two techniques [6–11], or have concentrated on a specific indication [12] or a particular type of lead [13]. In this article we report all lead and patch extractions, including epicardial leads and ICD patches, and open and percutaneous techniques, in our institution.
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Patients and Methods
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With approval and a waiver of consent from our Institutional Review Board, our customized database was queried. All lead and patch extraction procedures performed by a single operator (Henry M. Spotnitz) at Columbia University Medical Center between July 1993 and February 2008 were included. Key words defining infection were "infection," "wound erosion," "purulent drainage from wound," "bacteremia," "endocarditis," or "intracardiac vegetation involving a lead." A positive blood culture was the criterion for systemic infection. When blood cultures were not available, systemic infection was considered absent. A description of a local wound infection was required for inclusion in the local infection category.
Leads extracted to facilitate new lead insertion to upgrade from a pacemaker to an ICD or from a dual chamber pacemaker to a CRT device were counted in the upgrade category. The dysfunction category included leads that were dislodged, electrically abnormal, structurally damaged, or recalled by the manufacturer. Superior vena cava (SVC) syndrome and atrial thrombus categories were based on clinical presentation or imaging studies, or both.
Lead extraction was performed in the operating room under general anesthesia, with pump standby. Percutaneous techniques were attempted first in all patients except those presenting with large vegetations, atrial thrombus, epicardial leads, or ICD patches. Endocardial leads were dissected free at their venous entry site. Anchoring collars were removed. If gentle traction failed, techniques described by Byrd and colleagues [14] and equipment manufactured by Cook Medical Inc (Bloomington, IN) was used. A locking stylet was inserted into the lead, and traction was again attempted. If this too failed, telescoping sheaths were advanced over the lead, maintaining countertraction with the locking stylet. We did not use any ablative sheaths, retrieval baskets, or snares. Persistent inability to extract the lead prompted conversion to an open technique, when indicated.
The commonest open technique after failed endocardial extraction was pursestring or snare-controlled right atriotomy through a median sternotomy [15]. Inflow occlusion through superior and inferior vena cava snares was used in 1 patient. Median sternotomy with cardiopulmonary bypass were used only in the presence of atrial or SVC thrombi, or large vegetations on the leads or on the tricuspid valve.
Epicardial leads and patches were removed through a median sternotomy or left, right, or subxiphoid thoracotomy. The surgical approach was based on lead and patch location in relation to the body surface.
Results were classified based on the North American Society of Pacing and Electrophysiology Guidelines [16].
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Results
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Characteristics and Infection
Patient and lead demographics are summarized in Table 1. Indications for extraction are summarized in Table 2. Infection was local only in 40 patients (including 14 in whom blood culture results were unavailable), systemic infection only in 12 (positive blood cultures), and both local and systemic in 6. Wound erosion occurred in 20 patients. Table 3
delineates cultured pathogens.
Extraction Techniques
Extraction was percutaneous in 127 endocardial leads (88.8%). Median sternotomy and cardiopulmonary bypass was used for 9 endocardial leads (6.3%) in 4 patients for atrial thrombus, large lead vegetation, lead and tricuspid valve vegetations also requiring tricuspid valve replacement, and large SVC thrombus with several prior failed extractions by other physicians in a patient who also required atrial septal defect closure. Extraction by median sternotomy without bypass was used for 6 endocardial leads (4.2%) and 3 epicardial leads or patches (33.3%). Other thoracotomies (Figs 1 and 2)
were used in 6 (66.7%).
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Fig 1. Chest roentgenograms were taken (A) before and (B) after extraction of infected epicardial internal cardiac defibrillator (ICD) patches (black arrows). The tips of the epicardial rate-sensing leads could not be completely extracted for technical reasons (white arrow), and this patient ultimately developed recurrent infection after a new ICD was inserted. Patches were extracted via bilateral thoracotomies.
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Fig 2. Chest roentgenograms were taken (A) before and (B) after extraction of infected epicardial ICD patches (black arrows). The tip of an endocardial rate sensing lead was avulsed in the left subclavian vein during extraction (white arrow). The 2 rate-sensing leads and the superior vena cava coil were extracted percutaneously. The 2 epicardial patches were extracted by bilateral thoracotomies. This patient was not pacemaker-dependent, and a new endovascular ICD lead was inserted 1 week after the extraction. This patient was completely cured.
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Pacemaker pocket infection was discovered incidentally in a patient 1 week before a cardiac operation. The generator and ventricular lead were extracted, and intravenous antibiotics were started. Her right atrial lead (0.7%) could not be extracted and was removed under direct visualization at the time of aortic valve replacement and coronary artery bypass grafting. A new system was implanted on cardiopulmonary bypass.
Dwell Time and Reimplantation
Mean dwell time (time since implant) for extracted leads was 56.2 months (range, 2 days to 24.8 years). Dwell time could not be determined for 12 leads. There was a strong (r
2 = 0.92) correlation between dwell time and retention of lead fragments in the endovascular space (Fig 3).
Table 4
details time to reimplantation.
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Fig 3. Relationship is shown between lead dwell time and retention of lead fragments in the endovascular space. A linear regression line (dashed line) is superimposed.
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Complications
Nine complications (11.4%) occurred (Table 5). Three (3.8%) were major complications, and six (7.6%) were minor. There were no deaths due to surgical complications. Four deaths occurred related to preexisting conditions, including sepsis and severe congestive heart failure that failed to resolve in the postoperative period.
Tricuspid Regurgitation
Cardiac echocardiographic data on tricuspid valve function before and after extraction were available for 30 patients (39%) with endocardial leads. Of these, 26 (33.8%) showed improved or unchanged tricuspid regurgitation postoperatively, whereas the tricuspid regurgitation had worsened in 4 (5.2%). No specific treatment was required for this tricuspid regurgitation in the early postoperative period. Preoperative cardiac echocardiographic data were not available for an additional 8 patients (10.4%), but they had only trace or mild tricuspid regurgitation on postoperative cardiac echocardiography. No postoperative echocardiographic data were available for 38 patients (49.4%). Of these, 27 (35.1%) had no mention of signs or symptoms of tricuspid regurgitation at discharge or at any subsequent inpatient visits. The tricuspid valve in 1 patient (1.3%) was replaced at the time of lead extraction because of leaflet vegetations. The prosthetic valve had mild tricuspid regurgitation postoperatively.
Success Rates
Complete radiographic success was achieved for 131 leads (86.2%). Partial success (Fig 4) was achieved for 14 leads (9.2%). Failure to extract the lead (>4 cm retained) occurred for 7 leads (4.6%). Incomplete extractions are detailed in Table 6.
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Figure 4. Chest roentgenograms were taken (A) before and (B) after extraction of an infected pacemaker system, including a 24.75-year-old lead (black arrow). One lead tip (white arrow) was avulsed and retained in the right ventricular wall during percutaneous extraction. A new device was simultaneously implanted on the contralateral side because the patient was pacemaker-dependent. This patient was permanently cured.
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Comment
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With increasing use of cardiac arrhythmia devices worldwide, the need for lead extraction has grown and has stimulated a wide array of lead extraction techniques and technologies. Many previous studies have reviewed indications and outcomes for percutaneous extractions using various techniques such as locking stylets and laser sheaths [6–8, 17, 18]. Reviews on open extraction techniques are not as numerous and tend to be older. This is expected, because the use of the open technique has become less prevalent since the advent and advancement of percutaneous techniques. Reviews of extraction of epicardial leads are similarly lacking. Camboni and colleagues [13] compared their experience with open and percutaneous techniques only for endocardial ICD leads. In this article we report a contemporary series that describes pacemaker and ICD lead and patch extractions using percutaneous and open techniques.
Infection prompted extraction of 73.4% leads at our center, with lead dysfunction comprising the next largest group at 20.3%. Jones and colleagues [18] reported 60.3% infections and 29.3% lead dysfunction. The United States Lead Extraction Database [7] reports 54% for infection and 40% for dysfunction. The above studies only include percutaneous extraction of endovascular leads. Reviews of open techniques are usually skewed towards infection because removal of large vegetations percutaneously is discouraged. In our study, 75% of endovascular leads extracted using open techniques were extracted for infection.
The commonest wound pathogen in this series was Staphylococcus epidermidis, followed by S aureus. The commonest blood pathogen in this series, S aureus, was twice as prevalent as S epidermidis. This is consistent with a recent large series examining cardiac device infections [19]. Most of our patients in whom extraction was undertaken for infection did not have septicemia but rather presented with local infection at or near the implant site. This is also consistent with recent series [18, 19].
A critical issue in lead extraction is stability of the underlying rhythm. It is generally agreed that a hardware-free period of 3 to 7 days promotes complete recovery [19–21], but this is not possible in pacemaker-dependent patients. Also, temporary wires may not be feasible in patients with poor escape rhythms or refractory ventricular tachycardia. For such patients, we insert a new device at the time of lead extraction, generally contralateral to the lead extraction.
For patients with purulent wounds, we use a multistage procedure. First, the generator is exteriorized, the pocket is irrigated and débrided, and antibiotic treatment is initiated or continued. When wound cultures are negative, a lead extraction is performed. With increasing experience, we have abandoned a staged cephalad approach to infected wounds in favor of combined cephalad and caudad approach. The generator is extracted from above, the wound is cleaned, and nylon sutures are placed for delayed closure. A large Malecot catheter is placed from below. This has accelerated wound healing.
Although percutaneous extraction is favored in most circumstances due to lower morbidity and mortality, it cannot be applied to all lead extractions. Patients presenting with large lead vegetations or thrombi, or with vegetations on the tricuspid valve, have not undergone percutaneous extraction at our center because of the presumed risk of embolism. In addition, patients requiring lead extraction in whom percutaneous extraction is not possible due to the presence of epicardial leads or ICD patches require an open technique. Complications during percutaneous extraction, such as loss of structural integrity with exposure of dangerous wire fragments [22], may necessitate an open technique. Finally, patients who require other cardiac surgical procedures in addition to lead extraction are better served when both procedures are done at the same time.
When an open approach is considered, risks must be weighed against the benefits of lead extraction, and alternatives such as chronic antibiotic therapy should be considered. The need for open extraction, although minimized by advanced percutaneous techniques, still exists. Most of the leads in our series were extracted using only percutaneous techniques.
An open approach was the initial approach for 20 (80%) of the leads/patches extracted using open techniques. This includes 2 infected patients, previously managed by others. One was a pacemaker-dependent staff physician, with thrombosis of the SVC. Previous generator relocations were done by other physicians at the patient's request. Both endovascular leads were extracted through a median sternotomy with simultaneous closure of an atrial septal defect. In the other patient, with a diagnosis of heparin-induced thrombocytopenia, multiple extraction attempts in the electrophysiology laboratory were unsuccessful. His leads were extracted through a purse string-controlled atriotomy with inflow occlusion using a Cook locking stylet (Bloomington, IN) and telescoping sheath during median sternotomy and inflow occlusion. For the remaining 5 leads (20%) that were extracted using open techniques, the initial approach was percutaneous, with an open approach after endovascular extraction failed.
Considering all leads with endovascular approaches first, the conversion rate to an open technique was 3.8%. One lead was extracted during an open heart procedure after a failed attempt at extracting the lead percutaneously 1 week prior. In 2 patients, 1 of 2 leads could not be extracted percutaneously because of loss of structural integrity of the lead, prompting conversion to the open technique. The other lead was extracted using open techniques because the open approach had already been initiated. For purposes of analysis, we have assumed that the second lead in each case had to be extracted by the open technique; thus, the true conversion rate may be lower than reported.
The major complication rate in this series was 16.7% for the open group and 1.5% in the percutaneous group. The major complication rate in the percutaneous extraction group is within the range defined by several large-scale reviews [6, 7]. Our overall major complication rate was 3.8%, which is slightly higher than the 3% rate reported by Mathur and colleagues [17], which included percutaneous and open approaches for extraction of endocardial leads but excluded epicardial leads and patches. A lack of studies that include epicardial leads and patches makes it difficult to compare our complication rates in the open group with other reports.
Studies that have reported on open extraction of endocardial pacemaker leads have had much lower complication rates of 0% to 8% [9–11, 23–25], whereas the major complication rate for patients undergoing open extraction of ICD leads reported by Camboni and colleagues [13] was much higher at 19%. The high complication for the open technique observed in our series was partly because we included not only ICD leads but also epicardial leads and patches. Of the 2 patients experiencing major complications in the open group, 1 underwent bilateral thoracotomies for the purpose of extraction of infected epicardial ICD patches and an epicardial rate-sensing lead. All the extracted hardware in this patient had been in place for 14 years, and dense, vascularized adhesions were found around leads and patches.
Success rates in our series are comparable to others reporting extractions that used locking stylets [8] and telescoping sheaths [7], although the extrapolation of these results to our series is confounded by the inclusion of the open approach in our analysis. Our success rates are also similar to those reported in a series that more closely resembles ours in terms of selection and exclusion criteria [17].
Extraction methods summarized elsewhere [14] are not our primary focus. Locking stylets must pass all the way to the lead tip to facilitate forceful countertraction, which allows disruption of adhesions to surrounding structures by passing metal or Teflon cannulas along the lead course. An inventory of stylets is no longer required, because universal locking stylets of one size are sufficient. A fully mobilized lead tends to emerge intact, with the exception of the tip, which may become entangled in adhesions to the innominate or subclavian vein. Teflon ICD patches can often be removed through small incisions because the patch may be floating freely inside its capsule, especially if infection is active.
In this review of lead extraction, the predominant indication was infection that resolved successfully with antibiotics and hardware removal. Concurrent reinsertion was required in 37.9% of infected patients because of pacemaker or defibrillator dependence, but the overall cure rate for treatment of infection was 93.1%. Lead tip retention was dependent on dwell time. Major complication rates were 16.7% with epicardial extraction and 1.5% with endocardial extraction. Endocardial extraction is preferable when feasible, but epicardial techniques remain essential in selected patients.
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Acknowledgments
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Dr Rusanov was supported in part by Pacemaker-ICD Fellowship from Boston Scientific Corp. Dr Spotnitz is the George H. Humphreys, II, Professor of Surgery.
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Abstract
Introduction
