Ann Thorac Surg 2002;74:1494-1499
© 2002 The Society of Thoracic Surgeons
Original article: cardiovascular
Surgical lead-preserving procedures for pacemaker pocket infection
Makoto Yamada, MDa*,
Susumu Takeuchi, MDa,
Yasuhiro Shiojiri, MDa,
Kazuto Maruta, MDa,
Atsuyoshi Oki, MDa,
Katsuyoshi Iyano, MDa,
Toshihiro Takaba, MDa
a The First Department of Surgery, Showa University, Tokyo, Japan
Accepted for publication June 26, 2002.
* Address reprint requests to Dr Yamada, The First Department of Surgery, Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan.
e-mail: dayama{at}med.showa-u.ac.jp
 |
Abstract
|
|---|
BACKGROUND: In the treatment of pacemaker pocket infection, removal of the entire pacing system has been considered necessary to avoid recurrent infection. We report a series of patients treated surgically by our lead-preserving procedures.
METHODS: Between 1990 and 2001, a total of 18 patients underwent one of two types of lead-preserving procedures. Procedure 1 preserves the full length of the lead, and procedure 2 preserves only the distal part of the lead. Signs of bacteremia, endocarditis, or purulent material within the lead insulation preclude application of these procedures in patients with potential or definite pacemaker pocket infection.
RESULTS: Seventeen patients who met the indications for our procedures were discharged 7 to 14 days (8.9 ± 2.4 days, mean ± SD) postoperatively without signs of infection and were followed up for a total of 987 patient-months until the close of the study or death without recurrent infection. The remaining 1 patient, who did not meet the indications, suffered reinfection soon after the operation.
CONCLUSIONS: The follow-up data suggest that our lead-preserving procedures should be considered as alternatives to conventional removal of the entire pacing system in cases of pocket infection that meet specific criteria.
|
Introduction
|
|---|
To ensure eradication of infection associated with the implantable pacemaker, removal of the entire pacing system is generally considered necessary [1–8]. Historically, conservative treatments such as administration of appropriate systemic antibiotics, limited debridement, irrigation, and relocation of the pacemaker pocket have failed to control infection even for patients in whom no microorganisms have been detected [1–6, 9]. We report a favorable experience with 18 patients in whom lead-preserving procedures were performed for the treatment of pacemaker pocket infection.
|
Patients and methods
|
|---|
Study patients
Between January 1990 and September 2001, we treated 22 patients surgically for potential or definite infection of the pacemaker pocket. Of the 22 patients, 18 were treated by one of two types of lead-preserving procedures. The other 4 patients, 1 of them with bacteremia, underwent standard treatment (ie, complete removal of the pacing system). All patients who underwent lead-preserving procedures instead of complete removal of the infected pacing system gave their informed consent and are the subjects of this study.
Patient characteristics
Patient characteristics are shown in Table 1.
All 18 patients (7 men and 11 women) had endocardial leads, and all pacemaker pockets were located subcutaneously on the anterior chest. Patient ages ranged from 42 to 90 years (67.7 ± 13.2 years, mean ± SD). Factors predisposing to infection were diabetes mellitus (n = 4), corticosteroid treatment (n = 1), and advanced age (n = 1). Operations performed before infection were new implantation (n = 12) and pulse generator replacement (n = 6). Intervals between these operations and the onset of infection varied from 10 days to 102 months. Intervals between the recognized onset of infection and the lead-preserving procedure varied from 10 days to 13 months. One patient (case 2) had been treated conservatively by his cardiologist for 13 months with antibiotics, pus aspiration, and irrigation. No patient presented with bacteremia or endocarditis. Local signs of infection of the pocket site as reported by the patients’ cardiologists and signs observed on admission are listed in Table 1. Redness or abscess, which we considered to be the sign of infection, was recognized in 15 patients. Sixteen patients had been treated with systemic antibiotics for 7 days or more. Three patients were admitted to our hospital with a body temperature greater than 37.3°C. Blood cultures performed in 17 patients on admission were all negative.
Operative techniques
For procedure 1 (full-length lead preservation) (Fig 1),
the infected pocket is opened wide, and the infected pulse generator is removed. After the lead is released from surrounding granular tissue on the posterior surface of the pocket, the pocket is thoroughly debrided of all inflammatory tissue. The pocket and lead are irrigated with saline solution and disinfected by both wrapping the proximal pacemaker lead and packing the pacemaker pocket with povidone-iodine–soaked gauze for 15 minutes. During this 15-minute period, the surgeons and all assistants rescrub, and the operative field is assiduously disinfected with povidone-iodine solution. New drapes and another set of sterilized instruments are used. A 2-cm-long skin incision is made above the original pocket 1.5 cm below the clavicle, and the lead near the venous entry site is exposed. The proximal lead segment in the pocket is pulled out through this incision (Fig 1A). The lead is again disinfected with povidone-iodine solution for at least 5 minutes. The lead is then tunneled as far as possible from the previous pocket to the new pocket, which is located subcutaneously in the ipsi- or contralateral anterior or lateral chest. The lead is connected to a new pulse generator, and the subcutaneous layer of the incision is closed with polyglycolic acid sutures and the skin with nylon (Fig 1B). The infected pocket is closed at this time with no drain in place.
View larger version (15K):
[in this window]
[in a new window]
|
Fig 1. Procedure 1. (A) After managing the infected pocket, the proximal lead segment in the pocket is pulled out through the small incision made 1.5 cm below the clavicle. (B) The lead is tunneled to the new pocket and connected to a new generator. The lead tunnel is created as faraway as possible from the old pocket.
|
|
For procedure 2 (distal lead preservation) (Fig 2),
a 2-cm-long skin incision is made above the original pocket 1.5 cm below the clavicle, and a 3-cm length of lead near the venous entry site is exposed via this incision. The exposed lead is cut (Fig 2A), and continuity of the distal part of the lead is restored with a connector (splicing crimp and sleeve, Implantaid, Model 365-19; Intermedics, Inc., Angeleton, TX) by connecting it to the proximal part of a freshly cut new lead. This connection can be made only in unipolar leads because of their simple, single-wire structure. The connected lead and new pulse generator are implanted as in procedure 1 (Fig 2B). The infected pocket is then opened widely, and the infected pulse generator and proximal segment of the lead are removed. The infected pocket is closed without placement of a drain after immediate and thorough debridement and irrigation with saline and povidone-iodine solution.
View larger version (23K):
[in this window]
[in a new window]
|
Fig 2. Procedure 2. (A) The lead exposed by the small incision made 1.5 cm below the clavicle is cut. (B) The distal part of the lead is connected to the proximal part of a freshly cut new lead with a connector. The new lead is tunneled to the new pocket and connected to a new generator. The lead tunnel is kept as far away as possible from the infected pocket.
|
|
Indications and procedure selection
Indications for a lead-preserving procedure in potential or definite infection of the pacemaker pocket preclude signs of bacteremia or endocarditis and purulent material within the lead insulation. The latter is judged macroscopically during surgery. Procedure 2 was performed in unipolar lead cases after we introduced it in 1991. Beginning in 1995, however, we sometimes performed procedure 1 even in unipolar lead cases for reasons we discuss later.
Operative data
Our lead-preserving procedures were all performed within 4 days after patient admission. Purulence or inflammatory tissue was collected for bacteriologic culture from the pacemaker pocket at surgery in 17 patients. Purulent material within the right atrial lead insulation was seen in 1 patient (case 8). We performed procedure 2 on the ventricular lead in this patient after removal of the infected atrial lead. In another patient (case 14), we noted many defects in the insulation of the ventricular bipolar lead coiled behind the generator in the infected pocket. We thus suspected the inside of this lead to be infected, which is a condition that would normally fall outside our procedure criteria. We tried to remove this lead by manual traction but failed. Both open heart surgical removal under cardiopulmonary bypass and the use of intravascular lead extraction systems were thought too invasive for the patient because she was a 90-year-old woman with a body weight of only 28 kg. We reluctantly performed procedure 1 in this patient because no other choice of treatment was available to her. Procedure 1 was performed in 12 patients and procedure 2 in 6 patients, and operation time ranged from 95 to 290 minutes (156 ± 51 minutes). Local anesthesia was used on patients before 1995 (n = 5). We began to use general anesthesia in 1995 (n = 13). All patients received intravenous antibiotics for 5 to 7 days postoperatively followed by oral antibiotics for 0 to 7 days. Thereafter, no further antibiotics were given.
Follow-up
Follow-up was carried out for all patients after discharge, and records were updated for all survivors through February 2002 at a pacemaker clinic or by telephone contact with each patient’s cardiologist.
|
Results
|
|---|
Bacteriology
Microorganisms were detected in the operative specimens of 11 patients. Staphylococcus aureus was cultured in 2 patients and less virulent organisms such as S. epidermidis in the other 9. Among the 3 patients in whom signs of redness or abscess were not recognized, bacteriological cultures were positive in 2 patients.
Outcome
The 17 patients who met the indications for our lead-preserving procedures were discharged 7 to 14 days (8.9 ± 2.4 days) after the procedure with no signs of infection. These patients were followed up for a total of 987 postprocedure patient-months to the close of the study or the patient’s death. Follow-up periods ranged from 5 months to 11 years (58 ± 43 months). Three patients died of cardiac failure and 1 died of esophageal cancer during the follow-up period, all without signs of infection; 13 patients are currently alive and free of infection. The patient who did not satisfy our procedure criteria did not fare as well. An abscess was observed in the new pocket 11 days after the lead-preserving procedure was performed, and S. epidermidis was cultured from the abscess. The patient was treated successfully with a new pacing system upon complete removal of the infected system, which fortunately, was accomplished only by manual traction at a second operation.
|
Comment
|
|---|
The definition of pacemaker pocket infection is still controversial [10–16]. This may be due in part to differences in presentation between early and late infections. Fever is a sign of infection [12, 14], but late infection caused by microorganisms with low virulence is not usually accompanied by fever [17, 18]. Skin perforation may contribute to the controversy because it is sometimes not clear whether skin perforation is the result of infection or pressure necrosis. If skin perforation occurs as a result of infection, fever and local redness or abscess may appear. However, fever and local signs of infection may be relieved naturally by spontaneous drainage of purulent materials through the perforation. Appropriate administration of antibiotics may also prevent fever and local signs of infection. Even when perforation is the result of pressure necrosis, the culture may be positive because there is usually secondary bacterial invasion of the tissue. Redness or abscess was recognized in 15 of our 18 patients by their cardiologists or on admission. Cultures of operative specimens from the pockets were positive in 11 patients. If pocket infection is defined strictly as the presence of local redness or abscess along with a positive operative culture [8], there were 9 cases of proven infection among our patients. Harjula and associates [17] treated patients surgically by preserving the same lead and inserting a new generator, but the incidence of recurrent infection was greater than 75%. Among many other reports on conservative methods of treatment for pacemaker pocket infection, most unsuccessful, Vogt and associates [5] and Parry and associates [8] also reported a high incidence of recurrent infection in patients whose initial bacteriological culture was negative. Therefore, careful conservative treatment is necessary not only for patients with proven pocket infection but also for those with potential or unproven pocket infection.
Although we also agree that removal of the entire pacing system is the best approach to pacemaker pocket infection, difficulty in removing the transvenous pacemaker lead sometimes occurs. Although newer methods of transvenous lead extraction have proven effective [19–21], not all leads can be removed, and the complication rate, though low, should not be ignored [20–22]. Even if lead removal is accomplished, it is not known whether the new lead will function as well as the previous one. Implantation of a new lead via the contralateral vein carries with it the risk of bilateral subclavian vein occlusion [2, 23]. Thus, it is desirable to preserve the well-functioning in situ lead. Between 1990 and 1991, we surgically treated 5 patients for pacemaker pocket infection. We chose to remove the entire pacing system in 3 of these patients. We performed lead-preserving procedure 1 in 1 of the other 2 patients, and procedure 2 in the other, because these 2 patients, along with their cardiologists, were eager to preserve their well-functioning leads. Postoperative outcomes in these 2 patients were excellent. Therefore, by 1992, we had adopted our lead-preserving procedures as the treatment of choice in cases of pocket infection. The criteria we have established require that infection be limited to the pacemaker pocket. Because we observed recurrent infection in 1 patient in whom the interior of the lead was also infected, we now restrict lead-preserving procedures to patients who satisfy our established criteria.
We regard procedure 2 as cleaner than procedure 1 because the main steps in procedure 2 are performed in an aseptic operative field. Procedure 2, however, can be done only with unipolar leads and the use of a connector whose durability is not clearly known. Procedure 1 can be used for patients with a bipolar lead, which is presently the most common, and our results have been good so far. Thus, since 1995, we have sometimes used procedure 1 even for unipolar leads. If the lead is unipolar and the pocket infection appears virulent, procedure 2 may be necessary.
Conclusion
We regard the favorable outcomes of our patients to be the result of careful preparation and meticulous surgical procedure. Strict observance of cleanliness and relocation of the lead and new generator as far as possible from the infected site are both extremely important. General anesthesia is indicated for multiple skin incisions and for thorough debridement of infected tissue. Our follow-up data indicate that our lead-preserving procedures should be considered as alternatives to conventional removal of the entire pacing system in cases of localized pacemaker pocket infection that meet specific criteria.
|
References
|
|---|
- Choo M.H., Holmes D.R., Jr, Gersh B.J., et al. Permanent pacemaker infections: characterization and management. Am J Cardiol 1981;48:559-564.[Medline]
- Parry G., Goudevenos J., Jameson S., Adams P.C., Gold R.G. Complications associated with retained pacemaker leads. PACE 1991;14:1251-1257.
- Frame R., Brodman R.F., Furman S., Andrews C.A., Gross J.N. Surgical removal of infected transvenous pacemaker leads. PACE 1993;16:2343-2348.
- Abad C., Manzano J.J., Quintana J., Bolaños J., Manzano J.L. Removal of infected dual chambered transvenous pacemaker and implantation of a new epicardial dual chambered device with cardiopulmonary bypass: experience with seven cases. PACE 1995;18:1272-1275.
- Vogt P.R., Sagdic K., Lachat M., Candinas R., von Segesser L.K., Turina M.I. Surgical management of infected permanent transvenous pacemaker systems: ten year experience. J Card Surg 1996;11:180-186.[Medline]
- Molina J.E. Undertreatment and overtreatment of patients with infected antiarrhythmic implantable devices. Ann Thorac Surg 1997;63:504-509.[Abstract/Free Full Text]
- Wilhelm M.J., Schmid C., Hammel D., et al. Cardiac pacemaker infection: surgical management with and without extracorporeal circulation. Ann Thorac Surg 1997;64:1707-1712.[Abstract/Free Full Text]
- Chua J.D., Wilkoff B.L., Lee I., Juratli N., Longworth D.L., Gordon S.M. Diagnosis and management of infections involving implantable electrophysiologic cardiac devices. Ann Intern Med 2000;133:604-608.[Abstract/Free Full Text]
- Chait L.A., Ritchie B. A method of treating the exposed cardiac pacemaker. Br J Plast Surg 1979;32:281-284.[Medline]
- Morgan G., Ginks W., Siddons H., Leatham A. Septicemia in patients with an endocardial pacemaker. Am J Cardiol 1979;44:221-224.[Medline]
- Rettig G., Doenecke P., Sen S., Volkmer I., Bette L. Complications with retained transvenous pacemaker electrodes. Am Heart J 1979;98:587-594.[Medline]
- Muers M.F., Arnold A.G., Sleight P. Prophylactic antibiotics for cardiac pacemaker implantation: a prospective trial. Br Heart J 1981;46:539-544.[Abstract/Free Full Text]
- Bluhm G., Jacobson B., Julander I., Levander-Lindgren M., Olin C. Antibiotic prophylaxis in pacemaker surgery: a prospective study. Scand J Thorac Cardiovasc Surg 1984;18:227-234.[Medline]
- Ramsdale D.R., Charles R.G., Rowlands D.B., Singh S.S., Gautam P.C., Faragher E.B. Antibiotic prophylaxis for pacemaker implantation: a prospective randomized trial. PACE 1984;7:844-849.
- Da Costa A., Lelièvre H., Kirkorian G., et al. Role of the preaxillary flora in pacemaker infections: a prospective study. Circulation 1998;97:1791-1795.[Abstract/Free Full Text]
- Da Costa A., Kirkorian G., Cucherat M., et al. Antibioticprophylaxis for permanent pacemaker implantation: a meta-analysis. Circulation 1998;97:1796-1801.[Abstract/Free Full Text]
- Harjula A., Järvinen A., Virtanen K.S., Mattila S. Pacemaker infections: treatment with total or partial pacemaker system removal. Thorac Cardiovasc Surgeon 1985;33:218-220.[Medline]
- Mansour K.A., Kauten J.R., Hatcher C.R., Jr Management of the infected pacemaker: explantation, sterilization, and reimplantation. Ann Thorac Surg 1985;40:617-619.[Abstract]
- Byrd C.L., Schwartz S.J., Hedin N.B., Goode L.B., Fearnot N.E., Smith H.J. Intravascular lead extraction using locking stylets and sheaths. PACE 1990;13:1871-1875.
- Kennergren C. First European experience using excimer laser for the extraction of permanent pacemaker leads. PACE 1998;21:268-270.
- Manolis A.S., Maounis T.N., Chiladakis J., Vassilikos V., Melita-Manolis H., Cokkinos D.V. Successful percutaneous extraction of pacemaker leads with a novel (VascoExtor) pacing lead removal system. Am J Cardiol 1998;81:935-938.[Medline]
- Kratz J.M., Leman R., Gillette P.C. Forceps extraction of permanent pacing leads. Ann Thorac Surg 1990;49:676-677.[Abstract]
- Rosa Brusin M.C., Checco L., De Bernardi A., Morello M., Mangiardi L. The superior vena cava obstruction syndrome after the implantation of a permanent pacemaker: a clinical case report. Cardiologia 1998;43:201-204.[Medline]
This article has been cited by other articles:
|
|
|
|
 
F. L. Pimpec-Barthes, J.-P. Hubsch, S. Payelleville, and T. Similowski
Successful reimplantation of a phrenic nerve stimulator after traumatic exteriorisation
Eur. J. Cardiothorac. Surg.,
January 1, 2006;
29(1):
117 - 118.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
D Klug, F Wallet, D Lacroix, C Marquie, C Kouakam, S Kacet, and R Courcol
Local symptoms at the site of pacemaker implantation indicate latent systemic infection
Heart,
August 1, 2004;
90(8):
882 - 886.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
E. M. Kojic and R. O. Darouiche
Candida Infections of Medical Devices
Clin. Microbiol. Rev.,
April 1, 2004;
17(2):
255 - 267.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Yamada and T. Takaba
Preserving infected pacemaker systems: Reply
Ann. Thorac. Surg.,
April 1, 2004;
77(4):
1505 - 1505.
[Full Text]
[PDF]
|
|
|
|
|
|
|
R. A. Dieter Jr
Preserving infected pacemaker systems
Ann. Thorac. Surg.,
April 1, 2004;
77(4):
1504 - 1505.
[Full Text]
[PDF]
|
|
|
|
|
|
|
F.A.L.E. Bracke, A Meijer, and L.M. van Gelder
Lead extraction for device related infections: a single-centre experience
Europace,
January 1, 2004;
6(3):
243 - 247.
[Abstract]
[Full Text]
[PDF]
|
|
|
Top
Abstract
Introduction
