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The infected pacemaker pocket
The infected pacemaker pocket Between January, 1963, and September, 1978, a total of 1,789 pacemakers were implanted at Henry Ford Hospital. 1nfection at the site of implantation developed in 19 instances for an incidence of 1.06 percent. The most common organism cultured was Staphylococcus epidermidis, and conservative treatment was successful with these patients. 1n all patients with organisms other than Staphylococcus epidermidis, reimplantation of a new unit in a new, clean site was required.
F. M. Jara, M.D., L. Toledo-Pereyra, M.D., J. W. Lewis, Jr., M.D., and D. J. MagiIIigan, Jr., M.D., Detroit, Mich.
T
he remarkable bioengineering achievement of a totally implantable electronic pacemaker for management of heart block and other arrhythmias has benefited many patients with an otherwise gloomy prognosis. However, as remarkable as this advance may be, implanting a foreign material has introduced new problems, and one of the more troublesome and potentially dangerous is postoperative infection. Whereas the medical literature describes different policies for treating this complication.I'" this paper reports our experience with its clinical features, etiologic factors, and management.
Clinical experience Between January, 1963, and September, 1978, a total of 1,789 trans venous pacemakers were implanted at Henry Ford Hospital (epicardial pacemakers are not included). In the majority of cases the operation was performed in the Catheterization Laboratory via the cephalic vein or the external jugular vein. In all cases, prophylactic antibiotics were administered. Follow up of all patients was obtained from records from our Pacemaker Clinic, which follows all patients with pacemaker implants with a routine clinic visit or by contacting the family physician. Infection at the site of implantation was defined by the development of redness, tenderness, and swelling with or without necrosis of the skin overlying any part
of the pacemaker system and was confirmed by a minimum of two cultures obtained from purulent secretions after the surrounding skin was cleaned with Betadine solution. Among our patients there were 19 instances of infection (1.06 percent). Included are five patients with erosion of the skin over the power pack with secondary infection. Fourteen patients were men and five women with an average age of 67 years and a range of 32 to 85 years. In 10 cases, the cephalic vein was used at the level of the deltopectoral area; in nine cases the external jugular vein was used. Factors predisposing to infection were drainage of the pacemaker pocket with a Penrose drain (four cases); repositioning of the lead (six); development of hematoma in four cases, with needle aspiration in three; and erosion of skin because of pressure necrosis in five patients. The average time of presentation of infection was 8 days, ranging from 4 to 25 days. In the five patients with erosion of the skin, infection occurred at an average time of 16 months, ranging from 12 to 24 months. The most common organism cultured was Staphylococcus epidermidis, in nine cases. Staphylococcus aureus was found in four cases, and Enterobacter cloaca in two. Other organisms cultures were Pseudomonas aeruginosa, Klebsiella, Escherichia coli, and Proteus mirabilis,
Forms of therapy From the Department of Surgery and Division of Cardiac and Thoracic Surgery, Henry Ford Hospital, Detroit, Mich. Received for publication Feb. 6, 1979. Accepted for publication March 6, 1979. Address for reprints: Fernando M. lara, M.D., Division of Cardiac and Thoracic Surgery, Henry Ford Hospital, 2799 West Grand Blvd., Detroit, Mich. 40202.
298
Ten patients were treated by removal of the pacemaker unit (power pack and endocardial leads), debridement of the wound, and the use of proper antibiotics. Four patients had two tubes for continuous irrigation with 1 percent neomycin or 25 percent Betadine solution. However, in all cases, reimplantation of a
0022-5223179/0S029S+03$OO.30/0© 1979 The C. V. Mosby Co.
Volume 78
Infected pacemaker pocket
Number 2
299
August, 1979
new unit In a site distant from the original site was required to control the infection. Nine patients did not require reimplantation of a new unit. In all of these cases Staphylococcus epidermidis was the single organism cultured. In this group, six patients were treated by continuous irrigation of the pocket with two tubes for a minimum of I week with a solution of I percent neomycin (three cases) and 25 percent Betadine (three cases) and the use of proper systemic antibiotics according to the sensitivity of the organism. In the remaining three cases, the pocket was debrided of all necrotic tissue, closed primarily, and a course of antibiotics was administered for a minimum of 10 days. Although no deaths could be attributed to the development of infection, there was a considerable degree of morbidity. One patient required extraction of the endocardial lead through a right atriotomy because of continuous sepsis. Two patients with erosion of the skin underwent several plastic procedures in an attempt to cover the exposed pacemaker; however, this attempt was unsuccessful and reimplantation of a new unit was required. Discussion
Infection from a permanent trans venous cardiac pacemaker can lead to significant morbidity and mortality," although the incidence has decreased. Early reports cited figures up to 41 percent, whereas more recent reports show an incidence between zero and 12.6 percent. 2. 6 Whether or not this decrease is related to the widespread use of prophylactic antibiotics is subject to debate. Most of the pertinent literature advocates their use," although adequate, controlled trials of the use of prophylactic antibiotics in this setting are not available. It is assumed that most wounds became infected at the time of operation, and in our series, as well as in others," the most common organism involved was Staphylococcus epidermidis. Since this organism is a well-known saprophyte of the skin, meticulous preparation of the skin with soap and an antiseptic solution and irrigation of the wound with an antibiotic solution before closure should reduce the incidence of infection caused by this organism. If the cases involving Staphylococcus epidermidis were eliminated from this series, the general incidence of infection would be remarkably low. Factors predisposing to infection are various. Drainage of the pacemaker pocket, a practice used early in this series, is no longer recommended. We believe, as others dO,9 that it increased the incidence of infection independent of prophylactic antibiotics. 10 Extrusion of
the pulse generator from pressure necrosis of the skin with secondary contamination occurred in five cases. Hematoma appeared to be a contributing factor to wound infection, and needle aspiration was done in three of the four cases. Lead reposition was considered a predisposing factor in five cases. These findings indicate that when the lead is repositioned or hematoma develops, meticulous attention to aseptic technique is essential. The management of this complication depends in part on the virulence of the organism cultured. The general surgical principle that a foreign material must be completely removed to eradicate infection can be violated if the organism cultured is Staphylococcus epidermidis. As others!' have indicated, in situ management of this problem seems worthwhile. The approach should include local debridement, the use of antibiotics, and continuous irrigation with an antiseptic solution through two tubes. In our series, all of the patients in whom this organism was cultured responded to this type of therapy. If the organism cultured is not Staphylococcus epidermidis, the following principles should be adopted: I. The pacemaker must be removed before the infection can be eradicated. 2. Temporary pacing must be provided while the infection is under treatment. 3. A new, permanent pacemaker unit must be implanted at a new, clean site. If there is no evidence of sepsis, the new unit can be implanted immediately after the infected pacemaker has been removed. However, if sepsis is present, with or without endocarditis, implantation of a new unit should be delayed until all infection has been eliminated. The endocardial lead cannot always be removed because of fixation due to scarring in the right ventricle. If sepsis or endocarditis persists, the lead should be removed even if a right atriotomy is required. Extensive plastic procedures to cover an extruded pacemaker are not recommended. 12 In two patients in our series, attempts to cover the pacemaker were unsuccessful and resulted in considerable cost and suffering to the patient. REFERENCES Dargan E, Norman JC: Conservative management of infected pacemaker pulse generatorsites. Ann Thorac Surg 12:297-299, 1971
2 Firor WB, Lopez JF, Nanson EM, Morl M: Clinical management of the infected pacemaker. Ann Thorac Surg 6:431-436, 1968
3 Kennelly BM, Piller LW: Management of infected trans-
300 Jara et al.
The Journal of Thoracic and Cardiovascular Surgery
4 5 6 7
8
venous pennanent pacemakers. Br Heart J 36: 1133-1140, 1974 Smyth NPD: Cardiac pacemaker (collective review). Ann Thorac Surg 8:166-190, 1969 Harris A, Bluestone R, Busby E, et al: The management of heart block, Br Heart J 27:469-482, 1965 Kohn 0: Prosthetic cardiac process in community hospitals. Am Heart J 88:656-663, 1974 Hartstein AI, Jackson J, Gilbert DN: Prophylactic antibiotics and the insertion of permanent transvenous cardiac pacemakers. J THORAC CARDIOVASC SURG 75:219222, 1978 Lemire GG, Morin JE, Dobell ARC: Pacemaker infections. A 12-year review. Can J Surg 18: 181-184, 1975
9 Rao G, Ford WB, Zikria EA, et al: Incidence and prevention of infection in patients with permanent cardiac pacemaker. Int Surg 59:559-561, 1974 10 Margarey CH, Chant ADB, Rickford CRK, Margarey JF: Peritoneal drainage and systemic antibiotics after appendectomy. Lancet 2:179-182, 1971 II Golden GT, Lovett WL, Harrah JD, et al: The treatment of extruded and infected permanent cardiac pulse generators. Application of a technique of closed irrigation. Surgery 74:575-579, 1975 12 Coburn RJ, Blank HL, Campbell RM: Covering an exposed pacemaker. Case report. Plast Reconstr Surg 50:622-625, 1972
Information for authors Most of the provisions of the Copyright Act of 1976 became effective on January I, 1978. Therefore, all manuscripts must be accompanied by the following written statement, signed by one author: "The undersigned author transfers all copyright ownership of the manuscript (title of article) to The C. V. Mosby Company in the event the work is published. The undersigned author warrants that the article is original, is not under consideration by another journal, and has not been previously published. I sign for and accept responsibility for releasing this material on behalf of any and all co-authors." Authors will be consulted, when possible, regarding republication of their material.
F. M. Jara, M.D., L. Toledo-Pereyra, M.D., J. W. Lewis, Jr., M.D., and D. J. MagiIIigan, Jr., M.D., Detroit, Mich.
T
he remarkable bioengineering achievement of a totally implantable electronic pacemaker for management of heart block and other arrhythmias has benefited many patients with an otherwise gloomy prognosis. However, as remarkable as this advance may be, implanting a foreign material has introduced new problems, and one of the more troublesome and potentially dangerous is postoperative infection. Whereas the medical literature describes different policies for treating this complication.I'" this paper reports our experience with its clinical features, etiologic factors, and management.
Clinical experience Between January, 1963, and September, 1978, a total of 1,789 trans venous pacemakers were implanted at Henry Ford Hospital (epicardial pacemakers are not included). In the majority of cases the operation was performed in the Catheterization Laboratory via the cephalic vein or the external jugular vein. In all cases, prophylactic antibiotics were administered. Follow up of all patients was obtained from records from our Pacemaker Clinic, which follows all patients with pacemaker implants with a routine clinic visit or by contacting the family physician. Infection at the site of implantation was defined by the development of redness, tenderness, and swelling with or without necrosis of the skin overlying any part
of the pacemaker system and was confirmed by a minimum of two cultures obtained from purulent secretions after the surrounding skin was cleaned with Betadine solution. Among our patients there were 19 instances of infection (1.06 percent). Included are five patients with erosion of the skin over the power pack with secondary infection. Fourteen patients were men and five women with an average age of 67 years and a range of 32 to 85 years. In 10 cases, the cephalic vein was used at the level of the deltopectoral area; in nine cases the external jugular vein was used. Factors predisposing to infection were drainage of the pacemaker pocket with a Penrose drain (four cases); repositioning of the lead (six); development of hematoma in four cases, with needle aspiration in three; and erosion of skin because of pressure necrosis in five patients. The average time of presentation of infection was 8 days, ranging from 4 to 25 days. In the five patients with erosion of the skin, infection occurred at an average time of 16 months, ranging from 12 to 24 months. The most common organism cultured was Staphylococcus epidermidis, in nine cases. Staphylococcus aureus was found in four cases, and Enterobacter cloaca in two. Other organisms cultures were Pseudomonas aeruginosa, Klebsiella, Escherichia coli, and Proteus mirabilis,
Forms of therapy From the Department of Surgery and Division of Cardiac and Thoracic Surgery, Henry Ford Hospital, Detroit, Mich. Received for publication Feb. 6, 1979. Accepted for publication March 6, 1979. Address for reprints: Fernando M. lara, M.D., Division of Cardiac and Thoracic Surgery, Henry Ford Hospital, 2799 West Grand Blvd., Detroit, Mich. 40202.
298
Ten patients were treated by removal of the pacemaker unit (power pack and endocardial leads), debridement of the wound, and the use of proper antibiotics. Four patients had two tubes for continuous irrigation with 1 percent neomycin or 25 percent Betadine solution. However, in all cases, reimplantation of a
0022-5223179/0S029S+03$OO.30/0© 1979 The C. V. Mosby Co.
Volume 78
Infected pacemaker pocket
Number 2
299
August, 1979
new unit In a site distant from the original site was required to control the infection. Nine patients did not require reimplantation of a new unit. In all of these cases Staphylococcus epidermidis was the single organism cultured. In this group, six patients were treated by continuous irrigation of the pocket with two tubes for a minimum of I week with a solution of I percent neomycin (three cases) and 25 percent Betadine (three cases) and the use of proper systemic antibiotics according to the sensitivity of the organism. In the remaining three cases, the pocket was debrided of all necrotic tissue, closed primarily, and a course of antibiotics was administered for a minimum of 10 days. Although no deaths could be attributed to the development of infection, there was a considerable degree of morbidity. One patient required extraction of the endocardial lead through a right atriotomy because of continuous sepsis. Two patients with erosion of the skin underwent several plastic procedures in an attempt to cover the exposed pacemaker; however, this attempt was unsuccessful and reimplantation of a new unit was required. Discussion
Infection from a permanent trans venous cardiac pacemaker can lead to significant morbidity and mortality," although the incidence has decreased. Early reports cited figures up to 41 percent, whereas more recent reports show an incidence between zero and 12.6 percent. 2. 6 Whether or not this decrease is related to the widespread use of prophylactic antibiotics is subject to debate. Most of the pertinent literature advocates their use," although adequate, controlled trials of the use of prophylactic antibiotics in this setting are not available. It is assumed that most wounds became infected at the time of operation, and in our series, as well as in others," the most common organism involved was Staphylococcus epidermidis. Since this organism is a well-known saprophyte of the skin, meticulous preparation of the skin with soap and an antiseptic solution and irrigation of the wound with an antibiotic solution before closure should reduce the incidence of infection caused by this organism. If the cases involving Staphylococcus epidermidis were eliminated from this series, the general incidence of infection would be remarkably low. Factors predisposing to infection are various. Drainage of the pacemaker pocket, a practice used early in this series, is no longer recommended. We believe, as others dO,9 that it increased the incidence of infection independent of prophylactic antibiotics. 10 Extrusion of
the pulse generator from pressure necrosis of the skin with secondary contamination occurred in five cases. Hematoma appeared to be a contributing factor to wound infection, and needle aspiration was done in three of the four cases. Lead reposition was considered a predisposing factor in five cases. These findings indicate that when the lead is repositioned or hematoma develops, meticulous attention to aseptic technique is essential. The management of this complication depends in part on the virulence of the organism cultured. The general surgical principle that a foreign material must be completely removed to eradicate infection can be violated if the organism cultured is Staphylococcus epidermidis. As others!' have indicated, in situ management of this problem seems worthwhile. The approach should include local debridement, the use of antibiotics, and continuous irrigation with an antiseptic solution through two tubes. In our series, all of the patients in whom this organism was cultured responded to this type of therapy. If the organism cultured is not Staphylococcus epidermidis, the following principles should be adopted: I. The pacemaker must be removed before the infection can be eradicated. 2. Temporary pacing must be provided while the infection is under treatment. 3. A new, permanent pacemaker unit must be implanted at a new, clean site. If there is no evidence of sepsis, the new unit can be implanted immediately after the infected pacemaker has been removed. However, if sepsis is present, with or without endocarditis, implantation of a new unit should be delayed until all infection has been eliminated. The endocardial lead cannot always be removed because of fixation due to scarring in the right ventricle. If sepsis or endocarditis persists, the lead should be removed even if a right atriotomy is required. Extensive plastic procedures to cover an extruded pacemaker are not recommended. 12 In two patients in our series, attempts to cover the pacemaker were unsuccessful and resulted in considerable cost and suffering to the patient. REFERENCES Dargan E, Norman JC: Conservative management of infected pacemaker pulse generatorsites. Ann Thorac Surg 12:297-299, 1971
2 Firor WB, Lopez JF, Nanson EM, Morl M: Clinical management of the infected pacemaker. Ann Thorac Surg 6:431-436, 1968
3 Kennelly BM, Piller LW: Management of infected trans-
300 Jara et al.
The Journal of Thoracic and Cardiovascular Surgery
4 5 6 7
8
venous pennanent pacemakers. Br Heart J 36: 1133-1140, 1974 Smyth NPD: Cardiac pacemaker (collective review). Ann Thorac Surg 8:166-190, 1969 Harris A, Bluestone R, Busby E, et al: The management of heart block, Br Heart J 27:469-482, 1965 Kohn 0: Prosthetic cardiac process in community hospitals. Am Heart J 88:656-663, 1974 Hartstein AI, Jackson J, Gilbert DN: Prophylactic antibiotics and the insertion of permanent transvenous cardiac pacemakers. J THORAC CARDIOVASC SURG 75:219222, 1978 Lemire GG, Morin JE, Dobell ARC: Pacemaker infections. A 12-year review. Can J Surg 18: 181-184, 1975
9 Rao G, Ford WB, Zikria EA, et al: Incidence and prevention of infection in patients with permanent cardiac pacemaker. Int Surg 59:559-561, 1974 10 Margarey CH, Chant ADB, Rickford CRK, Margarey JF: Peritoneal drainage and systemic antibiotics after appendectomy. Lancet 2:179-182, 1971 II Golden GT, Lovett WL, Harrah JD, et al: The treatment of extruded and infected permanent cardiac pulse generators. Application of a technique of closed irrigation. Surgery 74:575-579, 1975 12 Coburn RJ, Blank HL, Campbell RM: Covering an exposed pacemaker. Case report. Plast Reconstr Surg 50:622-625, 1972
Information for authors Most of the provisions of the Copyright Act of 1976 became effective on January I, 1978. Therefore, all manuscripts must be accompanied by the following written statement, signed by one author: "The undersigned author transfers all copyright ownership of the manuscript (title of article) to The C. V. Mosby Company in the event the work is published. The undersigned author warrants that the article is original, is not under consideration by another journal, and has not been previously published. I sign for and accept responsibility for releasing this material on behalf of any and all co-authors." Authors will be consulted, when possible, regarding republication of their material.