Europace Advance Access originally published online on June 12, 2007
Europace 2007 9(10):890-893; doi:10.1093/europace/eum112
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
PACEMAKERS
Feasibility and safety of a simplified draping method for pacing procedures
Dipartimento di Cardiologia, Policlinico Universitario Tor Vergata, Viale Oxford 81, Roma 00133, Italy
Manuscript submitted 22 January 2007. Accepted after revision 29 April 2007.
* Corresponding author. Tel: +39 (0) 3478993059; fax: +39 (0) 0620900383. E-mail address: mark_m_gallagher{at}hotmail.com
 |
Abstract |
|---|
 Top Abstract IntroductionMethodsResultsDiscussionLimitationsConclusionReferences |
|---|
Aims Traditional draping for pacing procedures is time-consuming. We evaluated prospectively the safety of a simplified method using a single adhesive drape intended for use in cardiac catheterization.
Methods and results A single disposable adhesive drape was used in each of 250 consecutive pacing procedures by the same operator including 200 device implants and 50 revision procedures. We compared the results with those of 114 procedures performed in the same cardiac catheterization laboratory by three other operators using traditional draping methods for most cases. In the study group, no wound or pacemaker pocket infection, device erosion, or endocarditis was observed within the first 6 months after the procedure (0%, 95% CI 0–1.2%). One suspected infection occurred at 10 months (0.4%, 95% CI 0.1–2.2%). In the control group, there were two cases of early infection or suspected infection (2 of 114 procedures, 1.8%, 95% CI 0.27–6.1%), four cases of confirmed or suspected infection more than 6 months after the procedure giving an overall infection rate (6 of 114, 5.3%, 95% CI 2.1–11.0%) significantly higher than in the study group (P = 0.014, Fisher's exact test).
Conclusion A simplified draping method involving a single adhesive fenestrated drape can be used for pacemaker or ICD implantation or revision procedures without an excessively elevated risk of infective complications.
Key Words: Draping, Surgical technique, Pacemaker implantation, Pacemaker box change, Pacemaker infection, Complication
|
Introduction |
|---|
|
TopAbstractIntroductionMethodsResultsDiscussionLimitationsConclusionReferences |
|---|
Pacemaker implantation is complicated by infection in approximately 1.5% of cases, with a higher risk in revision procedures.1
Pacemaker infection can be lethal and its treatment generally requires the total removal of the pacing system.2 The frequency of this complication is relatively consistent in all of the larger studies available, with a slight downward trend in recent years,3–7 despite an apparently increasing frequency in clinical practice.8,9 The risk is reduced by prophylactic antibiotic therapy in the peri-procedural period,10 but not by antimicrobial agents applied to the pacemaker pocket.11 The range of organisms involved is so great that antibiotic prophylaxis can never be complete.12
The organisms responsible for pacemaker infection are generally Staphylococci13 and are usually derived from the axillary flora of the patient,14 suggesting that the preparation of the operative site is critical to the avoidance of infection. The draping of patients for pacing procedures traditionally involves the use of multiple cloth drapes.15 Adhesive strips and draping clamps are used to maintain the position of drapes during procedures. The process of applying multiple drapes while maintaining strict asepsis is time-consuming, and the drapes add greatly to the size of the sterile pack required for pacing procedures. In general surgery, disposable drapes have been shown to be safer than reusable drapes as well as being more convenient.16 The use of drapes of this sort has not been described in relation to pacing procedures. We sought to determine whether it is safe to perform pacing procedures using only a single adhesive disposable fenestrated drape designed for use in cardiac catheterization.
|
Methods |
|---|
|
TopAbstractIntroductionMethodsResultsDiscussionLimitationsConclusionReferences |
|---|
Because of restricted storage space in a single catheterization laboratory used for interventional radiology, coronary angiography, percutaneous coronary revascularization, diagnostic electrophysiological studies, ablations and pacing procedures, we adopted a simplified draping method for the majority of our pacing procedures. A single fenestrated drape was used for these pacing cases, permitting the use of the same relatively small (15 x 27 x 37 cm) disposable sterile pack for all cardiac catheterization, electrophysiology and pacing cases, with a smaller (20 x 30 x 10 cm) supplementary pack containing re-sterilized surgical instruments for pacing cases.
We prospectively evaluated the outcome of 250 consecutive procedures by the same experienced operator (first operator experience >500 pacing procedures before the current series) over a 3-year period from early 2003. Because of concerns about safety from infection, the simplified draping method was restricted to the most experienced operator. As a control group, we considered the 114 cases performed by three other operators in the same catheterization laboratory over the same period. These operators were less experienced, each having first operator experience of <100 cases at the start of the study period. The traditional draping method consisted of the application of one large non-adhesive cotton drape and three smaller cotton drapes each secured by an adhesive strip with additional attachment by the use of Backhaus towel clamps.
The drape used for study patients (Kimberly-Clark Femoral Angiography Drape 33166, Kimberly-Clark, Roswell, GA 30076, USA) was designed for use in interventional cardiology. It measured 225 x 330 cm, the lateral 70 cm on either side consisting of transparent polyethylene, the middle 85 cm of water-resistant, tear-resistant polypropylene-based fabric with an additional layer of absorbent fabric bonded to the upper surface of a 100 x 150 cm central portion. The drape contained two circular windows of adhesive polyethylene 13 cm in diameter, each with a central circular aperture of 6.8 cm in diameter. The windows of the drape were occluded during storage by waxed paper adherent to each polyethylene window; one of which was removed before the drape was used.
Patients fasted for at least 6 h pre-operatively and 3 h post-operatively. Depilation of the chest and axillae was performed 1–18 h pre-operatively. All pacing procedures were performed in the same cardiac catheterization laboratory equipped with laminar airflow. Patients received prophylactic antibiotic treatment beginning by intravenous infusion 1–4 h before the procedure and continuing for 5 days afterward, administered intravenously for at least the first 24 h, orally thereafter. Ceftriaxone was used as the intravenous antibiotic of first choice; amoxicillin and clavulanic acid was the oral antibiotic of first choice. Intravenous vancomycin followed by oral erythromycin was used in patients with a history of beta-lactam allergy. Local antimicrobial therapy to the pacemaker pocket was not used.
On arrival in the catheter laboratory, patients received light sedation if required. After attachment of ECG electrodes, a nasal oxygen tube and apparatus for monitoring of arterial pressure and oxygen saturation, the operative site was cleaned with two applications of tincture of iodine which was allowed to dry for at least 3 min and the operative site was dabbed dry using a sterile paper towel. In the case of study patients, the adhesive window of the fenestrated drape was applied at the site of the planned incision. The drape was unfolded, and a drip stand was used to suspend the upper corner of the side contralateral to the operative site to elevate the drape from the face of the patient. No other form of draping was permitted in the study patients, including the use of an occlusive dressing to cover the operative site during the procedure. In other patients, the adhesive drapes were attached in a manner that created a triangular operative window, the longest side measuring approximately 15 cm.
Strict aseptic technique was observed for all cases. Not more than four persons were present in the lab during pacemaker implantation, a maximum of seven for ICD implantation or for revision procedures involving lead extraction or implantation of a new ICD generator. A second operator was present in a minority of pacemaker implantation cases, but always present for ICD implantation or complex revision procedures. Entry to or exit from the catheter lab was not permitted during procedures.
For all pacemaker or ICD implantation procedures, the lateral extremity of the incision was sited at a point 5 mm inferior and 5 mm medial to the coracoid process. The incision extended infero-medially from this point for a distance of 35 mm in the case of single-chamber pacemakers, 40 mm for dual-chamber pacemakers, 50 mm for single- or dual-chamber ICDs, 55 mm for biventricular ICDs. The pacemaker pocket was formed before venous access was sought. Cephalic access was used for the right ventricular and atrial lead whenever possible. Subclavian access was routinely used for left ventricular leads. All of the pacing leads were 7F, and all of the defibrillation leads were 9F.
All patients were seen at a pacemaker clinic 1 week, 1, 3, and 6 months after implantation. At each visit, the function of the pacemaker was checked, the implantation site was inspected carefully and enquiry was made about the occurrence of symptoms suggestive of local or systemic infection. Continuous data are expressed as mean (SD). Categorical data are expressed as number and percentage with 95% CIs for proportions derived from a Bayesian calculation. Significance was set at P < 0.05.
|
Results |
|---|
|
TopAbstractIntroductionMethodsResultsDiscussionLimitationsConclusionReferences |
|---|
The study group included 250 consecutive pacing procedures performed by the same operator over a 3-year period from February 2003. The procedures included 200 device implantations and 50 revision procedures (Table 1). Including revision procedures, the series involved the implantation of 343 new pacing leads, the extraction of eight pacing leads and two defibrillation leads and the removal of 12 pacing leads implanted less than a year previously.
|
In the study group, active fixation was used for 29% of ventricular leads and 16% of atrial leads. Excluding revision procedures, cephalic access was used for 91% of right ventricular leads and 85% of atrial leads (89% excluding biventricular devices). New devices were implanted in sub-muscular pockets in 5% of cases and on the right side in 2%.
The control group consisted of 114 procedures carried out by three less-experienced operators, most of which were pacemaker implants (Table 1). These procedures involved the implantation of 174 new leads, 73 of which were atrial. Active fixation was used in 11% of atrial leads and 17% of ventricular leads. Cephalic access was used for 71% of ventricular leads and 60% of atrial leads, in both cases significantly lower proportions than in the study group (P < 0.001, 
2 test). All new devices were placed in subcutaneous pockets in the left pectoral area. The procedure duration was longer than in the study group (98 ± 42 vs. 61 ± 15 min, P < 0.001, Students t-test).
No case of pacemaker pocket infection, wound infection, device erosion, endocarditis, or unexplained pyrexia was observed in the study group within 6 months after the procedure (0%, 95% CI 0–1.2%). One patient presented with suspected late infection 10 months after implantation (0.4%, 95% CI 0.1–2.2%). In this case there was localized erythema over the inferolateral margin of the generator with thinning of the subcutaneous tissue without clinical or laboratory evidence of systemic infection. The patient remains asymptomatic 6 months after repositioning of the generator in a subpectoral pocket. All other patients remain free of evidence of infection 17 ± 9 months after the procedure.
In the control group there was one case of infection requiring system extraction 3 months after a device substitution and one suspected infection 5 months after implantation that resolved with conservative treatment (2 of 114 procedures, 1.8%, 95% CI 0.27–6.1%), two cases of confirmed infection or device erosion at 18 and 30 months that required system extraction and two cases of suspected infection at 9 and 22 months which resolved after antibiotic therapy with local debridement in one case. The overall rate of confirmed or suspected infection (6 of 114, 5.3%, 95% CI 2.1–11.0%), was significantly higher than in the study group (P = 0.014, Fisher's exact test) as was the proportion of cases requiring system extraction (2.6%, 95% CI 0.64–7.4% vs. 0%, 95% CI 0–1.2%, P = 0.03, Fisher's exact test).
Non-infective complications occurred in four cases (1.6%, 95% CI 0.49–4.0%) in the study group, including haematoma requiring drainage in one case (0.75%) and increased stimulation threshold requiring lead replacement or repositioning in three cases accounting for 0.87% of new leads implanted, including 2 of 140 atrial leads (1.4%) and 1 of 203 ventricular leads (0.5%). In the control group, non-infective complications occurred in eight cases (7.0%, 95% CI 3.2–13.2%), significantly more than in the study group (P = 0.011, Fisher's exact test). These complications were all lead displacements requiring re-intervention, and involved 3% of the ventricular leads and 6.8% of the atrial leads implanted in the control group.
|
Discussion |
|---|
|
TopAbstractIntroductionMethodsResultsDiscussionLimitationsConclusionReferences |
|---|
Our data demonstrate that a simplified method of draping can be used for almost all pacing procedures with a rate of infection comparable with the previously published data.1
,3–10 In our series the rate of infection associated with this draping method, when used by an experienced operator, was lower than that performed by less-experienced operators using traditional draping methods. This difference was largely attributable to a high infection rate in the traditional draping group, possibly linked to the inexperience of these operators.1
The rate of infection found in our series in keeping with that of previous series of substantial size. Harcombe et al.1 reported a 1.5% incidence of erosion or infection in 2621 consecutive pacing procedures after following the patients for up to 11 years. They observed a higher infection rate for revision procedures and for procedures performed by less-experienced operators.
In the studies in which the timing of infection was reported, approximately half of infective complications become evident within 6 months of implantation,5 so studies that involve a period of follow-up of less than 1 year are likely to underestimate the problem substantially. The median follow-up of 17 months in our series should have allowed the majority of infective complications to emerge.
Several large series have been reported in which the infection rate was lower than that of Harcombe et al. Among the 721 patients who underwent ICD implantation in the MADIT II trial,6 the incidence of infection requiring surgical re-intervention was 0.7% at a mean of 20 months after implantation. The incidence of other infective complications was not reported. Hill17 reported an incidence of only 0.5% of 589 consecutive cases. In most other series reporting an incidence of infection of <1.5%, the duration of follow-up was shorter than 6 months or was not clearly defined. Chauhan et al.3 reported a 0.84% incidence of infective complications within 2 weeks of implantation in 2019 consecutive cases with a slight excess in dual-chamber devices. Aggarwal et al.4 reported an incidence of infection or erosion of 1.3% in a follow-up of 2 months after implantation.
In contrast to the low rate of infection in recent clinical trials, data from routine clinical practice suggests that a serious problem remains. In 5648 primary implants performed in Denmark in the late-1990s, the rate of infection requiring re-intervention was 2%.8 Data from Medicare beneficiaries in the USA in the 1990s suggest a high and rising rate of device-related infection which more than doubled over the decade.9
In none of the previous papers on device-related infection is the method of draping described in detail. Our experience suggests that until the late-1990s most centres used multiple adhesive drapes as described in textbooks on the subject.15 We adopted the method described in this series in early 2003. We later became aware that other centres are using similar methods, though most use some supplementary drapes in addition to the drape designed for cardiac catheterization. All the centres of which we are aware adopted simplified methods of draping within the past decade. Neither of these centres has published data regarding the safety of the change in draping method, nor are we aware of any case in which its safety has been evaluated prospectively as we have done.
The lower incidence of infection with our simplified method of draping should not be taken as evidence of greater safety. The incidence of infection that we have reported is within the range described in previous studies with a similar duration of follow-up. The higher infection rate in the control group and in some previous series probably reflects the involvement of inexperienced operators. This is reflected also in a longer mean procedure duration and a rate of lead-related complications that is substantially higher than in the study group though lower than in some published studies.18 This study was performed to determine whether the new method of draping was associated with an increased risk of infection or other complications. We believe that the results indicate that it is not associated with significant excess either in comparison with published data or in comparison with other procedures performed in the same catheterization laboratory.
We have found the use of a single drape to be convenient, and we believe that it saves time during the preparation for pacing procedures. We did not measure the time spent on draping. More important, the simplified method of draping simplifies the storage of material in the catheterization laboratory, permitting the use of an identical sterile pack for pacing procedures and for cardiac catheterization procedures including electrophysiological studies and ablation. This factor is of great importance when the same catheterization laboratory is used for all of these procedures. Without the need for multiple dedicated drapes, a small supplementary pack is sufficient to convert a cardiac catheterization pack for use in pacing procedures.
The drape used in this series has lateral panels of transparent polyethylene that allow the operator free access to the controls for the image intensifier without compromising sterility. This allowed a reduction in the number of support staff in the laboratory during the procedure. For organizational reasons, we routinely had four staff members in the catheterization laboratory including the operator though the operator was able to perform the procedure assisted by one non-scrubbed assistant to monitor the patient and to measure the pacing characteristics of each lead. The other staff members were generally inactive during the procedure. Using this draping method, the majority of procedures could be performed with only two staff members in the catheterization laboratory, provided that others are available to attend quickly in case of difficulty.
|
Limitations |
|---|
|
TopAbstractIntroductionMethodsResultsDiscussionLimitationsConclusionReferences |
|---|
Our study was non-randomized and the groups were poorly matched. The simplified draping method was used by experienced operators and traditional draping was used only by inexperienced operators. Inexperienced operators have been shown to have higher rates of pacemaker-related complications.1
The duration of follow-up in this series is relatively short. Although the length of follow-up is sufficient to diagnose the majority of infections, more may yet emerge both in the study group and in the control group.
|
Conclusion |
|---|
|
TopAbstractIntroductionMethodsResultsDiscussionLimitationsConclusionReferences |
|---|
A simplified draping method involving a single adhesive fenestrated drape can be used for pacemaker or ICD implantation or revision procedures without an excessively elevated risk of infective complications.
Conflict of interest: none declared.
|
References |
|---|
|
TopAbstractIntroductionMethodsResultsDiscussionLimitationsConclusionReferences |
|---|
[1] Harcombe AA, Newell SA, Ludman PF, Wistow TE, Sharples LD, Schofield PM, et al. Late complications following permanent pacemaker implantation or elective unit replacement. Heart (1998) 80:240–4.
[2] Molina JE. Undertreatment and overtreatment of patients with infected antiarrhythmic implantable devices. Ann Thorac Surg (1997) 63:504–9.
[3] Chauhan A, Grace AA, Newell SA, Stone DL, Shapiro LM, Schofield PM, et al. Early complications after dual chamber versus single chamber pacemaker implantation. Pacing Clin Electrophysiol (1994) 17:2012–4.[CrossRef][Medline]
[4] Aggarwal RK, Connelly DT, Ray SG, Ball J, Charles RG. Early complications of permanent pacemaker implantation: no difference between dual and single chamber systems. Br Heart J (1995) 73:571–5.
[5] Zipes DP, Roberts D. Results of the international study of the implantable pacemaker cardioverter-defibrillator. A comparison of epicardial and endocardial lead systems. The Pacemaker-Cardioverter-Defibrillator Investigators. Circulation (1995) 92:59–65.
[6] Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med (2002) 346:877–83.
[7] Ellenbogen KA, Hellkamp AS, Wilkoff BL, Camunas JL, Love JC, Hadjis TA, et al. Complications arising after implantation of DDD pacemakers: the MOST experience. Am J Cardiol (2003) 92:740–1.[CrossRef][Web of Science][Medline]
[8] Moller M, Arnsbo P, Asklund M, Christensen PD, Gadsboll N, Svendsen JH, et al. Quality assessment of pacemaker implantations in Denmark. Europace (2002) 4:107–12.
[9] Cabell CH, Heidenreich PA, Chu VH, Moore CM, Stryjewski ME, Corey GR, et al. Increasing rates of cardiac device infections among Medicare beneficiaries: 1990–1999. Am Heart J (2004) 147:582–6.[CrossRef][Web of Science][Medline]
[10] Da Costa A, Kirkorian G, Cucherat M, Delahaye F, Chevalier P, Cerisier A, et al. Antibiotic prophylaxis for permanent pacemaker implantation: a meta-analysis. Circulation (1998) 97:1796–801.
[11] Lakkireddy D, Valasareddi S, Ryschon K, Basarkodu K, Rovang K, Mohiuddin SM, et al. The impact of povidone-iodine pocket irrigation use on pacemaker and defibrillator infections. Pacing Clin Electrophysiol (2005) 28:789–94.[CrossRef][Medline]
[12] Kouvousis N, Lazaros G, Christoforatou E, Deftereos S, Petropoulou-Milona D, Lelekis M, et al. Pacemaker pocket infection due to acremonium species. Pacing Clin Electrophysiol (2002) 25:378–9.[CrossRef][Medline]
[13] Chua JD, Wilkoff BL, Lee I, Juratli N, Longworth DL, Gordon SM. Diagnosis and management of infections involving implantable electrophysiologic cardiac devices. Ann Intern Med (2000) 133:604–8.
[14] Da Costa A, Lelievre H, Kirkorian G, Celard M, Chevalier P, Vandenesch F, et al. Role of the preaxillary flora in pacemaker infections: a prospective study. Circulation (1998) 97:1791–5.
[15] Austin EH. Techniques for pacemaker implantation. In: Singer I, ed. In: Interventional Electrophysiology (1997) Baltimore: Williams and Wilkins. 913–33.
[16] Muller W, Jiru P, Mach R, Polaschek F, Fasching W. The use of disposable draping materials in the operating room and its effect on the postoperative wound infection rate. Wien Klin Wochenschr (1989) 101:837–42.[Web of Science][Medline]
[17] Hill PE. Complications of permanent transvenous cardiac pacing: a 14-year review of all transvenous pacemakers inserted at one community hospital. Pacing Clin Electrophysiol (1987) 10:564–70.[CrossRef][Medline]
[18] Luria D, Bar-Lev D, Gurevitz O, Granit H, Rotstein Z, Eldar M, et al. Long-term performance of screw-in atrial pacing leads: a randomized comparison of J-shaped and straight leads. Pacing Clin Electrophysiol (2005) 28:898–902.[CrossRef][Medline]
CiteULike 
Connotea 
Del.icio.us What's this?
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||