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Archives of cardiovascular diseases
Volume 104, n° 5
pages 325-331 (mai 2011)
Doi : 10.1016/j.acvd.2011.02.003
Received : 5 October 2010 ;  accepted : 23 February 2011
Cardiac implantable devices: Surveillance of surgical site infections and assessment of professional practices
Dispositifs médicaux implantables en rythmologie : surveillance des infections de site opératoire et évaluation des pratiques professionnelles
 

Maguy Metais a, , Aurélien Hebrard b, Alexandre Duparc b, Pierre Mondoly b, Marc Delay b, Benoît Lepage a, Sandra Malavaud a
a Unité d’épidémiologie et hygiène hospitalière, service d’épidémiologie, hôpital Rangueil, avenue Jean-Poulhès, TSA 50032, 31054 Toulouse, France 
b Unité de rythmologie et stimulation cardiaque, CHU de Toulouse, hôpital Rangueil, avenue Jean-Poulhès, TSA 50032, 31054 Toulouse, France 

Corresponding author.
Summary
Background

A programme for quality assurance and prevention of infection risk during implantation of cardiac medical devices (pacemakers and defibrillators) was set up in our hospital.

Aim

We sought to assess surgical site infection rate and compliance with infection-control practices (principally antibiotic prophylaxis).

Methods

Surgical site infections associated with implanted medical devices were monitored in patients during a 6-month period and a 1-year follow-up. Professional practices concerning the use of prophylactic antibiotics in surgery were assessed.

Results

The surgical site infection rate was 2.3%. Overall compliance was 45% for the use of antibiotic prophylaxis.

Conclusions

Optimal compliance with antibiotic prophylaxis was not reached in the present series, which demonstrated a surgical site infection rate of 2.3%. More effort must be made to achieve full compliance with preventive measures in the implantation of medical devices.

The full text of this article is available in PDF format.
Résumé
Introduction

Un programme d’assurance qualité et de prévention du risque infectieux concernant les dispositifs médicaux implantés (DMI) en cardiologie (pacemaker et défibrillateurs) a été mis en place dans notre établissement.

Population et méthode

Une surveillance des infections de site opératoire (ISO) sur DMI a été réalisée chez les patients inclus au cours d’un semestre et après un suivi d’un an. Il a également été réalisé une évaluation de pratiques professionnelles portant sur l’antibioprophylaxie opératoire.

Résultats

Le taux d’infection de site opératoire est de 2,3 %. La conformité globale portant sur l’antibioprophylaxie est de 45 %.

Conclusion

L’observance des bonnes pratiques en antibioprophylaxie periopératoire n’est pas optimale dans cette série dans laquelle le taux d’infection du site opératoire est de 2,3 %. Les efforts doivent être poursuivis afin d’améliorer les taux d’observances des principales recommandations relatives à la maîtrise du risque infectieux lors de la mise en place de dispositifs cardiologiques implantables.

The full text of this article is available in PDF format.

Keywords : Cardiac devices, Surgical site infections, Professional practices

Mots clés : Dispositifs médicaux implantables, Infection de site opératoire, Évaluation des pratiques professionnelles


Abbreviations

APP : assessment of professional practice
ASA : American Society of Anesthesiologists
ICD : implantable cardioverter-defibrillator
IMD : implantable medical device
SSI : surgical site infection
RAISIN : Réseau d’alerte, d’investigation et de surveillance des infections nosocomiales
NNIS : National Nosocomial Infection Surveillance
AICD : automatic implantable cardioverter-defibrillator
MRSA : methicillin-resistant Staphylococcus aureus

Introduction

Since 2004, APP has been obligatory for French doctors [1]. APP consists of “the analysis of professional practice with respect to recommendations and according to a method drawn up or validated by the Haute Autorité de Santé , and includes the implementation and monitoring of improvement actions” [2], such as antibiotic prophylaxis, preoperative preparation of patient’s skin and presurgical alcohol-based hand rub. Meanwhile, SSI surveillance has been strongly recommended in the French surveillance and infection control programme. Although IMDs in cardiology are not specifically targeted, the assessment of SSI rates in this population is of great interest.

Up to 2008, the cardiology suites at Hôpital Rangueil used for the implantation of IMDs did not meet all of the characteristics of an operating theatre, in particular regarding air quality. In October 2008, the rhythmology and cardiac stimulation team moved into new premises that possessed all of these characteristics. A quality assurance programme, “Good hygiene practice in the operating theatre”, was then proposed and was implemented in September 2008. The programme comprised a revision of the protocol for prophylactic antibiotic use in surgery and its validation by the anti-infection committee; and information provided to the rhythmology team on preoperative preparation of a patient’s skin according to French guidelines, and the use by the surgical team of a presurgical alcohol-based hand rub, as recommended by French guidelines.

In 2009, after the rhythmology and cardiac stimulation team had adapted to the new premises and techniques, the infection control team, in cooperation with the rhythmology and cardiac stimulation unit, carried out an assessment of these professional practices, combined with epidemiological monitoring of SSIs. We sought to describe the results of IMD infection monitoring and to evaluate antibiotic prophylaxis practices.

Population and method
SSI surveillance

Consecutive patients were prospectively included from 17 February 2009 to 15 August 2009. Inclusion criteria were: first implantation, defined as implantation in a new patient; first contralateral implantation in a patient already having received an IMD on the opposite side; and reimplantation performed>30 days after the initial implantation. Exclusion criteria were: simple reinterventions on the scar; IMDs not implanted by the rhythmology team; IMD extraction; reinterventions in the same surgical site<30 days after the first implantation.

Exhaustivity was checked by the infection-control team by cross-reference with the roster of operations performed in the rhythmology suite.

Data collection

A standardized form was adapted from the PEOPLE cohort, a recent multicentre survey of pacemaker SSIs [3], taking into account the recommendations of the national network of surgical site monitoring [4]. The form comprised the following variables: age, sex, ASA score, Altemeier’s class of contamination, procedure duration, type of IMD and classical risk factors for infection (anticoagulants, valve prosthesis, resuscitation, admission to intensive care unit, hyperthermia) [3]. The use and timing of antibiotic prophylaxis was also recorded. Follow-up data were obtained by the infection control team from hospital records and suspected infections were analysed by the referring cardiologists (PM, AH, AD, MD).

Definition of SSI

As befits the implantation of foreign material [5], SSI was defined as any infection occurring in the year following implantation. All patients were followed for 1-year after implantation. SSI was defined as pus discharge from the wound, irrespective of microorganism identification or deep infection of the surgical site. Because the diagnosis of endocarditis or infection of the leads is elusive, even in cases of haematogenic infection [6], confirmation by transoesophageal echocardiography was obtained systematically for any suspicious biological (inflammatory syndrome, blood cultures) or clinical symptoms. Patient characteristics (age, sex), length of hospital stay, type of implantation (total first implantation, total reintervention), type of IMD (total pacemaker, ICD and total Holter), characteristics of interventions (emergency, procedure duration, ASA class, contamination class, NNIS score), compliance to antibiotic prophylaxis, and risk factors known from the literature (anticoagulant or antiplatelet treatment, valve prosthesis, previous resuscitation, intensive care stay, preoperative temperature>37.5°C) were recorded.

NNIS scores were calculated from the ASA score, which reflects performance status (range 1–5), Altemeier’s class of wound contamination, and duration of the surgical procedure classified in two classes according to the 75th percentile of duration of the present series.

Assessment of antibiotic prophylaxis practice

According to the recommendations of the French Anaesthesia and Resuscitation Society [7], the departmental protocol was to use cefuroxime (1.5g IVD 30–60min before the incision and repeat injections of 0.75g repeated every 2h when requested) or vancomycin in the case of allergy (slow perfusion of 1g over 1h, ≥1h before the incision, no repeat injections needed).

Compliance was assessed according to the Haute Autorité de santé [8] guidelines, which recommend:

injection of double the dose used in antiobiotherapy, administered 30–60min before the incision;
repeat injection (at the usual dose) every 2 half-lives, when necessary;
repeat injection only for the duration of implantation, and never for>48h.

Practice audits were also performed to study the preoperative preparation of a patient’s skin and the physician’s use of a presurgical alcohol-based hand rub.

Statistical analysis

Data were input and analysed using Microsoft Excel® and R [9]. Means and standard deviations are used to describe quantitative variables, and counts and percentages to describe qualitative variables. Patients’ characteristics, types of implantation, types of IMD, intervention characteristics, antibiotic prophylaxis, and risk factors were compared between patients with SSIs and noninfected patients using bilateral Fisher’s exact tests or Wilcoxon rank sum tests.

Results
SSI surveillance

During the 6-month study period, 304 interventions that satisfied the inclusion criteria were carried out. Most of the patients were elderly (mean age 70±15 years), male (sex ratio 2.2:1), with first implantations (73%); 59% were pacemakers and 40% were ICDs (Table 1). Mean duration of implantation was 83±4 (range 7–290)min. The 75th percentile value was 103min.

Patients were reviewed at 1, 3, 6 and 12 months after surgery by the referring cardiologist. Seven SSIs were observed (7/304, 2.3%, 95% confidence interval 0.9–4.7), all occurring within 4 months postimplantation (four SSIs occurred in<1 month, three SSIs between 1 and 3.5 months).

The characteristics of patients with an SSI are presented in Table 2. Of the seven SSIs, five concerned dual-chamber pacemakers, one a single-chamber automatic AICD and one a triple-chamber AICD. All cases of IMD infection were treated successfully by prolonged antibiotic treatment, device removal and contralateral reimplantation.

As shown in Table 1, three factors were univariately associated with SSIs: (i) history of contralateral IMD implantation (16/297 [5.4%] vs 2/7 [29%] in uninfected and infected patients, respectively, P <0.05); (ii) repositioning of generator and/or lead(s) (5/297 [1.7%] vs 2/7 [29%] in noninfected and infected patients, respectively, P <0.006); and (iii) antiplatelet or antiaggregant treatment (119/297 [40%] vs 7/7 [100%], in noninfected and infected patients, respectively, P <0.002).

APP in antibiotic prophylaxis

In 13 cases, antibiotic treatment was ongoing at the time of IMD implantation. Antibiotic prophylaxis was recorded in the remaining 291 patients (cefuroxime, 283 cases; vancomycin, 8 cases). The time between injection and incision was correct (i.e. 30–60min before incision [7]) in 153 patients (153/291, 52.6%; Table 3). In three patients (3/291, 1%), antibiotics were injected after incision.

Repeated injections of cefuroxime, which were indicated in 103 cases, were recorded in 94 cases. Unnecessary repeat injections were given in four patients. The rate of compliance for this variable was thus 95.4% (270/283 patients). The rates of compliance for each variable of antibiotic use (molecule, timing, repeat injection) and overall compliance are summarized in Table 4.

The seven patients who developed SSIs had received prophylactic cefuroxime. Of these, three had not received the first injection within the correct time period, and another was not given a second injection (the operation finished 10min after the time the second injection was due).

Discussion

Infection after IMD implantation is a serious complication. While infection rates showed a decrease from 0.13 to 19.9% in the 1980s, to 1–6% for pacemakers (3-year follow-up) or defibrillators (1-year follow-up) [10], a longitudinal study of Medicare beneficiaries showed a 124% increase in the rate of cardiac device infections during the 1990s (0.9% in 1990 to 2.1% in 1999) [11].

A recent 10-year (1994–2004) retrospective study done in Australia reported an IMD infection rate of 1.6% (including a 0.3% rate of endocarditis) [12]. In France, the PEOPLE trial (2000) observed an incidence of 0.68% after IMD implantation (95% CI 0.47–0.89) after 1year of follow-up.

In the present study, the overall rate of device infection (2.3%; 95% CI 0.91–4.7%) was statistically higher than the rate reported in the PEOPLE study (P =0.006), with comparable methods. This discrepancy may be related to the sizes of the two cohorts (304 vs 6319 patients) or to the noninclusion in the PEOPLE study of patients with erosive complications, although it has been suggested that an infectious process is found in most local device-related complications [13].

Five predictive variables were highlighted in the PEOPLE study: fever before implantation; temporary pacing before implantation; device replacement or revision; early reintervention; and absence of antibiotic prophylaxis [3]. Fever before surgery was not confirmed as a predictor of SSI in the present series, while device replacement and early reintervention were confirmed as significant adverse predictors. Of note, in the case of impending erosion, a second procedure is needed to reposition the device. In univariate analysis, repositioning was significantly related to subsequent device infection (2/7 cases, P =0.006), inducing a 20-fold increase in risk (odds ratio 23.4, 95% CI 3.6–150.5).

Antibiotic prophylaxis is mandatory in our institution, therefore all patients received some form of preventive treatment (100% received antibiotic treatment, with a 45% rate of compliance according to the Haute Autorité de santé criteria) and the present study could not assess this point. Interestingly, anticoagulant or antiplatelet therapy use was strongly related to occurrence of infection (P =0.002), but anticoagulant or antiplatelet therapy use was not related to reintervention (P =0.71).

The impact of the complexity of the device or of the procedure in infectious complications remains controversial. In a study carried out between 1992 and 1994, Aggarwal et al. found no significant difference in SSI rates between single- or dual-chamber pacemakers [14], whereas Chauhan et al. [15] reached the opposite conclusion, with SSI rates of 0.6% for single-chamber pacemakers and 2.1% for dual-chamber pacemakers. No differences in SSI rates between single-chamber and dual- or triple-chamber pacemakers were observed in the present study. Similarly, prolonged procedure duration and operator inexperience have been suggested as predictors of infection in some studies [16, 17]. Paradoxically, in the present cohort, the mean duration of implantation was slightly shorter in patients who subsequently developed an infection than in those who did not (82±57 vs 84±52 in infected and uninfected patients, respectively, P =0.88). Only one SSI occurred in a triple-chamber IMD, for which the operation to implant it is the longest.

Other risk factors such as diabetes, postoperative haematoma or operator inexperience remain controversial [6], as they have not been confirmed in the PEOPLE cohort [3]. More recently, statistically significant relationships between SSIs and fever occurring 24h after the implantation, early reintervention, and implantation of more than two leads have been demonstrated in the Leiden registry [17].

Two mechanisms are suggested for the development of SSIs: preoperative contamination and postoperative blood-borne contamination from a distant infectious site such as the skin, urinary tract or digestive tract [16]. The respective contribution of each of these mechanisms is unknown. However, early infection suggests perioperative contamination and is best controlled by strict application of infection control recommendations. In the present study, all SSIs developed within 3 months of device implantation. As in most studies [6, 12, 16, 18], we isolated exclusively the Staphylococcus genus. Early SSIs or endocarditis (occurring within 2 months) are related mainly to infection with Staphylococcus aureus , whereas in the subacute and chronic forms, S. epidermidis [16] is more prevalent.

The efficacy of preoperative screening for MRSA, already demonstrated in cardiovascular surgery [19], merits assessment in the field of ICD implantation for patients with risk factors for long-term colonization by this organism, such as diabetes, chronic skin ulcers or a previous stay in a resuscitation ward or long-term facility.

The crucial relevance of antibiotic prophylaxis and its timing in the reduction of SSI rates has been amply demonstrated [20, 21, 22]. The relevance of adapting antibiotic prophylaxis (doses, duration) to demonstrated risk factors should be evaluated.

As opposed to other surgical specialities, the objective here is to address infection with bacteria from the Staphylococcus genus. Prophylaxis with betalactamins, or vancomycin in the case of a contraindication or suspicion of MRSA, are recommended. However, similar to other specialities [23, 24], the most stringent criterion to meet is the timing of the injection. For this reason, the overall compliance rate for antibiotic prophylaxis was found to be only 45% in the present series.

Preparation of the patient’s skin [19] and presurgical alcohol-based hand-rub practices [25] were also audited during the same period according to national guidelines. Compliance rates of 43 and 21% for the preparation of the patient’s skin and hand rubs, respectively, were demonstrated.

Conclusion

Optimal compliance to antibiotic prophylaxis, preoperative preparation of the patient’s skin and presurgical alcohol-based hand rub recommendations were not reached in the present series, which demonstrated an SSI rate of 2.3%. Efforts should be paid to obtain full adhesion to preventive measures in IMD implantation.

Disclosure of interest

The authors declare that they have no conflicts of interest concerning this article.

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