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.
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.
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 . 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” , 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 , taking into account the recommendations of the national network of surgical site monitoring . 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) . 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 , 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 , 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 , the departmental protocol was to use cefuroxime (1.5 g IVD 30–60 min before the incision and repeat injections of 0.75 g repeated every 2 h when requested) or vancomycin in the case of allergy (slow perfusion of 1 g over 1 h, ≥ 1 h before the incision, no repeat injections needed).
Compliance was assessed according to the Haute Autorité de santé guidelines, which recommend:
- •
injection of double the dose used in antiobiotherapy, administered 30–60 min before the incision;
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repeat injection (at the usual dose) every 2 half-lives, when necessary;
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repeat injection only for the duration of implantation, and never for > 48 h.
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 . 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 103 min.
| Cohort ( n = 304) | Infection status | |||
|---|---|---|---|---|
| Uninfected ( n = 297) | SSI ( n = 7) | P a | ||
| Age (years) | 70 ± 15 | 70 ± 15 | 68 ± 14 | 0.87 |
| Days in hospital | 7 ± 7 | 6 ± 7 | 12 ± 14 | 0.15 |
| Male sex | 210 (69) | 204 (69) | 6 (86%) | 0.44 |
| Implantation | ||||
| Total first | 223 (73) | 218 (73) | 5 (71%) | 1.00 |
| First | 205 (92) | 202 (93) | 3 (60) | |
| Contralateral first | 18 (8) | 16 (7) | 2 (40) | 0.05 |
| Total reintervention | 81 (27) | 79 (27) | 2 (29) | |
| Change of generator and/or lead(s) | 74 (91) | 74 (94) | 0 (0) | |
| Repositioning of generator and/or lead(s) | 7 (9) | 5 (6) | 2 (100) | 0.006 |
| Type of IMD | ||||
| Total pacemaker | 178 (59) | 173 (58) | 5 (71) | 0.74 |
| Single-chamber pacemaker | 30 | 30 (17) | 0 (0) | 0.78 |
| Dual-chamber pacemaker | 127 | 122 (71) | 5 (100) | |
| CRT pacemaker (triple-chamber) | 21 | 21 (12) | 0 (0) | |
| Total ICD | 121 (40) | 119 (40) | 2 (29) | |
| Single-chamber ICD | 38 | 37 (31) | 1 (50) | 1.00 |
| Double-chamber ICD | 30 | 30 (25) | 0 (0) | |
| CRT defibrillator (triple-chamber) | 53 | 52 (44) | 1 (50) | |
| Total Holter | 5 (2) | 5 (2) | 0 (0) | |
| Intervention as emergency | 16 (5) | 16 (5) | 0 (0) | 1.00 |
| Duration of intervention (min) | 84 ± 52 | 84 ± 52 | 82 ± 57 | 0.88 |
| ASA class | ||||
| 1 | 12 (4) | 11 (4) | 1 (14) | 0.45 |
| 2 | 68 (22) | 67 (23) | 1 (14) | |
| 3 | 132 (43) | 129 (43) | 3 (43) | |
| 4 | 91 (30) | 89 (30) | 2 (29) | |
| 5 | 1 (0) | 1 (0) | 0 (0) | |
| Contamination class | ||||
| Clean | 223 (73) | 218 (73) | 5 (71) | 1.00 |
| Clean contaminated | 81 (27) | 79 (27%) | 2 (29) | |
| NNIS score | ||||
| 0 | 47 (15) | 46 (15) | 1 (14) | 1.00 |
| 1 | 118 (39) | 115 (39) | 3 (43) | |
| 2 | 139 (46) | 136 (46) | 3 (43) | |
| 3 | 0 (0) | 0 (0) | 0 (0) | |
| Literature-derived risk factors | ||||
| Anticoagulant and/or antiplatelet treatment | 126 (41) | 119 (40) | 7 (100) | 0.002 |
| Valve prosthesis | 38 (13) | 36 (12) | 2 (29) | 0.21 |
| Previous resuscitation, intensive care | 70 (23) | 67 (23) | 3 (43) | 0.20 |
| Temperature before intervention ≥ 37.5 °C b | 15 (6) | 15 (6) | 0 (0) | 1.00 |
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