CONTROLLED CLINICAL TRIAL
JOURNAL ARTICLE
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Prevention of Cardiac Implantable Electronic Device Infections: Single Operator Technique with Use of Povidone-Iodine, Double Gloving, Meticulous Aseptic/Antiseptic Measures and Antibiotic Prophylaxis.

BACKGROUND: Cardiac implantable electronic device (CIED) implantation is complicated by infection still at a worrisome rate of 2-5%. Since early on during device implantation procedures, we have adopted an infection-preventive technique which has hitherto resulted in effective prevention of infections. Herein we present our results of applying this technique by a single operator in a prospective series of 762 consecutive patients undergoing device implantation.

METHODS: A meticulous search for and treatment of active, occult, or smoldering infection was undertaken preoperatively. An aseptic/antiseptic technique was used for implantation of each device. Skin preparation is thorough with initial cleansing performed with alcohol followed by povidone-iodine 10% solution, which is also used in the wound and inside the pocket. In addition, we routinely use double gloving, and IV antibiotic prophylaxis 1 hour before and for 48 hours afterwards followed by oral antibiotic for 2-3 days after discharge. The skin is closed with absorbable sutures. The study includes 382 patients having a new pacemaker (n = 333) or battery change, system upgrade or lead revision (n = 49), and 380 patients having a new implantable cardioverter-defibrillator (ICD) (n = 296) or device replacement/upgrade/lead revision (n = 84).

RESULTS: The pacemaker group, aged 70.2 ± 16.5 years, includes 18% VVI, 49% DDD, 29% VDD, and 4% cardiac resynchronization therapy (CRT) devices. The ICD group, aged 61.3 ± 13.0 years, with a mean ejection fraction of 36 ± 13%, includes 325 ICD and 55 CRT implants. Over 26.6 ± 33.4 months for the pacemaker group and 36.6 ± 38.3 months for the ICD group, infection occurred in one patient in each group (0.26%) having a device replacement.

CONCLUSION: A consistent and strict approach of aseptic/antiseptic technique with the use of double gloving and povidone-iodine solution within the pocket plus a 4-day regimen of antibiotic prophylaxis minimizes infections in CIED implants.

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