Much debate over device infection study at Cardiostim


A study, which suggested that a novel therapy for managing cardiovascular implantable electronic device (CIED) infections could markedly diminish the need for device removal, sparked a lively discussion at Cardiostim (13–16 June, Nice, France).

Lead author and study presenter Moris Topaz, head of plastic surgery unit, Hillel Yaffe Medical Centre, Hadera, Israel, outlined a novel method of treating CIED infections that did not require (as is currently recommended) the complete removal of the device. He explained that as a method of treating CIEDs infections, his centre introduced combined treatment of continuous, in-situ targeted, ultra-high dose antibiotics (CITA) and regulated negative pressure assisted wound therapy (RNPT). He said: “In the RNPT basis, it is the application of computed regulated negative pressure, generated by a pump, led by tubing to contact the treated surface area by a sponge mould dressing. The dressing is covered and air tightly sealed by a drape.” Topaz added that the main effects of RNPT in the context of CIED infections were “bacterial isolation of the infected area, reversal of lymphatic flow, and containment of pocket fluid overflow.”

In Topaz
et al‘s study, 23 patients with a CIED who had an infection of the generator and/or proximal lead received CITA sealed under the RNPT system combined with minimally-invasive surgical procedures. Topaz noted: “All dressing changes and procedures were performed under strict sterile conditions in operating room settings.” On average, the CITA treatment lasted for eight days and was followed by a course of oral antibiotics for up to four weeks (as indicated by the patient’s clinical condition) and the mean follow-up time was 21.6±11.97 months.

He reported that 21 (91.3%) of the CIEDs treated were “salvaged with no clinical manifestation of infection following CITA treatment”. He added that the procedure had to be repeated in four patients because of mechanical wound closure failure, but said that all of their CIEDs were salvaged. Topaz concluded: “Our clinical experience demonstrates that infection of implants pockets and/or proximal subcutaneous wiring can be efficiently managed (91.3% success rate) by CITA and RNPT, diminishing the need for the removal of the device. CITA provides a new drug delivery concept.” He added that the RNPT provided “an ideal isolated microenvironment for pacemaker pharmaceutical re-sterilisation.”

In response to the study, co-chair of the session in which the study was presented, Pascal Defaye, University Hospital, Grenoble, France, said it was “very controversial.” He claimed: “It is difficult to believe you can cure infection with only antibiotics in this kind of patient.” A delegate in the audience added: “The problem is that when the pocket and device is infected, the lead by definition is infected.” Topaz replied by saying that with a lot of implanted devices, not just CIEDs, the infection is related to growth of bacterium on the device as a biofilm. He said: “The bacterium does not grow and spread immediately inside the heart–it takes some time and build up. So actually if you can treat the infection early when it is isolated to the generator and the pocket, and you treat with high-dose antibiotics, you can eradicate this kind of infection.”

He added, with some disagreement from the audience, that the notion that the tip of the lead was automatically infected if the generator was infected should be revised, but said that more data was needed (with longer follow-up) for the evaluation of combined CITA and RNPT system treatment of infected CIED.