Efficacy of a gentamycin-collagen sponge to prevent infection in implantable cardioverter defibrillator patients undergoing revision surgery - results of a monocentric ICD registry observational study

Thomas Kleemann (Ludwigshafen am Rhein)1, S. B. Mousavi (Ludwigshafen am Rhein)1, K. Kouraki (Ludwigshafen am Rhein)1, M. Strauß (Ludwigshafen am Rhein)1, O. Mohammad (Ludwigshafen am Rhein)1, A.-R. Wenz (Ludwigshafen am Rhein)1, U. Weiße (Ludwigshafen)2, C. Werling (Ludwigshafen)2, F.-U. Sack (Ludwigshafen)2, R. Zahn (Ludwigshafen am Rhein)1

1Klinikum der Stadt Ludwigshafen gGmbH Medizinische Klinik B Ludwigshafen am Rhein, Deutschland; 2Klinikum der Stadt Ludwigshafen gGmbH Klinik für Herzchirurgie Ludwigshafen, Deutschland

 

Introduction: Despite the obvious benefits, the use of implantable cardioverter defibrillators (ICDs) is associated with serious complications, including infections. In particular, device replacement or revision procedures are associated with an increased risk of infection.

Aim of the study was to compare the cardiac device infection rate with and without the use of the gentamycin-collagen sponge (GCS) in patients undergoing device replacement or revision procedures of implanted ICDs.

Methods:
A total of 491 consecutive ICD patients from a prospective single-centre ICD-registry who underwent elective device replacement, system upgrade or lead revision between 2017 and 6/2023 were analyzed. From September 2020 onwards, a GCS was inserted into the device pocket (GCS group, n = 256). These patients were compared to the patients implanted/ revised between 2017 and 8/2020 (control group, n = 235).

Results: The baseline characteristics and the PADIT score were similar in both groups (Table 1). The GCS was well tolerated and there were no complications associated with the GCS. The mean follow-time was 15 + 10 months in the GCS group and 30 + 11 months in the control group. The Kaplan-Meier estimated infection rate after one year was 1.0% in the GCS group and 3.5% in the control group (p = 0.03, Figure 1). Time from revision to infection was 144 + 134 days in the GCS group vs. 362 + 297 days in the control group.

Conclusion:
Adjunctive use of a GCS was associated with a lower incidence of device infections than standard-of-care infection-prevention strategies alone.

 

Table 1. Clinical and procedure characteristics of patients at time of index procedure

 

  

GCS group

(n = 256)

 

Control group

(n = 235)

 

p-value

 

Age (mean, years)

 

71 + 11

 

69 + 12

 

n.s.

 

Female

 

21%

 

23%

 

n.s.

 

EF < 30%

 

73%

 

69%

 

n.s.

 

Diabetes

 

24%

 

25%

 

n.s.

 

Renal failure (eGFR < 30 ml/min)

 

14%

 

8%

 

0.04

 

Number of previous CIED revisions (1 / 2 / > 3)

  22% / 6% / 7% 29% / 11% / 8% 

0.03

 

Anticoagulant

 

58%

 

57%

 

n.s.

 PADIT-Score (mean) 

8.2 + 1.7

 

8.6 + 1.8

 

0.03

 

Generator replacement

 

75%

 

66%

 

0.03

 

Early CIED-related surgical reintervention

 

1.2%

 

1.7%

 

n.s.

 

Surgery location

- operating room

- EP-lab

 

47%

53%%

 

65%

35%

 

< 0.001

 

Device pocket submuscular

 

78%

 

91%

 

0.001

 

Hematoma after revision

 

2.3%

 

3.4%

 

n.s.

 

  

 

Figure 1: Kaplan‐Meier curves for first CIED infection


Acknowledgement: The abstract contains data from the dissertation of Seyed Babak Mousavi

 

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