Evidence for a new approach to device pocket infections

By Dr Jonathan Shurlock

Localised device pocket infections are a well reported complication of cardiovascular implantable electronic device (CIED) implantation, with associated increased morbidity. Current guidelines highlight the importance of “Complete removal” in order to adequately treat infections. Dr Moris Topaz has led a group exploring the role of continuous, in-situ targeted, ultrahigh concentration of antibiotics (CITA) into the subcutaneous device pocket, in the context of infection. This work was done in an attempt to identify whether device and lead extraction could be avoided in this setting.

The authors identified 2 cohorts of patients, a “complete extraction cohort” of 329, and the CITA cohort of 80 patients. These groups were identified from all individuals referred with pocket infection between 2007-2021. Within the CITA group 65 patients were eligible for extraction, and instead opted for CITA treatment. This group was compared in a case-control format with 81 similar patients in the complete extraction group.

Antibiotic therapy alone was curative in 68 individuals (85%) over a median follow up of 3 years [IQR: 1.0-6.8 years]). Criteria to be considered ‘cured’ using CITA were: 

  1. no subsequent device/lead extraction at any time
  2. alive 30 days post-procedure
  3. no death from infection related to original pocket infection at any time during follow up.

The cure rate was significantly higher in the complete extraction group, when compared with the CITA case-control group (96.2% [n = 78 of 81] vs 84.6% [n = 55 of 65]; P = 0.027). Unsurprisingly serious complication rates were significantly higher in the complete extraction group (n = 12 [14.8%] vs n = 1 [1.5%]; P = 0.005). Serious complications included in this analysis were as follows:

  1. Stroke
  2. Need for thoracotomy
  3. Urgent blood transfusions
  4. Severe valvular damage follow extraction

The single serious complication in the CITA group was recorded as a stroke. Importantly all-cause 1-month and 1-year mortality were similar for CITA and device/lead extraction (0.0% vs 3.7%; P = 0.25 and 12.3% vs 13.6%; P = 1.00, respectively). 

The authors suggest that their findings support the use of CITA for patients who are unsuitable for, or unwilling to undergo device extraction, as an effective alternative therapy. While the study is limited in its generalisation, it certainly adds useful evidence to current guidelines which are based on restricted observational studies. No doubt clinicians will want to see further evidence prior to changing practice.
See the full paper here: https://www.jacc.org/doi/full/10.1016/j.jacc.2022.10.022