• dead space management
• ovine forestomach matrix
• seroma
• surgical drain

Background

The increasing use of cardiac implantable electronic devices (CIEDs) in a growing patient population has led to an even greater increase in CIED infection rates. Antibacterial CIED envelopes are often used as part of an infection risk-reduction strategy. However, best practices for when to use an envelope and which envelope to choose remain to be elucidated.

Methods

In this retrospective study, the records of 455 patients undergoing CIED implantation by a single surgeon were reviewed to identify trends in envelope use and outcomes after implantation through 12 months of follow-up. Of these patients, 165 were managed with a biologic antibacterial CIED envelope (CanGaroo®, Aziyo Biologics, Inc., Silver Spring, MD), 219 with a non-biologic envelope (Tyrx®, Medtronic Inc., Monmouth Junction, NJ), and 71 with no envelope.

Results

Most patients had two or more infection risk factors (77.9% with any envelope vs. 52.1% with no envelope; P < 0.001). Factors significantly associated with the use of an envelope included the history of heart failure, systemic anticoagulant use, the use of high-power or more complex devices, and reoperations. The overall rate of adverse events was 9.2% (n = 42). Rates of infection and hematoma were 1.8% and 2.6%, respectively. A decision tree is proposed that may aid clinical decision-making when considering CIED envelope usage.

Conclusions

There were no significant differences between groups in overall or individual adverse event rates. These data provide insight into real-world clinical decisions regarding the use of CIED envelopes and support the use of antibiotic-eluting CIED envelopes to limit infection risk in high-risk patients.

Cardiovascular implantable electronic devices (CIEDs) are implanted in an increasing number of patients each year, which has led to an increase in the risk of CIED infection. Antibacterial CIED envelopes locally deliver antibiotics to the implant site over a short-term period and have been shown to reduce the risk of implant site infection. These envelopes are derived from either biologic or non-biologic materials. There is a paucity of data examining patient risk profiles and outcomes from using these envelope materials in the clinical setting and comparing these results to patients receiving no envelope with their CIED implantation.

To evaluate risk profiles and outcomes of patients who underwent CIED procedures with an antibacterial envelope or no envelope.

After obtaining Internal Review Board approval, the records of consecutive patients who underwent a CIED implantation procedure by a single physician between March 2017 and December 2019 were retrospectively collected from our hospital. A total of 248 patients within this period were identified and reviewed through 12 mo of follow up. The CIED procedures used either no envelope (n = 57), a biologic envelope (CanGaroo^®, Aziyo Biologics) that was pre-hydrated by the physician with vancomycin and gentamicin (n = 89), or a non-biologic envelope (Tyrx™, Medtronic) that was coated with a resorbable polymer containing the drug substances rifampin and minocycline by the manufacturer (n = 102). Patient selection for receiving either no envelope or an envelope (and which envelope to use) was determined by the treating physician. Statistical analyses were performed between the 3 groups (CanGaroo, Tyrx, and no envelope), and also between the No Envelope and Any Envelope groups by an independent, experienced biostatistician.

On average, patients who received any envelope (biologic or non-biologic) were younger (70.7 ± 14.0 vs 74.9 ± 10.6, P = 0.017), had a greater number of infection risk factors (81.2% vs 49.1%, P < 0.001), received more high-powered devices (37.2% vs 5.8%, P = 0.004), and were undergoing more reoperative procedures (47.1% vs 0.0%, P < 0.001) than patients who received no envelope. Between the two envelopes, biologic envelopes tended to be used more often in higher risk patients (84.3% vs 78.4%) and reoperative procedures (62.9% vs 33.3%) than non-biologic envelopes. The rate of CIED implant site pocket infection was low (any envelope 0.5% vs no envelope 0.0%) and was statistically equivalent between the two envelope groups. Other reported adverse events (lead dislodgement, lead or pocket revision, device migration or erosion, twiddler’s syndrome, and erythema/fever) were low and statistically equivalent between groups (biologic 2.2%, non-biologic 3.9%, no envelope 1.8%).

CIED infection rates for biologic and non-biologic antibacterial envelopes are similar. Antibacterial envelopes may benefit patients who are higher risk for infection, however additional studies are warranted to confirm this.

• Cardiovascular implantable electronic device envelope
• Defibrillator
• Extracellular matrix
• Implantable cardioverter-defibrillator
• Infection
• Pacemaker