Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections.

Summary

The number of cardiac implantable electronic devices (CIEDs) implanted each year has grown rapidly over the past two decades. CIED infections, defined as infections involving the generator implant site (pocket) and/or intravascular leads, have become increasingly prevalent, with the rate of growth in infections outpacing that of CIED procedures. The odds of both short term and long term mortality are at least doubled in patients who suffer CIED infections, and long term survival is particularly poor in women. Optimal strategies to prevent CIED infections in high-risk patients are largely unproven. However, recent observational studies of an antibiotic-coated envelope implanted at the time of CIED procedure have shown that this strategy is associated with a low incidence of CIED infections. Other interventions to prevent CIED infections, including the use of antibiotic irrigant used to wash the pocket during implantation and postoperative oral antibiotics, are commonly used but not supported by rigorous controlled studies. The Specific Aim of this study is to test the hypothesis that the use of the antibacterial envelope alone is noninferior to a strategy using the antibacterial envelope and intraoperative antibacterial irrigant and postoperative oral antibiotics for the reduction of cardiac implantable device infections in patients with ≥2 risk factors for infection.

Conditions

• Sick Sinus Syndrome
• Complete Heart Block
• Syncope
• Chronic Systolic Heart Failure

Interventions

DRUG

polymixin/bacitracin

Antibacterial irrigation

DRUG

cephalexin, or levofloxacin, or clindamycin

Post operative oral antibiotics

DRUG

Saline

Saline irrigation

Sponsors & Collaborators

• Thomas Jefferson University

  collaborator OTHER

• The Cooper Health System

  collaborator OTHER

• Valley Health System

  collaborator OTHER

• Medtronic

  collaborator INDUSTRY

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Christopher Ellis, M.D. · Vanderbilt University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-01

Primary Completion

2021-03-31

Completion

2021-09-30

Countries

• United States

Study Locations