Antibacterial Envelope to Prevent Cardiac Implantable Device Infection

To the Editor: We urge caution when interpreting the findings of the industry-sponsored Worldwide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT) (May 16 issue),(1) given the loose definition for surgical-site or pocket infection, unblinded outcome assessment, unexplained crossover between groups, and unbalanced baseline characteristics. The percentage of patients with high-risk multiple-lead devices was higher in the control group than in the envelope group (53.6% vs. 51.7%), as was the percentage of patients with previous infection after placement of a cardiac implantable electronic device (CIED) (1.5% vs. 1.3%); the percentage of patients who had not previously received an implant was not . . .