Implantation success and infection in cardiovascular implantable electronic device procedures utilizing an antibacterial envelope.

BACKGROUND: Cardiovascular implantable electronic device (CIED) infection rates are increasing faster than implantation rates. More effective antimicrobial prophylaxis may help reduce CIED infections and improve clinical outcomes. The AIGIS(Rx)(®) antibacterial envelope is a polymer mesh implanted in the generator pocket with the CIED. After implantation it releases two antibiotics, minocycline and rifampin, that have been shown to reduce infections associated with other medical devices. The purpose of this retrospective cohort study is to determine the rate of CIED implantation success and CIED infection in procedures utilizing the antibacterial envelope. METHODS: This study enrolled consecutive CIED procedures utilizing the antibacterial envelope at 10 US academic, community, and Veterans Affairs medical centers. Procedures following an explantation for a prior CIED infection or off-label use of the antibacterial envelope were excluded. RESULTS: The 624 eligible procedures (age 70 ± 13 years, 68.1% men, 27.2% renal insufficiency, 35.4% oral anticoagulant use, 67.8% replacement/revision procedures) utilized pacemakers (35%), implantable cardioverter-defibrillators (ICD)(29%), and cardiac resynchronization therapy with defibrillator devices (CRT-D)(36%). Nearly half of the patients (49%) had at least three predefined risk factors for CIED infection. CIED implantation was successful in 621 procedures (99.5%[95% confidence interval (CI) 98.8-99.9]). There were three major infections (0.48%[95%CI 0.17-1.40]) after 1.9 ± 2.4 months follow-up. The infections followed one ICD revision and two CRT-D replacements. There were seven deaths; none was a result of the antibacterial envelope or the CIED procedure. CONCLUSIONS: CIED procedures that utilized an antibacterial envelope had a high rate of CIED implantation success (>99%). Although the follow-up to date is short, there was also a low rate of infection (<0.50%) in this population at high risk for CIED infection.

Cardiac resynchronization in patients with congestive heart failure and chronic atrial fibrillation: effect of upgrading to biventricular pacing after chronic right ventricular pacing.

OBJECTIVES: This study assessed the effects of biventricular pacing (BVP) on ventricular function, functional status, quality of life and hospitalization in patients with congestive heart failure (CHF), prior atrioventricular (AV) junction ablation and right ventricular (RV) pacing performed for chronic atrial fibrillation (AF). BACKGROUND: Although the benefit of BVP in CHF should theoretically extend to the patient with chronic RV pacing and AF, to our knowledge, no study has determined the effects of BVP on symptoms and ventricular function in these patients. This patient population allows for the evaluation of ventricular resynchronization independent of any BVP-induced changes on the AV interval. METHODS: Twenty consecutive patients with severe CHF (ejection fraction < or = 0.35, New York Heart Association [NYHA] functional class III or IV), prior AV junction ablation and RV pacing performed for permanent AF of at least six months' duration were studied. Electrocardiograms, echocardiograms, functional status evaluations and quality of life surveys were completed before and at three to six months after implant. RESULTS: The NYHA functional classification improved 29% (p < 0.001). The left ventricular (LV) ejection fraction increased 44% (p < 0.001), the LV diastolic diameter decreased 6.5% (p <0.003) and the end-systolic diameter decreased 8.5% (p < 0.01). The number of hospitalizations decreased by 81% (p < 0.001). The scores on the Minnesota Living with Heart Failure survey improved by 33% (p < 0.01). CONCLUSIONS: We conclude that BVP improves the LV function and the symptoms of CHF in patients with permanent AF and chronic RV pacing. These benefits are comparable to those described for patients in sinus rhythm suggesting that BVP acts through ventricular resynchronization rather than optimization of the AV delay.