Long-term cerebral thromboembolic complications of transapical endocardial resynchronization therapy

Purpose: Cardiac resynchronization therapy (CRT) is an established therapeutic option in selected heart failure patients (pts). However, the transvenous left ventricular (LV) lead implantation remains ineffectual in a considerable number of pts. Transapical LV (TALV) lead implantation is an alternative minimally invasive, surgical, endocardial implantation technique. The aim of the present prospective study is to determine the long-term outcome, including the cerebral thromboembolic complications, of pts

Comparison of the Efficacy of Two Surgical Alternatives for Cardiac Resynchronization Therapy: Trans-Apical versus Epicardial Left Ventricular Pacing

Background: Epicardial pacing lead implantation is the currently preferred surgical alternative for left ventricular (LV) lead placement. For endocardial LV pacing, we developed a fundamentally new surgical method. The trans-apical lead implantation is a minimally invasive technique that provides access to any LV segments. The aim of this prospective randomized study was to compare the outcome of patients undergoing either trans-apical endocardial or epicardial LV pacing. Methods: In group I, 11 end-stage heart failure (HF) patients (mean age 59.7 +/- 7.9 years) underwent trans-apical LV lead implantation. Epicardial LV leads were implanted in 12 end-stage HF patients (group II; mean age 62.8 +/- 7.3 years). Medical therapy was optimized in all patients. The following parameters were compared during an 18-month follow-up period: LV ejection fraction (LVEF), LV end-diastolic diameter (LVEDD), LV end-systolic diameter, and New York Heart Association (NYHA) function Results: Nine out of 11 patients responded favorably to the treatment in group I (LVEF 39.7 +/- 12.5 vs 26.0 +/- 7.8%, P < 0.01; LVEDD 70.4 +/- 13.6 mm vs 73.7 +/- 10.5 mm, P = 0.002; NYHA class 2.2 +/- 0.4 vs 3.5 +/- 0.4, P < 0.01) and eight out of 12 in group II (LVEF 31.5 +/- 11.5 vs 26.4 +/- 8.9%, P = < 0.001; NYHA class 2.7 +/- 0.4 vs 3.6 +/- 0.4, P < 0.05). During the follow-up period, one patient died in group I and three in group II. There was one intraoperative LV lead dislocation in gr Conclusions: Our data suggest that trans-apical endocardial LV lead implantation is an alternative to epicardial LV pacing. (PACE 2012;35:124-130

Antibacterial Envelope to Prevent Cardiac Implantable Device Infection

Background Infections after placement of cardiac implantable electronic devices (CIEDs) are associated with substantial morbidity and mortality. There is limited evidence on prophylactic strategies, other than the use of preoperative antibiotics, to prevent such infections. Methods We conducted a randomized, controlled clinical trial to assess the safety and efficacy of an absorbable, antibiotic-eluting envelope in reducing the incidence of infection associated with CIED implantations. Patients who were undergoing a CIED pocket revision, generator replacement, or system upgrade or an initial implantation of a cardiac resynchronization therapy defibrillator were randomly assigned, in a 1:1 ratio, to receive the envelope or not. Standard-of-care strategies to prevent infection were used in all patients. The primary end point was infection resulting in system extraction or revision, long-term antibiotic therapy with infection recurrence, or death, within 12 months after the CIED implantation procedure. The secondary end point for safety was procedure-related or system-related complications within 12 months. Results A total of 6983 patients underwent randomization: 3495 to the envelope group and 3488 to the control group. The primary end point occurred in 25 patients in the envelope group and 42 patients in the control group (12-month Kaplan-Meier estimated event rate, 0.7% and 1.2%, respectively; hazard ratio, 0.60; 95% confidence interval [CI], 0.36 to 0.98; P=0.04). The safety end point occurred in 201 patients in the envelope group and 236 patients in the control group (12-month Kaplan-Meier estimated event rate, 6.0% and 6.9%, respectively; hazard ratio, 0.87; 95% CI, 0.72 to 1.06; P&lt;0.001 for noninferiority). The mean (+/- SD) duration of follow-up was 20.7 +/- 8.5 months. Major CIED-related infections through the entire follow-up period occurred in 32 patients in the envelope group and 51 patients in the control group (hazard ratio, 0.63; 95% CI, 0.40 to 0.98). Conclusions Adjunctive use of an antibacterial envelope resulted in a significantly lower incidence of major CIED infections than standard-of-care infection-prevention strategies alone, without a higher incidence of complications