Effect of fixed-rate vs. rate-RESPONSIve pacing on exercise capacity in patients with permanent, refractory atrial fibrillation and left ventricular dysfunction treated with atrioventricular junction aBLation and bivEntricular pacing (RESPONSIBLE): a prospective, multicentre, randomized, single-blind study.

AIMS: Atrioventricular junction (AVJ) ablation followed by biventricular pacing is an established strategy for improving symptoms and morbidity in patients with permanent atrial fibrillation (AF), reduced left ventricular ejection fraction (LVEF), and uncontrolled ventricular rate. There is no clear evidence that such patients benefit from rate-responsive (RR) pacing. METHODS AND RESULTS: This prospective, randomized, single-blind, multicentre study was designed as an intra-patient comparison and enrolled 60 patients (age 69.5 ± 11.8 years, males 63.3%, NYHA 3.0 ± 0.6) with refractory AF and reduced LVEF (mean 32.4 ± 8.3%) treated with AVJ ablation and biventricular pacing. Two 6-minute walking tests (6MWT) were performed 1 week apart: one during VVI 70/min biventricular pacing and the other during VVIR 70-130/min biventricular pacing; patients were randomly and blindly assigned to Group A (n = 29, first 6MWT in VVIR mode) or B (n = 31, first 6MWT in VVI mode). Rate-responsive activation determined an increase of 18.8 ± 24.4 m in the distance walked during the 6MWT (P < 0.001). The increase was similar in both groups (P = 0.571). A >5% increase in the distance walked was observed in 76.7% of patients. The increase in the distance walked was linearly correlated with the increase in heart rate recorded during the 6MWT in the VVIR mode (r = 0.54; P < 0.001). CONCLUSION: In permanent AF patients with uncontrolled rate and reduced LVEF who had undergone AVJ ablation and biventricular pacing, RR pacing yields a significant gain in exercise capacity, which seems to be related to the RR-induced frequency during effort.

Defibrillation testing during implantable cardioverter-defibrillator implantation in Italian current practice: the Assessment of Long-term Induction clinical ValuE (ALIVE) project.

BACKGROUND: Clinical practice with regard to defibrillation threshold (DFT) testing during implantable cardioverter-defibrillator (ICD) implantation varies considerably, even among experienced implanting centers. International guidelines do not as yet mandate DFT testing. OBJECTIVE: The objective of this project is to assess current clinical decision making regarding DFT testing during ICD implantation. METHODS: The ALIVE project collected data on DFT testing from a multicenter network of Italian clinicians sharing a common system for the collection, management, analysis, and reporting of clinical and diagnostic data from patients with Medtronic (Minneapolis, MN) implantable devices. RESULTS: Data on 2,082 consecutive patients implanted with a Medtronic ICD in 111 Italian centers, over the period 2007 to 2010, were analyzed. Defibrillation threshold testing was performed in 33% of cases (678/2,082). The main reasons for performing the test were physician's clinical practice ("I always perform DFT") (80%) and secondary prevention implantation (12%). The main reasons for not performing DFT testing were centers' practice (44%), primary prevention (31%), and device replacement (15%). In 22 patients, ventricular fibrillation induction was not achieved; 656 patients completed DFT testing: 633 patients (96%) performed a single test, 19 patients (3%) performed a second induction test, and 4 patients (0.6%) underwent an additional induction test. CONCLUSIONS: The preliminary results of the ALIVE project show that a great number of implant procedures are performed without DFT testing in the common practice of the participating centers. We also measured an inhomogeneous, center-dependent DFT testing behavior, which suggests the importance of defining a common guideline for ICD implant testing. Follow-up data on our patients will provide more information on the clinical value of the test.

Ventricular antitachycardia pacing therapy in patients with heart failure implanted with a cardiac resynchronization therapy defibrillator device: Efficacy, safety, and impact on mortality.

BACKGROUND: Cardiac resynchronization therapy defibrillator can terminate ventricular tachycardia (VT) and fast VT (FVT) via antitachycardia pacing (ATP). OBJECTIVES: We evaluated efficacy and safety of ATP, whether ATP induces ventricular arrhythmias after inappropriate ATP or atrial fibrillation (AF) after appropriate ATP, and whether ATP is associated with mortality. METHODS: A total of 1404 patients with a cardiac resynchronization therapy defibrillator were followed in a prospective multicenter observational research. All-cause mortality rates were estimated in patient subgroups in order to uncouple the trigger (VT/FVT or other rhythms causing inappropriate detections) from ATP therapy. RESULTS: Over a median follow-up of 31 months, 2938 VT/FVT episodes were treated with ATP in 360 patients. The adjusted ATP success rate was 63% (95% confidence interval [CI] 57%-69%) on FVTs and 68% (95% CI 62%-74%) on VTs. Acceleration occurred in 55 (1.87%) and syncope in 4 (0.14%) of all ATP-treated episodes. In 14 true VT/FVT episodes in 5 patients, AF followed ATP therapy. In 4 episodes in 2 patients, VT followed ATP inappropriately applied during AF. Death rate per 100 patient-years was 5.6 (95% CI 4.3-7.5) in patients with appropriate ATP and 1.5 (95% CI 0.4-6.1) in patients with inappropriate ATP (P = .045). CONCLUSION: ATP was effective in terminating VT/FVT episodes and displayed a good safety profile. ATP therapies by themselves did not increase death risk; prognosis was indeed better in patients without arrhythmic episodes, even if they received inappropriate ATP, than in patients with ATP on VT/FVT episodes. Adverse outcomes observed in patients receiving implantable cardioverter-defibrillator therapies are probably related to the arrhythmia itself, a marker of disease progression, rather than to adverse effects of ATP.