Biventricular versus left ventricular only stimulation: an echocardiographic substudy of the B-LEFT HF trial.

BACKGROUND: The noninferiority of left ventricular pacing alone (LVp) compared with biventricular pacing (BIV) has not been yet definitely documented. In this study, we reviewed all the original echocardiographic measures of the Biventricular versus Left Univentricular Pacing with ICD Back-up in Heart Failure Patients (B-LEFT HF) trial in order to investigate mechanisms underlying LV remodelling with both pacing modalities. METHODS: Patients with New York Heart Association functional class (NYHA) III or IV despite optimal medical therapy, LVEF 35% or less, left ventricular end-diastolic diameter (LVEDD) more than 55 mm, QRS duration at least 130 ms were randomized to BIV or LVp for 6 months. The primary end point was a composite of at least 1 point decrease in NYHA class and at least 5 mm decrease in left ventricular end-systolic diameter (LVESD). An additional end point was a LVp reverse remodelling defined as at least 10% decrease in LVESD. Mitral regurgitation and all echocardiographic measures were reassessed after 6-month follow-up. RESULTS: One hundred and forty-three patients were enrolled. Seventy-six patients were in the BIV and 67 were in the LVp group. Left ventricular volumes decreased significantly without difference between groups (P = 0.8447). Similarly, left ventricular diameters decreased significantly in both groups with a significant decrease in LVESD with BIV (P < 0.0001), but not with LVp (P = 0.1383). LVEF improved in both groups without difference (P = 0.8072). Mitral regurgitation did not improve either with BIV, or with LVp. CONCLUSION: The echocardiographic sub-analysis of B-LEFT study showed the substantial equivalence of LVp in favouring left ventricular reverse remodelling as compared with BIV.

Rationale and design of the health economics evaluation registry for remote follow-up: TARIFF.

AIMS: The aims of the study are to develop a cost-minimization analysis from the hospital perspective and a cost-effectiveness analysis from the third payer standpoint, based on direct estimates of costs and QOL associated with remote follow-ups, using Merlin@home and Merlin.net, compared with standard ambulatory follow-ups, in the management of ICD and CRT-D recipients. METHODS AND RESULTS: Remote monitoring systems can replace ambulatory follow-ups, sparing human and economic resources, and increasing patient safety. TARIFF is a prospective, controlled, observational study aimed at measuring the direct and indirect costs and quality of life (QOL) of all participants by a 1-year economic evaluation. A detailed set of hospitalized and ambulatory healthcare costs and losses of productivity that could be directly influenced by the different means of follow-ups will be collected. The study consists of two phases, each including 100 patients, to measure the economic resources consumed during the first phase, associated with standard ambulatory follow-ups, vs. the second phase, associated with remote follow-ups. CONCLUSION: Remote monitoring systems enable caregivers to better ensure patient safety and the healthcare to limit costs. TARIFF will allow defining the economic value of remote ICD follow-ups for Italian hospitals, third payers, and patients. The TARIFF study, based on a cost-minimization analysis, directly comparing remote follow-up with standard ambulatory visits, will validate the cost effectiveness of the Merlin.net technology, and define a proper reimbursement schedule applicable for the Italian healthcare system. TRIAL REGISTRATION: NCT01075516.

Analysis of implantable cardioverter defibrillator signals for non conventional cardiac electrical activity characterization.

Implantable cardioverter defibrillators (ICDs) can store intracardiac electrograms (EGMs) in sinus rhythm (SR), at the onset of spontaneous ventricular tachyarrhythmias (VT) or during their course. This allows the investigation of unknown features of the heart electrical activity associated with different cardiac rhythms. In this study we propose a non conventional cardiac electrical activity characterization (CEAC) that extracts quantitative information about the power spectrum wideness and variability of the beat-by-beat morphology. We analyze 293 EGMs from 40 patients who underwent implantation of St Jude Medical-Ventritex ICDs that allow the storage of EGMs with two different modes of recording: bipolar (BIP) and unipolar or far-field (FF). The EGMs are studied with this CEAC by (1) exploring differences between the CEAC measured from FF and BIP EGMs during similar cardiac rhythms, and (2) investigating the mode of recording that allows a better separation between SR and VT rhythms. Results show that, with similar cardiac rhythm, the CEACs from FF or BIP recordings are different (for SR rhythm: sensitivity 81.5%, specificity 93.6%; for VT rhythm: sensitivity and specificity 100%); thus FF and BIP EGMs analyze different aspects of cardiac activity. The CEAC applied to FF EGMs distinguishes better EGMs obtained during SR from VT rhythms (VT vs SR with sensitivity 92.7% and specificity 79.7%) than when it is applied to BIP signals (VT vs SR with sensitivity 60% and specificity 73.3%).