Actions elicited during scheduled and unscheduled in-hospital follow-up of cardiac devices: results of the ATHENS multicentre registry.

AIM: The number of cardiac implantable electronic devices (CIEDs) is continuously growing and this translates into a high number of in-hospital follow-ups. This workload justifies the increasing popularity of remote monitoring systems for the follow-up of CIEDs. The ATHENS registry was designed to find out what actions are taken during in-hospital follow-up of CIEDs at 10 different centres in Northern Italy. METHODS AND RESULTS: Between 1 March 2010 and 30 June 2010, all patients who came to our centres for a follow-up of their CIEDs were enrolled in the registry. We defined as visit with an action (VWA) a follow-up that elicited an action in that patient. The primary endpoint was the prevalence of VWA on the whole population. The secondary endpoints were: prevalence of VWA on the pacemaker (PM) population; prevalence of VWA on the implantable cardioverter defibrillator (ICD) population; prevalence of VWA on the cardiac resynchronization therapy (CRT) population; predictors of VWA in univariate and multivariate analyses. A total of 3362 patients were recruited. The primary endpoint was reached in 762 patients, 22.8% of patients (95% CI 21.4-24.3). The prevalence of action was highest for CRT (29.8%), followed by PM (22.8%) and ICD (18.6%). In a multivariate model, the prevalence of action was higher for CRT, than for PM and was lowest for ICD and it was higher for unscheduled visits and first visits than for scheduled visits. CONCLUSIONS: Our registry demonstrates that 'some actions' are taken during about 20% of scheduled in-hospital follow-up of CIEDs. These data should encourage the use of remote follow-up systems.

An observational registry on efficacy and safety of the right ventricular outflow tract as a site for ICD leads: results of the EFFORT (EFFicacy Of Right ventricular outflow Tract as site for ICD leads) registry.

BACKGROUND: Although pacing from the right ventricular outflow tract (RVOT) has been shown to be safe and feasible in terms of sensing and pacing thresholds, its use as a site for implantable cardioverter defibrillator (ICD) leads is not common. This is probably due to physicians' concerns about defibrillation efficacy. To date, only one randomized trial, involving 87 enrolled patients, has evaluated this issue. OBJECTIVE: The aim of this observational study has been to compare safety (primary combined end point: efficacy of a 14-J shock in restoring sinus rhythm, R wave amplitude >4 mV and pacing threshold <1 V at 0.5 ms) and efficacy (in terms of effectiveness of a 14-J shock in restoring sinus rhythm after induction of VF, secondary end point) of two different sites for ICD lead positioning: RVOT and right ventricular apex (RVA). METHODS: The study involved 185 patients (153 males; aged 67 ± 10 years; range, 28-82 years). Site of implant was left to physician's decision. After implant, VF was induced with a 1-J shock over the T wave or--if this method was ineffective--with a 50-Hz burst, and a 14-J shock was tested in order to restore sinus rhythm. If this energy was ineffective, a second shock at 21 J was administered and--eventually--a 31-J shock followed--in case of inefficacy--by a 360-J biphasic external DC shock. Sensing and pacing thresholds were recorded in the database at implant, together with acute (within 3 days of implant) dislodgement rate. RESULTS: The combined primary end point was reached in 57 patients in the RVOT group (0.70%) and in 81 patients in the RVA group (0.79%). The 14-J shock was effective in 159 patients, 63 in the RVOT group (77%) and 86 in the RVA group (83%). Both the primary and the secondary end points are not statistically different. R wave amplitude was significantly lower in the RVOT group (10.9 ± 5.2 mV vs. 15.6 ± 6.4 mV, p < 0.0001), and pacing threshold at 0.5 ms was significantly higher (0.64 ± 0.25 V vs. 0.52 ± 0.20 V, p < 0.01), but these differences do not seem to have a clinical meaning, given that the lower values are well above the accepted limits in clinical practice. CONCLUSIONS: Efficacy and safety of ICD lead positioning in RVOT is comparable to RVA. Even if we observed statistically significant differences in sensing and pacing threshold, the clinical meaning of these differences is--in our opinion--irrelevant.