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.

ABSTRACT

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.