Safety and performance of a system specifically designed for selective site pacing

Abstract

Introduction: In the right ventricle, selective site pacing (SSP) has been shown to avoid detrimental hemodynamic effects induced by right ventricular apical pacing and, in the right atrium, to prevent the onset of atrial fibrillation and to slow down disease progression. The purpose of our multicenter observational study was to describe the use of a transvenous 4-French catheter-delivered lead for SSP in the clinical practice of a large number of centers.

Methods: We enrolled 574 patients in whom an implantable device was indicated. In all patients, SSP was achieved by using the Select Secure System™ (Medtronic Inc., Minneapolis, MN, USA).

Results: In 570 patients, the lead was successfully implanted. In 125 patients, atrial SSP was performed: in 75 (60%) the lead was placed in the interatrial septum, in 31 (25%) in the coronary sinus ostium, and in 19 (15%) in the Bachman bundle. Ventricular SSP was undertaken in 138 patients: in 105 (76%) the high septal right ventricular outflow tract (RVOT) position was paced, in seven (5%) the high free-wall RVOT, in 25 (18%) the low septal RVOT, and in one (1%) the low free-wall RVOT. In the remaining 307 patients, the His zone was paced: in 87 (28%) patients, direct His-bundle pacing and in 220 (72%) patients para-hisian pacing was achieved. Adequate pacing parameters and a lead-related complication rate of 2.6% were recorded during a follow-up of 20 ± 10 months.

Conclusions: Our results demonstrated that many sites, in the right atrium, in the right ventricle, and in His-bundle region, can be paced using the Select Secure System™.