2.1. General methodology
Between December 2020 and March 2021, 30 consecutive patients with bradycardia or heart failure indications were implanted with a LBBAP at the Heart Centre AZ Sint-Jan, Bruges, Belgium. All procedures were performed using a 5.6 Fr. stylet-driven pacing lead with an extendable helix (Solia S60, Biotronik, SE & Co, KG, Berlin, Germany) delivered through a pre-shaped sheath (Selectra 3D, curve 55 or 65, Biotronik, limited market release). Ten patients (validation-group) were implanted by conventional discontinuous lead deployment. After each rotation step pacing characteristics during pacing from the inserted lead stylet (LS) were compared to connector-pin (CP) pacing. Pacing characteristics were compared to validate similar performance of both pacing methods.
Additional twenty patients were implanted according to our novel continuous pace mapping technique (feasibility-group). In this group, performance and safety of uninterrupted lead implantation during continuous pacing from the LS were investigated. The study was approved by the local ethical committee.