Objectives: To assess the safety and efficacy of the Wattson temporary pacing guidewire. Background: Transcatheter aortic valve replacement (TAVR) requires a guidewire for device delivery and generally requires temporary pacing wire for burst and back-up pacing. The Wattson wire provides concomitant support and bipolar pacing without the need to place a temporary venous pacemaker (TVP). Methods: This was a single-center nonrandomized prospective clinical trial enrolling 20 patients. The primary endpoint was defined as successful rapid pacing and transcatheter heart valve (THV) delivery with no loss of capture. Safety, qualitative and quantitative secondary outcomes were also analyzed. Results: Mean age was 77.4 ± 9.0 years. Mean Society of Thoracic Surgery (STS) score was 3.0 ± 1.5%. All patients received a balloon-expandable valve via a transfemoral approach. All patients met the primary end-point. One patient (5%) had balloon predilatation and six patients (30%) had postdilatation, all using the wire. Mean pacing threshold was 2.2 ± 1.2 mA that was evaluated prior to placing an insulating catheter over the wire. One patient required TVP placement and subsequent permanent pacemaker implantation due to complete heart block post THV deployment. There were no incidences of cardiac perforation or tamponade. One patient required valve reintervention, which was not related to the device. Conclusions: The Wattson wire offered predictable guidewire support with concomitant reliable bipolar pacing at low thresholds to allow safe THV delivery in this patient cohort. It has the potential to make TAVR a safer and more efficient procedure.
- interventional devices/innovation
- new devices
- transcatheter valve implantation