Safety and Feasibility of a Novel Active Fixation Temporary Pacing Lead.

Objective. This first-in-human study evaluated the safety and technical feasibility of the Tempo temporary cardiac pacing lead [BioTrace Medical], which includes a novel fixation mechanism and soft tip. Background. Complications of temporary pacing leads include dislodgment. arrhythmias, and ventricular perforation. Temporary pacing applications have increased with transcatheter aortic valve replacement [TAVR] growth, for rapid pacing during balloon valvuloplasty [BAV] and valve deployment, and for periprocedural bradyarrhythmia support. Methods. Eligible patients required temporary pacing for TAVR, BAV, or electro-physiology [EP] procedures. Transthoracic echocardiograms were obtained at baseline and 24 hours after lead removal. Safety was defined as freedom from pericardial effusion requiring intervention or evidence of tamponade. Technical feasibility involved successful intracardiac delivery and pace capture. Additional evaluations included pacing threshold [PCT], rapid pacing, dislodgment. or sustained ventricular arrhythmias. Follow-up was to 30 days. Results. Twenty-five patients [60% female: mean age, 64 +/- 19 years] underwent 13 TAVRs Sapien 3 valves [Edwards Lifesciences], 4 CoreValves [Medtronic], and 2 Lotus valves [Boston Scientific]], 11 EP procedures, and 1 BAV at two New Zealand centers from January 2016 to June 2016. Safety was met in all patients. with no device-related adverse events. Technical feasibility was achieved in 23 cases [92%]; 2 patients had unsuitable anatomy. No patient had lead dislodgment or sustained ventricular arrhythmias, and the final procedural PCT was 0.7 +/- 0.5 mA. Rapid pacing was successful in all cases. Five patients had successful postprocedural use up to 5 days. Conclusion. This first-in-human study demonstrates the safety and technical feasibility of the Tempo lead, providing stable periprocedural temporary pacing support.