Real-World Data Presented for BioTrace Medical's Tempo Lead in TAVR Procedures
June 19, 2017— BioTrace Medical, Inc. announced that data on the company’s Tempo temporary pacing lead were presented at TVT 2017, the Transcatheter Valve Therapies conference held June 14–17 in Chicago, Illinois.
Tamim Nazif, MD, presented real-world experiences in the United States with the Tempo lead from transcatheter aortic valve replacement (TAVR) cases. The data highlighted by Dr. Nazif supported the safety of the device, demonstrating no dislodgements or perforations. Also, the findings demonstrated the technology’s reliable pace capture during and after the procedure, facilitating earlier patient ambulation in recovery. BioTrace Medical’s Tempo lead was cleared in October 2016 by the US Food and Drug Administration.
In the company's press release, Dr. Nazif commented, "Our real-world experience with the Tempo lead is consistent with the excellent results of New Zealand's first-in-human study demonstrating the safety and reliable performance of the device. The Tempo lead may improve the safety of TAVR and other structural heart procedures by reducing complications like cardiac perforation, loss of pacing capture, and valve embolization. There may also be opportunities with the Tempo lead to reduce the length of intensive care unit stay, expedite recovery, and reduce permanent pacemaker implantation with a strategy of watchful waiting in patients with transient conduction disturbances.” Dr. Nazif is Director of Clinical Services of the Structural Heart & Valve Center at NewYork-Presbyterian/Columbia University Medical Center in New York, New York.
At TVT 2017, Dr. Nazif presented an overview of the technology, highlighting two case studies from NewYork-Presbyterian/Columbia University Medical Center’s use of the Tempo lead, as well as early Tempo lead experience in the United States in several hundred cases with no device-related adverse events, no perforations, and no dislodgements. In addition, real-world experience shows patients ambulating postprocedure with the Tempo lead in place, and overall highly favorable operator feedback.
In the 2016 multicenter study of 25 patients conducted in New Zealand, the results demonstrated the safety of the Tempo lead, with no device-related adverse events, dislodgements, sustained ventricular arrhythmia, or cardiac perforations. Pacing with the Tempo lead was successful in all treated patients with no loss of pace capture or lead dislodgement. The average procedural pace capture threshold was 0.7 ± 0.5 mA. Rapid pacing was successful in all cases with no loss of capture, reported BioTrace Medical.