BioTrace Medical announced that its Tempo temporary pacing lead was featured in an oral presentation during the 2017 Transcatheter Valve Therapies (TVT) meeting (14–17 June, Chicago, USA). Tamim Nazif (NewYork-Presbyterian/Columbia University Medical Center, New York, USA) outlined real-world experiences of using the Tempo lead in transcatheter aortic valve implantation (TAVI) procedures.
According to a press release, Nazif’s presentation highlighted the safety of the Tempo lead, with real-world US experience to date—demonstrating no dislodgements or perforations as well as the technology’s reliable pace capture during and after the procedure, facilitating earlier patient ambulation in recovery.
Nazif presented an overview of the technology, highlighting two case studies from NewYork-Presbyterian/Columbia University Medical Center’s use of the lead, as well as early US Tempo lead experience in several hundred cases with no device-related adverse events, no perforations and no dislodgements.
“Our real-world experience with the Tempo lead is consistent with the excellent results of the New Zealand first-in-human study demonstrating the safety and reliable performance of the device. The Tempo lead may improve the safety of TAVI and other structural heart procedures by reducing complications like cardiac perforation, loss of pacing capture, and valve embolisation. There may also be opportunities with the Tempo lead to reduce the length of ICU stay, expedite recovery, and reduce permanent pacemaker implantation with a strategy of watchful waiting in patients with transient conduction disturbances,” Nazif comments.
The press release reports that results from a 2016 multicentre study of 25 patients conducted in New Zealand demonstrated the safety of the Tempo lead, with no device related adverse events, dislodgements, sustained ventricular arrhythmia, or cardiac perforations. It adds that pacing with the Tempo lead was successful in all treated patients with no loss of pace capture or lead dislodgement. Average procedural pace capture threshold was 0.7±0.5mA. Rapid pacing was successful in all cases with no loss of capture.