A first-in-human study has shown that a new temporary lead for cardiac pacing (Tempo Lead, BioTrace Medical) is safe and effective for use in procedures in which temporary pacing is indicated such as transcatheter aortic valve implantation (TAVI), balloon aortic valvuloplasty, or electrophysiology procedures. The new lead demonstrated no device related adverse events, dislodgements, sustained ventricular arrhythmia, or cardiac perforations.
Co-principal investigator, Mark Webster (Auckland City Hospital, Auckland, New Zealand), presented the results at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October‒2 November, Washington, DC, USA).
Data demonstrated that the Tempo Lead was successfully positioned in 23 (92%) patients, with two patients having unsuitable anatomy. Pacing with the device was successful in all treated patients with no loss of pace capture or lead dislodgement of the device from within the heart. Average procedural pace capture threshold was 0.7±0.5mA. Rapid pacing was successful in all cases with no loss of capture.
“The results of this first-in-human study of the technology demonstrate that the Tempo Lead is safe and effective for temporary cardiac pacing, and provides stable peri- and post-procedural pacing support,” said Webster. “Durable and stable procedural and post-procedural pacing is critical to the success of TAVI, and other clinical scenarios requiring temporary pacing.”
“The Tempo Lead represents an important advance that could help reduce serious complications associated with temporary pacing,” said co-principal investigator, Sanjeevan Pasupati (Waikato Hospital, Hamilton, New Zealand). “The technology is easy to use and offers secure placement. The secure placement of the Tempo Lead alleviates the need for patients to return to the cath lab for repositioning and aids early mobilisation of patients with confidence.”
The Tempo Lead, which recently received US Food and Drug Administration (FDA) 510(k) approval, is a small catheter with two electrodes placed in the right ventricle of the heart. The lead is then connected to an external pacemaker allowing to control a patient’s heart rate for several days. BioTrace Medical announced that it plans an immediate US commercial release of the Tempo Lead.