BioTrace Medical’s Tempo Temporary Pacing Lead Evaluated in Management of Bradyarrhythmia

November 15, 2021—BioTrace Medical, Inc. announced findings from a clinical study of the company’s Tempo Lead, a temporary pacing lead. In the study by Mitchell Stelzer, DO, et al, the investigators analyzed a series of 12 consecutive patients who underwent Tempo Lead placement for temporary pacing at OhioHealth Riverside Methodist Hospital in Columbus, Ohio.

“A Retrospective Analysis of a Single-Center Experience with the Tempo Temporary Pacing Lead in Management of Bradyarrhythmia and Other Cardiac Electrophysiology Procedures” was presented at the American Heart Association’s Scientific Sessions 2021, held November 13-15.

The investigators retrospectively reviewed 12 consecutive patients (83% male, mean age 71.3 ± 10.1 years) who underwent Tempo Lead placement for temporary pacing—75% symptomatic bradyarrhythmia; 25% other indications including permanent lead malfunction, permanent pacemaker infection, and complete heart block.

According to the company, the Tempo Lead was successfully positioned and fixed in the right ventricle in all 12 cases with no perforations, pericardial effusions, or device-related arrhythmias. Access was femoral in eight patients (67%) and jugular in three patients (25%), with one access point not indicated.

Procedural mean pace capture threshold was 0.96 ± 0.74 mA (n = 10). Mean lead indwelling duration was 53.5 hours with a range of 20.9 hours to 5.9 days (n = 11). Three patients were ambulatory (at least bed-to-chair) with the Tempo Lead in place without complications and with maintenance of thresholds < 1 mA.

Anish K. Amin, MD, a cardiac electrophysiologist at OhioHealth Riverside Methodist Hospital commented in BioTrace Medical’s press release, “The Tempo Lead is very useful for the support of temporary bradyarrhythmias that require reliable early- or medium-term temporary pacing as a bridge to resolution or permanent pacemaker implantation. Its unique design provides temporary pacing without the risk of dislodgment, loss of pace capture, or perforation inherent in conventional temporary leads.”

The Tempo Lead, which has received FDA clearance and CE Mark certification, is designed with retractable stabilizer loops and a soft tip that minimizes the risks of dislodgment and perforation, ensures stability during rapid pacing, and facilitates patient ambulation in recovery, stated the company.