The initial U.S. experience with the Tempo active fixation temporary pacing lead in structural heart interventions

Area of Science:

• Cardiology
• Medical Devices
• Interventional Procedures

Background:

• Temporary cardiac pacing is crucial for structural heart procedures.
• Existing temporary pacing leads have seen limited innovation.
• The Tempo lead features a soft tip and active fixation for improved safety and stability.

Purpose of the Study:

• To evaluate the safety and efficacy of the Tempo Temporary Pacing Lead in initial U.S. clinical use.
• To assess the performance of the Tempo lead during and after structural heart interventions.

Main Methods:

• Retrospective analysis of 269 consecutive structural heart procedures using the Tempo lead.
• Evaluation of device safety, including absence of perforation, effusion, or arrhythmia.
• Assessment of pacing efficacy, lead stability, and post-procedure outcomes.

Main Results:

• Successful pacing achieved in 98.1% of patients.
• No significant perforations, effusions, or device-related arrhythmias occurred.
• The lead enabled patient mobilization in 84.1% of cases without dislodgement.

Conclusions:

• The Tempo lead is a safe and effective option for temporary cardiac pacing in structural heart procedures.
• It provides reliable peri- and post-procedural pacing.
• The lead facilitates patient mobility while maintaining pacing stability.