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Multicenter clinical evaluation of a new SSIR pacemaker
M G Bongiorni1, E Soldati, G Arena
1Clinical Physiology Institute, Pisa, Italy.
Pacing and Clinical Electrophysiology : PACE
|November 1, 1992
Summary
The Sorin Swing 100 pacemaker, featuring a gravimetric sensor, demonstrated physiological pacing rates during Holter monitoring and exercise tests. This new pacemaker effectively adjusted pacing based on patient activity, with minimal interference from external sources.
Area of Science:
- Cardiology
- Biomedical Engineering
Background:
- Pacemaker technology aims to restore physiological heart rhythm.
- New pacemakers require rigorous clinical evaluation for safety and efficacy.
Purpose of the Study:
- To evaluate the clinical performance of the Sorin Swing 100, a novel single-chamber rate-responsive pacemaker with a gravimetric sensor.
- To assess the physiological behavior of the paced heart rate under various conditions.
Main Methods:
- Multicenter clinical trial involving 89 patients undergoing pacemaker implantation or replacement.
- Evaluation included 24-hour Holter monitoring, exercise stress tests, and mechanical external interference (MEI) testing.
- Pacing modes evaluated were VVIR and AAIR.
Main Results:
- Physiological paced heart rate behavior was consistently observed during Holter monitoring.
- A direct correlation between pacing rate and workload was evident during exercise stress tests.
- Mechanical external interference testing showed no significant impact on pacing rate.
Conclusions:
- The Sorin Swing 100 pacemaker exhibits appropriate physiological rate response.
- The device demonstrates reliable performance and minimal susceptibility to external interference.
- The gravimetric sensor effectively contributes to the pacemaker's rate-adaptive function.