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The monolithic fetal pacemaker: prototype lead design for closed thorax deployment
Joseph Dell'Orfano1, Howard A Chou, Daegyun Park
1University of Illinois College of Medicine, Chicago, Illinois, USA.
Pacing and Clinical Electrophysiology : PACE
|April 29, 2003
Summary
A novel prototype lead for a fetal pacemaker was successfully tested for intrauterine application. This breakthrough offers a potential solution for fetal bradycardia, preventing prenatal sudden cardiac death and hydrops fetalis.
Area of Science:
- Biomedical Engineering
- Fetal Cardiology
- Medical Device Development
Background:
- Complete heart block is a primary cause of prenatal sudden cardiac death and hydrops fetalis.
- Current medical technology lacks intrauterine pacing solutions for fetal bradycardia.
Purpose of the Study:
- To develop and evaluate a prototype lead for a novel fetal pacemaker.
- To demonstrate the feasibility of intrauterine lead deployment for fetal bradycardia treatment.
Main Methods:
- Development of a prototype lead for a fetal pacemaker.
- Deployment of the lead using hypochondriac, transdiaphragmatic, or subxiphoid approaches in a direct pacing model.
- Assessment of ventricular capture via QRS duration widening and echocardiogram-confirmed pulse increase.
Main Results:
- The prototype lead was safely and successfully deployed.
- Ventricular capture was achieved, evidenced by a significant increase in QRS duration (50.2 ± 9.8 ms to 95.1 ± 12.8 ms, P = 0.0001).
- Echocardiography confirmed increased pulse during pacing, validating the pacing effect.
Conclusions:
- This study provides proof-of-concept for a novel lead design for closed-thorax, over-the-wire deployment in fetal pacing.
- A monolithic fetal pacemaker system deployable in utero is feasible by integrating this lead with microcircuitry and a power source.