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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

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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.

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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.