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Cardiac resynchronization therapy device implantation using a new sensor-based navigation system: results from the

Sergio Richter¹, Michael Döring, Thomas Gaspar

¹Department of Electrophysiology, Heart Centre, University of Leipzig, Leipzig, Germany.

Circulation. Arrhythmia and Electrophysiology

|September 5, 2013

Summary

This study shows that a new electromagnetic tracking system (MediGuide Technology) is safe and effective for cardiac resynchronization therapy (CRT) implantation, potentially reducing procedure time and fluoroscopy exposure.

Keywords:

cardiac resynchronization therapy electromagnetic navigation implantation technique radiation exposure tracking

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Area of Science:

Cardiology
Medical Devices
Electrophysiology

Background:

Cardiac resynchronization therapy (CRT) device implantation is often challenging, lengthy, and requires significant fluoroscopy.
A novel sensor-based electromagnetic tracking system (MediGuide Technology [MGT]) has been developed to aid left ventricular lead placement.
This study reports on the First Human Use of MGT for CRT implantation.

Purpose of the Study:

To evaluate the feasibility, safety, and performance of a new CRT implantation approach using MGT.
To assess the impact of MGT on procedure time and fluoroscopy duration.

Main Methods:

Fifteen consecutive patients indicated for CRT underwent implantation using the MGT system.
Data collected included demographics, anatomical information, fluoroscopy time, procedure duration, and adverse events.
Patients were followed for 4 weeks post-implantation.

Main Results:

Successful CRT system implantation with appropriate left ventricular lead positioning in all patients.
Total procedure time averaged 116±43 minutes.
Median total fluoroscopy time was 5.2 minutes; median LV lead deployment fluoroscopy time was 2.6 minutes.
No severe perioperative or postoperative complications requiring intervention or reoperation were observed.

Conclusions:

The MediGuide Technology (MGT) enables safe and successful CRT implantation.
This novel approach shows potential for reduced fluoroscopy time during CRT procedures.
Further randomized studies are necessary to confirm these findings.