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Heart Rhythm. 2010 Jun;7(6):750-4. doi: 10.1016/j.hrthm.2010.02.020. Epub 2010 Feb 16.

Safety and efficacy of a new magnetic resonance imaging-compatible pacing system: early results of a prospective comparison with conventional dual-chamber implant outcomes.

Author information

1
Department of Internal Medicine, Division of Cardiology, University of Rome Tor Vergata, Rome, Italy. forleo@me.com

Abstract

BACKGROUND:

A new pacing system has been designed and tested preclinically for safe use in the magnetic resonance imaging (MRI) environment. Experience with this innovative system has not yet been reported.

OBJECTIVE:

The purpose of this study was to verify the safety and effectiveness of this newly designed system compared to conventional DDD implant outcomes.

METHODS:

Over an 11-month period, 107 consecutive patients (71 men and 36 women; age 72.6 +/- 8.5 years) were implanted with either the MRI system (n = 50; MRI group) or a dual-chamber, active-fixation lead (Medtronic 4076) non-MRI system (n = 57; DDD group). Data were collected at implant and during postoperative follow-up at 1, 3, 6, and 12 months. Procedural and fluoroscopic times at implant, as well as lead measurements, handling characteristics, and procedural-related complications, were prospectively analyzed.

RESULTS:

The implantation success rate in both groups was 100%. Cephalic access was 63% for MRI patients and 70% for DDD patients (P = NS). Follow-up was obtained for all patients (median 6.8 months, range 3-12 months). At implant and at the end of follow-up, stimulation thresholds, sensing, and impedance were acceptable. No cases of high pacing thresholds or inadequate sensing were noted. No complications occurred, and no patient experienced subsequent lead displacement.

CONCLUSION:

This prospective, controlled study provides strong evidence that the feasibility and safety of this novel technology compare favorably with those of the conventional technique.

PMID:
20167289
DOI:
10.1016/j.hrthm.2010.02.020
[Indexed for MEDLINE]

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