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  • Title: Initial clinical experience with cardiac resynchronization therapy utilizing a magnetic navigation system.
    Author: Gallagher P, Martin L, Angel L, Tomassoni G.
    Journal: J Cardiovasc Electrophysiol; 2007 Feb; 18(2):174-80. PubMed ID: 17239142.
    Abstract:
    INTRODUCTION: The placement of left ventricular (LV) leads during cardiac resynchronization therapy (CRT) involves many technical difficulties. These difficulties increase procedural times and decrease procedural success rates. METHODS AND RESULTS: A total of 50 patients with severe cardiomyopathy (mean LV ejection fraction was 21 +/- 6%) and a wide QRS underwent CRT implantation. Magnetic navigation (Stereotaxis, Inc.) was used to position a magnet-tipped 0.014'' guidewire (Cronus guidewire) within the coronary sinus (CS) vasculature. LV leads were placed in a lateral CS branch, either using a standard CS delivery sheath or using a "bare-wire" approach without a CS delivery sheath. The mean total procedure time was 98.1 +/- 29.1 minutes with a mean fluoroscopy time of 22.7 +/- 15.1 minutes. The mean LV lead positioning time was 10.4 +/- 7.6 minutes. The use of a delivery sheath was associated with longer procedure times 98 +/- 32 minutes vs 80 +/- 18 minutes (P = 0.029), fluoroscopy times 23 +/- 15 minutes vs 13 +/- 4 minutes (P = 0.0007) and LV lead positioning times 10 +/- 6 minutes vs 4 +/- 2 minutes (P = 0.015) when compared to a "bare-wire" approach. When compared with 52 nonmagnetic-assisted control CRT cases, magnetic navigation reduced total LV lead positioning times (10.4 +/- 7.6 minutes vs 18.6 +/- 18.9 minutes; P = 0.005). If more than one CS branch vessel was tested, magnetic navigation was associated with significantly shorter times for LV lead placement (16.2 +/- 7.7 minutes vs 36.4 +/- 23.4 minutes; P = 0.004). CONCLUSIONS: Magnetic navigation is a safe, feasible, and efficient tool for lateral LV lead placement during CRT. Magnetic navigation during CRT allows for control of the tip direction of the Cronus 0.014'' guidewire using either a standard CS delivery sheath or "bare-wire" approach. Although there are some important limitations to the 0.014'' Cronus magnetic navigation can decrease LV lead placement times compared with nonmagnetic-assisted control CRT cases, particularly if multiple CS branches are to be tested.
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