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Biotech / Medical : Future Medical Device Companies
STXS 2.920-1.7%Oct 29 3:59 PM EDT

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From: semi_infinite 5/20/2009 11:43:18 AM
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More interesting data presented at the HRS meeting last week on both Stereotaxis and Hansen systems. Stereotaxis results pretty much in line with conventional manual catheter with lower complications. Hansen results were all over the place from about the same as manual to much worse than manual. Lahey results below seems similar to Cleveland Clinic experience if recollection serves.

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PO04-35 - Robotic versus Manual Catheter Ablation for Atrial Fibrillation

Author(s): Matthew A. Bernabei, MD, Roberto C. Ugarte, MD, David T. Martin, MD, FHRS and Bruce G. Hook, MD. Lahey Clinic, Burlington, MA

Abstract:

Introduction:
Remote navigation technologies used in atrial fibrillation (AF) ablation seek to improve procedural efficiency, safety, and efficacy through improved catheter stability, tissue contact, and movement precision. We report our experience using a robotically controlled catheter system (Hansen Medical, Mountain View, CA) and compare it with our manual catheter ablation experience.

Methods:
Thirty-five patients (89% male, age 57±11 years, EF 56±7%, left atrial size 4.2±0.6 cm, AF duration 54±56 months, persistent/paroxysmal AF 16/19) underwent AF ablation with a robotic catheter system. Procedural and outcome data were then compared retrospectively with matched (age, type of AF, and EF) controls that had undergone manual catheter ablation.

Results:
The total procedure time was longer in the robotic catheter ablation group (R) than in the manual catheter ablation group (M) (320±66 min vs. 248±53 min; p<0.0001), while the fluoroscopy time was shorter (61±14 min vs. 74±20 min; p=0.003). There was no significant difference in the ablation time between R and M (75±38 min vs. 79±31 min; p=0.59). Major complications were observed in 17% of R and 6% of M. The robotic complications consisted of 3 retroperitoneal hemorrhages (all were contralateral to the 14F robotic catheter sheath, and occurred in cases 10, 32, and 34), 2 cases of cardiac tamponade (cases 6 and 15), and 1 pericardial effusion (case 31) that required a pericardial window two weeks after the procedure. The manual procedure complications comprised 1 stroke and 1 case of cardiac tamponade. At 6 months of follow-up, 95% of R and 84% of M were free of symptomatic atrial tachyarrhythmia (p=0.18).

Conclusions:
In this early single-center experience comparing robotic and manual catheter ablation for AF, the robotically controlled catheter system was associated with a longer procedure time, more complications, and a trend toward fewer recurrences of symptomatic atrial tachyarrhythmia. Future studies will be needed to define more clearly the risk/benefit ratio for this new technology and its role in AF ablation.

Disclosures:
M.A. Bernabei, None; R.C. Ugarte, None; D.T. Martin, None; B.G. Hook, None.
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