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  • Title: Percutaneous patent foramen ovale closure using Helex and Amplatzer devices without intraprocedural echocardiographic guidance.
    Author: Siddiqui IF, Michaels AD.
    Journal: J Interv Cardiol; 2011 Jun; 24(3):271-7. PubMed ID: 21114532.
    Abstract:
    OBJECTIVES: We compared procedural outcomes of patients undergoing patent foramen ovale (PFO) closure using Helex (W.L. Gore & Assoc., Flagstaff, AZ, USA) and Amplatzer (AGA Medical Corp., Plymouth, MN, USA) devices using intracardiac echocardiographic (ICE) versus fluoroscopic-only guidance. BACKGROUND: Use of transesophageal or ICE to guide PFO closure is associated with patient discomfort and cost. While fluoroscopic guidance of septal closure using Amplatzer is well established, there is no published experience for Helex. METHODS: We performed a single-center, single-operator analysis of patients undergoing PFO closure using Helex or Amplatzer occluders. Device and guidance strategy was selected by the operator. RESULTS: Of the 132 PFO patients, 23 were closed with Helex, and 109 were closed with Amplatzer (103 Cribriforms, 4 PFO occluders, and 2 atrial septal occluders). Fluoroscopic guidance was used for 15 (65%) Helex and 102 (94%) Amplatzer cases. Successful device placement was achieved in all patients with a 1.5% complication rate (1 arrhythmia and 1 device embolization). Procedure time was shorter for fluoroscopic guidance of Amplatzer cases compared to ICE guidance (P = 0.023), and for Amplatzer versus Helex cases (P = 0.0004). Among the Helex cases, there were no differences in procedure or fluoroscopy time comparing ICE to fluoroscopic guidance. There was no residual shunting by transthoracic echocardiographic bubble study in 93% of Helex and 95% of Amplatzer cases at 6 months. CONCLUSIONS: Use of right atrial angiography and fluoroscopic-only guidance for PFO closure using Helex and Amplatzer devices provides an efficient alternative to ICE guidance. While procedure and fluoroscopy times were significantly shorter for Amplatzer versus Helex cases, these times were similar for Helex comparing fluoroscopy versus ICE guidance.
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