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Updated: Jun 6, 2026
Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence
Published on: December 23, 2022
Percutaneous patent foramen ovale closure using Helex and Amplatzer devices without intraprocedural echocardiographic
Irfan F Siddiqui1, Andrew D Michaels
1Heart of Florida Regional Medical Center, Davenport, Florida, USA.
Insights
Fluoroscopic guidance for patent foramen ovale (PFO) closure with Helex and Amplatzer devices is an efficient alternative to intracardiac echocardiography (ICE). Amplatzer procedures were faster than Helex, but Helex procedure times were similar with ICE or fluoroscopic guidance.
Area of Science:
- Cardiology
- Medical Devices
- Interventional Procedures
Background:
- Intracardiac echocardiography (ICE) and transesophageal echocardiography for patent foramen ovale (PFO) closure increase patient discomfort and costs.
- Fluoroscopic guidance is established for Amplatzer device closure but not for Helex devices.
Purpose of the Study:
- To compare procedural outcomes of patent foramen ovale (PFO) closure using Helex and Amplatzer devices with intracardiac echocardiographic (ICE) versus fluoroscopic-only guidance.
- To evaluate the efficiency and safety of fluoroscopic-only guidance for PFO closure.
Main Methods:
- A single-center, single-operator analysis of 132 patients undergoing PFO closure with Helex or Amplatzer occluders.
- Device and guidance strategy were operator-selected, with comparison between ICE and fluoroscopic guidance.
Main Results:
- Successful device placement was achieved in all patients (1.5% complication rate).
- Procedure time was shorter for fluoroscopic guidance of Amplatzer versus ICE guidance (P = 0.023) and for Amplatzer versus Helex cases (P = 0.0004).
- No significant difference in procedure or fluoroscopy time for Helex cases comparing ICE versus fluoroscopic guidance; 93-95% closure success at 6 months.
Conclusions:
- Right atrial angiography and fluoroscopic-only guidance offer an efficient alternative to ICE for PFO closure with Helex and Amplatzer devices.
- While Amplatzer procedures were significantly shorter than Helex, Helex procedure and fluoroscopy times were comparable between ICE and fluoroscopic guidance.
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.
