Simplified percutaneous closure of patent foramen ovale and atrial septal defect with use of plain fluoroscopy: Single operator experience in 110 consecutive patients

Abstract

Objective: Percutaneous closure of patent foramen ovale (PFO) and atrial septal defect (ASD) is routinely performed under general anesthesia or deep sedation and use of transesophageal (TEE) or intracardiac echocardiography, incurring longer duration and higher cost. We have used a simplified, economical, fluoroscopy-only guided approach with local anesthesia, and herein report our data.

Methods: The study includes 112 procedures in 110 patients with PFO (n=75) or ASD (n=35), with use of an Amplatzer occluder, heparin and prophylactic antibiotics. Balloon sizing guided ASD-device selection. All patients received aspirin and clopidogrel for 6 months, when they all underwent TEE.

Results: All PFOs but one (98.7%) and all (100%) ASDs were successfully closed with only one complication (local pseudoaneurysm). At the 6-month TEE, there was no residual shunt in PFO patients, but 2 ASD patients had residual shunts. During long-term (4.3-year) follow-up, no stroke recurrence in PFO patients, and no other problems were encountered. Among 54 patients suffering from migraine, symptom relief or resolution was reported by 45 (83.3%) patients.

Conclusion: Percutaneous placement of an Amplatzer occluder was safe and effective with use of local anesthesia and fluoroscopy alone. There were no recurrent strokes over >4 years. Migraine relief was reported by >80% of patients.

Keywords: Amplatzer occluder; Atrial septal defect; Cryptogenic stroke; Migraine; Paradoxic embolism; Patent foramen ovale; Percutaneous closure.

Fig. 1

PFO and ASD patient data are displayed in the left upper panel. Procedural and post-procedural data are presented in the right panel (numbers indicate percentages). A histogram of the sizes (mm) of the occluder device employed in each ASD patient is displayed in the left lower panel. ASD = atrial septal defect; IASA = interatrial septal aneurysm; PFO = patent foramen ovale.

Fig. 2

A typical PFO patient having cryptogenic stroke(s) with brain MRI detecting multiple cerebral infarcts (white spots in panel A), TEE disclosing an aneurysmal interatrial septum (arrow in panel B) with positive bubble study (multiple bubbles passing through the PFO from the right atrium to the left atrium: double arrows in panel B), undergoing percutaneous PFO closure with the double disk device (panel C) guided by plain fluoroscopy, having a TEE the next day and 6 months later to confirm good device positioning and sealing of the PFO (no bubbles passing through to the left atrium, panel D; arrows indicate the left and the right disk of the device). LA = left atrium; RA = right atrium.

Fig. 3

A typical ASD patient having the ASD closed for right heart hemodynamic overload with pre-procedural TEE delineating the rims of the defect (arrows in panel A) and documenting significant left-to-right shunting (mosaic in panel B), intra-procedural measurement of the defect with the balloon-stretching method (panel C), followed by device positioning (panel D) and deployment (panel E), and finally next-day and 6-month TEE confirming good positioning (panel E) and lack of residual shunting.

Fig. 4

Correlation between TEE and balloon measurements (left panel). Bland-Altman plot indicating the limits of agreement between TEE and balloon sizing (right panel). TEE = transesophageal echocardiography.