Cor Vasa 2009, 51(3):195-201 | DOI: 10.33678/cor.2009.045

Follow-up of patients after patent foramen ovale closure with the Amplatz occluder

Miroslav Hudec^1,*, Jaroslav Januška¹, Jiří Kopecký², Miloslav Dorda¹, Libor Škňouřil¹, Marian Branny¹

¹ Kardiologické oddělení, Nemocnice Podlesí a. s., Třinec

² Interní oddělení, Šumperská nemocnice a. s., Šumperk, Česká republika

Aim of study: To determine the efficacy of patent foramen ovale (PFO) closure, complications of the procedure, and patients' symptoms during short- to medium-term follow-up.

Method: Follow-up included all patients undergoing catheter-based PFO closure, or attempted PFO closure, in our heart center over the years 2003-2007. Closure was indicated in patients after cryptogenic stroke or those with migraine. The Amplatz occluder was used in all cases. The study parameters included procedure-related complications, thromboembolism recurrence, pre- and postprocedural headache, patients' self-reported assessment of their overall health status.

Results: Overall, PFO closure was indicated in 82 patients (with one female patient on two occasions); hence, a total of 83 procedures were performed. The mean age of the study group was 49 (21-72) years. Patent foramen ovale was closed in 69 patients (84%); the procedure could not be performed in eight patients because of unsuitable anatomy, i.e., small PFO (10%), and PFO was not verified by catheterization in five patients (6%). The mean follow-up period was 19.3 (4-57) months. Postprocedural arrhythmia, i.e., palpitations, supraventricular extrasystoles, short supraventricular tachycardia, occurred in 11 out of the 69 patients (16%) undergoing implantation. There was one case (among the 83 procedures) of toxic or allergic exanthema (1%), one patient developed a small postprocedural groin hematoma and reported right lower limb pain (1%); no other complications were reported. There were no late complications such as cardiac tamponade, stroke, occluder displacement, or endocarditis. Sixty-four patients provided self-reports of their overall health, with 12 (19%) feeling markedly better, 28 (44%) better, 23 (36%) same as before, and one (1%) worse. Preprocedural and postprocedural headache was experienced by 24 (37.5%) and eight (12.5%) patients, respectively. There was not a single case of recurrent stroke.

Conclusion: Our short- and mid-term results document good efficacy of the procedure in preventing another thromboembolic event. While reduction or cessation of migraine was reported by migraine patients, their numbers were small. Procedure is associated with a low risk of complications.

Keywords: Patent foramen ovale; Stroke; Migraine; Amplatz occluder

Published: March 1, 2009  Show citation