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Percutaneous patent foramen ovale closure using the Occlutech Figulla device: More than 1,300 patient-years of follow up.
Snijder, Roel J R; Renes, Laura E; Suttorp, Maarten Jan; Ten Berg, Jurrien M; Post, Martijn C.
Afiliação
  • Snijder RJR; Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands.
  • Renes LE; Department of Emergency Medicine, St. Antonius Hospital, Nieuwegein, The Netherlands.
  • Suttorp MJ; Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands.
  • Ten Berg JM; Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands.
  • Post MC; Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands.
Catheter Cardiovasc Interv ; 93(6): 1080-1084, 2019 05 01.
Article em En | MEDLINE | ID: mdl-30461175
ABSTRACT

OBJECTIVE:

To evaluate the safety and efficacy of the Occlutech patent foramen ovale (PFO) device at long-term follow-up (FU).

BACKGROUND:

The Occlutech device has been proven safe and effective six-months after percutaneous PFO closure. We describe the safety and efficacy after more than 1,300 patient-years of FU.

METHODS:

All consecutive patients who underwent PFO closure between October 2008 and December 2015 were included. All complications were registered. Residual right-to-left shunt (RLS) was diagnosed using contrast transthoracic echocardiography and graded as minimal, moderate, or severe.

RESULTS:

In total, 250 patients (mean age 53.5 ± 10.7 years, 46.8% female) underwent percutaneous PFO closure using the Occlutech device. Mean FU was 5.9 ± 1.8 years, a total of 1,345 patient-years. Transient ischemic attack (TIA) or stroke was the main indication for closure (89.6%). Implantation was successful in 100%, no major complications occurred. Minor complications were inguinal hematoma in 16 patients (6.4%), pericardial effusion without the need for intervention in one patient (0.4%) and a supraventricular tachycardia in one patient (0.4%). A moderate or large shunt at one-year follow up was present in 5.9%. A cerebrovascular vascular event occurred in 2.0% at 1-year FU (four TIA, one stroke) and in 7.4% at long-term FU (nine TIA, eight stroke). The total cerebrovascular event rate (TIA and CVA) was 0.02% per patient-year of FU, with a stroke rate of 0.01%.

CONCLUSION:

The Occlutech device appears to be safe at long-term FU with a very low annual cerebrovascular event rate and a low moderate to large shunt rate at 1-year FU.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Cateterismo Cardíaco / Forame Oval Patente Tipo de estudo: Etiology_studies / Observational_studies / Risk_factors_studies Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2019 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Cateterismo Cardíaco / Forame Oval Patente Tipo de estudo: Etiology_studies / Observational_studies / Risk_factors_studies Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2019 Tipo de documento: Article