Multidisciplinary assessment of PFO with substantial right‐to‐left shunting and medium‐term follow‐up after PFO device closure: A single‐center experience

OBJECTIVES: To describe the multidisciplinary assessment of patent foramen ovale (PFO) with substantial right‐to‐left shunting (RLS) and medium‐term follow‐up after PFO closure for stroke or transient ischemic attack (TIA). BACKGROUND: PFO closure is a therapeutic option to prevent recurrent ischemic event in patients with cryptogenic stroke and TIA. The apparent lack of benefit seen in previous studies was in part due to the inclusion of patients with alternate mechanisms of stroke/TIA. However, the long‐term follow‐up results of RESPECT trial confirmed that PFO closure could reduce the recurrence rate of stroke compared to medical therapy. The obvious difference between RESPECT and the other studies is that RESPECT recruited more relevant patients with substantial RLS. METHODS: From May 2013 to October 2015, all subjects diagnosed as cryptogenic stroke or TIA with substantial RLS who underwent PFO closure at our institution were included. All patients underwent multidisciplinary assessment to exclude stroke/TIA with definite etiology. Baseline characteristics, clinical manifestations, procedural, and follow‐up data were reviewed. RESULTS: A total of 219 consecutive patients with substantial RLS undergoing PFO closure were identified. There were no procedure‐related deaths, strokes, or TIA. Mean follow‐up was 2.0 ± 0.7 years. Early residual shunting was visible in 9 patients (4.1%); however, during follow‐up, only 3 patients (1.4%) had residual RLS detected by contrast transthoracic echocardiography (cTTE). The annual risk of recurrent ischemic stroke or TIA was 0.457%. CONCLUSIONS: PFO closure can be performed safely and effectively in patients with cryptogenic stroke or TIA. In selected patients with substantial RLS, following appropriate multidisciplinary assessment, excellent results with low incidence of recurrent events may be achieved.