Percutaneous atrial shunt closure and the risk of recurrent ischemic stroke: A register-based, nationwide cohort study.

OBJECTIVES: We aimed to investigate the risk of recurrent stroke in patients with transcatheter closure of an atrial shunt (ASCIos), compared to patients with an atrial shunt and cerebrovascular event (CVE) but only medical treated (ASMed), and to age- and sex-matched control individuals without a previous CVE. METHODS: In total, 663 ASCIos patients were identified in the Swedish National Patient Register from 1997 to 2016 and matched by using propensity score with 663 ASMed patients. Nine age- and sex-matched controls to ASCIos patients (n = 6,302) without a diagnosis of atrial shunt or history of CVE were randomly selected from the general population. RESULTS: At a mean follow-up of 6.5 years, the incidence rate of recurrent stroke in the ASCIos group vs ASMed group was 0.9 vs 0.7 per 100 patient-years. The hazard ratio of recurrent stroke in the ASCIos group compared with index stroke in the control group was 9.9 (95% confidence interval, 5.5-17.9). The incidence of atrial fibrillation was similar in the ASCIos and the ASMed group, however four times higher in the ASCIos than in the control group. CONCLUSIONS: Our large nationwide, register-based cohort study showed that, unexpectedly, the risk of recurrent stroke in the ASCos group was as high as in the ASMed group and almost ten times higher than the risk of an index stroke in matched controls without previous stroke.

Recurrent cerebrovascular events in patients after percutaneous closure of patent foramen ovale.

BACKGROUND: Recent published trials have shown the efficacy of transcatheter closure of patent foramen ovale (PFO) for preventing recurrent cryptogenic cerebrovascular events. However, the risk of recurrent cerebrovascular events (rCVEs) is up to 5.7%, and the etiology is unclear. OBJECTIVE: This study aimed to investigate the risk factors for rCVEs after closure of PFO during long-term follow-up. METHODS: In our center, 282 consecutive patients underwent PFO closure because of a cryptogenic cerebrovascular event between 2006 and 2014. Their Risk of Paradoxical Embolism (RoPE) score was calculated retrospectively. We followed up with the patients by telephone, using hospital records to identify those who suffered from rCVEs. Patients with rCVEs were matched with two control patients of the same sex and RoPE score without rCVEs who underwent PFO closure at approximately the same time. The patients with rCVEs and controls participated in a clinical examination, including contrast transthoracic echocardiography (TTE) and Holter electrocardiography, to investigate the possible cause of rCVEs compared with controls. RESULTS: Fourteen (5%) out of the 282 consecutive patients who underwent PFO closure suffered from rCVEs during a mean follow-up of 8.4 years (1.7 rCVEs per 100 patient-years). The median RoPE score of the patients was 7. Recurrent CVE occurred in 3.2 patients per 100 patient-years in patients with residual shunting compared with 0.8 patients per 100 patient-years in those without residual shunt. These patients were on antiplatelet treatment or without any effective anticoagulant treatment at the time rCVE occurred. The risk ratio of rCVEs in patients with residual shunting was 2.9-times higher than in patients without residual shunting (95% CI: 1.4-6.1) at follow-up visit. Four patients who had the BioSTAR device implanted suffered from an rCVE despite lack of residual shunting. CONCLUSIONS: This study indicates that residual shunting and choice of the device may be the major reasons for rCVEs.

Closure of persistent foramen ovale with the BioSTAR biodegradable PFO closure device: feasibility and long-term outcome.

OBJECTIVES: The presence of a patent foramen ovale (PFO) has been associated with recurrent cryptogenic cerebrovascular event (CVE). The BioSTAR is a partly biodegradeable atrial septal repair implant. We investigated the feasibility and efficacy of the BioSTAR PFO-occluder. DESIGN: From October 2007 to December 2008, 59 consecutive patients underwent PFO closure at our institution with a history of at least one cryptogenic CVE defined by a neurologist. During the study period, all patients, who fulfilled our institutional criteria for PFO closure, were included. No patients were lost to follow-up. RESULTS: Of the 59 patients treated, a BioSTAR device could be implanted in 30 and in 29 patients another device, almost exclusively an Amplatzer, had to be used. No serious complications were observed during implantation of either. Four of 30 patients suffered a recurrent CVE after BioSTAR implantation as compared to 2/29 in the comparison group. At long-term follow-up 29/30 patients in the BioSTAR group had complete closure of their PFO as compared to 23 of 29 in the comparison group. CONCLUSIONS: The BioSTAR device could be selected for use in small shunts less than 10 mm while the Amplatzer may be chosen for larger defects or more complicated anatomy.