Introduction and objectives

At the end of 2017, three clinical trials demonstrated that, in selected patients, percutaneous closure of patent foramen ovale (PFO) after cryptogenic stroke (CS) reduces the risk of recurrence. Our aim was to determine the impact of these findings on routine clinical practice in a tertiary hospital.

Methods

Patients with CS and percutaneous closure of PFO during 2001–2020 were included. The clinical characteristics of the patient and the anatomical characteristics of the foramen were analyzed. Based on both, the closure indications were classified into three groups according to the latest European recommendations and were analyzed in two periods, before and after the publication date of the clinical trials.

Results

A total of 293 patients were included. The mean age was 49 ± 11 years, and 15% were older than 60 years. The median RoPE score was 6 [p25–75, 5–7] and 75% had complex anatomy (CA). After the publication of the studies, the frequency of CA and the mean age of the patients were significantly higher (89% vs. 69% p < 0.0005 and 51 ± 11 vs. 48 ± 11 years, p = 0.02, respectively), and the RoPE score, significantly lower (5 [5–7] versus 6 [5–7], p = 0.02). Inadequate closure indications were significantly reduced (8% vs. 18%, p = 0.02).

Conclusion

After the publication of clinical trials that have shown benefit of PFO closure after CS, the number of inappropriate indications for closure has decreased significantly in our institution, with a higher percentage of CA, despite a clinical profile suggestive of lower causal probability of PFO.

中文翻译：

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隐源性卒中后经皮闭合卵圆孔未闭的最新证据对日常临床实践的影响：单中心经验

简介和目标

2017 年底，三项临床试验表明，在选定的患者中，隐源性卒中 (CS) 后经皮闭合卵圆孔未闭 (PFO) 可降低复发风险。我们的目的是确定这些发现对三级医院常规临床实践的影响。

方法

纳入 2001-2020 年期间发生 CS 和 PFO 经皮闭合的患者。分析了患者的临床特征和孔的解剖特征。基于两者，根据最新的欧洲建议将关闭适应症分为三组，并在临床试验公布日期之前和之后两个时期进行分析。

结果

共纳入 293 名患者。平均年龄为 49 ± 11 岁，15% 的人超过 60 岁。RoPE 评分中位数为 6 [p25–75, 5–7]，75% 的人具有复杂的解剖结构 (CA)。研究发表后，CA 的频率和患者的平均年龄显着升高（分别为 89% vs. 69% p  < 0.0005 和 51 ± 11 vs. 48 ± 11 岁，p  = 0.02），并且RoPE 得分显着降低（5 [5-7] 对 6 [5-7]，p  = 0.02）。关闭不充分的指征显着减少（8% 对 18%，p  = 0.02）。

结论

在发表显示 CS 后关闭 PFO 有益的临床试验后，尽管临床资料表明 PFO 的因果概率较低，但在我们的机构中​​，关闭不适当适应症的数量显着减少，CA 的百分比更高。