Amplatzer 或 Figulla Flex II 封堵器：经导管卵圆孔未闭封堵术后结局的对比研究。

Amplatzer or Figulla Flex II Occluder: a comparative study of outcomes after transcatheter patent foramen ovale closure.

机构信息

The Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland.

The Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland. Email:

出版信息

J Invasive Cardiol. 2024 Apr;36(4). doi: 10.25270/jic/23.00291.

DOI:10.25270/jic/23.00291

PMID:38412438

Abstract

OBJECTIVES

Percutaneous closure of a patent foramen ovale (PFO) for the prevention of recurrent paradoxical thromboembolic events has been shown to be safe and effective in randomized controlled trials. However, it remains uncertain if differences in the structure and design of the occluder devices impact the outcomes. The aim of this study was to compare results of percutaneous PFO closure using 2 widely used double-disc occluders.

METHODS

Consecutive patients who underwent percutaneous PFO closure with the Abbott Amplatzer occluder (APO) or the Occlutech Figulla-Flex-II occluder (OPO) at the Heart Center Lucerne between February 2017 and December 2022 were included in a registry. The primary endpoint was effective closure of the PFO, defined as a residual shunt grade 0 or 1, assessed by contrast echocardiogram at 6-month follow-up. Secondary endpoints included procedural efficacy/safety and major adverse cardiovascular events during the hospital stay and at 6-month follow-up.

RESULTS

One hundred ninety-three consecutive patients (mean age 51.7 ± 12.5 years; 39% women; Risk of Paradoxical Embolism (RoPE) score = 7, IQR = 6-8) underwent percutaneous PFO closure with the APO (120 patients, 62.2%) or the OPO (73 patients, 37.8%). Main indications for closure were crypotogenic stroke in 168 patients (87.1%) and peripheral embolism in 13 patients (6.7%). At baseline, right-to-left shunt (RLS) greater than or equal to grade 2 was present in 189 patients (97.9%). Immediate procedural success was 99.5%. In 1 patient, an air embolism occurred during positioning of the APO occluder with transient chest pain and electrocardiogram changes, but without further sequelae to the patient. At 6-month follow-up, effective closure was achieved in 185 patients (95.8%; APO: 96.6% vs OPO: 94.5%, P = .30). Rates of atrial fibrillation and recurrent thromboembolic events were 4.2 and 0.5%, respectively.

CONCLUSIONS

PFO closure is safe and effective when performed with either the self-expanding Abbott Amplatzer or Occlutech Figulla Flex II PFO occluder.

摘要

目的

经皮卵圆孔未闭（PFO）封堵术预防复发性矛盾性血栓栓塞事件已在随机对照试验中被证明是安全有效的。然而，封堵器装置的结构和设计差异是否会影响结果仍不确定。本研究旨在比较使用两种广泛应用的双盘封堵器行经皮 PFO 封堵的结果。

方法

2017 年 2 月至 2022 年 12 月期间，在卢塞恩心脏中心接受雅培 Amplatzer 封堵器（APO）或 Occlutech Figulla-Flex-II 封堵器（OPO）行经皮 PFO 封堵的连续患者被纳入登记。主要终点是通过 6 个月随访时的对比超声心动图评估的有效封堵 PFO，定义为残余分流程度 0 或 1 级。次要终点包括手术疗效/安全性以及住院期间和 6 个月随访时的主要不良心血管事件。

结果

193 例连续患者（平均年龄 51.7±12.5 岁；39%为女性；风险悖论栓塞（RoPE）评分=7，IQR=6-8）接受 APO（120 例，62.2%）或 OPO（73 例，37.8%）行 PFO 封堵。封堵的主要适应证为 168 例隐匿性卒中（87.1%）和 13 例外周栓塞（6.7%）。基线时，189 例（97.9%）患者存在右向左分流（RLS）≥2 级。即刻手术成功率为 99.5%。1 例患者在放置 APO 封堵器时发生空气栓塞，伴有短暂胸痛和心电图改变，但患者无进一步后遗症。6 个月随访时，185 例（95.8%；APO：96.6% vs OPO：94.5%，P=.30）达到有效封堵。心房颤动和复发性血栓栓塞事件的发生率分别为 4.2%和 0.5%。