Węglarz Przemysław, Węgiel Michał, Konarska-Kuszewska Ewa, Kuszewski Piotr, Staszel Michał, Dziewierz Artur, Rakowski Tomasz
Center for Invasive Cardiology, Electrotherapy and Angiology, Oświęcim, Poland.
Department of Cardiology, Tytus Chałubiński Hospital, Zakopane, Poland.
Postepy Kardiol Interwencyjnej. 2023 Sep;19(3):257-261. doi: 10.5114/aic.2023.131479. Epub 2023 Sep 27.
Nowadays, percutaneous closure of patent foramen ovale (PFO) in patients after cryptogenic stroke is becoming a dominating strategy. The most commonly used and investigated device is the Amplatzer occluder. However, several other devices have been designed for transcatheter closure of PFO, which are not so well examined.
To assess the effectiveness and safety of PFO closure with the Lifetech CERA occluder.
A prospective, single-arm registry of patients with PFO treated with CERA occluder (Lifetech Scientific, Shenzhen, China) implantation was conducted. We assessed peri-procedural and 12-month follow-up. Patients were screened for the residual shunt in transcranial Doppler/transesophageal echocardiography.
Ninety-six patients entered the registry. Most patients were women (76%) and the analyzed group was relatively young (mean age of 42.3 ±13.6 years). Before closure, most patients had a large shunt through the PFO. Procedures of PFO closure were performed under TEE guidance. All procedures were made under local anesthesia and all patients had the PFO successfully closed. No device-related complications were reported in the peri-procedural period or during follow-up. No recurrent neurological ischemic events were reported at 12 months. During follow-up we observed a 9% rate of residual shunts, which were mostly small.
The study confirmed excellent immediate and 12-month results of CERA occluder implantation in patients with PFO.
如今，对不明原因卒中患者行经皮卵圆孔未闭（PFO）封堵术正成为一种主流策略。最常用且研究最多的器械是Amplatzer封堵器。然而，还有其他几种器械被设计用于经导管封堵PFO，但对它们的研究并不充分。
评估使用深圳先健科技公司的CERA封堵器封堵PFO的有效性和安全性。
对采用CERA封堵器（深圳先健科技公司，中国深圳）植入治疗的PFO患者进行了一项前瞻性单臂注册研究。我们评估了围手术期情况及12个月的随访结果。通过经颅多普勒/经食管超声心动图对患者进行残余分流筛查。
96例患者进入该注册研究。大多数患者为女性（76%），分析组相对年轻（平均年龄42.3±13.6岁）。封堵前，大多数患者通过PFO有大量分流。PFO封堵手术在经食管超声心动图（TEE）引导下进行。所有手术均在局部麻醉下完成，所有患者的PFO均成功封堵。围手术期及随访期间均未报告与器械相关的并发症。12个月时未报告复发性神经缺血事件。随访期间，我们观察到残余分流率为9%，且大多为小分流。
该研究证实了CERA封堵器植入治疗PFO患者的即刻及12个月时的良好效果。
