Verolino Giuseppe, Calderone Dario, Gavazzoni Mara, Sala Davide, Sganzerla Paolo
Invasive Cardiology, Department of Cardiology, San Luca Hospital, IRCCS Istituto Auxologico Italiano, 20149 Milan, Italy.
Cardiology Unit, San Luca Hospital, IRCCS Istituto Auxologico Italiano, 20149 Milan, Italy.
J Clin Med. 2023 Sep 13;12(18):5936. doi: 10.3390/jcm12185936.
PFO (Patent foramen ovale) is a common defect that affects about 25% of the population. Although its presence is asymptomatic in the majority of the cases, the remaining part becomes overt with different symptoms, including cryptogenic stroke. PFO closure is currently a widely available procedure in complex anatomy, with Amplatzer PFO Occluder (APO) being the most commonly used tool. However, the performance of another device, the GORE Septal Occluder (GSO), has not been completely explored with regard to different septal anatomies.
From March 2012 to June 2020, 118 consecutive patients with an indication of PFO closure were treated using the GSO system, included in a prospective analysis, and followed. After 12 months, every patient underwent transcranial Doppler ultrasound to evaluate the effectiveness of treatment.
Of 111 patients evaluated, 107 showed effective PFO closure (96.4%), and 4 showed a residual shunt (3.6%). To better evaluate the device performance, the overall population was sorted into two clusters based on the echocardiographic characteristics. The main difference between groups was for PFO width (4.85 ± 1.8 vs. 2.9 ± 1 mm, < 0.001) and PFO tunnel length (12.6 ± 3.8 vs. 7.2 ± 2, < 0.001), allowing complex and simple anatomies to be identified, respectively. Regardless of the aforementioned cluster, the GSO performance required to reach an effective closure was independent of anatomy type and the chosen device size.
The GSO device showed a high closure rate at 1-year follow-up in patients, with at least one anatomical factor of complexity of PFO irrespective of the level of complexity itself.
卵圆孔未闭（PFO）是一种常见的缺陷，影响约25%的人群。虽然在大多数情况下其存在是无症状的，但其余部分会出现不同症状，包括不明原因的中风。目前，在复杂解剖结构中，PFO封堵是一种广泛应用的手术，Amplatzer PFO封堵器（APO）是最常用的工具。然而，另一种装置——戈尔房间隔封堵器（GSO）在不同房间隔解剖结构方面的性能尚未得到充分研究。
从2012年3月至2020年6月，连续118例有PFO封堵指征的患者使用GSO系统进行治疗，纳入前瞻性分析并随访。12个月后，每位患者接受经颅多普勒超声检查以评估治疗效果。
在111例接受评估的患者中，107例显示PFO有效封堵（96.4%），4例显示有残余分流（3.6%）。为了更好地评估该装置的性能，根据超声心动图特征将总体人群分为两组。两组之间主要的差异在于PFO宽度（4.85±1.8 vs.2.9±1mm，P<0.001）和PFO隧道长度（12.6±3.8 vs.7.2±2，P<0.001），分别可用于识别复杂和简单的解剖结构。无论上述分组情况如何，实现有效封堵所需的GSO性能与解剖结构类型和所选装置尺寸无关。
GSO装置在患者1年随访时显示出较高的封堵率，无论PFO复杂程度如何，至少存在一项PFO解剖复杂性因素。
