Department of Cardiology, Amsterdam University Medical Centres, Amsterdam Cardiovascular Sciences, University of Amsterdam, Amsterdam, The Netherlands.
Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.
Catheter Cardiovasc Interv. 2023 Aug;102(2):273-280. doi: 10.1002/ccd.30691. Epub 2023 May 24.
NobleStitch EL is a novel suture-based technique used for patent foramen ovale (PFO) closure and an alternative to traditional double-disc devices without the need for antithrombotic therapy. However, successful closure rates are still unknown, and certain anatomies may be unfavorable for successful closure.
We assessed the efficacy of the NobleStitch EL and sought to identify patient-related anatomical features associated with successful suture-based closure.
We included 55 patients who underwent PFO closure with the NobleStitch EL in The Netherlands and Switzerland. Successful closure was defined as residual right-to-left shunt grade ≤1 with Valsalva maneuver at a cardiac ultrasound. Predefined possible anatomical determinants for effective closure included PFO length, atrial septal aneurysm, PFO entry- and exit diameter.
Successful closure was achieved in 33 patients (60%). The PFO length was shorter in patients with successful closure compared to unsuccessful closure with a median length of 9.6 mm (IQR 8.0-15.0) versus 13.3 mm (IQR 11.4-18.6) on preprocedural ultrasound (p = 0.041) and 9.9 mm (IQR 8.0-13.1) versus 12.5 mm (IQR 9.7-15.4) on angiography (p = 0.049). Additionally, the PFO exit diameter and PFO volume were smaller in patients with successful closure than unsuccessful closure, with a mean diameter of 7.0 ± 3.1 mm versus 9.5 ± 3.8 mm (p = 0.015) and a median volume of 381 mm (IQR 286-894) versus 985 mm (IQR 572-1550) (p = 0.016).
In our study cohort, the successful PFO closure rate using NobleStitch EL was relatively low (60%). With this alternative procedure, patients with a small PFO driven by a short PFO tunnel length and small exit diameter seem to be eligible for successful suture-based closure.
NobleStitch EL 是一种新型缝线技术，用于卵圆孔未闭（PFO）的封堵，是一种无需抗血栓治疗的替代传统双盘装置的方法。然而，成功的封堵率仍不清楚，某些解剖结构可能不利于成功封堵。
我们评估了 NobleStitch EL 的疗效，并试图确定与缝线封堵成功相关的患者相关解剖特征。
我们纳入了在荷兰和瑞士接受 PFO 封堵的 55 名患者。成功封堵定义为心脏超声瓦氏动作时残余右向左分流程度≤1 级。预先确定的有效封堵的可能解剖学决定因素包括 PFO 长度、房间隔瘤、PFO 入口和出口直径。
33 名患者（60%）成功封堵。与不成功封堵的患者相比，成功封堵的患者 PFO 长度更短，经术前超声测量的中位数分别为 9.6mm（IQR 8.0-15.0）和 13.3mm（IQR 11.4-18.6）（p=0.041），经血管造影测量的中位数分别为 9.9mm（IQR 8.0-13.1）和 12.5mm（IQR 9.7-15.4）（p=0.049）。此外，成功封堵的患者 PFO 出口直径和 PFO 体积小于不成功封堵的患者，平均直径分别为 7.0±3.1mm 和 9.5±3.8mm（p=0.015），中位数体积分别为 381mm（IQR 286-894）和 985mm（IQR 572-1550）（p=0.016）。
在我们的研究队列中，使用 NobleStitch EL 的 PFO 成功封堵率相对较低（60%）。对于这种替代方法，具有短 PFO 隧道长度和小出口直径驱动的小 PFO 的患者似乎有资格进行成功的缝线封堵。
