U.O.C. di Cardiologia, Ospedale S. Eugenio, ASL Roma 2, Rome, Italy.
EuroIntervention. 2018 Jun 8;14(3):e272-e279. doi: 10.4244/EIJ-D-18-00023.
The aim of this study was to assess the efficacy of a novel percutaneous "deviceless" suture-mediated patent foramen ovale (PFO) closure system.
Between June 2016 and October 2017, a prospective registry aimed at assessing the safety and efficacy of the NobleStitch EL (HeartStitch, Fountain Valley, CA, USA) suture-based PFO closure system was carried out at 12 sites in Italy. Among 200 consecutive patients evaluated, 192 were considered suitable for suture-mediated PFO closure (44±13 years, 114 female). Suture of the septum with the NobleStitch EL system was carried out successfully in 186 (96%) patients. Median fluoroscopy time was 16.1 (13.0-22.5) minutes and contrast volume 200 (150-270) ml. At 206±130 days follow-up, contrast transthoracic echocardiography with the Valsalva manoeuvre revealed no RLS (grade 0) in 139 (75%) patients and RLS grade ≤1 in 166 (89%) patients. Significant RLS was present in 20 (11%) patients (grade 2 and 3 in 11 and nine patients, respectively). There were no device-related complications.
The early results of this first Italian registry indicate that the suture-mediated "deviceless" closure of PFO is feasible in the majority of septal anatomies, and provides an effective closure of PFO comparable to traditional devices with a good safety profile at medium-term follow-up.
本研究旨在评估一种新型经皮“无器械”缝合介导的卵圆孔未闭（PFO）封堵系统的疗效。
2016 年 6 月至 2017 年 10 月，在意大利的 12 个地点进行了一项前瞻性注册研究，旨在评估 NobleStitch EL（HeartStitch，Fountain Valley，CA，USA）缝线式 PFO 封堵系统的安全性和疗效。在评估的 200 例连续患者中，192 例被认为适合缝线介导的 PFO 封堵（44±13 岁，114 例女性）。186 例（96%）患者成功进行了 NobleStitch EL 系统的隔瓣缝合。中位数透视时间为 16.1（13.0-22.5）分钟，造影剂用量为 200（150-270）ml。在 206±130 天的随访中，200 例患者中有 139 例（75%）在经胸超声心动图中经valsalva 动作未见残余分流（RLS）（0 级），166 例（89%）患者 RLS 分级≤1。20 例（11%）患者存在明显的 RLS（分别为 2 级和 3 级）。无器械相关并发症。
这项意大利首例注册研究的早期结果表明，在大多数中隔解剖结构中，经皮“无器械”缝合介导的 PFO 封堵是可行的，并且与传统器械相比，在中期随访中具有良好的安全性和有效的 PFO 封堵效果。
