Novel percutaneous suture-mediated patent foramen ovale closure technique: early results of the NobleStitch EL Italian Registry

被引：45

作者：

Gaspardone, Achille ^{[1
]}

De Marco, Federico ^{[2
]}

Sgueglia, Gregory A. ^{[1
]}

De Santis, Antonella ^{[1
]}

Iamele, Maria ^{[1
]}

D'Ascoli, Emanuela ^{[1
]}

Tusa, Maurizio ^{[2
]}

Corciu, Anca Irina ^{[2
]}

Mullen, Michael ^{[3
]}

Nobles, Anthony ^{[4
]}

Carminati, Mario ^{[3
]}

Bedogni, Francesco ^{[2
]}

机构：

[1] ASL Roma 2, Osped S Eugenio, UOC Cardiol, Piazzale Umanesimo 10, I-00144 Rome, Italy

[2] IRCCS Policlin S Donato, Milan, Italy

[3] UCL, Heart Hosp, London, England

[4] Westsachs Hsch, Sch Biomed Engn, Zwickau, Germany

来源：

EUROINTERVENTION | 2018年 / 14卷 / 03期

关键词：

clinical research; ischaemic stroke; PFO closure; ATRIAL SEPTAL-DEFECT; CRYPTOGENIC STROKE; TRANSCATHETER CLOSURE; MEDICAL THERAPY; PARADOXICAL EMBOLISM; OCCLUDER; SAFETY; FIBRILLATION; FEASIBILITY; AMPLATZER;

D O I：

10.4244/EIJ-D-18-00023

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Aims: The aim of this study was to assess the efficacy of a novel percutaneous "deviceless" suture-mediated patent foramen ovale (PFO) closure system. Methods and results: 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. Conclusions: 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.

引用

页码：272 / 279

页数：8

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