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

Achille Gaspardone, Federico De Marco, Gregory A. Sgueglia, Antonella De Santis, Maria Iamele, Emanuela D'Ascoli, Maurizio Tusa, Anca Irina Corciu, Michael Mullen, Anthony Nobles, Mario Carminati, Francesco Bedogni

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)e272-e279
JournalEuroIntervention
Volume14
Issue number3
DOIs
Publication statusPublished - Jun 1 2018

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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