| Affiliation: | 1. Department of Cardiology, Amsterdam University Medical Centres, Amsterdam Cardiovascular Sciences, University of Amsterdam, Amsterdam, The Netherlands;2. Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands 1st Chair and Department of Cardiology, Medical University of Warsaw, Warsaw, Poland;3. Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands;4. Department of Cardiology, Cantonal Hospital Baselland, Liestal, Switzerland |
| Abstract: | Background 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. Aims We assessed the efficacy of the NobleStitch EL and sought to identify patient-related anatomical features associated with successful suture-based closure. Methods 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. Results 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 mm3 (IQR 286–894) versus 985 mm3 (IQR 572–1550) (p = 0.016). Conclusion 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. |
