Initial clinical experience with the Coherex FlatStent™ and FlatStent™ EF PFO closure system for in-tunnel PFO closure: Results of the Coherex-EU study

Horst Sievert, Nina Wunderlich, Isabel Reiffenstein, Peter Ruygrok, Eberhard Grube, Lutz Buellesfeld, Bernhard Meier, Joachim Schofer, David Muller, Randall K. Jones, Linda Gillam

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Objective The Coherex-EU Study evaluated the safety and efficacy of PFO closure utilizing novel in-tunnel PFO closure devices. Background Transcatheter closure of patent foramen ovale (PFO) followed the development of transcatheter closure devices designed to patch atrial septal defects (ASDs). The Coherex FlatStent™ and FlatStent™ EF devices were designed specifically to treat PFO anatomy. Methods A total of 95 patients with a clinical indication for PFO closure were enrolled in a prospective, multicenter first in man study at six clinical sites. Thirty-six patients received the first-generation FlatStent study device, and 57 patients received the second-generation FlatStent EF study device, which was modified based on clinical experience during the first 38 cases. Two patients enrolled to receive the first generation did not receive a device. Results At 6 months post-procedure, 45% (17/38) of the intention-to-treat (ITT) cohort receiving the first-generation FlatStent device had complete closure, 26% (10/38) had a trivial residual shunt, and 29% (11/38) had a moderate to large residual shunt. In the ITT cohort receiving the second-generation FlatStent EF device, 76% (43/57) had complete closure, 12% (7/57) had a trivial shunt, and 12% had a moderate to large shunt. Five major adverse events occurred, all without sequelae. Conclusion This initial study of the Coherex FlatStent/FlatStent EF PFO Closure System demonstrated the potential for in-tunnel PFO closure. The in-tunnel Coherex FlatStent EF may offer an alternative to septal repair devices for PFO closure in appropriately selected patients; however, further investigation will be necessary to establish the best use of this device.

Original languageEnglish (US)
Pages (from-to)1135-1143
Number of pages9
JournalCatheterization and Cardiovascular Interventions
Volume83
Issue number7
DOIs
StatePublished - Jun 1 2014
Externally publishedYes

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Patent Foramen Ovale
Equipment and Supplies
Atrial Heart Septal Defects
Anatomy
Safety

All Science Journal Classification (ASJC) codes

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Sievert, Horst ; Wunderlich, Nina ; Reiffenstein, Isabel ; Ruygrok, Peter ; Grube, Eberhard ; Buellesfeld, Lutz ; Meier, Bernhard ; Schofer, Joachim ; Muller, David ; Jones, Randall K. ; Gillam, Linda. / Initial clinical experience with the Coherex FlatStent™ and FlatStent™ EF PFO closure system for in-tunnel PFO closure : Results of the Coherex-EU study. In: Catheterization and Cardiovascular Interventions. 2014 ; Vol. 83, No. 7. pp. 1135-1143.
@article{27c353896a0e44228021c298d28b3891,
title = "Initial clinical experience with the Coherex FlatStent™ and FlatStent™ EF PFO closure system for in-tunnel PFO closure: Results of the Coherex-EU study",
abstract = "Objective The Coherex-EU Study evaluated the safety and efficacy of PFO closure utilizing novel in-tunnel PFO closure devices. Background Transcatheter closure of patent foramen ovale (PFO) followed the development of transcatheter closure devices designed to patch atrial septal defects (ASDs). The Coherex FlatStent™ and FlatStent™ EF devices were designed specifically to treat PFO anatomy. Methods A total of 95 patients with a clinical indication for PFO closure were enrolled in a prospective, multicenter first in man study at six clinical sites. Thirty-six patients received the first-generation FlatStent study device, and 57 patients received the second-generation FlatStent EF study device, which was modified based on clinical experience during the first 38 cases. Two patients enrolled to receive the first generation did not receive a device. Results At 6 months post-procedure, 45{\%} (17/38) of the intention-to-treat (ITT) cohort receiving the first-generation FlatStent device had complete closure, 26{\%} (10/38) had a trivial residual shunt, and 29{\%} (11/38) had a moderate to large residual shunt. In the ITT cohort receiving the second-generation FlatStent EF device, 76{\%} (43/57) had complete closure, 12{\%} (7/57) had a trivial shunt, and 12{\%} had a moderate to large shunt. Five major adverse events occurred, all without sequelae. Conclusion This initial study of the Coherex FlatStent/FlatStent EF PFO Closure System demonstrated the potential for in-tunnel PFO closure. The in-tunnel Coherex FlatStent EF may offer an alternative to septal repair devices for PFO closure in appropriately selected patients; however, further investigation will be necessary to establish the best use of this device.",
author = "Horst Sievert and Nina Wunderlich and Isabel Reiffenstein and Peter Ruygrok and Eberhard Grube and Lutz Buellesfeld and Bernhard Meier and Joachim Schofer and David Muller and Jones, {Randall K.} and Linda Gillam",
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Sievert, H, Wunderlich, N, Reiffenstein, I, Ruygrok, P, Grube, E, Buellesfeld, L, Meier, B, Schofer, J, Muller, D, Jones, RK & Gillam, L 2014, 'Initial clinical experience with the Coherex FlatStent™ and FlatStent™ EF PFO closure system for in-tunnel PFO closure: Results of the Coherex-EU study', Catheterization and Cardiovascular Interventions, vol. 83, no. 7, pp. 1135-1143. https://doi.org/10.1002/ccd.24565

Initial clinical experience with the Coherex FlatStent™ and FlatStent™ EF PFO closure system for in-tunnel PFO closure : Results of the Coherex-EU study. / Sievert, Horst; Wunderlich, Nina; Reiffenstein, Isabel; Ruygrok, Peter; Grube, Eberhard; Buellesfeld, Lutz; Meier, Bernhard; Schofer, Joachim; Muller, David; Jones, Randall K.; Gillam, Linda.

In: Catheterization and Cardiovascular Interventions, Vol. 83, No. 7, 01.06.2014, p. 1135-1143.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Initial clinical experience with the Coherex FlatStent™ and FlatStent™ EF PFO closure system for in-tunnel PFO closure

T2 - Results of the Coherex-EU study

AU - Sievert, Horst

AU - Wunderlich, Nina

AU - Reiffenstein, Isabel

AU - Ruygrok, Peter

AU - Grube, Eberhard

AU - Buellesfeld, Lutz

AU - Meier, Bernhard

AU - Schofer, Joachim

AU - Muller, David

AU - Jones, Randall K.

AU - Gillam, Linda

PY - 2014/6/1

Y1 - 2014/6/1

N2 - Objective The Coherex-EU Study evaluated the safety and efficacy of PFO closure utilizing novel in-tunnel PFO closure devices. Background Transcatheter closure of patent foramen ovale (PFO) followed the development of transcatheter closure devices designed to patch atrial septal defects (ASDs). The Coherex FlatStent™ and FlatStent™ EF devices were designed specifically to treat PFO anatomy. Methods A total of 95 patients with a clinical indication for PFO closure were enrolled in a prospective, multicenter first in man study at six clinical sites. Thirty-six patients received the first-generation FlatStent study device, and 57 patients received the second-generation FlatStent EF study device, which was modified based on clinical experience during the first 38 cases. Two patients enrolled to receive the first generation did not receive a device. Results At 6 months post-procedure, 45% (17/38) of the intention-to-treat (ITT) cohort receiving the first-generation FlatStent device had complete closure, 26% (10/38) had a trivial residual shunt, and 29% (11/38) had a moderate to large residual shunt. In the ITT cohort receiving the second-generation FlatStent EF device, 76% (43/57) had complete closure, 12% (7/57) had a trivial shunt, and 12% had a moderate to large shunt. Five major adverse events occurred, all without sequelae. Conclusion This initial study of the Coherex FlatStent/FlatStent EF PFO Closure System demonstrated the potential for in-tunnel PFO closure. The in-tunnel Coherex FlatStent EF may offer an alternative to septal repair devices for PFO closure in appropriately selected patients; however, further investigation will be necessary to establish the best use of this device.

AB - Objective The Coherex-EU Study evaluated the safety and efficacy of PFO closure utilizing novel in-tunnel PFO closure devices. Background Transcatheter closure of patent foramen ovale (PFO) followed the development of transcatheter closure devices designed to patch atrial septal defects (ASDs). The Coherex FlatStent™ and FlatStent™ EF devices were designed specifically to treat PFO anatomy. Methods A total of 95 patients with a clinical indication for PFO closure were enrolled in a prospective, multicenter first in man study at six clinical sites. Thirty-six patients received the first-generation FlatStent study device, and 57 patients received the second-generation FlatStent EF study device, which was modified based on clinical experience during the first 38 cases. Two patients enrolled to receive the first generation did not receive a device. Results At 6 months post-procedure, 45% (17/38) of the intention-to-treat (ITT) cohort receiving the first-generation FlatStent device had complete closure, 26% (10/38) had a trivial residual shunt, and 29% (11/38) had a moderate to large residual shunt. In the ITT cohort receiving the second-generation FlatStent EF device, 76% (43/57) had complete closure, 12% (7/57) had a trivial shunt, and 12% had a moderate to large shunt. Five major adverse events occurred, all without sequelae. Conclusion This initial study of the Coherex FlatStent/FlatStent EF PFO Closure System demonstrated the potential for in-tunnel PFO closure. The in-tunnel Coherex FlatStent EF may offer an alternative to septal repair devices for PFO closure in appropriately selected patients; however, further investigation will be necessary to establish the best use of this device.

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