Direct Flow Medical valve.

Klaudija Bijuklic, Thilo Tübler, Reginald Low, Eberhard Grube, Joachim Schofer

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

To study the feasibility and safety of the non-metallic, repositionable and retrievable percutaneous Direct Flow Medical (DFM) aortic valve. The first-generation (22 Fr) DFM valve has been evaluated in a prospective non-randomised trial in 31 high-risk patients with severe symptomatic aortic stenosis. The procedural success rate was 71%, 30-day mortality 12.9%. Survival at three years was 60% and all patients had none/trace aortic regurgitation at three years. Based on the initial experience, an 18 Fr device has been developed with several important revisions to improve the efficacy and safety of the procedure. Currently, it is being evaluated in a multicentre non-randomised trial which will include 100 patients. The primary endpoint is freedom from all-cause mortality at 30 days. The 22 Fr DFM valve has been successfully assessed in a first-in-man feasibility and safety trial. Up to three-year follow-up sustained clinical benefit and haemodynamic performance was demonstrated with no or trace aortic regurgitation in all patients. The 18 Fr DFM valve is under investigation in an on-going trial.

Fingerprint

Aortic Valve Insufficiency
Safety
Mortality
Aortic Valve Stenosis
Feasibility Studies
Aortic Valve
Hemodynamics
Equipment and Supplies
Survival

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Direct Flow Medical valve. / Bijuklic, Klaudija; Tübler, Thilo; Low, Reginald; Grube, Eberhard; Schofer, Joachim.

In: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, Vol. 8 Suppl Q, 09.2012.

Research output: Contribution to journalArticle

@article{ec52ac8dde3642eb83149a47ac7d620d,
title = "Direct Flow Medical valve.",
abstract = "To study the feasibility and safety of the non-metallic, repositionable and retrievable percutaneous Direct Flow Medical (DFM) aortic valve. The first-generation (22 Fr) DFM valve has been evaluated in a prospective non-randomised trial in 31 high-risk patients with severe symptomatic aortic stenosis. The procedural success rate was 71{\%}, 30-day mortality 12.9{\%}. Survival at three years was 60{\%} and all patients had none/trace aortic regurgitation at three years. Based on the initial experience, an 18 Fr device has been developed with several important revisions to improve the efficacy and safety of the procedure. Currently, it is being evaluated in a multicentre non-randomised trial which will include 100 patients. The primary endpoint is freedom from all-cause mortality at 30 days. The 22 Fr DFM valve has been successfully assessed in a first-in-man feasibility and safety trial. Up to three-year follow-up sustained clinical benefit and haemodynamic performance was demonstrated with no or trace aortic regurgitation in all patients. The 18 Fr DFM valve is under investigation in an on-going trial.",
author = "Klaudija Bijuklic and Thilo T{\"u}bler and Reginald Low and Eberhard Grube and Joachim Schofer",
year = "2012",
month = "9",
language = "English (US)",
volume = "8 Suppl Q",
journal = "EuroIntervention",
issn = "1774-024X",
publisher = "EuroPCR",

}

TY - JOUR

T1 - Direct Flow Medical valve.

AU - Bijuklic, Klaudija

AU - Tübler, Thilo

AU - Low, Reginald

AU - Grube, Eberhard

AU - Schofer, Joachim

PY - 2012/9

Y1 - 2012/9

N2 - To study the feasibility and safety of the non-metallic, repositionable and retrievable percutaneous Direct Flow Medical (DFM) aortic valve. The first-generation (22 Fr) DFM valve has been evaluated in a prospective non-randomised trial in 31 high-risk patients with severe symptomatic aortic stenosis. The procedural success rate was 71%, 30-day mortality 12.9%. Survival at three years was 60% and all patients had none/trace aortic regurgitation at three years. Based on the initial experience, an 18 Fr device has been developed with several important revisions to improve the efficacy and safety of the procedure. Currently, it is being evaluated in a multicentre non-randomised trial which will include 100 patients. The primary endpoint is freedom from all-cause mortality at 30 days. The 22 Fr DFM valve has been successfully assessed in a first-in-man feasibility and safety trial. Up to three-year follow-up sustained clinical benefit and haemodynamic performance was demonstrated with no or trace aortic regurgitation in all patients. The 18 Fr DFM valve is under investigation in an on-going trial.

AB - To study the feasibility and safety of the non-metallic, repositionable and retrievable percutaneous Direct Flow Medical (DFM) aortic valve. The first-generation (22 Fr) DFM valve has been evaluated in a prospective non-randomised trial in 31 high-risk patients with severe symptomatic aortic stenosis. The procedural success rate was 71%, 30-day mortality 12.9%. Survival at three years was 60% and all patients had none/trace aortic regurgitation at three years. Based on the initial experience, an 18 Fr device has been developed with several important revisions to improve the efficacy and safety of the procedure. Currently, it is being evaluated in a multicentre non-randomised trial which will include 100 patients. The primary endpoint is freedom from all-cause mortality at 30 days. The 22 Fr DFM valve has been successfully assessed in a first-in-man feasibility and safety trial. Up to three-year follow-up sustained clinical benefit and haemodynamic performance was demonstrated with no or trace aortic regurgitation in all patients. The 18 Fr DFM valve is under investigation in an on-going trial.

UR - http://www.scopus.com/inward/record.url?scp=84877326502&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84877326502&partnerID=8YFLogxK

M3 - Article

VL - 8 Suppl Q

JO - EuroIntervention

JF - EuroIntervention

SN - 1774-024X

ER -