Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve

Joachim Schofer; Antonio Colombo; Silvio Klugmann; Jean Fajadet; Federico DeMarco; Didier Tchetche; Francesco Maisano; Giuseppe Bruschi; Azeem Latib; Klaudija Bijuklic; Neil Weissman; Reginald Low; Martyn Thomas; Christopher Young; Simon Redwood; Michael Mullen; John Yap; Eberhard Grube; Georg Nickenig; Jan-Malte Sinning; Karl Eugen Hauptmann; Ivar Friedrich; Michael Lauterbach; Michael Schmoeckel; Charles Davidson; Thierry Lefevre

doi:10.1016/j.jacc.2013.10.013

Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve

Joachim Schofer^*, Antonio Colombo, Silvio Klugmann, Jean Fajadet, Federico DeMarco, Didier Tchetche, Francesco Maisano, Giuseppe Bruschi, Azeem Latib, Klaudija Bijuklic, Neil Weissman, Reginald Low, Martyn Thomas, Christopher Young, Simon Redwood, Michael Mullen, John Yap, Eberhard Grube, Georg Nickenig, Jan-Malte SinningKarl Eugen Hauptmann, Ivar Friedrich, Michael Lauterbach, Michael Schmoeckel, Charles Davidson, Thierry Lefevre

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

137 Citations (Scopus)

Abstract

Objectives The study sought a prospective multicenter nonrandomized evaluation of the Direct Flow Medical ( DFM) system for the treatment of severe aortic stenosis.

Background The DFM transcatheter aortic valve system is a nonmetallic design with a pressurized support structure that allows precise positioning, retrieval, and assessment of valve performance prior to permanent implantation.

Methods One hundred high surgical risk patients with severe aortic stenosis were evaluated for the primary endpoint. There were 75 patients in the group evaluable for the secondary endpoints and 25 in the pre-specified roll-in training phase. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events adjudicated by clinical event committee and classified according to Valve Academic Research Consortium (VARC) criteria.

Results There was 99% freedom from all cause mortality at 30 days (primary endpoint). VARC criteria defined 30 day combined freedom from patient safety event rate was 91% and overall device success was 93%. The postimplantation echocardiography results demonstrated mild or no aortic regurgitation in 99% (73 of 74) with a mean gradient of 12.6 +/- 7.1 mm Hg ( n 72) and effective orifice area of 1.50 +/- 0.56 cm(2) and New York Heart Association functional class was I or II in 92% of cases.

Conclusions The present study demonstrates the safety and efficacy of the DFM system in surgical high risk patients with severe aortic stenosis and complex anatomy aortic regurgitation was less than moderate in 99% of patients. (c) 2014 by the American College of Cardiology Foundation

Original language	English
Pages (from-to)	763-768
Number of pages	6
Journal	Journal of the American College of Cardiology
Volume	63
Issue number	8
DOIs	https://doi.org/10.1016/j.jacc.2013.10.013
Publication status	Published - 4 Mar 2014

Keywords

aortic regurgitation
aortic valve stenosis
TAVR
transfemoral
HIGH-RISK PATIENTS
IMPLANTATION
REPLACEMENT
DEFINITIONS
OUTCOMES

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Schofer, J., Colombo, A., Klugmann, S., Fajadet, J., DeMarco, F., Tchetche, D., Maisano, F., Bruschi, G., Latib, A., Bijuklic, K., Weissman, N., Low, R., Thomas, M., Young, C., Redwood, S., Mullen, M., Yap, J., Grube, E., Nickenig, G., ... Lefevre, T. (2014). Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve. Journal of the American College of Cardiology, 63(8), 763-768. https://doi.org/10.1016/j.jacc.2013.10.013

@article{e3cc5fc0810b4607974b99bd5f1c5ae5,

title = "Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve",

abstract = "Objectives The study sought a prospective multicenter nonrandomized evaluation of the Direct Flow Medical ( DFM) system for the treatment of severe aortic stenosis.Background The DFM transcatheter aortic valve system is a nonmetallic design with a pressurized support structure that allows precise positioning, retrieval, and assessment of valve performance prior to permanent implantation.Methods One hundred high surgical risk patients with severe aortic stenosis were evaluated for the primary endpoint. There were 75 patients in the group evaluable for the secondary endpoints and 25 in the pre-specified roll-in training phase. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events adjudicated by clinical event committee and classified according to Valve Academic Research Consortium (VARC) criteria.Results There was 99% freedom from all cause mortality at 30 days (primary endpoint). VARC criteria defined 30 day combined freedom from patient safety event rate was 91% and overall device success was 93%. The postimplantation echocardiography results demonstrated mild or no aortic regurgitation in 99% (73 of 74) with a mean gradient of 12.6 +/- 7.1 mm Hg ( n 72) and effective orifice area of 1.50 +/- 0.56 cm(2) and New York Heart Association functional class was I or II in 92% of cases.Conclusions The present study demonstrates the safety and efficacy of the DFM system in surgical high risk patients with severe aortic stenosis and complex anatomy aortic regurgitation was less than moderate in 99% of patients. (c) 2014 by the American College of Cardiology Foundation",

keywords = "aortic regurgitation, aortic valve stenosis, TAVR, transfemoral, HIGH-RISK PATIENTS, IMPLANTATION, REPLACEMENT, DEFINITIONS, OUTCOMES",

author = "Joachim Schofer and Antonio Colombo and Silvio Klugmann and Jean Fajadet and Federico DeMarco and Didier Tchetche and Francesco Maisano and Giuseppe Bruschi and Azeem Latib and Klaudija Bijuklic and Neil Weissman and Reginald Low and Martyn Thomas and Christopher Young and Simon Redwood and Michael Mullen and John Yap and Eberhard Grube and Georg Nickenig and Jan-Malte Sinning and Hauptmann, {Karl Eugen} and Ivar Friedrich and Michael Lauterbach and Michael Schmoeckel and Charles Davidson and Thierry Lefevre",

year = "2014",

month = mar,

day = "4",

doi = "10.1016/j.jacc.2013.10.013",

language = "English",

volume = "63",

pages = "763--768",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

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Schofer, J, Colombo, A, Klugmann, S, Fajadet, J, DeMarco, F, Tchetche, D, Maisano, F, Bruschi, G, Latib, A, Bijuklic, K, Weissman, N, Low, R, Thomas, M , Young, C, Redwood, S, Mullen, M, Yap, J, Grube, E, Nickenig, G, Sinning, J-M, Hauptmann, KE, Friedrich, I, Lauterbach, M, Schmoeckel, M, Davidson, C & Lefevre, T 2014, 'Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve', Journal of the American College of Cardiology, vol. 63, no. 8, pp. 763-768. https://doi.org/10.1016/j.jacc.2013.10.013

TY - JOUR

T1 - Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve

AU - Schofer, Joachim

AU - Colombo, Antonio

AU - Klugmann, Silvio

AU - Fajadet, Jean

AU - DeMarco, Federico

AU - Tchetche, Didier

AU - Maisano, Francesco

AU - Bruschi, Giuseppe

AU - Latib, Azeem

AU - Bijuklic, Klaudija

AU - Weissman, Neil

AU - Low, Reginald

AU - Thomas, Martyn

AU - Young, Christopher

AU - Redwood, Simon

AU - Mullen, Michael

AU - Yap, John

AU - Grube, Eberhard

AU - Nickenig, Georg

AU - Sinning, Jan-Malte

AU - Hauptmann, Karl Eugen

AU - Friedrich, Ivar

AU - Lauterbach, Michael

AU - Schmoeckel, Michael

AU - Davidson, Charles

AU - Lefevre, Thierry

PY - 2014/3/4

Y1 - 2014/3/4

N2 - Objectives The study sought a prospective multicenter nonrandomized evaluation of the Direct Flow Medical ( DFM) system for the treatment of severe aortic stenosis.Background The DFM transcatheter aortic valve system is a nonmetallic design with a pressurized support structure that allows precise positioning, retrieval, and assessment of valve performance prior to permanent implantation.Methods One hundred high surgical risk patients with severe aortic stenosis were evaluated for the primary endpoint. There were 75 patients in the group evaluable for the secondary endpoints and 25 in the pre-specified roll-in training phase. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events adjudicated by clinical event committee and classified according to Valve Academic Research Consortium (VARC) criteria.Results There was 99% freedom from all cause mortality at 30 days (primary endpoint). VARC criteria defined 30 day combined freedom from patient safety event rate was 91% and overall device success was 93%. The postimplantation echocardiography results demonstrated mild or no aortic regurgitation in 99% (73 of 74) with a mean gradient of 12.6 +/- 7.1 mm Hg ( n 72) and effective orifice area of 1.50 +/- 0.56 cm(2) and New York Heart Association functional class was I or II in 92% of cases.Conclusions The present study demonstrates the safety and efficacy of the DFM system in surgical high risk patients with severe aortic stenosis and complex anatomy aortic regurgitation was less than moderate in 99% of patients. (c) 2014 by the American College of Cardiology Foundation

AB - Objectives The study sought a prospective multicenter nonrandomized evaluation of the Direct Flow Medical ( DFM) system for the treatment of severe aortic stenosis.Background The DFM transcatheter aortic valve system is a nonmetallic design with a pressurized support structure that allows precise positioning, retrieval, and assessment of valve performance prior to permanent implantation.Methods One hundred high surgical risk patients with severe aortic stenosis were evaluated for the primary endpoint. There were 75 patients in the group evaluable for the secondary endpoints and 25 in the pre-specified roll-in training phase. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events adjudicated by clinical event committee and classified according to Valve Academic Research Consortium (VARC) criteria.Results There was 99% freedom from all cause mortality at 30 days (primary endpoint). VARC criteria defined 30 day combined freedom from patient safety event rate was 91% and overall device success was 93%. The postimplantation echocardiography results demonstrated mild or no aortic regurgitation in 99% (73 of 74) with a mean gradient of 12.6 +/- 7.1 mm Hg ( n 72) and effective orifice area of 1.50 +/- 0.56 cm(2) and New York Heart Association functional class was I or II in 92% of cases.Conclusions The present study demonstrates the safety and efficacy of the DFM system in surgical high risk patients with severe aortic stenosis and complex anatomy aortic regurgitation was less than moderate in 99% of patients. (c) 2014 by the American College of Cardiology Foundation

KW - aortic regurgitation

KW - aortic valve stenosis

KW - TAVR

KW - transfemoral

KW - HIGH-RISK PATIENTS

KW - IMPLANTATION

KW - REPLACEMENT

KW - DEFINITIONS

KW - OUTCOMES

U2 - 10.1016/j.jacc.2013.10.013

DO - 10.1016/j.jacc.2013.10.013

M3 - Article

SN - 0735-1097

VL - 63

SP - 763

EP - 768

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 8

ER -

Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve

Abstract

Keywords

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