Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve System 12-Month Outcomes of the Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients with Severe Aortic Stenosis (DISCOVER) Study

Thierry Lefèvre, Antonio Colombo, Didier Tchétché, Azeem Latib, Silvio Klugmann, Jean Fajadet, Federico De Marco, Francesco Maisano, Giuseppe Bruschi, Klaudija Bijuklic, Stefano Nava, Neil Weissman, Reginald Low, Martyn Thomas, Christopher Young, Simon Redwood, Michael Mullen, John Yap, Eberhard Grube, Georg NickenigJan Malte Sinning, Karl Eugen Hauptmann, Ivar Friedrich, Michael Lauterbach, Michael Schmoeckel, Charles Davidson, Joachim Schofer

Research output: Contribution to journalReview article

27 Citations (Scopus)

Abstract

Objectives The aim of this study was to assess the 1-year outcome after transcatheter aortic valve replacement (TAVR) of the Direct Flow Medical (DFM) valve in patients with severe symptomatic aortic stenosis who were contraindicated or high risk for surgery. Background The DFM transcatheter heart valve is a new-generation, nonmetallic aortic valve with a pressurized support structure and conformable double-ring annular sealing delivered through an 18-F sheath. The device allows repositioning, retrieval, and assessment of valve performance before permanent implantation. Methods A prospective multicenter European registry was set up to determine the safety and performance of the valve in 100 consecutive patients (10 centers). Echocardiographic and angiographic data were evaluated by an independent core laboratory, and adverse events were adjudicated by a clinical events committee using Valve Academic Research Consortium criteria. Results Patients were 83.1 ± 5.9 years of age and had a logistic EuroSCORE of 22.5 ± 11.3% and a Society of Thoracic Surgeons score of 9.7 ± 8.7%. Correct valve positioning was obtained in 99% of cases with a combined 30-day safety endpoint at 10%, including major stroke in 5.0%, major vascular complications in 2.0%, and death in 1%. At 12 months, 95% of patients were in New York Heart Association functional class I or II. Freedom from any death was 90%, and freedom from any death or major stroke was 85%. Echocardiography demonstrated none/trace to mild aortic regurgitation in 100% of patients and an unchanged mean aortic gradient of 12.2 ± 6.6 mm Hg and effective orifice area of 1.6 ± 0.4 cm2. Conclusions At 1 year, the DFM transcatheter heart valve had durable hemodynamics. This study demonstrates that the low rate of early complications and the low risk of significant aortic regurgitation translated into midterm clinical benefit.

Original languageEnglish (US)
Pages (from-to)68-75
Number of pages8
JournalJACC: Cardiovascular Interventions
Volume9
Issue number1
DOIs
StatePublished - Jan 11 2016

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Aortic Valve Stenosis
Aortic Valve
Aortic Valve Insufficiency
Heart Valves
Stroke
Therapeutics
Safety
Blood Vessels
Registries
Echocardiography
Hemodynamics
Equipment and Supplies
Research

Keywords

  • aortic stenosids
  • transcatheter aortic valve replacement
  • transfemoral transcatheter aortic valve replacement

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve System 12-Month Outcomes of the Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients with Severe Aortic Stenosis (DISCOVER) Study. / Lefèvre, Thierry; Colombo, Antonio; Tchétché, Didier; Latib, Azeem; Klugmann, Silvio; Fajadet, Jean; De Marco, Federico; Maisano, Francesco; Bruschi, Giuseppe; Bijuklic, Klaudija; Nava, Stefano; Weissman, Neil; Low, Reginald; Thomas, Martyn; Young, Christopher; Redwood, Simon; Mullen, Michael; Yap, John; Grube, Eberhard; Nickenig, Georg; Sinning, Jan Malte; Hauptmann, Karl Eugen; Friedrich, Ivar; Lauterbach, Michael; Schmoeckel, Michael; Davidson, Charles; Schofer, Joachim.

In: JACC: Cardiovascular Interventions, Vol. 9, No. 1, 11.01.2016, p. 68-75.

Research output: Contribution to journalReview article

Lefèvre, T, Colombo, A, Tchétché, D, Latib, A, Klugmann, S, Fajadet, J, De Marco, F, Maisano, F, Bruschi, G, Bijuklic, K, Nava, S, Weissman, N, Low, R, Thomas, M, Young, C, Redwood, S, Mullen, M, Yap, J, Grube, E, Nickenig, G, Sinning, JM, Hauptmann, KE, Friedrich, I, Lauterbach, M, Schmoeckel, M, Davidson, C & Schofer, J 2016, 'Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve System 12-Month Outcomes of the Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients with Severe Aortic Stenosis (DISCOVER) Study', JACC: Cardiovascular Interventions, vol. 9, no. 1, pp. 68-75. https://doi.org/10.1016/j.jcin.2015.09.027
Lefèvre, Thierry ; Colombo, Antonio ; Tchétché, Didier ; Latib, Azeem ; Klugmann, Silvio ; Fajadet, Jean ; De Marco, Federico ; Maisano, Francesco ; Bruschi, Giuseppe ; Bijuklic, Klaudija ; Nava, Stefano ; Weissman, Neil ; Low, Reginald ; Thomas, Martyn ; Young, Christopher ; Redwood, Simon ; Mullen, Michael ; Yap, John ; Grube, Eberhard ; Nickenig, Georg ; Sinning, Jan Malte ; Hauptmann, Karl Eugen ; Friedrich, Ivar ; Lauterbach, Michael ; Schmoeckel, Michael ; Davidson, Charles ; Schofer, Joachim. / Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve System 12-Month Outcomes of the Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients with Severe Aortic Stenosis (DISCOVER) Study. In: JACC: Cardiovascular Interventions. 2016 ; Vol. 9, No. 1. pp. 68-75.
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title = "Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve System 12-Month Outcomes of the Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients with Severe Aortic Stenosis (DISCOVER) Study",
abstract = "Objectives The aim of this study was to assess the 1-year outcome after transcatheter aortic valve replacement (TAVR) of the Direct Flow Medical (DFM) valve in patients with severe symptomatic aortic stenosis who were contraindicated or high risk for surgery. Background The DFM transcatheter heart valve is a new-generation, nonmetallic aortic valve with a pressurized support structure and conformable double-ring annular sealing delivered through an 18-F sheath. The device allows repositioning, retrieval, and assessment of valve performance before permanent implantation. Methods A prospective multicenter European registry was set up to determine the safety and performance of the valve in 100 consecutive patients (10 centers). Echocardiographic and angiographic data were evaluated by an independent core laboratory, and adverse events were adjudicated by a clinical events committee using Valve Academic Research Consortium criteria. Results Patients were 83.1 ± 5.9 years of age and had a logistic EuroSCORE of 22.5 ± 11.3{\%} and a Society of Thoracic Surgeons score of 9.7 ± 8.7{\%}. Correct valve positioning was obtained in 99{\%} of cases with a combined 30-day safety endpoint at 10{\%}, including major stroke in 5.0{\%}, major vascular complications in 2.0{\%}, and death in 1{\%}. At 12 months, 95{\%} of patients were in New York Heart Association functional class I or II. Freedom from any death was 90{\%}, and freedom from any death or major stroke was 85{\%}. Echocardiography demonstrated none/trace to mild aortic regurgitation in 100{\%} of patients and an unchanged mean aortic gradient of 12.2 ± 6.6 mm Hg and effective orifice area of 1.6 ± 0.4 cm2. Conclusions At 1 year, the DFM transcatheter heart valve had durable hemodynamics. This study demonstrates that the low rate of early complications and the low risk of significant aortic regurgitation translated into midterm clinical benefit.",
keywords = "aortic stenosids, transcatheter aortic valve replacement, transfemoral transcatheter aortic valve replacement",
author = "Thierry Lef{\`e}vre and Antonio Colombo and Didier Tch{\'e}tch{\'e} and Azeem Latib and Silvio Klugmann and Jean Fajadet and {De Marco}, Federico and Francesco Maisano and Giuseppe Bruschi and Klaudija Bijuklic and Stefano Nava 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 Sinning, {Jan Malte} and Hauptmann, {Karl Eugen} and Ivar Friedrich and Michael Lauterbach and Michael Schmoeckel and Charles Davidson and Joachim Schofer",
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T1 - Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve System 12-Month Outcomes of the Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients with Severe Aortic Stenosis (DISCOVER) Study

AU - Lefèvre, Thierry

AU - Colombo, Antonio

AU - Tchétché, Didier

AU - Latib, Azeem

AU - Klugmann, Silvio

AU - Fajadet, Jean

AU - De Marco, Federico

AU - Maisano, Francesco

AU - Bruschi, Giuseppe

AU - Bijuklic, Klaudija

AU - Nava, Stefano

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 - Schofer, Joachim

PY - 2016/1/11

Y1 - 2016/1/11

N2 - Objectives The aim of this study was to assess the 1-year outcome after transcatheter aortic valve replacement (TAVR) of the Direct Flow Medical (DFM) valve in patients with severe symptomatic aortic stenosis who were contraindicated or high risk for surgery. Background The DFM transcatheter heart valve is a new-generation, nonmetallic aortic valve with a pressurized support structure and conformable double-ring annular sealing delivered through an 18-F sheath. The device allows repositioning, retrieval, and assessment of valve performance before permanent implantation. Methods A prospective multicenter European registry was set up to determine the safety and performance of the valve in 100 consecutive patients (10 centers). Echocardiographic and angiographic data were evaluated by an independent core laboratory, and adverse events were adjudicated by a clinical events committee using Valve Academic Research Consortium criteria. Results Patients were 83.1 ± 5.9 years of age and had a logistic EuroSCORE of 22.5 ± 11.3% and a Society of Thoracic Surgeons score of 9.7 ± 8.7%. Correct valve positioning was obtained in 99% of cases with a combined 30-day safety endpoint at 10%, including major stroke in 5.0%, major vascular complications in 2.0%, and death in 1%. At 12 months, 95% of patients were in New York Heart Association functional class I or II. Freedom from any death was 90%, and freedom from any death or major stroke was 85%. Echocardiography demonstrated none/trace to mild aortic regurgitation in 100% of patients and an unchanged mean aortic gradient of 12.2 ± 6.6 mm Hg and effective orifice area of 1.6 ± 0.4 cm2. Conclusions At 1 year, the DFM transcatheter heart valve had durable hemodynamics. This study demonstrates that the low rate of early complications and the low risk of significant aortic regurgitation translated into midterm clinical benefit.

AB - Objectives The aim of this study was to assess the 1-year outcome after transcatheter aortic valve replacement (TAVR) of the Direct Flow Medical (DFM) valve in patients with severe symptomatic aortic stenosis who were contraindicated or high risk for surgery. Background The DFM transcatheter heart valve is a new-generation, nonmetallic aortic valve with a pressurized support structure and conformable double-ring annular sealing delivered through an 18-F sheath. The device allows repositioning, retrieval, and assessment of valve performance before permanent implantation. Methods A prospective multicenter European registry was set up to determine the safety and performance of the valve in 100 consecutive patients (10 centers). Echocardiographic and angiographic data were evaluated by an independent core laboratory, and adverse events were adjudicated by a clinical events committee using Valve Academic Research Consortium criteria. Results Patients were 83.1 ± 5.9 years of age and had a logistic EuroSCORE of 22.5 ± 11.3% and a Society of Thoracic Surgeons score of 9.7 ± 8.7%. Correct valve positioning was obtained in 99% of cases with a combined 30-day safety endpoint at 10%, including major stroke in 5.0%, major vascular complications in 2.0%, and death in 1%. At 12 months, 95% of patients were in New York Heart Association functional class I or II. Freedom from any death was 90%, and freedom from any death or major stroke was 85%. Echocardiography demonstrated none/trace to mild aortic regurgitation in 100% of patients and an unchanged mean aortic gradient of 12.2 ± 6.6 mm Hg and effective orifice area of 1.6 ± 0.4 cm2. Conclusions At 1 year, the DFM transcatheter heart valve had durable hemodynamics. This study demonstrates that the low rate of early complications and the low risk of significant aortic regurgitation translated into midterm clinical benefit.

KW - aortic stenosids

KW - transcatheter aortic valve replacement

KW - transfemoral transcatheter aortic valve replacement

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