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.

MedStar author(s):
Citation: Jacc: Cardiovascular Interventions. 9(1):68-75, 2016 Jan 11.PMID: 26762913Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | Multicenter StudySubject headings: *Aortic Valve Stenosis/th [Therapy] | *Aortic Valve/pp [Physiopathology] | *Bioprosthesis | *Cardiac Catheterization/is [Instrumentation] | *Heart Valve Prosthesis | *Heart Valve Prosthesis Implantation/is [Instrumentation] | *Hemodynamics | Aged | Aged, 80 and over | Aortic Valve Insufficiency/et [Etiology] | Aortic Valve Insufficiency/pp [Physiopathology] | Aortic Valve Stenosis/di [Diagnosis] | Aortic Valve Stenosis/mo [Mortality] | Aortic Valve Stenosis/pp [Physiopathology] | Aortic Valve/ra [Radiography] | Aortic Valve/us [Ultrasonography] | Cardiac Catheterization/ae [Adverse Effects] | Cardiac Catheterization/mo [Mortality] | Disease-Free Survival | Europe | Female | Heart Valve Prosthesis Implantation/ae [Adverse Effects] | Heart Valve Prosthesis Implantation/mo [Mortality] | Humans | Kaplan-Meier Estimate | Logistic Models | Male | Middle Aged | Prospective Studies | Prosthesis Design | Registries | Risk Assessment | Risk Factors | Severity of Illness Index | Stroke/et [Etiology] | Time Factors | Treatment OutcomeYear: 2016Local holdings: Available online through MWHC library: 2008 - presentISSN:
  • 1936-8798
Name of journal: JACC. Cardiovascular interventionsAbstract: 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.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.Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.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.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.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 cm(2).All authors: Bijuklic K, Bruschi G, Colombo A, Davidson C, De Marco F, Fajadet J, Friedrich I, Grube E, Hauptmann KE, Klugmann S, Latib A, Lauterbach M, Lefevre T, Low R, Maisano F, Mullen M, Nava S, Nickenig G, Redwood S, Schmoeckel M, Schofer J, Sinning JM, Tchetche D, Thomas M, Weissman N, Yap J, Young CFiscal year: 2016Digital Object Identifier: Date added to catalog: 2017-03-06
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 26762913 Available 26762913

Available online through MWHC library: 2008 - present

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.

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.Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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.

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.

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 cm(2).

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