TY  - BOOK
AU  - Weissman, Neil J
TI  - 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
SN  - 1936-8798
KW  - *Aortic Valve Stenosis/th [Therapy]
KW  - *Aortic Valve/pp [Physiopathology]
KW  - *Bioprosthesis
KW  - *Cardiac Catheterization/is [Instrumentation]
KW  - *Heart Valve Prosthesis
KW  - *Heart Valve Prosthesis Implantation/is [Instrumentation]
KW  - *Hemodynamics
KW  - Aged
KW  - Aged, 80 and over
KW  - Aortic Valve Insufficiency/et [Etiology]
KW  - Aortic Valve Insufficiency/pp [Physiopathology]
KW  - Aortic Valve Stenosis/di [Diagnosis]
KW  - Aortic Valve Stenosis/mo [Mortality]
KW  - Aortic Valve Stenosis/pp [Physiopathology]
KW  - Aortic Valve/ra [Radiography]
KW  - Aortic Valve/us [Ultrasonography]
KW  - Cardiac Catheterization/ae [Adverse Effects]
KW  - Cardiac Catheterization/mo [Mortality]
KW  - Disease-Free Survival
KW  - Europe
KW  - Female
KW  - Heart Valve Prosthesis Implantation/ae [Adverse Effects]
KW  - Heart Valve Prosthesis Implantation/mo [Mortality]
KW  - Humans
KW  - Kaplan-Meier Estimate
KW  - Logistic Models
KW  - Male
KW  - Middle Aged
KW  - Prospective Studies
KW  - Prosthesis Design
KW  - Registries
KW  - Risk Assessment
KW  - Risk Factors
KW  - Severity of Illness Index
KW  - Stroke/et [Etiology]
KW  - Time Factors
KW  - Treatment Outcome
KW  - MedStar Heart & Vascular Institute
KW  - Journal Article
KW  - Multicenter Study
N1  - Available online through MWHC library: 2008 - present
N2  - 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)
UR  - http://dx.doi.org/10.1016/j.jcin.2015.09.027
ER  -