Insights from the early experience of the society of thoracic surgeons/American college of cardiology transcatheter valve therapy registry

JACC: Cardiovascular Interventions

Volumn 8, Issue 3, 2015, Pages 377-381

  Rumsfeld, John S ^a   Holmes, David R ^b   Stough, Wendy Gattis ^c   Edwards, Fred H ^d   Jacques, Louis B ^e   Mack, Michael J ^f  

^a VETERANS AFFAIRS MEDICAL CENTER   (United States)

^b MAYO CLINIC   (United States)

^c CAMPBELL UNIVERSITY   (United States)

^d UNIVERSITY OF FLORIDA HEALTH SCIENCE CENTER   (United States)

^e CENTERS FOR MEDICARE AND MEDICAID SERVICES   (United States)

^f Heart Hospital Baylor   (United States)

Author keywords

Centers for Medicare and Medicaid Services (U.S.); heart valve prosthesis implantation; investigational device exemption; National Cardiovascular Data Registry; registries; transcatheter aortic valve replacement; U.S. Food and Drug Administration

Indexed keywords

CLINICAL TRIAL (TOPIC); DEVICE APPROVAL; HEALTH CARE QUALITY; HUMAN; JOB EXPERIENCE; MEDICAL DEVICE; OUTCOME ASSESSMENT; PERCUTANEOUS AORTIC VALVE; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; REVIEW; THERAPY; TRANSCATHETER AORTIC VALVE IMPLANTATION; TRANSCATHETER VALVE THERAPY; UNITED STATES; ADVERSE EFFECTS; AORTA VALVE; DEVICES; HEART CATHETERIZATION; HEART VALVE DISEASES; HEART VALVE PROSTHESIS; HEART VALVE REPLACEMENT; HEMODYNAMICS; MEDICAL SOCIETY; PATHOPHYSIOLOGY; PROCEDURES; PROGRAM DEVELOPMENT; PROSTHESIS; REGISTER; STANDARDS; TOTAL QUALITY MANAGEMENT; TREATMENT OUTCOME;

AORTIC VALVE; CARDIAC CATHETERIZATION; HEART VALVE DISEASES; HEART VALVE PROSTHESIS; HEART VALVE PROSTHESIS IMPLANTATION; HEMODYNAMICS; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; PROGRAM DEVELOPMENT; PROSTHESIS DESIGN; QUALITY IMPROVEMENT; QUALITY INDICATORS, HEALTH CARE; REGISTRIES; SOCIETIES, MEDICAL; TREATMENT OUTCOME;

EID: 84926415787     PISSN: 19368798     EISSN: 18767605     Source Type: Journal    
DOI: 10.1016/j.jcin.2014.09.022     Document Type: Review

References (8)

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6. Using Registry Data, FDA Expands indication for Edwards' Sapien Transcatheter Heart Valves. Available at: http://www.forbes.com/sites/larryhusten/2013/09/23/using-registry-data-fda-expands-indication-for-edwards-sapien-transcatheter-heart-valves/. Accessed October 21, 2013.
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8. Food and Drug Administration. Strengthening our national system for medical device postmarket surveillance. Available at: http://www.fda.gov/downloads/MedicalDevices/Safety/CDRHPostmarketSurveillance/UCM348845.pdf. Accessed October 21, 2013.