[System for percutaneous replacement of mitral valve (MitraClip). Monitoring Study Protocol (1st part)]
Fernández de Gamarra JM, López de Argumedo M, Benguria-Arrate G, Asua J
Record ID 32018000496
Spanish
Original Title:
Sistema de reparación percutáneo de la válvula mitral (MitraClip). Protocolo del Estudio de Monitorización (1ª parte)
Authors' objectives:
Add knowledge about the results of implementation of the MitraClip generated by other records and studies, and guarantee the quality of application of the procedure during the «initial» phase of its use in Spain, by collecting and analysing relevant information to enable comparison with data provided by other valid records.
Authors' results and conclusions:
• Any recommendation to implement a MitraClip has to be determined by the heart team, in a personalised manner that should consider different situations.
• The diagnosis and assessment of the mitral insufficiency is established via transesophageal and transthoracic echocardiograms, with the use in some cases of a stress echocardiography to give further information about the severity of the mitral insufficiency.
• Before inserting the MitraClip, the existence of mitral stenosis mitral should be dismissed, along with the presence of rheumatic, calcified or severely retracted cusps, and the presence of clots at auricle level and endocarditis.
Conclusions
The monitoring study of the MitraClip implant in Spain, like that of any other new procedure where the available evidence is scarce or has more or less sizeable gaps, is justified by the need to improve knowledge about the results, as a prior stage to its final inclusion to the portfolio of treatments and subsequent general use, as well as by the need for its introduction into clinical routines to be a reasonably orderly process.
Authors' methods:
Search without time limit of the scientific literature in data bases that group together primary, secondary and applied research studies, such as the data bases of Medline, CRD (INAHTA, NHS EED, DARE), Cochrane Collaboration, National Guidelines ClearingHouse (NGC), EuroScan and ECRI in order to localise systematic reviews, Practice Guides or clinical trials that analyse the technique being studied.
Details
Project Status:
Completed
Year Published:
2017
URL for published report:
https://www.ogasun.ejgv.euskadi.eus/r51-catpub/es/k75aWebPublicacionesWar/k75aObtenerPublicacionDigitalServlet?R01HNoPortal=true&N_LIBR=051954&N_EDIC=0001&C_IDIOM=es&FORMATO=.pdf
English language abstract:
An English language summary is available
Publication Type:
Other
Country:
Spain
MeSH Terms
- Heart Valve Prosthesis
- Heart Valve Prosthesis Implantation
- Mitral Valve Insufficiency
- Mitral Valve
- Minimally Invasive Surgical Procedures
- Cardiac Catheterization
Keywords
- Mitral Valve
- Mitral Valve Insufficiency
- Mitral Valve Regurgitation
- MitraClip
- Percutaneous Catheter
- Válvula Mitral
- Insuficiencia de la Válvula Mitral
- Catéteres
- Epidemiological Monitoring
- Monitorización
Contact
Organisation Name:
Basque Office for Health Technology Assessment
Contact Address:
C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz
Contact Name:
Lorea Galnares-Cordero
Contact Email:
lgalnares@bioef.eus
Copyright:
Osteba (Basque Office for Health Technology Assessment) Health Department of the Basque Government
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.