Caseload management and outcome of patients with aortic stenosis in primary/secondary versus tertiary care settings-design of the IMPULSE enhanced registry.
aortic stenosis
facilitated data relay
quality of care
surgical aortic valve replacement
transcatheter aortic valve implantation
Journal
Open heart
ISSN: 2053-3624
Titre abrégé: Open Heart
Pays: England
ID NLM: 101631219
Informations de publication
Date de publication:
Historique:
received:
22
01
2019
revised:
31
05
2019
accepted:
13
06
2019
entrez:
16
8
2019
pubmed:
16
8
2019
medline:
16
8
2019
Statut:
epublish
Résumé
Severe aortic stenosis (AS) is one of the most common and most serious valve diseases. Without timely intervention with surgical aortic valve replacement or transcatheter aortic valve replacement, patients have an estimated survival of 2-3 years. Guidelines for the treatment of AS have been developed, but studies suggest that as many as 42% of patients with AS are not treated according to these recommendations.The aims of this registry are to delineate the caseload of patients with AS, outline the management of these patients and determine appropriateness of treatments in participating centres with and without onsite access to surgery and percutaneous treatments. The IMPULSE enhanced registry is an international, multicentre, prospective, observational cohort registry conducted at four central full access centres (tertiary care hospitals) and at least two satellite centres per hub (primary/secondary care hospitals). An estimated 800 patients will be enrolled in the registry and patient follow-up will last for 12 months. In addition to the primary aims determining the caseload management and outcome of patients with AS in primary, secondary and tertiary care settings, the registry will also determine a time course for the transition from asymptomatic to symptomatic status and the diagnostic steps, treatment decisions and the identification of decision-makers in tertiary versus primary/secondary care hospitals. The last patient will be enrolled in the registry in 2018 and results of the registry are anticipated in 2019. NCT03112629.
Sections du résumé
Background
Severe aortic stenosis (AS) is one of the most common and most serious valve diseases. Without timely intervention with surgical aortic valve replacement or transcatheter aortic valve replacement, patients have an estimated survival of 2-3 years. Guidelines for the treatment of AS have been developed, but studies suggest that as many as 42% of patients with AS are not treated according to these recommendations.The aims of this registry are to delineate the caseload of patients with AS, outline the management of these patients and determine appropriateness of treatments in participating centres with and without onsite access to surgery and percutaneous treatments.
Methods/design
The IMPULSE enhanced registry is an international, multicentre, prospective, observational cohort registry conducted at four central full access centres (tertiary care hospitals) and at least two satellite centres per hub (primary/secondary care hospitals). An estimated 800 patients will be enrolled in the registry and patient follow-up will last for 12 months.
Discussion
In addition to the primary aims determining the caseload management and outcome of patients with AS in primary, secondary and tertiary care settings, the registry will also determine a time course for the transition from asymptomatic to symptomatic status and the diagnostic steps, treatment decisions and the identification of decision-makers in tertiary versus primary/secondary care hospitals. The last patient will be enrolled in the registry in 2018 and results of the registry are anticipated in 2019.
Registration number
NCT03112629.
Identifiants
pubmed: 31413844
doi: 10.1136/openhrt-2019-001019
pii: openhrt-2019-001019
pmc: PMC6667938
doi:
Banques de données
ClinicalTrials.gov
['NCT03112629']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Pagination
e001019Déclaration de conflit d'intérêts
Competing interests: PB is the representative of the IPPMed, Cloppenburg, Germany. IPPMed has received research funding and honoraria for consultancy from Edwards Lifesciences. TKR, NF, ML, RPS and DM-Z received honoraria for advisory board meetings from Edwards Lifesciences. The institutions of these received funding for employing a study nurse.
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