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.
- quality of care
- aortic stenosis
- transcatheter aortic valve implantation
- surgical aortic valve replacement
- facilitated data relay
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Collaborators Principal investigators: TKR (Department of Cardiology, University of Cologne Heart Center, Cologne, Germany), NF (Department of Cardiology and Angiology, University of Kiel, Kiel, Germany), RPS (Queen Elizabeth Hospital, Birmingham, UK), DM-Z (Department of Cardiology, Bichat Hospital, Paris, France). IMPULSE enhanced registry group/investigators: France: Paris (DM-Z, LK and SP); Germany: Cologne (TKR, FD, FM, Ingo Ahrens and Andreas Kuhn), Kiel (NF, ML, KM and SR); UK: Birmingham (RPS, JF and HS); Edwards Lifesciences: Nyon (MT), Prague (JK); IPPMed: Cloppenburg (Cornelia Deutsch, CP and PB).
Contributors TKR, NF, RPS, DM-Z, JK, MT and PB were involved in the conception and design of the registry. TKR and PB drafted the manuscript and all other authors revised the article for important intellectual content. All authors gave final approval of the version to be published.
Funding Research grant provided by Edwards Lifescience (Nyon, Switzerland) to the Sponsor Institute for Pharmacology and Preventive Medicine (IPPMed, Cloppenburg, Germany).
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.
Patient consent for publication Not required.
Ethics approval The registry is established in accordance with the Declaration of Helsinki (1964), and prior ethical agreements have been obtained from the appropriate ethics committee at each site. Prior to enrolment, patients are required to provide informed consent and data are collected by a co-ordinating nurse in the form of electronic case report forms (eCRFs).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request.
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