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  • Caseload management and outcome of patients with aortic stenosis in primary/secondary versus tertiary care settings—design of the IMPULSE enhanced registry

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Valvular heart disease
Protocol
Caseload management and outcome of patients with aortic stenosis in primary/secondary versus tertiary care settings—design of the IMPULSE enhanced registry
  1. Tanja K. Rudolph1,
  2. David Messika-Zeitoun2,
  3. Norbert Frey3,
  4. Matthias Lutz3,
  5. Laura Krapf4,
  6. Stephanie Passefort5,
  7. John Fryearson6,
  8. Helen Simpson7,
  9. Kai Mortensen8,
  10. Sebastian Rehse9,
  11. Andreas Tiroke8,
  12. Fotini Dodos10,
  13. Florian Mies10,
  14. Christiane Pohlmann11,
  15. Jana Kurucova12,
  16. Martin Thoenes13,
  17. Peter Bramlage11 and
  18. Richard Paul Steeds14
  19. On behalf of the IMPULSE enhanced investigators
  1. 1Department of Cardiology, University of Cologne Heart Center, Cologne, Germany
  2. 2Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada
  3. 3Department of Cardiology and Angiology, University Medical Center Schleswig-Holstein, Kiel, Germany
  4. 4Department of Cardiology, Hopital Max Fourestier, Nanterre, France
  5. 5Department of Cardiology, Hopital André Grégoire, Montreuil, France
  6. 6Department of Cardiology, South Warwickshire NHS Foundation Trust, Warwick, UK
  7. 7Department of Cardiology, Birmingham Heartlands Hospital, Birmingham, UK
  8. 8Cardiology Practices, Kiel, Germany
  9. 9Department of Internal Medicine, Hospital Preetz, Preetz, Germany
  10. 10Practice for Internal Medicine, Cardiology, Pneumology / Practice for Cardiology Hohenlind, Cologne, Germany
  11. 11Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany
  12. 12Edwards Lifesciences, Prague, Czech Republic
  13. 13Edwards Lifesciences, Nyon, Switzerland
  14. 14Department of Cardiology, Queen Elizabeth Hospital, Birmingham, UK
  1. Correspondence to Dr Richard Paul Steeds; rick.steeds{at}uhb.nhs.uk

Abstract

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

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/openhrt-2019-001019

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    Footnotes

    • 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.