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Original research
Perioperative care differences of surgical aortic valve replacement between North America and Europe
  1. Bart J J Velders1,
  2. Michiel D Vriesendorp1,
  3. Rob A F De Lind Van Wijngaarden2,
  4. Vivek Rao3,
  5. Michael J Reardon4,
  6. Malakh Shrestha5,
  7. Michael W A Chu6,
  8. Joseph F Sabik III7,
  9. Fang Liu8,
  10. Robert J M Klautz1
  1. 1 Department of Cardiothoracic Surgery, Leiden University Medical Center, Leiden, The Netherlands
  2. 2 Department of Cardiothoracic Surgery, Amsterdam UMC Location AMC, Amsterdam, The Netherlands
  3. 3 Department of Cardiovascular Surgery, Toronto General Hospital, Toronto, Ontario, Canada
  4. 4 Department of Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas, USA
  5. 5 Department of Cardiothoracic, Transplantation and Vascular Surgery, Mayo Clinic, Rochester, Minnesota, USA
  6. 6 Department of Cardiothoracic Surgery, London Health Sciences Centre, London, Ontario, Canada
  7. 7 Department of Surgery, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA
  8. 8 Department of Biostatistics, Medtronic, Mounds View, Minnesota, USA
  1. Correspondence to Dr Bart J J Velders, Cardiothoracic Surgery, Leiden University Medical Center, Leiden 2300 RC, The Netherlands; b.j.j.velders{at}lumc.nl

Abstract

Objective To describe differences between North America and Europe in the perioperative management of patients undergoing surgical aortic valve replacement (SAVR).

Methods Patients with moderate or greater aortic stenosis or regurgitation requiring SAVR were enrolled in a prospective observational cohort evaluating the safety and efficacy of a new stented bioprosthesis at 25 centres in North America (Canada and the USA) and 13 centres in Europe (Germany, the Netherlands, France, the UK, Switzerland and Italy). While all patients underwent implantation with the same bioprosthetic model, perioperative management was left to the discretion of participating centres. Perioperative care was described in detail including outcomes up to 1-year follow-up.

Results Among 1118 patients, 643 (58%) were implanted in North America, and 475 (42%) were implanted in Europe. Patients in Europe were older, had a lower body mass index, less bicuspid disease and worse degree of aortic stenosis at baseline. In Europe, anticoagulant therapy at discharge was more aggressive, whereas length of stay was longer, and discharges directly to home were less common. Rehospitalisation risk was lower in Europe at 30 days (8.5% vs 15.9%) but converged at 1-year follow-up (26.5% vs 28.1%). Within continents, there were major differences between individual countries concerning perioperative management.

Conclusion Contemporary perioperative management of SAVR patients varies between North America and Europe in patient selection, procedural techniques, antithrombotic regimen and discharge management. Furthermore, rehospitalisation differed largely between continents and countries. Hence, geographical setting must be considered during design and interpretation of trials on SAVR.

Trial registration number NCT02088554.

  • heart valve prosthesis implantation
  • health care economics and organizations
  • aortic valve insufficiency
  • aortic valve stenosis

Data availability statement

Data may be obtained from a third party and are not publicly available.

Data availability statement

The data underlying this article were provided by the sponsor and will not be shared with third parties for purposes of reproducing the results.

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Data availability statement

Data may be obtained from a third party and are not publicly available.

Data availability statement

The data underlying this article were provided by the sponsor and will not be shared with third parties for purposes of reproducing the results.

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Footnotes

  • Contributors BJJV: conceptualisation; methodology; formal analysis; investigation; and writing – original draft; visualisation; guarantor. MDV: conceptualisation; methodology; writing – review and editing; and supervision. RAFDLVW: conceptualisation; resources; and writing – review and editing. VR: resources; writing and review and editing. MJR: resources and writing – review and editing. MS: resources; writing – review and editing. MWAC: resources; writing – review and editing. JFS: resources; writing – review and editing. FL: formal analysis; writing – review and editing; and visualisation. RJMK: conceptualisation; resources; writing and review and editing; supervision.

  • Funding The PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Pivotal Trial was funded by Medtronic Inc.

  • Map disclaimer The inclusion of any map (including the depiction of any boundaries therein), or of any geographic or locational reference, does not imply the expression of any opinion whatsoever on the part of BMJ concerning the legal status of any country, territory, jurisdiction or area or of its authorities. Any such expression remains solely that of the relevant source and is not endorsed by BMJ. Maps are provided without any warranty of any kind, either express or implied.

  • Competing interests BJJV: institutional research grant and speaker’s honorarium paid to his department by Medtronic. MDV: institutional research grant and reimbursement of travel expenses from Medtronic. VR: consultant to Medtronic, Gore and Abbott; advisory board, Medtronic. MJR: consultant to Medtronic, Abbott Medical, Boston Scientific, Gore Medical and Transverse Medical; fees paid to department. MWAC: speaker’s honoraria from Medtronic, Edwards Lifesciences, Terumo Aortic, Abbott Vascular and Cryolife. JFS: North American Principal Investigator of the PERIGON Pivotal Trial for Medtronic. FL: employee of Medtronic. RJMK: research support, consultation fees, and European Principal Investigator of the PERIGON Pivotal Trial for Medtronic.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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