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Randomized trial of a left ventricular assist device as destination therapy versus guideline-directed medical therapy in patients with advanced heart failure. Rationale and design of the SWEdish evaluation of left Ventricular Assist Device (SweVAD) trial
Sahlgrens Univ Hosp, Sweden.
Karolinska Univ Hosp, Sweden.
Karolinska Univ Hosp, Sweden.
Uppsala Univ Hosp, Sweden.
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2020 (English)In: European Journal of Heart Failure, ISSN 1388-9842, E-ISSN 1879-0844Article in journal (Refereed) Epub ahead of print
Abstract [en]

Aims Patients with advanced heart failure (AdHF) who are ineligible for heart transplantation (HTx) can become candidates for treatment with a left ventricular assist device (LVAD) in some countries, but not others. This reflects the lack of a systematic analysis of the usefulness of LVAD systems in this context, and of their benefits, limitations and cost-effectiveness. The SWEdish evaluation of left Ventricular Assist Device (SweVAD) study is a Phase IV, prospective, 1:1 randomized, non-blinded, multicentre trial that will examine the impact of assignment to mechanical circulatory support with guideline-directed LVAD destination therapy (GD-LVAD-DT) using the HeartMate 3 (HM3) continuous flow pump vs. guideline-directed medical therapy (GDMT) on survival in a population of AdHF patients ineligible for HTx. Methods A total of 80 patients will be recruited to SweVAD at the seven university hospitals in Sweden. The study population will comprise patients with AdHF (New York Heart Association class IIIB-IV, INTERMACS profile 2-6) who display signs of poor prognosis despite GDMT and who are not considered eligible for HTx. Participants will be followed for 2 years or until death occurs. Other endpoints will be determined by blinded adjudication. Patients who remain on study-assigned interventions beyond 2 years will be asked to continue follow-up for outcomes and adverse events for up to 5 years. Conclusion The SweVAD study will compare survival, medium-term benefits, costs and potential hazards between GD-LVAD-DT and GDMT and will provide a valuable reference point to guide destination therapy strategies for patients with AdHF ineligible for HTx.

Place, publisher, year, edition, pages
WILEY , 2020.
Keywords [en]
Advanced heart failure; Destination therapy; Mechanical circulatory support; Left ventricular assist device; HeartMate 3; Guideline-directed medical therapy; Randomized controlled trial
National Category
Cardiac and Cardiovascular Systems
Identifiers
URN: urn:nbn:se:liu:diva-164621DOI: 10.1002/ejhf.1773ISI: 000515900500001PubMedID: 32100946OAI: oai:DiVA.org:liu-164621DiVA, id: diva2:1417312
Note

Funding Agencies|Sahlgrenska University Hospital; Swedish Research CouncilSwedish Research Council; Swedish Heart-Lung FoundationSwedish Heart-Lung Foundation; Swedish Federal Government under the ALF agreement [ALFGBG-775351, 447561, 726481]

Available from: 2020-03-27 Created: 2020-03-27 Last updated: 2020-04-21

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van der Wal, HenrietteHolm, JonasHübbert, Laila
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Department of Cardiology in LinköpingDivision of Diagnostics and Specialist MedicineFaculty of Medicine and Health SciencesDepartment of Thoracic and Vascular SurgeryDepartment of Cardiology in Norrköping
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European Journal of Heart Failure
Cardiac and Cardiovascular Systems

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