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. (26th February 2020)

• Record Type: Journal Article
• Authors: Karason, Kristjan; Lund, Lars H.; Dalén, Magnus; Björklund, Erik; Grinnemo, Karl; Braun, Oscar; Nilsson, Johan; van der Wal, Henriette; Holm, Jonas; Hübbert, Laila; Lindmark, Krister; Szabo, Barna; Holmberg, Erik; Dellgren, Göran
• Is Part Of: European journal of heart failure. Volume 22:Number 4(2020)
• Page Start: 739
• Page End: 750
• Publication Date: 2020-02-26
• Subjects: Advanced heart failure -- Destination therapy -- Mechanical circulatory support -- Left ventricular assist device -- HeartMate 3 -- Guideline‐directed medical therapy -- Randomized controlled trial; Heart failure -- Periodicals; Heart Failure -- Periodicals; Insuffisance cardiaque -- Périodiques; Heart failure; Periodicals; 616.129005
• DOI: 10.1002/ejhf.1773
• Languages: English
• ISSNs: 1388-9842

Abstract

Abstract: 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.