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Eur J Heart Fail. 2020 Feb 26. doi: 10.1002/ejhf.1773. [Epub ahead of print]

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.

Author information

1
Departments of Cardiology and Transplantation, Sahlgrenska University Hospital, Gothenburg, Sweden.
2
Departments of Cardiology and Cardiothoracic Surgery, Karolinska University Hospital, Stockholm, Sweden.
3
Departments of Cardiology and Cardiothoracic Surgery, Uppsala University Hospital, Uppsala, Sweden.
4
Departments of Cardiology and Cardiothoracic Surgery, Skåne University Hospital, Lund, Sweden.
5
Departments of Cardiology and Cardiothoracic Surgery, Linköping University Hospital, Linköping, Sweden.
6
Health, Medicine and Caring Sciences, Linköping University, Norrköping, Sweden.
7
Department of Cardiology, Umeå University Hospital, Umeå, Sweden.
8
Department of Cardiology, Örebro University Hospital, Örebro, Sweden.
9
Regional Cancer Centre West, Sahlgrenska University Hospital, Gothenburg, Sweden.
10
Departments of Cardiothorax Surgery and Transplantation, Sahlgrenska University Hospital, Gothenburg, Sweden.

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.

KEYWORDS:

Advanced heart failure; Destination therapy; Guideline-directed medical therapy; HeartMate 3; Left ventricular assist device; Mechanical circulatory support; Randomized controlled trial

PMID:
32100946
DOI:
10.1002/ejhf.1773

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