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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

Karason, Kristjan ; Lund, Lars H. ; Dalén, Magnus ; Björklund, Erik ; Grinnemo, Karl ; Braun, Oscar LU ; Nilsson, Johan LU orcid ; van der Wal, Henriette ; Holm, Jonas and Hubbert, Laila , et al. (2020) In European Journal of Heart Failure 22(4). p.739-750
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... (More)
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. (Less)
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author collaboration
publishing date
type
Contribution to journal
publication status
published
in
European Journal of Heart Failure
volume
22
issue
4
pages
739 - 750
publisher
Elsevier
external identifiers
  • pmid:32100946
  • scopus:85080088348
ISSN
1879-0844
DOI
10.1002/ejhf.1773
language
English
LU publication?
no
id
eda43d37-a263-46cd-9bd7-82fdb2c3643d
date added to LUP
2021-12-10 10:22:09
date last changed
2022-04-27 06:33:15
@article{eda43d37-a263-46cd-9bd7-82fdb2c3643d,
  abstract     = {{Aims<br/>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.<br/><br/>Methods<br/>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.<br/><br/>Conclusion<br/>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.}},
  author       = {{Karason, Kristjan and Lund, Lars H. and Dalén, Magnus and Björklund, Erik and Grinnemo, Karl and Braun, Oscar and Nilsson, Johan and van der Wal, Henriette and Holm, Jonas and Hubbert, Laila and Lindmark, Krister and Szabo, Barna and Holmberg, Erik and Dellgren, Göran}},
  issn         = {{1879-0844}},
  language     = {{eng}},
  number       = {{4}},
  pages        = {{739--750}},
  publisher    = {{Elsevier}},
  series       = {{European Journal of Heart Failure}},
  title        = {{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}},
  url          = {{http://dx.doi.org/10.1002/ejhf.1773}},
  doi          = {{10.1002/ejhf.1773}},
  volume       = {{22}},
  year         = {{2020}},
}