Kristjan Karason1, Lars H Lund2, Magnus Dalén2, Erik Björklund3, Karl Grinnemo3, Oscar Braun4, Johan Nilsson4, Henriette van der Wal5, Jonas Holm5, Laila Hübbert6, Krister Lindmark7, Barna Szabo8, Erik Holmberg9, Göran Dellgren10. 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.
RCT Entities:
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 AdHFpatients 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.
Authors: Lorenzo Stretti; Dauphine Zippo; Andrew J S Coats; Markus S Anker; Stephan von Haehling; Marco Metra; Daniela Tomasoni Journal: ESC Heart Fail Date: 2021-12-16