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

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.

The year in cardiovascular medicine 2020: heart failure and cardiomyopathies

“…71,72 Studija SWEdish evaluation of left Ventricular Assist Device (SweVAD) istražit će utjecaj mehaničke cirkulatorne potpore spram smjernica vođene medikamentne terapije na preživljavanje u bolesnika s AHF-om nepodobnih za transplantaciju srca. 73…”

“…The SWEdish evaluation of left Ventricular Assist Device (SweVAD) will examine the impact of mechanical circulatory support vs. guidelinedirected medical therapy on survival in a population of AHF patients ineligible for heart transplant. 73…”

February 2021 at a glance: focus on amyloidosis, myocarditis and cardiomyopathy

“…19 Advanced heart failure A relatively large number of patients with advanced HF may benefit from long-term mechanical circulatory support. 20 This indication might be further expanded if this device therapy may cause regression of myocardial fibrosis. Unfortunately, such hypothesis was not proven in a recent study in 125 patients.…”

“…A relatively large number of patients with advanced HF may benefit from long‐term mechanical circulatory support 20 . This indication might be further expanded if this device therapy may cause regression of myocardial fibrosis.…”

April 2020 at a glance: epidemiology, prevention, and biomarkers

“…No trial evaluated the benefits of left ventricular assist device as destination therapy in Europe, to date. 20 Karason et al 21 show the design of a randomized comparison between left ventricular assist device and optimal medical therapy in patients with advanced HF not suitable for cardiac transplantation. Two-year survival, mid-term benefits, and costs will be explored.…”