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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.
European Journal of Heart Failure ( IF 18.2 ) Pub Date : 2020-02-26 , DOI: 10.1002/ejhf.1773
Kristjan Karason 1 , Lars H Lund 2 , Magnus Dalén 2 , Erik Björklund 3 , Karl Grinnemo 3 , Oscar Braun 4 , Johan Nilsson 4 , Henriette van der Wal 5 , Jonas Holm 5 , Laila Hübbert 6 , Krister Lindmark 7 , Barna Szabo 8 , Erik Holmberg 9 , Göran Dellgren 10 ,
Affiliation  

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.

中文翻译:

晚期心力衰竭患者左心室辅助装置作为目的地治疗与指导性药物治疗的随机试验。SWEdish评估左心室辅助装置(SweVAD)试验的原理和设计。

AIMS不适合进行心脏移植(HTx)的晚期心力衰竭(AdHF)患者可以在某些国家或地区使用左心室辅助装置(LVAD)进行治疗。这反映出缺乏对LVAD系统在这种情况下的效用及其益处,局限性和成本效益的系统分析。SWEdish评估左心室辅助装置(SweVAD)是一项IV期,前瞻性,1:1随机,无盲,多中心试验,将研究采用指南指导的LVAD目的地治疗(GD)进行机械循环支持的影响-LVAD-DT)使用HeartMate 3(HM3)连续流泵与指南指导的药物治疗(GDMT)来评估不适合HTx的AdHF患者的生存率。方法将在瑞典的七所大学医院招募80名患者参加SweVAD。研究人群将包括患有AdHF的患者(纽约心脏协会IIIB-IV级,INTERMACS档案2-6),尽管存在GDMT,但预后不良,并且不适合接受HTx。参与者将被追踪2年或直至死亡。其他终点将通过盲目裁决来确定。在研究分配的干预措施中停留超过2年的患者将被要求继续随访直至5年,以观察结果和不良事件。结论SweVAD研究将比较GD-LVAD-DT和GDMT的生存率,中期收益,成本和潜在危害,并将为指导不适合HTx的AdHF患者的目的地治疗策略提供有价值的参考点。
更新日期:2020-02-26
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