Swedish Evaluation of Left Ventricular Assist Device as Permanent Treatment in End-stage Heart Failure

Prior treatment

• Technical obstacles, which pose an inordinately high surgical risk

Other illness

• Eligible for heart transplantation or is likely to become eligible after VAD treatment (bridge-to-candidacy)
• Indication for revascularisation, valvular surgery or other cardiac intervention expected to improve cardiac function and prognosis (CABG, PCI TAVI, mitraclip etc.)
• Heart failure due to restrictive cardiomyopathy pericardial disease, active myocarditis or uncorrected thyroid disease.
• Moderate to severe aortic insufficiency without plans for correction

Lab values

• Active, uncontrolled infection
  • 11\. Stroke within 90 days or carotid artery stenosis \> 80 % 12. Significant vascular disease. 13. Severe COPD or severe restrictive lung disease. 14. Intrinsic hepatic disease as defined by liver enzyme values (AST or ALT or total bilirubin) \> 5 times the upper limit of normal, or INR \> 2.0, which is not due to anti-coagulant therapy.
  • 15\. Intolerance to anticoagulant or antiplatelet therapies or any other operative therapy the patient will require based upon the patient's health status.
  • 16\. Platelet count \< 50,000. 17. Measured GFR \<20 ml/min/1.73m2 unresponsive to inotrope treatment or chronic dialysis.
  • 18\. High risk for right ventricular failure according to echocardiography and/or invasive hemodynamic measurements as judged by the investigator (\>2 parameter constitute an exclusion criteria) using a combination of the:
• Severe TI b. TAPSE \< 0.72 cm c. RVEDD/LVEDD \> 0.72 d. CVP \> 16 mm Hg e. MPAP - RAP \< 10 mmHg SPAP-DPAP/CVPm \>1 ok, \<0.5 very bad, in between borderline f. CVP/PCWP \> 0.63 g. RVSWI \< 300 mm Hg x ml/m2 h. Bilirubin \> 34 micromol/L 19. Body Mass Index (BMI) \> 42 kg/m2. 20. Psychiatric disease, cognitive dysfunction, alcohol or drug abuse, or psychosocial issues that are likely to impair study compliance 21. Female of childbearing age with a positive pregnancy test or not willing to use adequate contraceptive precautions during the study.
  • 22\. Condition, other than heart failure, that could limit survival to less than 2 years.

Other

• INTERMACS profile 1 "crash and burn"
• On-going mechanical circulatory support.
• Mechanical aortic valve that will not be converted to a bioprosthesis or patch

• Signed informed consent
• Adult (≥ 18 years)
• Chronic heart failure ≥ 45 days or stable not supported by mechanical circulatory support since \>7days on single inotrope.
• Left ventricular ejection fraction ≤ 30%.
• NYHA IIIB-IV, INTERMACS profile 2-6
• At least 2 of 4 adverse prognostic criteria:
  • SHFM estimated 1-year survival ≤75%
  • NTproBNP ≥ 2000 ng/l
  • VO2 max \< 14 ml/kg/min or \<50% of predicted VO2max with attainment of anaerobic threshold (AT), or unable to perform.
  • Need for continuous or intermittent inotropic support or \>2 hospitalizations during last 6 months.
• Receiving medical management with optimal doses of betablockers, ACE-inhibitors or ARBs, and MRAs for at least 30 days if tolerated.
• Receiving CRT if indicated for at least 45 days.
• Receiving ICD if indicated and appropriate.
• Ineligible for cardiac transplantation (e.g. high age and/or co-morbidities)
• Considered suitable for the study by a multidisciplinary board