Early Versus Emergency Left Ventricular Assist Device Implantation in Patients Awaiting Cardiac Transplantation

Brief Summary

Detailed Description

Heart transplantation is considered the gold-standard therapy for end-stage systolic heart failure but the shortage of donor hearts in Germany and other countries has led to widespread use of left ventricular assist devices (LVAD). Even on the transplant list, patients' condition often deteriorate due to worsening heart failure so that they need an LVAD as a bridge until transplantation. The high mortality (one in five patients on the waiting list dies within 1 year) reflects the severity of the disease. In comparison, technical progress has reduced the complication rate seen with assist devices and, according to recent data, mortality during LVAD support is low. Patient status prior to LVAD implantation is a strong indicator for postoperative outcome, i.e. patients in worse condition are more likely to develop complications. Thus, the comparison between the standard indication and early LVAD implantation (T-status) appears timely and clinically necessary. The paucity of donor hearts necessitates the prospective evaluation of alternative treatment regimens. The aim of the study is to assess whether, in patients with end-stage heart failure awaiting cardiac transplantation, a strategy involving early LVAD implantation is superior to a strategy of conservative medical heart failure therapy and assist device implantation only after severe deterioration of heart failure. The investigators expect to gain insights that will be trail-blazing for the future treatment of patients with heart failure on the transplantation waiting list, including aspects of their medical care. If the study hypotheses are confirmed, the treatment of these seriously ill patients could be, on the one hand, further optimized. On the other hand, positive economic effects are highly probable. The results will form the basis of future guidelines for the treatment of this group of patients. Thus the study will also make a contribution to solving the problem of the ever increasing number of patients on the waiting list as opposed to the decreasing willingness to donate organs for transplantation. As a mean of quality control of the conducted study and to retrieve more data in this population all patients who fulfill the eligibility criteria of the study but do not consent to randomization are included in a standard treatment registry.

Primary Outcomes

Secondary Outcomes

• Heart failure survival score(Measured every 6 months from randomisation untill month 60 (60 months at the most, 48 months on average))
• Seattle heart failure score(Measured every 6 months from randomisation untill month 60 (60 months at the most, 48 months on average))
• Number of patients requiring urgent VAD implantation(Randomisation untill month 60 (60 months at the most, 48 months on average))
• Number of patients receiving a donor heart(Randomisation untill transplantation (60 months at the most, 48 months on average))
• VAD explantation due to myocardial recovery(Randomisation untill month 60 (60 months at the most, 48 months on average))
• Short Form-36 (SF-36)(Randomisation untill month 60 (60 months at the most, 48 months on average))
• Minnesota Living with heart failure questionnaire (MLHFQ)(Randomisation untill month 60 (60 months at the most, 48 months on average))
• Mini-mental state examination (MMSE)(Randomisation untill month 60 (60 months at the most, 48 months on average))
• Quality-adjusted life year (QALY)(Randomisation untill month 60 (60 months at the most, 48 months on average))
• Cardiovascular Death(Randomisation untill month 60 (60 months at the most, 48 months on average))
• Rate of recurrent hospitalizations(Randomisation untill month 60 (60 months at the most, 48 months on average))
• Stroke(Randomisation untill month 60 (60 months at the most, 48 months on average))
• Listing for high-urgency (HU) cardiac transplantation(Randomisation untill month 60 (60 months at the most, 48 months on average))
• Number of patients with de novo right heart failure measured by decreasing right heart ejection fraction, increasing central venous pressure and/or secondary organ failure needing catecholamines and/or right ventricular circulatory support(Randomisation untill month 60 (60 months at the most, 48 months on average))
• Number of patients with adverse events due to device failure(Randomisation untill month 60 (60 months at the most, 48 months on average))
• Number of device infections requiring antibiotics and/surgical intervention(Randomisation untill month 60 (60 months at the most, 48 months on average))
• Number of patients with hospitalizations due to device failure(Randomisation untill month 60 (60 months at the most, 48 months on average))
• Number of patients with major bleedings (needing >4 Units of blood) following VAD implantation and major bleedings due to anticoagulation therapy(Randomisation untill month 60 (60 months at the most, 48 months on average))
• Maximum oxygen uptake (VO2 max)(Measured every 6 months from randomisation untill month 60 (60 months at the most, 48 months on average))
• Number of patients suffering from secondary organ failure(Randomisation untill month 60 (60 months at the most, 48 months on average))
• New York Heart Association class (NYHA)(Measured every 6 months from randomisation untill month 60 (60 months at the most, 48 months on average))