right ventricular failure mechanical circulatory support LVAD Dutch: rechterkamerfalen, mechanische hartondersteuning, LVAD
Conditions
Interventions
Implantation of RV Impella
Sponsors
Erasmus Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: - Age >18 years of age - Setting: post-LVAD, post-cardiotomy, post-myocardial infarction - Refractory RV failure, defined as a cardiac index of 10ug/kg/min or equivalent for >120 minutes) or the administration of >1 vasopressor/inotrope AND at least 1 of the following: -central venous pressure (CVP) >18 mmHg -CVP/pulmonary capillary wedge pressure or left atrial pressure ration of >0.63 -global echocardiographic RV dysfunction, defined as a tricuspid annular systolic excursion (TAPSE) of 42 mm or RV short-axis/midcavity diameter of >35 mm
Exclusion criteria
Exclusion criteria: Definite exclusion criteria -profound cardiogenic shock, defined as a cardiac index of 10 -the presence of a thrombus in the right atrium, right ventricle or pulmonary artery -mechanical prosthetic tricuspid or pulmonary valve -severe tricuspid or pulmonary valve stenosis -pulmonary embolism -anatomic conditions precluding pump insertion -documented deep venous thrombosis or presence of an inferior vena cava filter Relative exclusion criteria -severe pulmonary hypertension, defined as a systolic pulmonary artery pressure of >60mmHg -RV failure post-cardiac transplant -severe tricuspid or pulmonary valve regurgitation -severe active infection, defined as 2 or more of the following: a temperature of >38.5 C or 12 000 or 90 bpm and respiratory rate of >22/min -known coagulopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of major bleeding, hemolysis, thrombus formation in RA/RV/PA, right heart valve dysfunction and tamponade from device implantation up to 30 days or hospital discharge after device removal and the occurrence of arrhythmias during device implantation | — |
Secondary
| Measure | Time frame |
|---|---|
| • Duration of implantation procedure • Cardiac index, inotrope dosage, LVAD flow, pump parameters, urine production, lactate and SvO2 compared to baseline and 4 and 24 hours after implantation. • Need for CVVH during admission • TAPSE, S RV and RV diameters compared to baseline at 24 and 48 hours after implantation, after device removal and at 30 days/before hospital discharge • ICU and hospital length of stay • Survival and quality of life at 30 days and 6 months | — |
Contacts
Public ContactA.E Engstrom
Academic Medical Center-University of Amsterdam, Department of Cardiology, room B2-115 Meibergdreef 9
Outcome results
None listed