A couple of weeks ago, I took care of a patient who desperately needed to get better from acute CHF. At that time, we placed the patient on an impella… but the next day, it was deemed that he needed ECMO to reperfuse his organs. After a week on ECMO with continued impella support, ECMO was titrated down and off while maintaining 3.9L/min flow from the impella. During the wean off ECMO, the patient had been extubated and was mentating clearly and interacting appropriately.
Fast forward a couple days after getting extubated, the patient was ripe for an LVAD. But which one? (We ended up placing the patient on HeartWare LVAD).
- Cost-effectiveness: HeartWare > HeartMate II (UK NHS study, April 2014)
- LV Geometry: HeartWare = HeartMate II (J CT Surg, 2013)
- Stroke & GI bleed risk: HeartWare > HeartMate II (J Card Surg 2013)
- Risk of device failure: HeartWare < HeartMate II
- ENDURANCE trial: Randomized patients eligible for DT 2:1 to the HeartWare centrifugal flow LVAD versus the HeartMate II axial flow LVAD. The trial did reach its primary noninferiority endpoint of stroke free survival at 2 years (55.0% in the HeartWare patients versus 57.4% in the HeartMate II patients). Of note, a change in the design of the HeartWare device during the trial (sintering of the inflow cannula) appeared to decrease the incidence of pump thrombosis. Overall, the stroke rate was higher in the HeartWare arm whereas device malfunctions requiring exchange or urgent transplantation were more common in the HeartMate II arm. Data analysis suggested that better blood pressure control in the HeartWare arm may decrease the stroke rate and a second cohort of patients is being enrolled with more attention being paid to blood pressures management.
- ROADMAP study: (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Heart Failure Patients) was an observational study of the Thoratec HeartMate II LVAD compared to optimal medical management in patients with advanced heart failure. Thirty day mortality was the same in both groups (1%) while one year survival was 80% in the LVAD group compared to 64% in the medical group (on an as treated basis). Functional status and quality of life improved significantly more in the LVAD group (analyzed by 6 minute walk, health related quality of life, and NYHA class). Unfortunately, adverse events in the LVAD group remained similar to what was previously reported in the DT trial, with bleeding being the most frequent adverse event.
- Bridge to Transplant: HeartWare = HeartMate II (Ann Thor Surg, Feb 2014)
- ADVANCE trial (bridge to transplant): 94% survival at 180 days with HeartWare
- PPT: LVAD Update 2015
- Anesthesia for LVAD