Initial Clinical Experience With the VentrAssist Left Ventricular Assist Device: The Pilot Trial

Right heart failure and “failure to thrive” after left ventricular assist device: Clinical predictors and outcomes

“…20,21 These figures, however, do not consider functionality and quality of life, and the DT patients in our study were less likely to thrive in the longer-term compared with BTT patients. This is likely partly due to their older age and other clinical factors that may have precluded consideration for transplantation.…”

Changes in Right Ventricular Function During Continuous-low Left Ventricular Assist Device Support

“…The first 9 patients were participants of a single-center pilot study where the VentrAssist was implanted in 4 elderly non-transplant candidates as destination therapy and later, after a protocol amendment, in 5 high-risk transplant-eligible patients. 15 The high-risk patients were defined as those unlikely to receive an approved device for bridge-to-transplant due to age, small body (body surface area Ͻ 1.7 m 2 ), presumably longer bridge-totransplant time (Ͼ 3 months), or covert infection. Patients with refractory right-sided HF or liver enzyme levels exceeding 10 times the upper limit of normal and those with a serum creatinine level exceeding 220 mol/liter were excluded.…”

Left Ventricular Assist Devices: From the Bench to the Clinic

“…This pump was tested in the animal lab over an approximate 4-year period with a cumulative experience of 55 sheep and a total support time of 4.8 years [26,27]. The results of the single-arm multicenter BTT clinical trial of 33 patients demonstrated that at the 154-day prespecified postimplant trial end point, 39.4% of patients were transplanted and 42.4% continued on device support with transplant eligible status with a total success rate of 82%, meeting the primary outcome of survival to transplant or continued transplant eligibility while on device support [28]. However, soon after this trial was completed, the company was declared bankrupt and this device is no longer available for clinical use.…”