Table 1.
Probabilities of Major Events per Monthly Cycle—BTT and DT
| Event | BTT | DT | Reference |
|---|---|---|---|
| Stroke | |||
| Ischemic | 0.007 | 0.014 | †‡ |
| Hemorrhagic | 0.007 | 0.005 | †‡ |
| Pump exchange | |||
| VAD thrombus | 0.003 | 0.005 | †‡ |
| VAD failure | 0.002 | 0.001 | †‡ |
| Driveline Infection | 0.021 | 0.020 | †‡ |
| GI bleed | 0.023 | 0.048 | †‡ |
| RHF | 0.031 | 0.023 | †‡ |
| RVAD | 11% | 7% | †‡ |
| Other AEs | 0.043 | 0.380 | †‡ |
| MM stroke | 0.002 | 0.002 | 12 |
| MM readmission (apart from stroke) | 0.300 | 0.300 | 12 |
| Heart transplant rate | 2.83% | — | 22 |
The values presented at the table are transformed monthly event rates as used in the model.
*Based on ENDURANCE Supplemental19 Data. Medtronic Internal Data on File.
BTT, bridge-to-transplant; DT, destination therapy; VAD, ventricular assist device; GI, Gastrointestinal; RHF, right heart failure; RVAD, right ventricular assist device; AE, adverse event; MM, medical management