Table 12. Adverse Events.
| Intermacs: June 2006 – March 2009 Primary LVAD; BTT and BTC n=954 | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Rates (events/100 patient months) in the 1st 6 months post implant | ||||||
| Adverse Event | Pulsatile (n=406) | Continuous (n=548) | Pulsatile/Continuous | |||
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| events | rate | events | rate | ratio | p-value | |
| Device Malfunction | 45 | 2.95 | 17 | 0.82 | 3.60 | < .0001 |
| Bleeding | 369 | 24.22 | 360 | 17.41 | 1.39 | < .0001 |
| Cardiac/Vascular | ||||||
| Right Heart Failure | 48 | 3.15 | 46 | 2.23 | 1.41 | .05 |
| Myocardial Infarction | 2 | 0.13 | 2 | 0.10 | 1.30 | .37 |
| Cardiac Arrhythmia | 154 | 10.11 | 218 | 10.54 | 0.96 | .65 |
| Pericardial Drainage | 44 | 2.89 | 30 | 1.45 | 1.99 | .003 |
| Hypertension* | 75 | 4.92 | 17 | 0.82 | 6.00 | < .0001 |
| Arterial Non-CNS Thromb | 7 | 0.46 | 6 | 0.29 | 1.59 | .21 |
| Venous Thromb Event | 38 | 2.49 | 32 | 1.55 | 1.61 | .03 |
| Hemolysis | 11 | 0.72 | 12 | 0.58 | 1.24 | .29 |
| Infection | 431 | 28.29 | 244 | 11.80 | 2.40 | < .0001 |
| Neurological Dysfunction | 66 | 4.33 | 40 | 1.93 | 2.24 | < .0001 |
| Renal Dysfunction | 63 | 4.14 | 45 | 2.18 | 1.90 | .0007 |
| Hepatic Dysfunction | 24 | 1.58 | 14 | 0.68 | 2.32 | .009 |
| Respiratory Failure | 121 | 7.94 | 89 | 4.31 | 1.84 | < .0001 |
| Wound Dehiscence | 8 | 0.53 | 9 | 0.44 | 1.20 | .34 |
| Psychiatric Episode | 43 | 2.82 | 38 | 1.84 | 1.53 | .03 |
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| Total “Burden” | 1549 | 101.69 | 1219 | 58.96 | 1.72 | < .0001 |
*
Hypertension: with current reporting, identification of hypertension with continuous flow pumps is unreliable