Table 11. Adverse Events.
| Intermacs: June 2006 – March 2009 Primary LVAD: n=1092 Adverse Event Rates (events/100 patient months) in the 1st 12 months post implant | ||
|---|---|---|
| Adverse Event | events | rate |
| Device Malfunction | 113 | 1.98 |
| Bleeding | 944 | 16.52 |
| Cardiac/Vascular | ||
| Right Heart Failure | 108 | 1.89 |
| Myocardial Infarction | 4 | 0.07 |
| Cardiac Arrhythmia | 439 | 7.68 |
| Pericardial Drainage | 86 | 1.50 |
| Hypertension* | 132 | 2.31 |
| Arterial Non-CNS Thromb | 20 | 0.35 |
| Venous Thrombo Event | 83 | 1.45 |
| Hemolysis | 31 | 0.54 |
| Infection | 998 | 17.46 |
| Neurological Dysfunction | 164 | 2.87 |
| Renal Dysfunction | 142 | 2.48 |
| Hepatic Dysfunction | 52 | 0.91 |
| Respiratory Failure | 257 | 4.50 |
| Wound Dehiscence | 27 | 0.47 |
| Psychiatric Episode | 112 | 1.96 |
|
| ||
| Total “Burden” | 3712 | 64.96 |
*
Hypertension: with current reporting, identification of hypertension with continuous flow pumps is unreliable
Unajudicated data