Table 1.
Demographic and clinical characteristics and response to cooling procedure.
| Patient Number | 1 | 2 | 3 | 4 | 5 |
|---|---|---|---|---|---|
| Decade of life | Seventh | Seventh | Fifth | Seventh | Ninth |
| Clinical presentation | Coronary artery disease | Aortic stenosis, coronary artery disease | Coronary artery disease | Coronary artery disease | Coronary artery disease |
| Body weight (kg) | 68 | 136 | 105 | 77 | 102 |
| Length of surgery (minutes) | 62 | 97 | 67 | 68 | 110 |
| Length of X-clamp (minutes) | 47 | 70 | 45 | 49 | 89 |
| Body core temperature before cooling (°C) | 35.0 | 36.4 | 35.9 | 35.9 | 36 |
| Brain temperature before cooling (°C) | 36.7 | 35.7 | 35.4 | 35 | 34.9 |
| Setting of heater/chiller T (°C) | 12 | 12 | 12 | 6 | 2 |
| Duration of cooling by NeuroSave system (minutes) | NA | 65 | 89 | 79 | 56 |
| Adverse events and serious adverse eventsa | Blurred vision Pulmonary edema Peripheral edema Paroxysmal atrial fibrillation |
Anemia Rapid atrial fibrillation Left pneumothoraxa |
Hypotension Patient fall Rapid atrial fibrillation Wheezing Right pneumothoraxa |
Low hemoglobin Sinus tachycardia Confusion and hallucination |
Confusion Peripheral edema Fluid overload |
a
All adverse events and serious adverse events occurred post-procedure, and none of the events were deemed device-related based upon an independent medical review.