Table 3.
Primary, secondary, and exploratory intraoperative echocardiographic and perioperative clinical endpoints in the hyperinsulinemic normoglycemic clamp (HNC) and standard therapy groups in patients with aortic stenosis (N=97).
| Variable | N | HNC (N = 49) | N | Standard (N = 48) | Difference (HNC minus Standard) (97.5% CI) | P |
|---|---|---|---|---|---|---|
| Intraoperative echocardiographic parameters | ||||||
| Primary outcomes | ||||||
| LV systolic strain (%)* | 36 | −16.8 ± 4.6 | 36 | −15.9 ± 4.6 | −1.2 (−2.87, 0.48) | 0.11 |
| LV systolic strain rate (sec−1)* | 33 | −1.1 ± 0.3 | 34 | −1.0 ± 0.3 | −0.2 (−0.3, −0.0) | 0.007 |
|
| ||||||
| Secondary outcomes | Difference (95% CI) | |||||
| RV systolic strain (%)* | 26 | −17.2 ± 4.3 | 28 | −17.3 ± 3.7 | −0.6 (−2.6, 1.5) | 0.57 |
| RV systolic strain rate (sec−1)* | 26 | −1.1 ± 0.3 | 28 | −1.1 ± 0.4 | −0.1 (−0.2, 0.1) | 0.45 |
|
| ||||||
| Exploratory outcomes | ||||||
| LV ejection fraction* | 45 | 67 ± 14 | 43 | 66 ± 12 | 5 (0.1, 9.0) | 0.046 |
| Systolic mitral annular velocity ( s′; cm/sec)* | 47 | 7 ± 3 | 44 | 6 ± 2 | 2 (1, 3) | 0.001 |
| Early diastolic mitral annular velocity (e′; cm/sec)* | 47 | 6 ± 2 | 44 | 5 ± 2 | 1 (0, 2) | 0.046 |
| Late diastolic mitral annular velocity (a′; cm/sec)* | 46 | 6 ± 3 | 44 | 5 ± 2 | 1 (0, 2) | 0.23 |
|
| ||||||
| Hemodynamic measures at end of surgery | ||||||
| Mean arterial pressure (mmHg)* | 49 | 73 ± 9 | 47 | 76 ± 11 | −3 (−7, 2) | 0.25 |
| Central venous pressure (mmHg)* | 48 | 15 ± 6 | 45 | 14 ± 6 | 1 (−3, 2) | 0.75 |
| Cardiac output (L/min)* | 36 | 5.4 ± 1.3 | 31 | 4.8 ± 1.4 | 0.3 (−0.3, 0.9) | 0.30 |
| Cardiac index (L/min/m2)* | 36 | 2.6 ± 0.5 | 31 | 2.4 ± 0.6 | 0.1 (−0.2, 0.3) | 0.5 |
| Requiring epinephrine | 49 | 9 (18) | 48 | 9 (19) | 0.98 (0.4, 2.3)** | 0.96 |
| Requiring norepinephrine | 49 | 19 (39) | 48 | 11 (23) | 1.7 (0.9, 3.2)** | 0.09 |
| Requiring milrinone | 49 | 2 (4) | 48 | 2 (4) | 0.98 (0.1, 6.7)** | 0.98 |
|
| ||||||
| Hemodynamic measures 30 min after ICU admission | ||||||
| Mean arterial pressure (mmHg) | 45 | 80 ± 9 | 45 | 79 ± 10 | 1 (−3, 5) | 0.59 |
| Cardiac output (L/min) | 29 | 5.9 ± 1.4 | 32 | 5.3 ± 1.6 | 0.6 (−0.2, 1.4) | 0.13 |
| Cardiac index (L/min/m2) | 28 | 2.9 ± 0.6 | 32 | 2.8 ± 0.8 | 0.1 (−0.3, 0.5) | 0.60 |
| Requiring epinephrine | 49 | 8 (16) | 48 | 7 (15) | 1.1 (0.4, 2.8)** | 0.81 |
| Requiring norepinephrine | 49 | 14 (29) | 48 | 5 (10) | 2.7 (1.1, 7.0)** | 0.03 |
| Requiring milrinone | 49 | 1 (2) | 48 | 0 (0) | NA | 0.32 |
|
| ||||||
| In-hospital time-to-event outcomes | Hazard Ratio | |||||
| Duration of mechanical ventilation (hrs) | 49 | 5 [4, 6] | 48 | 5 [3, 12] | 1.2 (0.8, 1.8) | 0.38 |
| Duration of ICU stay | 49 | 27 [23, 51] | 48 | 28 [22, 49] | 1.0 (0.7, 1.5) | 0.97 |
| Duration of hospital stay (days) | 49 | 6 [5, 8] | 48 | 6 [6, 8] | 1.2 (0.8, 1.8) | 0.70 |
|
| ||||||
| Postoperative binary outcomes | Relative Risk | |||||
| Hospital readmission within 30-days | 49 | 1(2) | 48 | 1(2) | 0.98 (0.06, 15) | 0.99 |
| 30-day mortality | 49 | 0(0) | 48 | 0(0) | NA | NA |
*
The analysis adjusted for the corresponding baseline measurement.
NA = not available due to zero event; LV = left ventricle; RV = right ventricle; ICU = intensive care unit;
**
relative risk (95% CI). +Ratio of means (95% CI)