mechanische circulatoire ondersteuning met of zonder unloading afterload resistance
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. the primary procedure is cardiac surgery by median sternotomy 2. the use of CPB 3. patients undergoing aortic valve replacement (AVR) due to aortic regurgitation, mitral valve plasty (MVP), mitral valve repair (MVR), valve sparing aortic root replacement or supracoronary aorta ascendens replacement (SCAR) 4. left ventricular ejection fraction of 60% or more 5. no clinical or echocardiographic signs of preoperative decompensation cordis 6. only elective procedures
Exclusion criteria
Exclusion criteria: - patients with left ventricular hypertrophy (LVH), severe aortic stenosis or hypertrophic obstructive cardiomyopathy. LVH is defined as an increased LVMI greater than 95 grams per square meter (g/m²) in women and greater than 115 g/m² in men. - patients with echocardiographically observed RV or LV dilatation are assessed using specific criteria. For RV dilatation, a TAPSE of less than 14 millimeters or an RV FAC of less than 35% is indicative of dilatation. For LV dilatation, an LV end-diastolic (LVED) diameter greater than 2.7 centimeters per square meter or exceeding 117% of the predicted value, adjusted for age and body surface area, is considered dilated. - patients undergoing more than one type of procedure (i.e. double valve surgery, CABG and AVR) - postoperative aortic valve mean pressure gradient of more than 20 mm Hg and mitral valve mean pressure gradient of more than 5 mm Hg - postoperative paravalvular leak grade 2 or more - postoperative persistent regional wall abnormalities or electrocardiographic signs of acute ischemia - other significant valve pathology, such as moderate mitral regurgitation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the mean absolute difference between measured LAP and PCWP under standard CI flow (2.4 L/min/m²) without LV unloading, analyzed via the Bland-Altman method. PCWP will be considered an adequate surrogate for LAP if 95% of the limits of agreement fall within ±4 mmHg. This margin adheres to the methodological requirement that the clinically relevant delta must exceed 1.96 × the SD of the differences. With an expected SD of 2.0 mmHg, a delta of 4 mmHg satisfies this criterion (1.96 × 2.0 = 3.92 mmHg). | — |
Secondary
| Measure | Time frame |
|---|---|
| Demographic and clinical information Variables: age, sex, ethnicity, BMI, smoking status, medication history, comorbidities (diabetes, hypertension, chronic kidney disease). Analysis: descriptive statistics (means, medians, percentages) and association analyses (chi-square, t-tests, linear regression). Echocardiographic parameters Variables: LVEF, LVEDV, LV hypertrophy, LV dilatation, LVOT dimension, E/e* ratio, RV function, RV dilatation, TAPSE, mitral valve regurgitation grade, left and right atrial volume index (LAVI/RAVI). Analysis: creation of pressure-volume loops using echocardiographic volume measurements and LAP/PCWP pressures. Pre- and postoperative LAP measurements in mitral valve surgery Variables: changes in LAP before and after correction of mitral valve pathology. Analysis: paired t-tests or Wilcoxon signed-rank test. Surgical variables Variables: aortic cross-clamp time (AoX), CPB time, type and amount of cardioplegia. Analysis: correlation and variance analyses (ANOVA/Kruskal-Wallis). Hemodynamic parameters Variables: CI flow (1.8, 2.0, 2.4, 2.6 L/min/m²) and LV unloading (yes/no). Analysis: linear mixed models (for repeated measures) and Bland-Altman plots per condition. Clinical and operative variables Descriptive statistics for postoperative complications, regional wall motion abnormalities, and ST-T changes. | — |
Countries
Netherlands
Outcome results
None listed