Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
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- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiogenic Shock, Pulmonary Edema Cardiac Cause. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Accurate hemodynamic monitoring is critical in cardiothoracic surgery, where left atrial pressure (LAP) serves as the gold standard for assessing left-sided cardiac filling pressures. However, its invasive nature limits use, favoring pulmonary capillary wedge pressure (PCWP) via Swan-Ganz catheter as a surrogate. Despite widespread use, evidence on their agreement under dynamic conditions-such as varying cardiac index (CI) flows during cardiopulmonary bypass (CPB) or left ventricular (LV) unloading-remains inconsistent and unstudied in adult cardiac surgery. Existing data show conflicting correlations: one study found that PCWP 35% higher than LAP in non-surgical patients, and another study found closer alignment in specific cohorts. This knowledge gap carries clinical urgency, as decisions on pulmonary edema management, vasopressor use, and LV decompression rely on these measurements. Building on Laplace's law, we hypothesize that LV unloading reduces ventricular wall stress (afterload), lowering myocardial oxygen demand and altering the LAP-PCWP relationship. Elevated CI during CPB may further distort this interaction via increased pulmonary-left atrial pressure gradients. The primary objective is to determine if PCWP reliably reflects LAP under standard CI-flow (2.4 L/min/m²) without unloading, using Bland-Altman analysis (±5 mmHg clinical margin). Secondary objectives assess agreement at other CI levels (1.8-2.6 L/min/m²), LV unloading effects, and patient/surgical variable impacts.
Detailed description
Effective hemodynamic monitoring is essential for optimizing postoperative management in cardiothoracic surgery. Left atrial pressure (LAP) is considered the gold standard for assessing left-sided cardiac filling pressures, but is typically measured directly only in selected cases due to its invasive nature. Pulmonary capillary wedge pressure (PCWP), measured via a Swan-Ganz catheter, is widely used as a less invasive surrogate for LAP. However, evidence suggests that the agreement between PCWP and directly measured LAP may vary under different hemodynamic conditions, particularly at higher cardiac index (CI) flow rates and with or without left ventricular (LV) unloading. To date, no in-vivo study has systematically quantified the agreement between these two methods in adult patients during cardiopulmonary bypass (CPB) at varying flow rates and unloading conditions.
Existing studies report inconsistent correlations between LAP and PCWP. For example, one study observed PCWP values 35% higher than LAP in non-surgical patients, while another study noted tighter correlations in specific cohorts. However, no in-vivo data exist for adult cardiac surgery patients under controlled CI-flow rates (+/- LV unloading). This gap is clinically critical, as decisions regarding pulmonary edema management, vasopressor use, and LV decompression rely on these measurements.
Building on Laplace's law, we hypothesize that LV unloading reduces ventricular wall stress (afterload), thereby lowering myocardial oxygen demand and improving recovery. Computational models and animal studies suggest that unloading decreases LV end-diastolic pressure (LVEDP) and left atrial (LA) volume, which may alter the LAP-PCWP relationship. Elevated CI during CPB could further modulate this interaction, as increased flow rates may exacerbate pressure gradients between the pulmonary vasculature and left atrium.
The primary objective of our study is therefore to determine whether PCWP can be considered an adequate surrogate for directly measured LAP under standard CI-flow (2.4 L/min/m²) without LV unloading, using a Bland-Altman analysis. Secondary objectives include evaluating the agreement between LAP and PCWP at other CI-flow rates and with LV unloading, as well as exploring the influence of patient characteristics and surgical variables. By addressing these questions, we hope to provide evidence to guide the interpretation of PCWP in clinical practice, potentially improving the safety and outcomes of patients undergoing cardiac surgery.
Primary outcome measures
- Agreement between left atrial pressure (LAP) and pulmonary capillary wedge pressure (PCWP) under standard cardiac index (CI) conditions. [Time frame: Intraoperatively]
Secondary outcome measures (11)
- Effect of different cardiac index (CI) flow rates and LV unloading on agreement between left atrial pressure (LAP) and pulmonary capillary wedge pressure (PCWP) [Time frame: Intraoperatively]
- Pre- and postoperative changes in left atrial pressure (LAP) and pulmonary capillary wedge pressure (PCWP) in mitral valve patients [Time frame: Intraoperatively]
- Association between echocardiographic parameters and invasive pressure measurements: LVEDV [Time frame: Intraoperatively]
- Association between echocardiographic parameters and invasive pressure measurements: LV wall thickness [Time frame: Intraoperatively]
- Association between echocardiographic parameters and invasive pressure measurements: LVEF [Time frame: Intraoperatively]
- Association between echocardiographic parameters and invasive pressure measurements: E/e' [Time frame: Intraoperatively]
- Association between echocardiographic parameters and invasive pressure measurements: TAPSE [Time frame: Intraoperatively]
- Association between echocardiographic parameters and invasive pressure measurements: mitral regurgitation grade [Time frame: Intraoperatively]
- Association between echocardiographic parameters and invasive pressure measurements: LAVI [Time frame: Intraoperatively]
- Association between echocardiographic parameters and invasive pressure measurements: RAVI [Time frame: Intraoperatively]
- Association between echocardiographic parameters and invasive pressure measurements: LVOT dimensions [Time frame: Intraoperatively]
Eligibility criteria
Inclusion criteria
- the primary procedure is cardiac surgery by median sternotomy
- the use of CPB
- 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)
- left ventricular ejection fraction of 60% or more
- no clinical or echocardiographic signs of preoperative decompensation cordis
- only elective procedures
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07163052 · HEART