Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients

NCT07163052 | Not Yet Recruiting DMC

• 1 other identifier: HEART
• Study Type: observational
• Target: 136
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cardiogenic Shock; Pulmonary Edema Cardiac Cause

Keywords

LV unloading; post-cardiotomy shock; PCS; filling pressures

Outcome Measures

Primary Outcomes (1)

• Agreement between left atrial pressure (LAP) and pulmonary capillary wedge pressure (PCWP) under standard cardiac index (CI) conditions.

  The primary outcome is the mean absolute difference between LAP and PCWP, quantified using Bland-Altman analysis. PCWP will be considered an adequate surrogate for LAP if the 95% limits of agreement fall within ±5 mmHg. Independent: cardiac index fixed at 2.4 L/min/m² without LV unloading Dependent: difference between LAP and PCWP (mmHg)

  Intraoperatively

Secondary Outcomes (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)

  Intraoperatively

• Pre- and postoperative changes in left atrial pressure (LAP) and pulmonary capillary wedge pressure (PCWP) in mitral valve patients

  Intraoperatively

• Association between echocardiographic parameters and invasive pressure measurements: LVEDV

  Intraoperatively

• Association between echocardiographic parameters and invasive pressure measurements: LV wall thickness

  Intraoperatively

• Association between echocardiographic parameters and invasive pressure measurements: LVEF

  Intraoperatively

Study Arms (1)

Total cohort

Patients with and without LV unloading under different cardiac indeces via cardiopulmonary bypass

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective cardiac surgery for aortic valve regurgitation, mitral valve, coronary or aortic disease. We aim to include patients without significant impairment in cardiac function. Nonetheless, there are inherent primary and secondary effects of cardiac pathology leading to structural disease. The procedures, as noted in the inclusion criteria (4.2), are standard procedures in our hospital and are regularly performed. We want to select the patient from our wait list. No extra measures are taken to include the patients.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

MeSH Terms

Conditions

Shock, Cardiogenic; Heart Failure

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Central Study Contacts

B U Baldan, MD

CONTACT

020 566 9111; b.u.baldan@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident cardiac surgery, MD

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 9, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share