Perioperative Portal Vein Pulsatility as a Postoperative Prognostic Indicator in Pulmonary Endarterectomy

Study Overview
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Brief Summary
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The investigators aim to evaluate the utility of portal vein pulsatility as a predictor of the composite outcome of persistent organ dysfunction plus death in patients undergoing elective or urgent pulmonary endarterectomy for thromboembolic pulmonary hypertension. The investigators' hypothesis is that the portal vein pulsatility fraction, measured using transesophageal echocardiography immediately after weaning of cardiopulmonary bypass, is proportional to the risk of developing subsequent end-organ dysfunction in the postoperative setting.

Detailed Description
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While transesophageal echocardiography is recommended in patients with known or suspected cardiovascular pathology which may impact outcomes, no study has evaluated it's perioperative use in pulmonary endarterectomy surgery. Most pulmonary endarterectomy patients suffer from severe pulmonary hypertension, right heart dysfunction and central venous hypertension. Postoperative complications are closely related to the importance of residual postoperative pulmonary hypertension and right ventricular dysfunction. A portal vein pulsatility fraction of 50% or more in the perioperative setting might indicate right ventricular dysfunction and/or hypervolemia-related severe venous congestion, which may be responsible for multiple organ dysfunction and significant morbidity or mortality in critically ill patients. The investigators believe pulmonary endarterectomy patients with a high portal vein pulsatility fraction immediately after weaning from cardiopulmonary bypass have a greater risk of developing postoperative persistent organ dysfunction and/or death. In this prospective descriptive study, the investigators will evaluate portal vein pulsatility as a predictor of the composite outcome of persistent organ dysfunction plus death 7 days after pulmonary endarterectomy. Left and right global longitudinal strain after weaning from cardiopulmonary bypass will also be evaluated as potential indicators of a higher risk of persistent organ dysfunction plus death 7 days after surgery.

Official Title
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Perioperative Transesophageal Portal Vein Pulsatility as a Predictor of Persistent Organ Dysfunction Plus Death 7 Days After Pulmonary Endarterectomy

Conditions
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Pulmonary Hypertension, Thromboembolism, Pulmonary, Perioperative/Postoperative Complications, Venous Hypertension, Cardiac Failure

Intervention / Treatment
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* Other: All patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Elective or urgent pulmonary endarterectomy Exclusion Criteria: absolute or relative contraindication to the use of transesophageal echocardiography, hepatic cirrhosis, portal vein thrombosis, concomitant coronary artery bypass grafting, patient refusal or unable to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with chronic post-embolic pulmonary hypertension eligible to pulmonary endarterectomy surgery will be evaluated for venous congestion and right ventricular failure after weaning of cardiopulmonary bypass, and followed until the 7th postoperative day for the development of postoperative organ dysfunction and/or death.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulmonary endarterectomy patients<br>All patients | Other: All patients<br>* TEE is performed before cardiopulmonary bypass (before the opening of the pericardium, if possible) and immediately after weaning from cardiopulmonary bypass and optimization of the hemodynamic status by the attending anesthesiologist. A detailed ultrasound examination including portal vein pulsatility, splenic vein pulsatility, right and left ventricular global longitudinal strain and right and left systolic and diastolic function is recorded. A measure of portal vein pulsatility using TTE is also recorded before the onset of general anesthesia and on the morning of the 7th postoperative day. On the 7th postoperative day, the investigators will evaluate for the presence of the primary outcome, POD + death.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistent organ dysfunction plus death (POD + death) 7 days after surgery | POD + death, defined as death or one of the following criterias (yes or no) present on the 7th postoperative day : (1) mechanical ventilation (excluding non-invasive ventilation) without breaks for more than 48 hours, (2) ongoing need for vasopressor therapy more than 2 hours per day (dopamine more than 5 mcg/kg/min, phenylephrine more than 50 mcg/min, norepinephrine, epinephrine, vasopressin), (3) ongoing need for mechanical circulatory support such as ECMO or IABP, and (4) continuous renal replacement therapy or new intermittent hemodialysis. | On the morning of the 7th postoperative day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous hypertension, Venous congestion, Strain, Right ventricular dysfunction, Pulmonary hypertension, Transesophageal ultrasound, TEE, Portal vein pulsatility, Splenic vein pulsatility