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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-26

Study Completion Date

2019-05-24

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.

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Pulmonary endarterectomy patients

All patients

Group Type EXPERIMENTAL

All patients

Intervention Type OTHER

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.

Interventions

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All patients

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.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No