The Clinical Significance of Portal Hypertension After Cardiac Surgery: a Multicenter Prospective Observational Study (TECHNO-MULTI)

The Clinical Significance of Portal Hypertension After Cardiac Surgery

Portal flow pulsatility detected by Doppler ultrasound is an echographic marker of cardiogenic portal hypertension from right ventricular failure and is associated with adverse outcomes based on previous studies performed at the Montreal Heart Institute. This multicenter prospective cohort study aims to determine if portal flow pulsatility after cardiopulmonary bypass separation is associated with a longer requirement of life support after cardiac surgery.

Study Overview

• Status: Completed
• Conditions: Surgery--Complications; Anesthesia; Congestive Heart Failure; Right Heart Failure; Venous Congestion
• Intervention / Treatment: Diagnostic test: Doppler assessment of portal vein flow

Detailed Description

Hypothesis: Portal flow pulsatility detected by Doppler ultrasound during cardiac surgery is an echographic marker of cardiogenic portal hypertension from right ventricular failure and is associated with adverse clinical outcomes.

Background: Peri-operative right ventricular failure is associated with a high mortality rate. In this context, organ perfusion is hampered by both the reduction of cardiac output and venous congestion from the elevation of central venous pressure. The clinician's objective is to appreciate the hemodynamic impact on end-organs in an effort to adjust the therapy accordingly since the ultimate goal is to optimize their perfusion. Based on this rationale, organ specific blood flow assessment using Doppler ultrasound could be used to personalize management. In order to non-invasively assess the presence of cardiogenic portal hypertension, Doppler ultrasound can be used to detect portal flow pulsatility, an abnormal variation in the velocity of blood flow within the main portal vein. In two single-center cohort studies, the presence of portal flow pulsatility after cardiac surgery was independently associated with post-operative complications such as major bleeding, acute kidney injury (AKI) and delirium as well as increased length of intensive care unit (ICU) stay.

Specific Objectives: This multi-center cohort study aim to determine whether the association between portal flow pulsatility and organ dysfunction seen in previous studies is present across multiple cardiac surgery centers.

• Study Type: Observational
• Enrollment (Actual): 360

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients undergoing cardiac surgery at high risk for complications.

Description

Inclusion Criteria:

• Adult patients (≥18 years old) and able to give informed consent undergoing cardiac surgery with the use of CPB for whom peri-operative TEE is planned.

• High surgical risk defined as at least one of the following:

  1. Multiple surgical procedures planned
  2. EuroSCORE II ≥ 5%
  3. Known pulmonary hypertension (mPAP>25mmHg or sPAP>40mmHg).

Exclusion Criteria:

• Patient with a critical pre-operative state defined as vasopressor requirement, mechanical circulatory support, dialysis, mechanical ventilation or cardiac arrest necessitating resuscitation.
• Patient with known condition that could interfere with portal flow assessment or interpretation (liver cirrhosis, portal vein thrombosis)
• Planned cardiac transplantation
• Planned ventricular assist device implantation

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High risk cardiac surgery patients; Defined as either: Multiple surgical procedures planned and/or,; EuroSCORE ≥ 5% and/or,; Known pulmonary hypertension (mPAP>25 mmHg or sPAP > 40 mmHg)	Diagnostic test: Doppler assessment of portal vein flow; Doppler assessment of portal vein flow using peri-operative trans-esophageal echography before and after cardiopulmonary bypass.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of invasive life support after cardiac surgery. (Tpod)	Defined as the time of Persistent Organ Dysfunction (POD) or Death	Up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause death	Death from any cause	Up to 28 days
Acute kidney injury according to KDIGO serum creatinine criteria	Stage 1: ≥50% or 27 umol/L increases in serum creatinine Stage 2: ≥100% increase in serum creatinine Stage 3 ≥200% increase in serum creatinine or an increase to a level of ≥254 umol/L or dialysis initiation.	Up to 28 days
Major bleeding defined by the Bleeding Academic Research Consortium (BARC)	Perioperative intracranial bleeding within 48h Reoperation after closure of sternotomy for the purpose of controlling bleeding Transfusion of ≥5 units of whole blood of packed red blood cells within a 48 hours period Chest tube output ≥2L within a 24 hours period	Up to 28 days
Surgical reintervention for any reasons	Re-operation after the initial surgery for any cause	Up to 28 days
Deep sternal wound infection or mediastinitis	Diagnosis of a deep incisional surgical site infection or mediastinitis by a surgeon or attending physician.	Up to 28 days
Delirium	Defined as a intensive care delirium screening checklist (ICDSC) score of ≥4 in the week following surgery or positive result for the Confusion Assessment Method for the ICU (CAM-ICU)	Up to 28 days
Stroke	A central neurologic deficit persisting longer than 72 hours	Up to 28 days
Total duration of ICU stay in hours	Number of hours passed in the ICU	Up to 28 days
Duration of hospital stay (in days)	Number of days hospitalized from the day of surgery to discharge	Up to 28 days
Duration of mechanical ventilation (in hours)	Number of hours of mechanical ventilation	Up to 28 days
A composite outcome of major morbidity or mortality (41): including death, prolonged ventilation, stroke, renal failure (Stage ≥2), deep sternal wound infection and reoperation for any reason.	Composite endpoint after cardiac proposed by the Society of Thoracic Surgeons	Up to 28 days

Collaborators and Investigators

• Sponsor: Montreal Heart Institute
• Investigators: Principal Investigator: André Denault, MD PhD, Montreal Heart Institute

Publications and helpful links

General Publications

• Denault A, Couture EJ, De Medicis E, Shim JK, Mazzeffi M, Henderson RA, Langevin S, Dhawan R, Michaud M, Guensch DP, Berger D, Erb JM, Gebhard CE, Royse C, Levy D, Lamarche Y, Dagenais F, Deschamps A, Desjardins G, Beaubien-Souligny W. Perioperative Doppler ultrasound assessment of portal vein flow pulsatility in high-risk cardiac surgery patients: a multicentre prospective cohort study. Br J Anaesth. 2022 Nov;129(5):659-669. doi: 10.1016/j.bja.2022.07.053. Epub 2022 Sep 30.

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2018
• Primary Completion (Actual): February 20, 2021
• Study Completion (Actual): February 20, 2021

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): September 4, 2018

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: echocardiography; Cardiac surgery; Portal Doppler
• Additional Relevant MeSH Terms: Digestive System Diseases; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Liver Diseases; Heart Failure; Hypertension; Hypertension, Portal; Hyperemia
• Other Study ID Numbers: TECHNO-MULTI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No