Perioperative Management & Outcome Following Preoperative Transthoracic Echocardiography in Noncardiac Surgery Patients

EuPreCHO: European Study on Perioperative Management and Outcome Following Preoperative Transthoracic Echocardiography in Noncardiac Surgery Patients

In August 2022 the European Society of Cardiology published updated guidelines including recommendations on preoperative transthoracic echocardiography. The update resulted in broadened criteria for preoperative transthoracic echocardiography. The impact of preoperative transthoracic echocardiography on outcome is controversial and the evidence was mostly derived from administrative databases. Also there is also a knowledge gap in terms of what changes in perioperative managements are derived from transthoracic echocardiography information in current daily practice in Europe and what their impact on outcome may be. Further, a secondary analysis in a large international cohort suggests that the criteria endorsed by the guidelines to define the class of recommendation of transthoracic echocardiography may not be efficient.

Study Overview

• Status: Not yet recruiting
• Conditions: Elective Surgical Procedure
• Intervention / Treatment: Other: Transthoracic Echocardiography Recieved

Detailed Description

The target population consists of patients at elevated cardiovascular risk undergoing elective, intermediate or high-risk noncardiac surgery. The planned sample size is 5500 exposed and 2750 non-exposed

• Study Type: Observational
• Enrollment (Estimated): 8250

Contacts and Locations

• Study Contact: Name: Saman Sepehr; Phone Number: 3222273999; Email: saman.sepehr@esaic.org

Study Locations

• Germany
  • Düsseldorf, Germany, 40225
    • University Hospital Düsseldorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

EuPreCHO is a prospective, international, case control study. RQ3 will be assessed in a cohort consisting of the cases only. Any hospital in Europe (as defined by the World Health Organisation) is welcome to participate as a study centre. Study centre registration occurs online via the dedicated Call for Centres form on the ESAIC website. Centres will be asked to enroll a minimum of 50 cases and 25 controls within the 12-month period planned for EuPreCHO enrollment. Within the enrollment period, the start of recruitment for individual centres is at the discretion of the local PI, provided that there is a prior IRB approval. Recruitment across all centres will continue until enrollment of the planned sample size.

Description

Inclusion Criteria

• aged ≥65 years OR
• above 18 years and presenting ≥2 cardiovascular risk factors (hypertension, smoking, dyslipidaemia, diabetes, family history of CVD) OR
• above 18 years with known cardiovascular disease

Exclusion Criteria

• under 18 years of age
• day surgery
• urgent/emergency procedures
• current ICU patient (i.e. in ICU on day-1 or the day of the index surgery (day 0)),
• cardiac surgery within the last month prior according to the index noncardiac procedure (of note this does not include cardiological interventions like TAVI or valvuloplasty),
• unwilling or unable to provide informed consent,
• unable to complete the WHODAS questionnaire (literacy or language barrier)
• Previous enrollment in EuPreCHO (in case of repeated surgery)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exposed group; 5500 exposed group will be patients in whom Transthoracic Echocardiography was performed within 3 months before surgery. Controls will be patients in whom Transthoracic Echocardiography was NOT performed.	Other: Transthoracic Echocardiography Recieved; Transthoracic Echocardiography Recieved

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Pathology	Decreased contractility (LVEF ≤40% by Simpson's method or eyeballing) or based on corresponding qualitative statement in TTE report. Significant LV diastoic: E/A <0.8 + E>50cm/sec OR E/A >0.8 to <2 + at least ≥ 2 additional criteria ( Average E/e' ratio >14, peak TR velocity >2,8 m/sec, LA volume index >34 mL/m2.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability-free survival at 30 days	WHODAS scale-none=0 to extreme=4, for a total maximal score of 48 and transformed into the percentage of maximal disability score	30 days

Collaborators and Investigators

• Sponsor: European Society of Anaesthesiology
• Investigators: Principal Investigator: Giovanna Lurati Buse, Prof, University Hospital Düsseldorf

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: transthoracic echocardiography
• Other Study ID Numbers: EuPreCHO

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