Echocardiography as Risk-Assessment for Major Adverse Cardiac Events in Major Vascular Surgery Patients

NCT04836702 | Completed

• 1 other identifier: 20906
• Study Type: observational
• Target: 813
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patient with coronary artery disease (CAD), heart failure and abnormal heart function undergoing major vascular surgery have a high associated high morbidity and mortality with myocardial infarction accounting for 33-50% of perioperative deaths. The prevalence of CAD in vascular surgery patients approaches 50%. Proper pre-procedure protocols to accurately assess patients and determine who may require further medical optimization prior to undergoing surgery help mitigate risk and improve outcomes. The investigators designed this study as a single center, retrospective cohort analysis to explore the association between ventricular (LV and RV function) and valvular (Aortic / Mitral / Tricuspid) function and expanded major adverse cardiac events (X-MACE).

Conditions

Left-Sided Heart Failure; Right-Sided Heart Failure; Heart Valve Diseases

Keywords

major vascular surgery; major adverse cardiac events

Outcome Measures

Primary Outcomes (1)

• Expanded Major Adverse Cardiac Events

  Composite outcome defined as any cardiovascular death, non-fatal MI, non-fatal stroke, post-operative CHF, or new dysrhythmias, all within the index hospital admission.

  In-hospital admission (within 120 days of index surgery)

Study Arms (3)

Left ventricular function

* Depressed LV function 1. LV ejection fraction \< 50% 2. LV systolic function; defined as mild / mod / sev decreased 3. LV diastolic function; defined as mild (g1 ) / mod (g2) / sev ( g3) decreased * Normal LV function

Right ventricular function

* Depressed RV function a. RV systolic function defined as mild / mod / sev decreased * Normal RV function

Valvular lesions

* Moderate or severe valvular lesions 1. Aortic stenosis 2. Aortic regurgitation 3. Mitral stenosis 4. Mitral regurgitation 5. Tricuspid regurgitation * Clinically normal valvular lesions 1. No valvular lesion 2. Mild stenosis / regurgitation of above mentioned lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent major vascular surgery operations at the University of Virginia

You may qualify if:

• Major vascular surgery operation (e.g. CEA, open aortic repair, suprainguinal and infrainguinal bypasses, EVAR, TEVAR) captured in the UVA Vascular Quality Initiative database
• Echocardiography within two years of index operation

You may not qualify if:

• If patient had additional qualifying vascular procedure within 30 days of the index operation, this procedure was excluded

Sponsors & Collaborators

• University of Virginia: lead

Related Publications (7)

• Reis PV, Lopes AI, Leite D, Moreira J, Mendes L, Ferraz S, Amaral T, Mourao J, Abelha F. Major Cardiac Events in Patients Admitted to Intensive Care After Vascular Noncardiac Surgery: A Retrospective Cohort. Semin Cardiothorac Vasc Anesth. 2019 Sep;23(3):293-299. doi: 10.1177/1089253218825442. Epub 2019 Jan 25.

  PMID: 30678531 BACKGROUND

• Golubovic M, Peric V, Stanojevic D, Lazarevic M, Jovanovic N, Ilic N, Djordjevic M, Kostic T, Milic D. Potential New Approaches in Predicting Adverse Cardiac Events One Month after Major Vascular Surgery. Med Princ Pract. 2019;28(1):63-69. doi: 10.1159/000495079. Epub 2018 Nov 4.

  PMID: 30391950 BACKGROUND

• Ouriel K, Green RM, DeWeese JA, Varon ME. Outpatient echocardiography as a predictor of perioperative cardiac morbidity after peripheral vascular surgical procedures. J Vasc Surg. 1995 Dec;22(6):671-7; discussion 678-9. doi: 10.1016/s0741-5214(95)70057-9.

  PMID: 8523601 BACKGROUND

• Flu WJ, van Kuijk JP, Hoeks SE, Kuiper R, Schouten O, Goei D, Elhendy A, Verhagen HJ, Thomson IR, Bax JJ, Fleisher LA, Poldermans D. Prognostic implications of asymptomatic left ventricular dysfunction in patients undergoing vascular surgery. Anesthesiology. 2010 Jun;112(6):1316-24. doi: 10.1097/ALN.0b013e3181da89ca.

  PMID: 20502115 BACKGROUND

• Lerman BJ, Popat RA, Assimes TL, Heidenreich PA, Wren SM. Association of Left Ventricular Ejection Fraction and Symptoms With Mortality After Elective Noncardiac Surgery Among Patients With Heart Failure. JAMA. 2019 Feb 12;321(6):572-579. doi: 10.1001/jama.2019.0156.

  PMID: 30747965 BACKGROUND

• Matyal R, Hess PE, Subramaniam B, Mitchell J, Panzica PJ, Pomposelli F, Mahmood F. Perioperative diastolic dysfunction during vascular surgery and its association with postoperative outcome. J Vasc Surg. 2009 Jul;50(1):70-6. doi: 10.1016/j.jvs.2008.12.032.

  PMID: 19563954 BACKGROUND

• Meyer MJ, Jameson SA, Gillig EJ, Aggarwal A, Ratcliffe SJ, Baldwin M, Singh KE, Clouse WD, Blank RS. Clinical implications of preoperative echocardiographic findings on cardiovascular outcomes following vascular surgery: An observational trial. PLoS One. 2023 Jan 19;18(1):e0280531. doi: 10.1371/journal.pone.0280531. eCollection 2023.

  PMID: 36656845 DERIVED

MeSH Terms

Conditions

Heart Failure; Heart Valve Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

• Matthew Meyer, MD

  Assistant Professor of Anesthesiology at University of Virginia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 8, 2021
• Study Start: January 1, 2011
• Primary Completion: June 23, 2020
• Study Completion: March 21, 2022
• Last Updated: June 14, 2024

Record last verified: 2024-06