Thoracic Epidural Reduces Risks of Increased Left Ventricular Mass Index During Coronary Artery Bypass Graft Surgery

High Thoracic Epidural Reduces Risks of Increased Left Ventricular Mass Index and Coronary Vascular Disease During Aortic Valve Replacement Alone or in Addition to Coronary Artery Bypass Graft Surgery

Increased left ventricular mass index (LVMI) results from aortic valve lesions as an adaptive mechanism to help limit systolic wall stress and preserve ejection fraction (EF). This study Aim to investigate the effects of sympathetic blockade by HTEA on systolic and diastolic LV function in patients undergoing aortic valve replacement (AVR) alone or in addition to coronary artery bypass graft (CABG). It Designs as A prospective randomized controlled comparative study in which eighty patients received either general anesthesia ( control group n=40) or with high thoracic epidural analgesia(HTEA group n=40). Each group subdivided to normal (LVM) (n=20)or increased(LVM) group(n=20), all submitted to (AVR) alone or in addition to (CABG).

Study Overview

• Status: Completed
• Conditions: Ischemia Coronary Artery Origin
• Intervention / Treatment: Device: thoracic epidural

Detailed Description

Background: Increased left ventricular mass index (LVMI) results from aortic valve lesions as an adaptive mechanism to help limit systolic wall stress and preserve ejection fraction (EF).

Aim: to investigate the effects of sympathetic blockade by HTEA on systolic and diastolic LV function in patients undergoing aortic valve replacement (AVR) alone or in addition to coronary artery bypass graft (CABG).

Design: A prospective randomized controlled comparative study. Methods: Eighty patients received either general anesthesia ( control group n=40) or with high thoracic epidural analgesia(HTEA group n=40). Each group subdivided to normal (LVM) (n=20)or increased(LVM) group(n=20), all submitted to (AVR) alone or in addition to (CABG).Perioperative heart rate (HR), mean arterial blood pressure (MAP), incidence of ischemic ECG, LV systolic and diastolic function changes were measured till 48 h, postoperatively.

Patients were subjected to ambulatory Holter monitoring, Hemodynamic measures, intraoperative transesophageal echocardiography (iTEE) and postoperative Trans Thoracic Echocardiography (TTE) to assess myocardial ischemia and Left ventricular systolic/diastolic function.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Ahmed Said Elgebaly

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 75 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients between 65 and 75 years with:
• physical status of ASA II and IV
• who underwent aortic valve replacement (for isolated or mixed aortic valve lesions) alone or in addition to-coronary artery bypass grafting. in the Cardio-thoracic Surgery Department of Tanta University Hospital during a two year period were enrolled in this study.
• Before inclusion in the study, all patients were evaluated with extended echocardiographic imaging, full history including cardiac symptoms (dyspnea, orthopnea, paroxysmal nocturnal dyspnea, chest pain, and low cardiac output symptoms) was taken from all patients. General (including body weight and height) and systematic (including cardiac examination) examinations were done to all patients.

Exclusion Criteria:

• Patients with an ejection fraction of 0.3, myocardial infarction within the last 4 weeks
• diabetes
• severe pulmonary or arterial hypertension.
• a contraindication for HTEA.
• patients without preoperative optimal echocardiographic imaging were excluded.
• Among the exclusion criteria were the administration of ticlopidine within 15 days before surgery and the administration of platelet glycoprotein IIb/IIIa inhibitors. In common with previous investigators, we did not consider treatment with low-molecular-weight heparin and aspirin below the dosage of 160 mg/day to be contraindications to the procedure.
• Patients with significant aortic insufficiency were also excluded from the study in order to avoid introducing further variables that could influence hemodynamic response to the procedure.
• Patients were excluded if they underwent an AVR on an emergency basis, had poor acoustic windows for adequate echocardiographic assessment, and/or did not undergo an echocardiogram before the operation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HTEA Group + N(LVMI)+ AVR alone(n=10)	Device: thoracic epidural; high thoracic epidural anesthesia (HTEA) combined with GA, transesophageal, transthoracic echocardiography and Holter ECG; Other Names: high thoracic epidural anesthesia (HTEA) combined with GA; transesophageal and transthoracic echocardiography; Holter ECG
Active Comparator: HTEA Group + ↑ (LVMI)+ AVR alone(n=10)	Device: thoracic epidural; high thoracic epidural anesthesia (HTEA) combined with GA, transesophageal, transthoracic echocardiography and Holter ECG; Other Names: high thoracic epidural anesthesia (HTEA) combined with GA; transesophageal and transthoracic echocardiography; Holter ECG
Active Comparator: HTEA Group + N(LVMI)+ AVR + CABG(n=10)	Device: thoracic epidural; high thoracic epidural anesthesia (HTEA) combined with GA, transesophageal, transthoracic echocardiography and Holter ECG; Other Names: high thoracic epidural anesthesia (HTEA) combined with GA; transesophageal and transthoracic echocardiography; Holter ECG
Active Comparator: HTEA Group +↑ (LVMI)+ AVR + CABG(n=10)	Device: thoracic epidural; high thoracic epidural anesthesia (HTEA) combined with GA, transesophageal, transthoracic echocardiography and Holter ECG; Other Names: high thoracic epidural anesthesia (HTEA) combined with GA; transesophageal and transthoracic echocardiography; Holter ECG
No Intervention: Control(GA) Group+ N(LVMI)+ AVR alone(n=10)
No Intervention: Control(GA) Group+ ↑ (LVMI)+ AVR alone(n=10)
No Intervention: Control(GA) Group+ N(LVMI)+ AVR + CABG(n=10); (GA) Group+ N(LVMI)+ AVR + CABG(n=10)
No Intervention: Control(GA) Group+↑ (LVMI)+ AVR + CABG(n=10)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changes in LV systolic.	LV end systolic diameter (LVESD)	5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively.
The changes in LV diastolic.	Left ventricular end diastolic diameter (LVEDD)	5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively.
ejection fraction percent	changes in percentage, of how much blood the left ventricle pumps out with each contraction.	5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively.
FAC percent	Fractional Area Change (FAC) percent Fractional Area Change (FAC)	5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively.
EDA	end-diastolic area (EDA)	5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative changes in heart rate (HR).	during evaluation of hemodynamic changes.	5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively
changes in mean arterial blood pressure (MAP)	during evaluation of hemodynamic changes.	5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively
the changes incidence of ischemic ECG.	Holter monitor tapes were analyzed for myocardial ischemia based the criteria of horizontal or down-sloping ST-segment depression of > 1 mm below the baseline, lasting for at least 1 min. Events were separated by at least 5 min without ECG ischemia ECG changes included new ST-T changes, T inversion, Q waves and/or a bundle branch block	5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively

Collaborators and Investigators

• Sponsor: Ahmed Said Elgebaly,MD
• Collaborators: Tanta University
• Investigators: Principal Investigator: ahmed S Elgebaly, MD, assist .professor

Publications and helpful links

General Publications

• Schmidt C, Hinder F, Van Aken H, Theilmeier G, Bruch C, Wirtz SP, Burkle H, Guhs T, Rothenburger M, Berendes E. The effect of high thoracic epidural anesthesia on systolic and diastolic left ventricular function in patients with coronary artery disease. Anesth Analg. 2005 Jun;100(6):1561-1569. doi: 10.1213/01.ANE.0000154963.29271.36.
• Berendes E, Schmidt C, Van Aken H, Hartlage MG, Wirtz S, Reinecke H, Rothenburger M, Scheld HH, Schluter B, Brodner G, Walter M. Reversible cardiac sympathectomy by high thoracic epidural anesthesia improves regional left ventricular function in patients undergoing coronary artery bypass grafting: a randomized trial. Arch Surg. 2003 Dec;138(12):1283-90; discussion 1291. doi: 10.1001/archsurg.138.12.1283.
• Blomberg S, Emanuelsson H, Kvist H, Lamm C, Ponten J, Waagstein F, Ricksten SE. Effects of thoracic epidural anesthesia on coronary arteries and arterioles in patients with coronary artery disease. Anesthesiology. 1990 Nov;73(5):840-7. doi: 10.1097/00000542-199011000-00008.
• Svircevic V, Nierich AP, Moons KG, Diephuis JC, Ennema JJ, Brandon Bravo Bruinsma GJ, Kalkman CJ, van Dijk D. Thoracic epidural anesthesia for cardiac surgery: a randomized trial. Anesthesiology. 2011 Feb;114(2):262-70. doi: 10.1097/ALN.0b013e318201d2de.
• Conrady AO, Rudomanov OG, Zaharov DV, Krutikov AN, Vahrameeva NV, Yakovleva OI, Alexeeva NP, Shlyakhto EV. Prevalence and determinants of left ventricular hypertrophy and remodelling patterns in hypertensive patients: the St. Petersburg study. Blood Press. 2004;13(2):101-9. doi: 10.1080/08037050410031855.
• Guarracino F, Cariello C, Tritapepe L, Doroni L, Baldassarri R, Danella A, Stefani M. Transoesophageal echocardiography during coronary artery bypass procedures: impact on surgical planning. HSR Proc Intensive Care Cardiovasc Anesth. 2010;2(1):43-9.
• El-Morsy GZ, El-Deeb A. The outcome of thoracic epidural anesthesia in elderly patients undergoing coronary artery bypass graft surgery. Saudi J Anaesth. 2012 Jan;6(1):16-21. doi: 10.4103/1658-354X.93048.
• Crescenzi G, Landoni G, Monaco F, Bignami E, De Luca M, Frau G, Rosica C, Zangrillo A. Epidural anesthesia in elderly patients undergoing coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2009 Dec;23(6):807-12. doi: 10.1053/j.jvca.2009.02.003. Epub 2009 Apr 19.
• Devereux RB, Reichek N. Echocardiographic determination of left ventricular mass in man. Anatomic validation of the method. Circulation. 1977 Apr;55(4):613-8. doi: 10.1161/01.cir.55.4.613.
• Orsinelli DA, Aurigemma GP, Battista S, Krendel S, Gaasch WH. Left ventricular hypertrophy and mortality after aortic valve replacement for aortic stenosis. A high risk subgroup identified by preoperative relative wall thickness. J Am Coll Cardiol. 1993 Nov 15;22(6):1679-83. doi: 10.1016/0735-1097(93)90595-r.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: October 22, 2018
• First Posted (Actual): October 25, 2018

Study Record Updates

• Last Update Posted (Actual): October 25, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Aortic valve; coronary bypass; Epidural.; ventricular mass
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: TantaU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No