Monitored Anesthesia Care vs. General Anesthesia for Transcatheter Aortic Valve Replacement

A Randomized Controlled Trial Comparing Monitored Anesthesia Care Versus General Anesthesia With Transesophgeal Echocardiography for Transcatheter Aortic Valve Replacement

This study is being done to evaluate the impact that monitored anesthetic care (MAC) versus general endotracheal anesthesia (GETA) has on hospital length of stay, rate of ICU admission, and procedural mortality for patients undergoing Transcatheter Aortic Valve Replacement (TAVR). Also, the investigators hope to determine if the use of Transesophageal Echocardiography (TEE) during GETA impacts device success. Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis may be eligible candidates for this study.

Study Overview

• Status: Recruiting
• Conditions: Transcatheter Aortic Valve Replacement
• Intervention / Treatment: Procedure: General Endotracheal Anesthesia; Procedure: Monitored anesthesia care

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: George Whitener, M.D.; Phone Number: 843-876-0758; Email: whiteneg@musc.edu
• Study Contact Backup: Name: Haley Nitchie; Phone Number: 843-792-1869; Email: nitchie@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Haley Nitchie; Phone Number: 843-792-1869; Email: nitchie@musc.edu
      • Contact: George Whitener, MD; Phone Number: 843-792-5699; Email: whiteneg@musc.edu
      • Principal Investigator: George Whitener, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult patients ≥ 18 years old
• Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis
• Adult patients who are medically eligible to receive both anesthetics (GA and MAC)

Exclusion Criteria:

• Inability to speak English
• Body Mass Index (BMI) > 37 kg/m2
• History of difficult airway requiring fiberoptic intubation
• Inability to lie flat
• Women who are pregnant
• Patients who have contraindications to either anesthetic, such as an allergy or history of malignant hyperthermia, will also be excluded from the study.
• Inability or unwillingness of subject to give informed consent based on any reason
• Patients with any of the following absolute contraindications to TEE:
• Perforated Viscus
• Esophageal Stricture
• Esophageal Tumor
• Esophageal Perforation
• Esophageal Diverticulum
• Active upper GI Bleed

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: General; Participants randomized to group A will receive general endotracheal anesthesia as their anesthetic procedure.	Procedure: General Endotracheal Anesthesia; Participants receive general endotracheal anesthesia for the procedure, as well as analyzing the information from their transesophageal echocardiography per routine clinical care.
Active Comparator: Sedation; Participants randomized to group B will receive monitored anesthesia care as their anesthetic procedure.	Procedure: Monitored anesthesia care; Participants receive monitored anesthesia care for their procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length of Stay	The total number of hours that the patient stayed in the hospital will be measured from the "Anesthesia Start" time until their time of discharge, as recorded in their electronic medical record.	Up to 1 month
ICU Admission Rate	The investigators will determine the ICU admission rate by taking the total number of patients admitted to the ICU and dividing it by the number of cases in each arm of the study, based on MUSC's "fast track" pathway and our inclusion.	Up to 48 hours
Procedural Mortality	The percentage of the study population that died within 30 days of their procedure or during index procedure hospitalization - if the postoperative length of stay is longer than 30 days.	Up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Paravalvular Regurgitation	Paravalvular regurgitation is a specific type of aortic regurgitation that is determined qualitatively by the echocardiographer. It is defined as the grade of aortic valve regurgitation around the perimeter of the implanted prosthesis. The assigned grade will be classified according to a unifying five-class scheme, at the determination of the cardiologist. Grade of aortic regurgitation is measured as none, mild, moderate, or severe. None is best, severe is worst. For GETA cases, paravalvular regurgitation will be recorded after valve implantation by the anesthesiologist performing TEE, as is routine. For all cases, paravalvular regurgitation will be recorded from a TTE report that is completed on post-operative day 1 or 2 (the 1st post-operative TTE) during routine clinical care, and again by TTE report at 1 year during routine clinical follow-up.	For GETA cases, will be recorded after valve implantation. For all cases, will be recorded from a TTE report that is completed on post-operative day 1 or 2 and at 1 year.

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: George Whitener, M.D., Medical University of South Carolina - Department of Anesthesia

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2019
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (Actual): September 27, 2019

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Anesthesia, TAVR, Cardiothoracic, Cardiology
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: Pro00088473

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