A Randomized Controlled Trial Comparing Monitored Anesthesia Care Versus General Anesthesia With Transesophgeal Echocardiography for Transcatheter Aortic Valve Replacement
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Transcatheter Aortic Valve Replacement
- Sponsor
- Medical University of South Carolina
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- ICU Admission Rate
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Investigators
George Whitener
Principal Investigator
Medical University of South Carolina
Eligibility Criteria
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
Outcomes
Primary Outcomes
ICU Admission Rate
Time Frame: Up to 48 hours
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.
Hospital Length of Stay
Time Frame: Up to 1 month
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.
Procedural Mortality
Time Frame: Up to 30 days
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.
Secondary Outcomes
- Paravalvular Regurgitation(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.)