Anesthesia Types for TAVR
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical University of South Carolina
Disqualifiers: High BMI, Difficult airway, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment for Anesthesia Types for TAVR?
Research suggests that monitored anesthesia care (MAC) may be more widely used and potentially safer than general anesthesia (GA) for transcatheter aortic valve replacement (TAVR), as it helps avoid some complications associated with GA.
12345Is anesthesia safe for TAVR procedures?
Research shows that both general anesthesia and monitored anesthesia care (MAC) are generally safe for TAVR procedures, with MAC being increasingly used due to fewer complications and a simpler process.
16789How does the anesthesia treatment for TAVR differ from other treatments?
The anesthesia treatment for TAVR is unique because it can be performed under monitored anesthesia care (MAC) or conscious sedation, which is less invasive than traditional general anesthesia (GA). This approach allows for quicker recovery and potentially fewer complications, as it avoids the need for a breathing tube and deep sedation.
147910Eligibility Criteria
Adults over 18 needing a TAVR for aortic valve stenosis and can receive both general anesthesia (GA) and monitored anesthesia care (MAC). Excluded are those who don't speak English, have BMI >37, difficult airways, pregnant women, unable to consent, allergic or with contraindications to the anesthetics or TEE.Inclusion Criteria
I am an adult getting a valve replacement through my thigh for a narrowed heart valve.
I can safely receive general and monitored anesthesia care.
I am 18 years old or older.
Exclusion Criteria
I cannot lie flat.
Inability or unwillingness of subject to give informed consent based on any reason
I do not have conditions like esophageal issues or active upper GI bleeding that prevent TEE.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo Transcatheter Aortic Valve Replacement (TAVR) with either monitored anesthesia care (MAC) or general endotracheal anesthesia (GETA)
1 day
1 visit (in-person)
Immediate Post-operative Monitoring
Participants are monitored for ICU admission and procedural mortality
Up to 48 hours
Follow-up
Participants are monitored for safety and effectiveness after treatment, including paravalvular regurgitation assessment
1 year
2 visits (in-person)
Participant Groups
The study compares two types of anesthesia in patients undergoing TAVR: MAC versus GA. It looks at hospital stay length, ICU admission rates, procedural mortality and if using TEE during GA affects device success.
2Treatment groups
Active Control
Group I: SedationActive Control1 Intervention
Participants randomized to group B will receive monitored anesthesia care as their anesthetic procedure.
Group II: GeneralActive Control1 Intervention
Participants randomized to group A will receive general endotracheal anesthesia as their anesthetic procedure.
General Endotracheal Anesthesia is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as General Anesthesia for:
- Surgical procedures requiring general anesthesia, including TAVR
🇺🇸 Approved in United States as General Anesthesia for:
- Surgical procedures requiring general anesthesia, including TAVR
🇨🇦 Approved in Canada as General Anesthesia for:
- Surgical procedures requiring general anesthesia, including TAVR
🇯🇵 Approved in Japan as General Anesthesia for:
- Surgical procedures requiring general anesthesia, including TAVR
🇨🇳 Approved in China as General Anesthesia for:
- Surgical procedures requiring general anesthesia, including TAVR
🇨🇭 Approved in Switzerland as General Anesthesia for:
- Surgical procedures requiring general anesthesia, including TAVR
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Medical University of South CarolinaCharleston, SC
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Who Is Running the Clinical Trial?
Medical University of South CarolinaLead Sponsor
References
Conscious sedation/monitored anesthesia care versus general anesthesia in patients undergoing transcatheter aortic valve replacement: A meta-analysis. [2023]To compare the merits and safety between conscious sedation/monitored anesthesia (CS/MAC) and general anesthesia (GA) for patients receiving transcatheter aortic valve replacement (TAVR).
Comparing outcomes of general anesthesia and monitored anesthesia care during transcatheter aortic valve replacement: The Cleveland Clinic Foundation experience. [2022]Monitored anesthesia care (MAC) has become more widely used during transcatheter aortic valve replacement (TAVR) to avoid the complications of general anesthesia (GA).
Outcome After General Anesthesia Versus Monitored Anesthesia Care in Transfemoral Transcatheter Aortic Valve Replacement. [2022]To evaluate outcomes of monitored anesthesia care (MAC) compared with general anesthesia (GA) in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR).
Comparison of clinical outcomes with the utilization of monitored anesthesia care vs. general anesthesia in patients undergoing transcatheter aortic valve replacement. [2022]There is no clear consensus in regard to the optimal anesthesia utilization during transcatheter aortic valve replacement (TAVR). The aim was to compare outcomes of transfemoral (TF) TAVR under monitored anesthesia care (MAC) vs. general anesthesia (GA) and evaluate the rates and causes of intra-procedural MAC failure.
A Pilot Analysis of the Association Between Types of Monitored Anesthesia Care Drugs and Outcomes in Transfemoral Aortic Valve Replacement Performed Without General Anesthesia. [2019]The types of agents used for monitored anesthesia care (MAC) and their possible differential effects on outcomes have received less study despite increased use over general anesthesia (GA) in transfemoral aortic valve replacements (TAVRs). In this pilot analysis of patients undergoing TAVR using MAC, the authors described the anesthetic agents used and sought to investigate the possible association of anesthetic agent choice with outcomes and the extent to which total weight and time-adjusted doses of anesthetics declined with increasing 10-year age increments.
Routine minimalist transcatheter aortic valve implantation with local anesthesia only. [2021]Conscious sedation instead of general anesthesia has been increasingly adopted in many centers for transfemoral transcatheter aortic valve replacement (TAVR). Improvement of materials and operators' experience and reduction of periprocedural complications allowed procedural simplification and adoption of a minimalist approach. With this study, we sought to assess the feasibility and safety of transfemoral TAVR routinely performed under local anesthesia without on-site anesthesiology support.
Local versus general anesthesia for transcatheter aortic valve implantation (TAVR)--systematic review and meta-analysis. [2022]The hypothesis of this study was that local anesthesia with monitored anesthesia care (MAC) is not harmful in comparison to general anesthesia (GA) for patients undergoing Transcatheter Aortic Valve Implantation (TAVR).TAVR is a rapidly spreading treatment option for severe aortic valve stenosis. Traditionally, in most centers, this procedure is done under GA, but more recently procedures with MAC have been reported.
Monitored Anesthesia Care Versus General Anesthesia for Transcatheter Aortic Valve Replacement. [2022]Monitored anesthesia care (MAC) has been increasingly used in lieu of general anesthesia (GA) for transcatheter aortic valve replacement (TAVR). We sought to compare outcomes and in-hospital costs between MAC and GA for TAVR at a Veterans Affairs Medical Center.
Patient Selection and Outcomes of Transfemoral Transcatheter Aortic Valve Replacement Performed with Monitored Anesthesia Care Versus General Anesthesia. [2018]The aim of this study was to compare outcomes of monitored anesthesia care (MAC) versus general anesthesia (GA) for transfemoral transcatheter aortic valve replacement (TF-TAVR) and to describe a selection process for the administration of MAC.
Outcome of patients undergoing TAVR with and without the attendance of an anesthesiologist. [2018]During the last few years there is a shift from performing Transcatheter Aortic Valve Replacement (TAVR) under general anesthesia towards conscious sedation and local anesthesia only. In the vast majority of centers, sedation is guided by a qualified anesthesiologist. In our center, all TAVR procedures are being performed under local anesthesia and mild sedation, however, since September 2014, a large portion of TAVR procedures are being performed under local anesthesia without the presence of an anesthesiologist. Here we compare 30days outcome of patients undergoing TAVR with and without the presence of anesthesiologist in the catheterization laboratory.