Anesthesia Types for TAVR

Overseen By Haley Nitchie

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: High BMI, Difficult airway, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

170 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 6 7 8 9}

How 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. ^{1 4 7 9 10}

Research Team

George Whitener, MD

Principal Investigator

Medical University of South Carolina - Department of Anesthesia

Eligibility 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.

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)

Treatment Details

Interventions

• General Endotracheal Anesthesia
• Monitored anesthesia care

Trial Overview 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.

Participant Groups

Group I: Sedation Active Control 1 Intervention

Participants randomized to group B will receive monitored anesthesia care as their anesthetic procedure.

Group II: General Active Control 1 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

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Findings from Research

In a review of 24 studies involving 141,965 patients, conscious sedation/monitored anesthesia (CS/MAC) was associated with lower risks of 30-day mortality and major complications compared to general anesthesia (GA), suggesting it may be a safer option for transcatheter aortic valve replacement (TAVR).

Patients receiving CS/MAC experienced shorter procedure times and reduced hospital stays without compromising the success rate of the procedure or increasing the risk of serious cardiac-vascular complications, indicating its efficacy and potential benefits over GA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conscious sedation/monitored anesthesia care versus general anesthesia in patients undergoing transcatheter aortic valve replacement: A meta-analysis. Hung, KC., Chen, JY., Hsing, CH., et al.[2023]

In a study of 998 patients undergoing transfemoral TAVR, monitored anesthesia care (MAC) was associated with significantly shorter procedural and fluoroscopy times, lower contrast volume, and reduced radiation exposure compared to general anesthesia (GA).

Patients receiving MAC had lower 30-day mortality rates (0.5% vs. 2.9%) and shorter ICU and hospital stays, indicating that MAC can improve efficiency and outcomes without compromising safety during TAVR procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing outcomes of general anesthesia and monitored anesthesia care during transcatheter aortic valve replacement: The Cleveland Clinic Foundation experience. Sammour, Y., Kerrigan, J., Banerjee, K., et al.[2022]

In a study of 1,494 patients undergoing transfemoral transcatheter aortic valve replacement (TAVR), monitored anesthesia care (MAC) showed similar 30-day mortality rates compared to general anesthesia (GA), indicating that MAC is a safe alternative for this procedure.

Both anesthesia methods resulted in comparable rates of complications, including paravalvular regurgitation and pacemaker implantation, suggesting that MAC can be effectively used without increasing immediate or long-term risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome After General Anesthesia Versus Monitored Anesthesia Care in Transfemoral Transcatheter Aortic Valve Replacement. D'Errigo, P., Ranucci, M., Covello, RD., et al.[2022]

Transcatheter aortic valve replacement (TAVR) performed under monitored anesthesia care (MAC) is safe and feasible, leading to shorter hospital stays compared to general anesthesia (GA), with a mean post-procedural hospital stay of 6.0 days for MAC versus 7.9 days for GA.

While the majority of TAVR procedures can be successfully completed under MAC, 12% of patients required conversion to GA, primarily due to cardiac instability and hypotension, highlighting the need for a complete heart team to manage potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of clinical outcomes with the utilization of monitored anesthesia care vs. general anesthesia in patients undergoing transcatheter aortic valve replacement. Kiramijyan, S., Ben-Dor, I., Koifman, E., et al.[2022]

In a study of 93 patients undergoing transfemoral aortic valve replacements (TAVRs) with monitored anesthesia care (MAC), the choice of anesthetic agents, particularly propofol and dexmedetomidine, did not show significant differences in postoperative outcomes such as delirium or length of hospital stay.

Despite recommendations to adjust anesthetic doses for older patients, the study found no significant trends in dose reductions with increasing age, suggesting that current practices may not adequately account for age-related changes in drug metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Analysis of the Association Between Types of Monitored Anesthesia Care Drugs and Outcomes in Transfemoral Aortic Valve Replacement Performed Without General Anesthesia. Chen, EY., Sukumar, N., Dai, F., et al.[2019]

In a study of 321 patients undergoing transfemoral TAVR, 98.1% were successfully treated with local anesthesia alone, demonstrating the feasibility of this approach without on-site anesthesiology support.

The procedure showed a low complication rate, with 30-day outcomes including a mortality rate of 1.6% and major vascular complications at 2.6%, indicating that local anesthesia is a safe option for most patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Routine minimalist transcatheter aortic valve implantation with local anesthesia only. Saia, F., Palmerini, T., Marcelli, C., et al.[2021]

In a systematic review of 1,542 patients undergoing Transcatheter Aortic Valve Implantation (TAVR), local anesthesia with monitored anesthesia care (MAC) was found to be as safe as general anesthesia (GA), with no significant differences in 30-day mortality or cardiac-related complications.

Patients receiving MAC experienced shorter procedure times and reduced hospital stays compared to those under GA, suggesting potential benefits in efficiency and recovery, although further randomized trials are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local versus general anesthesia for transcatheter aortic valve implantation (TAVR)--systematic review and meta-analysis. Fröhlich, GM., Lansky, AJ., Webb, J., et al.[2022]

In a study of 349 patients undergoing transcatheter aortic valve replacement (TAVR), monitored anesthesia care (MAC) was found to significantly reduce operating room time, intensive care unit length of stay, and total hospital length of stay compared to general anesthesia (GA).

After matching for similar patient characteristics, MAC TAVR was associated with a lower 180-day mortality rate (2.4% vs 12%) without a significant difference in overall hospitalization costs, indicating that MAC may enhance patient outcomes while maintaining cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitored Anesthesia Care Versus General Anesthesia for Transcatheter Aortic Valve Replacement. Holmes, HR., Falasa, M., Neal, D., et al.[2022]

In a study of 104 patients undergoing transfemoral transcatheter aortic valve replacement (TF-TAVR), monitored anesthesia care (MAC) resulted in a significantly shorter intensive care unit stay (48 hours vs. 74 hours) and reduced procedural times compared to general anesthesia (GA).

There were no significant differences in 30-day mortality or complications between the MAC and GA groups, indicating that MAC is a safe and effective alternative for suitable patients undergoing TF-TAVR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Selection and Outcomes of Transfemoral Transcatheter Aortic Valve Replacement Performed with Monitored Anesthesia Care Versus General Anesthesia. Pani, S., Cagino, J., Feustel, P., et al.[2018]

In a study of 324 patients undergoing transfemoral TAVR, the presence of an anesthesiologist did not significantly affect 30-day outcomes, including mortality and complications.

Both groups, with and without anesthesiologist presence, showed similar rates of procedural safety, indicating that TAVR can be safely performed under local anesthesia and mild sedation without an anesthesiologist.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of patients undergoing TAVR with and without the attendance of an anesthesiologist. Konigstein, M., Ben-Shoshan, J., Zahler, D., et al.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Conscious sedation/monitored anesthesia care versus general anesthesia in patients undergoing transcatheter aortic valve replacement: A meta-analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Comparing outcomes of general anesthesia and monitored anesthesia care during transcatheter aortic valve replacement: The Cleveland Clinic Foundation experience. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Outcome After General Anesthesia Versus Monitored Anesthesia Care in Transfemoral Transcatheter Aortic Valve Replacement. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of clinical outcomes with the utilization of monitored anesthesia care vs. general anesthesia in patients undergoing transcatheter aortic valve replacement. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

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]

6. United States pubmed.ncbi.nlm.nih.gov

Routine minimalist transcatheter aortic valve implantation with local anesthesia only. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Local versus general anesthesia for transcatheter aortic valve implantation (TAVR)--systematic review and meta-analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Monitored Anesthesia Care Versus General Anesthesia for Transcatheter Aortic Valve Replacement. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Patient Selection and Outcomes of Transfemoral Transcatheter Aortic Valve Replacement Performed with Monitored Anesthesia Care Versus General Anesthesia. [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Outcome of patients undergoing TAVR with and without the attendance of an anesthesiologist. [2018]