Transcatheter vs Surgical Valve Replacement for Bicuspid Aortic Valve

(BELIEVE-IT Trial)

Overseen By Mitch Gheorghiu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Recent cardiovascular intervention, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: Procedure duration

250 Participants Needed

Trial Summary

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 study team or your doctor.

What data supports the effectiveness of this treatment for bicuspid aortic valve stenosis?

Research shows that both transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) are used to treat severe bicuspid aortic valve stenosis, with studies comparing their outcomes. Although bicuspid aortic valves were not included in initial trials for TAVR, recent analyses suggest that TAVR is being used more frequently and shows promising results in certain patients. ^{1 2 3 4 5}

Is transcatheter or surgical valve replacement safe for humans?

Both transcatheter and surgical aortic valve replacements are generally considered safe procedures. Transcatheter aortic valve replacement (TAVR) is a less invasive option with lower risks of complications compared to traditional surgery, but specific safety data for bicuspid aortic valves is limited due to their exclusion from many trials. ^{3 5 6 7 8}

How does transcatheter aortic valve replacement differ from surgical aortic valve replacement for bicuspid aortic valve stenosis?

Transcatheter aortic valve replacement (TAVR) is a less invasive procedure compared to surgical aortic valve replacement (SAVR), as it involves inserting a new valve through a catheter, usually via a blood vessel, rather than open-heart surgery. This makes TAVR a potentially better option for patients who are at higher risk for surgical complications. ^{3 4 5 9 10}

What is the purpose of this trial?

The study protocol is a randomized trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV). Namely, the therapies to which patients will be randomized will be transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR), in patients deemed clinically suitable for both following heart team review. The purpose of this study is to compare the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) versus Surgical Aortic Valve Replacement (SAVR) for treating patients with severe aortic stenosis (AS) who have a congenital bicuspid aortic valve (BAV) anatomy. Patients with BAV anatomy have been under-represented in previous trials and this study might provide important information to help guide future treatment options. The study patients will be followed with standard of care procedures for 10 years.

Research Team

Raj Makkar, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for patients with severe aortic stenosis and bicuspid aortic valve who are suitable for both transcatheter (TAVR) and surgical valve replacement (SAVR). The heart team must approve their participation. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

Gated contrast CT available and suitable for core laboratory analysis

Provision of signed and dated informed consent form

My doctor says I need a valve replacement for my severe aortic stenosis.

Exclusion Criteria

Extreme or prohibitive TAVR or SAVR risk, determined by site or committee

Presence of an existing TAVR or SAVR device

Pregnancy or lactation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either Transcatheter Aortic Valve Replacement (TAVR) or Surgical Aortic Valve Replacement (SAVR)

Procedure duration

1 visit (in-person for procedure)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Regular visits as per standard of care

Treatment Details

Interventions

• Surgical Aortic Valve Replacement
• Transcatheter Aortic Valve Replacement

Trial Overview The study compares two standard treatments for severe aortic stenosis in patients with bicuspid valves: TAVR, which involves placing the valve via a catheter, versus SAVR, traditional open-heart surgery. Patients will be randomly assigned to one of these treatments.

Participant Groups

Group I: transcatheter aortic valve replacement (TAVR) Active Control 1 Intervention

50% of patients will be treated with standard TAVR procedure and followed up for 10 years

Group II: surgical aortic valve replacement (SAVR) Active Control 1 Intervention

50% of patients will be treated with standard SAVR procedure and followed up for 10 years

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Findings from Research

In a study of 1023 patients with stenotic bicuspid aortic valve (BAV), transcatheter aortic valve replacement (TAVR) showed comparable device success rates to surgical aortic valve replacement (SAVR) (94.2% vs. 97.1%), indicating TAVR is a viable alternative to surgery.

However, TAVR was associated with a higher incidence of mild-to-severe paravalvular regurgitation (PVR) compared to SAVR (19.4% vs. 7.9%), particularly in certain BAV morphologies, suggesting that while TAVR is effective, careful monitoring for PVR is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter and surgical aortic valve replacement in patients with bicuspid aortic valve. Husso, A., Airaksinen, J., Juvonen, T., et al.[2023]

In a study of 31,895 hospitalizations for patients with bicuspid aortic stenosis, transcatheter aortic valve replacement (TAVR) showed similar in-hospital mortality rates compared to surgical aortic valve replacement (SAVR), indicating that TAVR is a safe alternative for this population.

TAVR was associated with fewer complications such as acute myocardial infarction and post-operative bleeding, as well as a shorter hospital stay, although it did have a higher incidence of complete heart block requiring pacemaker insertion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal Trends and Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement for Bicuspid Aortic Valve Stenosis. Elbadawi, A., Saad, M., Elgendy, IY., et al.[2020]

In a meta-analysis of 54,047 patients with severe bicuspid aortic valve stenosis, transcatheter aortic valve replacement (TAVR) showed no significant differences in in-hospital mortality or stroke compared to surgical aortic valve replacement (SAVR).

TAVR was associated with a higher risk of permanent pacemaker implantation but lower risks of acute kidney injury and blood transfusion, suggesting it may offer certain safety advantages despite the increased pacemaker requirement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter versus surgical aortic valve replacement for stenotic bicuspid aortic valve: Systematic review and meta-analysis. Sakurai, Y., Yokoyama, Y., Kuno, T., et al.[2023]

In patients with bicuspid aortic stenosis (BAS), transcatheter aortic valve replacement (TAVR) shows comparable short-term outcomes to surgical aortic valve replacement (SAVR), with higher rates of permanent pacemaker implantation (PPI) but lower rates of bleeding events.

Type 1 BAS morphology in TAVR patients is linked to lower post-procedural transvalvular gradients and a higher incidence of conduction abnormalities, indicating that valve morphology can influence outcomes after TAVR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Meta-Analysis of Short-Term Outcomes of TAVR versus SAVR in Bicuspid Aortic Valve Stenosis and TAVR Results in Different Bicuspid Valve Anatomies. Improta, R., Di Pietro, G., Kola, N., et al.[2023]

Transcatheter aortic valve replacement (TAVR) is increasingly being used for patients with bicuspid aortic valve (BAV) stenosis, showing a growth in procedure rates from 0.39% in 2011 to 4.16% in 2014, indicating a shift in treatment options for this population.

In-hospital outcomes for TAVR in BAV patients show no significant difference in mortality compared to surgical aortic valve replacement (SAVR), while the median length of hospital stay decreased significantly, suggesting TAVR may offer similar safety with improved recovery times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve replacement in patients with bicuspid aortic valve stenosis: national trends and in-hospital outcomes. Soud, M., Al-Khadra, Y., Darmoch, F., et al.[2022]

In a study of 33 high-risk patients undergoing transcatheter aortic valve implantation, the procedure was feasible in 30 cases, demonstrating a significant reduction in aortic gradient from 43.58 mmHg to 10.54 mmHg, indicating improved blood flow.

The procedure had an overall 30-day mortality rate of 18.18%, with only one operative death, suggesting that while the procedure is generally safe, careful monitoring and long-term follow-up are necessary to assess outcomes and complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve implantation: results of the current development and implantation of a new Brazilian prosthesis. Gaia, DF., Palma, JH., Ferreira, CB., et al.[2022]

In a study of 187 patients with severe aortic stenosis, transcatheter aortic valve implantation (TAVI) showed similar 30-day mortality and morbidity rates compared to surgical aortic valve replacement (S-AVR), but resulted in shorter ICU stays and better immediate postoperative outcomes.

While TAVI patients had higher all-cause and noncardiac mortality rates over time due to their age and comorbidities, the overall morbidity and mortality associated with TAVI were lower than those expected from conventional surgery in high-risk patients, making it a viable option for those who are good surgical candidates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter vs. surgical aortic valve replacement: a retrospective analysis assessing clinical effectiveness and safety. Fusari, M., Bona, V., Muratori, M., et al.[2022]

Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) shows a comparable 30-day mortality rate to those with trileaflet aortic valves (TAV), indicating that TAVR can be a safe option for BAV patients.

However, patients with BAV experience a higher incidence of moderate to severe paravalvular leak (8.8% vs. 4.2% in TAV patients), suggesting that while TAVR is safe, it may be less effective in achieving optimal device success compared to TAV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of transcatheter aortic valve replacement in bicuspid aortic valve stenosis. Bob-Manuel, T., Heckle, MR., Ifedili, IA., et al.[2022]

In a study of 65,687 patients undergoing isolated surgical aortic valve replacement (SAVR), those with bicuspid aortic valves had significantly lower 5-year mortality rates compared to those with tricuspid valves, particularly among low-risk patients.

Both groups had similar 30-day mortality and major morbidity rates, but bicuspid patients also experienced lower rates of readmission for heart failure, stroke, and other cardiovascular issues over the 5-year period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benchmarking Outcomes of Surgical Aortic Valve Replacement in Patients With Bicuspid Aortic Valves. Hirji, SA., Wegermann, Z., Vemulapalli, S., et al.[2023]

Only 6.8% of patients with bicuspid aortic valve (BAV) disease underwent transcatheter aortic valve replacement (TAVR), and while TAVR showed higher initial hospitalization mortality compared to surgical aortic valve replacement (SAVR), risk-adjusted analyses indicated no significant difference in overall mortality between the two procedures.

Patients undergoing TAVR had higher rates of pacemaker implantation and reintervention compared to those receiving SAVR, suggesting that while TAVR can be a viable option, careful patient selection is crucial due to the potential for complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter and Surgical Aortic Valve Replacement in Patients With Bicuspid Aortic Valve Stenosis. Sanaiha, Y., Hadaya, JE., Tran, Z., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Transcatheter and surgical aortic valve replacement in patients with bicuspid aortic valve. [2023]

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

Temporal Trends and Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement for Bicuspid Aortic Valve Stenosis. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Transcatheter versus surgical aortic valve replacement for stenotic bicuspid aortic valve: Systematic review and meta-analysis. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A Meta-Analysis of Short-Term Outcomes of TAVR versus SAVR in Bicuspid Aortic Valve Stenosis and TAVR Results in Different Bicuspid Valve Anatomies. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve replacement in patients with bicuspid aortic valve stenosis: national trends and in-hospital outcomes. [2022]

6. Brazil pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve implantation: results of the current development and implantation of a new Brazilian prosthesis. [2022]

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

Transcatheter vs. surgical aortic valve replacement: a retrospective analysis assessing clinical effectiveness and safety. [2022]

8. China pubmed.ncbi.nlm.nih.gov

Outcomes of transcatheter aortic valve replacement in bicuspid aortic valve stenosis. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Benchmarking Outcomes of Surgical Aortic Valve Replacement in Patients With Bicuspid Aortic Valves. [2023]

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

Transcatheter and Surgical Aortic Valve Replacement in Patients With Bicuspid Aortic Valve Stenosis. [2023]