What is Tricuspid Regurgitation?
Tricuspid regurgitation (TR) is a common and serious heart valve disorder affecting millions of people worldwide. TR occurs when the tricuspid valve, which separates the right atrium and right ventricle, fails to close properly, allowing blood to flow backward into the right atrium (1).
This can lead to debilitating symptoms such as fatigue, shortness of breath, and fluid retention, significantly impacting patients’ quality of life and overall health. While mild cases of TR may not require intervention, severe TR can lead to heart failure and premature death if left untreated (1).
Traditional treatment options for severe TR have been limited, with open-heart surgery being the primary approach. However, many patients with severe TR are elderly or have multiple comorbidities, making them high-risk candidates for invasive surgical procedures (1).
In light of this unmet need, the recent FDA approval of the Edwards EVOQUE Tricuspid Valve Replacement System on February 1, 2024, marks a milestone in treating TR. This groundbreaking technology offers a less invasive alternative to open-heart surgery, providing new hope for patients suffering from the debilitating effects of severe TR (1).
How Is Tricuspid Regurgitation Treated?
Exploring How the EVOQUE System Works
The Edwards EVOQUE Tricuspid Valve Replacement System is a cutting-edge solution that replaces a diseased tricuspid valve without open-heart surgery. The system consists of two primary components: the EVOQUE valve and the delivery catheter (1).
The EVOQUE valve is a bioprosthetic valve from bovine (cow) tissue attached to a self-expanding nickel-titanium (nitinol) frame. This unique design allows the valve to be compressed and loaded onto the delivery catheter for minimally invasive implantation (1).
During the procedure, the physician accesses the femoral vein in the groin area and guides the delivery catheter with the compressed EVOQUE valve through the blood vessels to the heart. Once the catheter reaches the diseased tricuspid valve, the physician deploys the EVOQUE valve, which expands and anchors itself within the native valve (1).
The delivery catheter is then removed, leaving the new valve in place to function like a healthy tricuspid valve, ensuring unidirectional blood flow from the right atrium to the right ventricle (1).
This minimally invasive approach offers several advantages over traditional open-heart surgery. By avoiding the need for a large chest incision and cardiopulmonary bypass, the EVOQUE system reduces the overall procedural risk, shortens recovery times, and allows patients to return to their daily activities more quickly (1).
Benefits of the EVOQUE System
The Edwards EVOQUE Tricuspid Valve Replacement System offers several benefits for patients with severe TR. One of the primary advantages is the reduction in TR severity following the procedure (2).
Patients who undergo treatment with the EVOQUE system may experience improved quality of life and symptom relief. By reducing the severity of TR, the EVOQUE valve can help alleviate symptoms such as fatigue, shortness of breath, and fluid retention, enabling patients to engage in daily activities with greater ease and comfort (2).
Hearth Health and Exercise
The EVOQUE system has the potential to enhance patients’ exercise capacity. As TR severity decreases and heart function improves, patients can participate in physical activities more easily, improving overall health and well-being (2).
Clinical Study Results
The TRISCEND II pivotal trial demonstrated the benefits of the EVOQUE system compared to those who received optimal medical therapy (OMT) alone (2).
Effectiveness Conclusions
The trial met both co-primary effectiveness endpoints in the Breakthrough Pathway Cohort. At 6 months, a higher proportion of patients in the EVOQUE device group (98.8%) achieved a reduction in TR severity to moderate or less compared to the control group (21.6%), with a difference of 77.1% between the groups (2).
Additionally, the device group showed superiority over the control group in a hierarchical composite endpoint that evaluated improvements in Kansas City Cardiomyopathy Questionnaire (KCCQ) score, New York Heart Association (NYHA) functional class, and 6-minute walk distance (6MWD) from baseline to 6 months. The win ratio of 4.6 in favor of the device group further supports the effectiveness of the EVOQUE system in improving patient outcomes.
The available 1-year results from the full cohort also demonstrated favorable trends in the device group compared to the control group, with lower annualized rates of heart failure hospitalizations, and higher percentages of patients achieving meaningful improvements in KCCQ score, NYHA functional class, and 6MWD.
Safety Conclusions
The risks of the EVOQUE system were assessed through nonclinical laboratory studies, animal studies, and data from the TRISCEND II pivotal trial. Nonclinical and animal studies have shown that the EVOQUE valve is suitable for long-term implantation (2).
In the Breakthrough Pathway Cohort, the 30-day composite major adverse events (MAEs) rate in the device group was 27.4%, below the pre-specified performance goal of 70.0%, indicating an acceptable safety profile. The most common MAEs were new-onset arrhythmia and conduction disorders requiring permanent pacing (22.6%) and severe bleeding (10.5%) (2).
The 1-year results from the Full Cohort also showed favorable trends in the device group compared to the control group for all-cause mortality and the need for tricuspid valve surgical or percutaneous intervention (2).
Benefit vs Risk
The probable benefits of the EVOQUE system for patients with severe TR include a significant reduction in TR severity and clinically meaningful improvements in health status, as measured by KCCQ, NYHA functional class, and 6MWD (2).
The probable risks include MAEs such as cardiovascular death, severe bleeding, conduction disturbances requiring a new pacemaker, major access site and vascular complications, major cardiac structural complications, myocardial infarction, new need for renal replacement therapy, and device-related pulmonary embolism (2).
Patient perspectives, including patient-reported outcomes and preferences, were considered in the benefit-risk assessment. The available data support that for patients with at least severe TR, the probable benefits of the EVOQUE system outweigh the probable risks.
As the EVOQUE system becomes more widely available, it will be important
to continue monitoring its long-term safety and effectiveness in real-world clinical settings. Ongoing research and refinement of patient selection criteria will help maximize the benefits of this groundbreaking technology while minimizing potential risks.
The FDA approval of the Edwards EVOQUE Tricuspid Valve Replacement System marks an exciting new chapter in the treatment of severe TR, offering hope and improved quality of life for countless patients affected by this challenging condition.
At DKMD Consulting, we are committed to keeping our readers and clientele informed about the latest advancements in medical devices. As a trusted source of information and guidance, we will continue to monitor the progress of the Edwards EVOQUE Tricuspid Valve Replacement System and provide updates on its implementation and impact on patient care.
If your practice is considering adding the EVOQUE system to your treatment offerings, DKMD Consulting’s experienced team can assist in creating compelling and informative content to educate your patients and referral sources about this innovative technology, ensuring a smooth integration into your practice. Don’t hesitate to contact us today for all your medical writing needs!
References
- U.S. Food and Drug Administration. (2024, February 1). Edwards EVOQUE Tricuspid Valve Replacement System – P230013. FDA. Retrieved April 18, 2024.
- U.S. Food and Drug Administration. (2024). PMA P230013: Summary of Safety and Effectiveness Data (SSED) [PDF file]. FDA.
