Another Advance in Heart Health: Abbott TriClip FDA Approval
In our last post, we discussed the Edwards EVOQUE system, designed to help those who suffer from Tricuspid Regurgitation. The FDA approved this system in early February 2024. Only a month later, Abbott’s TriClip™ transcatheter edge-to-edge repair (TEER) system joined the FDA’s ranks.
The FDA’s approval follows a positive recommendation from the Circulatory System Devices Panel of the Medical Devices Advisory Committee, which voted 13 to 1 in favor of the benefits of TriClip outweighing its risks (1).
This decision was based on the findings of the TRILUMINATE Pivotal trial, the world’s first randomized, controlled clinical study to evaluate the safety and effectiveness of the TriClip system compared to medical therapy alone in patients with severe TR who are at intermediate or greater risk for open-heart surgery (1).
The TRILUMINATE Pivotal trial resulted in 90% of patients who received the TriClip system experiencing a significant improvement in their TR grade, reducing from severe or higher to moderate or less at 30 days – a reduction sustained at one year (1).
It also showcased a highly favorable safety profile, with 98% of patients remaining free of major adverse events through 30 days and reporting a significant improvement in quality of life (1).
Let’s examine the trial and the potential of this newest addition to FDA-approved treatments for tricuspid regurgitation.
How the TriClip System Transforms Tricuspid Valve Repair
The TriClip system is a non-surgical method that employs a catheter to place a clip on the tricuspid valve. This simple procedure adjusts the valve’s leaflets to reduce backflow, thus alleviating symptoms and improving quality of life. Its minimally invasive approach makes it a viable option for high-risk patients.
TRILUMINATE Pivotal Trial: Groundbreaking Evidence for TriClip’s Efficacy
The TRILUMINATE Pivotal trial was a prospective, multicenter, randomized, open-label trial comparing T-TEER (n=175) with medical therapy alone (n=175) in patients with severe symptomatic TR.
Health status was assessed at baseline and 1, 6, and 12 months using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Medical Outcomes Study Short-Form 36 Health Survey (SF-36). If you do not remember the KCCQ from last time, this is a heart failure-specific health status measure. It consists of 23 questions and entails five domains (2):
- Physical limitation
- Symptoms
- Quality of life
- Social limitation
- Self-efficacy
The primary health status outcome was the change in the KCCQ overall summary score (KCCQ-OS) from baseline to 12 months. Researchers used statistical methods (linear regression models) to see if changes in the severity of the heart valve problem (TR) were associated with changes in the KCCQ scores over one month and one year (2).
They also utilized Cox proportional hazards regression models to explore whether the early improvements in KCCQ scores (after one month) could predict major health events like death or hospitalization due to heart failure over the next year (2).
Detailed Results: Proving TriClip’s Superiority in Tricuspid Regurgitation Management
At baseline, patients in both groups had markedly impaired health status, with a mean KCCQ-OS of 55.8 ± 23.6. Following treatment, patients in the T-TEER group experienced significantly improved health status compared to the medical therapy group.
The mean between-group difference in KCCQ-OS was 9.4 points (95% CI: 5.3-13.4) at one month, increasing to 10.4 points (95% CI: 6.3-14.6) at 12 months. The proportion of patients “alive and well” at one year was significantly higher in the T-TEER group (74.8% vs. 45.9%; number needed to treat [NNT]=3.5) (2).
Subgroup analyses revealed that the health status benefit of T-TEER was generally consistent across the five patient domain characteristics, with a notable interaction between baseline KCCQ-OS and treatment effect. Exploratory analyses suggested that the observed health status improvements were related to the degree of TR reduction and were associated with a lower risk of death or heart failure hospitalization (2).
Analyzing TriClip’s Impact on Tricuspid Regurgitation
The health status analysis of the TRILUMINATE Pivotal trial demonstrates that T-TEER using the TriClip system results in substantial and sustained improvements in symptoms, functional status, and quality of life compared to medical therapy alone in patients with severe TR. The low NNT for achieving a clinically meaningful benefit highlights the potential impact of this treatment on patients’ lives.
While the trial’s open-label nature raises concerns about a potential placebo effect, several findings suggest that the observed health status improvements reflect a true biological effect. These include the durability of the benefit over 12 months, the association between TR reduction and health status improvement, and the relationship between early health status improvement and reduced risk of death or heart failure hospitalization (2).
The FDA’s approval of the TriClip system based on the TRILUMINATE Pivotal trial results underscores the importance of these health status findings. It provides evidence to guide patient selection and support using T-TEER in clinical practice.
Addressing Study Limitations: Perspectives on Future Research Needs
As with any clinical trial, some limitations should be noted, and they are as follows for the TRILUMINATE Pivotal trial (2):
- Long-term Benefits Unknown: While the health benefits from the T-TEER treatment were observed to last throughout the first year after treatment, it’s unclear if these benefits would continue beyond that period. More time and study are needed to understand the long-term effects.
- Possibility of Other Influencing Factors: Other health factors, especially those related to the function of the right side of the heart, might affect how much benefit a patient gets from T-TEER but were not specifically studied in this trial. This means there might be additional reasons some patients benefit more or less from the treatment that the researchers still need to identify.
- Impact of Patients Knowing Their Condition: Patients knowing their health status might have influenced how they reported their health improvements. If patients knew they were getting better or worse, they might have reported their symptoms differently, which could affect the reliability of the reported health status improvements.
- Validity of the Health Measurement Tool: Although the KCCQ is widely used and trusted in studies of other heart conditions, it has yet to be validated explicitly for use in patients with tricuspid regurgitation (TR). However, it does measure symptoms common in TR, such as shortness of breath and fatigue, and previous studies have shown it to reflect real changes in patients’ health due to treatment for TR.
- Generalizability of the Results: Benefits observed in this trial might not apply to all patients with TR. For example, those with other heart conditions or at a different risk level for surgery might not experience the same benefits. Also, the results might differ when using other treatment devices, not just the T-TEER.
DKMD Consulting: Your Partner in Advanced Cardiovascular Solutions
As the medical community embraces this groundbreaking technology, healthcare providers, researchers, and potential clients interested in medical services can benefit from expert insights into such advancements. DKMD Consulting, a leading consultancy in the medical field, is well-positioned to provide valuable guidance on how innovative solutions like TriClip can be effectively integrated into patient care strategies.
Our team of experienced medical writers and consultants specializes in creating engaging, informative copy that bridges the gap between complex medical concepts and patient understanding. We work closely with healthcare providers to develop customized content strategies that educate patients, showcase your expertise, and position your practice as a leader in cutting-edge cardiovascular care.
By partnering with DKMD Consulting, you’ll gain access to a wealth of knowledge and resources to help you effectively communicate the value of the TriClip system to your patients. Our medically backed content will explain how the TriClip system works and highlight its potential to improve quality of life for those suffering from severe tricuspid regurgitation.
From website copy and blog posts to patient brochures and white papers, DKMD Consulting delivers tailored content solutions that align with your unique needs and goals. Our commitment to scientific accuracy, coupled with our ability to distill complex information into accessible, engaging language, sets us apart as a trusted partner for healthcare providers looking to enhance their patient education efforts.
Contact DKMD Consulting today to learn more about how our services can help educate, inspire, and guide your patients on their journey to improved cardiovascular health.
References
- Abbott. (2024, April 2). Abbott receives FDA approval for TriClip™, first-of-its-kind device to repair leaky tricuspid heart valve. Abbott Media Room.
- Arnold, S. V., Goates, S., Sorajja, P., Adams, D. H., von Bardeleben, R. S., Kapadia, S. R., … Null, N. (2024). Health Status After Transcatheter Tricuspid-Valve Repair in Patients With Severe Tricuspid Regurgitation. Journal of the American College of Cardiology, 83(1), 1–13. doi:10.1016/j.jacc.2023.10.00
