Two late-breaking studies at the 2022 Transcatheter Cardiovascular Therapeutics (TCT) meeting provided positive data for Abbott's MitraClip transcatheter mitral valve repair (TMVR) device and the TriClip, a new iteration of the device for transcatheter tricuspid valve repair (TTVR). Both are transcatheter edge-to-edge repair (TEER) devices that clip the valve leaflets of the mitral or tricuspid valve to reduce or eliminate regurgitation.
MitraClip EXPAND G4 post-approval study results
Data was presented from the prospective, multi-center, global real-world EXPAND G4 study supporting the safety and effectiveness of the MitraClip G4 system for treating mitral regurgitation (MR). This is the latest iteration of the MitraClip that allows independent manipulation of each grasping arm during the procedure.
The study represents the largest report of 30-day core lab-assessed outcomes, which included more than 1,000 patients. The data confirm that MitraClip offers high success rates in terms of MR reduction, improvements in quality of life and low adverse event rates.
Key findings through 30 days include:
• Significant MR reduction to mild or less (≤ grade 1+ on a four-point scale) is achieved in 91% of patients, with lowest reported adverse event rates to date (1.3% all-cause mortality at 30 days).
• Clinical improvements including 83% of patients achieving New York Heart Association (NYHA) Functional Class I/II (a classification of functional limitations resulting from cardiac disease, with Class I/II meaning slight or no limitation of physical activity), an improvement of 52% from baseline of 31%; and an 18-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score (a self-assessment of social abilities, symptoms and quality of life), a 35% improvement from baseline score
• Multiple clip sizes enable tailoring the therapy to patients' mitral valve anatomy and expand the spectrum of TEER-suitable patients
"MitraClip therapy has fundamentally changed the way doctors treat mitral regurgitation, provides a valuable therapy option that does not require open-heart surgery, and goes beyond simply managing symptoms with medications," said Jason Rogers, MD, professor of cardiovascular medicine and director of interventional cardiology and structural heart training programs at the University of California, Davis Medical Center, in a statement. "These late-breaking data demonstrate and strengthen the evidence that Abbott's MitraClip system consistently reduces MR in a broad range of patients, while restoring proper function of the mitral valve and improving patients' quality of life."
The MitraClip system has been commercially available in the U.S. since 2013 and in Europe since 2008. It has been implanted in more than 150,000 patients worldwide.
First results from the TriClip TRILUMINATE pivotal trial
The TriClip iteration of the MitraClip is being used in the TRILUMINATE pivotal trial to test safety and efficacy of TEER in the tricuspid valve. The randomized, controlled clinical trial will include 700 patients with severe tricuspid regurgitation (TR) in the U.S., Canada and Europe. The data will be used to seek U.S. Food and Drug Administration (FDA) market approval for the device.
The data from the roll-in cohort through 30 days show:
• High implant success rate of 99%.
• At least a one-grade TR reduction in 91% of patients, with moderate or less residual TR achieved in 74%.
• Patients achieving around a 17-point improvement in the KCCQ score, a 30% improvement from baseline score, which demonstrates a substantial improvement in their quality of life.
The results from this trial are promising because there are currently few treatment options for TR patients, as surgical valve replacement generally has had poor outcomes.
"It is a valve that does not kill the patient, but makes them feel horrible," explained Joao Cavalcante, MD, director, cardiac MRI and structural CT labs, Minneapolis Heart Institute, who is involved with the trial. "These patients can barely do anything, they feel terribly exhausted and everything they do is like moving mountains. This does not cure the patients, but it does reduce the TR and the patients feel better."
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: dfornell@innovatehealthcare.com