Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER)

I am writing in support of the application for CMS coverage of tricuspid TEER therapy. For virtually all of my cardiology practice (21 years), we have rarely offered therapy for tricuspid regurgitation, despite abundant data showing a strong association between worsening TR, worsening RV size and function, and outcomes that all care about, such as mortality and heart failure (along with it's frequent requirement for hospitalization). TEER therapy now has a strong track record of safe and effective treatment of regurgitation, first in the mitral space, and now in the tricuspid space. It is granted that there is still much to learn about tricuspid valve intervention; but the ACC in partnership with the STS have created and harnessed the TVT database that will go a long way toward deepening our understanding of who should be treated, when they should be treated, and this will demonstrate profound benefits for patients.
Strong clinical trials to date have already demonstrated, in my mind, the safety of this procedure, and have already demonstrated significant, tangible benefits, which I fully expect will grow as time goes by. Based on the strong and favorable safety and outcomes data, I endorse approval of this technology for all Medicare recipients.

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Drink lots licorice root and rasberry bulb test with rose rub your body down with arnica oils an vitamins D, B, and K and vapor rub which will cause circulation to move through the issue lite movements and patience with your little one an your self. Maybe every a baby asprini and orange juice with beets juice mix in sanpellgrino or goood tasting $0.99 sparkling water like ICE or Clear Choice etc. with a few slices of citirus fruit light salads pre made from Walmart and Target with meats like chicken.

As Per Nature's Medicine Camille Campbell

Stage A: At risk. Risk factors for heart valve disease are present.
Stage B: Progressive. Valve disease is mild or moderate. There are no heart valve symptoms.
Stage C: Asymptomatic severe. There are no heart valve symptoms, but the valve disease is severe.
Stage D: Symptomatic severe. Heart valve disease is severe and is causing symptoms.

Cardiac catheterization. This test isn't often used to diagnose tricuspid valve disease. But it can be helpful if other tests haven't diagnosed the cause of the condition. A doctor guides a thin, flexible tube called a catheter through a blood vessel in the arm or groin. It's moved to an artery in the heart. Dye flows through the tube. This makes the heart arteries show up more clearly on X-rays taken during the test. Pressures in the heart also can be measured during this test.

Cardiac MRI. This test uses magnetic fields and radio waves to create detailed pictures of the heart. Cardiac MRI may help show the severity of tricuspid valve regurgitation. The test also gives details about the lower right heart chamber.

Electrocardiogram (ECG or EKG). This quick test records the electrical signals in the heart. It shows how the heart is beating. Sensors, called electrodes, stick to the chest and sometimes the legs. Wires connect the sensors to a computer, which displays or prints results.

Chest X-ray. A chest X-ray shows the condition of the heart and lungs.

Echocardiogram. This is the main test for diagnosing tricuspid valve regurgitation. It uses sound waves to create pictures of the beating heart. It shows how blood flows through the heart and the heart valves, including the tricuspid valve.

There are different types of echocardiograms. A standard echocardiogram is called a transthoracic echocardiogram (TTE). It creates pictures of the heart from outside the body. Sometimes, a more-detailed echocardiogram is needed to better see the tricuspid valve. This test is called a transesophageal echocardiogram (TEE). It creates pictures of the heart from inside the body. The type of echocardiogram you have depends on the reason for the test and your overall health.

Recent Reference of Acceptance of instruction
Mayo Clinic good review of information in full details.
11:38 AM 10/10/2024

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The recent development of structural interventions for treatment of valvular heart disease is one of the most significant advances in Medicine in the last 100 years. We finally can treat patients who otherwise often die of heart failure. The improvements in general health and cardiac outcomes provided by mitral TEER are impressive. Tricuspid TEER has similar potential for patients suffering from severe or greater tricuspid regurgitation. I heartily support Medicare coverage for this procedure to allow needy patients to benefit from this wonderful device.

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I am significantly in favor and strongly advocate for CMS approval for tricuspid valve TEER. This procedure is safe and associated with significant reduction in TR severity. Having been involved in the care of these patients and completed over 30 tricuspid TEER procedures I have been a direct witness of the immediate and mid-term impact on patient's symptoms, quality of life and heart failure class. It is quite remarkable in the appropriate clinical and anatomical setting.

Visualization of the tricuspid valve leaflet makes the procedure most challenging and laborious when compared to mitral TEER. Not infrequently, operators require the simultaneous of dual imaging with 3D-TEE and 3D intracardiac ultrasound to enhance procedural outcomes and device safety. Adding 3D ICE capabilities at the time of the procedure results in additional procedural access, procedural time and a major added cost (average $3500 per catheter/per case) to the organization. With that in mind, and contrary to mitral TEER, I would strongly advocate for CMS to support the add-on payment of 3D ICE in cases of tricuspid TEER for both physicians (RVU) and the organization (DRG). It will otherwise continue to represent an important financial burden for this innovative solution, and a risk to those patients that would otherwise benefit from its use.

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In expert hands and after thorough efforts of optimized medical therapy and continued GDMT and OMT after the T-TEER procedure, TriClip has shown to improve quality of life in patients who don't have other alternatives. In an attempt to achieve similar value for the patients, it appears critical to ask for the same thoroughness and expertise going forward. This is not a popular topic but in order to provide best value for these patients, guardrails like documented optimization of medical therapy prior to the procedure, shared decision making (similar to LAAO) and procedural volume requirements could be considered (i.e., >= 40 M-TEERs / year for the institution, or provider specific requirements). Of course, this comes with the caveat of allowing reasonable access to this therapy.

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I'm a Board Certified Cardiologist and practitioner. I treat patients with valvular heart disease on a daily basis. I have participated in the T-TEER FDA trials.
Tricuspid Regurgitation is a condition with limited surgical availability because the patients often have liver failure from passive congestion which makes them surgically inoperable. Most if not all of these patients with severe TR which is not adequately managed medically, will have an improved clinical outcome with tricuspid TEER. CMS should approve this condition so that medicare patients will have open access to this technology now that it has been approved by the FDA.

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As an operator of transcatheter edge to edge repair for Tricuspid Regurgitation, I can personally attest to the dramatic symptom and quality of life improvement experienced by my patients. The TriClip device has given this undertreated severe TR patients an opportunity to live and breath again! This therapy should be made easily accessible and widely available at appropriate medical centers so that patients can be treated in the communities in which they live and treated by experts who can deliver the best possible results.

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