New Horizons in
structural heart therapy

TricValve®

TricValve® Transcatheter Bicaval Valves is a system of two self-expanding biological valves for the treatment of patients with hemodynamically relevant tricuspid insufficiency and caval reflux.

The prostheses are implanted percutaneously into the superior and inferior vena cava without disturbing the native tricuspid valve. It is especially intended for use for patients at extreme risk or who are inoperable for open surgical therapy.

Scientific Events

The increasing elderly patient population with the prevalence of moderate-to-severe dysfunctional heart valves is very challenging.

Tricuspid valve insufficiency is reported as the most common valvular heart disease, affecting 65 to 85% of the population 1; the true prevalence of moderate or severe tricuspid regurgitation (TR) has been estimated at 1.6 million people in the United States 2

Surgical valve repair or valve replacement often corrects the condition but for those who cannot withstand an evasive procedure they face a poor prognosis, either from the valve disease itself or because of the complications from the underlying condition causing the valve problem.

1. Singh JP, Evans JC, Levy D, et al. : Prevalence and clinical determinants of mitral, tricuspid, and aortic regurgitation (the Framingham Heart Study). Am J Cardiol. 1999;83(6):897–902. 10.1016/S0002-9149(98)01064-9 [PubMed] [CrossRef] [Google Scholar]
2. Stuge O, Liddicoat J: Emerging opportunities for cardiac surgeons within structural heart disease. J Thorac Cardiovasc Surg. 2006;132(6):1258–61. 10.1016/j.jtcvs.2006.08.049 [PubMed] [CrossRef] [Google Scholar]

EuroPCR

Wednesday May 19th 2021
New Horizons in Tricuspid Therapy

Our TNT session at EuroPCR addressed the problems of tricuspid regurgitation and explained the unique TricValve Transcatheter Bicaval system solution

Hear from the experts

Concluding remark

Prof Haude concluded the session with key a take-home message; “TricValve implantation is safe, and the minimally invasive procedure seems feasible to treat severe TR with low complication rates.”

Learning objectives

  • To learn about the TricValve system’s approach to tricuspid regurgitation and right heart disease
  • To understand how this new generation of tricuspid valve system may reduce the procedural time and contribute to patients’ prognostic
  • To obtain first insights on real live case scenario

Case summary

A 67-year-old female patient was admitted with signs of right heart failure with NYHA class III. The patient had a history of chronic hypertension, dyslipidaemia and atrial fibrillation. She was diagnosed with Severe Functional Tricuspid Regurgitation with secondary to Chronic Fibrillation. Left ventricle EF was 38% with right atrium and ventricular dilatation. Echocardiogram showed a mild functional Mitral valve, severe functional Tricuspid valve, poor coaptation of Tricuspid valve leaflets, and reversal of hepatic vein systolic flow. She refused any surgical valve replacement due to high surgical risk. Therefore, she agreed to go for a transcatheter TricValve® implantation.

Frequently asked questions

  • Diagnostic Aspects

    Patient selection. Which patients do we expect to treat with the TricValve?

    Patients with torrentious TR and symptoms of right heart failure, who are at high risk for surgical treatment.

    Patients with unsuitable anatomy for clipping technologies (such as Triclip or Pascal) because of larger coaptation or dilated annulus

    Many of the patients have pacemaker or Defib leads. Is that a contraindication to the use of the TricValve system?

    No, this is one of the key advantages of the TricValve system – many patients have pre-existent  pacemakers. The leads will be sealed between the stent frame and the vessel wall without disturbing the PM function.

    CT in advance is important for working out a case strategy – any protocol for  CT scanning and the amount of contrast to use for visualization?

    A CT scan is key for structural heart in the planning of the case and in order to understand the anatomical constraint, the contraindication and the indications and device size planning. A dedicated protocol for visualizing the Vv.cavae is available on request.

    Is the system retrievable and up to which point?

    Yes, the system is retrievable up to 80 % deployment of the prosthesis.

    Do we always need TEE to guide us? Can a procedure be done under local anesthesia?

    The procedure can be done under GA with TEE guidance, but patients can also be treated under local anesthesia with just TTE. This is a key advantage as it is less invasive for this very ill patient cohort and also helps to avoid injuries by TEE use (as recently published)

    Is there a need or an indication for post-dilatation of the system?

    Post-dilatation isn’t needed with TricValve.

  • Device Aspects

    How high is the skirt of the valves?

    IVC and SVC skirting are of different lengths: SVC skirting is longer covering 2/3 of the belly therefore preventing paravalvular leakage in the SVC. The IVC skirt is much shorter with only 20 mm from the proximal stent part, thus preventing obstruction of the hepatic vein inflow and at the same time preventing paravalvular leakage.

    What is the bias of the system (should one always move towards the RA?)

    As the Tricvalve  is a nitinol self expandable device, valves always tend to move out of the delivery system, tend to go up the SVC, especially when the belly part is released. Equally the IVC valve tends to move into the right atrium during release, therefore it is extremely important to maintain tension when starting to deploy the valve. As the valve can be released very slowly, there is sufficient time to control the position with TEE/TTE. Optimally a landmark in the bone structure (such as a vertrebra) should be defined before release in order to keep it in a steady position. Once the valve is released 50-80 % the system gets very stable and the tension can be slowly released at this point.

  • Procedural Aspects

    Do we always need TEE to guide us? Can procedure be done under local anesthesia?

    The procedure can be done under GA and TEE, but patients can also be treated under local anesthesia with just TTE. 

    Key landmarks for SVC deployment:

    Level of confluence with the innominate, level of the PA when PA crossed the SVC and distance between the transition into RA, sufficient for the prosthesis which around 66-67mm

    Key landmarks for IVC deployment:

    Distance between ostium of the supra hepatic vein and transition to the atrium in order to avoid obstruction of the hepatic vein inflow. When implanting the IVC, if there is a high risk of perivalvular leak and if too low, the valve might prolapse into the ostium of the supra hepatic veins, as they tend to be severely dilated. At any point up to 80% the device is fully retrievable.

    Is there a need and an indication to post-dilate the system?

    This is different from TAVI. This is a venous system. If  there is  some sort of obstruction, it is probably a contraindication to using this device. There is no indication to post-dilate.

    Superior hepatic veins – do they have a chance to occlude?

    We have not seen this complication. Only 20 mm of the proximal part of the inferior valve is covered, the rest is not covered. The system is implanted 5-10 mm into the atrium and the distance between the superior hepatic vein to the atrium is around or in the range of 5-15 mm, that means the skirt of the valve remains between the atrium and the superior hepatic vein. Usually patients have a large ostium of the superior hepatic vein.

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