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 invasive 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]

GulfPCR-GIM 2022

December 15, 2022

Tricuspid Regurgitation – A new prospect in the management of patients with TR

Our Case-in-Point session at GulfPCR-GIM addressed the prevalence of tricuspid regurgitation and its global effects, introduced procedure techniques as well as patient selection criteria. The session also incorporated regional experiences with the TricValve technology with featured cases from Saudi Arabia and Kuwait.

Hear from the experts

M Haude
K Kiss
S Samargandy
A Alenezi

Read the Q&A with all panelists here.

Concluding remarks

In the take-home-message Prof. Haude reiterated:

  1. TricValve is feasible in advanced heart failure with TR, even with pacemaker/ICD leads.
  1. It is independent of annulus size of Tricuspid valve anatomy, as there is no interaction with the orthotopic valve.
  1. TricValve is the only medical device consisting of 2 pre mounted dedicated valves for Bicaval implantation in TR patients.
  1. TricValve reduces caval backflow and therefore signs of right heart failure such as peripheral edema, ascites, and hepatic congestion with related secondary symptoms.
  1. TricValve implantation is a safe and straight forward procedure not requiring excessive intraprocedural dedicated imaging skills.
  1. Viability of the device for all patients with functional tricuspid regurgitation.

Learning objectives

  • To know more about the TricValve Bicaval valves system
  • To understand how TricValve can help you in the management of patients with functional tricuspid regurgitation
  • To get an Insight from Middle East – Early adoption

Case summary

Case 1
A patient was referred to Dr. Samargandy at the age of late 60s, had previously undergone mitral replacement and suffered from post-surgical wound infection. She had been repeatedly admitted into hospitals with ascites and right-sided failure. After performing TEE and discussion by the heart team, she was not suitable for edge-to-edge repair for her tricuspid valve, so they went with TricValve Bicaval Valves System for the patient.
Dr. Samargandy shared her experience on how to choose a good position for the landing of both the SVC and IVC valve, with pigtail or PA catheters put into innominate vein, PA, and suprahepatic veins as reference.
After the procedure, echo showed that the valve had normal function, with no paravalvular leak and the patient had a good hemodynamic response. Angiogram also showed that there was no more regurgitant volume from going back into the IVC. Right atrium served as a reservoir for the regurgitation and IVC pressure had a drastic drop thus protecting the patient’s liver and kidney.
The implantation was successful and showing that TricValve provides an effective alternative to those tricuspid regurgitation (TR) patients who are anatomically unsuitable for TEER.

Case 2
Dr. Alenezi’s patient was a 70-year-old man, with previous ischemic heart disease, status post CABG and PCI, hypertension, dyslipidemia, diabetes mellitus, chronic kidney disease and atrial flutter status post ablation. The patient had been hospitalized repeatedly due to recurrent hepatic encephalopathy (one of the symptoms of severe TR). His TR started from endocarditis since 2013 and underwent TriClip procedure in 2021 with three clips implanted. Later, one of the clips had single leaflet detachment and TR reoccurred. Patient had shown normal LV systolic function, severe atria enlargement, moderate dilated RV with mild systolic dysfunction (TAPSE=12mm) and PASP 50mmHg. Right heart catheterization showed v-wave of 15mmHg in SVC, RA and IVC. The heart team considered TricValve as the only available option because of anatomical reasons.
During the implantation, no catheter was put in the pulmonary artery as it may cause dislodgement of the single leaflet detached clip. Instead, the sternal wire in the patient’s body was used as a landmark for positioning of the valves. Both the SVC and IVC valve were successfully implanted. After IVC valve deployment, no drop in IVC pressure and possible paravalvular leak was observed from echo although fluoroscopy showed no regurgitant into the IVC. Second IVC valve was placed at the same position of the first valve. Retrospectively, the team learned that the original position and results were good. The patient was discharged home at Day 2 and he had no recurrence of hepatic encephalopathy. Dr. Alenezi concluded that TricValve can be mainly guided by Fluoroscopy. The valve position is hard to be adjusted once implanted, but valve in valve can be performed to optimize the result. This successful case indicated that TricValve is an effective solution for patient with failure of TEER.

Frequently asked questions

  • Diagnostic Aspects

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

    Patients with torrential 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 veins 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.

    Supra 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 supra hepatic veins 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 supra hepatic veins. Usually patients have a large ostium of the supra hepatic veins.

G-70-1264 Rev02

Previous Events

EuroPCR 2022

GulfPCR-GIM 2021

AiCT-AsiaPCR 2021

EuroPCR 2021

IJN Virtual Press Conference 2021

AiCT-AsiaPCR 2020