Given the technical simplicity of the bicaval valve implantation (CAVI) technique compared to other transcatheter devices, CAVI is postulated as a suitable alternative for a wide variety of patients affected with severe+ tricuspid regurgitation.
1. Introduction
Severe symptomatic tricuspid regurgitation (TR) is associated with poor short- to medium-term clinical outcomes, representing a leading cause of moderate-to-severe heart valve disease in developed countries [
1,
2]. Medical treatment and tricuspid valve (TV) surgery are the currently accepted therapies to treat severe symptomatic TR. However, despite TV surgical volume steadily increasing in the US, in-hospital mortality has remained static at 9%, suggestive of the fact that TV surgery is typically offered too late in the course of disease [
3,
4]. Several percutaneous devices have emerged during last decade to treat severe TR, with promising results in early feasibility studies, with pivotal randomized trials ongoing [
5]. However, owing to its complex anatomy and challenges with peri-procedural imaging, many patients are still deemed unsuitable for these emerging percutaneous TV therapies that include edge-to-edge repair, direct annuloplasty and orthotopic valve replacement.
Caval valve implantation (CAVI) emerged initially as an alternative therapy for patients deemed as having ‘no other options’ for treating their severe symptomatic TR; such patients often afflicted with concomitant hepatic congestion and right heart failure [
5]. Given the emerging challenges and applicability of many emerging percutaneous TV therapies to the broader cohort of severe TR candidates, the simplicity of CAVI underscores its attractiveness as an effective treatment option for many severe TR patients. CAVI has subsequently rapidly evolved with the development of dedicated devices adapted to the specific anatomy of the caval venous system [
6,
7].
2. TricValve®: Evidence, Current Studies, and Future Trials
Special access program for compassionate use of the dedicated TricValve® system has been granted in 11 countries. To date, 47 patients have been treated within this program, with an implantation success of 98%, with only 1 out of 47 patients suffering from device embolization requiring surgical correction. So far, in hospital mortality is 0% and 30-day mortality is 4%, comparable with other tricuspid percutaneous devices.
Besides the global compassionate use program, there are currently 2 ongoing trials with specific protocols assessing the feasibility, safety and performance of the TricValve® system: TRICUS STUDY (NCT03723239), an early feasibility first-in-man trial; and TRICUS-EURO (NCT04141137), a CE mark trial. End-points also include assessment of the functional status, exercise capacity and quality of life. The 2 trials have single arm-an open label design and have completed patient enrollment. TRICUS included 9 patients from Lithuania, and TRICUS-EURO included 35 patients from Spain and Austria.
Inclusion Criteria |
Clinical
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Severe symptomatic TR demonstrated by echocardiography with significant backflow in the IVC and/or SVC
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NYHA functional Class III or IV despite OMT
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LVEF ≥ 40%
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Distance covered in 6-min walk test ≥ 60 m
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The patient shall be screened by a “Heart Team” (including interventional cardiologist and cardiac surgeon)
Hemodynamic
|
Exclusion Criteria |
Clinical
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Right ventricular failure (TAPSE ≤ 13 mmHg)
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Systolic pulmonary arterial pressure > 65 mmHg as assessed by Doppler echocardiography
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Untreated significant left sided valvular heart disease which requires treatment
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Requirement for other elective cardiac procedures (i.e., PCI, CABG, etc)
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Liver cirrhosis Child C
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Serum creatinine > 3.0 mg/dl or on dialysis
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Intra-cardiac shunt or congenital structural heart disease based on heart teams decision
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Documented primary coagulopathy or platelet disorder, or thrombocytopenia (absolute platelet count < 90 k)
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Contraindication or known allergy to device’s components, or VKA
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Thrombosis of the lower venous system or vena cava filter
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Life expectancy to less than one year for a non-cardiac condition
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This entry is adapted from the peer-reviewed paper 10.3390/jcm10194601