Figura 1. TricValve System-Products and Features.Superior vena cava device (left) and inferior vena ...

Figura 2. Measurements in angiotomography. Sizing in superior vena cava (left) and inferior vena cav...

Figura 3. Catheter positioning in right jugular vein and in right pulmonary artery (left). Device im...

Figura 4. . Device implantation of inferior vena cava (left). Angiographic control of both devices (...

INTRODUCtION

The severe tricuspid insufficiency (TI) is an entity associated to a high morbimortality. The available treatment has traditionally been scarce, limited to drugs, diuretics and surgery. The medical treatment is often not enough for this patients’ group, requiring each time highest diuretic doses, which in turn higher the percentage of renal insufficiency associated, and condition to a worst endpoint. Likewise, TI surgery isolated generally presents high perioperative mortality andthe long-term evidences on its effectiveness are very limited1. So, different therapeutic endovascular options have emerged, among which we can find TEER (transcatheter edge-to-edge repair), the orthotopic replacement (with dedicated devices) and the heterotopic bicaval replacement, among the widely used.

The heterotopic bicaval valve implantation (CAVI) with the TricValve device of Products and Features consists in the implant of two valves of bovine pericardium separately sutured to two self-expandable nitinol stents to be implanted at the level of superior and inferior vena cava, respectively (Figure 1). In this way, they restrict the pressure and volume recoil generated by the tricuspid insufficiency, reducing the symptoms associated with venous congestion of renal, hepatic and lower limbs veins. At the same time, due to the pressure increase in the right atrium, the regurgitant volume decreases, and therefore could improve the systolic volume of the right ventricle2.

Even if the evidence is not compelling in terms of reduction of mortality, its use was associated to the decrease inhospitalizations, in doses of diuretics used and to the improvement in the quality of life.

Then,we present a case which represents our first experience with this device.

CASE

An 85-year-old female patient, hypertensive, ex smoker required multiple hospitalizations due to heart failure right-sided, in the context of severe tricuspid insufficiency with right ventricular function preserved. In the Doppler echocardiogram she presented a dilated right ventricle (basal diameter: 59 mm, median diameter: 48 mm) with preserved function (TAPSE: 21 mm). Dilated tricuspid annulus with central coaptation deficit and severe tricuspid insufficiency with an estimated PSAP of 40 mmHg. Left ventricular function preserved, without left valvuloplasties.

Because of she is a woman undergoing high-risk surgery, she was evaluated with angiotomography which reveals an anatomy suitable with TricValve device of 25 mm in superior vena cava and of 32 mm in inferior vena cava (Figure 2).

It was decided to carry out the case under conscious sedation and transthoracic echocardiography. By surgical dissection, right common femoral vein was exposed and femoral introducer 18 Fr was placed. In left common femoral vein was placed an introducer 6 Fr for echo-guided puncture, through which a pigtail catheter was advanced towards the right pulmonary artery, which was the reference for the device positioning in superior vena cava. Afterwards, an extra support wire 0.35 was positioned towards right jugular vein (Figure 3). Once the valve was deployed in superior vena cava, the pigtail catheter was removed and was repositioned at the level of the suprahepatic vein. Immediately, the device of inferior vena cava was introduced, which was positioned in relation to the pigtail, without its radiopaque mark surpassing it and slow release was carried out, avoiding occlusion of marked suprahepatic vein.

On finishing, transthoracic echocardiography and coronary angiography were performed showing the correct placement of both valves with absence of periprosthetic leaks (Figure 4).

DISCUSSION

The main purpose of this device does not consist specifically in reducing thesevere tricuspid insufficiency, but in lower the venous congestion. However, due to the increase of right atrium pressure, a decrease in the degree of tricuspid regurgitation is observed and related to this a rise in the right ventricular output.

The first case reported in a human took place in 2013 in the hands of Figulla et al. who implanted the device for compassionate use in an 83 year-old-patient undergoing severe TI and prohibitive surgical risk3. Later, in order to demonstrate its feasibility and safety, the TRICUS EURO4 study was performed, in which 35 patients with severe TI were included, mostly Functional Class III with an average age of 76 years and an average EuroSCORE II of 5.8%. It is important to note that 68% of the patients have been submitted to a previous valve intervention. The inclusion criteria are resumed in Table 1.

On the other hand, those patients who presented severe right ventricular disfunction (TAPSE< 13mm), severe pulmonary hypertension (PSAP> 65 mmHg), renal disfunction (creatinine> 3 or dialysis requirement) and hepatic cirrhosis CHILD C were excluded. The technical success was of 97%, without deaths, ACV nor requirement of surgical procedures due to device failure. At 6 months follow- up, 79% of patients improved their functional class. The adverse effect more reported was the transitory omalgia referred by 28% of patients because of phrenic nerve compression4.

Currently with the aim of increasing the available evidence and in the recruitment phase, TRICUS REGISTRY, registry which is retrospective, multicenter and suggests including 450 patients, and the TRICAV study, multicenter that tries to randomize 250 patients with severe TI to optimal medical treatment vs. TricValve and evaluate its efficiency and safety5.

Today, we can say that it is a feasible and safe therapeutic strategy, which has shown benefits in terms of improving quality of life and reduction of symptoms in this group of patients with limited therapeutic alternative and that we understand that it cannot be demanded to increase this very sick population´s survival.

Our first experience with the device resulted very friendly, easy to use, allowing for a precise implantation and with the patient´s stability all the time.

1. Agarwal S, Tuzcu EM, Rodriguez ER, Tan CD, Rodriguez LL, Kapadia SR. Interventional cardiology perspective of functional tricuspid regurgitation. Circ Cardiovasc Interv 2009 Dec;2(6):565-73.

2. O’Neill BP. Caval valve implantation: are 2 valves better than 1? Circ Cardiovasc Interv 2018;11(2):e006334.

3. Figulla HR, Lauten A. Treatment of Ticuspid Regurgitation With Heterotopic Transcutaneous Valve Implantations. CRT (Cardiovascular Research Technologies) Meeting, Washington, DC, 2013.

4. Estévez-Loureiro R, Sánchez-Recalde A, Amat-Santos IJ, et al. 6-Month outcomes of the TricValve system in patients with tricuspid regurgitation: the TRICUS EURO study. JACC Cardiovasc Interv . 2022 Jul 11;15(13):1366-77.

5. Taramasso M, Hahn RT, Alessandrini H, et al. The international multicenter TriValve registry: which patients are undergoing transcatheter tricuspid repair? JACC Cardiovasc Interv 2017;10(19):1982-90.

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Tricuspid percutaneous valve replacement: Initial experience at the Trinidad Mitre Sanatorium

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