Figura 11.

Figura 2.

Figura 3.

Figura 4.

Figura 5.

INTRODUCTION

Same as it has happened with all the other right heart structures, the tricuspid valve has been forgotten and poorly studied for quite some time. Thanks to the arrival of new technologies, we’ve been able to gain greater knowledge on this structure, thus providing cardiologists with greater accuracy regarding diagnosis and an endless number of tools for the decision-making process.

Tricuspid regurgitation is the most common condition affecting this valve and, when it is significant and follows its natural progression, it has a grim prognosis.1 When associated with the left heart and has a surgical indication, there is no discussion that the tricuspid disease should be solved right when the condition is associated to its treatment.1

Problem is when severe tricuspid regurgitation is found as an isolated condition since in the context of conventional surgical treatment, both its morbidity and mortality rates are high (> 8%-to-10% in most series reported). If we add this to the comorbidities and procedures associated with most of these patients then surgical risk elevates from extremely high to prohibitive.

The development of percutaneous devices to treat this condition comes as a response to the pressing need for having an effective treatment for these populations whose risk per se—added to the risk associated with conventional surgery of the tricuspid valve—has left them with no therapeutic possibilities available beyond drug therapy. It is in this context that, eonce again, the advancement of science and technology in the field of interventional cardiology has taken the lead by readapting devices initially thought and developed to treat aortic valve disease and then dedicated valves that are implanted heterotopically in every vena cava to stop reflow due to tricuspid regurgitation.

The CAVI (Caval Valve Implantation) procedure with the TricValve device consists of the heterotopic percutaneous implantation of 2 self-expanding valves made of bovine pericardium pre-mounted on a nitinol stent and pre-shaped to adapt to the anatomy of each vena cava.

Valves designed for the superior vena cava (SVC) come with a long skirt to avoid paravalvular leak while those designed for the inferior vena cava (IVC) come with a short one to prevent supra-hepatic vein occlusions.

Like we mentioned before, the objective of this new technology is to reduce venous flow in patients with severe tricuspid regurgitation, and then improve the symptoms associated with retrograde congestion like antegrade cardiac output.

CASE REPORT

This is the case of the first CAVI procedure ever performed in Argentina, the case of a 61-year-old woman from Brazil with a past medical history of conventional heart surgery: pulmonary valvulotomy due to symptomatic severe pulmonary stenosis back in 1983 (with median sternotomy, on extracorporeal circulation and without tricuspid plication), and chronic atrial fibrillation on permanent anticoagulation therapy.

The patient is admitted to the hospital for examination with a multiple month history of symptoms of right heart failure, functional class III/IV already refractory to full pharmacological treatment associated with severe tricuspid regurgitation.

The Doppler ultrasound performed reveals the presence of right heart dilatation (right ventricle of 71 mm in diameter with a TAPSE as low as 16 mm), severe tricuspid regurgitation with reflow, and dilatation of inferior vena cava and without respiratory collapse. Moderate pulmonary hypertension with PASP of 50 mmHg. Right heart cavities with normal findings.

The multislice coronary computed tomography angiography performed confirmed these findings and the patient’s anatomy was studied in detail with additional findings of superior vena cava dilatation.

With the findings from all the studies performed, the case was discussed with the heart team regarding what treatment should be administered to the patient. The TricValve transcatheter bicaval valve system (CAVI) was decided for compassionate use.

PROCEDURE

Neuroleptoanalgesia, antibiotic prophylaxis, heparin (5000 IU), and transthoracic echocardiography were administered and performed at the cath lab. Bilateral femoral venous access: right main access using a 22-Fr dedicated introducer sheath. Left access also (7-Fr) for control and mark test purposes.

Using the main access, a JR catheter was mounted over a 0.035 in guidewire that was moved up to the right jugulo-subclavian venous confluence. Then, the guidewire was exchanged for a long Amplatz extra-support guidewire. Afterwards, the vascular access is predilated with larger introducer sheaths followed by the TricValve dedicated system implantation.

Via secondary venous access, a pigtail catheter was mounted over a 0.035 in guidewire and advanced towards the right pulmonary artery middle lobar branch to mark the valve implantation site on the SVC (of 25 mm selected based on measurements of the aforementioned studies). The valve has already been pre-mounted on its delivery system and advanced through the main access until reaching its correct position. Afterwards, it is carefully deployed with slow turns of the handle command resulting in a successful early deployment (up to 80% of the delivery of both valves can be retrieved). Afterwards, the delivery system is eventually removed.

Using the conventional 0.035 in guidewire, the pigtail catheter is repositioned from the secondary access inside the suprahepatic veins (SHV) to mark the valve implantation site insde the SVC (of 35 mm) in such a way that the valve radiolucent band remains at catheter level. Once this has been achieved, the valve is slowly deployed while the radiolucent band at end of the skirt is monitored at all time, so it does not block the lumen of the SHV. When 70% of the valve has already been deployed the patency of the SHV is reevaluated by performing an angiography. Once patency has been confirmed, the pigtail catheter is removed, and valve deployment is complete. Finally, the delivery system is eventually removed.

Afterwards, the pigtail catheter is moved upwards via secondary access to perform the final angiographic test and obtain hemodynamic measurements, both of which confirm the correct positioning of both valves, the ventriculization of atrial pressure, and significant changes to venous pressure curve. Therefore, the procedure is considered successful. Main access is closed using the Perclose ProGlide suture-mediated closure system. Manual pressure hemostasis is performed with contralateral access followed by bilateral compression bandaging.

The patient was, then, administered intensive therapy followed by a transthoracic echocardiogram that confirmed the values and results obtained in the cath lab.

The patient spent her first 3 days on intensive therapy followed by 5 days on intermediate therapy resulting in a significant improvement of the signs and symptoms of heart failure. She remained on full pharmacological and anticoagulation therapy due to her atrial arrhythmia. Afterwards, she was successfully discharged from the hospital.

Currently, the patient remains on outpatient follow-up with good disease progression, and NYHA functional class I/II.

DISCUSSION AND CONCLUSIONS

Tricuspid regurgitation is the most common disease of the tricuspid valve. When in its severe stage it undermines the patient’s quality of life tremendously. However, disease progression can be changed significantly with drug therapy. When this valvular heart disease is associated with other valvular heart diseases or with left heart disease, surgical treatment is indicated. However, when it appears as an isolated disease, conventional surgery has been associated with high morbidity and mortality rates in most series described. Therefore, the development of new technologies like the one discussed here is of paramount importance in the search for therapies capable of changing the course of this disease.2

The pilot study on CAVI—first-in-man—was conducted by Alexander Lauten et al. back in 2018. It revealed a good safety profile associated with this procedure and significant symptom and functional class improvements in these patients.5

These early results are reinforced by the most recent evidence coming from studies like the TRICUS STUDY and the TRICUS STUDY EURO. Both are single-arm clinical trials where the CAVI procedure was associated with a significantly high rate of procedural success and significant increases of both the patients’ quality of life and functional class at 6-month follow-up.

The data obtained were positive both following clinical improvement and lack of deaths associated with the procedure and the 6-month follow-up. The need for immediate surgical treatment or at follow-up was not described.

In conclusion, the evidence from early studies on the CAVI procedure is encouraging and seems that a promising future lies ahead in the management of isolated, symptomatic, severe tricuspid regurgitation as it was the case with the case report of the patient presented here.

Although results are encouraging, more robust scientific evidence is required, as well as randomized clinical trials with many more patients and longer follow-up periods on CAVI procedure before its indication can be extrapolated to other conditions.

1. María del Pilar Aguilar, Florencia Cristar. Insuficiencia tricuspídea:nuevas evidencias que revalorizan una valvulopatía olvidada; Artículo de revisión Rev Urug Cardiol 2015;30:312-25.

2. Alexander Lauten, Hans R. Figulla, Axel Unbehaun, et al. Interventional Treatment of Severe Tricuspid Regurgitation, Early Clinical Experience in a Multicenter, Observational, First-in-Man Study; published 14 Feb 2018, https://doi.org/10.1161/CIRCINTERVENTIONS.117.006061 Circulation: Cardiovascular Interventions. 2018;11:e006061.

3. Omar Abdul-Jawad Altisent, Rimantas Benetis, Egle Rumbinaite,et al. Caval Valve Implantation (CAVI): An Emerging Therapy for Treating Severe Tricuspid Regurgitation (Review), 7 October 2021 , Journal of Clinical Medicine.

4. Mirjam G. Wild, Fabien Praz. Caval Valve Implantation for Advanced Tricuspid Regurgitation: Closing a Therapeutic Gap?; JACC Cardiovascular Interventions; Volume 15, Issue 13, 11 July 2022, Pages 1378-1381.

5. Antonio Martínez Guisado; Estudio TRICUS EURO: resultados a 6 meses del sistema TricValve; 19 octubre 2022 | Cardiología Hoy; SEC.

6. Jorge Rodríguez-Capitán, Juan J. Gómez-Doblasa, Leticia Fernández-López, et al. Cirugía de la regurgitación tricuspídea grave: resultados a corto y largo plazo, Short- and Long-term Outcomes of Surgery for Severe Tricuspid Regurgitation, DOI: 10.1016/j.recesp.2013.02.003.

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Compassionate use of bicaval valve with the TricValve device (CAVI) to treat severe tricuspid regurgitation. First case ever performed in Argentina

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