Severe tricuspid regurgitation (TR) presents a reserved prognosis when not treated in time, seeing as systemic venous congestion might significantly limit quality of life in these patients. For many years it was thought diuretic therapy was the only option to treat these patients, since the surgical alternative offered suboptimal results and many patients were deemed inoperable.
Because severe TR evolves badly, several percutaneous strategies have been developed, such as edge-to-edge, PCI, transcatheter orthotopic valve replacement. However, due to the particular characteristics of this valve, there is a substantial population that make no good candidates for percutaneous strategies on the native valve. In response to this need, the heterotrophic valve replacement has surged as an alternative, aiming at improving systemic congestion.
The TricValve consists of two self-expanding nitinol valves with bovine pericardial leaflets that are implanted percutaneously into the superior vena cava (SVC) and inferior vena cava (IVC) to reduce systemic venous congestion.
The study presented by Blasco-Turrion, assessed TricValve outcomes at one year followup in two prospective non-randomized single arm studies: The TRICUS (a feasibility study of 9 patients in Lithuania) and the TRICUS EURO (an efficacy and safety CE mark trial on high surgical risk patients carried out in 12 centers from Spain and Austria). It included patients presenting severe TR despite optimal medical treatment, who were in functional class III or IV, and made no good candidates for conventional surgery. It excluded patients with severe right ventricular dysfunction (TAPSE ≤13), kidney failure Cr ≥3mg/dl) or dialysis.
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Primary end point was clinical improvement assessed by a combined outcome including changes in quality of life (QoL, according to KCCQ score), improved functional class, and changes in exercise functional capacity according to 6-minute walk test (6MWT). It also looked at major adverse events, rehospitalization for cardiac failure or device related events, as well as structural changes in the right ventricle and improved systemic venous congestion.
One year outcomes with mean 368 days, revealed that the average population was 76.2 years of age, and 82% were female. Most patients (86.4%) were in FC-III, 72% had a history of prior valve intervention, 93% presented atrial fibrillation, with mean EuroScore II 5.6±3.6%.
The combined primary end point of clinical improvement was achieved in 95.5% of patients, with significant improvement in QoL scores (p<0.001) and a remarkable increase (over 15 points) in 56.4%. As regards functional class, there was significant improvement (p<0.001), with 62.2% of patients in FC I/II at one year. Even though there were no significant changes in 6MWT, 40% of patients experienced a considerable improvement (≥40 m), though not statistical (P=0.285).
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As regards the secondary end points, there were 3 deaths (1 cardiovascular) and one case requiring emergency surgical intervention due to device embolization from SVC. 9% of the population experienced major gastrointestinal bleeding, 6.8% presented puncture site complications, and 9% a cerebrovascular event at followup. Rehospitalization rate for cardiac failure at one year was 29.5%, mainly in patients with prior valve intervention (27.3% vs 0%; P=0.012).
At echocardiographic assessment, there were no significant differences in right ventricular function according to TAPSE, but liver failure saw a considerable reduction in 63.8% of patients.
Conclusions
TricValve showed, at one year followup, symptomatic improvement of systemic congestion according to the specified combined primary end point. Even though this strategy has been applied to patients at high risk of surgery, with a challenging valve anatomy for PCI, promising data on a complex population is of significant progress. We expect data from randomized studies to reinforce the indication of this device.
Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.
Original Title: Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation One-Year Follow-Up Outcomes.
Reference: Blasco-Turrión, S, Briedis, K, Estévez-Loureiro, R. et al. Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: One-Year Follow-Up Outcomes. J Am Coll Cardiol Intv. null2023, 0 (0). https://doi.org/10.1016/j.jcin.2023.10.043.
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