Severe tricuspid regurgitation (TR) is associated with high mortality and morbidity. For patients with high surgical risk that cannot get surgery, the endovascular option has become an attractive solution this past decade.
Transcatheter intervention has focused on edge-to-edge repair and valve replacement. However, their success depends on anatomical characteristics and imaging guidance effectiveness.
The bicaval stent has emerged as a transcatheter alternative to indirectly treat TR systemic effects. The TricValve is a bicaval device with 2 self-expanding stents made of nitinol and bovine pericardium, one for the superior and the other for the inferior cava veins.
The aim of this prospective multicenter non-randomized study was to assess its 30-day safety and 6-month clinical efficacy in patients with severe symptomatic TR with high surgical risk.
Primary end point was change in functional class and quality of life measured by a questionnaire at 6 months. Secondary end point was major adverse events such as death, AMI, cardiac tamponade, cardiac surgery, stroke or major bleeding, functional capacity assessed by 6-minute walk test, implantation success, right catheterization at 3 months, echocardiogram and lab parameters.
It included 35 patients, mean age 76 and mostly women. All patients were symptomatic, mostly in functional class III and with signs of right cardiac failure. They also presented comorbidities such as atrial fibrillation (94%), prior pacemaker (23%), kidney failure (60%) and prior valvular intervention (68%). Mean EuroScore was 5.8. Left ventricular ejection fraction was 59%.
Technical success was 97% and procedural success was 94%, with no deaths or stroke. There were no cardiac tamponade or surgery cases. As regards primary end point, there was an increased quality of life and improved functional class with 79% of patients in FC I/II at 6 months.
Mortality at 6 months was 8.5%, none were of cardiovascular cause. There was no AMI or need for surgery at 6 months. The most frequent complication was major bleeding (17%), 2 cases were associated with access site and 4 were at follow up. Readmission for cardiac failure was 20%. Finally, there were no significant echocardiographic changes between baseline and 6 month outcomes.
Conclusion
The TricValve bicaval stent for the treatment of severe symptomatic TR is safe and effective and shows fast sustainable benefits in quality of life and functional capacity. However, we need more randomized studies comparing TricValve vs standard medical treatment to be able to better establish the role of this endovascular treatment of the tricuspid valve.
Dr. Andrés Rodríguez
Member of the editorial board of SOLACI.org.
Original Title: 6-Month Outcomes of the TricValve System in Patients With Tricuspid Regurgitation The TRICUS EURO Study.
Reference: Rodrigo Estévez-Loureiro, MD et al J Am Coll Cardiol Intv 2022;15:1366–1377.
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