Transfemoral Transcatheter Tricuspid Valve Replacement With the EVOQUE System: A Multicenter, Observational, First-in-Human Experience

JACC Cardiovasc Interv. 2021 Mar 8;14(5):501-511. doi: 10.1016/j.jcin.2020.11.045. Epub 2021 Feb 10.


Objectives: The purpose of this observational first-in-human experience was to investigate the feasibility and safety of the EVOQUE tricuspid valve replacement system and its impact on short-term clinical outcomes.

Background: Transcatheter tricuspid intervention is a promising option for selected patients with severe tricuspid regurgitation (TR). Although transcatheter leaflet repair is an option for some, transcatheter tricuspid valve replacement (TTVR) may be applicable to a broader population.

Methods: Twenty-five patients with severe TR underwent EVOQUE TTVR in a compassionate-use experience. The primary outcome was technical success, with NYHA (NYHA) functional class, TR grade, and major adverse cardiac and cerebrovascular events assessed at 30-day follow-up.

Results: All patients (mean age 76 ± 3 years, 88% women) were at high surgical risk (mean Society of Thoracic Surgeons risk score 9.1 ± 2.3%), with 96% in NYHA functional class III or IV. TR etiology was predominantly functional, with mean tricuspid annular diameter of 44.8 ± 7.8 mm and mean tricuspid annular plane systolic excursion of 16 ± 2 mm. Technical success was 92%, with no intraprocedural mortality or conversion to surgery. At 30-day follow-up, mortality was 0%, 76% of patients were in NYHA functional class I or II, and TR grade was ≤2+ in 96%. Major bleeding occurred in 3 patients (12%), 2 patients (8%) required pacemaker implantation, and 1 patient (4%) required dialysis.

Conclusions: This first-in-human experience evaluating EVOQUE TTVR demonstrated high technical success, acceptable safety, and significant clinical improvement. Larger prospective studies are needed to confirm durability and safety and the impact on long-term clinical outcomes.

Keywords: EVOQUE; transcatheter tricuspid valve replacement; tricuspid regurgitation.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Cardiac Catheterization / adverse effects
  • Female
  • Heart Valve Prosthesis Implantation* / adverse effects
  • Humans
  • Male
  • Time Factors
  • Treatment Outcome
  • Tricuspid Valve / diagnostic imaging
  • Tricuspid Valve / surgery
  • Tricuspid Valve Insufficiency* / diagnostic imaging
  • Tricuspid Valve Insufficiency* / surgery