Treating tricuspid regurgitation (TR) has gained increasing importance in interventionism. There is abundant literature on the negative natural evolution of this condition and its unfavorable prognosis, as well as the clinical challenges associated to optimal medical treatment.
Among its percutaneous treatment options, both edge-to-edge repair devices (TEER), as showed in TriValve and TRILUMINATE trials, and transcatheter tricuspid valve replacement devices (TTVR), according to TRISCEND, have presented promising results.
Despite TEER appears as the first treatment choice in these cases, because of experience in mitral management, it carries significant residual TR incidence ≥ severe, approximately in 43-48% of cases. Transcatheter replacement treatments have been developed to eliminate this residual pathology. Initial experiences have reported considerable reduction of TR severity in more than 98% of cases.
The EVOQUE system consists of a bovine pericardial prosthetic valve with three leaflets, currently available in 44-, 48-, and 52-mm sizes, with a femoral 28-F delivery system of promising results. Its anchoring mechanism uses a nitinol annulus with 9 ventricular anchors for stable implantation and a skirt to minimize paravalvular leak, which have been shown efficient.
Read also: New Advances in Mitral Regurgitation Devices with Promising Results.
To assess this system’s long term outcomes in a considerable sample, researchers looked at clinical and echocardiographic events within the TRISCEND framework, a prospective, multicenter single arm study. This study assessed the safety and performance of the EVOQUE system in patients with ≥ moderate symptomatic TR, despite optimal medical treatment and with suitable anatomy for TTVR.
It excluded patients with hemodynamic instability, severe pulmonary hypertension, severe right ventricular dysfunction, refractory cardiac failure and ejection fraction ≤25%. It also excluded patients with recently acquired pacemaker (within the last 3 months).
The safety primary end point was a composite of major adverse events at 30 days, which included cardiovascular mortality, stroke, acute myocardial infarction, renal complications, severe bleeding, non-elective valve intervention, major puncture site complications and vascular complications.
Performance end points were “device success”, defined as adequate implantation, “procedural success”, defined as absence of paravalvular leak at ECG and “clinical success” defined as the absence of major adverse events at 30 days.
Read also: SAFE-TAVI Study: Safety and Efficacy of the Pressure Sensor and Pacing Guidewire.
176 patients took part in the study, from 20 centers across US and Europe, mean age 78.7 and 71% women. STS score was 7.4%. Tricuspid regurgitation was ≥severe in over 88% of cases, being the predominant secondary etiology (68.2%). Clinically, 75.4% of patients were in functional class III or IV (NYHA). As regards comorbidities, 92% had atrial fibrillation, 84% high blood pressure and 75% pulmonary hypertension.
The transfemoral approach was successful in 99.4% of cases, with 3-day mean hospital stay. Device success was achieved in 94.4% of cases; procedural success in 93% and clinical success in 77.1%.
At 30 days, the composite of major adverse events resulted in 18.6%, with 1.7% cardiovascular mortality and 2.3% non-elective intervention. We should note that one of these case received a valve-in-valve for anatomical failure and 2 devices were removed because of embolization.
Read also: Heterotopic Tricuspid Intervention: TricValve One-Year Outcomes.
At one year followup, all-cause mortality was 9.1%, and hospitalization for cardiac failure was 10.2%. When comparing annual hospitalization for CF prior device implantation, there was a 74.9% relative reduction. At echocardiographic analysis, 97.6% of patients presented ≤mild tricuspid failure, while 69% presented trivial TR.
Conclusions
To conclude, the TRISCEND with EVOQUE, showed device and procedural success in 94.4% and 93% of patients, respectively, with 74.9% reduction in hospitalization due to CF. ECG analysis revealed 97.6% of patients presented ≤mild reduction.
Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.
Original Title: Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study.
Reference: Kodali, Susheel et al. “Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study.” European heart journal vol. 44,46 (2023): 4862-4873. doi:10.1093/eurheartj/ehad667.
Subscribe to our weekly newsletter
Get the latest scientific articles on interventional cardiology
