Short-term outcomes of tricuspid edge-to-edge repair in clinical practice – bRIGHT study

Selected in Journal of the American College of Cardiology by J. Curio , F. Praz , M. Wild

The aim of the b-RIGHT study was to assess the safety and performance of T-TEER using the TriClip (Abbott) in a contemporary, real-world setting...

Reviewers

Jonathan Curio

@CurioJonathan

Clinical researcher

Herzzentrum Uniklinik Köln - Köln, Germany

Fabien Praz

@FabienPraz

Interventional cardiologist / Cardiologist

Berne University Hospital - Bern, Switzerland

Mirjam Wild

Interventional cardiologist / Cardiologist

Universitäts-Herzzentrum Bad Krozingen - Bad Krozingen, Germany

Our Comment

Picot scheme highlighting key aspects of the study.
Courtesy of Mirjam Wild, Jonathan Curio, and Fabien Praz. Source: PCRonline

Picot scheme highlighting key aspects of the study.
Courtesy of Mirjam Wild, Jonathan Curio, and Fabien Praz. Source: PCRonline

Why this study – the rationale/objective? 

Transcatheter tricuspid valve interventions, in particular tricuspid transcatheter edge-to-edge repair (T-TEER), have emerged as a treatment option for patients with significant tricuspid regurgitation (TR) to address the previously unmet clinical need in these patients. Recently, the TRILUMINATE Pivotal trial as first randomized controlled trial in the field of TR interventions, comparing T-TEER versus medical therapy alone, was published.¹

The trial met its primary endpoint, favouring T-TEER over medical therapy, mainly driven by improvement in quality of life as assessed per KCCQ questionnaire, while mortality and heart failure hospitalizations did not differ between groups. Importantly, quality of life improvement was demonstrated to strongly correlate with the magnitude of TR reduction.

The aim of the b-RIGHT study (NCT04483089) was to assess the safety and performance of T-TEER using the TriClip (Abbott) in a contemporary, real-world setting. 

How was it executed? - the methodology

This prospective, single-arm, open-label, multi-centre post-market registry study was conducted at 26 sites across Europe, including 511 consecutive high-risk patients suffering from severe TR despite medical therapy.

Assessed endpoints were (only 30-day outcome reported):

• Primary: Acute procedural success (survival to discharge with successful TriClip implantation with at least 1 grade TR reduction)
• Secondary: All-cause mortality or tricuspid valve re-intervention at 1 year (not yet published) 

What is the main result?

All patients (56% female, mean age 78.9 ± 7.1 years) suffered from significant symptomatic TR (10% severe, 61% massive, 27% torrential). The majority (80%) were in NYHA functional class III/IV, 23% carried a transvalvular lead, and 40% had been hospitalized for heart failure in the year before the procedure.

• Implant success was 99% and procedural success (≥ 1 grade TR reduction) was achieved in 91%; the device type with longer arms (XT/XTW) was used in almost all patients
• In paired analysis at 30 days, 77% of patients had moderate or less TR; final TR grade was dependent on baseline TR with 95% of patients having moderate or less TR at follow-up with severe TR at baseline as compared to only 59% for torrential TR at baseline
• MAE rate at 30 days was 2.5%, with cardiovascular mortality of 0.8%; major bleeding (≥ BARC 3A) occurred in 7.2%, and single-leaflet device attachment in 3.8%
• NYHA class significantly improved (79% in NYHA class I/II) and KCCQ-score significantly increased (56% had an improvement ≥ 15 points); mean increase in KCCQ-score was linked to TR severity at 30 days
• Right-ventricular end-diastolic volume, tricuspid annular diameter, and right atrial volume were significantly decreased; TR severity, right-heart dimensions as well as tethering distance were the main predictors of successful TR reduction 

Critical reading and relevance for clinical practice

bRIGHT is the largest real-world registry study investigating T-TEER with the TriClip system. In analogy to the TRILUMINATE Pivotal trial, it confirms the high safety of the procedure, as well as its impact on symptoms, quality of life and functional status.

Echocardiographic core lab evaluation confirmed efficient TR reduction and right-heart positive remodelling even at short-term follow-up. All of this was observed despite patients in bRIGHT being further advanced in the disease with higher symptomatic burden (lower quality of life and higher rate of previous heart failure hospitalizations) and probably more complex anatomy (greater coaptation gaps, more frequent CIED-leads) at baseline compared to the patients included in TRILUMINATE.

bRIGHT is a valuable addition to the previous studies in this field and suggests that a broad spectrum of patients with TR can be effectively treated with the TriClip system at different disease stages and benefit from the procedure. The data also clearly reinforce the association between TR reduction and quality of life improvement.

Since right ventricular dimensions and tethering were predictors of successful TR reduction by T-TEER, the data clearly support timely evaluation and interdisciplinary management to contain disease progression and improve outcomes in this patient population without other treatment options. 

Reference

1. Sorajja P, Whisenant B, Hamid N, Naik H, Makkar R, Tadros P et al. Transcatheter Repair for Patients with Tricuspid Regurgitation. N Engl J Med 2023;May 18;388(20):1833-1842.