Transcatheter edge-to-edge repair (TEER) is safe and effective for the treatment of primary tricuspid regurgitation (TR) in a new international registry study, including durable 1-year results. Yet, a further analysis within the study comparing TEER with the current go-to treatment for primary TR patients — those who need surgery — found comparable safety and efficacy outcomes. The findings were published online and in the May 26 issue of JACC: Cardiovascular Interventions, led by Atsushi Sugiura, MD, PhD, of the University Hospital Bonn, Germany. Unlike the patients suffering secondary TR caused by dilation of the tricuspid valve annulus, the authors stressed that primary TR (affecting around 5% to 20% of patients) is the result of leaflet degeneration. Surgery remains the first-line treatment for primary TR. However, many patients with TR carry a high surgical risk since they commonly present with persistent TR leading to right ventricular (RV) re-modeling and comorbidities. While TEER has become widely used in secondary TR — the main focus of several previous studies — the technique’s feasibility in primary patients has remained unclear. “The main issue in primary TR is the pathologic tricuspid leaflets themselves, which may vary among individuals,” the researchers wrote. The current study therefore set out to assess the safety and feasibility of TEER in patients from the primary TR registry, a retrospective data collection of patients with primary TR who underwent TEER with the MitraClip (Abbott Cardiovascular), TricClip (Abbott Cardiovascular) or PASCAL system (Edwards Lifesciences) from February 2016 to April 2023 across the US, Germany and Switzerland. The researchers also integrated surgical data set of patients who underwent isolated tricuspid valve surgery for primary TR across multiple sites in France. A total 114 primary TR patients were included. At baseline, the mean age was 79.9 years, mean body mass was 25 kg/m2 (±4.4), mean TRI-SCORE was 5 and 53.5% were men. The MitraClip, TriClip and PASCAL systems were used in 26.3%, 39.5% and 34.2% of patients, respectively, while 36.8% of patients had 1 device implanted, 47.4% had 2 devices and 14.9% had 3 or more. The majority (83.3%) were in NYHA functional class III or IV. TR gradings were moderate in 1.8%, severe in 34.2%, massive in 37.7% and torrential in 26.3%, and TR pathologies were type 1 (flail leaflet, in 28.1%), type 2 (billowing prolapse, in 61.4%) and type 4 (restricted leaflets in both systole and diastole, in 10.5%), with no type 3 cases (leaflet perforation). In-hospital mortality rate occurred in 2 patients (1.8%), but no further deaths were observed during 30-day follow-up. There was no periprocedural death, myocardial infarction, stroke, embolization of devices, or emergency surgery after TEER. TR reduction at 1-year A significant reduction in the severity of TR was observed, with 83.3% reduced to moderate or less at discharge (p<0.001). Reduction in TR of at least 1 grade was seen for 91.4% of patients, and 71.3% showed TR reductions or 2 or more grades. “As for the association between TR reduction and 1-year outcomes, TR reduction to moderate or less at discharge was associated with lower risk for mortality,” the researchers wrote. NYHA functional class improved significantly over the year with 66.5% of patients in functional class I or II at follow-up versus 17.1% at baseline (P < 0.001). Comparable to surgery outcomes The researchers also compared the TEER group with the integrated surgery group from the French database, which had median follow-up post-surgery of 925 days. TR reduction was more pronounced in the surgical cohort (TR reduction to moderate or less at discharge: 83.3% in TEER vs 97.3% in surgery; P < 0.001). While in-hospital mortality tended to be lower for the TEER patients (1.8% vs 6.3%; P = 0.062), and there was a significant difference in length of hospital stay (3 days vs 13 days; P < 0.001), a Kaplan Meier analysis showed comparable outcomes between TEER and surgery for mortality (17.3% vs 9%; log-rank P = 0.25), and the composite of mortality and heart failure re-hospitalization (25.7% vs 21.6%; log-rank = 0.73). A multivariable Cox proportional hazards model analysis found that comparable survival rates between TEER and surgery (HR: 0.50; 95% confidence interval [CI]: 0.20-1.25; P = 0.14) and the composite outcome of mortality and hospitalization (HR: 0.70; 95% CI: 0.34-1.43; P = 0.33). Similarly, there were no differences in outcomes in the propensity score–matched cohort (mortality 10.1% vs 15.2% [log-rank P = 0.74], or the composite endpoint (15.0% vs 26.5% [log-rank P = 0.68]). The researchers stressed, however, that: “The surgical cohort differed greatly from TEER patients. Sugiura and colleagues concluded, “TEER for treating primary TR may be a viable alternative to surgery in selected patients if anatomically amenable to repair and at high surgical risk. The outcome benefit should be tested in randomized control trials.” Sources: Sugiura A, Dreyfus J, Bombace S, et al. Transcatheter Edge-to-Edge Repair in Patients With Primary Tricuspid Regurgitation. JACC: Cardiovasc Interv 2025;18:1289-1299. Image Credit: NanSan – stock.adobe.com