Percutaneous Treatment of Tricuspid Regurgitation with K-CLIP

Roughly 4% of the adult population presents tricuspid regurgitation (TR), a condition that might progress to severe or worse end-organ function, associated to hospitalizations and higher mortality. 

At present, drug therapy is limited for TR, and surgery continues to be the treatment of choice. However, in inoperable patients, transcatheter repair, especially edge-to-edge, presents as a valid alternative and is the most studied.  This technique has been shown to improve functional class and quality of life, and to reduce hospitalizations. 

A TriStar analysis was carried out, including 96 patients with severe TR (≥4+), functional and symptomatic, resistant to optimal medical treatment. 

The 30-day primary end point was major adverse events (MAE) rate, a composite of all-cause death, stroke, MI, acute kidney failure requiring dialysis, bleeding, conversion to surgery, perforation, right coronary artery stenosis ≥50%, need for definite pacemaker implantation, hospitalization for cardiac failure, vascular complications and infectious endocarditis. 

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Mean patient age was 72, and 57 women were included. Mean TriScore was 6, and most patients were in functional class III-IV. Amng clinical characteristics, 8 patients presented ascites, 57 had peripheral edema, 48 had received prior left valve surgery or percutaneous intervention, and 7 had undergone PCI. Only one patients carried a pacemaker, while 47 were hypertensive, 14 were diabetic, 85 had atrial fibrillation 16 had a history of stroke, 11 of kidney failure and 11 of peripheral vascular disease. 

K-Clip System Outcomes: Transcatheter Annuloplasty of Tricuspid Regurgitation

94 patients saw successful device implantation. 

Primary end point was 9.4%, 11.5% and 19.8% at 30 days, and 6 and 12 months, respectively. No patient presented cardiac mortality, MI, stroke, infectious endocarditis, acute kidney failure requiring dialysis, right coronary compromise, reintervention or crossover to surgery. 

Rehospitalization for cardiac failure was 1% at 30 days and 9.4% at one year, which represented a significant reduction of 64% vs. hospitalization for cardiac failure the year before. All-cause mortality at one year was 5.2%.

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There was sustained reduction of tricuspid regurgitation at one year, including a significant reduction of the contracted vein area.  

Also, patients saw improved functional class and quality of life, maintained along the year.  

Conclusion. Severe tricuspid regurgitation: K-Clip benefits in poor surgical candidates

The transcatheter annuloplasty system K-Clip showed high procedural success rate, favorable safety profile, sustained TR reduction and notable clinical and functional improvement at one year. 

Original Title: Mid-Term Outcomes of K-Clip Transcatheter Tricuspid Annuloplasty System in Patients With Severe Functional Tricuspid Regurgitation.

Reference: Hongfei Xu, et al. JACC Cardiovasc Interv. 2024;17:2796–2807.