Annuloplasty First! K-Clip® Successfully Debuts Novel Transcatheter Tricuspid Valve Annuloplasty Strategy at Cedars-Sinai Medical Center

THE BEST IS YET TO COME.

From Kay's to DeVega and then to the annuloplasty ring, reviewing the entire journey of Functional Tricuspid Regurgitation (FTR) repair, the classic surgical concept has been committed to "physiological repair" – annuloplasty continues to focus on the dilated annulus in order to promote the coaptation of native leaflets, without realizing that decades later today,HuiHe HealthcareOriginal ResearchK-Clip^®Has become the "final piece of the puzzle" for transcatheter tricuspid annuloplasty (TTVA).

Whether it is the extension of interventional valve technology from the left heart to the right heart, or the self-iteration and correction of concepts, as long as there is no dispute over the pathological mechanism and matrix, scientific concepts will also form a cyclical closed loop —— the tricuspid annuloplasty technique (TTVA) has returned again, and entered the strategic selection梯队 for interventional treatment of tricuspid regurgitation in a new way.

We know that the FDA has approved two different treatment devices in the TTVI field: TriClip (Abbott) and Evoque (Edwards Scientific). However, due to the late timing of TR patients seeking medical attention, nearly 50% of FTR patients with annular dilation are often outside the applicable range of these two devices at the time of treatment — either because of a large leaflet coaptation gap or an excessively large annulus — thus losing the chance for treatment. K-Clip^®Previously, compassionate use treatment had been attempted overseas (Canada, the United States, Europe) for multiple patients of this kind, achieving better-than-expected clinical outcomes. However, the case of the patient at Cedars-Sinai is more complex:

According to numerous clinical research reports, to achieve the best clinical outcomes, TR needs to be reduced to below moderate levels. For this patient, two K-Clips need to be implanted separately at the posterior annulus and the anterior-posterior annulus.In order to achieve the aforementioned goals, the coronary distance of the posterior annulus has become the biggest challenge. Due to excessive leaflet coaptation gap and annular perimeter, she has lost the opportunity for leaflet edge-to-edge repair and valve replacement. Annuloplasty is her only hope now.

To this end, Professor Song Guangyuan and Professor Raj Makkar's team held multiple online discussions, combining the previous K-ClipExperience, Single K-clip(Any model) can achieve more than 20% reduction in area under optimal clipping conditions, and ultimately, both parties reached a consensus — to implant one K-Clip.At the posterior annulus near the anterior leaflet of the patient, the primary goal is to perform annuloplasty, while creating opportunities for future edge-to-edge repair or replacement.

On the day of the surgery, in the operating room of Cedars-Sinai Medical Center, Professor Song Guangyuan and Professor Raj Makkar's team successfully implanted a 14T-K-Clip near the posterior annulus close to the anterior leaflet.The patient's annulus area decreased from a preoperative baseline of 24 cm² to 18 cm², and the TR was immediately reduced from 6+ to 4+. The maximum coaptation length of the leaflets was shortened from a baseline of 9.1 mm to 6.8 mm, falling within the TEER technique green zone (<7 mm). The annular perimeter and maximum diameter also fell within the applicable range for replacement surgery. The surgery achieved the expected results, and the patient was discharged smoothly on the second day after the operation.