Pioneering Nationwide Achievement |Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine Successfully Treats a Patient with Complex Tricuspid Valve Disease Using K-Clip®

Ultrasound Evaluation:

1. Type valve with type IIIb quadricuspid malformation and severe insufficiency (mean vena contracta: 7.4mm).
2. Regurgitation orifices located at the anteroseptal and posteroseptal commissures, with a 5.7×3.3mm gap detected in the center.
3. Myxomatous degeneration of tricuspid valve leaflets with mild prolapse-like changes of the valve body and mild Barlow-like changes.
4. No obvious dilatation of the tricuspid annulus (mean annulus diameter: 33mm).

CTA Evaluation:

1. Diastolic circumference of the tricuspid annulus: 124mm, area: 983mm² (little change in circumference and area between systole and diastole).
2. The closest distance between the right coronary artery (RCA) and the tricuspid annulus (TA) at the posterior annulus during systole is 2.5mm (the target of clip screw deployment can be adjusted to avoid injury).
3. Coronary distance >3mm during diastole. Low risk of coronary impact.
4. Optimal fluoroscopic projection: Tricuspid valve short-axis CAU15, LAO40.
5. Preliminary strategy: one 12T K-Clip® at the posteroseptal commissure and one 12T K-Clip® at the anteroposterior commissure.

Based on profound accumulation in cardiac anatomy and minimally invasive intervention, Professor Yu Feicheng integrated multi-dimensional imaging data from preoperative ultrasound and CT, combined with refined analysis of the patient's cardiac valve anatomical structure, and tailored a targeted treatment plan: a dual-point targeted implantation strategy was recommended, with 12T K-Clip® devices implanted at the septal portion of the posterior leaflet and the anteroposterior commissure respectively.

The core advantages of this treatment plan stem from the unique characteristics of the K-Clip® technology: First, it features excellent minimal invasiveness, eliminating the need for thoracotomy, which can minimize surgical trauma to the patient's body, reduce the risk of intraoperative bleeding and postoperative complications, and lay a foundation for the patient's rapid recovery. Second, it has precise targeted positioning capability, relying on the core design of the technology to achieve accurate implantation and fixation of the device at the target site. Supported by this technology, the tricuspid annulus is reduced, the leaflet coaptation is significantly improved, the pathogenesis of tricuspid regurgitation is blocked from the anatomical root, which provides a key structural guarantee for the recovery of the patient's cardiac function after surgery and greatly improves the therapeutic effect and prognosis quality.

After the patient was placed under general anesthesia, the jugular vein was punctured intraoperatively to establish surgical access. An 18Fr delivery sheath was advanced along a stiff guidewire to the mid-inferior right atrium, and the delivery system was introduced under ultrasound guidance. A 12T K-Clip® device was implanted at the posteroseptal commissure and another 12T K-Clip® device at the anteroposterior commissure respectively. The angle between the device and the annulus plane was adjusted through catheter deflection and rotation to direct the tip of the clip device to the target position. Under ultrasound MPR mode, the anchoring screw was deployed into the annulus. After confirming stable traction, the clamping arms were opened and apposed to the annulus, followed by retraction of the anchoring component to close the clamping arms for annuloplasty. The surgical effect was evaluated as satisfactory, and the clip components were then released.

Regurgitation Outcome:

Critical regurgitation (5+) reduced to moderate to severe regurgitation (3+).

Annuloplasty Outcome:

The K-Clip® transcatheter tricuspid valve annuloplasty adopts a unique physiological annuloplasty technology with no damage to native valve leaflets. Even in the face of complex anatomical structures such as myxomatous degeneration of tricuspid valve leaflets, mild prolapse of the valve body and mild balloon-like changes, this technology can still accurately reduce the annulus and complete annulus remodeling.

The procedure is performed with precise manipulation under real-time ultrasound guidance, providing a new minimally invasive and reliable treatment pathway for high-risk patients.

This technology breaks through the limitations of traditional surgery for complex lesions, especially opening a safe and effective intervention window for the vulnerable group of elderly patients with multiple comorbidities, showing broad clinical application prospects.