Jiang Wenbing and Chen Hao’s Team, Wenzhou People’s Hospital: K‑Clip® Minimally Invasive Annuloplasty Brings New Life to a Nonagenarian with Severe TR and Quadricuspid Valve Malformation
Recently, under the leadership of President Jiang Wenbing, the cardiovascular team of Wenzhou People's Hospital, led by Director Chen Hao, together with Director Xu Lixin from the Department of Ultrasonography, successfully applied K-Clip®, the only commercially available transcatheter tricuspid annuloplasty system in China. With the successful application of the K-Clip® transcatheter tricuspid annuloplasty system, the hospital has taken a historic step in the field of minimally invasive cardiac valve intervention. Tricuspid regurgitation has long been known as the "forgotten valvular heart disease". Traditional open-heart surgery is highly invasive and risky, and many elderly patients or those with multiple underlying diseases often miss the chance of treatment because they cannot tolerate the surgery. Nowadays, with the help of K-Clip®, a world-first minimally invasive technology, the relaxed tricuspid valve can be precisely repaired under ultrasound guidance only through a tiny puncture in the neck. It not only avoids the pain of open-chest surgery, but also greatly shortens the operation and recovery time, bringing hope of survival to patients with severe heart failure who were previously "turned away" by surgical operations.
Patient Profile
The patient is a 90-year-old male with a 5-year history of edema, which has worsened in the past 4 months. The edema is milder in the morning and severer in the evening, accompanied by chest tightness after activity and cough with white sticky sputum. Currently, he still has severe edema despite receiving 150mg furosemide combined with 15mg tolvaptan and 20mg finerenone. The patient has a poor general constitution and a decades-long medical history of "valvular heart disease, atrial fibrillation, and chronic heart failure". Echocardiography showed: 1. Combined valvular heart disease, considered degenerative; mitral valve calcification with mild stenosis and mild regurgitation; aortic valve calcification with regurgitation. 2. Global cardiac enlargement. 3. Severe tricuspid regurgitation. The patient was admitted to the hospital with the preliminary diagnosis of "valvular heart disease" after visiting the outpatient department of cardiovascular medicine of Wenzhou People's Hospital for further treatment.
Preoperative Evaluation
Echocardiographic findings:
Type IIIB quadricuspid tricuspid valve malformation with extremely severe regurgitation (grade 5+, mean vena contracta width 15mm). The regurgitant orifices are located at the anteroseptal, central, and posteroseptal regions, with a 4mm central gap. The tricuspid annulus is mildly dilated (mean annulus diameter 42mm), and right ventricular TAPSE is 17mm.
Preoperative 3D clore
Preoperative inflow-outflow tract xplan_clore
CTA Examination and Surgical Strategy
The tricuspid annulus circumference is 13.4 cm, and the annulus area is 14.2 cm². The distances between the RCA and the tricuspid annulus are all greater than 3mm.
Based on comprehensive evaluation of preoperative CT and TEE, the regurgitation mainly originates from the central posteroseptal and anteroseptal regions, and the surgical operation is highly difficult. It is planned to use 14T K-Clip® and 16T K-Clip® clipping devices at the posterior annulus and anteroposterior annulus respectively to reduce the annulus circumference while increasing the leaflet coaptation margin, thereby reducing tricuspid regurgitation.
Surgical Procedure
After general anesthesia, the surgical access was established by puncturing the jugular vein during the operation. An 18Fr delivery sheath was advanced along the stiff guidewire to the middle segment of the right atrium. Under ultrasound guidance, the delivery system was introduced, and 14T K-Clip® and 16T K-Clip® clipping devices were applied at the posterior annulus and anteroposterior annulus respectively. By steering and rotating to adjust the angle between the device and the annulus plane, the tip of the clipping device was directed to the target site. Under ultrasound MPR mode, the anchoring component was deployed at the annulus. After traction and stabilization, the clamping arms were opened and apposed to the annulus, then the anchoring component was pulled up to close the clamping arms for annuloplasty. The surgical effect was evaluated as satisfactory, and the clipping component was released.
The delivery system enters the RA via the SVC
The first 14T clip is implanted via the delivery system
Adjust the position to direct the clip toward the posteroseptal commissure (P2 side)
Deploy the anchoring screw
Traction test
Adjust the clip orientation
Open the clamping arms and appose to the annulus
Close the first 14T clip to reduce the annulus
The second 16T clip is implanted via the delivery system
Adjust the clip to point to the AP1 commissure
Test the trajectory of the anchoring screw
The second clip opens its clamping arms and apposes to the annulus
Close the second 16T clip to reduce the annulus
The result meets the expectation, and the clip is released
Surgical Outcome
After implanting one 14T K-Clip® at the junction of the posterior leaflet P2 and the septal leaflet annulus (toward P2 side) and one 16T K-Clip® at the junction of the posterior leaflet P1 and the anterior leaflet annulus, the overall annulus area decreased by 34%. The central gap of the valve leaflets was significantly reduced, the leaflet coaptation was improved, and the regurgitation was effectively reduced. The overall surgical effect exceeded expectations, and the operation was successfully completed.
Preoperative annulus area: 11.4 cm²
Annulus area after two clips: 7.48 cm²
Preoperative extremely severe regurgitation
Postoperative mild to moderate regurgitation
Postoperative DSA image
Postoperative Summary
The success of this operation not only marks a major breakthrough in the diagnosis and treatment of structural heart disease at Wenzhou People's Hospital, but also has far-reaching significance for the development of regional medical care. It complements the minimally invasive interventional treatment options for tricuspid valve disease, enabling patients in the hospital and surrounding areas to receive top-tier domestic cardiac interventional treatment at their doorstep without traveling far away. As a regional cardiovascular medical center, the hospital has always kept pace with cutting-edge technologies at home and abroad, and transformed high-end medical devices of "Intelligent Manufacturing in China" into practical capabilities to serve patients. In the future, the hospital will continue to play its leading and radiating role in technology, continuously improve the treatment level of difficult and critical cardiovascular diseases, and make greater contributions to safeguarding the health of local residents and promoting high-quality medical development.
Expert Profiles
Jiang Wenbing
Wenzhou People's Hospital
Chen Hao
Wenzhou People's Hospital
Han Sisi
Wenzhou People's Hospital
Xu Lixin
Wenzhou People's Hospital
K-Clip® Transcatheter Tricuspid Annuloplasty System:
1.Transvascular puncture access with minimal trauma, 18Fr outer diameter of the sheath.
2.Simple operation, all procedures are completed on the atrial side, with a short learning curve.
3.All operation steps are reversible before release, with controllable surgical effect.
4.Physiological annuloplasty technology, no damage to native valve leaflets.
