Interventional Therapy for Severe Tricuspid Regurgitation: Renji Hospital, Shanghai Successfully Performs a Challenging K-Clip® Transcatheter Tricuspid Annuloplasty
Recently, the Department of Cardiac Surgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine led a multidisciplinary team to successfully perform K-Clip® transcatheter tricuspid annuloplasty on a complex patient with prior aortic and mitral valve replacement combined with cardiac implantable electronic device (CIED) lead implantation. After the procedure, the patient's tricuspid regurgitation was reduced from severe grade 4+ to mild grade 1+, accompanied by remarkable improvement in clinical symptoms. The success of this case further validates the clinical value of transcatheter tricuspid intervention for complex valvular heart disease.
Clinical Background
The patient underwent aortic and mitral valve replacement for valvular heart disease 15 years ago, and received implantation of a cardiac implantable electronic device (CIED) for arrhythmia, with the pacing lead positioned at the septoposterior commissure. The patient presented with progressively worsening heart failure caused by severe tricuspid regurgitation (4+). Conventional surgical repair carries substantial trauma and high operative risks. Given the patient's history of multiple prior cardiac surgeries and CIED lead implantation, re-do sternotomy was associated with prohibitive risk, making interventional therapy the only viable treatment option.
Case Analysis and Procedural Strategy
This case involved a 73-year-old male with previous aortic and mitral valve replacement and CIED implantation, who suffered from obvious heart failure secondary to severe tricuspid regurgitation (4+) with poor response to medical therapy. Preoperative multimodal imaging assessment, including transthoracic echocardiography (TTE), transesophageal echocardiography (TEE) and cardiac computed tomography angiography (cardiac CTA), demonstrated significant tricuspid annular dilation. Regurgitation originated at the central annulus with prominent posterior annular dilation. The pacing lead traversed the septoposterior commissure and occupied part of the valvular orifice, increasing intraprocedural technical difficulty.
After thorough evaluation of annular anatomy, regurgitant orifice location and lead distribution, under the leadership of Director Xue Song, the team led by Professors Huang Ritai and Wang Ren from the Department of Cardiac Surgery held detailed preoperative discussions together with multidisciplinary specialists from the Department of Ultrasound, Anesthesiology and Radiology. The treatment strategy of transcatheter tricuspid annuloplasty was adopted. Clamping devices were implanted at the anteroposterior commissures to reduce annular circumference, improve leaflet coaptation and thereby mitigate regurgitation severity.
Preoperative TTE: Severe tricuspid regurgitation (4+).

Preoperative TTE
Preoperative CTA analysis: Systolic annular circumference 144.0 mm, annular area 1534.0 mm², maximum diameter 50.0 mm. The minimum distance between the tricuspid annulus and right coronary artery (TA-RCA) measured 3.8 mm, indicating low risk of coronary injury during anchoring and clamping.


Pacing lead
The pacing lead was visualized at the septoposterior commissure from the gastric view.
Procedural Steps
The operation was performed by Chief Physician Wang Ren. Under real-time ultrasound guidance, the cardiac surgery team precisely identified the course of the pacing lead, selected target sites avoiding the lead, and successfully implanted a size 14T clamping device at the anteroposterior commissure of the tricuspid valve.

Procedure workflow
Vascular access was established via right internal jugular vein puncture for stiff guidewire advancement into the inferior vena cava. Right radial artery puncture was performed, and a radiopaque guidewire was positioned in the right coronary artery for coronary angiography to establish baseline coronary reference and coordinate system.

Pre-procedural coronary angiography
1) Device Advancement: Under TEE guidance (mid-esophageal biatrial view), the delivery sheath was positioned in the mid-to-lower segment of the right atrium. The delivery system was advanced through the sheath until aligned with the sheath tip, followed by sheath retraction to expose the deflectable segment of the delivery system.

Advancement
2) Orientation Adjustment: Guided by TEE (mid-esophageal biatrial view, 3D surgical view), the deflection angle of the delivery system was increased with counterclockwise rotation to orient the clamping component toward the target site.

Orientation adjustment
3) Anchoring: Under multi-modality TEE guidance (mid-esophageal biatrial view, 3D surgical view, MPR mode), the anchor component was screwed clockwise into annular tissue. Gentle traction of the anchor was performed to confirm stable tissue fixation and exclude potential coronary artery compromise.

Anchoring

Anchoring – coronary angiography
4) Clamping: Under TEE guidance (mid-esophageal biatrial view, 3D surgical view, MPR mode), the clamping assembly was opened, and its axial orientation adjusted to align parallel to the annular plane for annular apposition. After the clamping arms contacted the annulus, the anchor was retracted and the clamping device closed. Repeat coronary angiography was conducted after complete closure to rule out coronary artery compression.

Apposition

Clamping

Clamping – coronary angiography
5) Device Detachment: After assessment of clamping efficacy, including annular area, annular circumference, tricuspid regurgitation severity and septolateral diameter, satisfactory procedural outcome was confirmed, and the clamping component was detached from the anchor.

Detachment – TEE

Detachment – DSA
The procedure proceeded smoothly without major complications. Immediate post-procedural echocardiography demonstrated tricuspid regurgitation reduced from baseline severe grade 4+ to mild grade 1+, with marked hemodynamic improvement and significant relief of the patient’s clinical symptoms. This outcome demonstrates the reliable efficacy of transcatheter tricuspid annuloplasty for patients with special anatomical conditions after CIED implantation.


Comparison of annular area and circumference before and after clamping


Comparison of tricuspid regurgitation severity pre- and post-procedure
Perspectives and Conclusions
The successful completion of this surgery delivers multiple clinical insights. First, this case proves the feasibility and safety of transcatheter tricuspid annuloplasty in patients with prior valve replacement, offering a novel therapeutic option for this population with prohibitive surgical risk. Second, the experience of safely navigating around CIED leads provides valuable technical reference for interventional treatment of tricuspid regurgitation in patients with pacemaker or ICD implants. Furthermore, Renji Hospital has continuously advanced transcatheter tricuspid valve interventions in recent years, having completed multiple K-Clip® procedures. Supported by precise multimodality image fusion, the center has established a full-spectrum interventional solution covering aortic, mitral, tricuspid and pulmonary valve diseases.
With population aging, the prevalence of tricuspid regurgitation keeps rising. As a minimally invasive technique associated with low trauma, rapid recovery and favorable safety profile, transcatheter tricuspid annuloplasty brings new hope to an increasing number of patients with severe tricuspid regurgitation who cannot tolerate conventional open-heart surgery. The successful delivery of this high-complexity procedure accumulates valuable Chinese experience in this field.
Expert Profile

Wang Ren
Renji Hospital, Shanghai Jiao Tong University School of Medicine

K-Clip® Transcatheter Tricuspid Annuloplasty System:
1. Vascular access via puncture with minimal trauma; outer diameter of the sheath is 18Fr.
2. Easy manipulation with all procedures performed on the atrial side, featuring a short learning curve.
3. All operational steps prior to release are reversible for controllable procedural outcomes.
4. Physiological annuloplasty technology without damage to native leaflets.
