Korean Circ J.  2025 Jan;55(1):20-31. 10.4070/kcj.2024.0147.

Safety and Efficacy of Pivot-Balloon for Severe Tricuspid Regurgitation: The First-in-Man Experiences

• Kim EK
• Chon MK
• Kim HS
• Park YH
• Lee SH
• Choo KS
• Je HG
• Kim DH
• Kim TO
• Koh YS
• Park JH
• Lee JH
• Choi YJ
• Shin ES
• Yoon HJ
• Lee SW
• Hahn JY

• KMID: 2564712
• DOI: http://doi.org/10.4070/kcj.2024.0147

Abstract

Background and Objectives
Among various emerging catheter-based treatments for severe tricuspid regurgitation (TR), the spacer device can reduce the regurgitation orifice without manipulating the valve leaflet. However, its clinical application has been hampered by traumatic anchoring to the myocardium and the coaxial alignment of the balloon resulting in insufficient TR reduction. This study aimed to evaluate the early-stage safety, technical feasibility, and preliminary efficacy of the novel atraumatic vertical spacer in patients with isolated severe TR.
Methods
All procedures were guided by fluoroscopy and transthoracic echocardiography. The maximum device placement time with an inflated balloon was 24 hours. Changes in the amount of TR, right ventricular function, and patient hemodynamics were measured during balloon deployment.
Results
A total of 7 patients (median age 74), underwent successful device implantation without procedure-related complications. During balloon inflation (median 25 minutes), there were no symptoms or signs indicative of TR intolerance. TR was reduced by 1 grade or greater in all patients, with 2 patients exhibiting a reduction of 3 grades, from torrential TR to a moderate degree. Mild TR after balloon inflation was achieved in 3 patients with baseline severe TR. The TR reduction observed during initial balloon deployment was sustained during the subsequent balloon maintenance period.
Conclusions
The Pivot-balloon procedure was safe, technically feasible, and effective in reducing TR in patients with severe TR. No periprocedural complications or adverse cardiovascular events were reported during device placement with TR reduction observed in all patients. However, longer-term follow-up is needed to confirm safety and treatment effect.

Keyword

Tricuspid regurgitation; Catheter; Therapy

Figure

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  Figure 1 Structure of the Pivot-balloon. The Pivot-balloon, a preliminary form of the Pivot-TR system, is a novel vertical spacer without myocardial anchoring. It consists of four parts: 1) a distal shaft; 2) balloon; 3) proximal shaft; and 4) pusher.

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  Figure 2 The procedure of the Pivot-balloon. The Pivot-balloon device was delivered along the pre-inserted guide wire so that the collapsed balloon was positioned across the tricuspid valve. After confirming the proper position of the device using fluoroscopy and TTE, the size of the balloon were adjusted and the shaft was rearranged to most effectively reduce the regurgitant area under TTE monitoring.TTE = transthoracic echocardiography.

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  Figure 3 Changes in tricuspid regurgitation before and during the Pivot-balloon. Echocardiographic and fluoroscopic findings representing changes in tricuspid regurgitation before and after the Pivot-balloon. Given the variation in location and direction of the residual TR during balloon inflation, jets were traced in various windows where represented the maximal degree of TR within the mid-to late systolic frame.TR = tricuspid regurgitation.

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