Safety and Efficacy of Pivot-Balloon for Severe Tricuspid Regurgitation:The First-in-Man Experiences
- Author:
Eun Kyoung KIM
1
;
Min-Ku CHON
;
Hyun-Sook KIM
;
Yong-Hyun PARK
;
Sang-Hyun LEE
;
Ki Seok CHOO
;
Hyung Gon JE
;
Dae-Hee KIM
;
Tae Oh KIM
;
Yoon Seok KOH
;
Jae-Hyeong PARK
;
Jae-Hwan LEE
;
Young Jin CHOI
;
Eun Seok SHIN
;
Hyuck-Jun YOON
;
Seung-Whan LEE
;
Joo-Yong HAHN
Author Information
- Publication Type:Original Research
- From:Korean Circulation Journal 2025;55(1):20-31
- CountryRepublic of Korea
- Language:English
-
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.
