The Journal of thoracic and cardiovascular surgery
May 4, 2026 · via Europe PMC
Randomized trial of tricuspid flexible band versus rigid ring in patients with moderate tricuspid regurgitation or greater: results of the JPH2019 trial.
Xu X, Gu J, Liu H, Du J, Gu W, Ni B, Shao Y.
AI summary — for doctors, generated from the abstract only
In this randomized trial of tricuspid annuloplasty, flexible bands had more recurrent tricuspid regurgitation at hospital discharge than rigid rings, but this difference did not persist during longer follow-up, and overall clinical outcomes were comparable between devices.
What was studied
A single-center randomized controlled trial (the JPH2019 trial) of 400 randomized (321 analyzed: 156 flexible band, 165 rigid ring) adult patients with moderate or greater tricuspid regurgitation undergoing annuloplasty, with recurrent tricuspid regurgitation as the primary outcome and death, pacemaker implantation, and other adverse events as secondary outcomes, over a median 3-year follow-up.
Key findings
- At hospital discharge, recurrent tricuspid regurgitation was significantly more common with the flexible band than the rigid ring (10.1% vs 3.8%, P=.03).
- During longer follow-up, this difference was no longer statistically significant (6.1% per patient-year vs 4.7% per patient-year, P=.21).
- Independent risk factors for recurrent tricuspid regurgitation included female sex (subdistribution hazard ratio 2.16), preoperative severe TR (sHR 2.09) or massive TR (sHR 4.63), and preoperative permanent pacemaker (sHR 3.69); secondary outcomes were comparable between the two device arms during follow-up.
Clinical relevance
The findings suggest that both flexible band and rigid ring annuloplasty provide broadly similar, acceptable correction of tricuspid regurgitation and safety over medium-term follow-up, though the early discharge-time difference favoring rigid rings, along with identified risk factors (female sex, severe/massive preoperative TR, pre-existing pacemaker), may be worth considering when selecting a device for higher-risk patients.
Who should care
Limitations
This was a single-center trial; the early difference in recurrent tricuspid regurgitation at discharge did not persist at follow-up, and subgroup analyses based on identified risk factors did not show significant between-arm differences, which limits firm conclusions about device superiority.
Flexible band and rigid ring tricuspid annuloplasty had similar medium-term outcomes despite a higher early recurrence rate with flexible bands.
This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates — verify against the original source before acting on it.
Abstract
Objective
To compare the efficacy and clinical outcomes of flexible band versus rigid ring annuloplasty for the correction of moderate tricuspid regurgitation (TR) or greater.
Methods
In this single-center randomized trial, adult patients with moderate or greater TR were assigned to receive either a flexible band or a rigid ring. The primary outcome was recurrent TR during follow-up. Secondary outcomes included death, permanent pacemaker implantation, and other adverse events.
Results
In total, 400 patients were randomized with a 1:1 ratio, and 321 were included in the final analysis (flexible band, n = 156; rigid ring, n = 165). Baseline characteristics were balanced between arms. At discharge, recurrent TR was significantly greater in the flexible band arm than the rigid ring arm (10.1% vs 3.8%, P = .03). However, the significance was no longer significant during follow-up (6.1%/patient-years vs 4.7%/ patient-years, P = .21). Multivariable analysis identified female sex (subdistribution hazard ratio [sHR], 2.16, 95% CI, 1.1-4.22, P = .025), preoperative severe TR (sHR, 2.09; 95% CI, 1.06-4.11, P = .033) and massive TR (sHR, 4.63; 95% CI, 1.29-16.61, P = .019), and preoperative permanent pacemaker implantation (sHR, 3.69; 95% CI, 1.35-10.09, P = .011) as independent risk factors for recurrent TR. Subgroup analyses based on these factors showed no significant between-arm difference in the primary outcome. secondary outcomes were also comparable between the arms during follow-up.
Conclusions
Both annuloplasty devices provided acceptable TR correction with similar adverse event rates over a median 3-year follow-up.
DOI
10.1016/j.jtcvs.2026.04.017
PMID
42092510
Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.
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