Flexible band annuloplasty resulted in similar rates of recurrent tricuspid regurgitation during follow-up compared to rigid ring annuloplasty (6.1%/patient-year vs. 4.7%/patient-year, P=0.21).
RCT (n=400)
1:1
No
Does flexible band annuloplasty reduce recurrent TR compared to rigid ring annuloplasty in adult patients with moderate or greater tricuspid regurgitation?
In patients with moderate or greater tricuspid regurgitation, flexible band and rigid ring annuloplasty provide comparable long-term TR correction and adverse event rates over a median 3-year follow-up.
Absolute Event Rate: 6.1% vs 4.7%
p-value: p=0.21
OBJECTIVE: To compare the efficacy and clinical outcomes of flexible band versus rigid ring annuloplasty for the correction of moderate 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 (PPI), and other adverse events. RESULTS: 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 higher in the flexible band arm than the rigid ring arm (10.1% vs. 3.8%, P = 0.03). However, the significance was no longer significant during follow-up (6.1%/patient-year PY vs. 4.7%/PY, P = 0.21). Multivariable analysis identified female sex (sHR:2.16, 95%CI:1.1-4.22, P = 0.025), preoperative severe TR (sHR:2.09, 95%CI:1.06-4.11, P = 0.033) and massive TR (sHR:4.63, 95%CI:1.29-16.61, P = 0.019), and preoperative PPI (sHR:3.69, 95%CI:1.35-10.09, P = 0.011) 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.
Xu et al. (Fri,) conducted a rct in Moderate or greater tricuspid regurgitation (n=400). Flexible band annuloplasty vs. Rigid ring annuloplasty was evaluated on Recurrent tricuspid regurgitation during follow-up (p=0.21). Flexible band annuloplasty resulted in similar rates of recurrent tricuspid regurgitation during follow-up compared to rigid ring annuloplasty (6.1%/patient-year vs. 4.7%/patient-year, P=0.21).