XEN45 real-life evaluation: Survival analysis with bleb needling and major revision outcomes

Purpose: To evaluate real-life outcomes of XEN45 stent surgery including bleb needling (BN) and surgical bleb revision (SBR). Methods: Retrospective analysis of all XEN45 gel stents implanted in a tertiary glaucoma center with a minimum follow-up of 6 months. The main outcomes were intraocular pressure (IOP), the number of glaucoma medications, postoperative maneuvers like BN, and subsequent SBR. Success was defined as IOP <= 18 and 20% reduction (criterion A), <= 15 and 25% reduction (criterion B), and <= 12 mmHg and 30% reduction (criterion C) reached with (qualified) or without (complete) medications at the last visit. Complete failure was defined as additional glaucoma surgery, loss of light perception, or sight-threatening complications. Multivariable Cox regression and Kaplan-Meier survival estimates tests were performed. Results: Fifty-eight eyes with either stand-alone or combined Phaco-XEN surgery were included. Complete success by the different definitions was 50.0% (95% confidence interval, 5.8%-84.5%) (A), 50.0% (5.8%-84.5%) (B), and 25% (0.9%-66.5%) (C) whereas qualified success was 38.3% (1.6%-80.1%), 31.7% (2.0%-71.4%), and 0%, respectively, at the 24-months visit. 30% of cases underwent BN with 5-Fluorouracil, and SBR was performed in 17.5% of eyes. Low IOP levels at 1-month and early BN were significantly associated with success. The highest chance of failure was achieved in the combined Phaco-XEN group undergoing SBR. Conclusions: In our real-life setting, the first month IOP was associated with greater success rates. Although BN obtained improved IOP values, SBR was associated with a greater bleb survival in the stand-alone XEN group. Both BN and SBR had poor outcomes in the combined Phaco-XEN group.