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

Abstract

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.

XEN45 Implant in Medically Controlled vs. Uncontrolled Eyes—Differential IOP Changes in Real-Life Conditions

“…Regarding safety, no patients experienced serious complications related to conventional glaucoma procedures, such as endophthalmitis, and only three cases in the MUE (10%) and one in the MCE (3.1%) group needed stent repositioning, which is a percentage similar to that described in the literature (1–12.5%) [ 19 , 39 , 41 ]. Furthermore, we found a percentage of hypotony (16% in MCE and 13% in the MUE group) that was also within the range of values (8–20%) of other studies [ 27 , 35 ]. It is worth mentioning that the cases with IOP peaks and hypotony were completely resolved in subsequent weeks with no adverse events.…”

“…In all previous studies [ 19 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 34 , 35 , 36 ], medically controlled eyes were merged into the same group with eyes without a response to topical medication. Due to this, these studies presented methodological challenges during data analysis, such as establishing an activity indicator suitable for both situations, since some of the most frequently used criteria, such as the % of IOP reduction ( Table 5 ), are not useful indicators of responses in MCE.…”

“…Some authors have described a sustained reduction in IOP in the early postoperative period (≤1 month) as a positive predictive factor of success [ 19 , 35 ]. Our results support this idea since the tendency was to reach the success conditions within 1 month after surgery and to maintain it during the follow-up.…”

“…Regarding the MUE group, the cumulative probability of success was 93% at 1 year and 85% at 2 and 4 years after surgery with a mean survival time of 49 ± 3.2 months (95% CI: 43-55 months). The cumulative probability of complete success was 93%, 81%, and 34% at 1, 2, and 4 years with a mean survival time of 41 ± 3.3 months (95% CI: [35][36][37][38][39][40][41][42][43][44][45].…”

XEN®-63 Compared to XEN®-45 Gel Stents to Reduce Intraocular Pressure in Glaucoma

“…There are several studies reporting promising results for needling or bleb revision after XEN ® -45 implantation [28][29][30][31][32], some favoring bleb revision over needling [31,32], as we do in the case of bleb fibrosis. Studies on an older, non-marketed version of XEN ® -63 after 1-5 years of follow-up reported an IOP reduction of 18-40% and a needling rate of 0-53% [16][17][18]33].…”