Efficacy and safety data for the XEN45 implant at 2 years: a retrospective analysis

Abstract

AimTo report efficacy and safety measures for XEN45 in a National Health Service setting after 24-month follow-up.MethodsThis is a retrospective, non-comparative audit of records of patients who underwent XEN45 procedure between June 2015 and May 2017. The main outcome measures were intraocular pressure (IOP) reduction and number of antihypertensive medications at each timepoint. Failure was defined as requiring further surgery or removal of XEN. Success was defined as 20% reduction of IOP without additional glaucoma medications or reduction in antihypertensive medications without increase in baseline IOP. Needling rates were assessed and subgroup analysis was performed.ResultsA total of 151 eyes were included in the study. The main diagnoses were primary open angle glaucoma (84.1%), angle closure glaucoma (8.6%) and refractory glaucoma (7.3%). Stand-alone procedure was performed in 62.3% and combined phaco-XEN was done in 37.7%. The mean IOP at baseline was 22.1±6.5 mm Hg, and the mean IOP at 12 and 24 months was 15.4±5.9 mm Hg and 14.5±3.3 mm Hg, respectively (p<0.001). The mean number of medications was 2.77±1.1 at baseline, and 0.3±0.7 and 0.5±1.0 medications at 12 and 24 months, respectively (p<0.001). 25% of patients failed at the 24-month timepoint. Needling was required in 37.7% of patients at 24 months. Non-Caucasian ethnicity was found to be related to higher failure rate. No significant adverse events were noted.ConclusionXEN45 is a viable, effective and safe procedure after 2 years of follow-up. Patients should be advised regarding failure rate as well as possible need for bleb revisions and medication use.

Efficacy and safety at 6 months of the XEN implant for the management of open angle glaucoma

“…This greater need of needling can be explained by the absence of conjunctival dissection in the bleb site. In a retrospective study by Gabbay et al 19 , the needling rate after XEN implantation reported 37.7% which is similar to ours but in a 24 months follow-up period. Two elements could explain this.…”

Comparing the efficacy of trabeculectomy and XEN gel microstent implantation for the treatment of primary open-angle glaucoma: a retrospective monocentric comparative cohort study

“…Rooney et al reported several cases of postoperative complications after XEN implantation. Gabbay et al also stated that patients should be advised regarding failure rates, possible need for bleb revision and the resumption of medication use after XEN implantation 16,48 .…”

“…13 . The IOP-lowering and medication-sparing efficacy of the XEN microstent has already been demonstrated in different single and multicenter trials 12,[14][15][16] . The aim of this study was to compare the efficacy and safety profile of the XEN microstent with standard TET in a comparable group of POAG cases in a retrospective, monocentric single surgeon setting.…”

<p>Surgical Approaches for Implanting Xen Gel Stent without Conjunctival Dissection</p>

“…Three studies (Reitsamer, Gillmann and Gabbay) have reported 24-month results following Xen Gel Stent implanted ab interno without conjunctival dissection. [3][4][5] Overall, they reported comparable IOP reduction to mid-teens (14.2 ± 3.8 to 15.2 ± 4.2 mmHg) from mean baseline IOP ranging from 19.8 ± 8.2 mmHg to 22.1 ± 6.5 mmHg across these studies. Similarly, there was a comparable reduction in the mean IOP-lowering medication count, ranging from 2.0 ± 1.3 to 2.77 ± 1.1 at baseline, to 0.4 ± 0.7 to 1.0 ± 1.0 at 24 months.…”

“…During surgery, if the implant is immobile or excessively curled (ie, "pig tailed") or when interstitial resistance from intra-Tenon's placement is suspected, primary needling is recommended. 5 Currently, many surgeons are incorporating primary needling as part of their routine intraoperative procedure despite the concern that this step may be associated with an increased risk of subconjunctival bleeding, as ensuring supra-Tenon's placement may outweigh the risk of bleeding.…”