Is the Xen® Gel Stent really minimally invasive?

Buffault, Juliette; Baudouin, Christophe; Labbé, Antoine

doi:10.1016/j.ajoc.2020.100850

Cited by 7 publications

(5 citation statements)

References 21 publications

(21 reference statements)

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“…Gel stent XEN45 was introduced in its current form with 45 micrometers lumen several years prior to the PreserFlo Microshunt, hence, several studies have been published on its safety and efficacy. In these studies, the observation period ranged from 6 months [6] to 3 years [7,8], and IOP reduction success rates were comparable to the Basel groups.…”

Section: Discussionmentioning

confidence: 89%

Retrospective Analysis of 12 Months Glaucoma Implant Efficacy: XEN45 and PreserFlo Microshunt

Saletta

Alexoudis

Gkatzioufas

et al. 2022

Klin Monbl Augenheilkd

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Purpose Several new implant devices have recently been introduced to glaucoma surgery using various techniques for reducing intraocular pressure (IOP). Two implants introduced during the past couple of years, XEN45 and PreserFlo Microshunt, are both designed to control subconjunctival filtration. There are two Swiss multicenter studies that collected the data retrospectively to analyze the efficacy and safety of these two devices separately. In this study, we report the analysis of the combined data subset from the University Hospital of Basel. Subjects and Methods The XEN45 implantation technique was introduced to Basel University Hospital in 2016 and PreserFlo Microshunt in 2018. Sixty operated patients, thirty in each group, were operated on by one surgeon, clinically followed up, and their data retrospectively analyzed from medical records. Only standalone procedures, without combined phacoemulsification, were considered in this analysis; the lens status, however, was neither an inclusion nor an exclusion criterion. Further inclusion criteria were the diagnosis of open-angle glaucoma, no previous glaucoma surgery, other than laser trabeculoplasty, and complete medical records during the 12 months of follow-up. IOP reduction during a 12-month postoperative period was the primary outcome measure as well as the number of IOP reducing drugs. The number of subsequent surgical interventions and complications/adverse events are descriptively reported. Results Patient age, gender, ophthalmological diagnosis, and initial preoperative IOP were well balanced between the two groups. Postoperative IOP course was comparable between the two methods for the first 12 months. IOP measurements were taken preoperatively and then on the first postop day, week 1, month 1, and months 3, 6, and 12 for the PreserFlo Microshunt vs. XEN45 (mmHg): 23.6 vs. 24.9, 9.0 vs. 8.9, 11.4 vs. 10.6, 13.0 vs.18.3, 16.8 vs.15.1, 15.9 vs.15.0, and 15.4 vs.14.5, respectively. IOP reducing medications were also comparable between the two groups. The study showed that subsequent interventions were more frequent in the XEN45 (13) than in the PreserFlo Microshunt group (7). Conclusion Both methods demonstrate satisfactory IOP control within a 12-month postoperative period with practically no serious adverse events/complications, but with relatively high numbers of subsequent interventions (needlings), particularly in the XEN45 group.

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Section: Discussionmentioning

confidence: 89%

Retrospective Analysis of 12 Months Glaucoma Implant Efficacy: XEN45 and PreserFlo Microshunt

Saletta

Alexoudis

Gkatzioufas

et al. 2022

Klin Monbl Augenheilkd

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“…We observe that the final visual outcomes are quite variable. Still, as a remarkable fact, 100% of the non-vitrectomized cases were early eviscerated or enucleated, 26 , 39 suggesting a clear benefit of performing early PPV on such patients.…”

Section: Discussionmentioning

confidence: 99%

Late-onset Endophthalmitis after XEN45® Implantation: A Retrospective Case Series and Literature Review

Matas¹,

Such-Irusta²,

Alfonso-Muñoz³

et al. 2022

Journal of Current Glaucoma Practice

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A bstract Aim and objective To report the incidence of late-onset endophthalmitis following XEN45 ® stent implantation. Background Long-term safety profile and efficacy in relation to the so-called microinvasive glaucoma surgery (MIGS) techniques are still under evaluation. The XEN45 ® gel stent entails a bleb formation and often requires postoperative conjunctival management, differing from the current reviewed concept of minimally invasive procedures. Endophthalmitis has been described among the complications, triggered in the majority of cases by tube extrusion. Cases description From our chart of 293 eyes operated on between November 2016 and November 2019, five (1.7%) patients developed endophthalmitis, which took place in the months 3, 4, 5, 11, and 14 after surgery, respectively. Sixty percent had undergone previous needling procedures. All of them showed a previous flat bleb and developed perforation of the conjunctiva caused by the distal portion of the tube. One patient was early eviscerated due to a fateful course. Treatment consisted of intravitreal, oral, and topical antibiotics, as well as topical corticosteroids. Eighty percent underwent device withdrawal, conjunctival gap suturing, anterior chamber washout, aqueous humor (AH) tab extraction (one positive for S. epidermidis and one for Streptococcus agalactiae ), and pars plana vitrectomy. A second patient was eviscerated due to phthisis bulbi. Out of three remaining patients, one underwent vitrectomy for retinal detachment, while two patients required glaucoma surgery for intraocular pressure control. The final VA was ≤20/125 in all patients. Conclusion The XEN45 ® device appears to trigger endophthalmitis by extruding the stent or unnoticed leakage through conjunctival defects. Special attention should be paid to flat and avascular blebs. Clinical significance This series shows a higher rate of endophthalmitis (1.7%) compared with previous studies with a significant sample size (0.4–1.4%). How to cite this article Burggraaf-Sánchez de las Matas R, Such-Irusta L, Alfonso-Muñoz EA, et al. Late-onset Endophthalmitis after XEN45 ® Implantation: A Retrospective Case Series and Literature Review. J Curr Glaucoma Pract 2021;15(3):153–160.

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“…Due to the more invasive process, the classification of bleb-forming devices as MIGS remains controversial. 9 Alternatively, most MIGS deliver the aqueous humor directly to Schlemm’s canal where it flows through the post-TM distal outflow channels. 8 MIGS procedures vary in terms of their attributes, surgical complexity, comprehensiveness, efficacy, and safety.…”

Section: Introductionmentioning

confidence: 99%

Systematic Literature Review of Clinical, Economic, and Humanistic Outcomes Following Minimally Invasive Glaucoma Surgery or Selective Laser Trabeculoplasty for the Treatment of Open-Angle Glaucoma with or Without Cataract Extraction

Cantor¹,

Lindfield²,

Ghinelli³

et al. 2023

OPTH

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Introduction Selective laser trabeculoplasty (SLT) and minimally invasive glaucoma surgery (MIGS) are increasingly used options for mild-to-moderate open-angle glaucoma (OAG) care. While most MIGS devices are indicated for use in combination with cataract surgery only, with phacoemulsification playing a role in lowering IOP, newer technologies can also be used as standalone glaucoma surgery. Methods This systematic literature review (SLR) aimed to assess the clinical, economic, and humanistic outcomes of MIGS and SLT for the treatment of OAG and was conducted according to PRISMA guidelines. Studies that assessed MIGS or SLT in at least one treatment arm versus any other glaucoma treatment in adults with mild-to-moderate OAG were included. Clinical, humanistic (health-related quality of life [HRQoL] and patient burden), and economic data were extracted, and the methodological quality of included studies was evaluated. Results A total of 2720 articles were screened, and 81 publications were included. Fifty-eight reported clinical outcomes. The majority assessed iStent or iStent inject (n=41), followed by OMNI (n=9), gonioscopy-assisted transluminal trabeculotomy (GATT) or the Kahook Dual Blade (KDB) (n=7), Hydrus (n=6), SLT (n=5), Xen Gel Stent (n=2), PreserFlo (n=1), and iTrack (n=1). IOP reduction was observed across prospective studies, varying from −31% to −13.7% at month 6 and from −39% to −11.4% at year 1 versus baseline. Most adverse events were transient and non-serious. Limited humanistic and economic data were identified. Conclusion Given their established efficacy and safety, there is a rationale for wider use of MIGS in mild-to-moderate OAG. Of the MIGS devices, iStent and OMNI have the largest clinical evidence base supporting their sustained effectiveness.

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Is the Xen® Gel Stent really minimally invasive?

Cited by 7 publications

References 21 publications

Retrospective Analysis of 12 Months Glaucoma Implant Efficacy: XEN45 and PreserFlo Microshunt

Retrospective Analysis of 12 Months Glaucoma Implant Efficacy: XEN45 and PreserFlo Microshunt

Late-onset Endophthalmitis after XEN45® Implantation: A Retrospective Case Series and Literature Review

Systematic Literature Review of Clinical, Economic, and Humanistic Outcomes Following Minimally Invasive Glaucoma Surgery or Selective Laser Trabeculoplasty for the Treatment of Open-Angle Glaucoma with or Without Cataract Extraction

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