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John P. Berdahl - One of the best experts on this subject based on the ideXlab platform.

  • Prospective Interventional Cohort Study of Ocular Surface Disease Changes in Eyes After Trabecular Micro-Bypass Stent(s) Implantation (iStent or iStent inject) with Phacoemulsification
    Ophthalmology and Therapy, 2020
    Co-Authors: Justin A. Schweitzer, Whitney H. Hauser, Mitch Ibach, Brandon Baartman, Subba R. Gollamudi, Andrew W. Crothers, John E. Linn, John P. Berdahl
    Abstract:

    Introduction This study sought to assess ocular surface disease changes following cataract surgery combined with trabecular micro-bypass Stent(s) implantation (iStent or iStent inject ). Methods This prospective interventional single-arm clinical trial enrolled 47 eyes with mild-to-moderate open-angle glaucoma (OAG) on 1–4 glaucoma medications who underwent phacoemulsification and trabecular micro-bypass Stent(s) implantation. Key glaucoma and ocular surface data through 3 months postoperatively included the Ocular Surface Disease Index score (OSDI), corneal/conjunctival staining (Oxford Schema), fluorescein tear break-up time (FTBUT), conjunctival hyperemia (Efron Scale), glaucoma medications, and intraocular pressure (IOP). Results Mean OSDI scores improved from 40.1 ± 21.6 (severe) preoperatively to 17.5 ± 15.3 (mild) at 3 months ( p  

  • trabecular microbypass Stent implantation with cataract extraction in pseudoexfoliation glaucoma
    Journal of Cataract and Refractive Surgery, 2017
    Co-Authors: Tanner J Ferguson, Mitch Ibach, Russell J Swan, Justin Schweitzer, Ramu G Sudhagoni, John P. Berdahl
    Abstract:

    Purpose To evaluate the safety and efficacy of a trabecular microbypass Stent (iStent) combined with cataract surgery in patients with pseudoexfoliation glaucoma (PXG). Setting Vance Thompson Vision, Sioux Falls, South Dakota, USA. Design Retrospective case series. Methods Eyes with PXG had implantation of 1 Stent. Data were collected preoperatively and postoperatively through 24 months. Data included intraocular pressure (IOP), number of glaucoma medications, the incidence of postoperative IOP pressure spikes of 15 mm Hg or higher at any timepoint, and the need for additional surgery. Results The series included 115 eyes. The mean preoperative IOP was 20.00 mm Hg ± 6.95 (SD). One year postoperatively, the mean IOP was 15.54 ± 3.83 mm Hg ( P P P Conclusion Trabecular microbypass Stent implantation during cataract surgery safely and effectively lowered IOP and medication use in patients with mild to severe PXG.

Jane Ellen Giamporcaro - One of the best experts on this subject based on the ideXlab platform.

  • prospective evaluation of two iStent trabecular Stents one iStent supra suprachoroidal Stent and postoperative prostaglandin in refractory glaucoma 4 year outcomes
    Advances in Therapy, 2018
    Co-Authors: Jonathan S Myers, Imran Masood, Dana M Hornbeak, Jose I Belda, Gerd U Auffarth, Anselm Junemann, Jane Ellen Giamporcaro, J M Martinezdelacasa, Iqbal Ike K Ahmed, Lilit Voskanyan
    Abstract:

    Introduction: This study evaluates long-term outcomes of two trabecular micro-bypass Stents, one suprachoroidal Stent, and postoperative prostaglandin in eyes with refractory open angle glaucoma (OAG). Methods: Prospective ongoing 5-year study of 80 eligible subjects (70 with 4-year follow-up) with OAG and IOP ≥ 18 mmHg after prior trabeculectomy and while taking 1–3 glaucoma medications. Subjects received two iStent® trabecular micro-bypass Stents, one iStent Supra® suprachoroidal Stent, and postoperative travoprost. Postoperative IOP was measured with medication and annually following medication washouts. Performance was measured by the proportion of eyes with ≥ 20% IOP reduction on one medication (the protocol-specified prostaglandin) versus preoperative medicated IOP (primary outcome); and the proportion of eyes with postoperative IOP ≤ 15 and ≤ 18 mmHg on one medication (secondary outcome). Additional clinical and safety data included medications, visual field, pachymetry, gonioscopy, adverse events, visual acuity, and slit-lamp and fundus examinations. Results: Preoperatively, mean medicated IOP was 22.0 ± 3.1 mmHg on 1.2 ± 0.4 medications, and mean unmedicated IOP was 26.4 ± 2.4 mmHg. Postoperatively, among eyes without later cataract surgery, mean medicated IOP at all visits through 48 months was ≤ 13.7 mmHg (≥ 37% reduction), and annual unmedicated IOP was ≤ 18.4 mmHg (reductions of ≥ 30% vs. preoperative unmedicated IOP and ≥ 16% vs. preoperative medicated IOP). At all postoperative visits among eyes without additional surgery or medication, ≥ 91% of eyes had ≥ 20% IOP reduction on one medication versus preoperative medicated IOP. At month 48, 97 and 98% of eyes achieved IOP ≤ 15 and ≤ 18 mmHg, respectively, on one medication. Six eyes required additional medication, no eyes required additional glaucoma surgery, and safety measurements were favorable throughout follow-up. Conclusion: IOP control was achieved safely with two trabecular micro-bypass Stents, one suprachoroidal Stent, and postoperative prostaglandin. This microinvasive, ab interno approach introduces a possible new treatment option for refractory disease. Trial Registration: NCT01456390. Funding: Glaukos Corporation.

  • cataract surgery with trabecular micro bypass Stent implantation in patients with mild to moderate open angle glaucoma and cataract two year follow up
    Journal of Cataract and Refractive Surgery, 2012
    Co-Authors: Randy E Craven, Jay L Katz, Jeffrey M Wells, Jane Ellen Giamporcaro
    Abstract:

    Purpose To assess the long-term safety and efficacy of a single trabecular micro-bypass Stent with concomitant cataract surgery versus cataract surgery alone for mild to moderate open-angle glaucoma. Setting Twenty-nine investigational sites, United States. Design Prospective randomized controlled multicenter clinical trial. Methods Eyes with mild to moderate glaucoma with an unmedicated intraocular pressure (IOP) of 22 mm Hg or higher and 36 mm Hg or lower were randomly assigned to have cataract surgery with iStent trabecular micro-bypass Stent implantation (Stent group) or cataract surgery alone (control group). Patients were followed for 24 months postoperatively. Results The incidence of adverse events was low in both groups through 24 months of follow-up. At 24 months, the proportion of patients with an IOP of 21 mm Hg or lower without ocular hypotensive medications was significantly higher in the Stent group than in the control group ( P =.036). Overall, the mean IOP was stable between 12 months and 24 months (17.0 mm Hg ± 2.8 [SD] and 17.1 ± 2.9 mm Hg, respectively) in the Stent group but increased (17.0 ± 3.1 mm Hg to 17.8 ± 3.3 mm Hg, respectively) in the control group. Ocular hypotensive medication was statistically significantly lower in the Stent group at 12 months; it was also lower at 24 months, although the difference was no longer statistically significant. Conclusions Patients with combined single trabecular micro-bypass Stent and cataract surgery had significantly better IOP control on no medication through 24 months than patients having cataract surgery alone. Both groups had a similar favorable long-term safety profile. Financial Disclosure Dr. Craven was an investigator in the clinical trial of the iStent. Dr. Katz is a consultant to Glaukos and was the medical monitor for the clinical trial of the iStent. Dr. Katz is a stockholder in Glaukos. Mr. Wells and Ms. Giamporcaro are employees of Glaukos.

  • randomized evaluation of the trabecular micro bypass Stent with phacoemulsification in patients with glaucoma and cataract
    Ophthalmology, 2011
    Co-Authors: Thomas W Samuelson, Jeffrey M Wells, Jay L Katz, Yijing Duh, Jane Ellen Giamporcaro
    Abstract:

    Objective To assess the safety and efficacy of the iStent trabecular micro-bypass Stent (Glaukos Corporation, Laguna Hills, CA) in combination with cataract surgery in subjects with mild to moderate open-angle glaucoma. Design Prospective, randomized, open-label, controlled, multicenter clinical trial. Participants A total of 240 eyes with mild to moderate open-angle glaucoma with intraocular pressure (IOP) ≤24 mmHg controlled on 1 to 3 medications were randomized to undergo cataract surgery with iStent implantation (treatment group) or cataract surgery only (control). Fifty additional subjects were enrolled to undergo cataract surgery with iStent implantation under protocol expansion. Data in this report are based on the first 240 eyes enrolled. Intervention Implantation of the iStent trabecular micro-bypass Stent in conjunction with cataract surgery or cataract surgery only. Main Outcome Measures The primary efficacy measure was unmedicated IOP ≤21 mmHg at 1 year. A secondary measure was unmedicated IOP reduction ≥20% at 1 year. Safety measures included best-corrected visual acuity (BCVA), slit-lamp observations, complications, and adverse events. Results The study met the primary outcome, with 72% of treatment eyes versus 50% of control eyes achieving the criterion ( P P = 0.003). The overall incidence of adverse events was similar between groups with no unanticipated adverse device effects. Conclusions Pressure reduction on fewer medications was clinically and statistically significantly better 1 year after Stent plus cataract surgery versus cataract surgery alone, with an overall safety profile similar to that of cataract surgery alone. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.

Yvan Douville - One of the best experts on this subject based on the ideXlab platform.

  • An in Vitro Twist Fatigue Test of Fabric Stent-Grafts Supported by Z-Stents vs. Ringed Stents
    Materials, 2016
    Co-Authors: Jing Lin, Robert Guidoin, Graeham R. Douglas, Zhu Danjie, Mark Nutley, Lygia Perron, Ze Zhang, Du Jia-li, Lu Wang, Yvan Douville
    Abstract:

    Whereas buckling can cause type III endoleaks, long-term twisting of a Stent-graft was investigated here as a mechanism leading to type V endoleak or endotension. Two experimental device designs supported with Z-Stents having strut angles of 35° or 45° were compared to a ringed control under accelerated twisting. Damage to each device was assessed and compared after different durations of twisting, with focus on damage that may allow leakage. Stent-grafts with 35° Z-Stents had the most severe distortion and damage to the graft fabric. The 45° Z-Stents caused less fabric damage. However, consiStent stretching was still seen around the holes for sutures, which attach the Stents to the graft fabric. Larger holes may become channels for fluid percolation through the wall. The ringed Stent-graft had the least damage observed. Stent apexes with sharp angles appear to be responsible for major damage to the fabrics. Device manufacturers should consider Stent apex angle when designing Stent-grafts, and ensure their devices are resistant to twisting.

  • Stent fabric fatigue of grafts supported by z Stents versus ringed Stents an in vitro buckling test
    Journal of Biomaterials Applications, 2014
    Co-Authors: Jing Lin, Robert Guidoin, Mark Nutley, Ze Zhang, Lu Wang, Ge Song, Yvan Douville
    Abstract:

    Stent-grafts externally fitted with a Z-shaped Stents were compared to devices fitted with ringed Stents in an in vitro oscillating fatigue machine at 200 cycles per minute and a pressure of 360 mmHg for scheduled durations of up to 1 week. The devices fitted with Z-Stents showed a considerably lower endurance limit to buckling compared to the controls. The contact between the apexes of adjacent Z-Stents resulted in significant damage to the textile scaffolds and polyester fibers due to the sharp angle of the Z-Stents. The ringed Stents did not cause any fraying in the textile scaffolds.

Mehdi H. Shishehbor - One of the best experts on this subject based on the ideXlab platform.

Daniel E Soffer - One of the best experts on this subject based on the ideXlab platform.

  • Abstract 18411: Sirolimus Stents, Late Incomplete Stent Malapposition, in Stent Restenosis, Oh My- Glagov’s Phenomenon Revisited
    Circulation, 2014
    Co-Authors: Jonathan E. Feig, Rony Shimony, Daniel E Soffer
    Abstract:

    A 52-year-old female with a history of hyperlipidemia and hypothyroidism presented with intermittent chest discomfort after minimal exertion. Her past medical history is significant for two mid left anterior descending artery (mLAD) Cypher sirolimus Stents (2.5mm x 23mm, 2.5mm x 8mm) placed in 2008 when she presented with a NSTEMI. Her medications were aspirin, amlodipine, pitavastatin, synthroid and a multivitamin. Electrocardiogram demonstrated normal sinus rhythm. Physical exam was unremarkable and cardiac enzymes were negative. Baseline ejection fraction was 60% and there were no wall motion abnormalities during stress echocardiogram. Due to recurrent chest discomfort, CT angiography (CTA) was ordered which revealed two sequential Stents with the proximal end of the first Stent appearing outside the vessel lumen. Coronary angiography revealed ISR in the mLAD with contrast outside the proximal Stent. Optical coherence tomography (OCT) was used which demonstrated positive remodeling, late incomplete Stent malapposition (ISA) and ISR. Since studies have shown that the staining outside the sirolimus Stent and ISA were associated with very late Stent thrombosis, we decided that percutaneous coronary intervention (PCI) was not the ideal treatment. We opted for robotic coronary artery bypass graft (CABG) surgery with LIMA-LAD. The patient was discharged five days later without any complications. This case highlights the value of multi-modality imaging which revealed a Cypher related process despite a negative stress test. These observations led us to reason that we need a more permanent solution for treatment and therefore we referred the patient for CABG. It also raises important issues such as the duration of dual anti-platelet therapy in patients who have Cypher Stents. Although Glagov’s phenomenon was originally described only for the case of arterial remodeling in response to growth of atherosclerotic plaques, our case emphasizes how a similar process can occur after PCI depending on the Stent type. In conclusion, this case illustrates the limitations of angiography which is simply luminography, the complementary roles of CTA and OCT, and how multi-modality imaging can play a critical role in helping direct clinical-decision making.

  • abstract 18411 sirolimus Stents late incomplete Stent malapposition in Stent restenosis oh my glagov s phenomenon revisited
    Circulation, 2014
    Co-Authors: Jonathan E. Feig, Rony Shimony, Daniel E Soffer
    Abstract:

    A 52-year-old female with a history of hyperlipidemia and hypothyroidism presented with intermittent chest discomfort after minimal exertion. Her past medical history is significant for two mid left anterior descending artery (mLAD) Cypher sirolimus Stents (2.5mm x 23mm, 2.5mm x 8mm) placed in 2008 when she presented with a NSTEMI. Her medications were aspirin, amlodipine, pitavastatin, synthroid and a multivitamin. Electrocardiogram demonstrated normal sinus rhythm. Physical exam was unremarkable and cardiac enzymes were negative. Baseline ejection fraction was 60% and there were no wall motion abnormalities during stress echocardiogram. Due to recurrent chest discomfort, CT angiography (CTA) was ordered which revealed two sequential Stents with the proximal end of the first Stent appearing outside the vessel lumen. Coronary angiography revealed ISR in the mLAD with contrast outside the proximal Stent. Optical coherence tomography (OCT) was used which demonstrated positive remodeling, late incomplete Stent malapposition (ISA) and ISR. Since studies have shown that the staining outside the sirolimus Stent and ISA were associated with very late Stent thrombosis, we decided that percutaneous coronary intervention (PCI) was not the ideal treatment. We opted for robotic coronary artery bypass graft (CABG) surgery with LIMA-LAD. The patient was discharged five days later without any complications. This case highlights the value of multi-modality imaging which revealed a Cypher related process despite a negative stress test. These observations led us to reason that we need a more permanent solution for treatment and therefore we referred the patient for CABG. It also raises important issues such as the duration of dual anti-platelet therapy in patients who have Cypher Stents. Although Glagov’s phenomenon was originally described only for the case of arterial remodeling in response to growth of atherosclerotic plaques, our case emphasizes how a similar process can occur after PCI depending on the Stent type. In conclusion, this case illustrates the limitations of angiography which is simply luminography, the complementary roles of CTA and OCT, and how multi-modality imaging can play a critical role in helping direct clinical-decision making.