Summary
Magnetic sphincter augmentation using the LINX® device is a minimally invasive surgical option for patients with gastroesophageal reflux disease. An estimated 30,000 devices have been ...implanted worldwide. Device removals and erosion are identified risks. The objective of this analysis is to explore the procedure evolution with an emphasis on the removals and associated characteristics that may guide future clinical practice. The Manufacturer and User Facility Device Experience and Ethicon’s complaint databases were queried for all surgical device explants since January 2013. Device unit sales were used to determine the rates. The endpoint was based upon the time from implant to explant. Explant and erosion rates were calculated at yearly intervals and the Kaplan-Meier estimator was used to measure the time to explant. Chi-square analyses were used to investigate the risk of explant associated with the size, geography and implant year. Overall, 7-year cumulative risk of removal was 4.81% (95% Confidence Interval (CI) CI: 4.31–5.36%). The likelihood of removal was significantly related to the device size (P < 0.0001), with smaller sizes being more likely to be explanted. The primary reasons for device removal and relative percentages were dysphagia/odynophagia (47.9%), persistent gastroesophageal reflux disease (20.5%) and unknown/other (11.2%). Overall, the 7-year cumulative risk of erosion was 0.28% (95% CI: 0.17–0.46%). The average device size increased from 14.2 beads ± 1.0 in 2013 to 15.3 beads ± 1.2 in 2019 (P < 0.001). Surgical technique and perioperative management play an important role in the outcomes. Clinical practice changes since magnetic sphincter augmentation has been incorporated into clinical use are associated with improved outcomes and should be further characterized. Smaller device size is associated with increased removal and erosion rates.
Background
Magnetic sphincter augmentation (MSA) is a surgical intervention for gastroesophageal reflux disease (GERD) which has been evaluated in numerous studies and has shown beneficial effects. ...Long-term effectiveness data for MSA as well as laparoscopic fundoplication (LF) in patients with GERD are needed.
Objective
The objective of this study was to evaluate the 3-year outcomes for MSA and LF in patients with GERD.
Methods
This prospective, multi-center, observational registry study evaluated MSA and LF in clinical practice over 3 years (ClinicalTrials.gov identifier: NCT01624506). Data collection included baseline characteristics, reflux symptoms, medication use, satisfaction and complications. Post-surgical evaluations were collected at yearly intervals.
Results
Between December 2009 and December 2014, 631 patients (465 MSA and 166 LF) were enrolled in the registry. Both MSA and LF resulted in improvements in total GERD-HRQL score (mean reduction in GERD-HRQL from baseline to 3 years post-surgery: MSA 22.0 to 4.6 and LF 23.6 to 4.9) and in satisfaction (GERD-HRQL satisfaction increase from baseline to 3 years: MSA 4.6% to 78.2% and LF 3.7% to 76.5%). Most patients were able to belch as needed with both therapies (MSA 97.6% and LF 91.7% at 3 years). MSA allowed a higher percentage of patients the ability to vomit as needed (MSA 91.2% and LF 68.0% at 3 years). PPI usage declined from baseline to 3 years for both groups after surgery (MSA 97.8% to 24.2% and LF 95.8% to 19.5%). The mean procedure time was shorter for MSA than for LF. Intraoperative and procedure-related complication rates (≤ 2%) were low for both therapies.
Conclusions
This 3-year prospective observational registry study contributes to the mounting evidence for the effectiveness of MSA and LF. Despite the more severe nature of GERD in the LF group, the clinical outcomes for MSA and LF were favorable from an effectiveness and safety standpoint.
To determine the effects of Artisan lens implantation on contrast sensitivity.
Prospective consecutive interventional case series.
Forty-nine eyes of 30 patients with myopia and myopia with ...astigmatism, who underwent implantation of the Artisan iris-fixated phakic intraocular lens. Preoperative testing served as the control.
Implantation of the Artisan phakic intraocular lens to correct myopia.
Refractive predictability and Snellen visual acuity were evaluated preoperatively and at least 4 months postoperatively. Additionally, photopic and mesopic contrast sensitivities were measured at 1.5, 3, 6, 12, and 18 cycles per degree, with and without glare testing.
The mean preoperative spherical equivalent (SE) was -12.16 diopters (D) (range, -6.88 to -18.00). The mean postoperative SE was -0.46+/-0.58 D (range, +0.50 to -1.75). Ninety percent of eyes were within 1.00 D of the predicted result, and 39% gained > or =1 lines of best-corrected visual acuity (BCVA). When compared with preoperative measurements, postoperative contrast sensitivity was increased under photopic conditions and slightly decreased under mesopic conditions. Adverse events were one wound leak requiring resuturing in the immediate postoperative period and one subluxed lens after significant blunt trauma. No eyes lost > or =2 lines of BCVA.
Artisan implantation for the correction of high myopia seems to be a predictable procedure. Increases in photopic contrast sensitivity values after implantation of this phakic intraocular lens stand in distinction to the decreases in photopic contrast sensitivity previously reported after LASIK correction of this degree of myopia.
To evaluate the refractive results of 193-nm excimer laser photorefractive keratectomy (PRK) performed on 48 highly myopic eyes in a multicenter study.
A Visx 2015 or 2000 argon-fluoride excimer ...laser and a single-zone ablation technique were used. Postoperatively, eyes were treated with topical fluoromethalone for up to 5 months. Most eyes were treated with a 6.0- to 6.2-mm beam diameter after undercorrections and increased regression were noted with a 5.5-mm beam in earlier studies. Forty-eight eyes were treated for myopia, which was between -8.0 and -15.25 diopters (D) (spherical equivalent). The mean preoperative refraction was -11.2 D. Retreatment was performed after 6 to 16 months on 11 eyes for undercorrection. All eyes not retreated were followed for at least 12 months.
At 6 months, follow-up was available on 47 eyes. Of these eyes, 40% and 64% achieved corrections within 1 and 2 D of attempted correction, respectively. At 1 year, 60% of eyes attained 20/40 visual acuity or better uncorrected. Eleven patients (23%) were retreated between 6 to 16 months for undercorrection and/or regression. After retreatment, 47% and 81% of eyes achieved corrections within 1 and 2 D of attempted correction, respectively. At 1 year, 15% of eyes lost two lines of best-corrected visual acuity, and no eyes lost more than two lines. There was slightly more corneal haze seen in this group compared with the haze seen in patients undergoing PRK for low and moderate myopia.
These data show that excimer PRK can correct high amounts of myopia with reasonable stability after 6 months. Excimer PRK is an effective surgical treatment of severe myopia, but long-term follow-up is still needed to assess the stability of its effect.
Accurate, predictable, and safe refractive surgery requires immobilization of the eye. We measured the effects of current eye fixation techniques on human cadaver eyes.
Central to our study was a ...device specially designed to secure cadaver eyes and stabilize intraocular pressure. Topographical measurements were made with a modified Model 2 Corneal Analysis System (EyeSys Technologies, Houston, Tex) mounted vertically to allow analysis of a cadaver eye mounted in the artificial orbit. The effect on human cadaver eyes of six fixation instruments was assessed: forceps, U-shaped fixation forceps, a full Hofman-Thornton ring, a VISX vacuum fixation ring, a Meditec suction ring, and a new instrument, the Eye Fixation Speculum.
The circular vacuum fixation rings caused minimal distortion, resulting in less than 1.00 diopter (D) of change. Forceps and U-shaped fixation forceps, which apply force at one or two points, caused significantly more distortion. Single-point fixation forceps distorted the cornea at the point of application a mean of +5.50 +/- 3.50 D, and, at 180 degrees from the point of instrument application, a mean of +2.00 +/- 1.90 D. U-shaped forceps apply force at two points, 90 degrees and 270 degrees, from the axis of instrument application. At these axes, the cornea was distorted a mean of +9.40 +/- 3.70 D and +8.30 +/- 3.10 D, respectively.
Single- and multi-point fixation instruments, due to an asymmetric application of fixation force, significantly distort the cornea. Ring fixation instruments, which apply a more equally distributed force, cause less distortion.
Excimer photorefractive keratectomy was performed at three centers on 16 highly myopic eyes (8 diopters D or more) and followed up for 6 months. Ablation depths ranged from 137 to 230 microns. The ...preoperative spherical equivalent of myopia ranged from -8.62 D to -14.50 D (mean +/- SD, -11.57 +/- 1.62 D). Six months after surgery, the mean refraction (spherical equivalent) was -0.90 +/- 2.13 D. Eleven of 16 eyes achieved refractions within 2 D of that attempted. All eight patients at one site were treated with a maximum-beam diameter of 6.0 mm and were corrected to within 2 D of that attempted, and all were 20/40 or better uncorrected. Three of eight eyes at the other two sites were treated with a 5.5- or 5.6-mm maximum-beam diameter, which achieved corrections within 2 D of that attempted. The epithelium healed within 3 to 4 days, and there were no erosions. Mild subepithelial reticular haze, similar to that seen with excimer photorefractive keratectomy for lower myopia, was seen in all patients, with two patients experiencing more significant corneal haze. This peaked at 3 to 6 weeks and then gradually diminished. All but two patients had a return of their best corrected preoperative visual acuity to within one Snellen line at 6 months. This preliminary study shows excimer photorefractive keratectomy to be a promising surgical treatment for patients with higher myopia.
Objetivo: Describir y comparar las manifestaciones clínicas en pacientes adultos diagnosticados con Síndrome de Sjögren primario (SSp) a edad menor o igual a 35 años versus mayores a 35 años. ...Materiales y métodos: Se incluyeron pacientes mayores de 18 años de edad, con diagnóstico de SSp de acuerdo a los criterios de clasificación ACR - EULAR 2002/2016, registrados en la base de datos GESSAR (Grupo de Estudio Síndrome de Sjögren Sociedad Argentina de Reumatología). Resultados: Se incluyeron 665 pacientes. Cien (15,04%) con edad al diagnóstico ≤ 35 años, 92% mujeres. El promedio de edad del grupo > 35 años, fue de 54 + 11 años, 96% mujeres. Se encontraron diferencias estadísticamente significativas entre < 35 años vs > 35 años, en xeroftalmia (90,72% vs 95,64%, p: 0,04) y xerodermia (42,35% vs 57,36%, p: 0,03) y en los siguientes dominios del ESSDAI (EULAR Activity Index for primary Sjögren’s syndrome): sistema nervioso periférico (4,05 vs 11,32, p: 0,03), respiratorio (6% vs 15,40%, p: 0,01) y renal (6% vs 1,59%, p: 0,02). Conclusión: Nuestro estudio sugiere un menor compromiso glandular en pacientes con SSp diagnosticados a menor edad, sin un patrón diferencial característico en cuanto al compromiso sistémico.
Objective: to describe and compare the clinical manifestations, in adult patients diagnosed with primary Sjögren’s Syndrome at age less than or equal to 35 years versus those over 35 years of age.
...Materials and Methods: we analyzed the data of patients older than 18 years, with diagnosis of primary Sjögren’s syndrome (American-European criteria 2002), included in the GESSAR database (Sjögren Syndrome Study Group of the Argentine Society of Rheumatology).
Results: 665 patients were included. One hundred of them with an age at diagnosis less than or equal to 35 years and with a mean age at diagnosis of 29 + 4 years, 92% of them women. The average age at diagnosis of the group over 35 years was 54 + 11 years, 96% women. Statistically significant differences were found between less than or equal to 35 years vs over 35 years, in xerophthalmia (90.72% vs 95.64%, p: 0.04) and xeroderma (42.35% vs 57.36% , p: 0.03), and in the following domains of ESSDAI (EULAR Activity Index for primary Sjögren’s syndrome): peripheral nervous system (4.05 vs 11.32, p: 0.03), respiratory (6% vs 15.40%, p : 0.01) and renal (6% vs. 1.59%, p: 0.02).
Conclusion: our study suggests less glandular involvement in patients with pSS diagnosed at a younger age, without a characteristic differential pattern regarding systemic involvement.
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