Prognostic value of chronic kidney disease in patients undergoing left atrial appendage occlusion.

AIMS: Atrial fibrillation (AF) and chronic kidney disease (CKD) often coexist and share an increased risk of thrombo-embolism (TE). CKD concomitantly predisposes towards a pro-haemorrhagic state. Our aim was to evaluate the prognostic value of CKD in patients undergoing percutaneous left atrial appendage occlusion (LAAO). METHODS AND RESULTS: A total of 2124 consecutive AF patients undergoing LAAO were categorized into CKD stage 1+2 (n = 1089), CKD stage 3 (n = 796), CKD stage 4 (n = 170), and CKD stage 5 (n = 69) based on the estimated glomerular filtration rate at baseline. The primary endpoint included cardiovascular (CV) mortality, TE, and major bleeding. The expected annual TE and major bleeding risks were estimated based on the CHA2DS2-VASc and HAS-BLED scores. A non-significant higher incidence of major peri-procedural adverse events (1.7 vs. 2.3 vs. 4.1 vs. 4.3) was observed with worsening CKD (P = 0.14). The mean follow-up period was 13 ± 7 months (2226 patient-years). In comparison to CKD stage 1+2 as a reference, the incidence of the primary endpoint was significantly higher in CKD stage 3 (log-rank P-value = 0.04), CKD stage 4 (log-rank P-value = 0.01), and CKD stage 5 (log-rank P-value = 0.001). Left atrial appendage occlusion led to a TE risk reduction (RR) of 72, 66, 62, and 41% in each group. The relative RR of major bleeding was 58, 44, 51, and 52%, respectively. CONCLUSION: Patients with moderate-to-severe CKD had a higher incidence of the primary composite endpoint. The relative RR in the incidence of TE and major bleeding was consistent across CKD groups.

Outcomes of Patients With Takotsubo Syndrome Compared With Type 1 and Type 2 Myocardial Infarction.

Background Takotsubo syndrome (TS) and myocardial infarction (MI) share similar clinical and laboratory characteristics but have important differences in causes, demographics, management, and outcomes. Methods and Results In this observational study, the National Inpatient Sample and National Readmission Database were used to identify patients admitted with TS, type 1 MI, or type 2 MI in the United States between October 1, 2017, and December 31, 2019. We compared patients hospitalized with TS, type 1 MI, and type 2 MI with respect to key features and outcomes. Over the 27-month study period, 2 035 055 patients with type 1 MI, 639 075 patients with type 2 MI, and 43 335 patients with TS were identified. Cardiac arrest, ventricular fibrillation, and ventricular tachycardia were more prevalent in type 1 MI (4.02%, 3.2%, and 7.2%, respectively) compared with both type 2 MI (2.8%, 0.8%, and 5.4% respectively) and TS (2.7%, 1.8%, and 5.3%, respectively). Risk of mortality was lower in TS compared with both type 1 MI (3.3% versus 7.9%; adjusted odds ratio [OR], 0.3; P<0.001) and type 2 MI (3.3% versus 8.2%; adjusted OR, 0.3; P<0.001). Mortality rate (OR, 1.2; P<0.001) and cardiac-cause 30-day readmission rate (adjusted OR, 1.7; P<0.001) were higher in type 1 MI than in type 2 MI. Conclusions Patients with type 1 MI had the highest rates of in-hospital mortality and cardiac-cause 30-day readmission. Risk of all-cause 30-day readmission was highest in patients with type 2 MI. The risk of ventricular arrhythmias in patients with TS is lower than in patients with type 1 MI but higher than in patients with type 2 MI.

Levodopa/Carbidopa to Augment the Treatment of Amblyopia: A Report by the American Academy of Ophthalmology.

PURPOSE: To review the published literature on the use of levodopa/carbidopa to augment the treatment of amblyopia. METHODS: Literature searches for English language studies were last conducted in October 2022 in the PubMed database with no date restrictions. The combined searches yielded 55 articles, of which 23 were reviewed in full text. Twelve of these were considered appropriate for inclusion in this assessment and were assigned a level of evidence rating by the panel methodologist. Nine studies were rated level I, and 3 studies were rated level II; there were no level III studies. RESULTS: The duration of treatment was limited to 3 to 16 weeks because of concern about long-term adverse effects such as tardive dyskinesia. This complication was not reported in any of the study participants. The dose of levodopa ranged from 1.5 to 8.3 mg/kg/day, generally divided into 3 daily doses. The carbidopa dose was approximately 25% of the levodopa dose in all treatments. Evidence from these studies indicates that augmenting traditional patch occlusion therapy with the oral administration of levodopa/carbidopa can improve the vision of amblyopic children, but the effect was small (0.17-0.3 logarithm of the minimum angle of resolution [logMAR] units) and only statistically significant when compared with patching alone in 2 of the 12 studies cited. Regression of vision was reported in the majority of studies (9 of 12 reported; range, 0-0.17 logMAR unit regression) after discontinuation of therapy. Short-term side effects of the medications were not consistently reported but were most frequently mild and included headache and nausea. CONCLUSIONS: The best available evidence is currently insufficient to show that augmenting amblyopia therapy using up to 16 weeks of levodopa/carbidopa will result in meaningful improvement in visual acuity. Given the potential for significant side effects such as tardive dyskinesia with long-term therapy, levodopa/carbidopa does not appear to be a viable option for amblyopia therapy FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Complications Occurring Through 5 Years Following Primary Intraocular Lens Implantation for Pediatric Cataract.

Importance: Lensectomy with primary intraocular lens (IOL) implantation is often used in the management of nontraumatic pediatric cataract, but long-term data evaluating the association of age and IOL location with the incidence of complications are limited. Objective: To describe the incidence of complications and additional eye surgeries through 5 years following pediatric lensectomy with primary IOL implantation and association with age at surgery and IOL location. Design, Setting, and Participants: This prospective cohort study used Pediatric Eye Disease Investigator Group cataract registry data from 61 institution- and community-based practices over 3 years (June 2012 to July 2015). Participants were children younger than 13 years without baseline glaucoma who had primary IOL implantation (345 bilateral and 264 unilateral) for nontraumatic cataract. Data analysis was performed between September 2021 and January 2023. Exposures: Lensectomy with primary IOL implantation. Main Outcome and Measures: Five-year cumulative incidence of complications by age at surgery (<2 years, 2 to <4 years, 4 to <7 years, and 7 to <13 years) and by IOL location (sulcus vs capsular bag) were estimated using Cox proportional hazards models. Results: The cohort included 609 eyes from 491 children (mean [SD] age, 5.6 [3.3] years; 261 [53%] male and 230 [47%] female). Following cataract extraction with primary IOL implantation, a frequent complication was surgery for visual axis opacification (VAO) (cumulative incidence, 32%; 95% CI, 27%-36%). Cumulative incidence was lower with anterior vitrectomy at the time of IOL placement (12%; 95% CI, 8%-16%) vs without (58%; 95% CI, 50%-65%), and the risk of undergoing surgery for VAO was associated with not performing anterior vitrectomy (hazard ratio [HR], 6.19; 95% CI, 3.70-10.34; P < .001). After adjusting for anterior vitrectomy at lens surgery, there were no differences in incidence of surgery for VAO by age at surgery (<2 years, HR, 1.35 [95% CI, 0.63-2.87], 2 to <4 years, HR, 0.86 [95% CI, 0.44-1.68], 4 to <7 years, HR, 1.06 [95% CI, 0.72-1.56]; P = .74) or by capsular bag vs sulcus IOL fixation (HR, 1.22; 95% CI, 0.36-4.17; P = .75). Cumulative incidence of glaucoma plus glaucoma suspect by 5 years was 7% (95% CI, 4%-9%), which did not differ by age after controlling for IOL location and laterality. Conclusions and Relevance: In this cohort study, a frequent complication following pediatric lensectomy with primary IOL was surgery for VAO, which was associated with primary anterior vitrectomy not being performed but was not associated with age at surgery or IOL location. The risk of glaucoma development across all ages at surgery suggests a need for long-term monitoring.

Outcomes of Patients Hospitalized With Cardiovascular Implantable Electronic Device-Related Infective Endocarditis, Prosthetic Valve Endocarditis, and Native Valve Endocarditis: A Nationwide Study, 2003 to 2017.

Background Most published reports describing outcomes of patients with cardiovascular implantable electronic device-related infective endocarditis (CIED-IE) are single-center studies with small patient sample sizes. The goal of this study was to utilize population-based data to assess trends in CIED-IE hospitalization and to compare outcomes between patients hospitalized with CIED-IE, prosthetic valve endocarditis (PVE), and native valve endocarditis (NVE). Methods and Results A query of the National (Nationwide) Inpatient Sample (NIS) database between 2003 and 2017 identified 646 325 patients hospitalized with infective endocarditis in the United States of whom 585 974 (90%) had NVE, 27 257 (4.2%) had CIED-IE, and 26 111 (4%) had PVE. There was a 509% increase in CIED-IE hospitalizations in the United States from 2003 to 2017 (P trend<0.001). In-hospital mortality and length of stay associated with CIED-IE decreased during the study period from 15% and 20 days in 2003 to 9.7% and 19 days in 2017 (P trend=0.032 and 0.018, respectively). The in-hospital mortality rate was lower in patients hospitalized with CIED-IE (9.2%) than in patients with PVE (12%) and NVE (12%). Length of stay was longest in the CIED-IE group (17 compared with 14 days for both NVE and PVE). Hospital costs were highest for the CIED-IE group ($56 000 compared with $37 000 in NVE and $45 000 in PVE). Conclusions Despite the fact that the number of comorbidities per patient with CIED-IE increased during the study period, mortality rate and hospital length of stay decreased. The mortality rate was significantly lower for patients with CIED-IE than for patients with NVE and PVE. Patients with CIED-IE had the longest lengths of stay and highest hospital costs.

AAMR syndrome in a 22-month-old and literature review.

PURPOSE: Alacrima is characterized by severely decreased or deficient tear production. It can be associated with systemic findings; most commonly Triple-A Syndrome with alacrima, achalasia, and adrenal dysfunction. METHODS: A case report and review of the literature. RESULTS: A 22-month-old boy with cognitive delay presented with a lack of tearing. MRI brain and orbits showed a bilateral absence of lacrimal glands. Biochemical testing revealed normal adrenal function. Genetic testing showed no abnormalities in the AAAS gene. Mutations in the AAAS gene are associated with Triple-A syndrome. Whole-exome sequencing did reveal compound heterozygosity for the GMPPA gene, and mutations in the GMPPA gene have been associated with AAMR syndrome with alacrima, achalasia, and mental retardation. A literature review revealed all AAMR syndrome patients with consanguineous parents. This is the first reported case of AAMR syndrome in non-consanguineous parents. CONCLUSIONS: In children older than 6 months old with decreased or deficient tear production, systemic work-up should include radiographic, biochemical, and genetic testing. Conditions associated with alacrima include familial dysautonomia, anhidrotic ectodermal dysplasia, Triple-A syndrome, and AAMR syndrome. One key clinical difference between the two syndromes is that patients with normal adrenal function have AAMR syndrome rather than Triple-A syndrome. After a child has a diagnosis with alacrima, these patients should be evaluated closely by a pediatric multidisciplinary team. Treatment for alacrima depends on the severity of ocular symptoms and ranges from the use of lubricant tears and ointment to moisture chambers.

A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 4 to 6 Years.

SIGNIFICANCE: Binocular treatment for unilateral amblyopia is an emerging treatment that requires evaluation through a randomized clinical trial. PURPOSE: This study aimed to compare change in amblyopic-eye visual acuity (VA) in children aged 4 to 6 years treated with the dichoptic binocular iPad (Apple, Cupertino, CA) game, Dig Rush (not yet commercially available; Ubisoft, Montreal, Canada), plus continued spectacle correction versus continued spectacle correction alone. METHODS: Children (mean age, 5.7 years) were randomly assigned to home treatment for 8 weeks with the iPad game (prescribed 1 h/d, 5 d/wk [n = 92], or continued spectacle correction alone [n = 90]) in a multicenter randomized clinical trial. Before enrollment, children wearing spectacles were required to have at least 16 weeks of wear or no improvement in amblyopic-eye VA (<0.1 logMAR) for at least 8 weeks. Outcome was change in amblyopic-eye VA from baseline to 4 weeks (primary) and 8 weeks (secondary) assessed by masked examiner. RESULTS: A total of 182 children with anisometropic (63%), strabismic (16%; <5∆ near, simultaneous prism and cover test), or combined-mechanism (20%) amblyopia (20/40 to 20/200; mean, 20/63) were enrolled. After 4 weeks, mean amblyopic VA improved by 1.1 logMAR lines with binocular treatment and 0.6 logMAR lines with spectacles alone (adjusted difference, 0.5 lines; 95.1% confidence interval [CI], 0.1 to 0.9). After 8 weeks, results (binocular treatment: mean amblyopic-eye VA improvement, 1.3 vs. 1.0 logMAR lines with spectacles alone; adjusted difference, 0.3 lines; 98.4% CI, -0.2 to 0.8 lines) were inconclusive because the CI included both zero and the pre-defined difference in mean VA change of 0.75 logMAR lines. CONCLUSIONS: In 4- to 6-year-old children with amblyopia, binocular Dig Rush treatment resulted in greater improvement in amblyopic-eye VA for 4 weeks but not 8 weeks. Future work is required to determine if modifications to the contrast increment algorithm or other aspects of the game or its implementation could enhance the treatment effect.

Adjustable Sutures in the Treatment of Strabismus: A Report by the American Academy of Ophthalmology.

PURPOSE: To review the scientific literature that evaluates the effectiveness of adjustable sutures in the management of strabismus for adult and pediatric patients. METHODS: Literature searches were performed in the PubMed database through April 2021 with no date limitations and were restricted to publications in English. The searches identified 551 relevant citations, of which 55 were reviewed in full text. Of these, 17 articles met the inclusion criteria and were assigned a level of evidence rating by the panel methodologist. The search included all randomized controlled studies regardless of study size and cohort studies of 100 or more patients comparing the adjustable versus nonadjustable suture technique, with a focus on motor alignment outcomes or reoperation rates. RESULTS: The literature search yielded no level I studies. Of the 17 articles that met the inclusion criteria, 11 were rated level II and 6 were rated level III. Among the 12 studies that focused on motor alignment outcomes, 4 small randomized clinical trials (RCTs) did not find a statistically significant difference between groups, although they were powered to detect only very large differences. Seven of 8 nonrandomized studies found a statistically significant difference in motor alignment success in favor of the adjustable suture technique, both overall and in certain subgroups of patients. Successful motor alignment was seen in both exotropia (in 3 studies that were not limited to children) and esotropia (in 1 study of adults and 2 of children). The majority of included studies that reported on reoperation rates found the rates to be lower in patients who underwent strabismus surgery with adjustable sutures, but this finding was not uniformly demonstrated. CONCLUSIONS: Although there are no level I studies evaluating the effectiveness of adjustable sutures for strabismus surgery, the majority of nonrandomized studies that met the inclusion criteria for this assessment reported an advantage of the adjustable suture technique over the nonadjustable technique with respect to motor alignment outcomes. This finding was not uniformly demonstrated among all studies reviewed and warrants further investigation in the development and analysis of adjustable suture techniques.

Distinct etiologies of high-sensitivity troponin T elevation predict different mortality risks for patients hospitalized with COVID-19.

BACKGROUND: Cardiovascular events in the context of COVID-19 infection increase the risk of negative patient outcomes, but large cohort studies describing this association are limited. The purpose of the current study was to investigate the potential associations between cardiovascular events and mortality in patients hospitalized due to COVID-19. METHODS: A retrospective chart review was performed in 2450 patients hospitalized for confirmed COVID-19 infection within a single hospital network between March 15 and June 15, 2020. Logistic regression analysis was used to identify predictors of mortality. RESULTS: In the study population, 57% of patients had elevated high sensitivity troponin (hs-TnT) levels. Acute heart failure occurred in 23% of patients and arrhythmias were observed in 8% of patients. Of the 1401 patients with elevated hs-TnT levels, a primary cardiac etiology (e.g., myocardial infarction) was identified in 653 (47%) patients. In the remaining 748 (53%) patients, there was evidence of a primary non-cardiac etiology for hs-TnT elevation such as renal failure (n = 304) and critical illness (n = 286). Elevated hs-TnT was associated with increased risk of mortality. A significantly higher mortality rate was observed for hs-TnT elevation associated with a primary cardiac etiology (OR 4.6, 95% CI: 2.7-7.6; P < 0.001) than a primary non-cardiac etiology (OR 2.7, 95% CI: 1.6-4.5; P < 0.001). CONCLUSIONS: Elevated hs-TnT in the context of COVID-19 infection is associated with a significantly increased mortality risk. Hs-TnT elevation in the context of a primary cardiac etiology confers a nearly 2-fold higher mortality risk than hs-TnT elevation due to a primary non-cardiac etiology.

Incidence of carditis and predictors of pacemaker implantation in patients hospitalized with Lyme disease.

BACKGROUND: Lyme carditis, defined as direct infection of cardiac tissue by Borrelia bacteria, affects up to 10% of patients with Lyme disease. The most frequently reported clinical manifestation of Lyme carditis is cardiac conduction system disease. The goal of this study was to identify the incidence and predictors of permanent pacemaker implantation in patients hospitalized with Lyme disease. METHODS: A retrospective cohort analysis of the Nationwide Inpatient sample was performed to identify patients hospitalized with Lyme disease in the US between 2003 and 2014. Patients with Lyme carditis were defined as those hospitalized with Lyme disease who also had cardiac conduction disease, acute myocarditis, or acute pericarditis. Patients who already had pacemaker implants at the time of hospitalization (N = 310) were excluded from the Lyme carditis subgroup. The primary study outcome was permanent pacemaker implantation. Secondary outcomes included temporary cardiac pacing, permanent pacemaker implant, and in-hospital mortality. RESULTS: Of the 96,140 patients hospitalized with Lyme disease during the study period, 10,465 (11%) presented with Lyme carditis. Cardiac conduction system disease was present in 9,729 (93%) of patients with Lyme carditis. Permanent pacemaker implantation was performed in 1,033 patients (1% of all Lyme hospitalizations and 11% of patients with Lyme carditis-associated conduction system disease). Predictors of permanent pacemaker implantation included older age (OR: 1.06 per 1 year; 95% CI:1.05-1.07; P<0.001), complete heart block (OR: 21.5; 95% CI: 12.9-35.7; P<0.001), and sinoatrial node dysfunction (OR: 16.8; 95% CI: 8.7-32.6; P<0.001). In-hospital mortality rate was higher in patients with Lyme carditis (1.5%) than in patients without Lyme carditis (0.5%). CONCLUSIONS: Approximately 11% of patients hospitalized with Lyme disease present with carditis, primarily in the form of cardiac conduction system disease. In this 12-year study, 1% of all hospitalized patients and 11% of those with Lyme-associated cardiac conduction system disease underwent permanent pacemaker implantation.

Botulinum Toxin Injection for the Treatment of Strabismus: A Report by the American Academy of Ophthalmology.

PURPOSE: To review the available evidence comparing the effectiveness of extraocular muscle botulinum toxin type A (BTXA) injection with eye muscle surgery for restoring ocular alignment in children and adults with nonparalytic, nonrestrictive horizontal strabismus. METHODS: Literature searches in the PubMed Cochrane Library, and clinical trial databases with no date restrictions, but limited to articles published in English, were conducted last on January 10, 2021. The searches yielded 515 citations, 40 of which were reviewed in full text by the first author. Fourteen articles met the criteria for inclusion (randomized or nonrandomized comparative studies, or case series with a minimum 50 patients; evaluating extraocular muscle BTXA injection for initial or repeat treatment of horizontal, nonparalytic, nonrestrictive strabismus; with at least 6 months of follow-up) and were graded by a methodologist. RESULTS: The 14 included studies consisted of 2 randomized clinical trials, 3 nonrandomized comparative studies, and 9 case series. All 5 comparative studies were graded level II evidence, and the 9 case series were graded level III evidence. Successful motor outcomes after BTXA injection were relatively consistent across 4 of the 5 comparative studies at 60%, when adjustment was made for differential selection bias in 1 of the studies. In the 4 studies, successful motor outcomes after surgery ranged from 66% to 77% with a mean follow-up of 23 to 75 months, and the outcomes were not significantly different from those after BTXA injection. In the fifth level II study, success was significantly higher with BTXA injection than with surgery (94% vs. 72%). The level III BTXA case series demonstrated higher motor success rates of 87% to 89% when children were treated in 2 muscles at a time; rates were lower in adults treated with single-muscle BTXA injection. CONCLUSIONS: Extraocular muscle injection of BTXA achieves a high rate of successful motor alignment, comparable with that achieved after eye muscle surgery for nonparalytic, nonrestrictive horizontal strabismus. Good alignment may require multiple BTXA injections, and it is not yet clear whether sensory outcomes are equivalent for BTXA injections versus eye muscle surgery in young children.

Home- and Office-Based Vergence and Accommodative Therapies for Treatment of Convergence Insufficiency in Children and Young Adults: A Report by the American Academy of Ophthalmology.

PURPOSE: To review home- and office-based vergence and accommodative therapies for treatment of convergence insufficiency (CI) in children and young adults up to 35 years of age. METHODS: Literature searches were conducted through October 2020 in the PubMed database for English-language studies. The combined searches yielded 359 abstracts, of which 37 were reviewed in full text. Twelve of these were considered appropriate for inclusion in this assessment and assigned a level of evidence rating by the panel methodologist. RESULTS: Of the 12 studies included in this assessment, 8 were graded as level I evidence, 2 were graded as level II evidence, and 2 were graded as level III evidence. Two of the level I studies included older teenagers and young adults; the remainder of the studies exclusively evaluated children. Two randomized controlled trials found that office-based vergence and accommodative therapies were effective in improving motor outcomes in children with symptomatic CI. However, the studies reported conflicting results on the efficacy of office-based therapy for treating symptoms of CI. Data were inconclusive regarding the effectiveness of home-based therapies (including pencil push-ups and home computer therapy) compared with home placebo. In young adults, office-based vergence and accommodative therapies were not superior to placebo in relieving symptoms of CI. CONCLUSIONS: Level I evidence suggests that office-based vergence and accommodative therapies improve motor outcomes in children with symptomatic CI, although data are inconsistent regarding symptomatic relief. Evidence is insufficient to determine whether home-based therapies are effective.

MAUDE Database Analysis of Post-Approval Outcomes following Left Atrial Appendage Closure with the Watchman Device.

Left atrial appendage closure (LAAC) is an important strategy to reduce stroke risk in patients with non-valvular atrial fibrillation (AF) who are at high risk of bleeding on long-term anticoagulation. Real-world assessments of the safety of the Watchman LAAC device remain limited. The objective of this study was to determine the frequency and timing of adverse events associated with Watchman LAAC device implants performed after FDA approval. Adverse events associated with Watchman LAAC implants performed between March 2015 and March 2019 were identified through a search of the FDA Manufacturer and User Facility Device Experience (MAUDE) database. During the study period, 3,652 unique adverse events were identified. An estimated 43,802 Watchman implants were performed in the United States during the study period. The overall adverse event rate was 7.3% and the mortality rate was 0.4%. Of the 159 unique types of adverse events identified, pericardial effusion was most common (1.4%). Most adverse events (73%) occurred intraoperatively (59%) or within 1 day of the procedure (15%). However, 19% of deaths, 24% of strokes and 27% of device embolizations occurred >1 month after implantation. The rates of most Watchman-related adverse events reported in the MAUDE database were comparable to those observed in clinical trials. A majority of adverse events occurred within 1 day of implant. In conclusion, while the absolute event rates were low, a significant proportion of device embolizations, strokes, and deaths occurred >1 month after Watchman implant.

Office- or Facility-Based Probing for Congenital Nasolacrimal Duct Obstruction: A Report by the American Academy of Ophthalmology.

PURPOSE: To review the published literature assessing the efficacy and safety of in-office probing compared with facility-based probing to treat congenital nasolacrimal duct obstruction (NLDO). METHODS: Literature searches were conducted in March 2020 in the PubMed database with no date restrictions and limited to studies published in English and in the Cochrane Library database with no restrictions. The combined searches yielded 281 citations. Of these, 21 articles were deemed appropriate for inclusion in this assessment and assigned a level of evidence rating by the panel methodologist. Four articles were rated level I, 2 articles were rated level II, and 15 articles were rated level III. RESULTS: Treatments consisted of observation, in-office nasolacrimal probing, or facility-based nasolacrimal probing. Success rates and complications or recurrences were recorded from 1 week to 6 months after surgery. Complete resolution of symptoms after surgery ranged from 66% to 95.6% for office-based procedures versus 50% to 97.7% for facility-based procedures. Level I evidence indicated that 66% of cases spontaneously resolved after 6 months of observation in infants between 6 and 10 months of age. Success rates for in-office probing were lower for bilateral than for unilateral NLDO (67% vs. 82%), whereas success rates were high in both unilateral (83%) and bilateral (82%) patients who underwent facility-based probing after 6 months of observation. Cost data did not indicate a definitive cost savings of either treatment method ($562 for in-office vs. $701 for facility-based, depending on cost models predicting spontaneous resolution rates at different ages). No serious adverse events with treatment or anesthesia were reported for either treatment method. CONCLUSIONS: Evidence supports the efficacy and safety of both in-office and facility-based surgery for congenital NLDO. However, treating bilateral NLDO in a facility setting may be better. Because a significant percentage of children achieved resolution spontaneously before 12 months of age, deferring treatment until 12 to 18 months of age is a reasonable option. Additional research may address symptom burden on families and the impact of anesthesia and emotional trauma of nonsedated office probings on patients and may explore further the cost of treatment for each treatment method.

Imaging Methods for Differentiating Pediatric Papilledema from Pseudopapilledema: A Report by the American Academy of Ophthalmology.

PURPOSE: To review the published literature on the accuracy of ophthalmic imaging methods to differentiate between papilledema and pseudopapilledema in children. METHODS: Literature searches were conducted in January 2020 in the PubMed database for English-language studies with no date restrictions and in the Cochrane Library database without any restrictions. The combined searches yielded 354 abstracts, of which 17 were reviewed in full text. Six of these were considered appropriate for inclusion in this assessment and were assigned a level of evidence rating by the panel methodologist. All 6 included studies were rated as level III evidence. RESULTS: Fluorescein angiography, a combination of 2 OCT protocols, and multicolor confocal scanning laser ophthalmoscopy (Spectralis SD-OCT; Heidelberg Engineering, Heidelberg, Germany) demonstrated the highest positive percent agreement (92%-100%; 95% confidence interval [CI], 69%-100%) and negative percent agreement (92%-100%; 95% CI, 70%-100%) with a clinical diagnosis of papilledema in children. However, results must be interpreted with caution owing to methodologic limitations, including a small sample size leading to wide CIs and an overall lack of data (there was only 1 study each for the above methods and protocols). Ultrasonographic measures showed either a high positive percent agreement (up to 95%) with low negative percent agreement (as low as 58%) or vice versa. Autofluorescence and fundus photography showed a lower positive (40%-60%) and negative (57%) percent agreement. CONCLUSIONS: Although several imaging methods demonstrated high positive and negative percent agreement with clinical diagnosis, no ophthalmic imaging method conclusively differentiated papilledema from pseudopapilledema in children because of the lack of high-quality evidence. Clinicians must continue to conduct thorough history-taking and examination and make judicious use of ancillary testing to determine which children warrant further workup for papilledema.

Accuracy of Autorefraction in Children: A Report by the American Academy of Ophthalmology.

PURPOSE: The purpose of this assessment is to evaluate the accuracy of autorefraction compared with cycloplegic retinoscopy in children. METHODS: Literature searches were last conducted in October 2019 in the PubMed and the Cochrane Library databases for studies published in English. The combined searches yielded 118 citations, of which 53 were reviewed in full text. Of these, 31 articles were deemed appropriate for inclusion in this assessment and subsequently assigned a level of evidence rating by the panel methodologists. Four articles were rated level I, 11 were rated level II, and 16 were rated level III articles. The 16 level III articles were excluded from this review. RESULTS: Thirteen of the 15 studies comparing cycloplegic autorefraction with cycloplegic retinoscopy found a mean difference in spherical equivalent or sphere of less than 0.5 diopters (D); most were less than 0.25 D. Even lower mean differences were found when evaluating the cylindrical component of cycloplegic autorefraction versus cycloplegic retinoscopy. Despite low mean variability, there was significant individual measurement variability; the 95% limits of agreement were wide and included clinically relevant differences. Comparisons of noncycloplegic with cycloplegic autorefractions found that noncyloplegic refraction tends to over minus by 1 to 2 D. CONCLUSIONS: Cycloplegic autorefraction is appropriate to use in pediatric population-based studies. Cycloplegic retinoscopy can be valuable in individual clinical cases to confirm the accuracy of cycloplegic autorefraction, particularly when corrected visual acuity is worse than expected or the autorefraction results are not consistent with expected findings.

Binocular Treatment of Amblyopia: A Report by the American Academy of Ophthalmology.

PURPOSE: To review the published literature assessing the efficacy of binocular therapy for the treatment of amblyopia compared with standard treatments. METHODS: Literature searches with no date restrictions and limited to the English language were conducted in January 2018 and updated in April 2019 in the PubMed database and the Cochrane Library database with no restrictions. The search yielded 286 citations, and the full text of 50 articles was reviewed. Twenty articles met the inclusion criteria for this assessment and were assigned a level of evidence rating by the panel methodologist. Six studies were rated level I, 1 study was rated level II, and 13 studies were rated level III because of the impact on the development and popularization of this technology. RESULTS: Two of the level I and II studies reviewed described a significant improvement in visual acuity in the binocular group versus standard patching standard treatment (the total number of patients in these 2 studies was 147). However, the 5 studies that failed to show a visual improvement from binocular therapy compared with standard treatments were larger and more rigorously designed (the total number of patients in these 5 studies was 813). Level I and II studies also failed to show a significant improvement over baseline in sensory status, including depth of suppression and stereopsis of those treated with binocular therapy. Several smaller level III case series (total number of patients in these 13 studies was 163) revealed more promising results than the binocular treatments studied in the level I and II studies, especially using treatments that are more engaging and are associated with better compliance. CONCLUSIONS: There is no level I evidence to support the use of binocular treatment as a substitute for current therapies for amblyopia (including patching and optical treatment). Furthermore, 2 large randomized controlled trials showed inferior performance compared with standard patching treatment. On the basis of this review of the published literature, binocular therapy cannot be recommended as a replacement for standard amblyopia therapy. However, more research is needed to determine the potential benefits of proposed binocular treatments in the future.

WATCHMAN implantation in patients with a history of atrial fibrillation and intracranial hemorrhage.

PURPOSE: Use of oral anticoagulation (OAC) in patients with a history of intracranial hemorrhage (ICH) is often considered high risk as OAC-related ICH is associated with high mortality rates. Left atrial appendage closure with a WATCHMAN device is an alternative management strategy to OAC to decrease thrombotic risk in atrial fibrillation patients; however use of OAC followed by dual antiplatelet therapy (DAPT) or DAPT therapy alone is required for 6 months post-procedurally. In this study, we examined the safety of WATCHMAN implantation followed by 6 months of anti-thrombotic therapy in patients with a history of ICH. METHODS: This is a retrospective analysis of 63 patients with a history of ICH prior to WATCHMAN implantation (Group I) and 95 patients without a history of ICH who underwent WATCHMAN placement (Group II). The primary outcome was death, stroke, or major bleeding within 6 months of WATCHMAN placement. RESULTS: The average CHA2DS2-VASc of Group I was 4.9 ± 1.7 vs 4.7 ± 1.4 for Group II (p = 0.34). The most common type of ICH in Group I was an intracerebral hemorrhage (57%). The median time between ICH and WATCHMAN implantation in Group I patients was 212 days. A total of 19% of Group I patients were managed with DAPT alone post-procedurally vs. 3% in Group II (p < 0.001). Similar to 89% of Group II (p = 0.19), 95% of Group I patients were free of the primary outcome at 6 months. No Group I patients had recurrent ICH within 6 months after WATCHMAN implantation. CONCLUSION: In a retrospective, multicenter series of patients with a history of ICH prior to WATCHMAN implantation, WATCHMAN placement was performed safely with 6-month outcomes that were similar to patients without a history of ICH, encompassing the time during which a patient with a history of ICH would need antithrombotic therapy to facilitate WATCHMAN placement.

Safety and In-Hospital Outcomes of Transvenous Lead Extraction for Cardiac Implantable Device-Related Infections: Analysis of 13 Years of Inpatient Data in the United States.

OBJECTIVES: The aim of this study was to investigate the safety and in-hospital outcomes of transcutaneous lead extraction (TLE) associated with device-related infection (DRI) in the United States from 2003 to 2015. BACKGROUND: DRI remains the most serious complication and the most common indication for lead extraction in patients with cardiac implantable electronic devices. The rates of DRI and associated lead extraction have been growing in line with the increasing number of cardiac implantable electronic device implantations worldwide. METHODS: Data for this study were drawn from the National (Nationwide) Inpatient Sample. The International Classification of Diseases-9th Revision-Clinical Modification coding system was used to identify hospitalizations with TLE for DRI and to investigate the rates of major adverse events. RESULTS: From a total of approximately 100 million unweighted hospitalizations over the 13-year study period, 12,257 unweighted observations were identified. This represents 59,082 (95% confidence interval [CI]: 58,982 to 59,182) patients who underwent TLE for DRI during the study period. A large majority of patients (75%) were older than 60 years. Patients were predominantly male (70%) and Caucasian (76%), and 80% had at least 1 comorbidity. The median length of stay was 8 days (interquartile range 5 to 14 days). At least 1 major adverse event occurred in 10.42% of procedures. The all-cause in-hospital mortality rate was 4.11%. Independent predictors of mortality were weight loss (adjusted odds ratio [aOR]: 4.02; 95% CI: 3.13 to 5.17), congestive heart failure (aOR: 3.28; 95% CI: 2.48 to 4.34), chronic kidney disease (aOR: 2.09; 95% CI: 1.70 to 2.56), pericardial complications (aOR: 2.87; 95% CI: 1.79 to 4.61), and procedure-related pulmonary injury (aOR: 2.06; 95% CI: 1.25 to 3.40). CONCLUSIONS: These results reflect the high rate of complications and mortality for TLE due to DRI in real-world experience, highlighting the importance of comorbidities, especially congestive heart failure and chronic kidney disease, as significant predictors of mortality in these patients.

A comparison of postprocedural anticoagulation in high-risk patients undergoing WATCHMAN device implantation.

BACKGROUND: Left atrial appendage closure (LAAC) is an alternative to long-term anticoagulation for thromboembolic protection in patients with atrial fibrillation (AF) and high bleeding risk. Short-term Warfarin use following LAAC is well-studied, while data pertaining to novel oral anticoagulant (NOAC) use in this setting is less robust. Specifically, data regarding the safety and efficacy of postprocedural NOAC use in high-risk patients is lacking. OBJECTIVE: To compare the safety and efficacy of Warfarin and NOAC use in a high-risk patient population undergoing LAAC with the WATCHMAN device. METHODS: From November 2015 to October 2017, 97 patients underwent LAAC with the WATCHMAN device. All patients were discussed at a multidisciplinary meeting prior to device implantation. Longitudinal data were collected and analyzed for a composite endpoint of stroke and death at 8 months, and major bleeding at 3 and 6 months. RESULTS: Among the 90 patients included in the safety and efficacy analysis, 43 were prescribed Warfarin and 47 were prescribed NOACs. Baseline characteristics were comparable between study groups. There were no procedural complications and no significant differences in the incidence of death and stroke at 8 months or major bleeding at 3 and 6 months. CONCLUSION: For patients with AF at high risk of both thromboembolic and hemorrhagic events, NOACs as compared to Warfarin, seem to be safe and effective for short-term anticoagulation following LAAC with the WATCHMAN device. Further validation in large randomized controlled trials is required.