Two-year Outcomes Research Articles

Two-Year Outcomes of Prostatic Artery Embolization for Symptomatic Benign Prostatic Hyperplasia: An International, Multicenter, Prospective Study

PurposeTo describe clinical outcomes among patients with benign prostatic hyperplasia (BPH) 24 months following prostatic artery embolization (PAE).Materials and MethodsThis was an international, multicenter, prospective trial of males with BPH with lower urinary tract symptoms (LUTS) or acute urinary retention (AUR) treated with PAE. The primary outcome was the 12 month change in the International Prostate Symptom Score (IPSS) for patients referred for bothersome LUTS, or urinary catheter independence for patients treated for AUR. Secondary outcome measures included changes in IPSS at 3 and 24 months, changes in quality of life (QoL), changes in the Sexual Health Inventory for Men (SHIM) questionnaire, technical success rate, and adverse events (AEs). Data were summarized using descriptive statistics.ResultsFour hundred seventy-eight consecutive patients underwent PAE (bothersome LUTS: N = 405; AUR: N = 73), mean age was 70 years. For patients treated for bothersome LUTS, mean total IPSS at baseline was 21.8 and decreased to 9.3, 10.6, and 11.2 at 3, 12, and 24 months following PAE, respectively (all p < 0.001); QoL at baseline was 4.7 and decreased to 2.0, 2.1, and 2.3 at 3, 12, and 24 months, respectively (all p < 0.001). The mean SHIM score at baseline and 12 months following PAE was 13.8 and 13.9, respectively. Of the 73 patients treated for AUR, 48 (65.8%) had their indwelling catheter removed within 3 months of PAE and remained catheter free at 24 months. Fifty-five patients (11.5%) experienced ≥ 1 AE and 10 (2.1%) experienced a serious AE.ConclusionPAE is a safe and effective treatment for symptomatic BPH and LUTS.Level of Evidence Level 3Trial registration ClinicalTrials.gov NCT03527589.Graphical

Two-Year Outcomes are Equal in Kellgren-Lawrence Osteoarthritis Grades 1-4 after Total Knee Arthroplasty with Medial-Pivot Implants and Kinematic Alignment.

Introduction While risks exist with total knee arthroplasty (TKA) and survivorship is not indefinite, delaying surgery may lead to further deterioration of the knee joint, functional outcomes, and health status. Most studies report that patients with high-grade osteoarthritis (OA) scores have higher satisfaction and functional scores, cautioning against TKA in those with lower OA grades. This study correlates Kellgren-Lawrence (KL) OA scores with outcomes following kinematically-aligned TKA. Methods Preoperative anteroposterior weight-bearing radiographs of 168 patients enrolled in a prospective trial were scored for KL grade. Patients were segregated into two groups: the low-grade OA group had KL scores of 1 or 2, the high-grade OA group had a KL score of 3 or 4. Outcomes as measured with Forgotten Joint Score (FJS), Knee Society Score (KSS), and Range of motion were compared up to 2-years. Results There were 29 subjects with low-grade KL scores and 127 with high-grade KL scores. There were no differences in BMI, age, or gender distribution. The only statistically significant difference was in the preoperative KSS Pain/Motion score, 60.6 in the low-grade OA group vs. 46.4 in the high-grade group (P&lt;0.008). There were no significant differences between the groups in FJS at one or two-year follow-up. There were no differences in KSS Functional or Composite Scores, or in range of motion (ROM) at pre-op, 1-year or 2-years, and in KSS Pain/Motion at 1 or 2-years. Conclusion There were no significant differences in FJS, KSS, and ROM in patients with low- vs. high-grade OA up to 2-year follow-up. Patients with lower grade OA demonstrated substantial improvements in their FJS, KSS scores, and ROM indistinguishable from the higher-grade OA cohort up to 2-years, suggesting no shorter-term downside to earlier intervention with kinematically-aligned medial-pivot (MP) TKA.

Necessity of posterior osteotomies for mild flexible cervical deformity correction.

Correction of mild flexible cervical deformity (CD) via the posterior approach has been described with and without the use of posterior osteotomies (POs), despite a lack of clarity regarding their necessity or risks. The purpose of this study was to determine whether the use of POs when correcting mild flexible CD leads to improved clinical or radiographic outcomes, as well as defining the relative risks in utilizing them. A prospective multicenter registry of operative CD patients was analyzed. Inclusion criteria were cervical kyphosis > 10°, cervical scoliosis > 10°, cervical sagittal vertical axis (cSVA) > 4 cm, or chin-brow vertical angle > 25°. Mild deformity was defined by a cSVA of 3-5 cm and/or kyphosis < 15°. Flexibility was defined by a C2-7 angular change > 5° on preoperative flexion/extension radiographs. Patients who received a posterior column osteotomy (PCO) (Ames grades 1 and 2) were compared with patients who did not undergo a PCO (noPCO) as well as those who underwent a three-column osteotomy (3CO) (Ames grades 3-6). Ninety-five patients (33 PCO, 49 noPCO, 13 3CO) met the inclusion criteria. Both the number of levels fused (9.2 vs 7.7, p = 0.001) and the estimated blood loss (EBL) (1027 vs 486 mL, p = 0.012) were higher in the PCO cohort. Patients in the noPCO group were more likely to have a cervical apex of kyphosis (71.1%, p = 0.046), while those undergoing 3COs were more likely to have a thoracic apex (58.3%, p = 0.005). Preoperative cSVA (PCO vs noPCO: 45.4 vs 37.9 cm, p = 0.084), T1 slope (32.5° vs 29.6°, p = 0.376), C2-7 lordosis (-8.9° vs -9.2°, p = 0.942), and modified Japanese Orthopaedic Association (mJOA) score (13.4 vs 13.5, p = 0.854) were similar; however, both Neck Disability Index (NDI) (55.6 vs 42, p = 0.002) and numeric rating scale (NRS) neck (7.2 vs 5.8, p = 0.028) scores were higher in the PCO group before surgery. When adjusting for the use of an anterior approach, there was no significant difference in 1-year postoperative cSVA (35.7 and 35.6 cm, respectively; p = 0.969), C2-7 lordosis (13.7° and 10.1°, respectively; p = 0.393), and patient-reported outcome measures (NRS, NDI, and mJOA) between the PCO and noPCO groups. Two-year radiographic outcomes were largely similar, except for C2 slope, which was higher in the PCO group (29.1° vs 18°, p = 0.026). The overall complication rates progressively increased with more complex osteotomy use (noPCO 68.8% vs PCO 71.9% vs 3CO 75%) but did not reach significance (p = 0.063). The use of POs for mild flexible adult CD may not be necessary to achieve desirable radiographic correction. They are associated with greater EBL and fusion burden. Further studies are needed to fully delineate the risks of adverse events for various types of osteotomies.

MERLIN: Two-Year Results of Brolucizumab in Participants with Neovascular Age-Related Macular Degeneration and Persistent Retinal Fluid

PurposeTo report the safety and efficacy of brolucizumab (Beovu®) 6 mg vs. aflibercept (Eylea®) 2 mg administered every 4 weeks in participants with neovascular age-related macular degeneration (nAMD) and persistent retinal fluid after the Week 52 primary endpoint analysis (from Week 52 up to Week 104, post-study termination). DesignMulticenter, randomized, double-masked Phase 3a study. ParticipantsParticipants with recalcitrant nAMD (persistent residual retinal fluid despite previous frequent anti-vascular endothelial growth factor treatment). MethodsStudy eyes were randomized 2:1 to intravitreal brolucizumab 6 mg or aflibercept 2 mg every 4 weeks for 100 weeks, or until study termination. Main Outcome MeasuresAll available efficacy (analysis of noninferiority in mean best-corrected visual acuity [BCVA], central subfield thickness [CST], fluid-free status [no intraretinal fluid and no subretinal fluid]), and safety data up to study termination, including data up to Week 104 for those participants who completed the study prior to its termination. All P values after Week 52 were nominal and reflect observed data for the efficacy analyses. ResultsBrolucizumab 6 mg every 4 weeks was noninferior to aflibercept 2 mg in mean BCVA change from baseline to Week 104 (least squares mean difference, -0.4 Early Treatment Diabetic Retinopathy Study letters; 95% confidence interval [CI], -3.7 to 3.0; P = 0.0169). The proportion of eyes with ≥15-letter loss was 6.2% for brolucizumab and 4.7% for aflibercept. (P = 0.0014), and a greater proportion of eyes were fluid free at Week 104 (52.5% brolucizumab vs. 28.2% aflibercept; 95% CI, 11.9−37.3; P < 0.001) in eyes treated with brolucizumab vs. aflibercept. Incidence of intraocular inflammation (IOI), including retinal vasculitis and retinal vascular occlusion, was 11.5% (0.8% and 2.2%) for brolucizumab vs 6.1% (0% and 0.6%) for aflibercept, respectively. ConclusionsConsistent with 52-week results, brolucizumab 6 mg every 4 weeks was noninferior in mean BCVA change with anatomic outcomes superior to aflibercept 2 mg every 4 weeks from baseline to Week 104 or study termination. The incidence of IOI, including retinal vasculitis and retinal vascular occlusion, was higher with brolucizumab vs. aflibercept; therefore, brolucizumab should not be used more frequently than every 8 weeks following the loading regimen.

Two-Year Outcomes of Primary Arthroscopic Surgery in Patients with Femoroacetabular Impingement: A Comparative Study of Labral Repair and Labral Reconstruction.

Labral repair has become the preferred method for the arthroscopic treatment of acetabular labral tears that are associated with femoroacetabular impingement (FAI) resulting in pain and dysfunction. Labral reconstruction is performed mainly in revision hip arthroscopy but can be utilized in the primary setting for absent or calcified labra. The purpose of this study was to compare the minimum 2-year patient-reported outcomes (PROs) and risk of revision or conversion to arthroplasty between primary labral reconstruction and primary labral repair. Patients with FAI who underwent primary hip arthroscopy with labral repair or reconstruction performed by the senior author between 2006 and 2018 were identified from a prospectively enrolled patient outcome registry. Exclusion criteria included confounding injuries, dysplasia, prior ipsilateral hip surgery, or a joint space of <2 mm. Patients who were 18 to 80 years old were eligible for inclusion. Multiple regression with inverse propensity score weighting was conducted to estimate the average treatment effect in the treated (ATT) for labral reconstruction versus labral repair with respect to postoperative PROs and the likelihood of subsequent surgery (revision hip arthroscopy or conversion to arthroplasty). PRO end points included the Hip Outcome Score Activities of Daily Living subscale (HOS-ADL), modified Harris hip score, Western Ontario and McMaster Universities Osteoarthritis Index total score (WOMAC), 12-Item Short Form Health Survey Physical Component Summary score (SF-12 PCS), and patient satisfaction. A total of 150 hips undergoing primary labral reconstruction and 998 hips undergoing primary labral repair were included. The median follow-up time was 5.3 years in the reconstruction group and 5.8 years in the repair group. Compared with labral repair, labral reconstruction was associated with a higher risk of conversion to total hip arthroplasty (THA) (20% versus 7%; adjusted odds ratio, 3.2; 95% confidence interval [CI], 1.2 to 8.8; p = 0.024). Inverse propensity score-weighted multiple regression estimated a significant negative effect of labral reconstruction, relative to labral repair, on the postoperative values for the HOS-ADL (ATT, -3.3; 95% CI, -5.8 to -0.7; p = 0.012) and WOMAC (ATT, 2.6; 95% CI, 0.1 to 5.2; p = 0.044). Compared with primary labral reconstruction, primary labral repair resulted in better postoperative HOS-ADL and WOMAC values and decreased conversion to THA. These findings were demonstrated in both the unadjusted group comparisons and multivariable modeling. These data support the use of labral repair in the primary setting of labral tears and the reservation of labral reconstruction for more advanced labral pathology or for revision cases. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Two-year outcomes of different subretinal fluid drainage techniques during vitrectomy for fovea-off rhegmatogenous retinal detachments: ELLIPSOID-2 study

BackgroundThe purpose of the study is to compare visual acuity, complications and outer retinal integrity following subretinal fluid (SRF) drainage from the peripheral retinal breaks (PRBs) versus posterior retinotomy (PR)...

Two-year Outcomes of Intravitreal Aflibercept Injection for Neovascular Age-related Macular Degeneration with "Observe before Treat-and-Extend" Method.

To evaluate 2-year outcomes of intravitreal aflibercept injection for neovascular age-related macular degeneration (nAMD) treated with "observe before treat-and-extend (O-TAE)" strategy in the real-world setting. This retrospective study included treatment-naive nAMD patients treated with aflibercept using O-TAE regimen and followed up for more than 2 years. Patients were observed bimonthly to check recurrence after three monthly loading injections. In case of recurrence, treatment was resumed using the TAE regimen starting from the fourth injection. In case of nonrecurrence, observation was continued. Best-corrected visual acuity (BCVA), central macular thickness (CMT), number of injections, TAE intervals, and proportion of recurrence after dry-up following three loadings were analyzed. A total of 38 eyes of 34 patients were included. Follow-up period was 37.0 ± 11.0 months. BCVA by logarithm of minimal angle of resolution improved from 0.33 ± 0.29 at baseline to 0.24 ± 0.23 in the first year (p = 0.010) and 0.25 ± 0.22 in the second year (p = 0.054). CMT decreased significantly from 357.43 ± 74.53 μm at baseline to 269.62 ± 48.12 μm in the first year (p < 0.001) and 279.14 ± 54.64 μm in the second year (p < 0.001). Number of injections were 5.11 ± 1.69 in the first year and 3.84 ± 2.39 in the second year. The percentage of eyes with a TAE interval of ≥12 weeks was 37.0% in the first year and 34.4% in the second year. Of the 36 eyes that dried up after three loadings, 28 eyes (77.8%) recurred, and the average period of recurrence was 6.5 months. The remaining eight eyes (22.2%) had no recurrence during the mean follow-up period of 29.7 months. This study showed that the newly suggested O-TAE strategy can reduce the treatment burden significantly reducing the number of injections while improving BCVA and CMT in the first and second year.

Two-year Outcomes of Ultra-low-dose Radiotherapy in the Treatment of Ocular Adnexal B-cell Lymphomas.

This study focuses on the efficacy and 2-year outcomes of ultra-low-dose radiotherapy (RT) in treating primary and secondary ocular adnexal lymphoma (OAL). A retrospective analysis was conducted on patients with OAL between 2017 and 2022, treated with 4 Gy of RT. The primary and secondary outcomes assessed were response rate, progression-free survival, and lymphoma-related death. Twenty-one patients with primary and secondary OAL of diverse, presentations, subtypes, and stages were included. The orbital tumors had an average size of 17 × 16 × 16 mm. Of the 14 primary OAL cases, 3 (14%) had T1N0M0 disease, 8 (38%) T2N0M0, and 3 (14%) T3N0M0 (AJCC 8th edition staging); of the 7 secondary OALs, 4 (19%) were stage IE, 2 (10%) stage IIE, and 1 (5%) stage IIIE (Ann Arbor staging). Ultra-low-dose RT yielded a 95% complete response rate and 100% progression-free survival rates, both locally and systemically at 2 years. Mild dry eyes were reported in 14% of patients as a late treatment toxicity. Ultra-low-dose RT emerges as an effective and well-tolerated treatment approach for OAL. Our findings support the use of 4 Gy, showcasing high complete response rates (95%) and durable disease control without significant local relapses over an average follow up of 27 months. Our results align with earlier investigations, validating the curative potential of ultra-low-dose RT and reinforcing the concept of achieving favorable outcomes with minimal intervention. This approach may potentially alleviate the burden of long-term ocular side effects associated with higher radiation doses, enhancing the overall quality of life for OAL patients.

The UT Health Living Room: Expanding the Psychiatric Crisis Continuum of Care.

Traditional forms of psychiatric crisis treatment increasingly are being buttressed by services along the Psychiatric Crisis Continuum of Care, such as short-term crisis stabilization services and peer crisis services. The UT Health Living Room (LR) is an outpatient crisis counseling service that adds three promising elements to the Continuum: (1) it integrates outpatient treatment plans into crisis counseling, (2) provides care in a space and with staff who are familiar to patients, and (3) provides training in evidence-based crisis intervention. We examined two-year LR feasibility and outcome data. Mixed-method analyses used longitudinal clinic data and patient self-report measures. Results provide initial support for the feasibility, cost effectiveness and clinical effectiveness of the LR. Limitations include non-blinded ratings, limited experimental control, and simple cost-effectiveness methodology. The UT Living Room is feasible and offers novel elements to help patients in community clinics address emotional crises.

Two-Year Results of Gonioscopy-Assisted Transluminal Trabeculotomy in Primary Congenital Glaucoma.

Gonioscopy-assisted transluminal trabeculotomy yielded a 45% reduction in intraocular pressure in primary congenital glaucoma, with a success rate of 86.6%. Hyphema was the most common complication. We did not encounter any vision-threatening complications. To assess the outcome of gonioscopy-assisted transluminal trabeculotomy (GATT) in primary congenital glaucoma (PCG) and identify the potential prognostic factors for adverse outcomes. This prospective study included patients aged <14 years, presenting with PCG from November 2019 till November 2021. We excluded eyes with hazy cornea, secondary glaucoma, peripheral anterior synechiae ≥90 degrees, and eyes in which the extent of GATT was <270 degrees. Success was defined as a final intraocular pressure (IOP) <18mmHg with IOP reduction >20%. Primary outcomes were reduction in IOP and medications, secondary outcomes were complications and correlation of IOP reduction and surgical success with possible risk factors. We included 60 eyes of 50 patients aged 1-156 months (mean: 25.5±36.5). A 353±21 degrees incision was created, with 85% achieving a 360-degree incision. There was a significant reduction in IOP and medications at all follow-up intervals up to 2 years, with a mean of 45% IOP reduction. The final success rate was 86.6%, with 76.7% being controlled without medications. There was a significant positive correlation between the preoperative cup-to-disc ratio (CDR) and failure rates ( P =0.03) and between the incision extent and the IOP reduction (r=0.4, P =0.001). Hyphema was the most common complication, affecting 33%, and resolved spontaneously in all cases. No vision-threatening complications occurred. GATT is a safe and effective procedure in eyes with PCG and clear cornea, including eyes that had previous failed glaucoma surgery. Circumferential GATT is associated with more favorable outcomes, while eyes with a larger CDR are at a higher risk for failure.

Two-year post-treatment outcomes following peanut oral immunotherapy in the Probiotic and Peanut Oral Immunotherapy-003 Long-Term (PPOIT-003LT) study.

Few studies have examined long-term outcomes following oral immunotherapy (OIT); none have examined long-term risks and benefits associated with distinct clinical outcomes (desensitization, remission). Participants completing the probiotic and peanut oral immunotherapy (PPOIT) -003 randomized trial were enrolled in a follow-on study, PPOIT-003LT. Peanut ingestion, reactions, and health-related quality of life (HRQOL) were monitored prospectively. Outcomes at 1-year and 2-years post-treatment were examined by treatment group and by post-OIT clinical outcome (remission, desensitization without remission [DWR], allergic). 86% (151/176) of eligible children enrolled. Post-treatment peanut ingestion at 2-years post-treatment were similar for PPOIT (86.7%) and OIT (78.7%) groups, both higher than placebo (10.3%). Reactions reduced over time for all treatment and clinical outcome groups (PPOIT 31.7% to 23.3%, OIT 37.7% to 19.7%, placebo 13.8% to 6.9%; remission 27.5% to 15.9%; DWR 57.9% to 36.8%; allergic 11.6% to 7%). At 2-years post-treatment, similar proportions of remission and allergic participants reported reactions (RD 0.09 (95%CI -0.03, 0.20), p = .127), whereas more DWR participants reported reactions than remission (remission vs DWR: RD -0.21 (95%CI -0.39; -0.03), p = .02) and allergic (DWR vs allergic: RD 0.30 (95%CI 0.13, 0.47), p = .001) participants. At 2-years post-treatment, 0% remission versus 5.3% DWR versus 2.3% allergic participants reported adrenaline injector usage. Remission participants had significantly greater HRQOL improvement (adjusted for baseline) compared with both DWR (MD -0.54 (95%CI -0.99, -0.10), p = .017) and allergic (MD -0.82 (95%CI -1.25, -0.38), p < .001). By 2-years post-treatment, remission participants reported fewer reactions, less severe reactions and greater HRQOL improvement compared with DWR and allergic participants, indicating that remission is the patient-preferred treatment outcome over desensitization or remaining allergic.

A Comparative Analysis of Single Versus Multiple Arterial Grafts in Coronary Arterial Bypass Grafting: Initial Experience in Iraq.

The global recognition of multiple arterial grafting (MAG) and total arterial grafting (TAG) in coronary artery bypass grafting (CABG) is increasing. However, many centers have not yet adopted these procedures. Our study aims to examine the intraoperative, early postoperative, and two-year follow-up outcomes associated with MAG and TAG in candidates for CABG. The goal is to provide valuable insights into the role of these procedures. A prospective comparative study was conducted at Sulaimani Cardiac Hospital to analyze a cohort of 300 patients who underwent CABG surgery between January 2021 and April 2022. Convenience sampling was used to select participants. Prior to surgery, patients underwent comprehensive pre-operative evaluations, with certain CABG types being excluded. The patients were then categorized into three groups based on their surgical approach: single arterial conduit (SA), two arterial conduits (MA), and total arterial revascularization (TA). The standard bypass procedure was performed for all patients, and they were monitored for 30 days, six months, and two years after the surgery. A range of variables, including bypass and cross-clamp times, as well as postoperative complications such as bleeding and stroke, were recorded and analyzed. Statistical Product and Service Solutions (SPSS, version 25; IBM Corp.,Armonk, NY) was used for this analysis, with a predetermined significance threshold of p ≤ 0.05. The study included 300 participants who underwent CABG. The participants had an average age of 61.19 ± 4.67 years (95% CI: 36-81) and an average BMI of 27.40 ± 8.4 kg/m² (95% CI: 18-45). Diabetes was present in 40.3% of the patients, and the majority of the participants were male (77.7%). The number of vessels involved in the bypass varied, with two vessels in 21% of cases, three vessels in 65%, and four vessels in 14%. The left internal thoracic artery (LITA) was primarily used for arterial revascularization, and additional arterial conduits were used in 30.3% of cases. Statistical analysis showed significant differences in the number of grafts among patient groups (P = 0.042). However, there were no significant differences in bypass duration, cross-clamp duration, stroke incidence, or in-hospital mortality rates among the groups (P > 0.05). The rates of myocardial infarction (MI) approached significance (P = 0.05), and the mortality rates were comparable over a two-year period after CABG (4.7%) and at shorter intervals. These findings highlight the importance of age and the number of grafts in determining outcomes in CABG patients. In a developing nation, the lack of a specialized center for MAG does not hinder the implementation of MAG or TAG. The overall occurrence of complications after CABG is similar across all groups, except for MI. Patients who undergo MAG have higher rates of overall survival compared to those who receive SA and TAG.

Transcatheter vs. Surgical Valve Replacement in Severe Aortic Stenosis with Small Annulus: A Meta-Analytical Review of Two-Year Outcomes

Transcatheter vs. Surgical Valve Replacement in Severe Aortic Stenosis with Small Annulus: A Meta-Analytical Review of Two-Year Outcomes

Midterm results for revision total knee arthroplasty for component malrotation

IntroductionAccurate positioning of components in total knee arthroplasty (TKA) is essential to a satisfactory outcome. Significant malrotation may lead to chronic pain, stiffness, and dysfunction. This study aims to quantify improvements in functional outcomes following revision surgery for malrotation of either one or both components in TKA versus revision for aseptic loosening. MethodsThis was a retrospective review of TKAs that matched and compared the two-year functional outcomes of the malrotation group to a functionally similar aseptic loosening group. Functional outcomes were compared between groups using Short Form (SF-12), Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and Knee Society Functional Score (KSFS). Student t-tests and chi-squared or Fisher’s tests were used for statistical analysis. ResultsOf the patients revised, 24 had malrotation and 57 had aseptic loosening. A total of 16 femoral and 17 tibial components were revised for malrotation. All 16 femoral components were internally malrotated (mean –4.8 ± 4.1 degrees; range, −0.5 to −16.6). Of the tibial components, 15 were internally malrotated, (mean −9.5 ± 6.6 degrees; range, −2.2 to –23.5) and 2 were externally malrotated (mean 4.6 ± 2.1 degrees; range, 3.1 to 6.0). All functional outcome measures significantly improved comparably within both groups preoperatively to 24 months postoperatively. At 24 months, functional outcome measures were comparable between the groups and WOMAC function scores were significantly higher in the malrotation group. ConclusionRevision TKA for malrotation can yield clinically and statistically significant functional improvements, similar in magnitude to those seen following revision TKA for aseptic loosening. Level of EvidenceLevel III

Posterior Cervical Foraminotomy Compared with Anterior Cervical Discectomy with Fusion for Cervical Radiculopathy: Two-Year Results of the FACET Randomized Noninferiority Study.

Posterior cervical foraminotomy (posterior surgery) is a valid alternative to anterior discectomy with fusion (anterior surgery) as a surgical treatment of cervical radiculopathy, but the quality of evidence has been limited. The purpose of this study was to compare the clinical outcome of these treatments after 2 years of follow-up. We hypothesized that posterior surgery would be noninferior to anterior surgery. This multicenter, randomized, noninferiority trial assessed patients with single-level cervical radiculopathy in 9 Dutch hospitals with a follow-up duration of 2 years. The primary outcomes measured reduction of cervical radicular pain and were the success ratio based on the Odom criteria, and arm pain and decrease in arm pain, evaluated with the visual analog scale, with a 10% noninferiority margin, which represents the maximum acceptable difference between the new treatment (posterior surgery) and the standard treatment (anterior surgery), beyond which the new treatment would be considered clinically unacceptable. The secondary outcomes were neck pain, Neck Disability Index, Work Ability Index, quality of life, complications (including reoperations), and treatment satisfaction. Generalized linear mixed effects modeling was used for analyses. The study was registered at the Overview of Medical Research in the Netherlands (OMON), formerly the Netherlands Trial Register (NTR5536). From January 2016 to May 2020, 265 patients were randomized (132 to the posterior surgery group and 133 to the anterior surgery group). Among these, 25 did not have the allocated intervention; 11 of these 25 patients had symptom improvement, and the rest of the patients did not have the intervention due to various reasons. At the 2-year follow-up, of 243 patients, primary outcome data were available for 236 patients (97%). Predicted proportions of a successful outcome were 0.81 after posterior surgery and 0.74 after anterior surgery (difference in rate, -0.06 [1-sided 95% confidence interval (CI), -0.02]), indicating the noninferiority of posterior surgery. The between-group difference in arm pain was -2.7 (1-sided 95% CI, 7.4) and the between-group difference in the decrease in arm pain was 1.5 (1-sided 95% CI, 8.2), both confirming the noninferiority of posterior surgery. The secondary outcomes demonstrated small between-group differences. Serious surgery-related adverse events occurred in 9 patients (8%) who underwent posterior surgery, including 9 reoperations, and 11 patients (9%) who underwent anterior surgery, including 7 reoperations (difference in reoperation rate, -0.02 [2-sided 95% CI, -0.09 to 0.05]). This trial demonstrated that, after a 2-year follow-up, posterior surgery was noninferior to anterior surgery with regard to the success rate and arm pain reduction in patients with cervical radiculopathy. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Association of delayed cord clamping with acute kidney injury and two-year kidney outcomes in extremely premature neonates: a secondary analysis of the Preterm Erythropoietin Neuroprotection Trial (PENUT).

Delayed cord clamping (DCC) occurs in most preterm births. Evaluate the association of DCC with acute kidney injury (AKI) and two-year kidney outcomes. Secondary analysis of the Preterm Erythropoietin Neuroprotection Trial of neonates born 240/7 to 276/7 weeks' gestation. AKI and two year kidney outcomes were compared in neonates with DCC (≥30 seconds after delivery) to those with early cord clamping (ECC) (<30 seconds after delivery). The incidence and severity of AKI did not differ between the DCC and ECC groups (aOR 1.17 [95%CI 0.76-1.80]). At two years corrected age, DCC was associated with a 4.5-fold times increased adjusted odds of eGFR <90 mL/min/1.73m2. No significant associations were noted between DCC and albuminuria or elevated BP. DCC was not associated with decreased neonatal AKI, but was associated with higher adjusted odds of eGFR <90 mL/min/1.73m2 at two years.

The Characteristics and Two-Year Neurodevelopmental Outcomes of Home Oxygen Therapy among Preterm Infants with Bronchopulmonary Dysplasia: A Retrospective Study in a Medical Center in Taiwan.

Home oxygen therapy (HOT) is frequently used as a therapeutic strategy for children experiencing chronic oxygen dependency associated with bronchopulmonary dysplasia (BPD). Recent studies have highlighted substantial variations in the characteristics and outcomes of infants requiring oxygen, primarily due to the absence of a consensus on the management of HOT in infants with BPD. We conducted this retrospective study and reviewed the medical records of extremely and very preterm infants who were diagnosed with BPD in a tertiary center in northern Taiwan from January 2020 to September 2021. Their neurodevelopmental outcomes were evaluated at 18 to 24 months of corrected age. A total of 134 patients diagnosed with BPD were divided into a HOT group (n = 39) and a room air group (n = 95). The children in the HOT group had a higher incidence of hemodynamic significant patent ductus arteriosus (PDA) (p = 0.005) and PDA ligation (p = 0.004), high-frequency oscillatory ventilation (p < 0.001), nitrogen oxide inhalation (p < 0.001), pulmonary hypertension (p = 0.01), and longer invasive ventilation (p < 0.001), as well as longer hospitalization (p < 0.001). A multivariate logistic regression model demonstrated that prolonged invasive ventilation (OR = 1.032, 95% CI 0.984-1.020, p = 0.001) was correlated with oxygen dependency in children. Infants with BPD born at advanced gestational age (OR = 0.760, 95%CI 0.582-0.992, p = 0.044) had a decreasing risk of requiring HOT. The children in the HOT group had a higher incidence of emergency room visits (p < 0.001) and re-hospitalization (p = 0.007) within one year of corrected age. The neurodevelopmental outcomes revealed the HOT group had an increasing portion of moderate to severe cognitive delay (18.2% vs. 3.7%, p = 0.009) and moderate to severe language delay (24.2% vs. 6.1%, p = 0.006) at 18 to 24 months of corrected age. In conclusion, infants with BPD necessitating HOT required prolonged invasive ventilation during hospitalization and exhibited a greater prevalence of unfavorable neurodevelopmental outcomes at 18 to 24 months of corrected age as well.

Two-Year Results of XEN Gel Stent Implantation for Pseudoexfoliative Glaucoma in Phakic versus Pseudophakic Eyes.

Objectives: To investigate whether phakia affects the outcome of XEN-45 gel stent implantation in the treatment of pseudoexfoliative glaucoma (PXG). Methods: A retrospective, comparative cohort study of 30 phakic and 55 pseudophakic PXG patients who received the XEN-45 gel stent at a tertiary centre. The primary outcome measure was two-year success defined as a ≥20% lowering of intraocular pressure (IOP) and a target IOP of 6-21 mmHg. Success was complete without and qualified irrespective of antiglaucoma medication use. Further glaucoma surgery other than needling was regarded as a failure. The secondary outcome measures included changes in IOP, revision and complication rates. Results: The complete two-year success rates were 70% and 59% in the phakic and pseudophakic groups, respectively (p = 0.75, log-rank test), and the qualified rates were 80% and 72%, respectively (p = 0.89). The median IOP reduction from baseline was 54% in phakic, and 46% in pseudophakic eyes. While needling rates were similar, the incidence of early incisional bleb revisions was significantly higher in the phakic eyes (13% vs. 0% within 3 months; p = 0.0098, chi-square). Increasing after a year, significantly more pseudophakic eyes failed due to secondary glaucoma surgery (16% vs. 0%; p = 0.0191). Conclusions: The XEN-45 gel stent offers equally effective IOP control for both phakic and pseudophakic patients. However, the onset of bleb revisions and the necessity for secondary glaucoma surgery differed significantly between the groups.

Decompression alone or decompression with fusion for lumbar spinal stenosis: five-year clinical results from a randomized clinical trial.

We compared decompression alone to decompression with fusion surgery for lumbar spinal stenosis, with or without degenerative spondylolisthesis (DS). The aim was to evaluate if five-year outcomes differed between the groups. The two-year results from the same trial revealed no differences. The Swedish Spinal Stenosis Study was a multicentre randomized controlled trial with recruitment from September 2006 to February 2012. A total of 247 patients with one- or two-level central lumbar spinal stenosis, stratified by the presence of DS, were randomized to decompression alone or decompression with fusion. The five-year Oswestry Disability Index (ODI) was the primary outcome. Secondary outcomes were the EuroQol five-dimension questionnaire (EQ-5D), visual analogue scales for back and leg pain, and patient-reported satisfaction, decreased pain, and increased walking distance. The reoperation rate was recorded. Five-year follow-up was completed by 213 (95%) of the eligible patients (mean age 67 years; 155 female (67%)). After five years, ODI was similar irrespective of treatment, with a mean of 25 (SD 18) for decompression alone and 28 (SD 22) for decompression with fusion (p = 0.226). Mean EQ-5D was higher for decompression alone than for fusion (0.69 (SD 0.28) vs 0.59 (SD 0.34); p = 0.027). In the no-DS subset, fewer patients reported decreased leg pain after fusion (58%) than with decompression alone (80%) (relative risk (RR) 0.71 (95% confidence interval (CI) 0.53 to 0.97). The frequency of subsequent spinal surgery was 24% for decompression with fusion and 22% for decompression alone (RR 1.1 (95% CI 0.69 to 1.8)). Adding fusion to decompression in spinal stenosis surgery, with or without spondylolisthesis, does not improve the five-year ODI, which is consistent with our two-year report. Three secondary outcomes that did not differ at two years favoured decompression alone at five years. Our results support decompression alone as the preferred method for operating on spinal stenosis.

Poster 285: Two-Year KOOS Improvement after Unloading Treatment With Implantable Shock Absorber in Post-Meniscectomy Patients

Objectives: Meniscectomy is a common orthopaedic procedure designed to improve symptoms. However, partial or full meniscectomy can reduce the structure’s ability to absorb and distribute normal joint load, which can result in post-meniscectomy pain. Subjects with and without previous meniscectomy and knee OA were treated with an implantable shock absorber (ISA) to unload the medial compartment. The purpose of this study was to compare subjects with and without previous meniscectomy who were treated with the ISA to evaluate if prior meniscectomy impacted outcomes scores. The objective was to determine if prior meniscectomy impacted two-year KOOS outcomes for patients treated with an implantable shock absorber. Methods: Eighty-one (81) subjects had the ISA implanted, and 23 subjects (28%) previously underwent partial (22) or full (1) medial meniscectomy. Subjects in the medial meniscectomy arm were 50.9 years old compared to 51.4 years old in the non-meniscectomy arm (p=0.8). The two arms were comparable for other baseline demographics, such as BMI, OA disease severity and duration of symptoms. Baseline and 2-year improvements in KOOS subscales were recorded. Results: Subjects with and without previous meniscectomy reported similar improvements in KOOS scores at two years. The post-meniscectomy group reported KOOS Pain improvement of 41.3 points from baseline, compared to a 47.3 point improvement in the non-meniscectomy group (p=0.2584) at two years. Similarly, the meniscectomy group reported a 43.6 improvement in KOOS ADL, compared to a 45.9 point improvement in the non-meniscectomy group (p=0.7075). Subjects reported similarly high levels of improvement in the post-meniscectomy arm compared to the non-meniscectomy group (38.2 vs. 51.4, p=0.1108) on the Sports/Rec Activities scale of KOOS. Through two years, none (0%) of the meniscectomy group underwent a conversion to arthroplasty, and study safety events were comparable between the two arms (p=0.2109). Conclusions: At two years, the implantable shock absorber provided dramatic improvement on KOOS subscales for subjects with prior meniscectomy and knee OA that is comparable to the improvement for subjects without history of meniscectomy. While this study population was more of a general OA population and not a sports-oriented population, the improvement in KOOS Sports/Rec was notable for the post-meniscectomy cohort. Given the attractive safety profile, the ISA is a potential treatment for patients with post-meniscectomy pain, and the treatment should be evaluated further in this population.