Comparison Of Clinical Outcomes Research Articles

Posterior iliac crest vs. proximal tibia: distinct sources of anti-inflammatory and regenerative cells with comparable 6-month clinical outcomes in treatment of osteoarthritis

BackgroundHuman bone marrow is a source of mesenchymal stem cells (MSCs), other progenitor cells, and factors with anti-inflammatory and regenerative capacity. Though the fraction of MSCs out of the nucleated cells is very small, bone marrow aspirate (BMA) for osteoarthritis (OA) has noteworthy effects. BMA is usually collected from the posterior or anterior iliac crest, and rarely from the proximal tibia. We investigated the clinically beneficial concentration of ex vivo MSCs, derived from BM harvested from the posterior iliac crest and proximal tibia by Marrow Cellution™ Aspiration System, and their phenotypic differences, in comparison to autologous Platelet-Rich Plasma (PRP) treatment prepared with a manual, closed system.MethodsA single-center, parallel, randomized controlled study was designed to investigate the efficacy of BMA from the posterior iliac crest compared to BMA from the proximal tibia, against a control group treated with PRP, in knee OA. Thirty patients with knee OA grade I-IV, according to Kellgren-Lawrence (KL), were distributed into each group. Visual Analog Scale (VAS) and Western Ontario & McMaster Universities Arthritis Index (WOMAC) score were used for clinical outcome evaluation.ResultsData from an intermediate analysis of 6-months follow-up, involving 15 patients in each arm, showed that the posterior iliac crest was significantly more densely populated with mononuclear cells, than the proximal tibia (p = 0.005). Flow cytometric analysis on ex vivo BMA showed a significantly greater number of MSCs in the BM-derived from the posterior iliac crest when compared with the proximal tibia (p < 0.001), together with a significantly higher number of platelets (PLTs) (p < 0.001). Surprisingly, despite these differences in cells number, the improvement in early pain and function scores, after each treatment, were statistically significant within each of the three arms. BM from the proximal tibia showed the highest ΔWOMAC, while BM from the posterior iliac crest showed the highest ΔVAS; however, these differences were not statistically significant across the three arms (p > 0.05). A better outcome, in terms of ΔVAS, was observed in patients classified as KL I-II, when treated with BMA from crest (p < 0.001) and PRP (p = 0.004). Moreover, the effect of BMA treatment on ΔVAS depends on MSCs % only in the Tibia Arm (r = -0.59, p = 0.021), where we also found a correlation between ΔWOMAC and monocytes (r = 0.75, p = 0.016).ConclusionThe results indicate that the iliac crest yields a higher concentration of MSCs compared to the proximal tibia, however both BM, independently of the MSCs concentration, show a beneficial clinical outcome in the treatment of knee OA. Furthermore, BMA is not superior to PRP treatment.

Comparison of Clinical Outcome and Dosimetric Parameters of Three‐Dimensional Conformal Radiotherapy Versus Intensity Modulated Radiotherapy in Patients with Head and Neck Squamous Cell Carcinoma: A Prospective Two Armed Observational Study

Comparison of Clinical Outcome and Dosimetric Parameters of Three‐Dimensional Conformal Radiotherapy Versus Intensity Modulated Radiotherapy in Patients with Head and Neck Squamous Cell Carcinoma: A Prospective Two Armed Observational Study

Robotic carotid artery stenting: a multicenter, propensity score–matched analysis of clinical outcomes and cost-effectiveness

OBJECTIVE Preclinical studies suggest that robotic carotid artery stenting (CAS) could be superior to manual CAS. However, very limited comparative data exist for patients who have undergone robotic versus manual CAS. In addition, no data exist comparing the costs of manual and robotic CAS. METHODS All robotic CAS cases at two academic neurosurgery centers were retrospectively reviewed and 1:1 propensity matched with manual CAS cases. Personnel costs, supply costs, and total procedure costs were collected in collaboration with hospital administration by using time-driven activity-based cost analysis. RESULTS A total of 24 robotic CAS operations were performed between 2019 and 2023. Comorbidities and baseline procedural characteristics were well matched between robotic and manual cases. Unplanned manual conversion was observed in only 1 robotic case (4.2%). Robotic CAS complications and outcomes were comparable to manual. Robotic CAS was associated with a significantly increased fluoroscopy time (29.0 vs 19.2 minutes; p &lt; 0.001). Robotic procedure time (88.9 ± 18.2 minutes) was significantly (p = 0.003) longer than manual time (68.72 ± 22.4 minutes). Health personnel costs ($1589.71 ± $176.92 vs $1375.99 ± $233.39, p = 0.005); supply costs ($3918.25 ± $421.20 vs $2152.74 ± $1030.26, p &lt; 0.001); and total procedure costs ($5306.11 ± $608.95 vs $3437.56 ± $1165.67, p &lt; 0.001) were greater for robotic CAS. CONCLUSIONS In the first multicenter study and largest sample to date, the authors show that robotic CAS, with a low rate of procedural failure and postoperative complications, is safe and feasible. In addition, robotic CAS achieves comparable clinical outcomes to manual CAS. Robotic CAS was associated with increased fluoroscopy time, but fluoroscopy time decreased as operators gained familiarity with the CorPath GRX system. Robotic CAS was associated with a greater procedural cost, which was driven by greater personnel and supply costs. Robotic CAS failed to show superiority to manual CAS. These findings set a foundation for randomized controlled trials of robotic CAS, and also highlight the need for further studies to optimize robotic CAS and reduce its associated costs.

The Midline Lateral Parapatellar Arthrotomy: A Safe Alternative Approach for Lateral Tibial Plateau Fractures.

The midline lateral parapatellar (LP) approach has been shown in a cadaveric study to provide superior articular exposure compared to the anterolateral approach (AL). The purpose of this study was to report on outcomes and complications with the LP approach. Design: Retrospective comparative cohort study and prospective cohort. Academic Level-I trauma center. Adult patients with minimum 3 months follow up who underwent open reduction internal fixation (ORIF) of an acute, isolated lateral tibial plateau fracture (OTA/AO 41-B1, 41-B2, 41-B3) via a LP arthrotomy or AL submeniscal arthrotomy between 2010-2019.Outcome Measures and Comparisons: Retrospective cohort evaluated using postoperative complications including infection, delayed wound healing, and reoperation rate. Prospective cohort evaluated using Short Musculoskeletal Function Assessment (SMFA), knee range of motion (ROM), and complications. The mean age for the LP cohort was 41.5 years (19-79) and 18/32 (56.3%) were male. The mean age for the AL cohort was 42.8 years (18-71) and 29/49 (59.2%) were male. The mean age for patients in the prospective study was 31.4 years (19-59) and 9/14 (64.3%) were male. Mean follow-up was 9.3 months and 20.3 months for the retrospective and prospective cohorts respectively. There was no significant difference in complication or reoperation rate (p>0.39). For the prospective cohort mean ROM was 130 degrees. Mean SMFA dysfunction index (DI) was 9.0 and mean bother index (BI) was 11.1. The lateral parapatellar approach resulted in comparable clinical and functional outcomes to those seen historically with the anterolateral approach. It is a safe alternative and may be of most benefit when treating comminuted lateral tibial plateau fractures. Level III.

Failure rate of the pulmonary embolism rule-out criteria rule for adults 35 years or younger: Findings from the RIETE Registry.

The use of a computed tomography pulmonary angiogram to diagnose pulmonary embolism (PE) has increased, leading not only to higher PE diagnoses but also to overdiagnosis and unnecessary radiation exposure, even in young patients despite a lower PE incidence. The aim of this study was to assess the failure rate of the pulmonary embolism rule-out criteria 35 (PERC-35) rule developed to reduce unnecessary testing in individuals aged ≤35 years among patients included in the Registro Informatizado de la Enfermedad TromboEmbolica Venosa (RIETE) Registry. This retrospective cohort study used data from the RIETE Registry, an ongoing, international prospective registry of patients with objectively confirmed venous thromboembolism. The primary outcome was the missed PE rate using PERC-35 criteria. Secondary outcomes included the comparison of demographic and clinical characteristics, PE localization, treatment strategies, and outcomes between PERC-negative (PERC-35N) versus PERC-positive (PERC-35P) patients. Of 58,918 adult patients with acute PE, the PERC-35 rule demonstrated a low missed PE rate of 0.35% (n = 204), with an upper 95% confidence interval [CI] of 0.40%. The missed rate was 7.0% (95% CI 6.0%-7.9%) in the 18- to 35-year subgroup. Compared to PERC-35P patients, PERC-35N patients were younger (mean age 28.4 years), with a lower body mass index, and included a higher proportion of pregnant/postpartum women. PERC-35N patients had a significantly lower rate of chronic diseases and presented less frequently with dyspnea or syncope but more often with chest pain. They showed lower rates of positive D-dimer and troponin levels. PERC-35N patients experienced fewer major bleeding episodes, similar recurrence rates of PE/deep vein thrombosis, and no deaths during anticoagulation. The PERC-35 rule demonstrated a low failure rate to exclude PE in patients aged 18-35 years and could reduce imaging and radiation exposure in young patients with a low PE pretest probability if confirmed prospectively.

Comparison of clinical outcomes between conventional and underwater endoscopic mucosal resection for duodenal neuroendocrine tumors

Duodenal neuroendocrine tumors are relatively rare subepithelial tumors that arise from cells of the neuroendocrine system. Small duodenal neuroendocrine tumors can be treated endoscopically because of their low potential for metastasis. This study aimed to evaluate the clinical outcomes of conventional and underwater endoscopic mucosal resection for duodenal neuroendocrine tumors. Between March 2009 and March 2023, 15 patients with duodenal neuroendocrine tumors resected using conventional (n = 7) and underwater (n = 8) endoscopic mucosal resections were retrospectively enrolled. The median specimen size and median tumor size were 1.0 cm (interquartile range: 0.8–1.2 cm) and 0.6 cm (interquartile range: 0.4–0.6 cm), respectively. More than half of duodenal neuroendocrine tumors were located in the duodenal bulb (9/15, 60%). The en bloc and complete resection rates of both conventional and underwater endoscopic mucosal resections were 100%. Only one perforation event occurred in the conventional endoscopic mucosal resection group (14.3%). The patient with the perforation was treated with endoscopic clipping. The median follow-up period was 39.5 months (interquartile range: 19.5–57.3 months). There was no local recurrence or distant metastasis during the follow-up period. Underwater endoscopic mucosal resection is a safe and effective treatment option for small duodenal neuroendocrine tumors and is the preferred treatment option for flat-type duodenal neuroendocrine tumors.

Comparison of clinical outcomes between Castor single-branched stent graft and in situ fenestration in treating Stanford type B aortic dissection involving the left subclavian artery: A retrospective case-control study

Stanford type B aortic dissection involving the left subclavian artery (LSA) poses significant clinical challenges. The Castor single-branch stent graft and in situ fenestration are commonly used techniques, but the better endovascular treatment remains debated. This study evaluates the clinical effects of the Castor single-branched stent graft versus in situ fenestration in treating Stanford type B aortic dissection involving the LSA. We selected 75 patients with Stanford type B aortic dissection involving the LSA, admitted to the Second Affiliated Hospital of Nanchang University from January 2018 to May 2022. All patients underwent thoracic endovascular aortic repair; 34 received the Castor single-branched stent graft, while 41 underwent in situ fenestration. Clinical efficacy and perioperative complications were compared. The technical success rate of the Castor single-branch stent graft was significantly higher than that of in situ fenestration (97.06% vs 80.49%, P = .04). The Castor group exhibited significantly better outcomes in operative time (136.45 ± 25.53 min vs 157.08 ± 18.14 min), LSA blood flow recovery time (6.8 ± 2.3 min vs 20.1 ± 9.8 min), blood loss (29.03 ± 9.78 mL vs 35.69 ± 10.77 mL), contrast medium usage (288.71 ± 72.70 mL vs 352.78 ± 81.02 mL), and immediate postoperative endoleaks (1/34 vs 7/41) (P &lt; .05). Stroke incidence (1/34 vs 2/41) and perioperative mortality (0/34 vs 1/41) were similar (P &gt; .05). Hospital stays were comparable (15.71 ± 6.04 days vs 14.22 ± 5.01 days, P = .28). However, the cost of medical supplies (154,168.62 ± 28,288.44 CNY vs 119,589.72 ± 34,199.67 CNY) and total hospital expenses (192,665.88 ± 40,027.99 CNY vs 153,920.47 ± 42,670.87 CNY) were significantly higher in the Castor group (P &lt; .05). The median follow-up time was 9 months (1–60 months). Follow-up showed similar 30-day postoperative mortality (1/41 vs 0/34, P = 1.00), stent patency (33/34 vs 39/41, P = .67), and stent migration rates (0/34 vs 1/41, P = 1.00). However, the endoleak rate was significantly higher in the in situ fenestration group (11/41 vs 1/34, P = .01). Both the Castor single-branch stent graft and the in situ fenestration technique effectively protect and reconstruct the LSA in Stanford type B aortic dissection, with the Castor single-branch stent graft showing higher technical success and fewer complications, indicating better clinical potential.

Arthroscopic Partial Repair of Large to Massive Rotator Cuff Tears Shows Comparable Clinical Outcomes and Survivorship at Minimum 10-year Follow-Up Compared with Arthroscopic Complete Repair

PurposeThis research aimed to compare the survival rate (revision surgery) and clinical and radiologic outcomes of arthroscopic partial versus complete repair for large to massive rotator cuff tears over a minimum 10-year follow-up. MethodsA retrospective analysis was conducted on patients who underwent arthroscopic partial or complete repair of large to massive rotator cuff tears between 2008 and 2013, with a minimum 10-year follow-up. Functional outcomes were measured using the visual analog scale, subjective shoulder value, American Shoulder and Elbow Surgeon score, University of California Los Angeles shoulder score, and passive range of motion (PROM) preoperatively and at the last follow-up. Failure was defined as the need for revision surgery (reverse shoulder arthroplasty) owing to significant pain and functional loss. Radiographic assessments included X-ray (preoperatively and at the latest follow-up) and magnetic resonance arthrography (preoperatively and 6 months postoperatively). The groups were compared for subjective and objective outcomes. ResultsThe study included 90 participants, 34 in Group P and 56 in Group C. At the latest follow-up, no significant differences were found in clinical scores and the percentage of participants exceeding the MCID was comparable for both groups in all variables. Groups P and C showed forward flexion of 133° ± 7° and 136° ± 10° (95% CI, -6.4 to 2.2, p=0.319); external rotation of 41° ± 5° and 42° ± 6° (95% CI, -3.8 to 2.0, p=0.465); internal rotation of 11 ± 1 and 11 ± 2 (95% CI, -0.3 to 0.2, p=0.284). Despite differences in retear size at 6 months (p<0.001) and acromiohumeral distance at the lastest follow-up (Group P: 4.5 ± 1.1 mm; Group C: 5.8 ± 0.7 mm), the survival rates at 10 years were similar: 77% (n=8) for Group P and 84% (n=11) for Group C (p=0.674). ConclusionsWhile radiological outcomes were inferior in the partial repair group, both groups had comparable survival rates and clinical outcomes over the 10-year follow-up. Level of EvidenceIII, retrospective comparative study

Comparison of fusion rate, radiologic and clinical outcome between CaO-SiO2-P2O5-B2O3 bioactive glass-ceramics 7 (BGS-7) spacer and allograft spacer with iliac bone graft in multilevel ACDF.

CaO-SiO2-P2O5-B2O3 bioactive glass-ceramics7 (BGS-7) are known for their strong integration with bone and stability and are commonly used in spinal fusions. This study aimed to compare fusion rates and radiological and clinical outcomes between BGS-7 and allograft spacers with iliac bone grafts (IBG) in multilevel anterior cervical discectomy and fusion (ACDF) surgeries. This retrospective study was conducted at BRM Medical Center. We included patients who underwent multilevel ACDF at BRM Medical Center between January 2012 and December 2023. The patients had symptoms such as cervical radiculopathy and myelopathy due to cervical disc herniation, stenosis, and spondylosis. We evaluated the preoperative and postoperative Japanese Orthopedic Association (JOA) scores, neck disability index (NDI), functional rating index (FRI), and visual analog scale (VAS) scores for the neck, shoulder, and upper extremities at 6 months and 1 year after surgery. Fusion rates were assessed using dynamic radiography and computed tomography (CT) scans at 1 year postoperatively. Radiological measurements were obtained from preoperative and postoperative plain radiographs. At the 1-year follow-up, the fusion rates were 89.5% for BGS-7 and 92.2% for the allograft cage on dynamic radiographs (p=0.156) and 93.4% and 90.4%, respectively, on CT scans (p=0.319), confirming both internal and external osseointegration. Subsidence rates were 4% for BGS-7 and 10% for the allograft spacer group. Both groups showed increased cervical lordosis (CL), segmental lordosis (SL), and segmental height postoperatively, with maintained lower segmental height (LSH) in the BGS-7 group than in the allograft spacer group at postoperatively 1 year. No adjacent segmental disease (ASD) occurred in either group. The JOA, NDI, and FRI showed significant improvements in both groups. The VAS scores decreased significantly in both groups, indicating improved clinical outcomes. In multilevel ACDF, BGS-7 demonstrated fusion rates comparable to those of the allograft spacer with IBG, experiencing fewer instances of subsidence and cage fracture. Therefore, BGS-7 spacer can be safely utilized in multilevel ACDF as a substitute for traditional allograft spacers, without the need for additional IBG.

Comparison of clinical characteristics, risk factors, and outcomes of patients infected with Bacteroides fragilis group at a tertiary care hospital in central China between 2017 and March 2024

ObjectivesThis study aimed to explore the epidemiology, clinical presentation, and risk factors for treatment failure in patients infected with various Bacteroides fragilis group (BFG) species. MethodsWe analyzed clinical and laboratory data from 178 patients infected with BFG who were admitted to our hospital between 2017 and 2024. We analyzed categorical data using Chi-square and Fisher exact tests, continuous variables using Student's t-tests or Mann–Whitney U-tests, and risk factors using multivariate logistic regression and Pearson's chi-squared tests. ResultsBacteroides fragilis (69.7 %) and Bacteroides thetaiotaomicron (16.9 %) were the most prevalent species among 178 BFG isolates. Most patients had polymicrobial infections, with the following pathogens isolated from concurrent samples: Escherichia coli, Klebsiella spp., and Enterococcus spp. Intra-abdominal sites were most frequently infected with BFG. Patients aged >50 years and those who had intravascular catheters were infected with more other Bacteroides species than B. fragilis. Admission to an ICU, respiratory, renal and cardiovascular diseases, and chest drainage were associated more often with B. thetaiotaomicron than with B. fragilis. Gastrointestinal diseases, tracheal intubation, and ICU admission were associated more frequently with treatment failure in patients infected with B. fragilis whereas solid cancers, renal disease, multiple organ dysfunction syndrome, and tracheal intubation were more likely to be associated with treatment failure in patients infected with other Bacteroides spp. ConclusionsThe most prevalent BFG species in the patients were B. fragilis and B. thetaiotaomicron. The demographic characteristics of the patients, underlying diseases, and risk factors for poor clinical outcomes clearly differed among species.

A comparison of clinical and radiological outcomes following laminectomy and laminectomy with fusion in patients of cervical spondylotic myelopathy: A systematic review and meta-analysis.

To conduct a systematic review and meta-analysis comparing the functional and radiological outcomes in cervical spondylotic myelopathy (CSM) when treated by Laminectomy (LC) vs. laminectomy with instrumented fusion (LCF). The systematic review was conducted in accordance with PRISMA guidelines. A systematic electronic search was performed in PubMed, EMBASE, and CENTRAL databases. All Studies comparing clinical and radiological outcomes in patients with CSM when treated with LCF and LC were included in the systematic review. Neuromuscular function measured by modified Japanese orthopaedic association (mJOA), Cervical lordosis measured by C2-C7 Cobb's angle, and data on complications were retrieved from the studies. Random effect meta-analysis was used to account for heterogeneity. Quality assessment was performed using ROBINS-I and ROB-2 tools. Certainty of evidence was assessed using the GRADE working group recommendations. A total of 3985 articles were retrieved from the databases, of which 9 articles (1 RCT, 8 controlled comparative trials; n = 1146) met the eligibility criteria. The improvement in mJOA showed results favouring laminectomy with fusion with an SMD of 0.45 (95% CI, 0.07-0.84; p = 0.02). The loss of cervical lordosis was significantly lesser in the laminectomy with fusion group with an SMD of - 0.454 (95% CI, (- 0.12) - (- 0.79), p = 0.01). The complication rate in the LCF group was lower (LogOR = - 0.92; 95% CI: (- 1.30) - (- 0.55); p = < 0.05). In CSM, laminectomy with fusion is superior to standalone laminectomy in terms of improvement in m-JOA, maintenance of cervical lordosis and reduction in complications.

Evaluating the Efficacy of Inhaled Colistin via Two Nebulizer Types in Ventilator-Associated Pneumonia: Prospective Randomized Trial.

Backgroud: This prospective randomized trial evaluated the clinical efficacy of inhaled colistin administered through two distinct nebulizer types, a vibrating mesh nebulizer (VMN) and a jet nebulizer (JN), in the treatment of ventilator-associated pneumonia caused by multidrug-resistant bacteria. In addition, an in vitro model was used to determine the optimal delivery of colistin. Method: Thirty-two patients prescribed intravenous (IV) colistin inhalation were randomized to receive either a VMN (n = 17) or a JN (n = 15), then compared to the control group (IV alone) over a 7-to 10-day period. The primary endpoint was the clinical pulmonary infection score (CPIS), and the secondary endpoints were the Sequential Organ Failure Assessment (SOFA) score, Acute Physiology and Chronic Health Evaluation (APACE) score, and duration of ventilator use. Results: Results from in vitro testing demonstrated that VMN delivered a significantly higher colistin dose than JN (35.68 ± 3.55% vs. 23.56 ± 3.31%; p < 0.001) when positioned at the humidifier inlet. Compared to the IV alone group, the IV with inhalation group yielded significant improvements in CPIS, SOFA score, and APACHE score on day 7; nevertheless, clinical outcomes between the two nebulizers were statistically indistinguishable. Conclusions: In conclusion, although VMN delivers a higher dose in vitro, both nebulizers yielded comparable clinical outcomes. This study was registered at US Clinical Trial Registration (NCT04633317).

Intraprocedural Three-Dimensional Imaging Registration Optimizes Magnetic Resonance Imaging–Guided Focused Ultrasound and Facilitates Novel Applications

BACKGROUND AND OBJECTIVE: Transcranial magnetic resonance–guided focused ultrasound (MRgFUS) has revolutionized ablative treatment of essential tremor in recent years. However, limitations in precision targeting may account for suboptimal efficacy and significant side effects. We describe a simple intraprocedural three-dimensional image-guided lesion shaping technique that can improve overall outcomes of MRgFUS for essential tremor and facilitate expansion to novel indications. METHODS: A retrospective review of 84 consecutive MRgFUS procedures performed at Pennsylvania Hospital was performed. Comparison of patient demographics, treatment parameters, and clinical outcomes before and after implementation of this protocol was conducted. Further application of this technique in pallidotomy treatments and ablative disconnection of hypothalamic hamartoma are described. RESULTS: After implementation, the median of total number of sonications (7 vs 9, P = .001), number of therapeutic sonications (3 vs 4, P &lt; .0001), and interval time between the first and last sonication (46:10 vs 68:53 minutes, P = .0004) were significantly reduced. Patients expressed greater satisfaction of treatment (94.1% vs 82.4%, P = .018), greater global impression of change (CGI) (7 vs 6, P = .033), and reduced median number of side effects at 6 months (0 vs 1, P = .026). We also successfully implemented this protocol for novel indications. CONCLUSION: Intraprocedural lesion shaping for MRgFUS is a simple and versatile imaging protocol augmentation that improves ablation precision and can improve treatment efficacy and broader neurological application.

Comparison of clinical outcomes, complications and patient satisfaction following deep anterior lamellar keratoplasty and penetrating keratoplasty

BackgroundKeratoplasty is a surgical procedure in which a damaged or diseased cornea is replaced with healthy donor tissue, thereby restoring vision. Recent advancements have led to the replacement of penetrating keratoplasty (PKP) with the more selective deep anterior lamellar keratoplasty (DALK) procedure, especially for treating keratoconus. Although DALK typically has a shorter recovery time, less pain and a lower risk of rejection, PKP is still being performed for more severe corneal diseases. A comparative study of clinical profiles, treatment outcomes and patient-reported satisfaction will provide valuable insights into the cost-effectiveness, impact on quality of life and ability of each procedure to treat different pathologies of the cornea. Here, we aimed to compare the clinical and subjective outcomes of DALK with those of the PKP at a single center in the Kingdom of Saudi Arabia.MethodsThis retrospective cohort study included eyes that underwent either PKP or DALK from January 2017 to January 2021. The demographic features, indications, best corrected visual acuity (BCVA) and complications of the patients were recorded for both groups, analyzed and compared. A subgroup of eyes with keratoconus was analyzed separately and compared to the larger group. A 6-item survey was conducted via telephone to assess patient satisfaction and expectation, and the results were compared between the two procedures. The chi-square test or Fisher’s exact test for categorical variables or the t test or Kruskal‒Wallis test for continuous variables were used as appropriate for all comparisons, and the level of significance was set at α = 0.05.ResultsA total of 97 patients were included. PKP and DALK were performed on 63 and 39 eyes, respectively. Patients who underwent DALK were younger (mean ± standard deviation 31 ± 10.82 years versus 43 ± 26.89 years for patients who underwent PKP). The most frequent indication for PKP was keratoconus (35.5%); however, in 97.4% of the eyes undergoing DALK, the indication was keratoconus. In both groups, visual acuity and refractive error improved, but the postoperative corrected distance visual acuity in the DALK group (0.3 log MAR) was noticeably greater than that in the PKP group (0.6 log MAR). Compared with PKP, DALK may carry a lower risk of early graft edema and rejection. Overall, the reported postoperative patient satisfaction was similar for both procedures.ConclusionThe findings highlight the effectiveness of PKP and DALK in improving visual acuity and emphasize the importance of considering patient-reported outcomes in evaluating success. DALK has been demonstrated to be beneficial for protecting the corneal endothelium and lowering the risk of complications and graft rejection.

Comparison of 3-month clinical outcomes between two enhanced monofocal intraocular lenses: A single-center prospective study.

This study aims to compare the 3-month clinical outcomes between two enhanced monofocal intraocular lenses (IOLs) following cataract surgery.Setting: Eye Clinic of Careggi University Hospital, Florence, Italy. Single-center prospective study. We included patients with cataract and corneal astigmatism less than 0.75 D, with no ocular comorbidities, who underwent unilateral cataract surgery with implantation of either the Tecnis Eyhance ICB00 (N = 25) or Evolux (N = 25) IOLs. Standard cataract procedures were performed without complications. The main outcome measures included uncorrected and corrected visual acuity at distance (4 m), intermediate (60 cm) and near (40 cm) at 3-month follow-up. Additionally, monocular defocus curves, aberrometric profiles, and perceptions of halo and glare were evaluated. The study involved 50 patients (26 male, 24 female) with a mean age of 68 ± 8 years. Preoperative characteristics were similar between the groups, and no intraoperative or postoperative complications were reported. Statistically significant differences were observed between the groups, with the Evolux IOL showing superior results (p < 0.05) in terms of uncorrected and corrected visual acuity at near, intermediate, and distance, as well as in aberrometric profiles (lower-order aberration root-mean-square [RMS], higher-order aberration RMS, spherical equivalent RMS, and point spread function) and defocus curves. Based on our experience, while both IOLs offer substantial visual performance for intermediate and distance vision, the Evolux IOL demonstrated superior mean visual outcomes and objective parameters at the 3-month follow-up compared to the Tecnis Eyhance IOL. This indicates a potential advantage of the Evolux IOL in providing better visual performance.

Comparison of clinical outcomes and cost-utility between unilateral biportal endoscopic discectomy and percutaneous endoscopic interlaminar discectomy for single-level lumbar disc herniation: a retrospective matched controlled study

ObjectiveThis study aimed to compare the efficacy and cost-utility of unilateral biportal endoscopy (UBE) versus percutaneous endoscopic interlaminar discectomy (PEID) for the treatment of single-level lumbar disc herniation (LDH).MethodsA retrospective analysis was conducted on 99 patients who underwent either UBE (n = 33) or PEID (n = 66) between July 2022 and December 2023 at the Second Xiangya Hospital. Patients were matched 1:2 based on age, sex, and surgery level to ensure comparability. Clinical outcomes were assessed using Visual Analog Scale (VAS), European Quality of Life-5 Dimensions (EQ-5D), and Oswestry Disability Index (ODI) scores, with quality-adjusted life years (QALYs) calculated for cost-utility analysis. Hospitalization costs were analyzed, and the incremental cost-utility ratio (ICER) was determined.ResultsBoth UBE and PEID groups demonstrated significant postoperative improvements in VAS, EQ-5D, and ODI scores (p < 0.05). The operative time, blood loss and nursing cost were significantly higher for UBE compared to PEID (p < 0.05). UBE has higher gained QALY and overall costs, but the differences are not statistically significant (p = 0.643 for QALY, p = 0.327 for costs). The Incremental Cost-Effectiveness Ratio (ICER) for UBE compared to PEID was calculated to be $354.5 per QALY gained, indicating that for each additional QALY gained through UBE, an additional cost of $354.5 is incurred compared to PEID.ConclusionIn our single-center study conducted in China, both the UBE and PEID procedures have demonstrated comparable short-term efficacy in alleviating pain and improving functional ability in patients with single-level LDH. UBE procedure demonstrates greater cost-utility than the PEID procedure in cost-utility analysis, despite its longer operative time, higher nursing costs and greater blood loss.

Comparison of clinical outcomes and return to sport between unicortical versus bicortical button fixation techniques for subpectoral biceps tenodesis.

There is limited clinical outcome data comparing fixation methods for tenodesis of the long head of the biceps tendon (LHBT), particularly button fixation. The purpose of this study was to compare clinical outcomes, patient-reported outcomes, and return to sport (RTS) between patients undergoing LHBT with bicortical versus unicortical button technique. The authors hypothesized these fixation methods would be similar for all outcomes. Patients who underwent LHBT using unicortical or bicortical button fixation with minimum 2-year follow-up were identified. Postoperative outcomes were evaluated using the American Shoulder and Elbow Surgeons (ASES) questionnaire and visual analogue scale (VAS) pain score. A sports activity survey was collected to assess baseline sport participation and ability to return to pre-injury activities. Continuous variables were analyzed using the Mann-Whitney-U test. Categorical variables were analyzed using Chi-squared tests. Multivariable logistic and linear regression were performed to determine predictors of RTS and time to RTS. Sixty-four subjects (19 unicortical and 45 bicortical button fixation) were included (average follow-up 3.5 (range: 2.0-7.8) years). There were no significant differences found between button groups for VAS pain score (1.5 vs. 1.2; p = 0.876), VAS pain during sport score (1.6 vs. 1.1, p = 0.398), and ASES score (66 vs. 71; p = 0.294). There were no significant differences in rate of RTS (75.0 vs. 77.4%; p = 0.885) or average time to return to sport (11.7 ± 7.3 vs. 7.0 ± 4.0months; p = 0.081) between groups. There were no significant differences in clinical outcomes, pain, or return to sport between patients who underwent LHBT with unicortical or bicortical button fixation.

Abstract 4136704: Comparison of Early Clinical Outcomes with Balloon-Expanding Valves Versus Self-Expanding Valves in Transcatheter Aortic Valve Replacement: A Meta-Analysis of Randomized Controlled Trials

Background: Transcatheter aortic valve replacement (TAVR) is an effective percutaneous intervention in patients with severe aortic stenosis, particularly in those with contraindications for surgical repair. Currently, two types of aortic valves are used in clinical practice: balloon-expanding valves (BEV) and self-expanding valves (SEV). The current data comparing early (30-day) clinical outcomes of BEV to SEV in patients with severe aortic stenosis undergoing TAVR are inconsistent. Methods: A systematic literature search spanning PubMed, Embase, Cochrane, and Scopus databases was conducted to retrieve randomized controlled trials (RCTs) comparing balloon-expanding valves to self-expanding valves in patients undergoing TAVR. The DerSimonian and Laird random-effects model was used to pool the odds ratios (OR) with 95% confidence intervals. Statistical significance was set at p&lt;0.05. Results: This meta-analysis included five RCTs with 2190 severe aortic stenosis patients (1097 in the BEV group and 3621 in the SEV group). BEV-TAVR was associated with a significantly lower risk of 30-day new permanent pacemaker (PPM) implantation [OR: 0.67; 95% CI: 0.48, 0.93; p=0.02] and 30-day re-hospitalization for heart failure [OR: 0.20; 95% CI: 0.04, 0.96; p=0.04] compared to SEV-TAVR. The risks of 30-day mortality, 30-day cardiac mortality, 30-day all-cause stroke, 30-day myocardial infarction, 30-day life-threatening bleeding, 30-day vascular complications, 30-day acute kidney injury, and 30-day repeat procedures for valve-related dysfunction were comparable between the two groups. Conclusion: TAVR in patients with severe aortic stenosis using BEV is advantageous over SEV in terms of 30-day new PPM implantation and 30-day rehospitalization for heart failure, with comparable risks for other outcomes. These findings underscore the safety and efficacy of newer generation valves, including Sapien 3 and EvolutPro, in TAVR. The choice of prosthetic aortic valve is dependent on individual anatomy and operator preference. Further RCTs are warranted to evaluate other newer-generation valves with varying severities of aortic stenosis.

Abstract 4139177: Five-Year Clinical Outcomes of Balloon-Expandable versus Self-Expanding Transcatheter Aortic Valve Replacement in Patients with Small Aortic Annulus

Introduction: Self-expanding transcatheter aortic valves (SEV) have reportedly better hemodynamic outcomes, and similar clinical outcomes compared to balloon-expanding valves (BEV) at 1 year in patients with a small aortic annulus based on results from the SMART trial. Head-to-head comparison of long-term clinical outcomes, however, is lacking. Objectives: To compare the long-term (5 years) echocardiographic and cardiovascular outcomes in BEV versus SEV in patients with small aortic annulus undergoing transcatheter aortic valve replacement (TAVR). Methodology: The RESOLVE registry included consecutive patients who underwent TAVR and survived up to 30 days at Cedars-Sinai Medical Center with either BEV or SEV from 2015 to 2020, with clinical variables obtained from the STS/TVT registry. CT core lab analysis identified patients with a small aortic annulus (&lt;430 mm 2 ), who were systematically followed up with clinical exams and echocardiography until December 2023. The primary outcome was a composite of all-cause mortality, stroke or transient ischemic attack, or heart failure hospitalization at 5 years. Results: Out of 1392 patients, a total of 423 met criteria for small aortic annulus (345 BEV, 78 SEV), with a median follow-up of 5 years (4-6 years). There were no significant differences in baseline sociodemographic and clinical characteristics between the BEV and SEV groups. (Figure 1) The post-TAVR invasive aortic valve mean gradient were similar in both groups [Median (IQR): BEV:3(1-5.8), SEV: 3.4(0.4-6.6), p 0.58], while echocardiographic gradients were higher in BEV group [Median (IQR): BEV:12 (9-15), SEV:8(6-11), p&lt;0.001)].There was no significant difference in primary outcome at 5 years in Cox multivariable regression analysis (HR:1.21, 95% CI 0.81-1.82, p 0.33) (Figure 2). There were no significant differences in other clinical endpoints at 5 years, although patients with SEV had lower echocardiographic gradients and higher indexed effective orifice area. (Figure 2-3) Conclusion: Post-TAVR invasive aortic valve gradients were similar between BEV and SEV, despite higher echocardiographic transaortic gradients in BEV patients. We found no significant difference in 5-year clinical outcomes between patients who received TAVR with BEV or SEV.

Abstract 4135286: Comparative Efficacy of Intracardiac and Transesophageal Echocardiography in Left Atrial Appendage Occlusion: A Meta-Analysis of Clinical Outcomes

Background: Left atrial appendage occlusion (LAAO) is essential for stroke prevention in patients with non-valvular atrial fibrillation where anticoagulation is contraindicated. Intracardiac Echocardiography (ICE) has been proven effective and safe for LAAO since 2011, yet adoption rates remain low, with only 2.2% of LAAOs guided by ICE between 2015 and 2019. Transesophageal Echocardiography (TEE), the current gold standard, and ICE differ significantly in operational dynamics and patient impacts, influencing procedural outcomes. Objective: This study aims to compare the efficacy and safety of ICE and TEE in facilitating LAAO, offering insights into their comparative clinical use. Methods: A systematic review and meta-analysis were conducted according to PRISMA guidelines. Searches were performed in MEDLINE/PubMed, OVID, and Scopus through December 2023, comparing ICE and TEE in LAAO. Inclusion criteria centered on studies reporting technical success, with secondary outcomes including length of stay (LOS), mortality, and adverse outcomes such as stroke, transient ischemic attacks (TIA), pericardial effusion, cardiac tamponade, device thrombosis, device embolization, and peri-device leaks. Data synthesis employed statistical methods utilizing R Studio. Results: Fourteen studies involving 4184 patients were included. The meta-analysis revealed no significant differences in technical success (OR 1.34, 95% CI: [0.76, 2.36]), LOS (OR 1.66, 95% CI: [0.80, 3.42]), or mortality (OR = 1.00, 95% CI: [0.50, 2.00]) between ICE and TEE. Similarly, non-significant differences were noted in stroke, TIA, pericardial effusion, and device leaks, with minimal heterogeneity (I 2 = 0%). Conclusion: ICE and TEE provide comparable clinical outcomes in LAAO, with no significant efficacy or safety differences. These results suggest that the choice between ICE and TEE should be based on procedural convenience, patient anatomy, and resource availability, rather than clinical outcomes alone. The equivalence in performance between these modalities allows for flexibility in clinical practice, ensuring that patient care can be customized to individual needs without compromising safety or effectiveness.