Two-year Outcomes Research Articles

Two-Year Outcomes of Primary Prophylactic Use of Defibrillators for Ischemic and Non-Ischemic Cardiomyopathy - Propensity Score-Matched Analysis From the Nippon Storm Study.

In 2016, the DANISH study reported negative results regarding the efficacy of implantable cardioverter-defibrillators (ICDs) in patients with non-ischemic cardiomyopathy (NICM) and reduced left ventricular ejection fraction (LVEF). In this study we determined the efficacy of using ICDs for primary prophylaxis in patients with NICM.Methods and Results: We selected 1,274 patients with underlying cardiac disease who were enrolled in the Nippon Storm Study. We analyzed the data of 451 patients with LVEF ≤35% due to NICM or ischemic cardiomyopathy (ICM) who underwent ICD implantation for primary prophylaxis (men, 78%; age, 65±12 years; LVEF, 25±6.4%; cardiac resynchronization therapy, 73%; ICM, 33%). After propensity score matching, we compared the baseline covariates between groups: NICM (132 patients) and ICM (132 patients). The 2-year appropriate ICD therapy risks were 27.7% and 12.2% in the NICM and ICM groups, respectively (hazard ratio, 0.390 [95% confidence interval, 0.218-0.701]; P=0.002). This subanalysis of propensity score-matched patients from the Nippon Storm Study revealed that the risk of appropriate ICD therapy was significantly higher in patients with NICM than in those with ICM.

Two-Year Follow-up Outcomes of Non-lesional Epilepsy Surgery in Iran

Background: Despite treatment with anti-epileptic drugs, 30% of epileptic patients continue to experience seizures, making surgery a viable option. Surgery has shown efficacy even in non-lesional epileptic individuals, although there is limited research on this topic. Objectives: This study aimed to investigate surgical outcomes in individuals with drug-resistant epilepsy (DRE) who undergo surgery despite having non-lesional magnetic resonance imaging (MRI) findings. Methods: This observational longitudinal study was conducted between 2017 and 2020 at a referral hospital in Tehran, Iran. Using census sampling, we screened 750 epilepsy cases and enrolled 80 patients (42 women and 38 men) with DRE and non-lesional MRI findings who underwent epilepsy surgery. We collected patients' demographics and seizure characteristics. A 2-year follow-up was conducted to assess the seizure freedom rate. We compared seizure-free and non-seizure-free patients who underwent temporal epilepsy surgery, extratemporal epilepsy surgery, corpus callosotomy, and Vagus nerve stimulation (VNS) using chi-square, Fisher exact, and binary logistic regression tests. Results: The seizure freedom rate was 62.7% for temporal surgery, 83.33% for extratemporal surgery, 26.66% for corpus callosotomy, and none for patients who underwent VNS. There was no difference between seizure-free and non-seizure-free patients in terms of their baseline characteristics, seizure semiology, lesion features, and post-operative findings (P-values > 0.05), except that patients without a history of febrile convulsions tended to experience more seizure freedom after extratemporal surgery (P = 0.007). Additionally, older patients tended to experience more seizure freedom after temporal surgery (P = 0.03). Conclusions: This study underscores the potential benefits of epilepsy surgery in non-lesional DRE patients. Further research is needed to establish criteria for patient selection in this context.

DETERMINATION OF FEED QUALITY CHARACTERISTICS OF SOME SILAGE MAIZE (Zea mays L.) HYBRIDS CULTIVATED IN EASTERN MEDITERRANEAN CONDITIONS

The research was carried out in Kahramanmaras Eastern Mediterranean Transition Zone Agricultural Research Institute (DAGTEM) in the main crop growing season of 2019 and 2020, in a randomized blocks trial design with three replications to determine the silage quality characteristics of 20 different silage maize hybrids (Macha, Ranger, Simon, AS160, Dracma, DS0224, DKC6442, Colonia, Inove, Antex, Everest, Torro, 73may81, Kilowaatt, Klips, PR31Y43, 30B74, DKC7240, C955, and Gladius). The study showed that silage quality varied significantly for maize hybrids and the region's climatic conditions in different years. According to the two-year average results, the dry matter content (T60), dry matter recovery, crude protein content, crude ash content, starch content, NDF content, ADF content, and ADL content were between 28.43-32.59%, 90.11-97.69%, 6.01-7.44%, 4.93-7.52%, 18.88-27.04%, 44.28-54.69%, 23.85-30.30%, and 2.00-3.62%, respectively, and C955, Everest, and PR31Y43 were the hybrids that potential silage nutritional value of them was prominent.

Two-Year Results of a Five-Year Personalized Integrative Obesity Coaching Program (IBO) Based upon a Systems Health Perspective and an Evolutionary Longitudinal Study Approach.

This study presents the outcomes of a 5-year personalized integrative coaching program for adults with obesity (body mass index BMI ≥ 30 kg/m2), based upon a systems health perspective, during the first 2 years. This longitudinal study, which had an evolutionary design, included all adults who enrolled in the program. Health-related quality of life (HRQoL) was measured with the Short Form-36 (SF-36), and physical outcomes included weight, waist circumference, aerobic capacity, lipid profile, and HbA1c. Subsequently, participants completed questionnaires (e.g., the Symptom Checlist-90 (SCL-90) and the Checklist Individual Strength (CIS)). Seventy-nine adults with a mean BMI of 39.5 kg/m2 (SD 5.3) were included. Forty-four participants completed 2 years in the program. Compared to baseline, there were significant improvements in the SF-36 subscales 'physical functioning' (MD 9.9 points, 95% CI: 2.1-17.5, p = 0.013) and 'general health perceptions' (MD 9.3 points, 95% CI 2.9-15.7, p = 0.006). Furthermore, significant improvements in physical outcomes and psychosocial questionnaires (e.g., weight loss (MD 3.5 kg, 95% CI: 1.2-5.7, p = 0.003), waist circumference (MD 5.1 cm, 95% CI: 2.4-7.8, p < 0.001), and CIS fatigue (MD 6.8, 95% CI: 3.1-10.5, p = 0.001) were observed. This study highlights the importance of a systems health perspective supporting the development of a personalized integrative coaching program for adults with obesity in a 'real-world' setting.

Two-year outcomes of internal fixation with femoral neck system in patients with femoral neck fracture in an Asian population

BackgroundFemoral neck fractures (FNF) are one of the most common fractures, with a projected increase in incidence with population growth and ageing. The Femoral Neck System (FNS) launched in 2019 was developed specifically for fixation of FNF with the purported advantages of providing both angular and rotational stability. We report our experience with the FNS and evaluate its effectiveness and associated complications. MethodsA retrospective case series of 50 patients who underwent surgical fixation for FNF from August 2020 to October 2021 using the FNS in two Singapore tertiary institutions with at least 2 years follow-up were included. Clinical data (patients’ demographics, fracture classification, intra-operative and post-operative complications) were reviewed. Radiological analysis assessed the pre- and immediate post-operative garden alignment index (GAI) and presence of femoral neck shortening at 3 months. ResultsThe mean age was 63.5 years (SD 16.9, range 26–92). Five (10 %), 34 (68 %) and 11 (22 %) were ASA 1, 2 and 3 respectively. Twenty-four (48 %), 16 (32 %), 4 (8 %), and 6 (12 %) patients sustained Garden's 1, 2, 3 and 4 FNF respectively. The mean operative duration was 66.2 min (SD 20.5) and length of stay was 6.9 days (SD 4.6).The post-operative improvement in garden alignment index (GAI) was a mean of 9.1° (p < 0.001) on lateral view. The mean femoral neck shortening was 1.97 mm (SD 5.3) at 3 months. There were no intra-operative complications. Post-operatively, 1 (2 %) patient required blood transfusion, 1 (2 %) patient had implant cut-out and non-union managed non-operatively, 2 (4 %) patients developed avascular necrosis and required revision to total hip replacements. There were two (4 %) cases of 1-year mortality. ConclusionThe FNS achieved good outcomes with low rates of complications. The promising results justify its continued use and further evaluation in comparison to other devices.

An Effective Treatment for Progressive Keratoconus with Two-Year Outcomes: Accelerated Epithelium-on Corneal Cross-Linking

Purpose: Corneal collagen cross-linking is a surgical technique for progressive keratoconus. There are several technical modifications with varying clinical outcomes. This study aimed to evaluate the long-term outcomes of the accelerated epithelium-on collagen cross-linking. Design &amp; Methods: A retrospective study was performed on progressive keratoconus patients treated via the accelerated epithelium-on collagen cross-linking who completed the 24th-month follow-up. We included 111 eyes of 77 patients. Clinical variables, including visual acuity, aberrometry, topographic measurements, and refractive outcomes, were evaluated at the postoperative 12th and 24th months. Results: There was a significant improvement in postoperative visual acuity in 50.4% of the patients (p

Multi-Center Two-Year Patency Outcomes of Endovascular Arteriovenous Fistulas (endoAVF) Created with a 4 French System.

To assess multicenter two-year patency outcomes of endovascular arteriovenous fistulas (endoAVF) created with the WavelinQ device. Patients who had fistulas created at three centers from January 2018 to December 2020 were included in this retrospective study. In total, 112 patients underwent endoAVF creation [40 females, 72 males; mean age 60years (range 18-88)]. Data collected included patient demographics, location of fistula creation, interventions performed, and brachial artery flows pre- and post-creation. Two-year cumulative patency, functional patency, and primary patency were assessed with Kaplan-Meier methodology. Factors affecting patency and maturation were examined using the Cox proportional hazards model. Technical success defined as angiographically successful endoAVF creation was 97.3% (109/112). In 11 patients the fistula did not mature for dialysis use. For 98 patients (87%) with endoAVF maturation, 12- and 24-month cumulative patency was 94.3% and 91.7%. Functional patency (two-needle cannulation) at 12 and 24months was 95.7% and 92.7%, respectively. Median maturation time is 95days (IQR 51-231days). Male gender and brachial vein coiling at the time of endoAVF creation were predictive of maturation. There were 34 censored events (four patients undergoing renal transplantation; 30 patients deceased). Number of reinterventions per patient year was 0.73 where 43 were maturation procedures and 101 were maintenance procedures. One Grade 3 complication occurred of arterial access puncture site pseudoaneurysm. A high two-year functional and cumulative patency following endoAVF creation with the WavelinQ device was observed in this multicenter real-world experience Level of Evidence: 3 Level of Evidence III.

Two-Year Clinical Outcomes of Staged Transcatheter Mitral Edge-to-Edge Repair After Transcatheter Aortic Valve Replacement

Residual significant mitral regurgitation (MR) can increase the risk of adverse events following transcatheter aortic valve replacement (TAVR). The clinical benefits of staged transcatheter edge-to-edge repair (TEER) post-TAVR remain underexplored. This study aimed to investigate the clinical outcomes of staged TEER for residual significant MR post-TAVR. This observational study included 314 consecutive patients with chronic residual grade 3+ or 4+ MR at 30 days follow-up post-TAVR, with 104 (33.1%) treated with staged TEER (TEER group) and 210 (66.9%) with medical therapy alone (MT group). The primary composite outcomes were all-cause mortality and heart failure (HF) hospitalization at 2 years. Additional analysis, including changes in MR grade and the New York Association (NYHA) functional classification, and subgroup outcome comparisons based on MR etiology were also conducted. In our study, the rate of primary composite outcome was lower in the TEER group than in the MT group (33.7% vs. 48.1%, p = 0.015). Significant improvement in MR grade and NYHA class was observed in the TEER group after 2 years. Subgroup analysis demonstrated that, among patients with degenerative MR, a lower incidence of composite outcome and HF hospitalization was observed in the TEER group (hazard ratio: 0.35; 95% confidence interval: 0.23–0.53, p < 0.001).In conclusion, staged TEER post-TAVR was associated with reduced MR and improved clinical outcomes. The clinical significance of MR post-TAVR should be carefully evaluated, and TEER should be considered for patients with significant residual MR, particularly those with degenerative MR.

TWO- TO FIVE-YEAR OUTCOMES OF 503 FIXED-BEARING ANKLE ARTHROPLASTIES

IntroductionThis is a multi-centre, prospective, observational study of 503 INFINITY fixed bearing total ankle arthroplasties. We report the minimum two-year results of this prosthesis which was introduced to the UK Market in 2014 and is now the most used ankle arthroplasty in the National Joint Registry of England and Wales.MethodsPatients were recruited from 11 centres in the United Kingdom between June 2016 and November 2019. Demographic, radiographic, and functional outcome data (Ankle Osteoarthritis Scale, Manchester Oxford Foot Ankle Questionnaire and Euroquol 5D-5L) were collected preoperatively, at 6 months, 1 year and 2 years and 5 years. The average age was 67.8 (range 23.9 to 88.5) and average BMI 29.3 (18.9 to 48.0). The COFAS grading system was used to stratify deformity. There were 261 (51.9%) COFAS Type 1, 122 (24.2%) COFAS Type 2, 31 (6.2%) COFAS 3 and 89 (17.7%) COFAS type 4. 38 patients (7.6%) presented with inflammatory arthritis. 99 (19.7%) implantations utilised patient specific instrumentation. Complications and reoperations were recorded as adverse events. Radiographs were assessed for lucencies, cysts and/or subsidence.ResultsThe mean follow up was 34.2 months (range 24–64). 15 patients have died, 8 withdrawn and 3 lost to follow up. 8 implants (1.6%) have been revised. According to the Glazebrook classification there were low grade complications in 6.6%, medium grade in 1.4% and high grade in 1.6%. There have been an additional 13 non revision re-operations (2.6%) at the latest follow up. There was a significant (p &lt; 0.01) improvement across all functional outcome scores at a minimum of 2yr follow up.Discussion and conclusionThis large cohort has shown a low early revision rate and high functional outcomes with a low-profile fixed bearing prosthesis.

Two-year outcomes of radiofrequency device treatment of the nasal valve for nasal airway obstruction.

Temperature-controlled radiofrequency (TCRF) device treatment of nasal valve dysfunction (NVD) was superior to a sham procedure control in reducing the symptoms of nasal airway obstruction (NAO) in this randomised controlled trial (RCT). Two-year outcomes for 108 patients actively treated in a prospective, multicenter, patient-blinded RCT were used to determine treatment effect durability and changes in medication/nasal dilator usage. A responder was defined as ≥ 20 reduction in NOSE score or 1 reduction in severity class. The mean (SD) age of patients was 48.5 (12.3) years; 66 (61.1%) women. Baseline NOSE score was 76.3. The 2-year responder rate was 90.4% and NOSE score treatment effect was -41.7; 54.7% improvement. Of 57 patients using medications/nasal dilators at baseline, 45 (78.9%) either stopped all use (33.3%) or stopped/decreased (45.6%) use in >=1 class at 2 years. Concurrent septal deviation, septal swell body, or turbinate enlargement did not significantly affect the odds of exhibiting a NOSE score of ≤ 25 at 2 years. TCRF device treatment of NVD resulted in significant and sustained improvements in the symptoms of NAO at 2 years, accompanied by a substantial reduction in medication/nasal dilator use.

Two-Year Outcomes of Daily and Twice-Weekly Teriparatide Treatment in Postmenopausal Women with Severe Osteoporosis: A Randomized Non-Blinded Prospective Study.

The long-term effects of daily teriparatide (D-TPTD) and twice-weekly TPTD (W-TPTD) injections are compared among postmenopausal women with severe osteoporosis. A total of 102 patients were enrolled and randomly allocated into two groups for the administration of either D-TPTD or W-TPTD. Treatment efficacy was measured as the percentage change in bone mineral density (ΔBMD) from baseline in the lumbar spine, total hip, and femoral neck. The findings were compared between the two groups. At 24 months after treatment, the persistence rates and medication possession ratios in the D-TPTD and W-TPTD groups were 68.6% and 56.9%, and 87.8% and 92.0%, respectively. The ΔBMD in the lumbar spine, total hip, and femoral neck were 15.6%±10.2%, 5.3%± 6.3%, and 5.5%±6.2%, respectively, in the D-TPTD group; and 9.5%±7.9%, 2.3%±6.2%, and 3.1%±7.4%, respectively, in the W-TPTD group following 24 months of treatment. The ΔBMD of the lumbar spine (p=0.008) at 24 months and total hip (p=0.024) at 18 months differed significantly between the two groups. D-TPTD administration resulted in a significantly higher BMD in the lumbar spine and total hip, supporting this therapeutic regimen for postmenopausal women with severe osteoporosis.

Two-year Outcome of Intravitreal Anti-vascular Endothelial Growth Factor Therapy for Polypoidal Choroidal Vasculopathy

Two-year Outcome of Intravitreal Anti-vascular Endothelial Growth Factor Therapy for Polypoidal Choroidal Vasculopathy

Two-Year Results of Sleeve Gastrectomy Combined with Posterior Fundoplication for Obesity Patients with Gastroesophageal Reflux Disease.

Currently, gastroesophageal reflux disease (GERD) is the main side effect after sleeve gastrectomy (SG), causing discomfort and potential long-term risks. Surgical techniques combining fundoplication with SG are being evaluated to limit postoperative GERD. This single-center retrospective study evaluated patients who underwent SG with posterior fundoplication in the context of GERD between 2018 and 2021, with postoperative follow-up up to 24 months. The results were compared to a control group (ratio 1 to 4) who had SG without fundoplication. Observed total weight loss (TWL) was compared to predicted TWL using the Sophia multinational study's machine learning-based calculator. The series included 22 patients (mean body mass index 44.4 kg/m2) with GERD conditions: GERD symptoms (n = 15), hiatal hernia (n = 6), esophagitis (n = 7), and Barrett's esophagus (n = 5). Two patients required reoperation, including one for valve perforation. At 2 years, GERD was present in three patients (13.6%), including two who regularly took proton pump inhibitors. Compared to the control group (n=88), the frequency of GERD persisting at 2 years was significantly reduced in the SG with fundoplication group (p=0.05). The TWL at 12 and 24 months was 27.7% and 26.1%, respectively, with no significant difference compared to the weight predicted by the model, nor compared to the control group. The combination of posterior fundoplication with SG can be proposed in patients with GERD who have a contraindication to Roux-en-Y gastric bypass. Specific morbidity may exist at the beginning of the experience.

Marginal Ulcer Perforation after One Anastomosis Gastric Bypass: Surgical Treatment and Two-Year Outcomes.

Background: Marginal ulcer (MU) perforation is a chronic complication after One-anastomosis Gastric Bypass (OAGB). This study's purpose was to analyze patients undergoing OAGB revision due to MU perforation and describe the two-year outcomes. Methods: A retrospective analysis of a database in a single-tertiary hospital. All patients undergoing surgical revision due to MU perforation were included. Results: During the study period, 22 patients underwent OAGB revision due to MU perforation. The rate of MU perforation was 0.98%. The median age was 48 years and there were 13 men (59%). The median time from OAGB to MU perforation was 19 months with a median total weight loss of 31.5%. Nine patients (41%) were smokers. Omental patch (±primary closure) was performed in 19 patients (86%) and three patients (14%) underwent conversion to Roux-en-Y gastric bypass (RYGB). At a median follow-up of 48 months, three patients (14%) had recurrent MU diagnosis, of which one had a recurrent MU perforation. Four patients (18%) underwent conversion to RYGB during follow-up. Conclusions: MU perforation is a chronic complication after OAGB. In this cohort, most patients were men and likely to be smokers. Omental patch was effective in most cases. Recurrent MU rates at two years follow-up were acceptable.

Two-year outcomes of Xen 45 gel stent implantation in patients with open-angle glaucoma: real-world data from the Fight Glaucoma Blindness registry

ObjectiveTo evaluate efficacy and safety outcomes of the Xen 45 gel stent implant over 24 months of follow-up.MethodsA retrospective analysis of prospectively collected data from the Fight Glaucoma Blindness observational...

#367 PROTECT and NefIgArd two-year proteinuria and eGFR outcomes in adults with IgA nephropathy: matching-adjusted indirect comparison

Abstract Background and Aims Immunoglobulin A (IgA) nephropathy is a rare kidney disorder characterized by deposition of IgA in the glomeruli causing progressive loss of kidney function and increased risk of kidney failure. In the absence of a head-to-head trial, this study used unanchored matching-adjusted indirect comparison (MAIC) of clinical trial data to compare two-year efficacy outcomes between Sparsentan in PROTECT and targeted-release formulation (TRF) budesonide plus real-world optimized and stable renin-angiotensin system inhibition (RASi) standard-of-care (SoC) in NefIgArd. Method We conducted an unanchored MAIC using individual patient level data from the PROTECT trial and aggregate data from the NefIgArd trial. Patients in the sparsentan arm of PROTECT were weighted to match key baseline characteristics of patients in the targeted-release formulation (TRF) budesonide + RASi SoC arm of NefIgArd based on publicly accessible, clinically pertinent baseline characteristics and prognostic factors using the method of moments. After weighting, percentage reduction of urine protein-creatinine ratio (UPCR) relative to baseline and two-year eGFR total slope (based on available data, chronic slope estimates are currently not available from NefIgArd) were estimated. A mixed model for repeated measures (MMRM) was used for UPCR relative percentage reduction and a random effect coefficient model for eGFR total slope. A two-tailed z-test with a pooled standard error was conducted for the indirect comparison. Results After assessing PROTECT and NefIgArd cross-trial characteristics on key outcome definitions, inclusion and exclusion criteria, and patient population, the two trials were considered sufficiently similar for unanchored MAIC. After weighting individual patient data from PROTECT, all matched baseline patient characteristics were well-balanced between arms of the two trials. Comparative results showed patients treated with sparsentan in PROTECT (−43.2% relative reduction in UPCR) exhibited a greater mean percentage reduction in proteinuria at two-years compared to TRF budesonide + RASi SoC (−30.7% relative reduction in UPCR), a relative percentage reduction of 18.1% (p = 0.03; Fig. 1A). For eGFR total slope, patients treated with sparsentan exhibited a slower decline in kidney function compared to TRF budesonide + RASi SoC, a difference of 0.54 ml/min/1.73 m2 per year; however, this difference was not statistically significant (p = 0.35; Fig. 1B). Conclusion Aligned to an earlier analysis of percentage reduction in proteinuria at 9-months (−37%, p &amp;lt; 0.0001 favoring sparsentan), our MAIC results show that sparsentan in PROTECT was associated with a greater relative percentage reduction in proteinuria at two-years compared to TRF budesonide plus real-world optimized and stable RASi SoC in NefIgArd. eGFR total slope for sparsentan in PROTECT was comparable to that reported for TRF budesonide plus real-world optimized and stable RASi SoC in NefIgArd. Results comparing chronic slope may provide a better indication of the long-term nephroprotective value of both therapies.

#368 Matching-Adjusted Indirect Comparisons of eGFR slopes in the PROTECT study with UK RaDaR IgA nephropathy population and the control arm of NefIgArd

Abstract Background and Aims Immunoglobulin A nephropathy (IgAN) is a rare kidney disorder characterized by deposition of IgA in the glomeruli leading to an increased risk of kidney failure. The PROTECT clinical trial in IgAN was designed to determine the long-term (approximately 2 year) nephroprotective potential of treatment with sparsentan compared to a blinded active control angiotensin receptor blocker (ARB) irbesartan, titrated to the maximum labelled dose after randomization (achieved in 97% of patients). To understand PROTECT clinical trial results relative to delivery of standard of care (SoC) treatment for IgAN in other clinical settings, this study compared two-year eGFR total slope outcomes between the two arms of PROTECT and delivery of SoC in two populations applying similar eligibility criteria: Method Using individual patient data (IPD) from PROTECT, unanchored matching-adjusted indirect comparisons (MAICs) were performed. Patients in both arms of PROTECT were weighted to match key baseline characteristics of the two comparator populations. Matching was based on published clinical characteristics using the method of moments. After weighting, two-year eGFR total slopes were calculated using random coefficients models. Two-tailed z-tests with pooled standard errors were used for indirect comparison. Results Based on assessment of cross-data source characteristics, populations were found to be sufficiently comparable for unanchored MAIC. After weighting IPD from PROTECT, all matched baseline patient characteristics were well-balanced between data sources. Comparative results showed that patients treated with maximally titrated irbesartan or sparsentan in PROTECT exhibited a slower decline in kidney function compared to SoC delivered in a real-world setting (RaDaR), with differences of: Similar results were observed compared to SoC delivered in a clinical trial (NefIgArd), with differences of: Conclusion Both “maximally tolerated dose of ARB” (as recommended in the KDIGO guideline for IgAN) using irbesartan in PROTECT and sparsentan were associated with significantly slower decline in kidney function compared to real-world SoC treatment for IgAN (RaDaR) and delivery of physician defined, optimized SoC (&amp; placebo) in the context of a clinical trial (NefIgArd). 2-year eGFR slope differences between clinical trials in IgAN need to be considered in the context of what is achieved in current clinical practice. With existing real-world and emerging clinical trial data in IgAN, MAIC is an approach that can be applied to compare outcomes between relevant, sufficiently aligned data sources.

Two-year safety outcomes of iPS cell-derived mesenchymal stromal cells in acute steroid-resistant graft-versus-host disease

The first completed clinical trial of induced pluripotent stem cell (iPS cell)-derived cells was conducted in 15 participants with steroid-resistant acute graft-versus-host disease. After intravenous infusion of mesenchymal stromal cells (CYP-001 derived from a clone of human iPS cells), we reported the safety, tolerability and efficacy within the primary evaluation period at day 100. We now report results at the 2-year follow-up: 9 of 15 (60%) participants survived, which compares favorably with previously reported outcomes in studies of steroid-resistant acute graft-versus-host disease. Causes of death were complications commonly observed in recipients of allogeneic hematopoietic stem cell transplantation, and not considered by the investigators to be related to CYP-001 treatment. There were no serious adverse events, tumors or other safety concerns related to CYP-001. In conclusion, systemic delivery of iPS cell-derived cells was safe and well tolerated over 2 years of follow-up, with sustained outcomes up to 2 years after the first infusion. ClinicalTrials.gov registration: NCT02923375.

Two-Year Results of Ceramic-on-Ceramic Hip Resurfacing in an International Multicenter Cohort

BackgroundHip resurfacing arthroplasty (HRA) is a bone-conserving alternative to total hip arthroplasty. We present the 2-year clinical and radiographic follow-up of a novel ceramic-on-ceramic HRA in an international multicenter cohort. MethodsPatients undergoing HRA between September 2018 and January 2021 were prospectively included. Patient-reported outcome measures (PROMs) in the form of the Forgotten Joint Score, Hip Disability and Osteoarthritis Outcome Score Jr., Western Ontario and McMaster Universities Arthritis Index, Oxford Hip Score, and University of California, Los Angeles, Activity Score were collected preoperatively, and at 1 and 2 years postoperation. Serial radiographs were assessed for migration, component alignment, evidence of osteolysis or loosening, and heterotopic ossification formation. ResultsThe study identified 200 patients who reached a minimum 2-year follow-up (mean 3.5 years). Of these, 185 completed PROMs follow-up at 2 years. There was a significant improvement in Hip Disability and Osteoarthritis Outcome Score (P < .001) and Oxford Hip Score (P < .001) between the preoperative, 1-year, and 2-year outcomes. Patients had improved activity scores on the University of California, Los Angeles, Active Score (P < .001), with 45% reporting a return to high-impact activity at 2 years. At 1 and 2 years, the Forgotten Joint Score was not significantly different (P = .38). There was no migration, osteolysis, or loosening of any of the implants. No fractures were reported over the 2-year follow-up, with only 1 patient reporting a sciatic nerve palsy. There were 2 revisions, 1 for unexplained pain at 3 months due to acetabular component malposition and 1 at 33.5 months for acetabular implant failure. ConclusionsThe ceramic-on-ceramic resurfacing at 2 years postoperation demonstrates promising results with satisfactory outcomes in all recorded PROMs. Further long-term data are needed to support the widespread adoption of this prosthesis as an alternative to other HRA bearings.

Two-Year Outcomes for Patients with Non-ST-Elevation Acute Coronary Syndrome Treated with Magmaris and Absorb Bioresorbable Scaffolds in Large-Vessel Lesions.

The acute coronary syndrome (ACS) continues to be a fundamental indication for revascularization by percutaneous coronary intervention (PCI). Drug-eluting stent (DES) implantation remains a part of contemporary practice but permanent caging of the vascular structure with the metallic stent structure may increase the rate of device-related adverse clinical events. As an alternative to classic metallic DESs, the bioresorbable scaffolds (BRSs) have emerged as a temporary vascular support technology. We evaluated the mid-term outcomes of two generations of bioresorbable scaffolds-Absorb (Abbott-Vascular, Chicago, IL, USA) and Magmaris (Biotronik, Germany)-in patients with non-ST-elevation ACS. The study cohort consisted of 193 subjects after Magmaris implantation and 160 patients following Absorb implantation in large-vessel lesions. At 2 years, a significantly lower rate of a primary outcome (cardiac death, myocardial infarction, stent thrombosis) was observed with Magmaris (5.2% vs. 15%; p = 0.002). In addition, we observed a significantly lower rate of MI in the target vessel (2.6% vs. 9.4%; p = 0.009) and a lower rate of scaffold thrombosis (0% vs. 3.7%; p = 0.008). The TLF rate between the two groups was not significantly different. Magmaris demonstrated a good safety profile and more favorable clinical outcomes when compared to Absorb in patients with non-ST-elevation ACS.