Rate Of Treatment-related Complications Research Articles

Treatment outcomes and the role of the DES scheme in the appropriate treatment selection for high-grade dural arteriovenous fistulas.

Endovascular and microsurgical treatment are viable options for the majority of Borden type III dural arteriovenous fistulas (dAVFs). The aim of this study was to examine treatment outcomes in a comparative analysis of endovascular and surgical treatment modalities for Borden type III fistulas and explore clinical implications of the DES scheme in selecting ideal candidates for surgical therapy. Patients diagnosed with dAVFs with leptomeningeal venous drainage admitted to the Departments of Neurosurgery or Neuroradiology of the University Hospital Zurich between January 2014 and October 2021 were included in this study. Comprehensive patient data including demographics, clinical presentation, and dAVF characteristics, including established classifications, were collected. Treatment outcomes were assessed based on postinterventional angiography findings. In addition, treatment-related complications were assessed based on the Clavien-Dindo classification. Among all Borden type III dAVFs, 15 were initially treated endovascularly (60% complete occlusion rate) and 10 with microsurgical disconnection (90% complete occlusion rate) (p = 0.18). Subgroup analysis of dAVFs meeting the criteria for directness and exclusivity based on the DES scheme showed a 100% complete occlusion rate after microsurgical disconnection, whereas embolization achieved a complete occlusion rate of 60% (p = 0.06). There was no significant difference in the rate or severity of treatment-related complications between treatment modalities. This study suggests that microsurgical disconnection is a viable primary treatment modality for Borden type III dAVFs, particularly for dAVFs that meet the criteria of directness and exclusivity according to the DES scheme. The DES scheme demonstrates its relevance in selecting the most appropriate treatment strategy for affected patients.

Megaprosthetic replacement in complex distal humerus fractures in elderly patients: a case series

BackgroundManaging distal humeral fractures can be challenging for orthopedic surgeons. There are several treatment options for managing this type of fracture, and the treatment method for these fractures should be based on patient-related factors. In elderly patients with osteoporotic bone and severe comminution of the fracture, adequate fixation can be a major challenge for surgeons. The use of megaprosthesis has been recently proposed in traumatology as an alternative to osteosynthesis or conventional prosthesis for the management of comminuted articular fractures in elderly patients with poor bone stock.MethodsA consecutive case series of 5 patients who underwent reconstruction of the elbow joint with a trabecular hinged modular elbow megaprosthesis was reviewed retrospectively. All patients included had AO/OTA 13C2 and 13C3 fractures with metaphyseal extension and considerable bone loss of the distal humerus. The primary outcome was the evaluation of functional and clinical outcomes with the MEPS score in comminuted distal humerus fractures with metaphyseal extension and poor bone stock in elderly patients treated with elbow megaprosthesis. The secondary outcome was assessing the treatment-related complication rate of this technique in non-oncological fields.ResultsFive patients were included in the study with a mean age of 82.66 ± 7.72 years at surgery. The mean MEPS value was 63 ± 24.2 at 1 month, 81 ± 23.53 at 3 months, 83 ± 24.2 at 6 months, and 84 ± 24.57 at 12 months. No intraoperative complications were recorded in our series. Of 5 patients, four patients had excellent clinical and functional outcomes. We did not encounter wound dehiscence, prosthetic joint infection, aseptic loosening, or periprosthetic fractures.ConclusionsThe indication for this type of treatment must be selected and narrowed down, as it is a salvage procedure, and any failure would cause even more complex situations. Short operating times and early mobilization of the elbow are the advantages of this technique.

Endoscopic resection of early gastric cancer

Endoscopic resection (ER) is an effective treatment for early gastric cancer (EGC) without metastases. Existing endoscopic mucosal resec-tion (EMR) is easy to perform, has few complications, and can be ap-plied when the lesion size is small. However, <i>en bloc</i> and complete re-section rates vary depending on the size and severity of the lesion. EMR using the cap-mounted panendoscopic method and EMR after circum-ferential preamputation of the lesion are useful in the treatment of EGC. However, completely oversized lesions (≥2 cm) and lesions associated with ulcers or submucosal fibrosis are more likely to fail resection. En-doscopic submucosal dissection has been widely used to resect tu-mors larger than 2 cm in diameter and has a higher acceptable compli-cation rate and <i>en bloc</i> and complete resection rates than EMR. ER for EGC is superior to surgical resection in terms of improving patient quali-ty of life. Additionally, compared to surgery, emergency rooms have a lower rate of treatment-related complications, shorter hospital stays, and lower costs. Accordingly, the indications for ER are expanding in the field of therapeutic endoscopy. Long-term outcomes regarding re-currence are excellent in both absolute and extended criteria for ER in EGC. Close surveillance should be performed after ER to detect early metachronous gastric cancer and precancerous lesions that can be treated with ER. Follow-up gastroscopy and abdominopelvic computed tomography scans every 6 to 12 months are recommended for patients who undergo curative ER for EGC on absolute or extended criteria.

Early clinical experience with the new generation Pipeline Vantage flow diverter in the treatment of unruptured saccular aneurysms using short-term dual antiplatelet therapy.

The Pipeline Vantage flow diverter with Shield technology (PV) used in this study is a 4th-generation flow diverter (FD) designed to reduce thrombogenicity, promote endothelialization of the implant and increase efficiency in achieving aneurysm closure. In this study, we report the aneurysm occlusion rate, complication rate and clinical outcome with short-term dual antiplatelet therapy (DAPT) in the treatment of unruptured intracranial saccular aneurysms using the PV. We retrospectively identified patients treated between September 2021 and January 2023 with the PV and subsequently underwent short-term DAPT for 3 months. Patient and aneurysm characteristics, peri- and post-procedural complications, clinical outcomes and the grade of aneurysm occlusion were documented. Thirty patients with 32 aneurysms were treated. Successful FD implantation was achieved in all cases (100%). No periprocedural complications were documented. The overall symptomatic complication rate was 10% and the neurologic, treatment-related symptomatic complication rate was 6.6%. Only one symptomatic complication (3.3%) was device-related. Permanent clinical deterioration occurred in 2/30 patients (6.6%), leading to deterioration of the mRS within the first 3 months after treatment. No mortality was documented. The rate of complete aneurysm occlusion after 3 months and after a mean imaging follow-up of 9.9 months was 65.6% and 75%, respectively. Implantation of the PV for the treatment of saccular intracranial aneurysms achieves a good aneurysm occlusion rate with a low rate of complications. In addition, the use of short-term DAPT after PV implantation appears to be safe.

Tympanomastoidectomy versus parenteral antibiotic therapy for pediatric otorrhea

ObjectiveTo evaluate the efficacy of tympanomastoidectomy versus parenteral antibiotic therapy for otorrhea as a result of chronic suppurative otitis media (CSOM) without cholesteatoma in the pediatric population. MethodsA retrospective review of 221 patients treated for otorrhea at a tertiary academic pediatric hospital was performed to evaluate the impact of tympanomastoidectomy versus parenteral antibiotic therapy on resolution of otorrhea. Inclusion criteria were age 0–18 years, prior treatment with otic and/or oral antibiotic, prior history of tympanostomy tube placement for recurrent otitis media, history of otorrhea, treatment with tympanomastoidectomy or parenteral antibiotic therapy, and follow-up of at least 1 month after intervention. Time to resolution was compared between the two modalities adjusting for age, bilateral ear disease status, and comorbidities using a Cox proportional hazard model. ResultsEighty-three ears from 58 children met the inclusion criteria. Ears that initially underwent tympanomastoidectomy had a significantly shorter time to resolution of symptoms (median time to resolution) 9 months (95 % confidence interval CI: 6.2–14.8) vs. 48.5 months (95 % lower CI 9.4, p = 0.006). On multivariate analysis, however, only bilateral ear disease status was independently associated with time to resolution of symptoms (hazard ratio 0.4, 95 % CI 0.2–0.9, p = 0.03). There was no statistically significant difference in the rate of treatment-related complications when comparing tympanomastoidectomy to parenteral antibiotic therapy (p = 0.37). ConclusionWhen adjusting for age, bilateral ear disease status, and comorbidities, there does not appear to be a significant difference in time to resolution of symptoms when comparing parenteral antibiotic therapy to tympanomastoidectomy. An informed discussion regarding risks and benefits of each approach should be employed when deciding on the next step in management for patients with CSOM who have failed more conservative therapies.

Therapeutic Targets in Myelodysplastic Neoplasms: Beyond Hypomethylating Agents.

To discuss novel targeted therapies under investigation for treatment of myelodysplastic neoplasms (MDS). Over the last few years, results of phase 3 trials assessing novel therapies for high-risk MDS have been largely disappointing. Pevonedistat (NEDD-8 inhibitor) and APR-246 (TP53 reactivator) both did not meet trial endpoints. However, early phase trials of BCL-2, TIM3, and CD47 inhibitors have shown exciting data and are currently under phase 3 investigation. Moreover, combination of hypomethylating agents (HMA) with novel therapies targeting the mutational (IDH, FLT3, spliceosome complex) or immune (PD-1/PDL-1, TIM-3, IRAK-4) pathways are being investigated in early phase clinical trials and have shown adequate safety and promising efficacy. Myelodysplastic neoplasms (MDS) are a group of hematopoietic neoplasms defined by cytopenias and morphological dysplasia. They are characterized by clonal proliferation of aberrant hematopoietic stem cells caused by recurrent genetic abnormalities. This leads to ineffective erythropoiesis, peripheral blood cytopenias, abnormal cell maturation, and a high risk of transformation into acute myeloid leukemia (AML). Allogeneic hematopoietic stem cell transplantation is the only curative therapy; however, it is not a suitable option for majority patients due to their age, comorbidities, and the high rate of treatment-related complications. HMAs remain the only FDA-approved treatment option for high-risk MDS. Due to intolerance, primary, and secondary resistance to HMA, there is a large unmet need to develop new safe and effective therapies for patients with MDS. In this review, we focus on the current management strategies and novel therapies in development for treatment of high-risk MDS.

Repeat hepatectomy versus microwave ablation for solitary and small (≤3 cm) recurrent hepatocellular carcinoma with early or late recurrence: A propensity score matched study

BackgroundRepeat hepatectomy (RH) and microwave ablation (MWA) are frequently used procedures for the treatment of recurrent hepatocellular carcinoma (HCC) after curative resection. This study aimed to compare the long-term outcomes of RH and MWA for solitary and small HCC with early or late recurrence. MethodThis retrospective study enrolled patients who underwent RH or MWA for solitary and small (≤3 cm) recurrent HCC at Tongji hospital between April 2006 and December 2020. Propensity score matching (PSM) was further employed to analyze the prognosis of different treatment methods. ResultsA total of 256 patients were analyzed, of whom 94 and 162 underwent RH and MWA, respectively. The overall treatment-related complication rate was higher in the RH group. Both recurrence-free survival (RFS) and overall survival (OS) rates of RH were significantly better than those of MWA. Multivariate analysis showed that MWA, early recurrence (within 24 months after initial resection), cirrhosis, and AFP >400 ng/ml were independent risk factors for poor prognoses of recurrent HCC. The stratified analysis demonstrated that MWA and RH had similar long-term outcomes in patients with early recurrence. Nevertheless, MWA had worse RFS and OS than RH in patients with late recurrence. The same results were obtained in the PSM analysis. ConclusionThe long-term outcomes of HCC patients with late recurrence were significantly better than those with early recurrence. RH should be the first choice for solitary small recurrent HCC patients with late recurrence, while MWA should be selected for those with early recurrence.

Clinical performance of the Femoral Neck System within 1 year in 125 patients with acute femoral neck fractures, a prospective observational case series

IntroductionOsteosynthesis of femoral neck fractures (FNFs) is an important treatment option, especially for younger patients. We aimed to assess the rate of early implant-related complications in FNF osteosynthesis using the Femoral Neck System (FNS).Patients and methodsConsecutive patients diagnosed with displaced or nondisplaced FNFs were treated with FNS in this prospective, observational, multicenter investigation. Patients were followed up for minimally 3 months and up to 12 months if radiologic bone union and no pain was not achieved beforehand. Predefined treatment-related adverse events (AEs, defined as implant failure, loss of reduction, iatrogenic fractures, deep infection, and surgical revision), radiologic bone union, and patient-reported Harris hip score (HHS) and EQ-5D-5L index score were assessed.ResultsOne hundred and twenty-five patients were included in the study. Thirty-eight (30.4%) fractures were displaced (Garden III and IV), and 37 (29.6%) were vertical fractures (Pauwels type III). Predefined treatment-related AE rate at 3 months was 8 patients, 6.4% (95% CI, 2.8–12.2), and at 12 months, 11 patients, 8.8% (95% CI, 4.5–15.2). Cumulative incidences of bone union were 68% at 3 months, 90% at 6 months, and 98% at 12 months. The mean changes of HHS and EQ-5D-5L index score between preinjury and at 12 months were -7.5 (95% CI, [ – 21.1] to [6.2]) and – 0.03 (95% CI, [ – 0.21] to [0.15]), respectively; neither were statistically significant.ConclusionThe current study on osteosynthesis of FNFs with the FNS resulted in treatment-related complication rates of 6.4% (95% CI, 2.8–12.2) at 3 months and 8.8% (95% CI, 4.5–15.2) at 12 months. On average, patients returned to preinjury function and quality of life. The current study may also indicate that the conventional wisdom of treating stable FNF in patients aged between 60 and 80 years with osteosynthesis may need to be reconsidered.RegistrationThe study is registered with ClinicalTrials.gov (registration number: NCT02422355).

Stereotactic body radiation therapy versus radiofrequency ablation in hepatocellular carcinoma: an up-date meta-analysis.

Radiofrequency ablation (RFA) and stereotactic body radiotherapy (SBRT) are available locoregional curative treatments for nonsurgical Hepatocellular carcinoma (HCC) patients. We aimed to compare the clinical efficacy and safety of SBRT versus RFA for HCC. A computerized bibliographic search was performed using PubMed, Embase, the Cochrane Library and Web of Science to identify comparative studies. The primary outcome was overall survival (OS), and the secondary outcomes were freedom from local progression (FFLP) and treatment-related complications. In total, there were 17 trials involving 22,180 patients. Patients receiving RFA showed significantly better 1-, 2- year OS (OR 0.69, 95% CI 0.50-0.96, P = 0.141,OR 0.69, 95% CI 0.53-0.89, P = 0.082), whereas SBRT resulted in significantly better 1-, 2-, 3- year FFLP (OR 2.19, 95% CI 1.44-3.34, P = 0.303; OR 1.57, 95% CI 1.12-2.19, P = 0.268; OR 2.22, 95% CI 1.70-2.90, P = 0.470). There were no significant differences for 3-, 5- year OS in both groups (OR 0.94, 95% CI 0.65-1.38, P = 0.001; OR 0.98, 95% CI 0.68-1.34, P = 0.016). The overall treatment-related complication rate did not differ significantly between the two treatment arms, while SBRT was significantly associated with Child-Pugh worsening. Though SBRT has excellent FFLP, RFA yields superior short-term survival for HCC. But the discrepancy between FFLP and OS requires further investigation.

Endoscopic variceal obturation and retrograde transvenous obliteration for acute gastric cardiofundal variceal bleeding in liver cirrhosis

Background/AimsWe retrospectively compared the effect of endoscopic variceal obturation (EVO) and retrograde transvenous obliteration (RTO) in acute cardiofundal variceal bleeding.MethodsPatients with acute cardiofundal variceal bleeding treated with EVO or RTO at two hospitals were included.ResultsNinety patients treated with EVO and 86 treated with RTO were analyzed. The mean model for end-stage liver disease score was significantly higher in EVO group than in RTO group (13.5 vs. 11.7, P = 0.016). The bleeding control rates were high (97.8% vs. 96.5%), and the treatment-related complication rates were low in both EVO and RTO groups (2.2% vs. 3.5%). During the median follow-up of 18.0 months, gastric variceal (GV) and esophageal variceal rebleeding occurred in 34 (19.3%) and 7 (4.0%) patients, respectively. The all-variceal rebleeding rates were comparable between EVO and RTO groups (32.4% vs. 20.8% at 2-year, P = 0.150), while the GV rebleeding rate was significantly higher in EVO group than in RTO group (32.4% vs. 12.8% at 2-year, P = 0.003). On propensity score-matched analysis (71 patients in EVO vs. 71 patients in RTO group), both all-variceal and GV rebleeding rates were significantly higher in EVO group than in RTO group (all P < 0.05). In Cox regression analysis, EVO (vs. RTO) was the only significant predictor of higher GV rebleeding risk (hazard ratio 3.132, P = 0.005). The mortality rates were similar between two groups (P = 0.597).ConclusionsBoth EVO and RTO effectively controlled acute cardiofundal variceal bleeding. RTO was superior to EVO in preventing all-variceal and GV rebleeding after treatment, with similar survival outcomes.

Three-Dimension-Printed Custom-Made Prosthetic Reconstructions in Bone Tumors: A Single Center Experience.

Bone can be affected by different neoplastic conditions. Limb salvage surgery has become the preferred treatment strategy for most malignant tumors of the extremities. Advanced 3D printing technology has transformed the conventional view of oncological surgery. These types of implants are produced by electron beam melting (EBM) technology by sintering titanium powder in a scaffold shape designed following a project designed from HRCT and MRI. The aim of our study was to evaluate the outcomes and the mid-term follow-up of a population treated with 3D-printed custom-made prosthesis implantation in major oncological bone resection or after failure of primary implants. The primary outcome was the general patient satisfaction one year after surgery. The secondary outcomes were: mortality rate, treatment related complication rate, functional and clinical outcomes (KPS, ADL and IADL). Eight patients were included, five females and two males, with a mean age of 50.3 (±23.72) years at the surgery. The enrolled patients reported a mean satisfaction rate after surgery of 7.38 (±2) where 10 was the maximum value. There were no changes between pre- and postoperative mean KPS (81.43 +/−10.69). Mean preoperative ADL and IADL score was in both cases 4.86 (±1.07), while postoperative was 5 (±0.82), with a delta of 0.13 (p > 0.05). Custom-made prosthesis permits reconstructing bone defects caused by large tumor resection, especially in anatomically complex areas, restoring articular function.

Comparison of different treatment modalities for favorable risk acute myeloid leukemia: Standard-dose anthracycline versus high-dose anthracycline versus addition of gemtuzumab ozogamicin.

e19016 Background: The standard remission induction regimen for medically fit patients with AML consists of a backbone of cytarabine &amp; an anthracycline (“7+3” therapy). However, the choice &amp; dose of the anthracycline varies between institutions &amp; practitioner preference, particularly in patients with favorable risk cytogenetics. Gemtuzumab ozogamicin (GO) may improve outcomes in this patient population but is associated with increased toxicities. Methods: We performed a retrospective analysis on medically fit patients ≥ 18 yo with favorable risk AML from 2015-2020 treated with 7+3 at the University of Virginia. Patients were stratified based on standard dose (45 or 60 mg/m2 daunorubicin) (SD) vs higher dose (90 mg/m2 daunorubicin or 12 mg/m2 idarubicin) (HD) of anthracycline vs the addition of GO. Measures included rates of remission, EFS, RFS, and OS as well as rates of treatment-related complications. Results: In total, 58 patients were identified, of which 33 received induction with SD, 19 received HD, &amp; 6 received GO. The majority (75%) of patients were &lt; 60 years old &amp; 93% had de novo AML. The rates of complete remission in the SD, HD &amp; GO groups were 90.9%, 89.5% &amp; 100%, respectively (p = 0.57). EFS at 2-years was 43.9%, 36.7%, &amp; 66.7%, respectively (p = 0.85). RFS at 2-years was 53.0%, 39.0%, &amp; 100%, respectively (p = 0.18). OS at 2-years was similar between all groups (58.9%, 56.9%, &amp; 66.7%, p = 0.92). The rate &amp; duration of cytopenias after induction were similar among all groups (median duration 29 days), however cytopenias were more common in the GO group following consolidation. The rates of major bleeding, admission to the intensive care unit (ICU), and new onset cardiomyopathy (EF &lt; 50%) were higher in the GO group (major bleeding: 0% in SD, 5.3% in HD, 33.3% in GO; ICU admission: 12.1% in SD, 21.1% in HD, 33.3% in GO; cardiomyopathy: 12.1% in SD, 26.3% in HD, 33.3% in GO). The rate of infection, liver dysfunction, &amp; acute renal injury were similar among all groups. No patients developed veno-occlusive disease. Conclusions: Patients receiving GO had a trend toward improved EFS &amp; RFS, however with a similar OS at the expense of higher rates of cytopenias, major bleeding, ICU admission, &amp; cardiotoxicity. Patients receiving HD had a trend toward worse outcomes than those who received SD. A major limitation of our study is the small sample size &amp; single institution experience, however multi-institutional analysis is ongoing for further investigation.[Table: see text]

Comparison of Pipeline Embolization Device and Traditional Endovascular Therapeutic Approaches in Distal Cerebral Circulation Aneurysms Using Propensity Score Matching Analysis.

BackgroundCoiling and stent-assisted coiling remain the first-line treatments for distal cerebral circulation aneurysms (DCCAs). The off-label use of the pipeline embolization device (PED) for these aneurysms has been explored recently but remains controversial.ObjectiveTo compare traditional endovascular therapeutic approaches (coiling and stent-assisted coiling) and PED for DCCAs in a multicenter cohort of patients.MethodsA multicenter, retrospective cohort comparison study was conducted that included consecutive patients with unruptured DCCAs treated with either traditional endovascular therapeutic approaches or PED placement at three centers between 2016 and 2020. Propensity score matching analysis was applied to adjust for baseline risk factors between the PED and TET groups. Matching was based on age, sex, aneurysm size, location, morphology, adjunctive coiling, treatment history, and preoperative mRS score.ResultsIn total, 209 patients with DCCAs treated with PED or traditional endovascular therapeutic approaches were identified. Thirty-seven patients underwent PED treatment, and 172 patients underwent traditional endovascular therapeutic approaches. After propensity score matching, 37 aneurysm pairs were matched, and the baseline characteristics of the patients were balanced between the groups. The complete occlusion rate between PED and traditional endovascular therapeutic approach in both matched cohorts (91.7 vs. 92.3%, p > 0.78) was similar. The rate of periprocedural treatment-related complications in both the PED and traditional endovascular therapeutic groups was 13.5%. Univariate analysis identified average parent vessel diameter as the only predictor of complete occlusion (p = 0.038).ConclusionsPED is a viable option for treating DCCAs by providing occlusion and complication rates similar to those of traditional endovascular therapeutic approaches. A rigid patient selection procedure and proper planning should be undertaken to reduce treatment-related complications.

Endovascular and Antithrombotic Treatment in Blunt Cerebrovascular Injuries: A Systematic Review and Meta-Analysis

ObjectivesIschemic stroke has been estimated to occur in up to 26% of patients with blunt cerebrovascular injury (BCVI). Antithrombotic therapy (AT) may be used for stroke prevention, but the role of endovascular treatment (ET) remains unclear. We systematically reviewed the literature on AT and ET for the treatment of patients with BCVIs. Materials and methodsPubMed, EMBASE, Web of Science, and Cochrane were searched upon the PRISMA guidelines to include studies reporting the use of ET in BCVI patients. Post-ET neurologic outcomes, radiographic responses, and complication rates were assessed. A fixed-effect model meta-analysis was performed to compare treatment-related post-BCVI ischemic stroke rates between AT and ET protocols. ResultsWe included 16 studies comprising 352 patients undergoing ET for BCVI. Mean post-ET rates of good neurologic outcomes and radiologic responses were 86.9% (range, 63.6–100%) and 94.0% (range 57.1–100%), respectively. Mean post-ET complication rate was 5.2% (range, 0–66.7%). Seven studies compared the roles of AT (delivered in 805 patients) and ET (performed in 235 patients) for preventing the onset of post-BCVI ischemic strokes. No significant difference in rates of post-BCVI ischemic stroke was found between patients receiving AT vs patients undergoing ET (OR 0.71, 95% CI: 0.35–1.42, p = 0.402). ConclusionAT and ET may be comparable in preventing the occurrence of ischemic stroke following BCVIs. AT may be preferred as the less-invasive first-line therapy, but ET showed favorable rates of post-treatment clinical and radiologic outcomes, coupled with low rates of treatment-related complications.

Evaluating the Optimal Management of Inoperable Giant Cell Tumors of the Spine: A Systematic Review and Meta-Analysis.

Simple SummarySpine giant cell tumors (SGCTs) are intermediate malignant bone tumors, sometimes aggressive and responsible for debilitating axial pain and sensorimotor impairments. Non-surgical therapies, including denosumab, radiotherapy, and selective arterial embolization (SAE), have shown promising results in the treatment of patients with inoperable SGCTs. In this systematic review, we aimed to comprehensively analyze the current literature on denosumab, radiotherapy, and SAE for inoperable SGCTs, comparing treatment outcomes and complications using a random-effect model meta-analysis. We found that all three treatments were equally effective in providing symptom improvement and radiological tumor response, also showing low and comparable rates of treatment-related complications. Patients treated with denosumab showed lower rates of local recurrences and distant metastases.Background: Surgical resection remains the preferred treatment in spine giant cell tumors (SGCTs), but it is not always feasible. Conservative strategies have been studied for inoperable cases. We systematically reviewed the literature on inoperable SGCTs treated with denosumab, radiotherapy or selective arterial embolization (SAE). Methods: PubMed, Scopus, Web-of-Science, Ovid-EMBASE, and Cochrane were searched following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to include studies of inoperable SGCTs treated with denosumab, radiotherapy or SAE. Treatment outcomes were analyzed and compared with a random-effect model meta-analysis. Results: Among the 17 studies included, 128 patients received denosumab, 59 radiotherapy, and 43 SAE. No significant differences in baseline patient characteristics were found between the three groups. All strategies were equally effective in providing symptom improvement (p = 0.187, I2 = 0%) and reduction in tumor volume (p = 0.738, I2 = 56.8%). Rates of treatment-related complications were low (denosumab: 12.5%; radiotherapy: 8.5%; SAE: 18.6%) and comparable (p = 0.311, I2 = 0%). Patients receiving denosumab had significantly lower rates of local tumor recurrence (10.9%) and distant metastases (0%) compared to patients receiving radiotherapy (30.5%; 8.5%) or SAE (35.6%; 7%) (p = 0.003, I2 = 32%; p = 0.002, I2 = 47%). Denosumab was also correlated with significantly higher overall survival rates at 18 months (99.2%) and 24 months (99.2%) compared to radiotherapy (91.5%; 89.6%) and SAE (92.5%; 89.4%) (p = 0.019, I2 = 8%; p = 0.004, I2 = 23%). Mortality was higher in patients receiving SAE (20.9%) or radiotherapy (13.6%) compared to denosumab (0.8%) (p < 0.001), but deaths mostly occurred for unrelated diseases. Conclusions: Denosumab, radiotherapy, and SAE are safe and effective for inoperable SGCTs. Clinical and radiological outcomes are mostly comparable, but denosumab may provide superior tumor control.

One-Year Outcomes of the ROBUST II Study Evaluating the Use of a Drug-Coated Balloon for Treatment of Urethral Stricture

Objective To report 1-year results of the ROBUST II study investigating the safety and efficacy of a paclitaxel-coated balloon for the treatment of recurrent urethral strictures. Methods Subjects were adult men with a single anterior urethral stricture ≤ 3 cm in length and at least 2 prior stricture treatments. After treatment with the Optilume urethral drug-coated balloon (DCB), subjects were followed through 1 year. The primary safety endpoint was the rate of treatment-related serious complications at 90 days post-procedure. Efficacy outcomes included symptomatic assessments, erectile function measured using the International Index of Erectile Function (IIEF), Qmax, and anatomic success. Results Sixteen men with an average of 4.1 prior dilations were treated with the DCB. Anatomic success was achieved at 6 months in 73%. Average IPSS improved from 18.4 to 6.0 at 1 year (P &lt; 0.001). Qmax improved from 6.9 mL/sec to 20.8 mL/sec (P &lt; 0.001). There was no change in IIEF. Four subjects received additional treatment within 1 year. There were no treatment-related serious complications. Conclusions Short-term follow-up of men with urethral stricture treated with the Optilume DCB showed durable anatomic results at 6 months and sustained symptomatic improvement through 1 year. Treatment with the device was safe.

Evolution of Therapy for Older Patients With Acute Myeloid Leukemia: How Should We Use Currently Available Agents?

Most patients with newly diagnosed acute myeloid leukemia (AML) are 65 years or older. The treatment of AML in older patients has been characterized by distinct patient- and disease-related challenges that have impeded the meaningful progress that has been observed in younger patients with AML. Higher rates of comorbidities and frailty contribute to higher rates of treatment-related complications, whereas adverse disease features such as poor-risk genomics and secondary AML are associated with therapeutic resistance and shortened survival. Intensive chemotherapy and allogeneic stem cell transplant, although still considered standard for many newly diagnosed patients with AML, may not be appropriate for a larger subset of older patients with AML. Lower-intensity approaches such as hypomethylating agents have been widely applied for newly diagnosed older and unfit patients with AML, improving tolerability among this subset, but providing more modest response rates. Numerous analyses have attempted to tackle the utility of higher- versus lower-intensity therapy in older AML and identify the factors that can help choose the approach that best optimizes tolerability and efficacy. Recently, a greater understanding of the genomic and biologic heterogeneity of AML has led to better risk stratification and has contributed to the development of specific targeted therapies that are starting to narrow the gap between safety and efficacy. Newly approved agents, such FLT3 (FMS-like tyrosine kinase 3) inhibitors, IDH1 and IDH2 inhibitors, and the BCL2 inhibitor venetoclax, as well postremission maintenance therapy with CC-486 (oral 5-azacitidine), are being systematically incorporated into the evolving treatment of older patients with newly diagnosed AML.

Evolving Therapeutic Approaches for Older Patients with Acute Myeloid Leukemia in 2021.

Simple SummaryThe better understanding of disease biology, the availability of new effective drugs and the increased awareness of patients’ heterogeneity in terms of fitness and personal expectations has made the current treatment paradigm of AML in the elderly very challenging. Here, we discuss the evolving criteria used to define eligibility for induction chemotherapy and transplantation, the introduction of new agents in the treatment of patients with very different clinical conditions, the implications of precision medicine and the importance of quality of life and supportive care, proposing a simplified algorithm that we follow in 2021.Acute myeloid leukemia (AML) in older patients is characterized by unfavorable prognosis due to adverse disease features and a high rate of treatment-related complications. Classical therapeutic options range from intensive chemotherapy in fit patients, potentially followed by allogeneic hematopoietic cell transplantation (allo-HCT), to hypomethylating agents or palliative care alone for unfit/frail ones. In the era of precision medicine, the treatment paradigm of AML is rapidly changing. On the one hand, a plethora of new targeted drugs with good tolerability profiles are becoming available, offering the possibility to achieve a prolonged remission to many patients not otherwise eligible for more intensive therapies. On the other hand, better tools to assess patients’ fitness and improvements in the selection and management of those undergoing allo-HCT will hopefully reduce treatment-related mortality and complications. Importantly, a detailed genetic characterization of AML has become of paramount importance to choose the best therapeutic option in both intensively treated and unfit patients. Finally, improving supportive care and quality of life is of major importance in this age group, especially for the minority of patients that are still candidates for palliative care because of very poor clinical conditions or unwillingness to receive active treatments. In the present review, we discuss the evolving approaches in the treatment of older AML patients, which is becoming increasingly challenging following the advent of new effective drugs for a very heterogeneous and complex population.

Finnish flow diverter study: 8 years of experience in the treatment of acutely ruptured intracranial aneurysms

BackgroundFlow diversion of acutely ruptured intracranial aneurysms (IAs) is controversial due to high treatment-related complication rates and a lack of supporting evidence. We present clinical and radiological results of the...

Mobile endovascular therapy for acute treatment of ruptured vertebral artery dissecting aneurysm in multiple hospitals.

The patients with ruptured vertebral artery dissecting aneurysm (rVADA) should be treated as early as possible because VADA carries extremely high risk of rebleeding in the acute phase. We have established a mobile endovascular strategy for the patients with rVADA between our flagship center and its affiliated local hospitals. We introduced and reviewed our mobile endovascular therapy in this study. We retrospectively evaluated 98 consecutive patients who underwent endovascular surgery for rVADA from 2000 to 2018 at our institution or five affiliated hospitals. When each patient was initially transported to the local affiliated hospitals, neuroendovascular surgeons traveled directly to the affiliated hospital from the flagship center in order to treat the patient there. Clinical outcomes using modified Rankin Scale at 6months after treatment, radiological results, and procedure-related complications were reviewed to justify our mobile endovascular strategy. All aneurysms were cured successfully by internal trapping. Favorable outcome was achieved in 61 patients (62.2%) even though 53 patients (54.1%) had presented with severe subarachnoid hemorrhage. Overall mortality rate, treatment-related mortality rate, and treatment related complication rate were 18.4% (18/98), 0%, and 16% (16/98), respectively. There were no differences in clinical and radiological outcomes between the patients treated in the flagship center and those who treated in the affiliated hospitals. Treatment in the affiliated hospital was not a predictive factor of unfavorable outcome in our multivariate analysis, and elderly age (≥ 60) was negatively associated with favorable outcome. Our results prove the efficacy and safety of mobile endovascular therapy for the treatment of rVADA in the ultra-acute stage. Mobile endovascular therapy may work well in the acute treatment of rVADAs in the certain circumstance.