Similar Efficacy Rates Research Articles

Safety Outcomes After Sacubitril/Valsartan Initiation in a Community Teaching Hospital: A Retrospective Observational Study.

Sacubitril/valsartan is one of the main foundational medications in heart failure (HF), and recent data show that it provides a mortality benefit in this patient population. Some of the main safety concerns associated with this drug class include hypotension, hyperkalemia, angioedema, and acute kidney injury (AKI). Other studies have focused on sacubitril/valsartan effects on blood glucose levels, which is a newer concept that has not been as researched. This study seeks to explore the safety of angiotensin receptor-neprilysininhibitors (ARNi) when initiated in acute hospitalized patients, where data on tolerability will assist in patient selection and monitoring. The results of this study will help distinguish the HF population at a community teaching hospital and aid clinician decision-making. This was a single-center, retrospective, observational review utilizing electronic health records. To be included in this study, patients had to be 18 years or older with an HF diagnosis and must have taken at least two doses of sacubitril/valsartan before discharge. Primary safety outcomes will include discontinuation of sacubitril/valsartan, incidence of angioedema, hyperkalemia, AKI, hypotension, and hypoglycemia. Secondary outcomes included hospital length of stay and 30-day readmission rate. Data were collected for a total of 227 patients. AKI was the most common primary safety adverse effect captured with 30 patients (14.02%), followed by hypotension in 20 patients (9.35%), and hyperkalemia in 19 patients (8.9%). Only one patient (0.44%) experienced both angioedema and hypotension, and it happened to be the same patient. Additionally, only one patient (0.47%) was found to be hypoglycemic. Sacubitril/valsartan was discontinued in 41 patients (18.1%), and 20 of those patients (8.8%) were restarted at a lower dose. Lastly, 63 patients (27.8%) were readmitted within 30 days of discharge. Patents that also had diabetes had worse safety outcomes and were associated with 30-day readmission. Conclusions: This study of patients admitted with HF and started on sacubitril/valsartan found similar rates of efficacy and safety outcomes to previously published reports. However, the rate of hypoglycemia associated with sacubitril/valsartan was low in only one patient, and it was strongly associated with previous antidiabetic medication use. This differs from previously published reports and analyses on the association of sacubitril/valsartan and hypoglycemia. More research is needed for the argument that sacubitril/valsartan has an effect on glycemic outcomes. Patients with diabetes were found to have worse safety outcomes and a higher 30-day readmission. Providers should consider monitoring these patients closely and making sure that patients are on guideline-directed medication therapy before discharge. Other common safety events associated with sacubitril/valsartan were also seen in this population.

P-680 Comparison of ovarian hyperstimulation syndrome (OHSS) rates resulting from conventional dosing versus personalized dosing of follitropin delta in ovarian stimulation, analysis of RITA, ESTHER-1 trials

Abstract Study question To compare OHSS rates with conventional dosage of follitropin delta in the RITA-1 and RITA-2 trials (hereafter ‘RITA’) to personalized dosing in the ESTHER-1 trial. Summary answer RITA and ESTHER-1 had similar efficacy and OHSS rates despite differences in dosing regimens, possibly due to differences in fresh transfer cancellation rates. What is known already Follitropin delta is a human cell-line derived follicle stimulating hormone whose fixed dosage in ovarian stimulation, personalized based upon body weight and serum anti-Müllerian hormone (AMH) and body weight, has been shown to be safe and effective in Gonadotrophin Releasing Hormone (GnRH) antagonist ovarian stimulation protocols. In the present trial, conventional dosing of follitropin delta allowing for dose revisions has been evaluated in GnRH antagonist ovarian stimulation protocols to demonstrate the broad utility of this gonadotrophin therapeutic and to address United States (US) regulatory considerations. Study design, size, duration RITA were randomized, double-blind, controlled, US multicentre trials of follitropin delta. The primary endpoint was cumulative ongoing pregnancy rate after fresh/frozen transfers within 12 months of cycle start. 1058 women 18-42 years randomized 10:1 to follitropin delta or placebo. ESTHER-1 was a randomized, European multicentre, assessor-blind, noninferiority trial of follitropin delta. The primary endpoints were fresh transfer ongoing pregnancy and implantation rates. 1329 women 18-40 years randomized 1:1 to follitropin delta or follitropin alfa. Participants/materials, setting, methods In RITA, 12 µg/day, 15 µg/day dosages were used for 4 days: 18-34 or 35-42 years, respectively, with 3 µg dose adjustments thereafter depending on response. Human chorionic gonadotropin (hCG) was used if < 20 follicles of ≥ 12 mm and estradiol level <3,000 pg/mL. Else, agonist trigger and fresh transfer cancellation; ≥20 oocytes retrieved also cancelled fresh transfer. In ESTHER-1, hCG was used if < 25 follicles of ≥ 12 mm. Else, agonist trigger, and fresh transfer cancellation. Main results and the role of chance The ongoing pregnancy rate per fresh transfer with follitropin delta was 41.9% in RITA and 36.3% in ESTHER-1. The primary efficacy endpoint was met for all 3 trials. Rates and severity defined by Golan criteria of OHSS observed in RITA and ESTHER-1 were similar, respectively for: all OHSS, any grade (3.1% versus 3.5%), Grade 1 (0.3% versus 0.5%), Grade 2 (0.8% versus 0.9%), Grade 3 (1.8% versus 1.1%), Grade 4 (0.2% versus 0.6%), and Grade 5 (0.1% versus 0.5%). The rate of early OHSS, defined as onset ≤9 days after trigger of final follicular maturation, was also similar, respectively for any grade (2.2% versus 2.6%), Grade 1 (0.3% versus 0.3%), Grade 2 (0.6% versus 0.9%), Grade 3 (1.1% versus 0.8%), Grade 4 (0.1% versus 0.3%) and Grade 5 (0.1 % versus 0.3%). However, the fresh transfer cancellation rate was >3x higher in RITA (35.2%) than in ESTHER-1 (11.1%). Limitations, reasons for caution Other reasons for transfer cancellation in all trials included adverse events or no blastocyst available for transfer; however, no significant differences were observed. A placebo comparator was selected for RITA to meet regulatory requirements for double-blinding; women with ≤3 oocytes retrieved were offered support for treatment outside of the trials. Wider implications of the findings Stimulation with follitropin delta is effective and associated with low rates of OHSS when used with either conventional or personalized dosing. However, stricter criteria for the use of hCG as trigger and allowance of fresh transfer may be required with conventional dosing to maintain this safety profile. Trial registration number NCT01956110, NCT03740737, NCT03738618

Rates and Predictors of Pain Reduction With Intracranial Stimulation for Intractable Pain Disorders.

Intracranial modulation paradigms, namely deep brain stimulation (DBS) and motor cortex stimulation (MCS), have been used to treat intractable pain disorders. However, treatment efficacy remains heterogeneous, and factors associated with pain reduction are not completely understood. We performed an individual patient review of pain outcomes (visual analog scale, quality-of-life measures, complications, pulse generator implant rate, cessation of stimulation) after implantation of DBS or MCS devices. We evaluated 663 patients from 36 study groups and stratified outcomes by pain etiology and implantation targets. Included studies comprised primarily retrospective cohort studies. MCS patients had a similar externalized trial success rate compared with DBS patients (86% vs 81%; P = .16), whereas patients with peripheral pain had a higher trial success rate compared with patients with central pain (88% vs 79%; P = .004). Complication rates were similar for MCS and DBS patients (12% vs 15%; P = .79). Patients with peripheral pain had lower likelihood of device cessation compared with those with central pain (5.7% vs 10%; P = .03). Of all implanted patients, mean pain reduction at last follow-up was 45.8% (95% CI: 40.3-51.2) with a 31.2% (95% CI: 12.4-50.1) improvement in quality of life. No difference was seen between MCS patients (43.8%; 95% CI: 36.7-58.2) and DBS patients (48.6%; 95% CI: 39.2-58) or central (41.5%; 95% CI: 34.8-48.2) and peripheral (46.7%; 95% CI: 38.9-54.5) etiologies. Multivariate analysis identified the anterior cingulate cortex target to be associated with worse pain reduction, while postherpetic neuralgia was a positive prognostic factor. Both DBS and MCS have similar efficacy and complication rates in the treatment of intractable pain. Patients with central pain disorders tended to have lower trial success and higher rates of device cessation. Additional prognostic factors include anterior cingulate cortex targeting and postherpetic neuralgia diagnosis. These findings underscore intracranial neurostimulation as an important modality for treatment of intractable pain disorders.

Comparing clinical outcomes of vitamin K antagonists vs non-vitamin K antagonists in anticoagulant therapy for mesenteric venous thrombosis

ObjectiveNon-vitamin K antagonist oral anticoagulants have shown similar efficacy and lower bleeding rates than vitamin K antagonists for venous thromboembolism. However, this has not been proven in mesenteric vein thrombosis. This study aimed to compare the clinical outcomes of vitamin K antagonists and non-vitamin K antagonist oral anticoagulants. MethodsBetween January 2014 and July 2022, mesenteric vein thrombosis was diagnosed on computed tomography in 225 patients in a tertiary hospital. Among them, a total of 44 patients who underwent long-term anticoagulation therapy over 3 months were enrolled in this study. Patients were divided into two groups based on the anticoagulant used: vitamin K antagonists (Group 1, n = 21) and non-vitamin K antagonist oral anticoagulants (Group 2, n = 23). The efficacy outcomes were symptom recurrence and thrombus resolution on follow-up computed tomography, and the safety outcome was bleeding complications. ResultsThe median age of the patients was 56 years (range, 46-68 years), and 52% were men. The most common risk factors were unprovoked intra-abdominal infections (30%). The median duration of anticoagulation therapy was 13 months (20 months in Group 1 vs 6 months in Group 2; P = .076). Of the 44 patients, 17 (39%) received the standard treatment. The median follow-up period was longer in Group 1 than in Group 2 (57 vs 28 months; P = .048). No recurrence of mesenteric vein thrombosis-related symptoms were observed in either group. The median duration of follow-up computed tomography was 31 months (42 months in Group 1 vs 18 months in Group 2; P = .064). Computed tomography revealed complete thrombus resolution, partial resolution, and no changes in 71%, 19%, and 10%, respectively (P = .075). Regarding bleeding complications, varix bleeding and melena developed in two patients in Group 2, and anticoagulation treatment thereafter ceased. ConclusionsDespite the short follow-up duration in the non-vitamin K antagonist oral anticoagulants group, there was no clinically significant difference in the thrombus resolution rate or bleeding complications when compared with the vitamin K antagonists group. Although research on the long-term effects of non-vitamin K antagonist oral anticoagulants in patients is limited, non-vitamin K antagonist oral anticoagulants can be considered an alternative to conventional treatments.

Comparing the efficacy of 308-nm light-emitting diode and 308-nm excimer lamp for treating vitiligo: A randomized controlled trial.

In previous studies, the 308-nm light-emitting diode (LED) has been proven safe and effective for treating vitiligo. However, direct comparisons between the 308-nm LED and 308-nm excimer lamp (308-nm MEL) for the treatment of vitiligo are lacking. To compare the efficacy of the 308-nm LED and 308-nm MEL for treating nonsegmental stable vitiligo. This randomized controlled trial was conducted between January 2018 and August 2023. Enrolled patients were randomly assigned to either the 308-nm LED or the 308-nm MEL groups, both receiving 16 treatment sessions. Adverse events that occurred during the treatment were documented. In total, 269 stable vitiligo patches from 174 patients completed the study. A total of 131 lesions were included in the 308-nm LED group, and 138 lesions were included in the 308-nm MEL group. After 16 treatment sessions, 38.17% of the vitiligo patches in the 308-nm LED group achieved repigmentation of at least 50% versus 38.41% in the 308-nm MEL group. The two devices exhibited similar results in terms of efficacy for a repigmentation of at least 50% (p = .968). The incidence of adverse effects with the two phototherapy devices was comparable (p = .522). Treatment of vitiligo with the 308-nm LED had a similar efficacy rate to the 308-nm MEL, and the incidence of adverse effects was comparable between the two devices.

Application of plasma metagenomic next-generation sequencing improves prognosis in hematology patients with neutropenia or hematopoietic stem cell transplantation for infection.

Metagenomic next-generation sequencing (mNGS) is a novel technique for detecting pathogens. This retrospective study evaluated the diagnostic value of mNGS using plasma for infections in hematology patients and its impact on clinical treatment and prognosis in different subgroups of hematology patients. A total of 153 hematology patients with suspected infection who underwent mNGS using plasma were enrolled in the study. Their clinical histories, conventional microbiological test (CMT) results, mNGS results, treatment and prognosis were retrospectively analyzed. In 153 plasma samples, mNGS yielded a higher positivity rate than CMT (total: 88.24% vs. 40.52%, P<0.001; bacteria: 35.95% vs. 21.57%, P < 0.01; virus: 69.93% vs. 21.57%, P<0.001; fungi: 20.26% vs. 7.84%, P<0.01). mNGS had a higher positivity rate for bacteria and fungi in the neutropenia group than in the non-neutropenia group (bacteria: 48.61% vs. 24.69%, P<0.01; fungi: 27.78% vs. 13.58%, P<0.05). mNGS demonstrated a greater advantage in the group of patients with hematopoietic stem cell transplantation (HSCT). Both the 3-day and 7-day efficacy rates in the HSCT group were higher than those in the non-HSCT group (3-day: 82.22% vs. 58.65%, P < 0.01; 7-day: 88.89% vs. 67.31%, P < 0.01), and the 28-day mortality rate was lower in the HSCT group than in the non-HSCT group (6.67% vs. 38.89%, P < 0.000). The neutropenia group achieved similar efficacy and mortality rates to the non-neutropenia group (7-day efficiency rate: 76.39% vs. 71.43%, P > 0.05; mortality rate: 29.17% vs. 29.63%, P > 0.05) with more aggressive antibiotic adjustments (45.83% vs. 22.22%, P < 0.01). mNGS can detect more microorganisms with higher positive rates, especially in patients with neutropenia. mNGS had better clinical value in patients with hematopoietic stem cell transplantation (HSCT) or neutropenia, which had a positive effect on treatment and prognosis.

Zero x-ray pulmonary vein isolation with heliostar radiofrequency balloon: efficacy and safety

Abstract Introduction Single shot pulmonary vein isolation techniques are currently an attractive and effective alternative to point-by-point ablation. The Heliostar® radiofrequency balloon is capable of producing single shot isolation with reduced procedure times and high efficacy and safety. A particular feature of this new balloon is its ability to be visualized on the Carto 3® navigation system, which makes it possible to reduce or even eliminate the use of X-rays (XR) in this type of procedure. Objectives Our objective was to demonstrate the efficacy and safety of pulmonary vein isolation with Heliostar® radiofrequency balloon without the use of XR. Methods Twenty-five patients with paroxysmal (68%) or persistent (32%) atrial fibrillation were prospectively included in our centre and underwent pulmonary vein isolation with radiofrequency balloon. Ten cases were performed without XR (40%), and the remaining 15 (60%) using fluoroscopy. All cases were performed under general anaesthesia and using the Carto 3® navigation system. Electroanatomical mapping was performed pre and post ablation in all cases. Mapping was performed in sinus rhythm. In cases without XR, intracardiac echocardiography was used to guide the transseptal puncture and the rest of the procedure. Technical and clinical data were collected. Cases with and without XR were compared. Results There were no complications in either group. All veins were successfully isolated, with 56% first pass isolation in the non-XR group versus 68% in the XR group (non-significant difference). The vein with the highest percentage of first pass isolations was the left inferior vein in both groups. Procedure times were similar (median left atrial dwell time of 34 minutes in the non-XR group and 36 minutes in the XR group, non-significant difference). There was also no difference in the median time to isolation from the start of radiofrequency application in each vein (10 seconds in both groups). Left atrial size was normal in most patients, and ventricular function was preserved, with no differences between the two groups. The non-XR group had a higher number of patients with left main trunk, but the XR group had a higher percentage of patients with persistent forms of atrial fibrillation. Conclusion Zero-XR pulmonary vein isolation with Heliostar® balloon is possible and safe, with similar efficacy and first pass isolation rate, similar procedure time and no relevant complications in our series.

Relationships, Current Issues, Safety and Efficacy of Oral Anticoagulation in Cancer Patients with Atrial Fibrillation.

A relationship between malignancy and impaired hemostasis has been proven, and balancing clotting and bleeding risks can be challenging. Half of cancer patients with atrial fibrillation (AF) do not receive any oral anticoagulation (OAC). Using PubMed on the relationship between cancer and AF and their association with hemostasis, targeting studies comparing vitamin K antagonists (VKAs) and direct OAC (DOAC) strategies in AF cancer patients, three RCTs (>3000 patients) and eight observational studies (>250,000 patients) comparing different OACs were retrieved. The VKA prescribed was always warfarin. Dabigatran was the only DOAC not analyzed in the RCTs but the most used in non-randomized studies, whereas edoxaban-treated patients were the majority in the RCTs. Overall, the DOAC patients showed similar or lower rates of efficacy (thromboembolic) and safety (bleeding) outcomes compared to the VKA patients. DOACs are subject to fewer interactions with antineoplastic agents. DOACs may be preferable to VKAs as a thromboembolic prophylaxis in cancer patients with non-valvular AF.

Comparative analysis of transvaginal natural orifice transluminal endoscopic surgery versus laparoendoscopic single-site sacrocolpopexy for pelvic organ prolapse: A propensity score matching study

PurposeTo compare the safety, feasibility, and effectiveness of transvaginal natural orifice transluminal endoscopic sacrocolpopexy (vNOTES-SC) and laparoendoscopic single-site sacrocolpopexy (LESS-SC) for pelvic organ prolapse (POP). MethodNinety-four patients with POP who underwent vNOTES-SC or LESS-SC from October 2016 to November 2018 were included. The propensity score matching method was used for 1:1 matching between the two surgery groups. After matching, the general perioperative indicators, surgical complications, and the subjective and objective therapeutic effects of the two groups 3 years post-surgery were analyzed. ResultsAfter matching, 36 patients in each group were included, exhibiting balanced and comparable baseline data and an average follow-up of 48.6 ± 7.44 months. The operation time and postoperative hospitalization days were significantly reduced in the vNOTES-SC group (P < 0.05). However, perioperative complication incidence was not significantly different between the two groups (P > 0.05). Additionally, no significant differences were detected in de novo stress urinary incontinence (16.7% vs. 13.9%), de novo overactive bladder (de novo OAB, 8.3% vs. 0.0%), urination disorder (2.8% vs. 0.0%), defecation disorder (0.0% vs. 2.8%), lumbosacral pain (0.0% vs. 2.8%), or mesh complication (2.8% vs. 5.6%) incidences between the vNOTES-SC and LESS-SC groups (P > 0.05). Prolapse recurrence was not reported in either group. The quantitative description of pelvic organ position (POP-Q), Pelvic Floor Impact Questionnaire-7 (PFIQ-7), and Patient Global Impression of Improvement scale (PGI-I) scores showed improvement after the operation, but no significant differences were observed between the two groups (P > 0.05). ConclusionThe 3-year follow-up revealed that vNOTES-SC and LESS-SC had similar complications and efficacy rates. Compared with LESS-SC, vNOTES-SC resulted in shorter operation time and fewer postoperative hospitalization days (corresponding to the enhanced recovery after surgery [ERAS] concept), along with better cosmetic results without a scar. Therefore, our study findings suggest that clinicians should choose the surgery method based on the specific situation, and we recommend choosing vNOTES-SC when both surgeries are suitable.

Novel or established cryoballoon ablation system for pulmonary vein isolation: the prospective ICE-AGE-1 study.

Catheter ablation with a cryoballoon (CB) provides effective and durable pulmonary vein (PV) isolation (PVI) associated with encouraging clinical outcome data. The novel POLARx CB incorporates unique features, which may translate into improved safety, efficacy, and outcomes. The ICE-AGE-1 study aimed to assess the efficacy, safety, and 1-year clinical follow-up of the POLARx CB in comparison to the Arctic Front Advance Pro CB (AF-CB4). A total of 103 consecutive patients with paroxysmal or persistent atrial fibrillation (AF) who underwent POLARx-based PVI (POLARx group) were prospectively enrolled and were compared to 102 consecutive patients previously treated with the AF-CB4 (AF-CB4 group). The mean age was 68.7 ± 10.2 (POLARx) and 65.7 ± 12 (AF-CB4, P = 0.0551) years. A total of 412 (POLARx) and 404 (AF-CB4) PVs were identified. All PVs, except for one PV in the POLARx group, were successfully isolated. A significant difference regarding the mean minimal CB temperature reached using the POLARx CB (-56.1 ± 8.3°C) and AF-CB4 (-46.9 ± 10.1°C) was observed (P < 0.0001). Real-time PVI was visualized in 71% of PVs in the POLARx group and 46% of them in the AF-CB4 group (P < 0.001). The mean procedure time was comparable: 54.5 ± 17.1 min for POLARx and 59.4 ± 18.6 min for AF-CB4 (P = 0.0509). No differences were observed in terms of periprocedural complications. There were comparable rates in freedom of AF or atrial tachycardia recurrence after 12 months, beyond a 90-day long blanking period: 78.9% in the POLARx group vs. 77.2% in the AF-CB4 group (P = 0.804). The novel POLARx CB showed similar safety, efficacy, and 1-year recurrence-free survival rates compared to the AF-CB4. A higher rate of real-time electrical PV recordings and significantly lower balloon temperatures were observed using the POLARx as compared to AF-CB4.

Fusion imaging versus ultrasound-guided percutaneous thermal ablation of liver cancer: a meta-analysis.

Ultrasound-guided percutaneous thermal ablation has become an alternative treatment for small hepatocellular carcinoma (HCC). Recent evidence suggests that fusion imaging (FI) may improve the feasibility and efficacy of thermal ablation for HCC, while the clinical evidence remains limited. To compare FI versus ultrasound-guided thermal ablation for HCC. Relevant cohort or randomized controlled trials were found by searching Medline, Web of Science, Cochrane Library, and Embase. The pooling of results was performed using a random-effects model incorporating heterogeneity. In this meta-analysis, 15 studies involving 1472 patients (1831 tumors) for FI-guided ablation and 1380 patients (1864 tumors) for ultrasound-guided ablation were included. Pooled results showed that compared to conventional HCC ablation guided by ultrasound, the FI-guided procedure showed a similar technique efficacy rate (risk ratio [RR] = 1.01, 95% confidence interval [CI] = 1.00-1.02, P = 0.25; I2 = 30%). However, FI-guided tumor ablation was associated with a lower incidence of overall complications (RR = 0.70, 95% CI = 0.50-0.97, P = 0.03; I2 = 0%). Moreover, patients receiving FI-guided tumor ablation had a lower risk of local tumor progression during follow-up than those with ultrasound-guided ablation (RR = 0.61, 95% CI = 0.47-0.78, P < 0.001; I2 = 13%). Subgroup analysis according to FI strategy, imaging techniques in controls, and tumor diameter showed consistent results (p for subgroup difference all >0.05). FI-guided thermal ablation may be more effective and safer than ultrasound-guided ablation for patients with HCC.

Efficacy and safety of pulmonary vein isolation with irrigated radiofrequency balloon with a zero-fluoroscopy protocol

Abstract Funding Acknowledgements Type of funding sources: None. Introduction From the beginning, the use of X-ray (XR) has been a critical component in both the guidance and development of arrhythmia ablation procedures. Despite the development of non-fluoroscopic navigators, the single-shot techniques for atrial fibrillation ablation procedures still rely almost exclusively on the use of XR. Recently, the Heliostar® irrigated radiofrequency balloon has been developed, which can be completely visualized on the Carto 3® navigation system. This special feature makes it possible to minimise the use of XR in this type of procedure or even suppress it. We present our first experience after the implementation of a "zero-XR" protocol for this procedure. Objectives The aim of this study was to demonstrate that "zero-XR" ablation of atrial fibrillation with Heliostar® radiofrequency balloon is possible and safe. Methods This is a single-centre study. Consecutively 22 patients with paroxysmal (63.6%) or persistent (36.4%) atrial fibrillation underwent pulmonary vein isolation by irrigated radiofrequency balloon (Heliostar®). Eight of the cases were performed without fluoroscopy, supported by the navigation system and intracardiac ultrasound, and the remaining 14 were performed without limitation of the use of XR. Clinical, echocardiographic and technical data were collected from all 22 patients. All cases were performed under general anaesthesia, with the Carto 3® navigation system. Mapping was performed in sinus rhythm whenever possible. Results 100% isolation of the veins was achieved, with 62.1% first pass isolation in the non-XR group versus 56.4% in the XR group (non-significant difference). The vein with the highest percentage of first pass isolations was the left inferior vein in both groups. There were no complications in either group. Procedure times were similar (left atrial dwell time of 32 minutes in the non-XR group and 40 minutes in the XR group, non-significant difference), although the mapping time was slightly shorter in the non-XR group (9,9±5 non-XR vs 16±6.9, p=0.04). There was also no difference in the mean time to isolation from the start of radiofrequency application in each vein (10.6 seconds in the non-XR group and 11 seconds in the XR group, p=0.75). The non-XR group had a higher number of patients with left main trunk, but the XR group had a higher percentage of patients with persistent forms of atrial fibrillation. Left atrial size was normal in most patients, and ventricular function was preserved, with no differences between the two groups. Conclusion Pulmonary vein isolation with the Heliostar® radiofrequency balloon without XR is possible and safe, with similar efficacy and first pass isolation rate, similar procedure time and no relevant complications in our series.

Comparison between Ultrasound and Fluoroscopy-guided Percutaneous Nephrolithotomy (PCNL) at Raden Mattaher Jambi Hospital

PurposeTo investigate the effectiveness and safety of ultrasound-guided and Percutaneous Nephrolithotomy (PCNL) compared to the standard fluoroscopy-guided PCNL.MethodsThis study is a comparative retrospective study obtained from medical records within the last 5 years of Raden Mattaher Hospital, Jambi. Patients were divided into 2 groups, fluoroscopy- and ultrasonography-guided PCNL with large kidney stone > 20 mm. Patient characteristics were divided into pre- and post-operative procedures and analyzed using SPSS ver. 25.0 (SPSS Inc., Chicago, IL, USA). Data were analyzed using Kolmogorov–Smirnov, chi-square and/ Fischer’s exact test and p value < 0.05 was considered statistically significant.ResultsOf 201 patients’ data from medical records were divided into ultrasound-guided and fluoroscopy-guided groups. Ultrasound-guided group were consisted of 89 patients and fluoroscopy-guided were of 112 patients. US Guided significantly identifies the severity of hydronephrosis compared to PCNL. The demographic data obtained age, sex, body mass index, and preoperative hemoglobin levels showed a normal distribution. On the post-operative results, significant results occurred in post-PCNL stent placement. Installation of a DJ stent alone is more commonly performed on fluoroscopy-guided PCNL procedures compared to ultrasound-guided PCNL. This had a positive impact on post-procedure outcomes, meaning that the post-operative outcome of ultrasound-guided PCNL was better than that of fluoroscopy-guided PCNL.ConclusionThe reported data demonstrate that PCNL and ultrasound-guided has similar efficacy and complication rates with PCNL fluoroscopy-guided. This could be a good alternative in urological centers with no access to fluoroscopy. However, ultrasound-guided group was still associated with higher rate nephrostomy tube placement and longer surgery duration.

Efficacy of oblique lumbar interbody fusion combined with different internal fixation methods in the treatment of degenerative lumbar diseases

Objective: To compare the efficacy among stand-alone oblique lateral lumbar interbody fusion (OLIF-SA), OLIF combined with lateral screw internal fixation (OLIF-AF) and OLIF combined with posterior percutaneous pedicle screw internal fixation (OLIF-PF) in the treatment of degenerative lumbar diseases. Methods: The clinical data of patients with degenerative lumbar diseases who underwent OLIF-SA, OLIF-AF and OLIF-PF in the Department of Neurosurgery, Xuanwu Hospital, Capital Medical University from January 2017 to January 2021 were retrospectively analyzed. Patients' visual analogue score (VAS) and Oswestry disability index (ODI) at 1 week and 12 months postoperatively were recorded, and efficacy of OLIF surgery with different internal fixation methods was evaluated by comparing clinical scores and imaging examinations at preoperative, postoperative and follow-up, and bony fusion and postoperative complications were recorded. Results: A total of 71 patients were included in the study, with 23 males and 48 females, aged (65±11) (34-88) years. There were 25 patients in the OLIF-SA group, 19 patients in the OLIF-AF group, and 27 patients in the OLIF-PF group. Compared with those of OLIF-PF group [(196±46) min and 50 (50, 60) ml], OLIF-SA and OLIF-AF groups had shorter operative time [(97±38) min and (118±48) min] and less intraoperative blood loss [20 (10, 50) ml and 40 (20, 50) ml] (both P<0.001). There was no statistically significant difference in the fusion rate among three groups (P>0.05). No statistically significant differences of VAS and ODI scores were observed among OLIF-SA, OLIF-AF and OLIF-PF groups during preoperative period [VAS: 5.0 (4.0, 6.0), 5.0 (4.0, 6.0) and 5.0 (4.0, 5.3); ODI: 44.0% (35.0%, 47.0%), 46.5% (43.3%, 46.5%) and 43.5% (35.8%, 46.0%)], and at one week postoperatively [VAS: 2.0 (2.0, 3.0), 3.0 (2.0, 3.0) and 2.0 (2.0, 3.0); ODI: 13.0% (12.0%, 18.0%), 21.0% (13.5%, 21.8%) and 16.5%(14.0%, 21.0%)] and final follow-up [VAS: 1.0 (0, 1.0), 1.0 (1.0, 2.0) and 1.0 (1.0, 2.0); ODI: 7.0% (5.0%, 11.0%), 10.0% (7.0%, 14.8%) and 8.0% (6.0%, 12.0%)], respectively (all P>0.05). Conclusion: Compared with OLIF-AF and OLIF-PF, OLIF-SA is a safe and effective surgical method with similar efficacy and fusion rates, decreases the cost of internal fixation, and reduces intraoperative time blood loss.

Efficacy, safety and indirect comparisons of lasmiditan, rimegepant, and ubrogepant for the acute treatment of migraine: A systematic review and network meta-analysis of the literature.

We performed a random-effects network meta-analysis to study the efficacy and safety of newly developed drugs for the acute treatment of migraine attacks. MEDLINE via PubMed, Embase and The Cochrane Register of Controlled Trials were searched from inception to 11 February 2022. Phase 3 randomized controlled trials examining all formulations of lasmiditan, rimegepant and ubrogepant for the acute treatment of adults with migraine, were included. Data were extracted following the PRISMA guidelines. Seven studies (SAMURAI, SPARTAN, CENTURION, Study 302, Study 303, ACHIEVE I and II) involving n = 12,859 patients were included. All treatments were superior in efficacy to placebo. Lasmiditan 200 mg showed the highest two-hour pain freedom, while two-hour freedom from most bothersome symptom was equally achieved by the higher doses of lasmiditan (100 and 200 mg), rimegepant and the higher doses of ubrogepant (50 and 100 mg). The odds of treatment-emergent adverse events were greatest with all doses of lasmiditan. Lasmiditan 200 mg was the most effective intervention in the treatment of migraine attacks, although it was associated with high degrees of dizziness, nausea and somnolence. Rimegepant showed slightly lower, but similar efficacy rates to lasmiditan. Ubrogepant had overall the best tolerability profile. These conclusions are limited by the absence of head-to-head comparisons, limitations of individual trials and of the meta-analysis methodology itself.PROSPERO trial registration: CRD42022308224.

Comparison of 4-factor prothrombin complex concentrate and andexanet alfa for reversal of apixaban and rivaroxaban in the setting of intracranial hemorrhage.

The purpose of this study was to evaluate and compare clinical outcomes in patients who experienced intracranial hemorrhage (ICH) while taking apixaban or rivaroxaban and were reversed with four-factor prothrombin complex concentrates (4F-PCC) or andexanet alfa (AA). This retrospective cohort included adult patients that received 4F-PCC or AA for the initial management of an apixaban- or rivaroxaban-associated ICH. A primary outcome of excellent or good hemostatic efficacy at 12h post-reversal was assessed. Secondary outcomes evaluated were change in hematoma volume size at 12h, functional status at discharge, need for surgical intervention or additional hemostatic agents post-reversal, new thrombotic event within 28days, 28-day all-cause mortality, discharge disposition, and hospital and intensive care unit lengths of stay. A total of 70 patients were included (4F-PCC, n = 47; AA, n = 23). For the primary outcome analysis, 21 patients were included in the 4F-PCC group and 12 in the AA group. The rate of effective hemostasis was similar between the 4F-PCC and AA groups (66.7% vs 75%, p = 0.62). There were no statistically significant differences between the groups for secondary outcomes, including 28-day mortality (40.4% vs 39.1%, p = 0.92) and thrombotic complications within 28days of reversal (17.0% vs 21.7%, p = 0.63). In patients who experienced an ICH while taking apixaban or rivaroxaban, 4F-PCC and AA were found to have similar rates of excellent or good hemostatic efficacy.

783: COMPARATIVE COHORT STUDY OF REVERSAL AGENTS FOR BLEEDING ASSOCIATED WITH FACTOR XA INHIBITORS

Introduction: While andexanet alfa (AA) is approved for reversal of bleeding associated with factor Xa inhibitors, rates of mortality, efficacy, and thrombotic events from retrospective studies evaluating AA and four factor prothrombin complex concentrate (PCC) are similar, with significant differences noted in cost between agents. However, many of these studies have low power and competing findings. This study sought to characterize all-cause mortality, efficacy, and morbidity of patients administered AA and PCC within a single hospital network. Methods: This was a retrospective cohort study of adult patients administered AA or PCC between October 2018 and June 2020 for reversal of bleeding associated with factor Xa inhibitor usage. Patients were excluded if reversal was attempted prior to an emergent operation. The primary endpoint was hospital mortality, with concurrent evaluation of 60-day all-cause mortality, thrombotic event rates, and discharge disposition. Results: 142 patients presented with bleeding requiring anticoagulation reversal within the study period. 94 patients received PCC and 48 patients received AA. Patient groups were similar with regards to all demographic characteristics except for gender, and had similar Glasgow Coma Scale (GCS) and Charlson Comorbidity Index (CCI) scores. Traumatic injury causing bleeding was noted in 44.7% vs 41.7% of PCC vs AA patients (p=0.732). Central nervous system (CNS) bleeds were noted in 43.6% vs 43.8% of PCC and AA patients, with similar rates of CNS, gastrointestinal (GI), and other locations of bleeding between groups. Efficacy within 48 hours was 75.9% vs 82.4% for PCC and AA in patients with CNS bleeding. In-hospital mortality was higher for patients receiving AA (14.9% vs 27.1%, p=0.006), with similar 60-day mortality, hospital length of stay (LOS), rates of thrombotic events, and discharge disposition. Average cost of AA across study patients was $36,094, while the average cost of PCC was $5,596 (p< 0.001). Conclusions: AA is associated with higher mortality compared to PCC, although with similar rates of thromboembolic complications and efficacy. The mortality difference requires further investigation for confirmation. The cost of AA was higher in comparison to PCC.

East asian herbal medicine for the treatment of children with attention deficit hyperactivity disorder: A Systematic Review and Meta-analysis

BackgroundAttention deficit hyperactivity disorder (ADHD) is a mental illness that can place a significant burden on individuals, their families, and society. East Asian Herbal Medicine (EAHM) has long been used in East Asian nations to treat mental illness in children. Nevertheless, the evidence for the effectiveness of EAHM for the treatment of ADHD is insufficient. A systematic review was performed to examine the effectiveness and safety. In addition, research on core herbal combinations was also conducted to help clinicians in their prescription selection. Materials and methodsThis systematic review and meta-analysis were prepared according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. The following databases were searched: 4 English databases (PubMed, Cochrane Library, Cumulative Index to Nursing & Allied Health Literature (CINAHL), EMBASE), 4 Korean databases (Korean Studies Information Service System (KISS), Research Information Service System (RISS), Oriental Medicine Advanced Searching Integrated System (OASIS), Korea Citation Index (KCI)), 2 Chinese databases (Chinese National Knowledge Infrastructure Database (CNKI), Wanfang Data), and 1 Japanese database (CiNii) database. The publication bias was evaluated using funnel plots. GRADE pro was used to evaluate the evidence of the study. The core herb combination of EAHM used in this study was revealed using apriori algorithm-based association rule mining. ResultsThis review assessed 42 studies that evaluated 3484 children and adolescents. In meta-analysis, EAHM monotherapy had a similar clinical efficacy rate to conventional medicine (CM) (n = 2166; random effects RR 1.09, 95% CI 1.05 to 1.13; heterogeneity χ2= 25.08, df = 23, p = 0.35, I2=8%). EAHM-combined therapy showed a better clinical efficacy rate than when conventional therapy was used alone (n = 746; fixed effects RR 1.19, 95% CI 1.12 to 1.26; heterogeneity χ2= 11.80, df = 9, p = 0.22, I2=24%). For adverse events, EAHM had a lower incidence than conventional therapy. In GRADE pro, each outcome varied from moderate to very low quality. The constituents of the herb combinations with consistent association rules were Fossilia Ossis Mastodi, Polygalae Radix, and Acori Graminei Rhizoma. ConclusionEAHM monotherapy has similar effects to CM but with fewer side effects. Hence, it will be helpful for children with ADHD suffering from the side effects of CM. EAHM-combined therapy has a better effect than conventional therapy. Accordingly, it will be useful for children with ADHD who do not respond to treatment with conventional therapy. Nevertheless, more well-designed studies will be needed to confirm this in the future.

Ustekinumab to guselkumab transitions: A series of 54 patients emulating the navigate trial in real life.

NAVIGATE clinical trial demonstrated a higher rate of Psoriasis Assesment Severity Index (PASI)90 response in patients treated with guselkumab when compared to ustekinumab and an improved response in those who switched from ustekinumab to guselkumab due to partial response. The objective of the study is to describe ustekinumab to guselkumab switching in clinical practice. Observational, multicentric, descriptive study including 54 psoriasis patients who switched to guselkumab after treatment with ustekinumab from March 2019 to February 2021. Mean basal PASI with ustekinumab (16.7) was higher than with guselkumab (7.2). Up to 49.01% of patients were able to reach PASI90 with ustekinumab and up to 21.56% had a less frequent dosage regime vs. summary of product characteristics. Main reason to start guselkumab was a loss of ustekinumab cutaneous or articular response (82.36%) but up to 17.64% were switched in order to increase dosage regime efficiency. Six months after starting guselkumab, the absolute PASI was lower than 2 in 72% of patients and 38.5% of them were treated with a reduced dosage regime. Guselkumab doses used by our cohort were 19.5% lower than the expected according to the summary of product characteristics. No adverse events reported. There is no real-world evidence regarding patients who switched from ustekinumab to guselkumab. A short paragraph in the article by Fougerousse et al, reported 63 patients with a mean basal PASI of 5.3 and similar efficacy rate at week 16 to NAVIGATE. Our study adds practical information regarding efficacy, safety and efficiency through dose optimization in a real-world cohort.

Effects of Surgery Combined with Different Chemotherapy on Matrix Metalloproteinase-9 and Tissue Inhibitors of Metalloproteinase-1 in Children with Neuroblastoma.

Background Neuroblastoma (NB) is a common extracranial malignancy in children and accounts for 15% of all cancer-related deaths in children, with the 5-year survival of patients in an advanced stage being lower than 40%. Preoperative adjuvant chemotherapy has been reported to facilitate surgical resection and improve the 2-year survival of patients. Objective To analyze the efficacy of surgery plus different chemotherapy on children with NB and to investigate the correlation of matrix metalloproteinase-9 (MMP-9) and tissue inhibitors of metalloproteinase-1 (TIMP-1) with chemotherapy efficacy. Methods From April 2005 to May 2017, a total of 92 cases of NB treated in our hospital were assessed for eligibility and recruited. They were assigned at a ratio of 1: 1 to receive either CAV (cyclophosphamide + vincristine + adriamycin) (group A) and EP (etoposide + cisplatin) alternately or TOPO (topotecan) + CTX (cytoxan) + CiE (etoposide + cisplatin) + CPV (cyclophosphamide + pirarubicin + vincristine) (group B). The outcome measures include chemotherapy efficacy, surgical resection rates, complications, 2-year recurrence, and 2-year survival. The levels of NK cells, CD4+/CD8+ cells, MMP-9, TIMP-1, and urine catecholamine (VMA) in peripheral blood of patients before and after initial chemotherapy were determined to analyze the correlation of MMP-9, TIMP-1, and VMA with the efficacy of chemotherapy. Results The two groups had similar efficacy (84.00% vs. 95.24%) and surgical resection rates (60.00% vs. 61.90%) after the initial chemotherapy (P > 0.05). Surgery for all eligible patients was successful after second chemotherapy. All eligible patients showed myelosuppression after chemotherapy, including 48 cases with stages I-II (52.17%) and 44 cases with stages III-IV (47.83%). The ratio of CD4+/CD8+ cells, MMP-9, TIMP-1, and VMA expression levels in peripheral blood of patients decreased (P < 0.05) after chemotherapy, and the ratio of CD4+/CD8+ cells was further reduced after surgery (P < 0.05), while natural killer (NK) cells levels increased (P < 0.05). However, intergroup differences were absent in the incidence of myelosuppression, CD4+/CD8+ cell ratio, NK cells, MMP-9, TIMP-1, and VMA expression levels (P > 0.05). MMP-9 and TIMP-1 were positively correlated with VMA (P < 0.05), and the expression levels of MMP-9 and TIMP-1 and VMA after chemotherapy were negatively correlated with chemotherapy efficiency (P < 0.05). Patients with high expressions of MMP-9, TIMP-1, and VMA were associated with lower 2-year survival versus those with low expressions (P < 0.05). Conclusion Surgery plus chemotherapy for children with NB yields a promising clinical efficacy and a favorable surgical resection outcome. MMP-9 and TIMP-1 may be the potential biological indicators for chemotherapy efficiency and have a reference value for following surgical treatment of patients.