Differences In Baseline Characteristics Research Articles

Eculizumab for adult patients with atypical haemolytic-uraemic syndrome: full dataset analysis of Japanese post-marketing surveillance.

Eculizumab has been approved for atypical haemolytic-uraemic syndrome (aHUS) in Japan since 2013. Post-marketing surveillance enrolled patients with aHUS who received ≥ 1 dose of eculizumab to assess eculizumab safety and effectiveness. We evaluated serious adverse events and effectiveness endpoints, i.e., haematologic normalization, a decrease of ≥ 25% in serum creatinine (sCr) levels, and complete thrombotic microangiopathy (TMA) response in adult patients with aHUS without otherunderlying diseases. In addition, the difference of baseline characteristics between patients who did and did not meet effectiveness endpoints was examined. In this safety and effectiveness analysis, 79 adult patients were included; median age was 54.0years, median treatment duration was 30weeks. Total exposure time of eculizumab was 75.51 patient-years, and 94 serious adverse events were reported in 39 patients. No unexpected safety signals were identified in this population. Mean platelet count, lactate dehydrogenase and estimated glomerular filtration rate significantly improved after 7daysof treatment. Complete TMA response, haematologic normalization and the improvement of sCr levels were met by 35.3%, 40.4% and 51.3% of patients, respectively. Median treatment duration was shorter in patients who did not achieve complete TMA response (6weeks) than in patients who did (114weeks). Multivariate analysis suggested that the time from the most recent TMA episodeto start ofeculizumab treatment was negatively associated with kidney function improvement. No unexpected safety signals of eculizumab were identified in Japanese patients with aHUS in a real-world setting. Renal outcomes were negatively associated with the time from the most recent TMA episodeto the initiation of eculizumab treatment.

Analysis of weight loss, metabolism, and anti-reflux effect of sleeve gastrectomy combined with fundoplication as treatment of obesity complicated by gastroesophageal reflux disease

Objective: To explore the weight-loss, metabolism, and anti-reflux effect of laparoscopic sleeve gastrectomy combined with fundoplication (SGFD) as treatment of obesity complicated by gastroesophageal reflux disease (GERD) with the aim of identifying the best treatment for such patients. Methods: This was a retrospective cohort study. Relevant clinical data of 140 patients with obesity (body mass index≥30 kg/m2) complicated by GERD (confirmed by preoperative GerdQ score, gastroscope, upper gastrointestinal radiography, 24-hour pH monitoring of esophagus, and high-resolution esophageal manometry) who had undergone bariatric surgery in the Minimally Invasive Surgery, Hernia and Abdominal Surgery Department of the People's Hospital of Xinjiang Uygur Autonomous Region from January 2019 to February 2023 were collected. The participants were allocated to the following groups according to surgical procedure performed: sleeve gastrectomy group (SG group, 92 cases) versus SGFD (SGFD group, 48 cases). SGFD, a new type of anti-reflux weight loss surgery that achieves both anti-reflux and weight loss effects by a procedure involving "cutting first and then folding", was developed by our team. In this study, our main aim was to compare and analyze differences in outcomes between the SG and SGFD groups in terms of weight loss and improvements in metabolism and reflux 3 and 6 months postoperatively. Results: The 140 patients comprised 50 men and 90 women of average age 36.0±9.6 years and preoperative body mass index (BMI) (38.5±6.5) kg/m2. The average preoperative GERD score was 10.2±1.6. There were no significant differences in baseline characteristics between the SGFD and SG groups (all P>0.05). There were also no significant differences in postoperative hospital stay, intraoperative blood loss, or postoperative complications between the two groups (all P>0.05). However, the operation time was longer in the SGFD than SG group (137.5±10.5 minutes vs. 105.3±12.6 minutes, t=-15.131, P<0.001). Compared with preoperative values, fasting blood glucose, cholesterol, body mass, BMI, and GERD score were all lower 3 months postoperatively (all P<0.05). Six months postoperatively, triglyceride, uric acid, and DeMeester score were lower in the SGFD than SG group; however, the lower esophageal sphincter resting pressure was higher in the SGFD group (all P<0.05). There were no significant differences in weight loss indexes (body mass, BMI, percentage of excess body mass loss) or metabolic indexes (fasting blood glucose, triglyceride, cholesterol, and uric acid concentrations) between the SG and SGFD groups 3 and 6 months postoperatively (all P>0.05). However, anti-reflux indexes (GerdQ score, DeMeester score, and lower esophageal sphincter resting pressure) were all significantly better in the SGFD than SG group 6 months postoperatively (all P<0.05). Conclusion: Obese patients with GERD get good weight loss, metabolism improvement and anti-reflux effect after SGFD. SGFD is a safe and feasible surgical method, and its anti-reflux effect is better than SG at the 6th month after operation, so it is feasible.

Evaluation of the quality of life of patients with leadless pacing system during 1 year follow-up period

Abstract Background Leadless pacemakers (LesPM) are a new safe alternative technology for pacing the right ventricle. However, not enough information is available on their potential benefits for quality of life (QoL) in patients with LesPM. The purpose of the study was the quality of life comparison of patients with LesPM and conventional pacemakers (ConvPM). Methods The study included patients who underwent implantation of a single-chamber pacemaker from December 2018 to March 2023. We used the SF-36 Questionnaire to assess quality of life at baseline and after 12 and 24 months of follow-up. We also used a questionnaire consisting of 10 specific questions related to the implantation procedure. Results Total of 50 patients were included (25 LesPM; 25 ConvPM). There were no differences in baseline characteristics between groups (LesPM vs. ConvPM), except for age (47.5 vs. 57.3 years; P = 0.012) and diabetes 28% vs. 21%; P = 0.021). Baseline SF-36 did not differ between groups. After 6 months of follow-up, patients in the LesPM group showed significantly higher scores on physical function (47 vs 32; P&amp;lt;0.001), physical role (53 vs 37; P=0.004) and mental health (67 vs 52; P=0.017), even after adjusting for covariates. Pacemaker-related discomfort and physical limitations were significantly lower in the LesPM group. Conclusion LesPM is associated with a better quality of life than ConvPM, both in terms of physical and mental health. Patients who underwent LesPM implantation reported less procedure-related discomfort, physical limitations, and anxiety.

Weight change does not impact the long-term outcomes following pulmonary vein isolation in obese patients with atrial fibrillation

Abstract Background Weight loss has been shown to reduce the burden of atrial fibrillation (AF) in obese patients. However, there are limited data on the impact of weight loss on long-term outcomes in patients with atrial fibrillation (AF) who undergo pulmonary vein isolation (PVI). Objective To understand the impact of weight change, as assessed by freedom from recurrent AF, in obese patients undergoing cryoballoon (CB) PVI. Methods We enrolled consecutive obese (BMI ≥ 30 kg/m2) patients with AF who underwent CB PVI; all patients had an implantable loop recorder (ILR) for long-term ECG monitoring. The cohort was divided into 3 groups based on their weight change 1-year after ablation: (1) weight loss (WL) &amp;gt; 3% weight decrease; (2) no weight change (NWC) - weight change &amp;lt; 3%, (3) weight gain (WG) &amp;gt; 3% weight increase. We assessed long-term AF recurrences, after excluding an initial 3-month post-ablation blanking period. Results Out of total of 137 pts with obesity, 61 pts had weight available at the ablation and at 1-year follow-up (65 ± 9 years; 41 [67%] male; 23 [38%] PAF; CHA2DS2-VASc 2.9 ± 1.7). There were no differences in baseline characteristics. At follow-up, 24 (39%), 26 (43%), and 11 (18%) pts lost, had no change, or gained weight, respectively. Of the 24 pts who lost weight, 3 pts lost &amp;gt; 10% body weight. During a follow-up of 964 ± 512 days, 41 (67%) pts had recurrent AF; the change in weight did not impact outcomes (Figure), including those who lost &amp;gt; 10% body weight. Conclusions During 3-years of follow-up, 2/3 of obese patients had objective evidence of AF recurrence following CB PVI. Weight change in the first-year post ablation did not alter long-term outcomes. Other strategies may be needed in these patients to improve outcomes.

First comparison of single-tip versus single-shot pulsed field ablation for pulmonary vein isolation in paroxysmal atrial fibrillation: interim analysis of a randomized trial

Abstract Background Non-thermal pulsed field ablation (PFA) is an emerging technology to perform pulmonary vein isolation (PVI) for atrial fibrillation (AF). Different PFA systems are available, but no comparative data exist. Purpose Randomized trial to compare single-tip versus single-shot PFA for initial PVI in paroxysmal AF patients. Methods In this single-center trial, paroxysmal AF patients are prospectively enrolled and 1:1 randomized in the single-tip or single-shot PFA group. Single-tip PVI is performed using a PFA generator and a 3.5mm contact-force enabled ablation catheter guided by 3D mapping system. The pulsed electric field dosing is 25 Ampere (A) (anterior) and 22 A (posterior), respectively. In the single-shot PVI group, a 31 or 35mm pentaspline PFA catheter is used for fluoroscopy-guided PVI. Eight PFA applications (2.0 kV) are applied per PV. In this interim analysis, acute efficacy, safety and short term clinical outcome within the 3 months blanking period were assessed. A subset of patients underwent cerebral MRI to detect silent lesions. Results To date, 50 patients were enrolled and underwent PVI in conscious sedation (25 single-tip, 25 single-shot, 63 ± 5 years, 42% female, CHA2DS2-VASc 2 [1-3]). There were no differences in baseline characteristics. Acute PVI was achieved in 100%. In the single-tip group, total procedure time was significantly longer (125 ± 31 min vs. 44 ± 12 min, p &amp;lt;0.001) and fluoroscopy time was significantly shorter (4 ± 2 min vs. 15 ± 6 min, p &amp;lt;0.001) as compared to the single-shot group. One groin hematoma was noted in the single-shot group. In the single-tip group, 1 aneurysm spurium was detected and 1 pericardial tamponade requiring drainage resulted from coughing during single-tip PFA while no real-time visualization of the catheter was available. No permanent sequelae occurred. There were no PFA specific complications and no cerebral embolisms were detected in all 14 MRI scans. At 3 months, 92% (single-shot group) and 80% in the single-tip group were free from arrhythmia (p=0.42). AF recurrences in the blanking period occurred in 2 patients in the single-shot group and in 5 patients in the single-tip group after a median of 2 [1-5] days following the procedure. Conclusions In this interim analysis of a randomized trial, single-shot or single-tip PFA for PVI both demonstrated high acute efficacy and a favourable 3 months clinical outcome. Procedural time was significantly longer in the single-tip PFA group. No silent lesions were detected in cerebral MRI. Non-availability of real-time visualization and contact-force information of the single-tip ablation catheter during energy application is a current technical limitation that could be associated with complications.

Post-operative atrial fibrillation after noncardiac surgery: diagnostic role of ambulatory rhythm monitoring for recurrent arrhythmia after hospital discharge

Abstract Introduction Postoperative atrial fibrillation (POAF) after noncardiac surgery constitutes 10-15% of all cases of incident atrial fibrillation (AF) in the community and has been associated with an increased risk of stroke. The risk of subsequent AF among patients with POAF is not well defined. Purpose To evaluate the role of systematic 30-day electrocardiographic (ECG) monitoring in the detection of AF recurrence after POAF. Methods In a prospective interventional study, patients who underwent major noncardiac surgeries and had new AF documented by ECG in the post-operative period between May 2022 and April 2023 were identified. For these patients, a 30-day ambulatory ECG monitor was recommended upon discharge, with final ordering deferred to the primary inpatient teams. Rates of recurrent AF of any duration detected by 30-day monitoring plus routine care versus routine care alone after the surgery were compared. Results Eighty-five patients with new-onset POAF were included (mean age 72 years, male 67%). Of these, 35 (41%) patients underwent up to 30 days [median 23 (IQR 6-27) days] of continuous ECG monitoring after hospital discharge. There were no significant differences in baseline characteristics between patients who did or did not undergo monitoring (Table 1). During median 281 (IQR 197-385) days of follow-up, recurrent AF was documented in 14/35 (40%) patients in the monitoring group as opposed to 7/50 (14%) patients in the usual care group (log-rank p=0.003, Figure 1). The median time from day of surgery until documented AF recurrence was 25 (IQR 6-53) days in the monitoring group and 66 (IQR 25-145) in the usual care group. Overall, 81% of recurrent AF events in both groups were detected in the first 3 months after surgery. The median burden of AF in the cardiac monitoring group was 7% (IQR 1-15), with the longest AF event lasting a median of 6 (IQR 2-18) hours. Anticoagulation for AF was prescribed in 24/64 (37%) patients with POAF without recurrence and in 16/21 (76%) patients with recurrent AF. Conclusion Recurrent AF following POAF is common and detected most frequently in the first 3 months after noncardiac surgery. Systematic ambulatory rhythm monitoring is associated with a higher rate of AF detection following hospital discharge and may identify a patient subgroup who might benefit from anticoagulation therapy.Table 1Figure 1

Prophylactic administration of glycopyrrolate prevents vasovagal responses induced by pulsed field ablation in patients with atrial fibrillation

Abstract Background The FarapulseTM system was the first pulsed field ablation device to receive regulatory approval. Vagal Responses (VR) during pulmonary vein isolation (PVI) with this pentaspline device are frequent and often require back-up pacing or the administration of parasympathetic drugs. Glycopirrolate (GLY) is a medication of the muscarinic anticholinergic group; its efficacy for VR prevention when administered prophylactically before PVI has never been reported. Objective To evaluate the effectiveness of prophylactic intravenous administration of GLY on VRs induced by PFA. Methods Consecutive AF patients undergoing first-time PVI with PFA via the FarapulseTM system between April and October 2023 were prospectively enrolled in 3 European centers. Prophylactic administration of GLY (0.2 mg intravenous administration before femoral vein puncture) [Group GLY(+)] was adopted based on operator’s preference. VR was defined as at least one of the following: sinus bradycardia (&amp;lt;40 beats/min), asystole (&amp;gt;6 sec), or atrioventricular block (AVB) occurring immediately after a pulsed electric field application. VRs and maximum pause duration (maximum RR interval) were determined for each PV. Temporary backup pacing was performed as per the operator's preference. Results We enrolled 141 patients [GLY(+): 64 patients; GLY(-): 77 patients] undergoing PVI with the pentaspline FarapulseTM system. Median age was 54.1 years (54.1- 70), and 76 (54%) patients were males with an average CHA2DS2-VASc Score of 1.0 (0 – 2). A total of 563 PVs, including 3 left common PVs and 2 accessory middle PVs, were successfully isolated with the FarapulseTM PFA system. There were no statistically significant differences in baseline and procedural characteristics between two groups. VRs during PVI occurred in a total of 53 (37.6%) patients. GLY administration reduced significantly the incidence of any VRs (4.7% vs 64.9%; p&amp;lt;0.001) (Figure 1A). Additionally, GLY resulted in a lower incidence of VRs during LSPV (4.7% vs 62.3%; p&amp;lt;0.001) and LIPV (1.6% vs 9.1%; p&amp;lt;0.001) (Figure 1B) isolation and the need for temporary backup pacing during LSPV (24.7% vs 1.6%; p&amp;lt;0.001) isolation. Maximum pause duration was significantly shorter in the GLY(+) group after PFA of LSPV (1195 vs 3459 sec; p&amp;lt;0.001), LIPV (1128 vs 1556 sec; p&amp;lt;0.001), RSPV (1138 vs 1607 sec; p&amp;lt;0.001) and RIPV (1103 vs 1343 sec; p&amp;lt;0.001) compared to GLY(-) group (Figure 1C). Conclusions Glycopyrrolate is highly effective in the prevention of VRs induced by PFA ablation in AF patients undergoing first-time PVI.Figure 1

#2891 Comparing health-related quality of life and symptom burden in patients undergoing twice-weekly versus thrice-weekly haemodialysis

Abstract Background and Aims Patients with kidney failure who initiate haemodialysis (HD) have traditionally followed a thrice-weekly, 4-hour schedule. Recently, incremental dialysis (i.e. initiating HD with lower frequency and/or treatment duration) has been advocated. It has been suggested that residual kidney function is better preserved, while mortality is similar when initiating dialysis with a twice versus thrice weekly schedule. It remains unclear which impact initiating dialysis twice a week has on health-related quality of life (HRQoL) in the short and long term. Therefore, the aim of this study was first to investigate the impact of following a twice-weekly dialysis schedule on the mental and physical HRQoL and symptom burden compared to thrice-weekly dialysis during the first year of dialysis. Second, to investigate the long term impact on mental and physical HRQoL and symptom burden of patients who solely started on a twice-weekly versus thrice-weekly schedule. Method Data were obtained from the ongoing multicentre, prospective, observational Dutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes (DOMESTICO). This study longitudinally compares HRQoL between home and in-center dialysis. For this analysis, incident HD patients &amp;gt; 18 years were included, if they started on a twice-weekly or thrice-weekly schedule. Mental and physical HRQoL was measured using the validated 12-item Short Form Health Survey (SF12, summary scores ranging from 0 to 100). Symptom burden was measured using the dialysis symptom index (DSI), consisting of 30 items on dialysis-related symptoms, these symptoms are reported using a 5-point Likert scale. The overall burden score, ranging from 0 to 150, was calculated by summing every symptom and its severity. The first aim was longitudinally analysed using linear mixed models, using measures at 3, 6 and 12 months after start dialysis. The second aim was cross-sectionally analysed at 1, 2 and 3 years after dialysis initiation using linear regression models. All models were adjusted for possible confounders. Results A total of 1007 patients were included, of whom 205 started on a twice-weekly schedule and 802 on a thrice-weekly schedule. The total population had a mean age of 64 ± 15 years and 35% were women. There was no significant difference in baseline characteristics between twice-weekly and thrice-weekly dialysis. At baseline mental and physical HRQoL for patients on twice-weekly dialysis were 45.9 ± 9.5 and 36.0 ± 10.7, respectively. In thrice-weekly dialysis this was 45.8 ± 10.3 and 35.0 ± 9.7. The symptom burden score at baseline was 33.0 ± 19.6 for twice-weekly and 34.0 ± 21.7 for thrice-weekly patients. As shown in Table 1, there were no significant differences in HRQoL or symptom burden over the first year of dialysis when comparing twice-weekly with thrice weekly HD. In Table 2 the long-term cross-sectional analyses show that starting with a twice-weekly schedule results in physical and mental HRQoL scores gradually becoming lower, with a statistically significant decrease in physical HRQoL score at 3 years after start dialysis (ß = −0.825, 95% CI −14.11; −2.38). There was no significant difference in symptom burden between the two schedules. Conclusion We found no differences in HRQoL or symptom burden during the first year of dialysis comparing incident patients on a twice-weekly versus thrice-weekly hemodialysis schedule. Conversely, starting on a twice-weekly dialysis schedule appears to be associated with a lower HRQoL, especially physical HRQoL, in the longer term. Following our results, physicians should be cautious of the possible negative effects on HRQoL when prescribing a twice-weekly dialysis schedule.

#1378 A single-center retrospective study on clinical characteristics and outcomes of extended-spectrum beta-lactamases positive acute pyelonephritis

Abstract Background and Aims The increase of extended-spectrum beta-lactamases (ESBL) releasing bacteria in acute pyelonephritis (APN) is a growing problem world-wide. Recently, little is known about the incidence, clinical features and outcomes of ESBL positive APN. This study intends to describe the epidemiology and clinical outcomes of ESBL positive APN. Method A retrospective study of 1631 culture positive patients with APN admitted from Jan, 2011 to Dec, 2019 in a single-center was performed. Adults over 18 years of age were included, and outpatient treatment, pregnant women, and transplant patients were excluded. Result A total of 2818 patients were diagnosed as APN during this period and causative bacteria was confirmed in1631 patients among them (57.9%). ESBL positive bacteria were found in 553 patients (33.9%). There were no differences in baseline characteristics between ESBL positive and negative groups. Most common strain was Escherichia coli, followed by Klebsiella and Pseudomonas species. The proportion of ESBL positive APN increased when evaluated at one-year intervals for 8 years (from 4.9% in 2011 to 20.9% in 2019). The rate of positive blood culture was higher in ESBL positive patients (39.2% vs 21.1%, p&amp;lt;0.001). Hospital stay was longer in ESBL positive patients (12.3 ± 2.2 vs. 5.4 ± 5.2, p&amp;lt;0.001) and the number of re-admission is higher (1.7 ± 1.3 vs. 1.2 ± 0.6, p&amp;lt;0.001). The incidence of acute kidney injury according to KDIGO was higher in ESBL positive groups (25.4% vs 12.3%, p&amp;lt;0.001). There was no hospital mortality between two groups. Conclusion We should attempt to detect ESBL positive bacteria through timely performing blood and urine culture and administer appropriate antibiotics if APN is clinically suspected because of poor clinical courses.

#2609 Comparison of baseline patient characteristics of the CONVINCE randomized controlled trial with existing trial and registry populations

Abstract Background and Aims The generalizability of randomized controlled trials (RCTs) results is based on representativeness of the population involved. Trial populations may have different baseline characteristics compared to the general population that could benefit from the intervention. We compare the baseline characteristics of patients involved in the CONVINCE trial with those involved in all previous RCTs and representative registries of patients receiving hemodialysis as renal replacement therapy. Method Based on world class methods for systematic reviews, we identified all RCTs comparing hemodiafiltration (HDF) with hemodialysis (HD) published up to January 2024 and extracted data on baseline patient characteristics. Where data were missing, authors have been contacted and data so far obtained were included in this analysis (Fig. 1). Additional contact attempts are being performed. In addition, a comprehensive search was conducted to identify renal registries from all geographic regions. Those without information in English, without information on HDF and registries focusing on special patient groups (e.g. transplantation only) were excluded. This registry data will not be analyzed in this abstract as we are in progress of extracting the patient data from the latest registry annual reports available up to January 2024 for further analysis. Results We have selected 11 RCTs for further analysis, with the selection criteria and outcomes presented in Fig. 1. Key patient characteristics from RCTs were compared with those of patients in the CONVINCE trial using descriptive statistics and forest plots (Fig. 1). Comparison of differences was analyzed with the Kruskal-Wallis-Test. Interpretation of the results are as follows: • Age: Mean age of 76.5 years noted in Morena et al. (2017) because study inclusion criterion was ≥65 years. Other RCTs ranged from 54.1 to 68 years, which is consistent with 62.4 years in the CONVINCE trial (χ2 = 10, df = 10, p = 0.44). • Sex: 16.7% and 50% female noted in Selby et al. (2006) and Meert et al. (2009) respectively probably due to limited sample size (12 patients and 14 patients respectively). Other RCTs ranges from 30.4% to 42.5%, which is consistent with 36.0% in the CONVINCE trial (χ2 = 11, df = 11, p = 0.44). • Diabetes comorbidities: Ranges from 17.8% to 45%. CONVINCE trial is 35.0% (χ2 = 6, df = 6, p = 0.42). • Cardiovascular diseases comorbidities: Range from 26.4% to 45%. CONVINCE trial is 45% (χ2 = 3, df = 3, p = 0.39). • AVF as vascular access: value of 100% in Pedrini et al. (2011) because it was an inclusion criterion. Other RCTs ranged from 79.4% to 90%, which is consistent with 82% in the CONVINCE trial (χ2 = 7, df = 7, p = 0.43). There were no significant differences between CONVINCE and other RCTs data regarding all 5 patient baseline characteristics. Conclusion Our analysis showed the CONVINCE trial has no significant differences in patient baseline characteristics compared to previous RCTs. For a more comprehensive evaluation of representativeness of the trial's population, we are currently retrieving missing data from the trial authors and analyzing data from hemodialysis registries.

Racial and ethnic characteristics and outcomes of patients diagnosed with CLL/SLL in the United States.

Background This study was designed to compare outcomes among patients by race and ethnicity in the post-covalent Bruton tyrosine kinase inhibitor (cBTKi) treatment era. Methods A nationwide electronic health record (EHR)-derived de-identified database was utilized that included patients diagnosed with CLL from 2013-2022 who received systemic therapy for their disease. Use of cBTKi therapy, time to next treatment or death (TTNT-D), and overall survival (OS) were compared by race in unadjusted (Kaplan-Meier method) and adjusted analyses (Cox proportional hazards regression). Results This study included 4,572 White (71.8%) and 558 Black (8.8%) patients with CLL; 270 were Hispanic or Latino (4.2%). Patients who were Black were significantly younger, more were female, had later stage disease, were of lower socioeconomic status (SES), more likely to have unmutated immunoglobulin heavy chain gene (IGHV) and to havereceived cBTKi therapy than White patients (all p≤0.002). SES was also significantly different by ethnicity. TTNT-D and OS were not different by race in either unadjusted or adjusted analyses (all p>0.05). Conclusion In unadjusted and adjusted analyses, TTNT-D and OS were not different by race. These data did not identify racial healthcare disparities in the era following the introduction of cBTKi therapy despite differences in baseline characteristics.

Comparison of lateral flank approach and low anterior access for single port (SP) retroperitoneal partial nephrectomy: an analysis from the single port advanced research consortium (SPARC).

Single Port (SP) robotic partial nephrectomy (RPN) can be performed via retroperitoneal and transperitoneal approach. We aim to compare outcomes of two commonly described incisions for retroperitoneal SP RPN: lateral flank approach (LFA) and low anterior access (LAA). We performed a retrospective study of patients who underwent SP retroperitoneal RPN from 2018 to 2023 as part of a large multi-institute collaboration (SPARC). Baseline demographic, clinical, tumor-specific characteristics, and perioperative outcomes were compared using χ2, t test, Fisher exact test, and Mann-Whitney U test. Multivariable analyses were conducted using robust and logistic regressions. A total of 70 patients underwent SP retroperitoneal RPN, with 44 undergoing LAA. Overall, there were no significant differences in baseline characteristics between the two groups. The LAA group exhibited significantly lower median RENAL scores (8 vs. 5, p < 0.001) and more varied tumor locations (p = 0.002). In the bivariate analysis, there were no statistically significant differences in ischemia time, estimated blood loss, or complication rates between the groups. However, the LAA group had longer operative times (101 vs. 134min, p < 0.001), but was more likely to undergo a same-day discharge (p < 0.001). When controlling for other variables, LAA was associated with shorter ischemia time (p = 0.005), but there was no significant difference in operative time (p = 0.348) and length of stay (p = 0.122). Both LFA and LAA are acceptable approaches for SP retroperitoneal RPN with comparable perioperative outcomes. This early data suggests the LAA is more versatile for varying tumor locations; however, larger cohort studies are needed to ascertain whether there is an overall difference in patient recovery.

Real-world effectiveness of dupilumab versus benralizumab and mepolizumab.

In the United States, this real-world study compared the effectiveness of dupilumab, benralizumab, andmepolizumab in reducing exacerbations and systemic corticosteroid (SCS) prescriptions among patients with asthma. Patients (12 years old) who initiated dupilumab, benralizumab, or mepolizumab (index) between November 2018 and September 2020 were identified by using electronic medical record data. Subjects were included if they had greater than or equal to 12 months of data before and after the index date and two or more severe asthma-related exacerbations before the index date. Differences in baseline characteristics were addressed by using inverse probability treatment weighting (IPTW). Pairwisecomparisons between dupilumab and benralizumab, or mepolizumab were conducted by using negative binomial regression, adjusting for baseline rates and unbalance characteristics (greater than or equal to 10% standardized differences) after IPTW. Overall, a total of 1737 subjects met all criteria: 825 dupilumab, 461 benralizumab, and 451 mepolizumab initiators.In the postindex period, dupilumab was associated with a 24% and 28% significant reduction in the risk of severe asthmaexacerbations versus benralizumab (incidence rate ratio [IRR] 0.76 [95% confidence interval {CI}, 0.67-0.86)] and mepolizumab(IRR 0.72 [95% CI, 0.63-0.82]), respectively. In addition, dupilumab treatment significantly reduced SCS prescriptionsby 16% and 25% versus benralizumab and mepolizumab, respectively (p < 0.05). This study represents one of the largest real-world comparisons of biologics (dupilumab, benralizumab, and mepolizumab) for asthma in the United States to date. This analysis shows that the use of dupilumab was associated with a significantly greater reduction in both severe asthma exacerbations and SCS prescriptions compared with benralizumab and mepolizumab.

DECENNIAL ANALYSIS OF AVNRT ABLATION IN A SINGLE CENTRE

Abstract Background Transcatheter ablation represents the first line therapy for atrio–ventricular nodal re–entrant tachycardia (AVNRT). Both radiofrequency (RF) and cryoablation (CRYO) have been shown to be effective, with a better safety profile for CRYO. Data on very long–term efficacy are scarces. Purpose To review our experience in AVNRT ablation performed in the last ten years and evaluate safety, efficacy and very long–term outcome of RF and CRYO. Methods We retrospectively analyzed all patients who underwent AVNRT ablation (RF or CRYO) between January 2013 and May 2023 at our centre. The majority of procedures were performed under electro–anatomical mapping (EAM) guidance to reduce radiation exposure. Acute efficacy endpoint was defined as slow pathway ablation, while long–term outcome was defined as the absence of AVNRT recurrence. Results A total of 387 consecutive patients (60,5% F; mean age 48 ± 19 years) were included; CRYO was performed in 241 patients (62%), RF in 131 patients (34%), hybrid approach (CRYO+RF) in 15 patients (4%). AVNRT induction was obtained during EPS in 295 cases (76%), in 25,4% after isoprotenerol administration. No significant differences for baseline characteristics were observed between the two groups except for age (CRYO: 42,2 ± 18 years vs RF 57,19 ± 16,5 years p &amp;lt;0.001). In pediatric population CRYO was performed in 93% of procedures. Figure 1 shows the distribution of RF/CRYO over 10 years at our centre, with a trend of significant increase in CRYO utilizations in the last years. Acute success was achieved in all 387 cases (100%; delta WP 28,5 ± 23,1 ms, delta AVN ERP 72,4 ± 44,7 ms). No permanent AV block or major periprocedural complications occurred, however transient AH prolongation was observed in 0.8% in CRYO pts vs 2,8% RF pts. The mean follow–up was 73±45 months, range 6–129 months. Overall long–term success rate was 93,3%, ranging from 91,3 % in CRYO and 96,6% in RF. Recurrence occurred in 26 cases (6,7%) after a median time of 20 months (4–40months). Recurrent AVNRT were treated with RF in the majority of cases, CRYO in 6 procedures, hybrid in only 1 case. Conclusions Transcatheter ablation is a safe and effective therapy for AVNRT. Our very long–term outcome data confirmed very high success rate even after 10 years follow–up. The increasing choice for CRYO may be due to the increasing number of pediatric and young patient referred to our centre.

Safety and efficacy of Yaobitong capsules for lumbar disc herniation: A multicenter, randomized, double-blinded, parallel, positive-controlled clinical trial.

Lumbar disc herniation (LDH) is one of the most common diseases and is a global medical and socioeconomic problem characterized by leg or back pain, weakness in the lower extremities and paresthesia. A multicenter, randomized, double-blinded, parallel, positive-controlled clinical trial was conducted to evaluate the efficacy and safety of Yaobitong capsules (YBT) for LDH. Patients (n = 479) were recruited and randomized into YBT and Jingyaokang capsule (JYK) groups (the positive control), and received YBT or JYK at a dose of 3 capsules 3 times per day after a meal for 30 days. The primary efficacy outcome was the Oswestry Disability Index (ODI), with the visual analogue scale (VAS) used as the secondary efficacy outcome. The adverse events and adverse reactions were also evaluated. There was no significant difference in baseline characteristics between YBT (n = 358) and JYK groups (n = 120), and no difference was observed between groups for mean ODI score at day 0 (p = 0.064) or day 7 (p = 0.196), but there were differences at days 14, 21 and 30 (p < 0.001). The YBT showed more decline from baseline, and the decreased ODI score was substantially different from JYK (p < 0.001). The differences in decreased VAS scores between YBT and JYK were also significant at each time point (days 7, 14, 21, and 30), with better scores in the YBT group than in the JYK group (p < 0.001). In terms of safety, there was no obvious disparity in adverse events or adverse reactions between the 2 groups (p > 0.05). Yaobitong was better than JYK for LDH treatment, with no significant difference in safety. The study suggests that YBT is a promising and effective treatment for LDH.

Ejection Fraction-Related Differences of Baseline Characteristics and Outcomes in Troponin-Positive Patients without Obstructive Coronary Artery Disease.

Background: The development and course of myocardial infarction with non-obstructive coronary artery (MINOCA) disease is still not fully understood. In this study, we aimed to examine the baseline characteristics of in-hospital outcomes and long-term outcomes of a cohort of troponin-positive patients without obstructive coronary artery disease based on different left ventricular ejection fractions (LVEFs). Methods and results: We included a cohort of 254 patients (mean age: 64 (50.8-75.3) years, 120 females) with suspected myocardial infarction and no obstructive coronary artery disease (MINOCA) in our institutional database between 2010 and 2021. Among these patients, 170 had LVEF ≥ 50% (84 females, 49.4%), 31 patients had LVEF 40-49% (15 females, 48.4%), and 53 patients had LVEF < 40% (20 females, 37.7%). The mean age in the LVEF ≥ 50% group was 61.5 (48-73) years, in the LVEF 40-49% group was 67 (57-78) years, and in the LVEF < 40% group was 68 (56-75.5) years (p = 0.05). The mean troponin value was highest in the LVEF < 40% group, at 3.8 (1.7-4.6) µg/L, and lowest in the LVEF ≥ 50% group, at 1.1 (0.5-2.1) µg/L (p = 0.05). Creatine Phosphokinase (CK) levels were highest in the LVEF ≥ 50% group (156 (89.5-256)) and lowest in the LVEF 40-49% group (127 (73-256)) (p < 0.05), while the mean BNP value was lowest in the LVEF ≥ 50% group (98 (48-278) pg/mL) and highest in the <40% group (793 (238.3-2247.5) pg/mL) (p = 0.001). Adverse in-hospital cardiovascular events were highest in the LVEF < 40% group compared to the LVEF 40-49% group and the LVEF ≥ 50% group (56% vs. 55% vs. 27%; p < 0.001). Over a follow-up period of 6.2 ± 3.1 years, the all-cause mortality was higher in the LVEF < 40% group compared to the LVEF 40-49% group and the LVEF ≥ 50% group. Among the different factors, LVEF < 40% and LVEF 40-49% were associated with an increased risk of in-hospital cardiovascular events in the multivariable Cox regression analysis. Conclusions: LVEF has different impacts on in-hospital cardiovascular events in this cohort. Furthermore, LVEF influences long-term all-cause mortality.

Postoperative radiotherapy does not improve survival in patients with Masaoka-Koga stage IIB thymomas: A propensity score matching study based on the SEER database.

This study, based on a population, explored the prognostic value of postoperative radiotherapy (PORT) for Masaoka-Koga IIB stage thymomas. Patients diagnosed with thymoma from 2004 to 2017 in the Surveillance, Epidemiology, and End Results (SEER) database were included in the retrospective study. Through propensity score matching, the baseline characteristics of the patients were successfully matched to mitigate the selection bias of PORT. Survival rates and survival curves were compared between the PORT and non-PORT groups, with potential confounding factors addressed using a multivariate Cox regression model. In this study, 785 cases of IIB stage thymoma were included from the SEER database, and 303 patients were successfully matched between PORT and non-PORT groups through propensity score matching, with no significant differences in baseline characteristics. In the PORT and non-PORT groups, 10-year overall survival rates were 65.2% versus 59.6%, and cancer-specific survival rates were 87.0% vs. 84.4%, PORT did not yield statistically significant improvements in overall survival (P = .275) or cancer-specific survival (P = .336) for stage IIB thymomas. Based on the SEER database, the results of our study indicated that PORT does not confer a significant survival benefit for IIB stage thymomas.

Implementation of a geriatric in-reach service improves acute surgical unit outcomes; a retrospective before-and-after study.

Australia's ageing population is challenging for surgical units and there is a paucity of evidence for geriatric co-management in acute general surgery. We aimed to assess if initiating a Geriatric Medicine in-reach service improved outcomes for older adults in our Acute Surgical Unit (ASU). The Older Adult Surgical Inpatient Service (OASIS) was integrated into ASU in 2021. We retrospectively reviewed all patients over age 65 admitted to ASU over a 12-month period before and after service integration with a length of stay (LOS) greater than 24 h. There was no subsequent truncation or selection. Primary outcomes were 30-day mortality, LOS, and 28-day readmissions. Secondary outcomes were discharge disposition, in-hospital mortality, and hospital-acquired complications (HACs). 1339 consecutive patients were included in each group, with no differences in baseline characteristics. There was a significant decrease in 28-day readmissions from 20.2% to 16.0% (P < 0.05), greatest in patients undergoing non-EL operative procedures (21.9% pre-OASIS vs. 12.6% post-OASIS; P < 0.05). Trends towards reduced 30-day mortality (7.17% vs. 5.90%; P = 0.211), in-hospital mortality (3.88% vs. 2.91%; P = 0.201), permanent care placement (7.77% vs. 7.09%; P = 0.843) and HACs (8.14% vs. 7.62%; P = 0.667) were seen, although statistical significance was not demonstrated. LOS remained unchanged at 4 days (P = 0.653). The addition of a geriatric in-reach service to a tertiary ASU led to a significant reduction in 28-day readmissions. Downtrends were seen in mortality, permanent care placement, and HAC rates, while LOS remained unchanged.

Risk assessment by acute bedside echocardiography prior to acute coronary angiography in patients with ST-elevation myocardial infarction: a feasibility study

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): Novo Nordisk Foundation. Background Early risk assessment by hemodynamic measurements in patients with ST-elevation myocardial infarction (STEMI) could be useful for early detection of patients at risk of developing hemodynamic instability after primary percutaneous coronary intervention (pPCI). Anterior STEMI patients have larger infarct size and may be of particular interest. Transthoracic echocardiography (TTE) is a quick, non-invasive, and available tool, however, evidence regarding the use of acute TTE prior to acute coronary angiography (CAG) is limited. Purpose To assess the feasibility of acute bedside hemodynamic assessment in the cath. lab. by TTE in addition to clinical examination, and blood samples in STEMI patients without CS at arrival in the cath. lab. Methods STEMI patients without CS at hospital arrival and treated with pPCI were included in the study during a five week period. Clinical examination (Killip class), blood sampling (lactate, troponin T (TNT), proB-type natriuretic peptide (proBNP), and focused bedside 2D TTE with Doppler were performed prior to the acute CAG. The TTE protocol was focused (approx. 5 minutes) on hemodynamic measurements, infarction related complications, and differential diagnoses e.g. aortic dissection. The TTE was performed during preparation for the acute CAG. Patients were stratified in anterior- vs. non-anterior STEMI based on the culprit artery and prehospital ECG. Feasibility was estimated by all of the following echocardiographic parameters; left ventricular ejection fraction (LVEF), left ventricular outflow tract (LVOT) velocity time integral (VTI), and right ventricular function (tricuspid annular plane systolic excursion (TAPSE)). Results A total of 60 STEMI patients (aged mean 63 years, 18% female) were included, and 47% had an anterior STEMI. No differences in baseline characteristics between the two groups were found including comorbidities, clinical parameters, and time from cath. lab. arrival to first wire over the culprit lesion (median (IQR) 28 (23; 38) vs 32 (24; 40) minutes). Admission biomarkers of blood glucose, lactate, and proBNP plasma concentrations were similar between the two groups. Whereas admission TNT were higher for patients with anterior STEMI (median (IQR) 110 (37; 449) vs. 37 (20; 94) ng/L, p=0.01). The feasibility of TTE-study protocol was 93%. Patients with anterior STEMI had lower LVEF (mean: 36±11 vs. 48±9%, p=0.0003; missing: n=0), and a trend to lower LVOT VTI (19 (6.4) vs. 22 (5.0) cm, p=0.06; missing: n=4). No difference in parameters of diastolic function or TAPSE (missing: n=0) were found. None of the included patients had echocardiographic visible complications related to the infarction. Conclusion Acute TTE is to a high degree feasible and does not delay time to acute revascularization in STEMI patients. Patients with anterior STEMI have significantly higher admission TNT levels, lower LVEF, and a trend to lower LVOT VTI compared with non-anterior STEMI patients.

Midazolam as mean sedative agent in out-of-hospital cardiac arrest shock: is it associated to increased mortality?

Abstract Funding Acknowledgements None. Background The choice of a sedative agent for patients undergoing invasive ventilation has been widely studied. However, data regarding the optimal sedation strategy after Out-of-Hospital Cardiac Arrest (OHCA) when the patients are suffering from post-OHCA shock is sparse. Aim To explore whether the use of midazolam in patients admitted for OHCA that are additionally haemodynamically unstable increases in-hospital mortality, cardiovascular (CV) mortality, cerebral performance status (CPC) at discharge, and days of intubation or admission, when used selectively during the acute phase of deteriorating post-OHCA shock patients. Methods We report a prospective, observational, single-centre cohort that included all-comers admitted due to OHCA of presumed cardiac cause between May-2019 and July-2023, that remained comatose at admission. Midazolam was only administrated as the mean sedation agent when the patient was in a hemodynamically deteriorating situation (SCAI D-E). Baseline characteristics, OHCA features, blood samples measurements, in-hospital treatments and neurological condition at discharge were registered. Primary outcome was in-hospital death from any cause. Secondary outcomes included CPC at discharge (1-2 VS 3-5), CV mortality, days of admission, days of intubation, need of tracheostomy, myopathy, enolase at 48h and heart transplant during admission. Patients were stratified according to whether they had received midazolam as mean sedation agent at some stage of admission or not. Results 103 patients of the 109 admitted were included (6 refused consent), 45 of them (43%) received midazolam at some stage of admission. No differences in baseline characteristics were found. Mean age was 60.6 years, 79.6% were male, most frequent comorbidities were hypertension (53.4%) and dyslipidaemia (46.6%), and 20,4% had had a previous myocardial infarction. OHCA characteristics, shock parameters and administered treatments did not significantly differ between the two groups (Table 1). In-hospital mortality was numerically higher in the midazolam group but did not reach statistical significance (56% vs. 38%, p=0.075) (Figure 1). There were no differences neither in secondary outcomes (CV mortality 4% vs. 5%, p=0.865; CPC 1-2 70% vs. 83%, p=0.244; days of intubation 6 vs. 4, p=0.203; tracheostomy 18% vs. 10%, p=0.275; days of admission 14 vs. 15, p=0.851; 48h enolase 38 vs. 29, p=0.919; heart transplant during admission 0% vs. 1,7%, p=0.376; myopathy 30% vs. 21% p=0.282). Conclusion In patients admitted due to OHCA, even though the administration of midazolam is given in unstable patients, it is not related to a higher in-hospital mortality nor poorer outcomes.Table 1.OHCA and shock characteristicsFigure 1.Cumulative Survival