Single-arm Observational Study Research Articles

First Experience with the NPseal®: A Novel Mechanically Powered Negative Pressure Dressing Applied to Colorectal Surgery Wounds.

The use of prophylactic closed-incisional negative pressure wound therapy after colorectal procedures has been shown to reduce postoperative wound complications and surgical site infection. We present our experience with a novel, closed-incision, mechanically powered negative pressure (MP-NPD) dressing after colorectal procedures. This was a prospective, single-center, single-arm observational study assessing patient reported and wound healing outcomes of colorectal surgical incisions dressed with a MP-NPD. Consecutive patients, 18years and older, that met inclusion criteria were enrolled between May 2021 and December 2021. Thirty patients were included (13 male/17 female) with a mean age of 62.7 ± 11.8years and mean body mass index of 25.5 ± 4.4kg/m2. The mean incision length covered was 3.0 ± 1.8cm. The median number of manual pinches required to initially activate the dressing with negative pressure within -75 to -125mmHg was 12 (range 7-20). Four dressings were changed (13.3%) after drainage was noted inside the pump; not including these, 88.5% (23/26) of dressings held pressure consistently without any re-pinching during the 72-h period since they were first applied in the operating room. 75.9% of patients reported the dressing was "very comfortable" and none reported the dressing restricted mobility. 79.3% of patients reported the dressing was "very easy" to use. There were no cases of major wound complication or surgical site infection within 30days. The use of MP-NPD appears to be feasible on primarily-closed colorectal incisions. Further randomized controlled study is warranted to ascertain its clinical efficacy.

Early Discharge Program After TAVI Based On Close Follow-up Supported by Telemonitoring Using Artificial Intelligence: the TeleTAVI Study

Abstract Introduction and objectives Evidence regarding the safety of early discharge following transcatheter aortic valve implantation (TAVI) is limited. The aim of this study was to evaluate the safety of very early (<24) and early discharge (24-48h) as compared to standard discharge (>48h), supported by the implementation of a voice-based virtual assistant using Artificial Intelligence (AI) and Natural Language Processing. Methods Single-arm prospective observational study that included consecutive patients who underwent TAVI in a tertiary hospital in 2023 and were discharged under an AI follow-up program. Primary end point was a composite of death, pacemaker implantation, readmission for heart failure, stroke, acute myocardial infarction, major vascular complications, or major bleeding, at 30-day follow-up. Results A total of 274 patients were included. 110 (40.1%) patients were discharged very early (<24h), 90 (32.9%) early (24-48h) and 74 (27.0%) were discharged after 48h. At 30-day follow-up no significant differences were found among patients discharged very early, early and those discharged after 48h for the primary endpoint (very early 9.1% vs early 11.1% vs standard 9.5%; p = 0.88). The AI platform detected complications that could be effectively addressed. The implementation of this follow-up system was simple and satisfactory for TAVI patients. Conclusions Early and very early discharge in patients undergoing TAVI, supported by close follow-up using AI, was shown to be safe. Patients with early and very early discharge had similar 30-day event rates compared to those with longer hospital stays. The AI system contributed to the early detection and resolution of complications.

Aromatase inhibitors, bone microstructure, and estimated bone strength in postmenopausal women with breast cancer: a 5-year prospective study.

Aromatase inhibitors (AIs) are the standard treatment for early breast cancer (EBC) and are typical causative agents of cancer treatment-induced bone loss. However, the effects of long-term treatment with these drugs on bone microstructure remain unclear. This prospective, single-arm observational study included postmenopausal, non-osteoporotic women with hormone receptor-positive EBC. Patients who underwent dual-energy X-ray absorptiometry (DXA), high-resolution peripheral quantitative computed tomography (HR-pQCT), and tartrate-resistant acid phosphatase-5b (TRACP-5b) or procollagen type I N-terminal propeptide levels were compared at baseline and at 60months after commencing AI treatment. Fifteen women were included in the study, with a median age of 58years and a quartile range of 56.5-62.5years. At 60months, HR-pQCT revealed that the cortical area and thickness decreased with increased cortical porosity in the cortical bone. In addition, the number of trabeculae decreased and trabecular separation increased trabecular bones decreases, and trabecular bone separation opens, resulting in a decrease in the trabecular bone volume fraction. Total bone mineral density (BMD), trabecular volumetric BMD, and cortical volumetric BMD, and estimated bone strength significantly decreased. DXA BMD values significantly decreased in the total hip and femoral neck but not the lumbar spine. TRACP-5b values after 5years of AI treatment showed a significant negative correlation with the rate of change in the total volumetric BMD in the distal tibia. Postmenopausal women who received AIs for 5years for EBC experienced significant deterioration in the bone microstructure, BMD, and estimated bone strength.

Association between Immune-Related Adverse Events and Atezolizumab in Previously Treated Patients with Unresectable Advanced or Recurrent Non-Small Cell Lung Cancer.

Real-world, large-scale studies on the association between immune-related adverse events (irAE) and immune checkpoint inhibitor therapy effectiveness are limited. We evaluated overall survival (OS) and progression-free survival based on the occurrence and grade of irAEs. We used data from Japanese patients with unresectable advanced or recurrent non-small cell lung cancer (NSCLC) who received atezolizumab and were enrolled in J-TAIL, a multicenter, prospective, single-arm observational study. Among the 1,002 patients, 190 (19.0%) developed irAEs. The most common irAEs were skin disorders (3.8%) of any grade and interstitial lung disease (1.5%) of grade ≥3. Patients who developed irAEs within 4 or 6 weeks of treatment initiation had higher baseline C-reactive protein levels than those without irAEs. OS was longer in patients with irAEs [HR, 0.66; 95% confidence interval (CI), 0.54-0.82], particularly in those with low-grade irAEs (HR, 0.45; 95% CI, 0.33-0.62), than in patients without irAEs. The HR (95% CI) for OS in patients with low-grade and high-grade skin or endocrine disorder-related irAEs was 0.42 (0.28-0.64) and 0.37 (0.15-0.88), respectively. The HR (95% CI) for OS in patients with low-grade and high-grade irAEs other than skin or endocrine disorders was 0.44 (0.30-0.65) and 1.27 (0.96-1.69), respectively. In patients with unresectable advanced or recurrent NSCLC treated with atezolizumab in real-world settings, irAEs are associated with a clinical benefit except in those with high-grade irAEs other than skin and endocrine disorders. Immune checkpoint inhibitors are useful for treating NSCLC but can cause life-threatening irAEs. This study had a large sample size and stratified the analysis by irAE type and grade. The results suggest that improved management of irAEs may improve the therapeutic effect of atezolizumab.

Equity in Modifying Plaque of Women With Undertreated Calcified Coronary Artery Disease: Design and Rationale of EMPOWER CAD study

BackgroundCoronary artery disease (CAD) is the leading cause of death for women, yet they remain underrepresented in interventional CAD studies. Women have been shown to be at increased risk of mortality and major adverse events after percutaneous coronary intervention (PCI). The poorer outcomes are likely because women are typically diagnosed with CAD late, at an older age, with more comorbidities, and with more challenging anatomy including smaller vessels and higher prevalence of coronary artery calcification. MethodsThe EMPOWER CAD study (NCT05755711) is a postmarket, prospective, multicenter, single-arm observational study of the Shockwave Coronary intravascular lithotripsy (IVL) system for the treatment of women with calcified coronary artery disease. The study will enroll 400 female patients referred for PCI with coronary IVL and stenting. The primary safety end point is target lesion failure (TLF) at 30 days, defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. The primary effectiveness end point is procedural success, defined as stent delivery with a residual in-stent stenosis ≤30% in all target lesions and without in-hospital TLF as assessed by an independent core laboratory and clinical events committee. Patients will be followed up for 3 years. ConclusionsThe EMPOWER CAD study will enroll real-world female patients. Adjunctive use of IVL with other calcium modification technologies will be assessed, as well as a subcohort analysis of patients with optical coherence tomography imaging. The EMPOWER CAD study therefore directly addresses the underrepresentation of women in interventional cardiology clinical trials.

Real-world Effectiveness of Sarilumab in RA: Results from the Open-label, Prospective, Single-arm Observational PROFILE Study.

The 1-year PROspective sarilumab (preFILled syringe/pen) multinational, obsErvational (PROFILE) study evaluated the real-world effectiveness and safety of sarilumab in patients with moderate-to-severe rheumatoid arthritis (RA). Safety endpoints included adverse events (AEs) and lab abnormalities. Effectiveness endpoints included the ACR core set. The primary endpoint was the change from baseline in Clinical Disease Activity Index (CDAI). All statistics are descriptive and pvalues were nominal. In total, 595 patients were treated, of whom 223 (37.5%) received sarilumab monotherapy and 372 (62.5%) received combination therapy. Upon initiation of sarilumab, an improvement in the mean (SD) CDAI score was observed at week 24 [11.4 (10.3)] and was maintained through week 52 [10.0 (10.5)], resulting in a mean [SD] reduction of -14.9 (12.7) and -14.4 (12.9), respectively. There were consistent improvements in disease activity that were similar for patients on monotherapy vs. combination therapy. An increase in the proportion of patients achieving remission and low disease activity was reported. By week 52, both groups had improved physical function and quality of life. There were no new safety signals. The proportions of any patients reporting a treatment-emergent adverse event (TEAE) or serious treatment-emergent AE (SAE) was 66.2% and 5.9%, respectively, and were similar between both treatment groups. Overall, 15.6% of patients discontinued sarilumab treatment due to TEAEs. The most commonly reported TEAE of interest was neutropenia (14.1%). In this 1-year, observational real-world study, sarilumab therapy resulted in improved clinical outcomes. The safety profile was consistent with that observed in sarilumab randomized clinical trials. This study was entered on the German website (Paul Ehrlich Institute) on January 11, 2018, with NIS No.: 423.

Symptom burden, coagulopathy and heart disease after acute SARS-CoV-2 infection in primary practice

SETANTA (Study of HEarT DiseAse and ImmuNiTy After COVID-19 in Ireland) study aimed to investigate symptom burden and incidence of cardiac abnormalities after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)/COVID-19 and to correlate these results with biomarkers of immunological response and coagulation. SETANTA was a prospective, single-arm observational cross-sectional study condcuted in a primary practice setting, and prospectively registered with ClinicalTrials.gov (identifier: NCT04823182). Patients with recent COVID-19 infection (≥ 6 weeks and ≤ 12 months) were prospectively enrolled. Primary outcomes of interest were markers of cardiac injury detected by cardiac magnetic resonance imaging (CMR), which included left ventricular ejection fraction, late gadolinium enhancement and pericardial abnormalities, as well as relevant biomarkers testing immunological response and coagulopathy. 100 patients (n = 129 approached) were included, amongst which 64% were female. Mean age of the total cohort was 45.2 years. The median (interquartile range) time interval between COVID-19 infection and enrolment was 189 [125, 246] days. 83% of participants had at least one persistent symptom, while 96% had positive serology for prior SARS-CoV-2 infection. Late gadolinium enhancement, pericardial effusion, was present in 2.2% and 8.3% respectively, while left ventricular ejection fraction was below the normal reference limit in 17.4% of patients. Von Willebrand factor antigen was elevated in 32.7% of patients and Fibrinogen and D-Dimer levels were found to be elevated in 10.2% and 11.1% of patients, respectively. In a cohort of primary practice patients recently recovered from SARS-CoV-2 infection, prevalence of persistent symptoms and markers of abnormal coagulation were high, despite a lower frequency of abnormalities on CMR compared with prior reports of patients assessed in a hospital setting.Trial Registration: Clinicaltrials.gov, NCT04823182 (prospectively registered on 30th March 2021).

Chemotherapy effects on bone mineral density and microstructure in women with breast cancer.

Chemotherapy involves the administration of steroids to prevent nausea and vomiting; however, its effect on bone microstructure remains unknown. This study aimed to evaluate the changes in bone mineral density (BMD) and bone microstructure associated with chemotherapy using high-resolution peripheral quantitative computed tomography (HR-pQCT) in women with early breast cancer. This prospective single-arm observational study included non-osteoporotic, postmenopausal women with breast cancer. The patients underwent dual-energy X-ray absorptiometry (DXA), HR-pQCT, and tartrate-resistant acid phosphatase-5b (TRACP-5b) or procollagen type-I N-terminal propeptide (P1NP) measurements at baseline, end of chemotherapy, and 6months after chemotherapy. The primary endpoint was the change in total volumetric BMD at the distal tibia and radius. Eighteen women were included in the study (median age: 57years; range: 55-62years). At 6months after chemotherapy, HR-pQCT indicated a significant decrease in total volumetric BMD (median: distal tibia -4.5%, p < 0.01; distal radius -2.3%, p < 0.01), cortical volumetric BMD (-1.9%, p < 0.01; -0.8%, p = 0.07, respectively), and trabecular volumetric BMD (-1.1%, p = 0.09; -3.0%, p < 0.01, respectively). The DXA BMD also showed a significant decrease in the lumbar spine (median: -4.5%, p < 0.01), total hip (-5.5%, p < 0.01), and femoral neck (-4.2%, p < 0.01). TRACP-5b and P1NP levels were significantly increased at the end of chemotherapy compared to baseline. Postmenopausal women undergoing chemotherapy for early breast cancer experienced significant BMD deterioration in weight-bearing bone, which was further reduced 6months after chemotherapy.

Droxidopa for Vasopressor Weaning in Critically Ill Patients with Persistent Hypotension: A Multicenter, Retrospective, Single-Arm Observational Study.

Persistent vasopressor requirements are a common reason for delayed liberation from the intensive care unit (ICU) and adjunct oral agents are sometimes used to hasten time to vasopressor discontinuation. We sought to describe the use of droxidopa for vasopressor weaning in critically ill patients with prolonged hypotension. This retrospective, single-arm, observational study included adult patients admitted to an ICU at two academic centers between 06/2016-07/2023 who received droxidopa for vasopressor weaning. Patients who received droxidopa prior to admission or for another indication were excluded. The primary outcome was time to vasopressor discontinuation, defined as when vasopressors were stopped and remained off for at least 24 h. Secondary outcomes included rates of tachycardia and hypotension post-initiation, norepinephrine equivalents pre- and post-initiation, concomitant oral agent use, and dosing. A subgroup analysis was conducted in patients receiving droxidopa via feeding tubes. A total of 30 patients met inclusion criteria. Median age was 62 years old, 12 (40%) were female, and 73% were in a cardiac/cardiac surgical ICU. Patients were on vasopressors for a median of 16 days prior to droxidopa initiation. Median (IQR) time to vasopressor discontinuation was 70 h (23-192) and norepinephrine equivalents decreased immediately after initiation (0.08 vs 0.02 mcg/kg/min, p < 0.001). MAP increased after droxidopa initiation (68.8 vs 66.5 mm Hg, p = 0.008) while heart rates were unchanged (86 vs 84 BPM, p = 0.37) after initiation. Patients who weaned from vasopressors within 72 h versus longer than 72 h after droxidopa initiation were more likely to be on lower norepinephrine equivalents prior to initiation (0.05 vs 0.12 mcg/kg/min, p = 0.013). Feeding tube administration did not impact time to vasopressor discontinuation (p = 0.93). Droxidopa may be considered an adjunct therapy for vasopressor weaning. Effects were similar when analyzing patients receiving droxidopa via feeding tube.

Ten-Year Follow-Up of Mitral Valve Replacement With the Epic Porcine Valve in a Medicare Population

BackgroundBioprosthetic surgical mitral valve replacement (SMVR) remains an important treatment option in the era of transcatheter valve interventions. This study presents 10-year clinical outcomes of Medicare beneficiaries who underwent SMVR with a contemporary low-profile mitral porcine valve. MethodsThis was a single-arm observational study using Medicare fee-for-service claims data. Deidentified patients undergoing SMVR with the Epic mitral valve (Abbott) in the United States between January 1, 2008 and December 31, 2019 were selected by International Classification of Diseases, Ninth and Tenth Revision procedure codes and then linked to a manufacturer device tracking database. All-cause mortality, heart failure (HF) rehospitalization, and mitral valve reintervention (surgical or transcatheter valve-in-valve) were evaluated at 10 years by using the Kaplan-Meier method. ResultsAmong 75,739 Medicare beneficiaries undergoing SMVR during the study period, 14,015 received the Epic mitral valve (Abbott), 76.5% (10,720) of whom had underlying HF. The mean age was 74 ± 8 years. Survival at 10 years in patients without preoperative HF was 40.4% (95% CI, 37.4%-43.4%) compared with 25.4% (95% CI ,23.8%-27.0%) for patients with HF (P < .001). The 10-year freedom from HF rehospitalization was 51.3% (95% CI, 49.4%-53.1%). Freedom from mitral valve reintervention was 91.4% (95% CI, 89.7%-92.7%) at 10 years. ConclusionsThis real-world nationwide study of Medicare beneficiaries receiving the Epic mitral valve demonstrates >90% freedom from all-cause valve reintervention and >50% freedom from HF rehospitalization at 10 years after implantation. Long-term survival and HF rehospitalization in this population with mitral valve disease treated with SMVR was found to be affected by underlying HF.

Continuous Glucose Monitoring Among Patients with Type 1 Diabetes in Rwanda (CAPT1D) Phase I: Feasibility Study.

The development of minimally invasive continuous glucose monitoring systems (CGMs) has transformed diabetes management. CGMs have shown clinical significance by improving time in the euglycemic range, decreasing rates of hypoglycemia, and improving HbA1c. In Rwanda, CGMs are currently not in routine use, and no clinical studies of CGM use were identified in the literature. To determine impact and feasibility of real-time CGM use among people living with T1D in Rwanda, through assessment of sensor usage, time in range, rates of hypo-and-hyperglycemia, HbA1c and rates of diabetes-related hospitalizations over time. The Continuous Glucose Monitoring Among Patients with Type 1 Diabetes in Rwanda (CAPT1D) study is a single-arm prospective observational study conducted at the Rwandan Diabetes Association (RDA) clinic in Kigali, Rwanda, aiming to assess the impact and feasibility of CGM use in Rwanda. A cohort of 50 participants diagnosed with T1D were enrolled. Participants were at least 21 years old, undergoing multiple daily insulin therapy, and not currently pregnant. Phase I of the study was conducted over 12 months, using the Dexcom G6 CGM. Phase II and Phase III extended CGM use for an additional 6 months respectively, using the next generation, Dexcom G7 CGM. Here we report the quantitative results of the Phase I study. Participants used the sensor for >80% of the time throughout the study period. A significant increase in time in range was observed within 3 months, and sustained over 12 months. HbA1c decreased significantly in 3 months and stayed lower throughout the 12-month period. Mean HbA1c levels decreased by 2.8% at 6 months (p<0.01) and 3.2% at 12 months (p<0.01) A total of 12 diabetes-related hospitalizations were reported during the study period. No cases of DKA or episodes of severe hypoglycemia occurred. Significant and meaningful improvements in key glycemic indices indicate the potential feasibility and impact of CGM among people living with T1D in Rwanda. Future studies could be designed to include pre- and post-intervention analysis to determine the effectiveness in terms of complications and costs.

An app promoting weight gain prevention via healthy behaviours amongst young women with a family history of breast cancer: Acceptability and usability assessment.

Breast cancer is the most frequent female malignancy in the UK. Around 20% of cases are linked to weight gain, excess weight and health behaviours. We designed a weight gain prevention, health behaviour intervention for young women at increased risk. The study comprised a single arm observational study over 2 months testing acceptability and usability of the intervention: online group welcome event, app and private Facebook group. Females aged 18-35 years at moderate or high risk of breast cancer (>17% lifetime risk) were recruited via invite letters and social media posts. The app included behaviour change techniques and education content. Online questionnaires were completed at baseline, as well as at 1 and 2 months. We also assessed feasibility of study procedures. Both recruitment methods were successful. Thirty-five women were recruited, 26% via social media posts. Median age was 33 (interquartile range = 28.2-34.5) years, the majority (94.1%) were of White ethnicity. Thirty-four participants were included in the analyses, of which 94% downloaded the app. Median self-monitoring logs per participant during the study period was 10.0 (interquartile range = 4.8-28.8). App quality mean (SD) score was 3.7 (0.6) at 1 and 2 months (scale: 1-5). Eighty-nine per cent rated the app at average or above at 1 month and 75.0% at 2 months. Nineteen women (55.9%) joined the Facebook group and there were 61 comments and 83 reactions and votes from participants during the study period. This first iteration of the app and intervention was well received and is suitable to progress to the next stage of refining and further testing.

Insights into Digital MedicRehApp Maintenance Model for Pulmonary Telerehabilitation: Observational Study.

Maintenance strategies after center-based pulmonary rehabilitation (CBPR) are currently needed. This study aimed to evaluate the feasibility and effect on the quality of life of a home-based pulmonary rehabilitation (HBPR) program delivered by a digital app. As secondary objectives, the patients' adherence, symptoms, effort tolerance changes, and safety were evaluated. This was a single-arm prospective observational monocentric study on 30 patients referred for chronic respiratory diseases. The prescription and evaluations of the HBPR programs performed at the pulmonary facility and delivery of structured exercise and counselling by the digital health tool were achieved under the supervision of a respiratory therapist. Digital capabilities included aerobic, strength, and respiratory exercises, which were monitored with a fitness tracker. The engagement rate of the HBPR after the CBPR was 1:10. The EuroQoL VAS score increased from 66.2 ± 16.28 to 75.60 ± 16.07 (p < 0.001), mainly in younger subjects. No patient was lost during the HBPR program. The global adherence session rate was 94%. The Medical Research Council dyspnea scale (MRC), COPD Assessment Test (CAT) score, and six-minute walking test (6MWT) improved from admission into the pulmonary unit to the end of the HBPR program. Between the beginning and end of the CBPR, the CAT score decreased from 14.4 ± 6.39 to 8.50 ± 5.39 (p < 0.001), the MRC decreased from 1.87 ± 0.9 to 1.17 ± 0.83 (p < 0.001), and the 6MWT increased from 451 ± 93 to 473 ± 115 m (p < 0.05). The average Technology Acceptance Model score for usability was high (145 ± 12.1) and no adverse events occurred during the HBPR program. This HBPR model seemed to be feasible and well-accepted by patients, leading to improvements in quality of life, symptoms, and functional capacity.

Prognostic Ability of the Wound, Ischemia, Foot Infection (WIfI) Classification System in Diabetic Patients with Non-Healing Ulcer

Abstract Objectives Several classifications have been published to predict limb salvage in diabetic patients with non-healing ulcer to aid in the management plan. The Society for Vascular Surgery (SVS) Lower Extremity Guidelines Committee has composed a new classification system that reflects the three major factors that impact amputation risk and clinical management Our goal was to evaluate the predictive ability of this wound, ischemia and foot infection(WIfI) classification as a predictor of limb salvage in diabetic patients with non-healing ulcer Methods a prospective single arm observational cohort study conducted on 50 patients within 2022 at single center, Ain Shams University Hospitals, Patients are diabetics who had non healing ulcers some of the cases underwent angioplasty or debridement, then follow up of the wounds was done. Limbs were stratified into clinical stages 1 to 4 based on the SVS WIfI classification for amputation risk. Results Our study included 38 males (76%) and 12 females (24%). The age range between 35 years and 73 years with mean age of 59±8.81. All of the patients are diabetic. The percentage of patients with hypertensive ( 76 %), 54% of them were smoker &amp; 7 were suffering from ESRD. limb salvage was achieved on 75 % of cases. All cases have been classified according to WIFI classification into clinical stages I-IV and their percentage were 6%,12%,40% and 42% respectively. WIfI classification was significant in predicting the major or minor amputation as well as ulcer healing. As Major amputation among each WIfI classification group low, moderate and high risk was 0%, 10%, 47% respectively. Risk of minor amputation was 22%, 40% and 76% respectively. While ulcer healing was 100%, 85% and 52% respectively. Conclusion The likelihood of an amputation after one year in patients with non healing ulcer increases with higher WIfI stages, so The WIfI classification is applicable in prediction of limb salvage in diabetic patients with non-healing ulcer. Smoking and aging also decreases the chance of limb salvageability

Cumulative sucrose exposure for repeated procedural pain in preterm neonates and neurodevelopment at 18 months of corrected age: a prospective observational longitudinal study

IntroductionOral sucrose is repeatedly administered to neonates in the neonatal intensive care unit (NICU) to treat pain from commonly performed procedures; however, there is limited evidence on its long-term cumulative...

Survival outcomes of billroth-I reconstruction following distal gastrectomy for gastric cancer patients in Vietnam: A 5-year follow-up

This study aims to describe the long-term survivorship of Billroth I (or Pean's) reconstruction technique in patients with distal gastric cancer. A single-arm longitudinal observational study was conducted at Viet Duc University Hospital, Hanoi, Vietnam, from 2018 to 2021. A total of 103 patients who were diagnosed with primary carcinoma in the lower third of the stomach and underwent lower pole gastrectomy with Péan anastomosis were recruited. The Kaplan–Meier analysis was used to estimate the survival outcome. A multivariate Cox proportional hazard regression model was used to measure the factors associated with survivorship. Results showed that 8.7% died during the study period. The Restricted Mean Survival Time (RMST) was 61.9 (95%CI=59.4-64.4) months. RMST was significantly different across the stages of cancer, T and N. Specifically, patients with advanced stage (III) had a substantially lower RMST (49.2 months) compared to those with early-stage (I&amp;II). Patients with T4 or N3 also had the lowest RMST compared to those with other characteristics (p&lt;0.05). Female patients had a lower risk of dying than their male counterparts (HR=0.092, 95%CI=0.013-0.661). Patients with a higher level of Node (N) had a significantly higher risk of dying than those with a lower level (HR=5.103; 95%CI=1.716-15.178). Having comorbidities was associated with a lower risk of dying (HR=0.066; 95%CI=0.008-0.531) than not having comorbidity. To conclude, the findings indicate favourable long-term results for patients with distal gastric cancer undergoing the Billroth I (or Pean's) reconstruction technique. The practice above may be the established protocol for managing these particular patients.

Baseline monocyte count predicts symptom improvement during intravenous ketamine therapy in treatment-resistant depression: a single-arm open-label observational study.

Neuroinflammatory processes in depression are associated with treatment resistance to conventional antidepressants. Ketamine is an effective new therapeutic option for treatment-resistant depression (TRD). Its well-established immunomodulatory properties are hypothesized to mediate its antidepressant effect. In this context, higher levels of inflammation may predict a better treatment response. However, conclusive evidence for this hypothesis is lacking. We thus investigated whether standard peripheral inflammatory cell markers and C-reactive protein (CRP) levels could predict symptom improvement during intravenous ketamine therapy in TRD patients. 27 participants with TRD were treated with six weight-adjusted intravenous ketamine infusions (0.5 mg/kg bodyweight) over three weeks. Baseline assessments included CRP, absolute monocyte count (AMC), and absolute neutrophil count (ANC). Depression severity was measured using the Montgomery-Åsberg Depression Rating Scale (MADRS) at baseline (D1), after the first (D3) and before the last ketamine infusion (D18). Raters were blinded for the baseline laboratory assessments. 13 participants responded to ketamine treatment, and 8 participants partially responded. Baseline AMC showed a strong negative correlation with MADRS change at D3 (r=-0.57, p=0.002) and at D18 (r =-0.48, p=0.010), indicating that a high baseline AMC was associated with greater symptom improvement. A generalized linear model confirmed the association of baseline AMC with symptom improvement during ketamine treatment when additionally accounting for age, sex, and body mass index. Specifically, baseline AMC demonstrated predictive value to discriminate responders and partial responders from non-responders, but lacked discriminative ability between partial responders and responders. Baseline ANC correlated with the MADRS changes at D3 (r=-0.39, p=0.046), while CRP values did not correlate at all. Our prospective single-arm open-label observational study demonstrated that baseline AMC reliably predicted symptom improvement during intravenous ketamine treatment in TRD patients. AMC could therefore serve as a simple and easily accessible marker for symptom improvement during ketamine therapy in daily clinical practice. Future studies with larger sample sizes and a more detailed longitudinal assessment of AMC subtypes are needed to better understand the specific relationship between monocytes and the neuromodulatory effects of ketamine.

Docetaxel, Oxaliplatin with Capecitabine (TEX Regimen) in Metastatic Gastric and Gastroesophageal Adenocarcinoma: A Prospective Single-Arm Observational Study from a Tertiary Cancer Center in Kashmir

Abstract Background Metastatic gastric and gastroesophageal adenocarcinoma (MGGEAC) is a challenging disease with limited treatment options. The Taxotere, Eloxatin, and Xeloda (TEX) regimen has shown promising results in several clinical trials. There exists a dearth of data pertaining to the efficacy and tolerance of the treatment approach in the populace of Kashmir. Methods This study was performed at the Department of Medical Oncology, Sher-I-Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir. Patients with MGGEAC received treatment with biweekly TEX regimen that included docetaxel 50 mg/m2-D1, oxaliplatin 85 mg/m2-D1, and capecitabine 1250 mg/m2/day, twice daily orally, for 14 days. The effectiveness of the regimen was assessed based on the overall response rate (ORR), progression-free survival (PFS), and overall survival (OS), along with the prognostic factors, safety, and tolerability of the regimen. Results The ORR was 63.5% after four cycles. The median PFS and OS were 9.1 and 13 months, respectively. Univariate and multivariate analysis showed that a higher number of sites of metastases is associated with poor PFS. The TEX regimen was well tolerated. The most observed grade 3 to 4 toxicities were neutropenia (36.7%), anemia (20%), fatigue (20%), and febrile neutropenia (16.7%). Conclusion Using the TEX regimen in MGGEAC showed better response rates and a slightly longer PFS. A higher number of sites of metastases is a poor prognostic factor in MGGEAC, as seen in our study. The toxicity profile shows that the regimen is tolerable. We recommend a randomized controlled study comparing CapeOx with TEX to test this regimen further.

A prospective multicenter European observational study of a single incision sling (Altis®): A safe and effective treatment option for women

Introduction:Single-incision slings were introduced for female stress urinary incontinence (SUI) treatment to decrease surgery time, postoperative pain, and the amount of mesh used. Objective:This multicenter study aims to examine Altis® usage in real-world clinical practice, its effectiveness in treating SUI, patient satisfaction, quality of life, sexual function, and complication rates. Methods:Between 2015 and 2022, a prospective single-arm observational cohort study was conducted across 33 European centers involving 564 patients, investigating the clinical effectiveness of the Altis® sling. Patients were monitored for 36 months. The primary endpoint (success) was a positive impression of improvement and absence of serious/severe/Clavien Dindo (CD) ≥ III-related adverse events at 12 months. Secondary endpoints included effectiveness at 36 months, impact on quality of life, and risk factors for failure. Results:An Altis® was implanted in 564 women. At 12-months, 86.6% of patients achieved success, 97.2% endorsed the surgery, and 90.4% were satisfied with the outcomes. At 36 months, 83.0% reported significant improvement, 94.5% endorsed the surgery, and 89.9% were satisfied. Altis® demonstrated decreased daily pad usage and improved quality of life. Dyspareunia and sexual function largely remained unchanged. However, 11.3% reported pain, and there were instances of serious adverse events. Conclusion:The Altis® implant demonstrated substantial improvements in symptoms and overall quality of life for a majority of women with SUI. Potential complications such as mesh exposure, reoperation, voiding dysfunction, and urinary retention emphasize the importance of preoperative counseling. The Altis® implant is a viable option within the available surgical treatments of SUI.

Periarterial and Sub-adventitial Divestment Along with Triangle Operation and RAMPS for Pancreatic Body Cancer

BackgroundLocally advanced cancers of the pancreatic body can abut or involve the celiac axis, hepatic artery, or superior mesenteric artery. Recent evidence suggests that these tumors are amenable to surgery after neoadjuvant chemotherapy (Hackert et al., Locally advanced pancreaticcancer: neoadjuvant therapy with FOLFIRINOX results inresectability in 60 % of the patients. Ann Surg 264:457–463, 2016; Rangelova et al., Surgery improves survival after neoadjuvant therapy for borderline and locally advanced pancreatic cancer: a single-institution experience. Ann Surg 273:579–86, 2021). An arterial divestment technique can be used for these cancers to get an R0 clearance, thereby avoiding morbid arterial resections (Miao et al., Arterial divestment instead of resection for locally advanced pancreatic cancer (LAPC). Pancreatology 16:S59, 2016; Habib et al., Periadventitial dissection of the superior mesenteric artery for locally advanced pancreatic cancer: surgical planning with the “halo sign” and “string sign.” Surgery 169(5):1026–1031, 2021; Diener et al., Periarterial divestmentin pancreatic cancer surgery. Surgery 169(5):1026–31, 2020). Two techniques are described for arterial divestment. In the periarterial divestment technique, the plane of the dissection is between the tumor and the adventitia (Habib et al., Periadventitial dissection of the superior mesenteric artery for locally advanced pancreatic cancer: surgical planning with the “halo sign” and “string sign.” Surgery 169(5):1026–1031, 2021; Diener et al., Periarterial divestmentin pancreatic cancer surgery. Surgery 169(5):1026–31, 2020). In sub-adventitial dissection, the plane of dissection is between the tunica adventitia and the external elastic lamina (Gao et al., Sub-adventitial divestment technique for resecting artery-involved pancreatic cancer: a retrospective cohort study. Langenbecks Arch Surg 406:691–701, 2021). The TRIANGLE operation also is one of the surgical techniques to achieve R0 resection in locally advanced pancreatic cancer (Hackert et al., The TRIANGLE operation: radical surgery after neoadjuvant treatment for advanced pancreatic cancer: a single-arm observational study. HPB Oxford 19:1001–1007, 2017). This multimedia article aims to demonstrate peri-arterial and sub-adventitial divestment techniques as well as the TRIANGLE operation for a locally advanced cancer of the body of the pancreas. The video also highlights the technique of posterior radical antegrade modular pancreato-splenectomy (RAMPS) together with lymph node clearance.Patient and MethodsA 57-year-old women was detected to have pancreatic body adenocarcinoma with tumor contact of the artery and superior mesenteric artery. After neoadjuvant chemotherapy, she was planned to undergo surgical resection.ResultsThe surgical technique consisted of peri-arterial and sub-adventitial divestment, the TRIANGLE operation and RAMPS (Fig. 1). The procedure was performed within 240 min and involved blood loss of 250 mL. After the procedure, pancreatic leak (POPF-B), chyle leak and diarrhea developed, which were managed conservatively. The final histopathology showed residual, viable, moderately differentiated adenocarcinoma (ypT2N1M0) with all resection margins free.ConclusionThe surgical technique consisting of peri-arterial and sub-adventitial divestment, the TRIANGLE operation and RAMPS helps in R0 resection of locally advanced pancreatic body cancer without any compromise in oncologic outcomes and offers an alternative surgical approach to morbid arterial resection.