Single-arm Observational Study Research Articles

Characteristics and outcomes of patients treated with sotrovimab to prevent progression to severe COVID-19 in Belgium

ABSTRACT Objective Sotrovimab, a dual-action, engineered human monoclonal antibody, has been demonstrated to significantly reduce the risk of hospitalisation and death in high-risk patients with COVID-19. Here, we describe the real-world use of, and outcomes from, sotrovimab treatment in Belgium during the Delta and Omicron waves among patients with COVID-19 at high risk of developing severe disease. Methods This was a multicentric, single-arm observational cohort study of non-hospitalised patients receiving outpatient sotrovimab treatment between 1 November 2021 and 2 August 2022 at nine hospitals in Belgium. The primary outcomes were all-cause and COVID-19-related hospitalisations and all-cause deaths during the 29-day acute follow-up period from first administration of sotrovimab. Results A total of 634 patients were included (63.4% aged < 65 years; 50.3% male). A high proportion (67.7%; n = 429/634) of patients were immunocompromised, with 36.9% (n = 234/634) actively treated for malignancy. During the 29-day acute period, 12.5% (n = 79/634) of sotrovimab-treated patients were hospitalised due to any cause (median duration 4 days; median time to hospitalisation 14 days) and 1.1% (n = 7/634) died due to any cause. The proportion of sotrovimab-treated patients experiencing COVID-19-related hospitalisation was highest during the Delta predominance and Delta/BA.1 codominance (both 6.3%) periods. During the BA.1 predominance, BA.1/BA.2 codominance and BA.2/BA.5 codominance periods, COVID-19-related hospitalisations were consistently low (all ≤2.7%). Conclusion This study indicated low rates of COVID-19-related hospitalisations and all-cause deaths in sotrovimab-treated patients in Belgium, including during Omicron subvariant periods, despite over two-thirds of the study population being immunocompromised.

Visual Outcomes and Patient Satisfaction of Trifocal or Trifocal Toric IOLs in Chinese Cataract Patients: Focus on Near Vision at 33 cm.

To examine the visual outcomes, particularly at 33 cm, and assess patient satisfaction following the implantation of a diffractive trifocal intraocular lens (IOL) and its toric variant. This prospective single-arm observational study involved 45 Chinese patients (90 eyes) underwent bilateral cataract surgery and PanOptix or PanOptix toric intraocular lenses (IOLs) implantation. Postoperatively, visual acuity was evaluated at various distances, including 40 cm and 33 cm, for both monocular and binocular outcomes. Patient satisfaction was evaluated using the VF-14 questionnaire. 72 eyes underwent PanOptix IOLs implantation, and 18 eyes received PanOptix toric IOLs. At 3-month postoperative mark, the mean monocular UDVA, UIVA, and UNVA at 40 cm and 33 cm were -0.02±0.09, 0.00±0.07, 0.02±0.07, and 0.07±0.14 logMAR, respectively, with proportions of visual acuity exceeding 0.1 logMAR were 96.7%, 96.7%, 94.4%, and 74.4%, respectively. The mean binocular UDVA, UIVA, and UNVA at 40 cm and 33 cm were -0.05±0.06, -0.03±0.05, 0.00±0.05, and 0.04±0.07 logMAR, respectively, with proportions of visual acuity exceeding 0.1 logMAR were 97.8%, 100.0%, 100.0%, and 91.1%, respectively. When the near point shifted from 40cm to 33cm, some patients showed a decline for UDVA, but the average reduction was less than one line. The overall VF-14 questionnaire score was 4.02±4.19. PanOptix can provide Chinese patients with a full range of satisfying visual acuity, near to 33cm. Though the visual acuity of some patients at 33 cm did not match the level at 40 cm, the gap of one line may not carry clinical significant.

Interoceptive bodily awareness in patients seeking pain relief with osteopathic manipulative treatment: an observational cohort pilot study.

Interoceptive bodily awareness (IBA) is one's attentional focus on and relationship with comfortable and uncomfortable (e.g., pain) internal body sensations. Integrating IBA into research on osteopathic manipulative treatment (OMT) is growing, both as an outcome and predictor of treatment outcomes; however, it has yet to be studied in a clinical setting. We aimed to conduct a pilot study to measure IBA, with the Multidimensional Assessment of Interoceptive Awareness (MAIA), in patients seeking OMT for pain, and to test if OMT exposure may be associated with higher IBA as measured by the MAIA. The primary outcome was the change in MAIA scores, and the secondary outcomes were reduction in pain intensity, reduction in pain interference, and increase in participants' perception of change post-OMT. A convenience sample was recruited from individuals presenting for OMT appointments at a College of Osteopathic Medicine OMT teaching clinic. Participants were recruited into our single-arm observational cohort study (n=36), and categorized into one of two groups, OMT-naïve (n=19) or OMT-experienced (n=17), based on prior exposure to OMT. We measured MAIA scores and clinical pain-related outcomes prior to, immediately after, and at 1 and 3weeks after a usual-care OMT session in the clinic. Covariates including experience with mind-body activities, non-OMT body work, and physical and emotional trauma were also collected to explore potential relationships. We utilized t tests to compare MAIA scores and pain outcomes between groups and across time points. Stepwise regression models were utilized to explore potential relationships with covariates. The OMT-experienced group scored higher on theMAIA scales "Not-worrying" (p=0.002) and "Trusting" (p=0.028) at baseline. There were no significant changes in the MAIA scores before and after the single OMT session. Analysis of secondary outcomes revealed that all pain outcomes significantly decreased post-OMT (p<0.05), with the largest relative improvements in the acute pain and OMT-naïve subgroups, with diminishing effects over time. Assessing IBA with MAIA in a clinical OMT setting is feasible. There were significant positive correlations between OMT exposure and two of the eight MAIA scales. Future studies are justified to further explore this relationship.

Feasibility and acceptability of remotely monitoring spirometry and pulse oximetry as part of interstitial lung disease clinical care: a single arm observational study

BackgroundRemote monitoring of patient-recorded spirometry and pulse oximetry offers an alternative approach to traditional hospital-based monitoring of interstitial lung disease (ILD). Remote spirometry has been observed to reasonably reflect clinic spirometry in participants with ILD but remote monitoring has not been widely incorporated into clinical practice. We assessed the feasibility of remotely monitoring patients within a clinical ILD service.MethodsProspective, single-arm, open-label observational multi-centre study (NCT04850521). Inclusion criteria included ILD diagnosis, age ≥ 18 years, FVC ≥ 50% predicted. 60 participants were asked to record a single spirometry and oximetry measurement at least once daily, monitored weekly by their local clinical team. Feasibility was defined as ≥ 68% of participants with ≥ 70% adherence to study measurements and recording measurements ≥ 3 times/week throughout.ResultsA total of 60 participants were included in the analysis. 42/60 (70%) were male; mean age 67.8 years (± 11.2); 34/60 (56.7%) had idiopathic pulmonary fibrosis (IPF), Median ILD-GAP score was 3 (IQR 1–4.75). Spirometry adherence was achieved for ≥ 70% of study days in 46/60 participants (77%) and pulse oximetry adherence in 50/60 participants (83%). Recording ≥ 3 times/week every week was provided for spirometry in 41/60 participants (68%) and pulse oximetry in 43/60 participants (72%). Mean difference between recent clinic and baseline home spirometry was 0.31 L (± 0.72). 85.7% (IQR 63.9–92.6%) home spirometry attempts/patient were acceptable or usable according to ERS/ATS spirometry criteria. Positive correlation was observed between ILD-GAP score and adherence to spirometry and oximetry (rho 0.24 and 0.38 respectively). Adherence of weekly monitoring by clinical teams was 80.95% (IQR 64.19–95.79). All participants who responded to an experience questionnaire (n = 33) found remote measurements easy to perform and 75% wished to continue monitoring their spirometry at the conclusion of the study.ConclusionFeasibility of remote monitoring within an ILD clinical service was demonstrated over 3 months for both daily home spirometry and pulse oximetry of patients. Remote monitoring may be more acceptable to participants who are older or have more advanced disease.Trial Registrationclinicaltrials.gov NCT04850521 registered 20th April 2021

Novel adaptation of the KCC-questionnaire for cardiomyopathy screening in a racially diverse obstetric population

Cardiomyopathy occurring during pregnancy or postpartum represents a leading cause of maternal mortality. An overlap between pregnancy-associated symptoms and symptoms of cardiomyopathy contributes to delays in diagnosis. To address the need for screening and improve the diagnosis of pregnancy-related cardiomyopathy, we sought to evaluate the association between cardiovascular symptoms, an adapted version of the 12-item Kansas City Cardiomyopathy Questionnaire for pregnancy (KCCQ-P) and left ventricular systolic dysfunction (LVSD). We conducted a single-arm prospective observational study of pregnant and postpartum participants enrolled between October 2021 and October 2022. A symptom questionnaire, KCCQ-P, and a resting echocardiogram were performed. The primary study outcome was LVSD, defined as left ventricular ejection fraction (LVEF) < 50%. We sub-divided those with LVEF (≥50%) into subclinical LVSD (left ventricular global longitudinal strain (GLS) > –18), and no LVSD (GLS ≤ −18). Ninety women were included in the final analysis. The median age was 31 years (Q1: 28, Q3: 35), 37% identified as Non-Hispanic White, 30% as Non-Hispanic Black, and 23% as Hispanic or Latino. KCCQ-P total scores were markedly lower with LVSD (median: 30.2; Q1: 22.9, Q3: 61.5) vs. subclinical LVSD (median: 60.7; Q1: 47.0, Q3: 76.2) vs. no LVSD (median: 86.5; Q1: 62.5, Q3: 95.8) p < 0.001. KCCQ-P score was able to detect LVSD with an AUC of 0.848. While individual cardiovascular symptoms were not associated with LVSD, KCCQ-P scores were significantly lower in those with apparent and subclinical LVSD and may be useful as a screening tool pending additional evaluation in larger cohorts.

Management of Moderate to Severe Plaque Psoriasis with Brodalumab in Daily Practice: Real-World Evidence from the LIBERO Study in the Czech Republic.

Psoriasis is a chronic, immune-mediated inflammatory skin disease. Despite the availability of several therapies, many patients affected by this disease remain untreated, do not have adequate response, or suffer from treatment-related toxic effects. It has been shown that the interleukin (IL)-17 pathway plays a key role in the immunopathogenesis of psoriasis. Brodalumab, the first human monoclonal IgG2 antibody that selectively binds to subunitA of the human IL-17 receptor, blocking interactions with a number of cytokines of the IL-17 family, has confirmed fast onset of action, high complete clearance rates, and sustained efficacy. Nevertheless, there is only a limited amount of published real-world evidence (RWE) data. This was an open-label, multicenter, real-world, prospective, non-interventional, non-controlled (single-arm) observational study (LIBERO-CZ) assessing the management of moderate to severe psoriasis with brodalumab in daily practice for up to 52weeks of treatment. Fifty-four patients (70.4% male, mean age 46.9 ± 13.4years, weight 95.6 ± 22.7kg, disease duration 18.6 ± 12.7years) were enrolled and included in the final analysis. Forty-nine of the patients completed the study and five discontinued prematurely; 51.8% of all the enrolled patients were biologic-naïve. At baseline, 28% patients were classified as severe (psoriasis area severity index (PASI) ≥ 20). Overall, the mean PASI decreased by 15.6 from 16.1 (± 5.0) at baseline to 0.5 (± 1.2) at the last visit. The primary endpoint of an absolute PASI ≤ 3 at week12 (as observed analysis) was achieved by 95.9% of patients. The static Physician's Global Assessment (sPGA) success (defined as clear = 0 and almost clear = 1) at week52 was achieved by 92.1% of patients. PASI75, PASI90, and PASI100 were achieved by 98.0%, 87.8%, and 75.5% of patients, respectively, after approximately 52weeks of treatment. The study also recorded very positive results concerning patient-reported outcomes. LIBERO-CZ confirms the fast onset and high clearance rates of brodalumab in real life in both biologic-naïve and biologic-experienced patients.

A leadless ventricular pacemaker providing atrioventricular synchronous pacing in the real-world setting: results from the Micra AV post-approval registry

Abstract Introduction Advances in leadless pacemaker technology have enabled accelerometer based atrioventricular synchronous (AVS) pacing by sensing atrial mechanical contraction. However, longer-term performance of these devices in real-world clinical practice has not been assessed. Objectives To report the performance of the Micra AV transcatheter pacemaker from the worldwide Micra AV post-approval registry (PAR) through 1-year post-implant. Methods The Micra AV PAR is an ongoing prospective single-arm observational study designed to assess the safety and effectiveness of the Micra AV system in the real-world setting. Patients enrolled in the Micra AV PAR will be followed for 3 years. For the present interim analysis, baseline characteristics, total AV synchrony index (sum of %AM-VP, %AM-VS, and AV conduction mode switch percentage), major complications, and system revisions through 12-months of implant were summarized and compared to a historical cohort of 2,667 transvenous dual chamber (TV-DC) pacing patients. Results The device was successfully implanted in 797 of 801 patients (99.4%) at 98 centers in 19 countries between February 2020 and April 2022. Mean age was 74.1±15.1 years, 42.2% were female, and 31.3% were precluded from transvenous device therapy. Micra AV patients were on average older (74.1 vs. 71.1 yrs, P&amp;lt;0.0001) and had a significantly higher incidence of renal disease (22.3% vs. 9.8%, P&amp;lt;0.0001) compared with TV-DC patients. Mean follow-up was 7.7±6.4 months. Through 12-months, the major complication rate was 4.2% in Micra AV patients compared to 8.8% TV-DC patients (HR: 0.48, P&amp;lt;0.001, Figure). At 12-months, the system revision rate was 1.9% in Micra AV patients compared to 5.5% for TV-DC patients (HR: 0.28, P&amp;lt;0.001). The reduction in system revisions was largely driven by the absence of lead dislodgements requiring revision. Of the 397 patients with device interrogation files available for analysis, 315 (79.4%) were programmed to VDD mode at last follow-up and had a median AV synchrony index of 86.4% (IQR: 68.8% - 97.4%). Conclusions The Micra AV leadless pacemaker was implanted with a high rate of success in patients with a high co-morbidity burden, with a significantly lower rate of complications and system revisions through 12-months compared to dual-chamber transvenous pacemakers despite patients being older and having a higher incidence of renal disease. Longer-term performance will continue to be assessed in this ongoing trial.Major Complications Through 12-months

Abstract 18897: Safety and Efficacy of Coronary Intravascular Lithotripsy for Percutaneous Coronary Intervention of Severely Calcified Left Main Stenosis

Introduction: Coronary Intravascular Lithotripsy has been shown to be a safe and effective modality for the modification of non-left main calcific stenosis. This study was done to evaluate the safety and efficacy of IVL during percutaneous coronary intervention (PCI) of severely calcified left main (LM) bifurcation disease. Methods: This was a prospective, single-arm observational study in which 22 patients with significant calcific LM bifurcation disease undergoing angioplasty were enrolled. Pre and Post-IVL Optical coherence tomography (OCT) was done in all patients as an imaging modality. The primary safety end-point was peri-procedure complications and freedom from major adverse cardiovascular events (MACE) defined as cardiac death, non-fatal MI, and target vessel revascularization at 30 days, and the primary efficacy endpoint was stent expansion of more than 80% in stratified stented segment. The secondary efficacy endpoint was mean stent area more than the accepted target value of 5.0 mm 2 , 6.3 mm 2 , and 8.2 mm 2 for the ostial LCX, ostial LAD, and distal LM, respectively. Results: 15 (68.2%) patients underwent LM bifurcation angioplasty using provisional strategy and 7(31.81%) using upfront two stent strategy (DKC 22.7% &amp; TAP 9.1%). A total of 55 Ca lesions were modified using one IVL per patient with a mean size of 3.38 ± 0.40mm. Stent expansion at LM was 95.64±5.89%, left anterior descending (LAD) was 87.20±6.81% and left circumflex (LCx) was 85.56±5.89%. The primary efficacy endpoint of more than 80% stent expansion was noticed in all LM segments (22/22), 18/20 (90%) LAD segments, and 9/9 LCX segments. The primary safety endpoints were met in 21 (95.45%) patients undergoing IVL-assisted distal LM bifurcation angioplasty. Target MSAs were achieved in all 22 (100%) of all IVL-treated segments, and stent apposition was achieved in 21 (95%) of all stented segments. No perforation (0%) or slow/no flow (0%) were observed, while minor 3 (13.6%) and major dissections 3 (13.6%) were seen. None of the major dissections were flow-limiting. Conclusions: IVL appears to be a safe and effective device for percutaneous coronary intervention of severely calcific LM disease with a high success rate.

Abstract 15771: Cardiosphere-Derived Cell Extracellular Vesicles (CDC-EVs) Alter C-C Chemokine Receptor Type 2 (CCR2) Mediated Monocyte Pro-Inflammatory Signaling Following Cardiac Injury

Background: Following cardiac damage, CCL2 (a cytokine released by the injured cardiac tissue) recruits CCR2+ monocytes to the site of injury. Heightened CCL2 levels, however, can over activate the CCR2+ mediated pro-inflammatory response leading to poor cardiac healing. Cardiosphere-derived cell extracellular vesicles (CDC-EVs) have been shown to suppress the inflammatory response by decreasing CCR2 monocyte expression. We hypothesized that treatment with CDC-EVs would suppress CCR2 expression of peripheral monocyte in patients with acute MI. Methods: A prospective single arm observational study was performed. Inpatients at Buffalo General Medical Center were recruited following these criteria: 1) &gt;18 years of age AND 2) a type I MI. Subjects were excluded for the following: 1) fever in last 2 days/infection, 2) is or may be pregnant, or 3) currently undergoing cancer treatment. Monocytes were isolated from peripheral blood samples using Ficoll/centrifugation followed by magnetic activated cell sorting. Isolated monocytes were incubated with either PBS, normal human dermal fibroblast EVs (NHDF-EVs) or CDC-EVs. Monocytes then were analyzed for CCR2 expression by flow cytometry. Multi-variate analysis was performed. Results: CDC-EVs significantly reduced classical monocyte expression of CCR2 by 23% as quantified by flow cytometry compared with PBS (p&lt;0.05, one way ANOVA, n=23) and by 13% compared with NHDF-EVs (p&lt;0.05, one way ANOVA, n=23) in patients with recent MI. This reduction was seen regardless of patients’ pre-existing co-morbidities, medications, LVEF, or history of PCI. Smoking was associated with decreased response to CDC-EV mediated CCR2 suppression (Linear regression model R -0.93, p&lt;0.05, n=23). Conclusions: CDC-EVs effectively downregulate CCR2 expression in patients with recent MI, representing a potential adjunct to current clinical therapies in patients with a heightened pro-inflammatory response post-MI.

Sintilimab plus fluorouracil, leucovorin, oxaliplatin and docetaxel regimen as neoadjuvant therapy for resectable gastric cancer and biomarker exploration.

At present, preoperative chemotherapy is the standard of care for the neoadjuvant treatment of potentially resectable gastric cancer (GC). However, because the efficacy and prognosis are not ideal, curative effects for this population are unsatisfactory. With the development of immune checkpoint inhibitors, the results of a few encouraging early trials of immunotherapeutic agents as neoadjuvant therapies for resectable GC have been reported. However, markers of theefficacy ofimmune checkpoint inhibitors remain unclear. This prospective single-center, single-arm observational study was designed to evaluate the efficacy of sintilimab plus the fluorouracil, leucovorin, oxaliplatin and docetaxel regimen as a neoadjuvant treatment for localized GC. More importantly, this workassesses multiple dimensions and include ctDNA, the immune microenvironmentand intestinal microbiome to explorecorrelations between biomarkers and neoadjuvant therapeutic efficacy. Clinical trial registration: ChiCTR2200061629 (www.chictr.org.cn/index.aspx).

Heart rate responses, agreement and accuracy among persons with severe disabilities participating in the indirect movement program: Team Twin-an observational study.

Heart rate (HR) monitors are rarely used by people living with disabilities (PLWD), and their accuracy is undocumented. Thus, this study aims to describe the HR response during the Team Twin co-running program and, secondly, to assess the agreement and accuracy of using HR monitors among PLWD. This 16-week single-arm observational study included 18 people with various disabilities. During the study, the subjects wore a Garmin Vivosmart 4 watch (wrist). To evaluate the agreement and accuracy we applied Garmin's HRM-DUAL™ chest-worn HR monitors for comparison with the Vivosmart 4. The HR response analysis was performed descriptively and with a mixed regression model. The HR agreement and accuracy procedure was conducted on a subsample of five subjects and analyzed using Lin's concordance analysis, Bland and Altman's limits of agreement, and Cohen's kappa analysis of intensity zone agreement. This study was prospectively registered at Clinical Trials.gov (NCT04536779). The subjects had a mean age of 35 (±12.6), 61% were male, 72% had cerebral palsy were 85% had GMFCS V-IV. HR was monitored for 202:10:33 (HH:MM:SS), with a mean HR of 90 ± 17 bpm during training and race. A total of 19% of the time was spent in intensity zones between light and moderate (30%-59% HR reserve) and 1% in vigorous (60%-84% HR reserve). The remaining 80% were in the very light intensity zone (<29% HR reserve). HR was highest at the start of race and training and steadily decreased. Inter-rater agreement was high (k = 0.75), limits of agreement were between -16 and 13 bpm, and accuracy was acceptable (Rc = 0.86). Disability type, individual, and contextual factors will likely affect HR responses and the agreement and accuracy for PLWD. The Vivosmart 4, while overall accurate, had low precision due to high variability in the estimation. These findings implicate the methodical and practical difficulties of utilizing HR monitors to measure HR and thus physical activity in adapted sports activities for severely disabled individuals.

Feasibility and Usability of a Mobile App-Based Interactive Care Plan for Migraine in a Community Neurology Practice: Development and Pilot Implementation Study.

Migraine is a common and major cause of disability, poor quality of life, and high health care use. Access to evidence-based migraine care is limited and projected to worsen. Novel mobile health app-based tools may effectively deliver migraine patient education to support self-management, facilitate remote monitoring and treatment, and improve access to care. The risk that such an intervention may increase the care team workload is a potential implementation barrier. This study aims to describe a novel electronic health record-integrated mobile app-based Migraine Interactive Care Plan (MICP) and evaluate its feasibility, usability, and impact on care teams in a community neurology practice. Consecutive enrollees between September 1, 2020, and February 16, 2022, were assessed in a single-arm observational study of usability, defined by 74.3% (127/171) completing ≥1 assigned task. Task response rates, rate and type of care team escalations, and patient-reported outcomes were summarized. Patients were prospectively recruited and randomly assigned to routine care with or without the MICP from September 1, 2020, to September 1, 2021. Feasibility was defined by equal to or fewer downstream face-to-face visits, telephone contacts, and electronic messages in the MICP cohort. The Wilcoxon rank-sum test was used to compare continuous variables, and the chi-square test was used for categorical variables for those with at least 3 months of follow-up. A total of 171 patients were enrolled, and of these, 127 (74.3%) patients completed ≥1 MICP-assigned task. Mean escalations per patient per month was 0.9 (SD 0.37; range 0-1.7). Patient-confirmed understanding of the educational materials ranged from 26.6% (45/169) to 56.2% (95/169). Initial mean headache days per week was 4.54 (SD 2.06) days and declined to 2.86 (SD 1.87) days at week 26. The percentage of patients reporting favorable satisfaction increased from a baseline of 35% (20/57) to 83% (15/18; response rate of 42/136, 30.9% to 28/68, 41%) over the first 6 months. A total of 121 patients with MICP were compared with 62 patients in the control group. No differences were observed in the rate of telephone contacts or electronic messages. Fewer face-to-face visits were observed in the MICP cohort (13/121, 10.7%) compared with controls (26/62, 42%; P<.001). We describe the successful implementation of an electronic health record-integrated mobile app-based care plan for migraine in a community neurology practice. We observed fewer downstream face-to-face visits without increasing telephone calls, medication refills, or electronic messages. Our findings suggest that the MICP has the potential to improve patient access without increasing care team workload and the need for patient input from diverse populations to improve and sustain patient engagement. Additional studies are needed to assess its impact in primary care.

Can mobile-health applications contribute to long-term increase in physical activity after medical rehabilitation?-A pilot-study.

Due to the positive effects of rehabilitation declining over time, the aim of this study was to investigate the long-term physical activity level (PAL) following inpatient rehabilitation in relation to the use of a smartphone-based after-care program. 202 patients (mean Body Mass Index (BMI): 30,8 kg/m2; 61% female) with chronic diseases (e.g., diabetes mellitus, obesity, chronic low back pain, depression) were recruited between 08/2020 and 08/2021 in this single-arm observational study. All patients underwent a 3-week inpatient rehabilitation program. PAL (in total activity minutes/week) was measured with a validated (online) questionnaire (Freiburger Questionnaire on PA) after 3, 6, 9, and 12 months. App usage (online time, completion of a course) was recorded automatically and used to evaluate the app user behavior (adherence). A variety of socio-economic factors (age, sex, education level, income etc.) were collected to identify possible barriers of app use. Except for sex, no significant difference was observed for socio-economic factors regarding app usage behavior. Median PAL significantly increased after rehabilitation in the total cohort from 360 min/week (before rehabilitation) to 460 min/week 6 months after rehabilitation, then declined to 420 min/week 9 months after rehabilitation before falling below baseline level after 12 months. There was no significant difference in PAL between app users (45%, 91/202) and non-users (55%, 111/202), although app users tended to retain higher activity levels after 3 and 6 months, respectively. Overall, our study emphasizes the effectiveness of a 3-week rehabilitation program on PAL and the acceptance and usability of a smartphone-based after-care program in this patient group. The adherence to this 3-months after-care app program was acceptable (30%), with modest evidence supporting the effectiveness of app use to sustain PAL in the short term.

Automated Assessment of Digital Images of Uterine Cervix Captured Using Transvaginal Device-A Pilot Study.

In low-resource settings, a point-of-care test for cervical cancer screening that can give an immediate result to guide management is urgently needed. A transvaginal digital device, "Smart Scope®" (SS), with an artificial intelligence-enabled auto-image-assessment (SS-AI) feature, was developed. In a single-arm observational study, eligible consenting women underwent a Smart Scope®-aided VIA-VILI test. Images of the cervix were captured using SS and categorized by SS-AI in four groups (green, amber, high-risk amber (HRA), red) based on risk assessment. Green and amber were classified as SS-AI negative while HRA and red were classified as SS-AI positive. The SS-AI-positive women were advised colposcopy and guided biopsy. The cervix images of SS-AI-negative cases were evaluated by an expert colposcopist (SS-M); those suspected of being positive were also recommended colposcopy and guided biopsy. Histopathology was considered a gold standard. Data on 877 SS-AI, 485 colposcopy, and 213 histopathology were available for analysis. The SS-AI showed high sensitivity (90.3%), specificity (75.3%), accuracy (84.04%), and correlation coefficient (0.670, p = 0.0) in comparison with histology at the CINI+ cutoff. In conclusion, the AI-enabled Smart Scope® test is a good alternative to the existing screening tests as it gives a real-time accurate assessment of cervical health and an opportunity for immediate triaging with visual evidence.

Autonomic Neuropathy in Ambulatory Type 2 Diabetes Mellitus Patients: A Single-arm Prospective, Observational Study

Abstract Introduction: Diabetic autonomic neuropathy (DAN), a serious complication of diabetes, is a significant contributor to increased morbidity and mortality. Although DAN often coexists with different peripheral neuropathies and other complications, it may also present in isolation. The present study aimed to understand the DAN status of a cohort of ambulatory type 2 diabetics in a tertiary care setting. Methods: A single-arm prospective observational study was carried out, where enrolled patients were interviewed for basic demographics and comorbidities, screened for symptoms of autonomic dysregulation, and other risk factors such as smoking and alcoholism. Based on the presence of overt symptoms, they were divided into two groups with or without any overt symptoms of autonomic neuropathy. Both groups were subjected to a battery of autonomic neuropathy tests, and their DAN status was characterized based on the observed scores. Results: The overall prevalence of DAN, as observed in our study, was 36%. Of 108 patients, 97 presented with one or more symptoms of autonomic dysregulation, whereas the rest, 10.1%, were without any symptoms. Among heart rate-based tests, a significant (P &lt; 0.001) decrease followed by an increase in the Valsalva ratio was observed in 6 months and 12 months, respectively. A significant decrease (P &lt; 0.001) in deep breathing test (E: I) values was observed in the 12th month. Most of the DAN patients presented with moderate autonomic dysfunction, followed by mild and severe, respectively. However, no significant change in DAN severity was noted with time. Conclusion: Using simple cardiovascular tests, DAN can be detected during the asymptomatic phase of the disease.

A Bespoke Electronic Health Journal for Monitoring Response to Botulinum Toxin in Treatment of Cervical Dystonia: Open-Label Observational Study of User Experience.

The mainstay of treatment for cervical dystonia (CD) is regular botulinum toxin injections every 3-4 months. Clinical evaluation of response is dependent on the patient's recall of how well symptoms responded to the previous injection. A mobile health app could assist both patients and health care professionals to monitor treatment benefits and side effects to assist with the selection of muscle and toxin dose to be injected at the next visit. The DystoniaDiary is a bespoke electronic health journal for monitoring symptoms of CD and response to treatment. The objective of this study was to assess the acceptability and utility of the DystoniaDiary in patients with CD treated with botulinum toxins as part of their usual care. In this open-label, single-center, single-arm observational study, patients attending a botulinum toxin injection clinic were invited to download the DystoniaDiary app. Patients selected up to 3 of their most troublesome CD symptoms (from a predefined list) and were prompted every 3 days to rate the control of these symptoms on a scale from 0 (very badly) to 100 (very well). Dates of onset and wearing off of response to injected botulinum toxin and responses to the Cervical Dystonia Impact Profile (CDIP-58) questionnaire at baseline and week 6 were also recorded in the app. A total of 34 patients installed DystoniaDiary. Twenty-five patients (25/34, 74%) recorded data for ≥12 weeks and 21 patients (21/34, 62%) for ≥16 weeks. Median time between the first and last data input was 140 days with a median of 13 recordings per patient. User experience questionnaires at weeks 4 and 12 (20 respondents) indicated that the majority of respondents found the DystoniaDiary app easy to install and use, liked using it, would recommend it to others (19/20), and wished to continue using it (16/20). A smaller proportion indicated that the DystoniaDiary gave a greater sense of control in managing their CD (13/20). There was interindividual variation in patients' perceptions of control of their symptoms after botulinum toxin injection. Response to treatment was apparent in the symptom control scores for some patients, whereas the severity of other patients' symptoms did not appear to change after treatment. This observational study demonstrated that the DystoniaDiary app was perceived as useful and acceptable for a large proportion of this sample of patients with CD attending a botulinum toxin clinic. Patients with CD appear to be willing to regularly record symptom severity for at least the duration of a botulinum injection treatment cycle (12-16 weeks). This app may be useful in monitoring and optimizing individual patient responses to botulinum toxin injection.

Treatment of sinus headache using a device that combines acoustic vibration with oscillating expiratory pressure.

To determine if simultaneous administration of acoustic vibration and oscillating expiratory pressure affects the severity of facial pain among patients with complaint of "sinus headache". This is a prospective single-arm observational study performed at a tertiary care medical center. Subjects with complaint of sinus headache without evidence of chronic rhinosinusitis on exam or computed tomography participated in a clinical study applying simultaneous acoustic vibrations and positive expiratory pressure to the nasal cavity twice daily over 4 weeks. Efficacy was assessed using three validated pain metrics-pain visual analog scale (VAS), brief pain inventory-short form (BPI-SF), and McGill pain questionnaire-short form (MPQ-SF). Device safety and patient satisfaction were also assessed using questionnaires. Twenty-nine patients (mean age 49 years, 55% female) completed the study without any major adverse events. At the 4 week follow-up, facial pain VAS improved from mean ± SD of 59.6 ± 15.7 to 34.6 ± 21.7 (p < .001), BPI mean pain (mean ± standard deviation) improved from 4.4 ± 2.0 to 2.9 ± 1.9 (p = .007), and MPQ-SF total improved from 12.2 ± 6.5 to 6.5 ± 5.2 (p < .001) with approximately 70% of patients achieving a minimal clinically important difference (MCID) across all metrics. Additionally, pain VAS was assessed 5 min after a single use at baseline with significant improvement (p < .001). Eighty-six percent of subjects would both use device again and recommend it to others. Simultaneous administration of acoustic vibration and oscillating expiratory pressure appears to be a safe treatment for sinus headaches in patients without objective evidence of chronic sinusitis. Results from this initial study are promising with regard to efficacy in treatment of sinus headaches but will require further study. 2c.

Efficacy and Safety of Cold Snare Polypectomy of Colorectal Polyps 10–15 mm with a Hybrid Snare: A Prospective Observational Pilot Study

Introduction: Cold snare polypectomy (CSP) is a safe and effective procedure for small colorectal polyps ≤9 mm. There are only limited data regarding CSP of larger neoplastic lesions. This study evaluated the efficacy and safety of CSP for polyps between 10 and 15 mm in size. Methods: In this prospective single-arm observational pilot study, patients with a least one polyp 10–15 mm were included. These polyps were preferably removed by CSP using a dedicated hybrid snare. The primary outcome was the histological complete resection rate (CRR) determined by pathologically negative margins of the specimen and no neoplastic tissue obtained from biopsies of the resection site margin. Secondary outcomes were en bloc resection rate, failure of CSP, and incidence of adverse events. Results: A total of 61 neoplastic polyps were removed from 39 patients. Overall CRR was 80.3% (49/61). CSP was feasible in 78.7% (48/61) of polyps and the CRR in this group was 85.4% (41/48). When CSP failed (13/61; 21.3%), lesions were successfully resected by immediate HSP using the same snare with a CRR of 61.5% (8/13) in this group. One patient presented delayed hemorrhage after HSP of a polyp but successful hemostasis was achieved with two hemoclips. No other adverse events occurred. No recurrence was seen on follow-up colonoscopy in cases with incomplete resected polyps. Conclusion: CSP seems to be efficient and safe in removing colorectal polyps up to 15 mm. A hybrid snare seems to be particularly advantageous for these polyps as it allows immediate conversion to HSP if CSP might fail in larger polyps. This trial is registered at ClinicalTrials.gov (NCT04464837).

A leadless ventricular pacemaker providing atrioventricular synchronous pacing in the real-world setting: acute results from the Micra AV post-approval registry

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Medtronic, inc. Introduction Advances in leadless pacemaker technology have enabled accelerometer based atrioventricular synchronous (AVS) pacing by sensing atrial mechanical contraction. However, acute safety performance of these devices in real-world clinical practice has not been assessed. Objectives To report the acute performance of the Micra AV transcatheter pacemaker from the worldwide Micra AV post-approval registry (PAR). Methods The Micra AV PAR is an ongoing prospective single-arm observational study designed to assess the safety and effectiveness of the Micra AV system in the real-world setting. Patients enrolled in the Micra AV PAR will be followed for 3 years. For the present interim analysis, baseline characteristics, total AV synchrony index (sum of %AM-VP, %AM-VS, and AV conduction mode switch percentage), and major complications occurring within 30-days of implant were summarized and compared to a historical cohort of 2,667 transvenous dual chamber (TV-DC) pacing patients. Results The device was successfully implanted in 797 of 802 patients (99.4%) at 99 centers. Mean age was 74.1±15.1 years and 42.3% were female. The most common pacing indication was AV block (55.7%). Comorbidities included diabetes (29.7%), CAD (22.8%), and heart failure (12.1%), with 31.3% precluded from transvenous device therapy. Micra AV patients were on average older (74.1 vs. 71.1 yrs, P&amp;lt;0.0001) and had a significantly higher incidence of renal disease (22.3% vs. 9.8%, P&amp;lt;0.0001). Major complications occurred in 2.6% of Micra AV patients and in 7.1% TV-DC patients (P&amp;lt;0.001, Figure). The reduction in major complications was largely driven by the absence of pneumothoraces and lead dislodgements among Micra AV patients. Of the 309 patients programmed to VDD mode with at least 30 days of device follow-up, the median AV synchrony index was 86.0% (IQR: 69.2% - 97.2%). Mean A4 amplitude was 2.1±1.6 m/s2 post-implant and 2.2±1.7 m/s2 at follow-up (P=0.57) in 308 patients with paired assessments. Conclusions The Micra AV leadless pacemaker was implanted with a high rate of success in patients with a high co-morbidity burden, with a significantly lower rate of acute complications relative to dual-chamber transvenous pacemakers despite patients being older and having a higher incidence of renal disease. Longer-term performance will continue to be assessed in this ongoing trial.

Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer (POLA)-Study protocol for a single-arm prospective observational multicenter study.

In the era of neoadjuvant chemotherapy in advanced gastric cancer (GC), the role of staging laparoscopy (SL) will become more established. However, despite guidelines recommendations, SL for optimal preoperative staging remains underutilized. Diagnostic value of near-infrared (NIR) / indocyanine green (ICG) guided sentinel node (SN) mapping in GC confirmed its technical feasibility, however no data exist regarding its potential role in pathological nodal staging. To the best of our knowledge, current study is the first to evaluate the role of ICG in nodal staging of advanced GC patients undergoing SL. This single-arm prospective observational multicenter study was approved by the Bioethical Committee of Medical University of Lublin (Ethic Code: KE-0254/331/2018). The protocol is registered at clinicaltrial.gov (NCT05720598), and the study results will be reported according to the Strengthening of Reporting of Observational Studies in Epidemiology (STROBE) statement. The primary endpoint of this study is the identification rate of ICG-guided SN in advanced GC patients. The secondary endpoints include pathological and molecular assessment of retrieved SNs and other pretreatment clinical variables potentially associated with SL: pattern of perigastric ICG distribution according to patients' pathological and clinical characteristics, neoadjuvant chemotherapy compliance, 30-day morbidity, and mortality. POLA study is the first to investigate the clinical value of ICG-enhanced sentinel node biopsy during staging laparoscopy in advanced GC patients in a Western cohort. Identifying pN status before multimodal treatment will improve GC staging process.