Accurate and safe diagnosis and treatment of neoplastic biliary lesions using a novel 9F and 11F digital single-operator cholangioscope.

Background and study aims Digital single-operator cholangioscopy (DSOC) allows the diagnosis of biliary duct disorders and treatment for complicated stones. However, these technologies have limitations such as the size of the probe and working channel, excessive cost, and low image resolution. Recently, a novel DSOC system (eyeMAX, Micro-Tech, Nanjing, China) was developed to address these limitations. We aimed to evaluate the usefulness and safety of a novel 9F and 11F DSOC system in terms of neoplastic diagnostic accuracy based on visual examination, ability to evaluate tumor extension and to achieve complete biliary stone clearance, and procedure-related adverse events (AEs). Patients and methods Data from ≥ 18-year-old patients who underwent DSOC from July 2021 to April 2022 were retrospectively recovered and divided into a diagnostic and a therapeutic cohort. Results A total of 80 patients were included. In the diagnostic cohort (n = 49/80), neovascularity was identified in 26 of 49 patients (46.9%). Biopsy was performed in 65.3% patients with adequate tissue sample obtained in 96.8% of cases. Biopsy confirmed neoplasia in 23 of 32 cases. DSOC visual impression achieved 91.6% sensitivity and 87.5% specificity in diagnosing neoplasms. In the therapeutic cohort (n = 43/80), 26 of 43 patients required lithotripsy alone. Total stone removal was achieved in 71% patients in the first session. Neither early nor late AEs were documented in either the diagnostic or therapeutic cohort. Conclusions The novel DSOC device has excellent diagnostic accuracy in distinguishing neoplastic biliary lesions as well as therapeutic benefits in the context of total stone removal, with no documented AEs.

Assessing Endoscopic Ultrasound-Guided Radiofrequency Ablation in Unresectable Pancreatic Ductal Adenocarcinoma: A Single-Center Historic Cohort Study.

BACKGROUND: /aims: Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) has emerged as an alternative for the local treatment of unresectable pancreatic ductal adenocarcinoma (PDAC). We aim to assess the feasibility and safety of EUS-RFA in patients with unresectable PDAC. METHODS: The following was a historic cohort compounded by locally advanced (LA) and metastatic (m) PDAC naïve patients, who underwent EUS-RFA between October 2019 to March 2022. EUS-RFA was performed with a 19-g needle electrode with a 10 mm active tip for energy delivery. Study primary endpoints were feasibility, safety, and clinical follow-up; secondary endpoints were performance status (PS), local control (LC) and overall survival (OS). RESULTS: Twenty-six patients were selected: 15/26 LA-PDAC and 11/26 mPDAC. Technical success was achieved in all patients with no major adverse events. Six months after EUS-RFA, OS was 11/26 (42.3%), with significant PS improvement (P=.03). LC was achieved, with tumor reduction from 39.5 to 26 mm (P=.04). Post-treatment hypodense necrotic area was observed at six-month follow-up in 11/11 alive cases. Metastatic disease was a significant factor for OS worsening (HR 5.021; IC 95% 1.589 - 15.87; P=.004) CONCLUSIONS: EUS-RFA of pancreatic adenocarcinoma is a minimally invasive and safe technique that may have an important role as targeted therapy for local treatment of unresectable cases, as well as an alternative for poor surgical candidates. Also, RFA may play a role in downstaging cancer with potential OS increase in non-metastatic cases. Large prospective cohorts are required to evaluate this technique in clinical practice.

Hemodynamic performance of self-expandable transcatheter aortic valve replacement systems during valve deployment.

OBJECTIVES: Little is known about valve hemodynamic performance during the Evolut and Neo deployment course. We aimed to evaluate transvalvular mean and peak-to-peak gradients over several intraprocedural timepoints during TAVR with Evolut PRO+ (Medtronic) and Neo (Boston Scientific) systems. METHODS: This was single-center pilot sub-study from the SavvyWire EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI) trial. Participants received either the Evolut PRO+ or Neo for native valve severe aortic stenosis and the SavvyWire (OpSens Medical) was used for device delivery, pacing, and continuous left ventricular and aortic pressure measurements. For the Evolut, evaluation was done for baseline, two-thirds of valve deployment (still recapturable), 90% of valve deployment (no longer recapturable), and post-deployment hemodynamics. For the Neo, analysis was done at baseline, after the first step (top-crown deployment), and at final status. RESULTS: Nineteen patients were included (Evolut = 15; Neo = 4). There were no statistically significant changes in peak-to-peak gradients (44 mm Hg [IQR:33-69] vs 43 mm Hg [IQR:26-62], P = .41) between baseline and two-thirds of valve deployment in the Evolut patients. There was a significant decrease in mean (40 mm Hg [IQR:32-54] vs 14 mm Hg [IQR:10-18], P less than .001) and peak-to-peak (43 mmHg [IQRS:26-62] vs 9 mm Hg [IQR:8-13], P less than .001) transvalvular gradients between two-thirds and 90% of valve deployment for Evolut. Neo patients exhibited a decrease in transvalvular gradients after top-crown deployment (42.5 mm Hg baseline vs 13 mm Hg). CONCLUSIONS: Transvalvular gradients did not vary between the point of "no-recapture" compared to baseline values in patients receiving the Evolut, whereas a significant reduction in transvalvular gradients was observed when the valve was deployed at 90% and fully deployed. The Neo valve was slightly obstructive after the first step of deployment.

Development of convolutional neural network models that recognize normal anatomic structures during real-time radial-array and linear-array EUS (with videos).

BACKGROUND AND AIMS: EUS is a high-skill technique that requires numerous procedures to achieve competence. However, training facilities are limited worldwide. Convolutional neural network (CNN) models have been previously implemented for object detection. We developed 2 EUS-based CNN models for normal anatomic structure recognition during real-time linear- and radial-array EUS evaluations. METHODS: The study was performed from February 2020 to June 2022. Consecutive patient videos of linear- and radial-array EUS videos were recorded. Expert endosonographers identified and labeled 20 normal anatomic structures within the videos for training and validation of the CNN models. Initial CNN models (CNNv1) were developed from 45 videos and the improved models (CNNv2) from an additional 102 videos. CNN model performance was compared with that of 2 expert endosonographers. RESULTS: CNNv1 used 45,034 linear-array EUS frames and 21,063 radial-array EUS frames. CNNv2 used 148,980 linear-array EUS frames and 128,871 radial-array EUS frames. Linear-array CNNv1 and radial-array CNNv1 achieved a 75.65% and 71.36% mean average precision (mAP) with a total loss of .19 and .18, respectively. Linear-array CNNv2 obtained an 88.7% mAP with a .06 total loss, whereas radial-array CNNv2 achieved an 83.5% mAP with a .07 total loss. CNNv2 accurately detected all studied normal anatomic structures with a >98% observed agreement during clinical validation. CONCLUSIONS: The proposed CNN models accurately recognize the normal anatomic structures in prerecorded videos and real-time EUS. Prospective trials are needed to evaluate the impact of these models on the learning curves of EUS trainees.

EUS-guided drainage of a segment VI liver abscess using a lumen-apposing metal stent.

Video 1EUS-guided FNA and lumen-apposing metallic stent deployment.

Transcatheter aortic valve implantation in patients with extra-small aortic annuli.

BACKGROUND: A small aortic annulus (SAA) is a risk factor for prosthesis-patient mismatch (PPM) in patients undergoing surgical or transcatheter aortic valve implantation (TAVI). Data regarding TAVI in patients with extra-SAA are scarce. AIMS: The aim of this study was to analyse the safety and efficacy of TAVI in patients with extra-SAA. METHODS: A multicentre registry study including patients with extra-SAA (defined as an aortic annulus area <280 mm2 and/or perimeter <60 mm) undergoing TAVI was established. Primary efficacy and safety endpoints were defined as device success and early safety at 30 days, respectively, using the Valve Academic Research Consortium-3 criteria, and were analysed according to valve type: self-expanding (SEV) versus balloon-expandable (BEV). RESULTS: A total of 150 patients were included, of which 139 (92.7%) were women, and 110 (73.3%) received an SEV. Intraprocedural technical success was 91.3%, with a higher rate in patients receiving an SEV (96.4% vs 77.5% with BEV; p=0.001). Overall, 30-day device success was 81.3%, (85.5% with SEV vs 70.0% with BEV; p=0.032). The primary safety endpoint occurred in 72.0% of patients (with no difference between groups; p=0.118). Severe PPM occurred in 12% (9.0% with SEV and 24.0% with BEV; p=0.039), with no impact on all-cause mortality, cardiovascular mortality, or heart failure readmission at 2-year follow-up. CONCLUSIONS: TAVI is a safe and feasible treatment in patients with extra-SAA with a high rate of technical success. The use of SEV was associated with a lower rate of intraprocedural complications, higher device success at 30 days and better haemodynamic outcomes compared to BEV.

Endoscopic Ultrasound-Guided Gallbladder Drainage Versus Percutaneous Drainage in Patients With Acute Cholecystitis Undergoing Elective Cholecystectomy.

INTRODUCTION: Cholecystectomy (CCY) is the gold standard treatment of acute cholecystitis (AC). Nonsurgical management of AC includes percutaneous transhepatic gallbladder drainage (PT-GBD) and endoscopic ultrasound-guided gallbladder drainage (EUS-GBD). This study aims to compare outcomes of patients who undergo CCY after having received EUS-GBD vs PT-GBD. METHODS: A multicenter international study was conducted in patients with AC who underwent EUS-GBD or PT-GBD, followed by an attempted CCY, between January 2018 and October 2021. Demographics, clinical characteristics, procedural details, postprocedure outcomes, and surgical details and outcomes were compared. RESULTS: One hundred thirty-nine patients were included: EUS-GBD in 46 patients (27% male, mean age 74 years) and PT-GBD in 93 patients (50% male, mean age 72 years). Surgical technical success was not significantly different between the 2 groups. In the EUS-GBD group, there was decreased operative time (84.2 vs 165.4 minutes, P < 0.00001), time to symptom resolution (4.2 vs 6.3 days, P = 0.005), and length of stay (5.4 vs 12.3 days, P = 0.001) compared with the PT-GBD group. There was no difference in the rate of conversion from laparoscopic to open CCY: 5 of 46 (11%) in the EUS-GBD arm and 18 of 93 (19%) in the PT-GBD group ( P value 0.2324). DISCUSSION: Patients who received EUS-GBD had a significantly shorter interval between gallbladder drainage and CCY, shorter surgical procedure times, and shorter length of stay for the CCY compared with those who received PT-GBD. EUS-GBD should be considered an acceptable modality for gallbladder drainage and should not preclude patients from eventual CCY.

Leaving obstacles aside: Antegrade paravalvular leakage closure after transcatheter aortic valve replacement.

Paravalvular leakage (PVL) is yet a potential and serious complication after transcatheter aortic valve replacement. Percutaneous PVL closure may be the treatment of choice upon failure of balloon postdilation in patients with excessive surgical risk. If the retrograde approach fails, an antegrade strategy might provide the solution.

Cardiac amyloidosis and left atrial appendage closure. The CAMYLAAC study.

INTRODUCTION AND OBJECTIVES: Transthyretin cardiac amyloidosis (ATTR-CA) patients often have atrial fibrillation and increased bleeding/thrombogenic risks. We aimed to evaluate outcomes of left atrial appendage closure (LAAC) compared with patients without a known diagnosis of CA. METHODS: Comparison at long-term of patients diagnosed with ATTR-CA who underwent LAAC between 2009 and 2020 and those without a known diagnosis of CA. RESULTS: We studied a total of 1159 patients. Forty patients (3.5%) were diagnosed with ATTR-CA; these patients were older and had more comorbidities, higher HAS-BLED and CHA2DS2-VASc scores, and lower left ventricular function. Successful LAAC was achieved in 1137 patients (98.1%) with no differences between groups. Regarding in-hospital and follow-up complications, there were no differences between the groups in ischemic stroke (5% vs 2.5% in those without a known diagnosis of CA; P=.283), hemorrhagic stroke (2.5% and 0.8% in the control group; P=.284), major or minor bleeding. At the 2-year follow-up, there were no significant differences in mortality (ATTR-CA: 20% vs those without known CA: 13.6%, 0.248); however, the at 5-year follow-up, ATTR-CA patients had higher mortality (40% vs 19.2%; P <.001) but this difference was unrelated to hemorrhagic complications or ischemic stroke. CONCLUSIONS: LAAC could reduce the risk of bleeding complications and ischemic cerebrovascular events without increasing the rate of early or mid-term complications. Although long-term survival was impaired in ATTR-CA patients, it was comparable to that of patients without a known diagnosis of CA at the 2-year follow-up, suggesting that LAAC for patients with ATTR-CA might not be futile.

Prophylactic EUS-guided gallbladder drainage prevents acute cholecystitis in patients with malignant biliary obstruction and cystic duct orifice involvement: a randomized trial (with video).

BACKGROUND AND AIMS: Patients with distal malignant biliary obstruction (MBO) and cystic duct orifice tumoral involvement have an increased risk for the development of acute cholecystitis after self-expandable metallic stent (SEMS) placement. We aimed to determine whether primary EUS-guided gallbladder drainage prevents acute cholecystitis in these patients. METHODS: This was a single-center, randomized control trial in patients with distal MBO enrolled from July 2018 to July 2020. Patients were randomized into 2 groups: an interventional group treated with conventional ERCP biliary drainage with SEMS placement and subsequent primary EUS-guided gallbladder drainage (EUS-GBD) and a control group treated with conventional biliary drainage alone. The primary outcome of the study was the occurrence of post-treatment acute cholecystitis, assessed for ≤12 months or until death. The secondary outcomes were hospitalization length and median survival time. RESULTS: Forty-four patients were included in the study: 22 in each group. Five patients in the control group (22.7%) and none in the intervention group experienced acute cholecystitis. The median hospitalization time was significantly lower in the interventional group than in the control group (2 days vs 1 day, P = .017). There was no difference in the observed median survival rates in the primary EUS-GBD group (2.9 months) and the control group (2.8 months) (P = .580). CONCLUSION: In this single-center study of patients with unresectable MBO and occlusion of the cystic duct orifice, prophylactic EUS-GBD demonstrated a reduced incidence of acute cholecystitis.

Psychiatric and Psychosocial Characteristics of a Cohort of Spanish Individuals Attending Genetic Counseling Due to Risk for Genetically Conditioned Dementia.

Background: Predictive genetic tests are presently effective over several medical conditions, increasing the demand among patients and healthy individuals. Considering the psychological burden suspected familial dementia may carry on individuals, assessing personality, coping strategies, and mental health could aid clinicians in findings the appropriate time for delivering genetic test results and predict compliance regarding genetic counseling and expectations towards the genetic condition depending on the outcome. Objective: To describe the psychiatric, psychological, and coping characteristics of a sample of Spanish individuals at risk of familial dementia before genetic test results were given. Methods: We included 54 first degree relatives of patients diagnosed with Alzheimer's disease, lobar frontotemporal degeneration, or prion diseases. The NEO-FFI-R, COPE, and HADS tests evaluated personality, coping strategies, and psychological distress, respectively. Results: Anxiety and depression were below the cut-off point for mild severity. Conscientiousness and Agreeableness were the most preponderant personality factors, while Neuroticism was the least. Positive reinterpretation and Acceptance were the most frequent coping strategies, and Denial and Alcohol and drug use were the least used. Ongoing medical pathologies increased depression, while psychiatric disorders worsened psychological distress. Conclusion: Contrary to our expectations, PICOGEN candidates showed psychological distress and personality traits within normative ranges, and the use of problem-focused coping strategies prevailed over avoidance coping strategies. Nevertheless, clinicians should pay particular attention to individuals attending genetic counseling who are women, aged, and present an ongoing psychiatric disorder and psychiatric history at inclusion to ensure their mental health and adherence throughout the process.

Endoscopic ultrasound elastography for malignant pancreatic masses and associated lymph nodes: Critical evaluation of strain ratio cutoff value.

BACKGROUND: Endoscopic ultrasound (EUS) can detect small lesions throughout the digestive tract; however, it remains challenging to accurately identify malignancies with this approach. EUS elastography measures tissue hardness, by which malignant and nonmalignant pancreatic masses (PMs) and lymph nodes (LNs) can be differentiated. However, there is currently little information regarding the strain ratio (SR) cutoff in Hispanic populations. AIM: To determine the diagnostic accuracy of EUS elastography for PMs and LNs with an SR cutoff value in Hispanics. METHODS: A retrospective study of patients who underwent EUS elastography for PMs between December 2013 and December 2014. A qualitative (analysis of color maps) and quantitative (SR) analysis of PMs and their associated LNs was performed. The accuracy of EUS elastography in identifying malignant PMs and LNs and cutoff value for SR were analyzed. A PM and/or its associated LNs were considered malignant based on histopathological findings from fine-needle aspiration biopsy samples. RESULTS: A sample of 121 patients was included, 45.4% of whom were female. 69 (57.0%) PMs were histologically malignant, with a median SR of 50.4 vs 33.0 for malignant vs nonmalignant masses (P < 0.001). EUS evaluation identified associated LNs in 43/121 patients (35.5%), in whom 22/43 (51.2%) patients had histologically confirmed malignant diagnosis, with a median SR of 30 vs 40 for malignant vs nonmalignant LNs (P = 0.7182). In detecting malignancy in PMs, an SR cutoff value of > 21.5 yielded a sensitivity of 94.2%, while a cutoff value of > 121 yielded a specificity of 96.2.2%. There were significant differences in the Giovannini scores, a previously established elastic score system, between the patients grouped by their final histology results (P < 0.001). For LNs, SR cutoff values of > 14.0 and > 155 yielded a sensitivity of 90.9% and a specificity of 95.2%, respectively, in detecting malignancy. CONCLUSION: EUS elastography is a helpful technique for the diagnosis of solid PMs and their associated LNs. The proposed SR cutoff values have a high sensitivity and specificity for the detection of malignancy.

Newly proposed quantitative criteria can assess chronic atrophic gastritis via probe-based confocal laser endomicroscopy (pCLE): a pilot study.

Background and study aims Probe-based confocal laser endomicroscopy (pCLE) can provide high magnification to evaluate chronic atrophic gastritis (CAG), but the current pCLE criteria are qualitative and prone to variability. We aimed to propose a quantitative CAG criterion based on pCLE to distinguish non-atrophic gastritis (NAG) from CAG. Patients and methods This observational, exploratory pilot study included patients with NAG and CAG evaluated via esophagogastroduodenoscopy, pCLE, and histology. We measured the gastric glands density, gastric gland area, and inter-glandular distance during pCLE. Results Thirty-nine patients (30/39 with CAG) were included. In total, 194 glands were measured by pCLE, and 18301 were measured by histology, with a median of five glands per NAG patient and 4.5 per CAG patient; pCLE moderately correlate with histology (rho = 0.307; P  = 0.087). A gland area of 1890-9105 µm 2 and an inter-glandular distance of 12 to 72 µm based on the values observed in the NAG patients were considered normal. The proposed pCLE-based CAG criteria were as follows: a) glands density < 5; b) gland area < 1/16 the pCLE field area (< 1890 µm 2 ) or > 1/4 the pCLE field area (> 9105 µm 2 ); or c) inter-glandular distance < 12 or > 72 µm; CAG was diagnosed by the presence of at least one criterion. The proposed criteria discriminated CAG with a ranged sensitivity of 76.9 % to 92.3 %, a negative predictive value of 66.6 % to 80.0 %, and 69.6 % to 73.9% accuracy. Conclusions The proposed pCLE criteria offer an accurate quantitative measurement of CAG with high sensitivity and excellent interobserver agreement. Larger studies are needed to validate the proposed criteria.

Novel EUS-guided microwave ablation of an unresectable pancreatic neuroendocrine tumor.

Video 1EUS-guided microwave ablation of an unresectable pancreatic mass using a novel generator platform and a specialized 19.5-gauge needle antenna.

Cusp-overlapping TAVI technique with a self-expanding device optimizes implantation depth and reduces permanent pacemaker requirement.

INTRODUCTION AND OBJECTIVES: This study aimed to determine the safety and efficacy of modifying the classic implantation technique for aortic transcatheter heart valve (THV) implantation to a cusp-overlap-projection (COP) technique to achieve a higher implantation depth and to reduce the burden of new permanent pacemaker implantation (PPMI) at 30 days. Aortic self-expanding THV carries an elevated risk for PPMI. A higher implantation depth minimizes the damage in the conduction system and may reduce PPMI rates. METHODS: From March 2017, 226 patients were consecutively included: 113 patients were treated using the COP implantation technique compared with the previous 113 consecutive patients treated using the classic technique. In all patients, implantation depth was assessed by 3 methods (noncoronary cusp to the THV, mean of the noncoronary cusp and the left coronary cusp to the THV, and the deepest edge from the left coronary cusp and the noncoronary cusp to the THV). RESULTS: The COP group had a lower implantation depth than the group treated with the classic technique (4.8 mm± 2.2 vs 5.7 mm± 3.1; P=.011; 5.8 mm± 3.1 vs 6.5 mm± 2.4; P=.095; 7.1 mm± 2.8 vs 7.4 mm±3.2; P=.392). Forty patients (17.7%) required a new PPMI after the 30-day follow-up but this requirement was significantly lower in the COP group (12.4% vs 23%, P=.036). The COP implantation technique consistently protected against the main event (OR, 0.45; 95%CI, 0.21-0.97; P=.043), with similar procedural success rates and complications. CONCLUSIONS: The COP implantation technique is a simple modification of the implantation protocol and provides a higher implantation depth of self-expanding-THV with lower conduction disturbances and PPMI rates.

Transaxillary transcatheter ACURATE neo aortic valve implantation - The TRANSAX multicenter study.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) via transaxillary (TAx) approach with ACURATE neo valve is an off-label procedure. Our aim was to gather information on ACURATE neo cases implanted via TAx approach and report major outcomes. METHODS AND RESULTS: The TRANSAX Study (NCT04274751) retrospectively gathered patients from nine centres in Europe and North America treated with ACURATE neo valve through TAx approach up to May/2019. Follow up was pre-specified at 1-year and was obtained for all patients. A total of 75 patients (79 ± 10 years; 32% women) were included. Left axillary (72%) and conscious sedation (95.2%) were the most common setting. Risk scores were higher when right axillary artery and surgical cut-down were selected. Severe complications including valve embolization, coronary obstruction, annulus rupture, and procedural mortality did not occur. Cardiac tamponade occurred in two cases (2.7%) with one requiring conversion to open surgery (1.3%). Bail-out stenting and surgical vascular repair were required in 7 (9.3%) and 3 (4%) cases, respectively. The need for new permanent pacemaker was 8%. Procedural success (96%), in-hospital (2.7%), and 1-year mortality (8%) were comparable in all settings. Only one case (1.3%) complicated with cerebrovascular event and one (1.3%) presented moderate aortic regurgitation before discharge. CONCLUSIONS: TAx TAVR procedures with the ACURATE neo valve were presented high success rate and low in-hospital and 1-year mortality.