Technical Success Rate Research Articles

Image-guided percutaneous microwave ablation for unresectable pancreatic cancers: A multicenter retrospective study

ObjectiveThis study aims to assess the feasibility, effectiveness, and safety of image-guided percutaneous microwave ablation (PMWA) for unresectable pancreatic cancer. MethodsIn this retrospective study, 72 patients from four hospitals were enrolled between November 2009 and October 2022. Descriptive statistics were employed to describe the patients’ characteristics and prognostic factors. The primary endpoint compassed the complete ablation rate (CAR), incidence of complications and the pain relief rate (PRR). ResultsThe median age of the 72 patients was 61 (interquartile range (IQR) 52.5–67.0) years, with 62.5 % (45/72) being male. 26 cases received computed tomography (CT) guidance; 46 cases received ultrasound guidance. A total of 74 tumors were identified (2 in 2 patients), with 56.8 % (42/74) at the body and tail, and the rest at the head and neck. Overall, 73 ablation sessions were carried out, achieving a technical success rate (TSR) of 100 %. The CAR was 40.5 % (30/74). The median follow-up time was 4.6 (1–43.4) months. 50 % (36/72) of patients had died with a median overall survival (OS) of 5.6 (1–27) months. Regarding complications, 18.1 % (13/72) of cases were classified as grade I and II, and 9.8 % (7/72) as grade IIIa. Before surgery, 33 patients experienced pain symptoms, and the postoperative PRR was 96.7 % (32/33). The average pain score decreased from 6.3 (4–10) before surgery to 2.0 (0–8) after ablation (P<0.001). ConclusionsImage-guided PMWA for unresectable pancreatic cancer is safe and feasible, effectively relieving cancer pain and improving patients’ the quality of life.

Real-world data to support post-market safety and performance of embolization coils: evidence generation from a medical device manufacturer and data institute partnership

BackgroundRecognizing the limitations of pre-market clinical data, regulatory authorities have embraced total product lifecycle management with post-market surveillance (PMS) data to assess medical device safety and performance. One method of proactive PMS involves the analysis of real-world data (RWD) through retrospective review of electronic health records (EHR). Because EHRs are patient-centered and focused on providing tools that clinicians use to determine care rather than collecting information on individual medical products, the process of transforming RWD into real-world evidence (RWE) can be laborious, particularly for medical devices with broad clinical use and extended clinical follow-up. This study describes a method to extract RWD from EHR to generate RWE on the safety and performance of embolization coils.MethodsThrough a partnership between a non-profit data institute and a medical device manufacturer, information on implantable embolization coils’ use was extracted, linked, and analyzed from clinical data housed in an electronic data warehouse from the state of Indiana’s largest health system. To evaluate the performance and safety of the embolization coils, technical success and safety were defined as per the Society of Interventional Radiology guidelines. A multi-prong strategy including electronic and manual review of unstructured (clinical chart notes) and structured data (International Classification of Disease codes), was developed to identify patients with relevant devices and extract data related to the endpoints.ResultsA total of 323 patients were identified as treated using Cook Medical Tornado, Nester, or MReye embolization coils between 1 January 2014 and 31 December 2018. Available clinical follow-up for these patients was 1127 ± 719 days. Indications for use, adverse events, and procedural success rates were identified via automated extraction of structured data along with review of available unstructured data. The overall technical success rate was 96.7%, and the safety events rate was 5.3% with 18 major adverse events in 17 patients. The calculated technical success and safety rates met pre-established performance goals (≥ 85% for technical success and ≤ 12% for safety), highlighting the relevance of this surveillance method.ConclusionsGenerating RWE from RWD requires careful planning and execution. The process described herein provided valuable longitudinal data for PMS of real-world device safety and performance. This cost-effective approach can be translated to other medical devices and similar RWD database systems.

Features and Limitations of Robotically Assisted Percutaneous Coronary Intervention (R-PCI): A Systematic Review of R-PCI.

Background: Ischaemic heart disease is one of the major drivers of cardiovascular death in Europe. Since the first percutaneous coronary intervention (PCI) in 1977, developments and innovations in cardiology have made PCI the treatment of choice for stenotic coronary artery disease. To address the occupational hazards related to chronic exposure to radiation and wear and tear from heavy lead-based radioprotective aprons, the concept of robotically assisted PCI (R-PCI) was introduced in 2005. Aim: To explore the features and limitations of R-PCI, we first discuss the concept and evolution of R-PCI platforms and then systematically review the available clinical data. Methods: A systematic review has been performed across the Pubmed, Embase and Cochrane databases in order to assess the efficacy and safety of R-PCI. Secondary endpoints, such as operator and patient exposure to radiation, contrast volume used and procedural time, were assessed when available. Results: In selected patients, R-PCI provides high technical and clinical success rates, ranging from 81 to 98.8% and from 93.3 to 100%, respectively. In-hospital and 1-year MACE rates ranged from 0 to 10.4% and 4.8 to 10.5%, respectively. R-PCI is able to significantly reduce the operator's exposure to radiation. Further research analysing the patient's and cath lab staff's exposure to radiation is needed. Therapy escalation with R-PCI seems to be limited to complex lesions. R-PCI procedures add approximately 10 min to the procedural time. Conclusions: The efficacy and safety of R-PCI have been proven, and R-PCI is able to significantly reduce occupational hazards for the first operator. The lack of adoption in the community of interventional cardiologists may be explained by the fact that current generations of R-PCI platforms are limited by their incompatibility with advanced interventional devices and techniques needed for escalation in complex interventions.

Axillary artery access considerations in Impella 5.5insertion: Insights from exclusive axillary approach forsuccessful support.

The Impella 5.5® is commonly inserted via the axillary artery (AX) in patients with cardiogenic shock. The right AX has traditionally been preferred to avoid crossing the aortic arch, and a minimum diameter of 7 mm has been recommended to accommodate the device (21 Fr). There is limited data on choice of laterality of access and AX size required, both in terms of technicality of the procedure as well as outcomes. We performed a single-center retrospective cohort analysis of patients who underwent Impella 5.5® implantation between December 2020 and February 2024 (N = 75). Data including demographics and outcomes were stratified both by diameter (small, <7 mm vs. normal, ≥7 mm) and laterality of access (right vs. left). Adverse events included stroke, limb ischemia, procedural bleeding or infection, and unplanned explant due to complications. Delivery time was defined as time from advancing the first wire to activation of the device. AX approach was attempted in all (N = 74) but one requiring innominate access, with a technical success rate of 95.9% (N = 71/74). The mean age was 58.8 ± 13.3 years, with 81.1% males. The median delivery time was 7.0 (25th, 75th percentiles: 4.0, 11.5) min with a median support duration of 13 (7.7, 24) days. Ten patients (13.5%) had a small AX, with a mean diameter of 6.3 ± 0.5 mm and were more likely to be younger compared to the normal AX group. Fifty-nine patients (79.7%) had insertion via the right AX. Median delivery time was comparable across all groups (small, 5.4 [3.5, 10.9] vs. normal, 7 [4.0, 12.1] min, p = 0.59) and (right, 10.4 [5.3, 15.2] vs. left, 6 [3.7, 10.4] min, p = 0.35). There was no difference between the rates of stroke, ischemia, bleeding, or infection when comparing by size or laterality. Survival to discharge was 59.5%, with 21.1% mortality on support, all in patients with a normal AX diameter, but with no difference between right versus left. In our study, laterality and a small diameter of AX access did not affect outcomes of Impella 5.5®, with a similar safety profile.

Flexible endoscopic treatment of Zenker's diverticulum-a retrospective, observational multicenter study.

The European Society of Gastroenterology and Endoscopy recommends a primarily flexible endoscopic approach for the treatment of Zenker's diverticulum. Due to the rarity of the disorder, evidence for its effectiveness and safety comes mainly from small, retrospective, single-center studies. In this retrospective, observational, multicenter cohort study, data from six German tertiary referral centers were analyzed. The primary outcome parameters were technical and clinical success; among the secondary outcomes, the rates of adverse events (AE) and re-admission with symptomatic recurrence and mortality were the most relevant. Between 2003 and 2024, 384 treatments were performed in 327 patients (61.8% male, mean age 74.70 (± 10.60)). Incision methods/techniques were 250 needle knives, 44 ESD knives, 64 stag beetle knives, 24 staplers, one APC-probe, and one Z-POEM. The Zenker's diverticulum overtube was used in 65.1%, prophylactic clipping in 30.2%, and antibiotic therapy in 25.3% of treatments. The rates of technical and clinical success were 99.2% and 97.4%, and the rates of AE and re-admission with symptomatic recurrence were 11.2% and 16.7%, respectively. Mortality was 0.3%. Comparative subgroup analyses of 312 diverticula without prior treatment versus 72 symptomatic recurrences and incision methods/techniques showed no significant differences in outcome parameters. The use of additional devices and prophylactic measures (clipping, antibiotic therapy) were not independent predictors of technical/clinical success or AE in uni-/multivariable regression analysis. Flexible endoscopic Zenker's diverticulotomy is a safe and effective minimally invasive treatment. Recurrences can be treated by flexible endoscopy with comparable results. None of the cutting methods, ancillary devices, or prophylactic measures showed superiority in effectiveness or safety.

Early and Mid-Term Results of Endovascular Aneurysm Repair with the Cordis Incraft Ultra-Low Profile Endograft: A High-Volume Center Experience.

Background/Objectives: In recent years, manufacturers have developed new low-profile stent grafts to allow endovascular treatment of abdominal aortic aneurysms (AAA) in patients with small access vessels. We evaluated the early and mid-term outcomes of the Incraft (Cordis Corp, Bridgewater, NJ, USA) ultra-low profile endograft implantation in a high-volume single center. Methods: Between 2014 and 2023, 133 consecutive endovascular aneurysm repair (EVAR) procedures performed using the Incraft endograft were recorded in a prospective database. Indications included infrarenal aortic aneurysms, common iliac aneurysms, and infrarenal penetrating aortic ulcers. Mid-term results were analyzed using the Kaplan-Meier method. Results: During the study period, 133 patients were treated with the Cordis Incraft endograft, in both elective and urgent settings. The Incraft graft was the first choice for patients with hostile iliac accesses, a feature characterizing at least one side in 90.2% of the patients in the study cohort. The immediate technical success rate was 78.2%. The intraoperative endoleak rate was 51.9% (20.3% type 1 A, 0.8% type 1 B, and 30.8% type 2 endoleak). Within 30 days, technical and clinical success rates were both 99.3%; all type 1A and 1B endoleaks were resolved at the 30-day follow-up CT-angiogram. After a mean follow-up of 35.4 months, the actuarial freedom from the re-intervention rate was 96.0%, 91.1%, and 84.0% at 1, 3, and 5 years, respectively. The iliac leg patency rate was 97.1%, 94.1%, and 93.1% at 1, 3, and 5 years, respectively. No statistically significant differences were observed between hostile and non-hostile access groups, nor between the groups with grade 1, grade 2, and grade 3 access hostility. Conclusions: The ultra-low profile Cordis Incraft endograft represents a valid option for the endovascular treatment of AAA in patients with hostile iliac accesses. The procedure can be performed with high rates of technical and clinical success at 30 days and the rates of iliac branch occlusion observed during the follow-up period appear acceptable in patients with poor aorto-iliac outflow.

Endoscopic submucosal resection (ESD) and endoscopic full-thickness resection (EFTR) via balloon-assisted enteroscopy (BAE) in small bowel subepithelial lesions: experience in treating fifteen cases.

The study objective was to evaluate the primary feasibility of endoscopic submucosal resection (ESD) and endoscopic full-thickness resection (EFTR) via balloon-assisted enteroscopy (BAE) to treat small bowel subepithelial lesions (SELs). A retrospective case series study was performed. The first fifteen consecutive patients who underwent ESD (n = 10) and EFTR (n = 5) via BAE to remove small bowel SELs from November 2016 to December 2023 were included. The main outcome measures were the technique success rate, operative time and complication rate. This research focused on 15 cases of jejunoileal SELs, four cases of lipomyoma, three cases of ectopic pancreas, two cases of NETs, three cases of benign fibrous tumours and three cases of angioma. The overall technique success rate was 86.7%, with 100% (10/10) and 60% (3/5) for BAE-ESD and BAE-EFTR, respectively, in removing small bowel SELs. Two cases of EFTR failed, as the BAE operation was unsuitable for tumour resection and suture repair of a perforated wound. No serious bleeding or any postoperative complications occurred. The median time of endoscopic resection via BAE for SELs was 44min (range 22-68min). ESD and EFTR via BAE might be alternative choices for treating small SELs in the small bowel, with the advantages of clear and accurate positioning and minimal invasiveness. However, its superiority over surgery still needs to be further investigated.

Is endovascular arteriovenous fistula a feasible alternative for hemodialysis patients?

For hemodialysis (HD) patients, the selection of vascular access (VA) is a crucial factor that significantly affects morbidity and mortality. Historically, native Arteriovenous Fistulas (AVFs) have been established using surgical techniques. However, devices facilitating percutaneous endovascular arteriovenous fistula formation have recently been introduced in clinical practice, showing promising initial evidence. The primary objectives were technical success, efficacy, and cannulation rates. The secondary objectives included primary and cumulative patency, safety, and the number of procedures required to maintain fistula patency. A prospective, single-center, single-arm study that included all patients who underwent endovascular arteriovenous fistulas (endoAVF) creation using the WavelinQ™ EndoAVF System at a University Hospital between December 2021 and August 2023. A total of 20 patients who underwent an endoAVF were included. Technical success was 100%. 75% (15) of the endoAVFs met the criteria for physiological suitability. The cannulation rate was 66% (10/15) for endoAVFs that reached physiological suitability. At 6 months of follow-up, the primary and cumulative patency rates were 65% and 75%, respectively; at 12 months, these were 50% and 70%, respectively. Serious adverse events were not observed. The reintervention rate was 0.33 procedures/patient-year. Based on our experience, creating AVFs using the WavelinQ 4-F EndoAVF system is safe and effective, with high technical success rates and acceptable patency and reintervention rates.

Endoscopic clipping combined with cyanoacrylate injection vs. transjugular intrahepatic portosystemic shunt in the treatment of isolated gastric variceal bleeding: Randomized controlled trial.

Although the incidence of isolated gastric varices type 1 (IGV1) bleeding is low, the condition is highly dangerous and associated with high mortality, making its treatment challenging. We aimed to compare the safety and efficacy of endoscopic clipping combined with cyanoacrylate injection (EC-CYA) vs. transjugular intrahepatic portosystemic shunt (TIPS) in treating IGV1. In a single-center, randomized controlled trial, patients with IGV1 bleeding were randomly assigned to the EC-CYA group or TIPS group. The primary end-points were gastric variceal rebleeding rates and technical success. Secondary end-points included cumulative nonbleeding rates, mortality, and complications. A total of 156 patients between January 2019 and April 2023 were selected and randomly assigned to the EC-CYA group (n = 76) and TIPS group (n = 80). The technical success rate was 100% for both groups. The rebleeding rates were 14.5% in the EC-CYA group and 8.8% in the TIPS group, showing no significant difference (P = 0.263). Kaplan-Meier analysis revealed that the cumulative nonbleeding rates at 6, 12, 24, and 36 months for the two groups lacked statistical significance (P = 0.344). Similarly, cumulative survival rates at 12, 24, and 36 months for the two groups were not statistically significant (P = 0.916). The bleeding rates from other causes were 13.2% and 6.3% for the respective groups, showing no significant difference (P = 0.144). No instances of ectopic embolism were observed in either group. The incidence of hepatic encephalopathy (HE) in the TIPS group was statistically higher than that in the EC-CYA group (P = 0.001). Both groups are effective in controlling IGV1 bleeding. Notably, EC-CYA did not result in ectopic embolism, and the incidence of HE was lower than that observed with TIPS.

Endoscopic ultrasound-guided gastrojejunostomy with wire endoscopic simplified technique: Move towards benign indications (with video).

Endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) is an alternative to duodenal stenting and surgical GJ (SGGJ) in malignant gastric outlet obstruction (MGOO). European Society of Gastrointestinal Endoscopy guidelines restricted EUS-GJ for MGOO only, because of misdeployment. The aim was to evaluate its outcomes focusing on benign indications. This was a retrospective study conducted from 2016 to 2023 in a tertiary center. Patients included had malignant or benign GOO indicated for EUS-GJ. Techniques were the direct approach until August 2021, and the wire endoscopic simplified technique (WEST) afterwards. The main objective was to compare outcomes in benign vs. MGOO. Secondary end-points were technical success, adverse events rates, and describing the evolution of techniques and indications. In all, 87 patients were included, 46 men, mean age 66 ± 16.2 years. Indications were malignant in 60.1% and benign in 39.1%. The EUS-GJ technique was direct in 33 patients (37.9%) and WEST in 54 (62.1%). No difference was found in terms of technical, clinical, or adverse events rates. The initial technical success rate was 88.5%. The final technical and clinical success rates were 96.6% and 94.25%, respectively. In the last year, benign exceeded malignant indications (70.4% vs. 29.6%, P < 0.05). Seven misdeployments occurred, six being addressed with the rescue technique. The misdeployment rate was significantly decreased using the WEST approach compared to the direct one: 3.7% vs. 18% (P < 0.05). The severe postoperative adverse events rate was 2.3%. This study demonstrated similar outcomes of EUS-GJ between benign and MGOO, with a decreasing misdeployment rate (<4%) applying WEST. This represents an additional step towards recommending EUS-GJ in benign indications.

SP4.8 - A Systematic Review on The Safety and Efficacy of Percutaneous cholecystolithotomy (PCCL)

Abstract Aims To summarize the evidence available thus far on the safety and efficacy of percutaneous cholecystolithotomy (PCCL). So, the research question we set out to answer is: Is PCCL a safe and efficacious procedure? Methods This is a secondary research project involving a literature search to gather evidence on the research question raised above. An SR protocol and search strategy are developed, literature search is conducted using two search engines: Ovid Medline and Ovid Embase. The two search terms used were: (a) (Percutaneous and (removal or extract) and (Gallstones* or Gall stone* or cholelithiasis or cholecystolithiasis*)), (b) Cholystolithomy. Our inclusion/exclusion criteria are clear and appropriate. PRISMA protocol was followed. Results The collected data from the 29 studies that fit our criteria is analyzed, and the results showed that the procedure is safe and effective compared to the gold standard which is laparoscopic cholecystectomy. The clinical and technical success is over 90%, and the combined complication rate is 14.8%, 9.3% major complication rate, and 6.9% minor complication rate. The 30-day mortality of the procedure is 0.8%. Conclusions This systematic review shows that PCCL is a safe and efficacious procedure with high technical and clinical success rates. The reported low 30-day mortality and major complication rates, despite multiple comorbidities and frequently old and sick patients, make PCCL outcomes comparable to the gold standard treatment. However, the current evidence is based on single-center data with heterogeneous reporting standards. Further research should aim at an appropriate sample size, a clear definition of recorded variables, and a refinement of current technologies and techniques.

Impact of Accidental High or Low Implantation Depth on Peri-Procedural Outcomes after Implantation with the Self-Expanding ACURATE neo2.

Background: Precise implantation could play a crucial role in the technical success of transcatheter aortic valve replacement (TAVR) for some prostheses. The impact of an accidental implantation depth (ID) outside the recommended range has not been assessed for the ACURATE neo2 (NEO2). Methods: Data from 1839 patients with severe native aortic stenosis treated with the NEO2 prosthesis were evaluated. We compared the results of prostheses implanted in an ID both inside and outside the recommendations. The outcome assessment followed the Valve Academic Research Consortium-3 criteria. Results: Patients were retrospectively divided into high (<3 mm; n = 412), optimal (3-7 mm; n = 1236), and low (>7 mm; n = 169) implantations. Technical success (94.7% vs. 94.7% vs. 91.7%, p = 0.296) and device success were high (90.1% vs. 89.3% vs. 84.6%, p = 0.112) without differences between groups. Rates of relevant paravalvular regurgitation (PVL; >mild or VinV due to PVL) were comparable (1.2% vs. 1.8% vs. 1.2%, p = 0.759). Even when hemodynamics were superior in the high-implantation group, with greater iEOA (1.01 cm2/m2 vs. 0.95 cm2/m2 vs. 0.92 cm2/m2, p < 0.001), spontaneous embolization or after post-dilatation was more common. Low implantation was associated with a higher rate of associated pacemaker implantation (PPI) (6.1% vs. 8.8% vs. 14.8%, p = 0.001). Conclusions: Implantation with the ACURATE neo2 showed excellent hemodynamic results, including low gradients and a small number of relevant PVL, in line with a high technical success rate that was irrespective of the ID. A favorable outcome can also be achieved in accidental low or high positions. Low implantation was associated with a higher rate of associated pacemaker implantation. Deliberately high implantation should be avoided due to the risk of embolization.

Transarterial Coil Embolization for Type II Endoleak After Endovascular Aneurysm Repair (EVAR).

Background Endovascular aneurysm repair (EVAR) has evolved into treatment of choice for infrarenal abdominal aortic aneurysms (AAA). Type II endoleaks, although frequently benign, can lead to sac enlargement and rupture. Management of these endoleaks by endovascular means can be quite challenging and may require complex techniques and assistance of interventional radiologists, not always available in all vascular units. This is a single-center study of management of type II endoleaks with transarterial coil embolization performed by vascular surgeons and with minimum requirements regarding the necessary equipment. Methods From 2017 to 2022, 13 patients with type II endoleak were treated. Local anaesthesia and transfemoral or transbrachial approach was used. The superficial mesenteric artery (SMA) was catheterized and through the Riolan arch, coiling of the inferior mesenteric artery and/or the sac aneurysm was performed. Results The mean time period between the primary EVAR procedure and the transarterial intervention for the endoleak was 3.9 years. Primary technical success was achieved in 11 (84.6%) patients, whilesecondary technical success was 12 (92.3%). In the mean follow-up period, which was 2.6 years, the endoleak was treated successfully in 11 (84.6%) patients. Conclusions Transarterial coil embolization of type II endoleaks is a minimal low-cost procedure, with small percentage of complications, high technical and treatment success rates. It could be considered as a first-line treatment of unresolvable type II endoleaks, minimizing the need for open repair.

Endovascular Repair of Ruptured Abdominal Aortic Aneurysms Using the Endurant™ Endograft.

Background: Endovascular aortic aneurysm repair (EVAR) represents a valid treatment modality for ruptured abdominal aortic aneurysms (rAAAs). This study aimed to present rAAA outcomes treated by EVAR using the Endurant endograft. Methods: A single-center retrospective analysis of consecutive patients treated with standard EVAR (sEVAR) or parallel graft (PG)-EVAR for infra- or juxta/para-renal rAAA using the Endurant endograft (1 January 2008-31 December 2023) was undertaken. The primary outcomes were technical success, mortality, and reintervention. Follow-up outcomes, including survival and freedom from reintervention, were assessed using Kaplan-Meier estimates. Results: Eighty-eight patients were included (87.5% sEVAR and 12.5% PG-EVAR). The mean aneurysm diameter was 73.3 ± 19.3 mm (71.4 ± 22.2 mm sEVAR and 81.7 ± 33.0 mm PG-EVAR). Among 77 patients receiving sEVAR, 26 (33.8%) received an aorto-uni-iliac device. All PG-EVAR patients were managed with bifurcated devices, one receiving a single PG, seven double PGS, and three triple PGs. Technical success was 98.8% (100.0% sEVAR and 90.9% PG-EVAR). The 30-day mortality was 47.2% (50.7% sEVAR and 27.3% PG-EVAR), with nine (10.2%) deaths recorded on the table. The mean time of follow-up was 13 ± 9 months. After excluding 30-day deaths, the estimated survival was 75.5% (standard error (SE) 6.9%) at 24 months. The estimated freedom from reintervention was 89.7% (SE 5.7%) at 24 months. Only one endoleak type Ia event was recorded during follow-up. Conclusions: Endurant showed high technical success rates and low rates of endoleak type Ia events and reinterventions, despite the emergent setting of repair. rAAA is still a highly fatal condition within 30 days, with an acceptable mid-term survival of 30-day survivors at 75.5%.

Two-Year Outcomes of Prostatic Artery Embolization for Symptomatic Benign Prostatic Hyperplasia: An International, Multicenter, Prospective Study

PurposeTo describe clinical outcomes among patients with benign prostatic hyperplasia (BPH) 24 months following prostatic artery embolization (PAE).Materials and MethodsThis was an international, multicenter, prospective trial of males with BPH with lower urinary tract symptoms (LUTS) or acute urinary retention (AUR) treated with PAE. The primary outcome was the 12 month change in the International Prostate Symptom Score (IPSS) for patients referred for bothersome LUTS, or urinary catheter independence for patients treated for AUR. Secondary outcome measures included changes in IPSS at 3 and 24 months, changes in quality of life (QoL), changes in the Sexual Health Inventory for Men (SHIM) questionnaire, technical success rate, and adverse events (AEs). Data were summarized using descriptive statistics.ResultsFour hundred seventy-eight consecutive patients underwent PAE (bothersome LUTS: N = 405; AUR: N = 73), mean age was 70 years. For patients treated for bothersome LUTS, mean total IPSS at baseline was 21.8 and decreased to 9.3, 10.6, and 11.2 at 3, 12, and 24 months following PAE, respectively (all p < 0.001); QoL at baseline was 4.7 and decreased to 2.0, 2.1, and 2.3 at 3, 12, and 24 months, respectively (all p < 0.001). The mean SHIM score at baseline and 12 months following PAE was 13.8 and 13.9, respectively. Of the 73 patients treated for AUR, 48 (65.8%) had their indwelling catheter removed within 3 months of PAE and remained catheter free at 24 months. Fifty-five patients (11.5%) experienced ≥ 1 AE and 10 (2.1%) experienced a serious AE.ConclusionPAE is a safe and effective treatment for symptomatic BPH and LUTS.Level of Evidence Level 3Trial registration ClinicalTrials.gov NCT03527589.Graphical

Efficacy and safety of a novel polytetrafluoroethylene-coated self-expandable metal stent for distal malignant biliary obstruction.

Stent migration and sludge formation remain significant problems associated with covered self-expandable metal stents (CSEMSs). The EGIS biliary stent fully covered flare type (EGIS biliary stent), a new type of polytetrafluoroethylene-coated self-expandable metal stent with low axial force and an anti-migration system, was developed to overcome these disadvantages. We conducted this study to evaluate the efficacy and safety of this stent in comparison with conventional CSEMS (c-CSEMS). We retrospectively analyzed consecutive patients with unresectable pancreatic cancer who received initial CSEMS for distal malignant biliary obstruction. The primary outcome was time to recurrent biliary obstruction (RBO). Secondary outcomes included technical success rate, functional success rate, stent-related adverse events, causes of RBO, and re-intervention. A total of 40 patients were included (EGIS group: 20; c-CSEMS group: 20). The technical and functional success rates were similar between the two groups. Stent-related adverse event rates (20% vs. 15%, p > 0.99) and overall RBO rates (56% vs. 50%, p > 0.99) were not significantly different between the two groups. Stent migration was the most common cause of RBO in the EGIS group, while stent occlusion was in the c-CSEMS group. The median time to RBO (102 vs. 434 days, p = 0.10) was not significantly different between the two groups. Endoscopic transpapillary re-intervention was successful in most patients in both groups. The EGIS biliary stent was not associated with a longer time to RBO compared to c-CSEMS. Further improvements, especially against stent migration, are needed to improve its efficacy.

Liquid nitrogen-based cryoablation: complication rates for lung, bone, and soft tissue tumors cryoablation.

This study aimed to assess the complication rate during and 24 hours after cryoablation in lung, bone, and soft tissue tumors. We reviewed complications in a total of 85 consecutive patients who underwent cryoablation using a liquid nitrogen-based system in various lesions between April 2017 and October 2022. There were no liver and renal lesions. Complications were categorized using the Society of Interventional Radiology classification. Eighty-five patients were treated for 96 lesions in the bone (36.4%; 35 of 96), lung (18.8%; 18 of 96), and soft tissue (44.8%; 43 of 96). The primary technical success rate was 97.7% (83 of 85). The total grade 2 and 1 complication rates were 5.2% (5/96) and 20.8% (20/96), respectively. Two patients had asymptomatic pulmonary embolisms incidentally noted at the 24-hour follow-up computed tomography (grade 2). The most frequent complications were simple and hemorrhagic pleural effusions (18.7%; 18 of 96). Lung procedures had the highest complication rate, where 13 patients (72.2%; 13 of 18) reported complications, including 2 cases of symptomatic hydropneumothorax requiring drainage (grade 2) and an additional 2 days of hospital stay. Eight patients (24.2%; 8 of 33) with bone lesions and 4 (9.3%; 4 of 43) with soft tissue lesions experienced complications. Cryoablation using a liquid nitrogen-based system is safe, with only minor complications observed. This study provides data on the safety of liquid nitrogen-based percutaneous cryoablation in tumors located in lung, in bones and in soft tissues. Despite using larger diameter cryoprobes than those typically reported with argon-based system, our experience shows that complications are mostly low and comparable in frequency and severity.

Safety and effectiveness of additional triamcinolone acetonide with endoscopic radial incision and cutting for benign stenosis of the lower gastrointestinal tract: A pilot study.

Radial incision and cutting (RIC) is being investigated as an alternative endoscopic dilation method for lower intestinal tract stenosis, providing a high technical success rate and improving subjective symptoms. However, several patients develop re-stenosis following RIC. In this pilot study, we aimed to evaluate the safety and efficacy of triamcinolone acetonide (TA) addition after RIC. RIC with TA was performed in 20 patients with lower gastrointestinal tract stenosis. We evaluated the rate of adverse events 2 months after RIC with TA. We investigated the short- and long-term prognoses, as well as the improvement in subjective symptoms, using a visual analog scale. The delayed bleeding rate after RIC was 23.8%. Endoscopic hemostasis was achieved in all patients with delayed bleeding. No perforations were observed. The cumulative re-stenosis-free, re-intervention-free, and surgery-free rates 1 year after RIC were 52.9%, 63.7%, and 85.2%, respectively. Subjective symptoms, including abdominal pain, abdominal bloating, nausea, and dyschezia, significantly improved after RIC with TA. Although additional TA administration after RIC could be safe, additional TA may not be effective on luminal patency after dilation. Further investigation is warranted.

789. EFFICACY AND SAFETY OF CRYOBALLOON-180 ABLATION FOR THE TREATMENT OF DYSPLASTIC BARRETT ESOPHAGUS: PRELIMINARY RESULTS FROM A PROSPECTIVE MULTICENTER STUDY

Abstract Background Cryoballoon-ablation is a relatively novel method for the eradication of dysplastic Barrett esophagus (BE). While the focal cryoballoon-ablation system has shown to be efficacious for BE of limited extent, the cryoballoon180-ablation system (CBAS180) is developed to treat longer BE segments by semi-circumferential ablation over 3cm, in a single step. A first-in-human study demonstrated the feasibility of CBAS180 treatment, yet the optimal dose needs to be determined. The current prospective, multicenter study, investigates CBAS180 at lower dosages for patients with dysplastic BE. Methods A total of 62 patients with ablation naïve BE (C≤3 and M≥1) will be enrolled in six Dutch Barrett expert centers. Treatment consists of a full circumferential ablation over 3 cm of length, using two semi-circumferential ablations at a dose of 1.2 mm/sec. Follow-up consisted of phone calls at days 1, 7 and 30, a symptom diary during 14 days, and an endoscopy after 3 months. Outcomes included (1) technical success rate; (2) BE regression percentage at follow-up scored by an independent adjudication committee; (3) incidence of adverse events; (4) post-procedural pain (scored on a scale of 0-10); and (5) post-procedural dysphagia (scored on a validated scale of 0-4). Follow-up treatment consisted of focal cryoballoon-ablation until complete eradication of visible BE was achieved, confirmed by biopsies from the neo-Z-line. Results So far, 25 patients (80% male; mean age 67) with a median BE length of C0M2 (p25-p75 C0-1M2-4) were included. Technical success rate was 92% (23/25; 95% CI 74-99%). In two patients, treatment was technically unsuccessful due to unstable positioning of the balloon (n=1) or a device malfunction (n=1). Median procedure time was 14 (p25-p75 11-16) 4) minutes and median ablation time was 5 (p25-p75 3-5) minutes. All 23 successfully treated patients completed follow-up endoscopy at 3 months. Median BE regression was 90% (p25-p75 75%-100%) evaluated by the independent adjudication committee. Overall, CBAS180 adverse event rate was 8% (2/23); one patient developed esophageal stricture (1/23; 4% [95% CI 1-16%]) resolved after a single endoscopic dilation. Another patient (1/23; 4% [95% CI 1-16%]) experienced post-procedural bleeding, with re-endoscopy without intervention. The CBAS180 procedure was well tolerated with low post-procedural pain (median 2 [p25-p75 1-4] at day 1 and 0 [p25-p75 0-1] at day 7) and dysphagia (56% and 70% of patients with score 0 at days 1 and 7, respectively) scores. So far, 22/23 (95%) patients were additionally treated with focal cryoballoon-ablation and 18/22 (82%) achieved a complete endoscopis and histologic eradication of BE after median 1 (p25-p75 1-3) treatment, the other 4 are still under treatment. After focal cryoballoon-ablation, 2/22 patients developed strictures, resolved after 1 and 2 endoscopic dilatations. Conclusion Based on these preliminary results, circumferential ablation with CBAS180 at 1.2 mm/sec, followed by focal cryoballoon-ablation, emerges as an effective and safe procedure for dysplastic BE eradication in the hands of expert endoscopists. Further avenues for exploration should encompass the assessment of multiple CBAS180 ablations stacked on top of each other in larger segments and the validation of outcomes in a larger patient cohort.

Meta-analysis of application of minimally-invasive ablation methods and classical surgical approach in osteoid osteoma and osteoblastoma

Abstract Osteoblastoma and osteoid osteoma are rare benign bone tumours, sometimes considered variations of the same pathologic process. However, they differ in location, incidence, age group, and size. The gold standard treatment is surgical excision for osteoblastoma and radiofrequency ablation for both. Minimally invasive techniques, including radiofrequency ablation, microwave ablations, cryoablation, ultrasound ablation, and laser ablation, are increasingly used. This meta-analysis aimed to review current treatments, focusing on minimally invasive methods versus traditional surgical excision. A data comparison of 17 original articles from the PubMed database (2014-2024) was conducted, examining treatment methods, patient numbers, success rates, pre/post-operative pain scores, and complication rates. New ablation methods achieve similar clinical results to traditional surgery for treating osteoid osteoma and osteoblastoma while minimizing invasiveness. Most procedures have technical success rates near 100%. Both invasive and non-invasive methods significantly reduce preoperative pain. Classical surgery has higher minor complication rates compared to minimally invasive treatments. Among ablation techniques, magnetic resonance guided focused ultrasound surgery is the least invasive, avoiding radiation and antibiotic-related complications. However, in ablation methods caution is needed to prevent thermal damage to nearby joints and nerves. Protective methods, such as skin protection, hydrodissection, gas dissection, and intraoperative neurostimulation, are recommended. New ablation methods provide less invasive alternatives to surgery, with high clinical and technical success rates and lower complication rates. Among these, magnetic resonance guided focused ultrasound surgery is the least invasive and most promising, though more clinical data is needed due to its recent development.