Low Reintervention Rates Research Articles

Two-year outcomes of Micra AV leadless pacemakers in the Micra AV CED study.

Leadless pacing is a safe and effective alternative to transvenous pacing for bradycardia. Micra AV is a leadless, single-device solution that provides atrioventricular synchronous ventricular pacing therapy. Early results from the Micra AV CED study showed reductions in short-term complications associated with the Micra AV leadless pacemaker among US Medicare patients. The objective of this study is to compare chronic complications, re-interventions, and all-cause mortality at 2 years between patients implanted with a Micra AV leadless pacemaker and a traditional dual-chamber transvenous (DC-TV) pacemaker. Patients implanted with a Micra AV leadless pacemaker (n = 7552) or a DC-TV pacemaker (n = 110 558) in 2020 and 2021 were identified using device registration-linked Medicare administrative claims data. Competing risk models compared the unadjusted and propensity score overlap weight-adjusted complication, re-intervention, and all-cause mortality rates of Micra AV and DC-TV patients at 2 years. Micra AV patients had significantly more comorbidities (end-stage renal disease 14.9 vs. 2.0%, P < 0.0001; renal dysfunction 47.9 vs. 34.2%, P < 0.0001; diabetes 46.2 vs. 38.3%, P < 0.001; congestive heart failure 41.4 vs. 30.6%, P < 0.0001). Two years post-implant, Micra AV patients had lower complication rates [adjusted 5.3 vs. 9.6%, hazard ratio (HR): 0.54, 95% confidence interval (CI) 0.49-0.61, P < 0.0001] and lower re-intervention rates (adjusted 3.5 vs. 5.6%, HR: 0.62, 95% CI 0.54-0.72, P < 0.0001) than DC-TV patients. Upgrades to cardiac resynchronization therapy were low in both groups (adjusted 1.6 vs. 1.7%, P = 0.40), as were Micra AV upgrades to a dual-chamber system (adjusted 1.4%). All-cause mortality rates remained higher in Micra AV than in DC-TV patients (unadjusted HR: 2.48, 95% CI 2.35-2.62, P < 0.0001; adjusted HR: 1.53, 95% CI 1.44-1.62, P < 0.0001). Patients implanted with Micra AV had lower complications and re-intervention rates at 2 years than patients implanted with a traditional DC-TV pacemaker. All-cause mortality remained higher in Micra AV patients, likely due to their higher comorbidity burden and other differences in baseline characteristics. ClinicalTrials.gov ID NCT04235491.

Prostate Artery Embolization – Mid to Long-term Outcomes in 1075 Patients

BackgroundTo assess the mid to long-term safety and efficacy of Prostatic Artery Embolization (PAE) at a single-center, cohort of 1075 patients. MethodsThis IRB-approved retrospective-study included patients with moderate-to-severe Lower-Urinary-Tract-Symptoms(LUTS) or urinary-retention who underwent PAE from January-2014 to July-2023. Patients were assessed at 1, 3, 6, and 12-months post-PAE and yearly thereafter. International-Prostate-Symptom-Score(IPSS), Quality-of-Life(QoL) score, International-Index of Erectile-Function–5 score(IIEF-5), Prostate-Specific-Antigen(PSA), Prostate-volume(PV), Post-void-Residual(PVR), Benign-Prostatic-Obstruction(BPO)-medication usage, urinary-catheter status, and further prostate-interventions were assessed. Adverse-events were recorded and classified using the Society of Interventional-Radiology Adverse-Events(SIR-AE) severity classification. ResultsThe mean follow-up was 458.4±559.5 days. Mean age was 70.4±9.0 years, median(IQR) prostate-volume was 107gm(76-150), median pre-procedure IPSS, QoL, IIEF-5, and PSA were 23(18-28), 5(4-6), 17(10-21), and 4.7(2.6-8), respectively. In the LUTS subgroup, at 1-3, 6-12, and 48-60 months, the median-IPSS was 7(4-12, p<0.001), 6(3-11, p<0.001), and 9(4-15, p<0.001). The QoL was 2(1-2, p<0.001), 1(0-2, p<0.001), 2(0-3, p<0.001) at the same time-points. 119(94%) out of 126-patients in the retention cohort were catheter-free at the 3-month follow-up. Ninety-patients(16% of re-intervention eligible patients) required a second prostatic-intervention upto 60-months post-PAE. 65.5% of patients post-PAE were BPO-medication-free at 1-year. 7 patients (0.65%) had SIR-AE severity-Severe: transient ischemic-attacks:3, Urosepsis-2 (treated in inpatient-setting with IV-antibiotics), prostate-sloughing–2(needing TURP). All adverse events resolved without sequelae. ConclusionIn a large cohort with long-term longitudinal follow-up, PAE shows significant, sustained long-term relief of LUTS, improved QoL, low re-intervention rate, and high BPO medication-free rates. 94% of catheter-dependent patients at baseline were catheter-free at 3-months.

A School-Goer’s Nightmare: Case Report of CABG in an 8 Year-Old with Kawasaki Disease

Introduction: Kawasaki disease (KD) is an acute vasculitis primarily affecting medium-sized arteries, particularly the coronary arteries (CA). Its impact varies, with some patients developing transient dilation while others experience severe coronary artery aneurysms (CAA), leading to complications such as thrombosis, stenosis, and myocardial ischemia. Male gender, delayed diagnosis, incomplete presentation of KD, and resistance to Intravenous Immunoglobulin (IVIG) therapy are risk factors for CAA. The Japanese Ministry of Health classifies CAAs by size, with giant aneurysms (&gt;8 mm) carrying significant long-term risks, including coronary thrombosis and acute coronary syndrome. Case Report: We report the case of an 8-year-old Malay boy with giant CAA secondary to KD. The patient presented with classical KD symptoms and inflammatory markers, with echocardiography revealing a giant aneurysm (8.7 mm) in the left anterior descending artery (LAD), alongside smaller aneurysms in the left circumflex and right coronary arteries (RCA). Initial management included IVIG, aspirin, and heparin, with warfarin and clopidogrel added subsequently. Coronary angiography indicated severe LAD stenosis (95%) with total occlusion and an aneurysmal segment distal to the occlusion. A multidisciplinary team determined that coronary artery bypass grafting (CABG) using bilateral internal mammary arteries was the optimal intervention. The patient had a favourable recovery and was stable at discharge. Discussion: CABG is recognized as a preferred treatment for severe or multivessel coronary involvement in KD, offering lower reintervention rates compared to percutaneous coronary intervention (PCI). Studies support CABG’s efficacy in managing coronary complications in KD, especially for complex or multivessel cases. Conclusion: This case illustrates the complexities of managing giant CAAs in paediatric KD and underscores the necessity of a multidisciplinary approach and long-term monitoring to

Ventricular assist devices as bridge to heart transplantation: minimally invasive approach with axial pumps vs sternotomy approach with centrifugal pumps: short term results

Abstract Introduction Microaxial flow ventricular assist devices (VADs) with hybrid approach could provide an advantage over centrifugal flow VADs with surgical implantation via median sternotomy as bridge to heart transplantation. Purpose We aimed to compare short-term results in intensive cardiac care unit between both groups. Methods Single-center retrospective registry comparing patients supported with microaxial flow VADs with hybrid approach (Impella 5.0 or 5.5) and surgical centrifugal flow VADs (biventricular or left univentricular CentriMag) as bridge to heart transplantation. Results Including 12 patients (January 2020-March 2022), 7 patients in hybrid approach group (2 patients with Impella 5.0-16,7% and 5 patients with Impella 5.5-41,7%) and 5 pacientes in sternotomy approach group (33.3% biventricular support and 8.3% left ventricular support). In first 48 hours after VAD implantation, worsening of renal function was greater in sternotomy approach group (Cr 2.23±0.88, 1.07±0.58;p=0.021) and there was a trend toward lower hemoglobin values (7.72±0.19, 8.9±1.35;p =0.059), with no differences in other analyzed variables (Table). A trend toward earlier respiratory weaning was observed in hybrid approach group (median 12 vs 48 hours,p=0.067). Sternotomy approach group required more frequent use of continuous renal replacement therapy (60% vs 0%,p=0.045). There were statistically non-significant differences in need for blood products or surgical reinterventions, although percentage of red blood cells transfused in first 48 hours after VAD implantation were lower in hybrid approach group than sternotomy approach group (median 4 (1.5-8) versus 8(2.5-13.5) in sternotomy approach group, p=0.309). The most common complication in sternotomy approach group was tamponade (80%- 4 patients versus 0 patients in hybrid approach) and in hybrid approach group access-related infections (28.57%, 2 patients). Ten patients received a transplant, one died for non-cardiovascular cause, and another underwent the implantation of long term VAD as bridge to transplantation. There were no differences in time from assistance implantation to heart transplantation. The most common complication after heart transplantation was primary graft failure in both groups (40%,2 patients) with no differences in mortality. Conclusions Microxial flow VADs with hybrid approach provide adequate support, with less need for continuous renal replacement therapy and shorter duration of mechanical ventilation after VAD implantation to admission in intensive cardiac care unit, a trend towards lower rates of reintervention due to bleeding was observed. The advantages of minimally invasive approach could increase its use as bridge to heart transplantation compared to VADs with sternotomy approach although small sample size may negatively influence the failure to reach statistical significance, and more studies are necessary to validate our preliminary experience.Variables analyzed 48 hours of admission

Lumen-apposing metal stents for anastomosis creation throughout the gastrointestinal tract: A large single-center experience.

The introduction of lumen-apposing metal stents (LAMSs) has revolutionized the field of therapeutic endoscopic ultrasound. This study aims to evaluate the efficacy and safety of LAMS in creating an endoscopic ultrasound-guided anastomosis between two segments of the gastrointestinal (GI) tract. Data from all consecutive LAMS procedures for anastomosis creation between two segments of the GI, conducted between October 2019 and February 2024, were retrospectively analyzed for technical success (defined as correct deployment of the LAMS in the target), clinical success (defined as achievement of the intended clinical goal), and adverse events. A total of 145 LAMS procedures were performed in 136 patients. Indications for LAMS procedures included the need for endoscopic access to or reversal of surgically excluded segments of the GI tract (n = 73, 50.3%), and the alleviation of any GI outflow obstruction (n = 72, 49.7%). The overall technical and clinical success rates were very high (97.2% and 95.2%, respectively). Adverse events were observed in 20/145 (13.8%) cases, including 11 (7.6%) minor events (AGREE <3) and nine (6.2%) major events (AGREE ≥3). Major events included stent migration (n = 1), persisting fistula (n = 3), and bleeding (n = 4). All adverse events were successfully managed, and there were no procedure-related deaths. Loss of LAMS patency occurred in 4/145 (2.8%) cases and could be endoscopically managed in all cases. The creation of anastomoses with LAMS between two segments of the GI tract appears to be effective and safe, with a low reintervention rate due to loss of LAMS patency.

Meta-Analysis of Randomised Controlled Trials Comparing Bypass and Endovascular Revascularisation for Peripheral Artery Disease.

Peripheral artery disease affects approximately 250 million people globally. Multiple randomised controlled trials have compared bypass and endovascular interventions but the optimum revascularisation approach remains unclear. The recently published BEST-CLI and BASIL-2 trials provide current and robust data addressing this question, however their findings are not concordant. This systematic review and meta-analysis provides an overview of the worldwide randomised evidence comparing bypass surgery and endovascular revascularisation in lower limb peripheral artery disease. A comprehensive literature search of MEDLINE, Embase and CENTRAL databases was performed of all time periods up to 7 May 2023 to identify randomised controlled trials comparing bypass and endovascular revascularisation for treating lower limb peripheral artery disease. The primary outcome was major amputation. Secondary outcomes were mortality, re-intervention, 30-day adverse events and 30-day mortality. Odds ratios were calculated and pooled using the random-effects model. Risk of bias was assessed using the Cochrane risk of bias 2 tool. Fourteen cohorts were identified across thirteen studies, enrolling 3840 patients. There was no significant difference in major amputation (OR 1.12; 95% CI 0.80-1.57) or mortality (OR 0.96; 95% CI 0.79-1.17) between the bypass and endovascular groups. Bypass was associated with a significant reduction in re-intervention compared with endovascular treatment (OR 0.57, 95% CI 0.40-0.82). These findings suggest that rates of major amputation and mortality are similar following bypass and endovascular interventions. Patients who undergo bypass surgery have a significantly lower re-intervention rate post-operatively.

Endoscopic ultrasound-guided gastroenterostomy versus duodenal stenting for gastric outlet obstruction: A systematic review, meta-analysis, and meta-regression.

Gastric outlet obstruction (GOO) refers to mechanical obstruction at the level of the gastric outlet and is associated with significantly impacted quality of life and mortality. Duodenal stenting (DS) offers a minimally invasive approach to managing GOO but is associated with a high risk of stent obstruction. Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) is a novel intervention that uses lumen-apposing metal stents to open the restricted lumen. The current evidence comparing EUS-GE to DS is limited and inconsistent. We conducted a systematic literature search on PubMed, Embase, Cochrane, Scopus, and clinicaltrials.gov to retrieve studies comparing EUS-GE to DS for GOO. Odds ratios (OR) and mean differences (MD) with their 95% confidence intervals (CI) were pooled using the DerSimonian-Laird inverse variance random-effects model. Statistical significance was set at P < .05. Ten studies with a total of 1275 GOO patients (585: EUS-GE and 690: DS) were included. EUS-GE was associated with statistically significant higher clinical success [OR: 2.52; 95% CI: 1.64, 3.86; P < .001], lower re-intervention rate [OR: 0.12; 95% CI: 0.06, 0.22; P < .00001], longer procedural time [MD: 20.91; 95% CI: 15.48, 26.35; P < .00001], and lower risk of adverse events [OR: 0.49; 95% CI: 0.29, 0.82; P = .007] than DS. Technical success [OR: 0.62; 95% CI: 0.31, 1.25] and the length of hospital stay [MD: -2.12; 95% CI: -5.23, 0.98] were comparable between the 2 groups. EUS-GE is associated with higher clinical success, longer total procedural time, lower re-intervention rate, and lower risk of adverse events than DS. Technical success and the length of hospital stay were comparable between the 2 groups. EUS-GE appears to be a safe and effective procedure for managing GOO. Further large, multicentric randomized controlled trials are warranted to investigate the safety and outcomes of EUS-GE in patients with malignant GOO.

772. EVALUATING OUTCOMES OF LES OBSTRUCTION AND REFLUX IN PATIENTS UNDERGOING PERORAL ENDOSCOPIC MYOTOMY GUIDED BY THE 16CM IMPEDANCE PLANIMETRY CATHETER

Abstract Background Peroral endoscopic myotomy (POEM) is a standard treatment option in achalasia. The endoluminal functional lumen imaging probe (FLIP) system utilizes impedance planimetry to measure diameter and distensibility at the esophagogastric junction (EGJ) in real-time. Most reports of the intraoperative FLIP experience focus on the 8 cm balloon, but the 16 cm balloon catheter also provides topographical assessments in addition to EGJ metrics. The aim of this study is to determine the clinical outcomes after a tailored myotomy using the 16 cm balloon during POEM. Methods We conducted a retrospective review of consecutive patients who underwent POEM with intraoperative FLIP with the 16 cm balloon catheter between January 2020 and September 2023. Operative reports were reviewed, and data including FLIP metrics and topographical assessments and myotomy length, which was guided by FLIP panometry, were recorded. Clinical parameters for lower esophageal sphincter (LES) obstruction (defined by FLIP-EGJ metrics, BEDQ/Eckardt scores and/or need for LES re-intervention) and reflux (defined by GERD-HRQL/RSI scores, +pH testing, LA B/C/D reflux esophagitis, PPI use and/or need for anti-reflux surgery) were collected during the 6-36 month follow up time period. Results Of 100 patients (57 female, mean 56.1y), 82 had Achalasia, 15 EGJOO, and 3 hypercontractile esophagus. Myotomy length was tailored (mean 8.2cm, range 3 – 15) by FLIP, and 10% had a short myotomy (≤4cm). Among 16 patients with previous Heller, the myotomy targeted contractile activity proximal to the previous myotomy in 10 cases. On follow up of 71 patients (median time 14mo), clinical outcomes are noted in Table 1. Obstructive symptoms and FLIP metrics showed significant improvement. Repeat myotomy was required in 5.6%. While reflux symptom scores improved, 37.5% had abnormal %AET, 4.7% had reflux esophagitis, and 7.0% required anti-reflux surgery. Conclusion A tailored myotomy with guidance of a 16 cm FLIP catheter to assess EGJ metrics and topographical assessments during POEM appears to be safe and effective at 6-36 month follow up. A tailored myotomy allows for a shorter myotomy than traditional surgical lengths and can be extended to capture residual disease noted with the 16 cm FLIP catheter in patients with previous surgery. Use of the 16 cm balloon during POEM results in overall low rates of LES re-intervention and post-myotomy reflux.

Endovascular Aortic Repair With the E-Tegra Device: Preliminary Outcomes From a Multicenter National Registry.

Endovascular aortic repair (EVAR) is currently expanding its feasibility thanks to design innovations, but hostile proximal necks and narrow iliac arteries are still a constraint, as expressed by the Instructions for Use (IFU) of most devices. Our aim is to report the preliminary results of the E-Tegra endograft in infrarenal abdominal aortic aneurysms (AAAs) performed in 15 high-volume centers. The e-Tegra Italian endoGraft REgistry (TIGRE) is a prospectively maintained database of consecutive EVAR with the E-Tegra stent-graft across 15 participating centers between March 2021 and March 2023. The registry records baseline clinical data, anatomic measurements of the abdominal aorta, perioperative and postoperative outcomes, with a scheduled follow-up period of 3 years for all patients. This is a preliminary analysis of the first results updated to January 2024. The primary endpoints are technical and clinical success, perioperative mortality, freedom from endograft rupture, and aortic-related mortality. The secondary endpoints are freedom from reintervention, and any type of endoleak (EL). The results were analyzed in relation with the anatomic characteristics of the AAAs, namely, iliac axes tortuosity and proximal neck hostility. The registry included 147 consecutive EVAR (138 elective and 9 in emergent setting), 7 of which were associated with an iliac branch implantation. Ninety patients had at least 1 criterion of anatomical hostility, and 25 were treated outside the device IFU. Primary technical success was achieved in 146 cases (99.3%) and assisted success in 147 (100%), with no perioperative mortality. After a median follow-up period of 20 months, no aneurysm-related mortality occurred. Reinterventions were 5: 2 for type IB EL and 3 for type II ELs with aneurysm sac increase. Five more type II ELs with aneurysm sac stability are under observation. No differences in terms of reinterventions were noted between aneurysms with standard and hostile anatomy. The E-Tegra endograft is safe and effective in treating AAAs with standard and hostile anatomy, with a low rate of complications and reinterventions, although longer-term outcomes and larger numbers are needed to compare its performances related to specific anatomic criteria. This multi-center nationwide Registry reports a real-world experience of EVAR performed with the E-Tegra abdominal endograft across 15 high-volume Centers, providing early- and mid-term device-specific results, which will help vascular surgeons in endograft selection. In particular, this study focuses on clinical results obtained in treating aneurysms with hostile anatomy, analyzing the performances of the E-Tegra endograft in cases of hostile proximal necks and narrow or tortuous iliac axes.

Endoscopic ultrasound- versus ERCP-guided primary drainage of inoperable malignant distal biliary obstruction: systematic review and meta-analysis of randomized controlled trials.

We assessed efficacy and safety of endoscopic ultrasound-guided biliary drainage (EUS-BD) vs. endoscopic retrograde cholangiopancreatography (ERCP) as first-line intervention in malignant distal biliary obstruction (MDBO). PubMed/Medline, Embase, and Cochrane databases were searched until 01 /12 /2023 for randomized controlled trials of EUS-BD vs. ERCP for primary biliary drainage in patients with inoperable MDBO. The primary outcome was technical success. Secondary outcomes were clinical success, adverse events, mean procedure time, 1-year stent patency, and overall survival. Relative risk (RR) with 95 %CI were calculated using a random effects model. Five studies (519 patients) were included. RR (95 %CI) for EUS-BD was 1.06 (0.96 to 1.17; P = 0.27) for pooled technical success and 1.02 (0.97 to 1.08; P = 0.45) for clinical success. 1-year stent patency was similar between the groups (RR 1.15, 0.94 to 1.42; P = 0.17), with lower reintervention with EUS-BD (RR 0.58, 0.37 to 0.9; P = 0.01). The RR was 0.85 (0.49 to 1.46; P = 0.55) for adverse events and 0.97 (0.10 to 0.17; P = 0.98) for severe adverse events. On subgroup analysis, EUS-guided placement of lumen-apposing metal stent (LAMS) outperformed ERCP in terms of technical success (RR 1.17, 1.01 to 1.35; P = 0.03). Procedure time was lower with EUS-BD (standardized mean difference -2.36 minutes [-2.68 to -2.05; P < 0.001]). EUS-BD showed a statistically significant lower reintervention rate than ERCP, but with similar technical success, stent patency, clinical success, and safety. Technical success of EUS-BD with LAMS was better than ERCP.

Common Arterial Trunk Repair at the Red Cross War Memorial Hospital, Cape Town: A 20-Year Review of Surgical Practice and Outcomes.

This study describes the 20-year experience of managing common arterial trunk (CAT) in a low-and-middle-income country and compares the early and medium-term outcomes following the transition from conduit to nonconduit repair at the Red Cross War Memorial Children's Hospital. Single-center retrospective study of consecutive patients aged less than 18 years who underwent repair of CAT from January 1999 to December 2018 at the Red Cross War Memorial Children's Hospital. Patients with interrupted aortic arch or previous pulmonary artery banding were excluded. Fifty-four patients had CAT repair during the study period. Thirty-four (63.0%) patients had a conduit repair, and 20 (37.0%) patients had a nonconduit repair. There were two intraoperative deaths. Thirty-day in-hospital mortality was 22.2% (12/54). Overall, in-hospital mortality was 29.6% (16/54). Eight (21.1%) late mortalities were observed. The actuarial survival for the conduit group was 77.5%, 53.4%, and 44.5% at 6, 12, and 27 months, respectively, and the nonconduit group was 58.6% at six months. The overall freedom from reoperation between the conduit group and nonconduit group was 66.2% versus 86.5%, 66.2% versus 76.9%, and 29.8% versus 64.1% at 1, 2, and 8 years, respectively. The outcomes following the transition to nonconduit repair for CAT in a low- and middle-income setting appear to be encouraging. There was no difference in mortality between conduit and nonconduit repairs, and importantly the results suggest a trend toward lower reintervention rates.

Multicenter CT Image-Based Anatomic Assessment of Patients with Aortoiliac Aneurysm Undergoing Endovascular Repair with Iliac Branch Devices

ObjectiveThe Global Iliac Branch Study (NCT05607277) is an international, multicenter, retrospective cohort study of anatomic predictors of adverse iliac events (AIE) in aortoiliac aneurysms treated with iliac branch devices (IBDs). MethodsPatients with pre- and post-IBD CT imaging were included. We measured arterial diameters, stenosis, calcification, bifurcation angles, and tortuosity indices using a standardized, validated protocol. A composite of ipsilateral AIE was defined, a priori, as occlusion, type I or III endoleak, device constriction, or clinical event requiring reintervention. Paired t-test compared tortuosity indices and splay angles pre- and post-treatment for all IBDs and by device material (stainless steel and nitinol). Two-sample t-test compared anatomical changes from pre- to post-treatment by device material. Logistic regression assessed associations between AIE and anatomic measurements. Analysis was performed by IBD. ResultsWe analyzed 297 patients (286 males, 11 females) with 331 IBDs (227 stainless steel, 104 nitinol). Median clinical follow-up was 3.8 years. Iliac anatomy was significantly straightened with all IBD treatment, though stainless steel IBDs had a greater reduction in total iliac artery tortuosity index and aortic splay angle compared to nitinol IBDs (absolute reduction -.20 [-.22 to -.18] versus -.09 [-.12 to -.06], P<.0001 and -19.6° [-22.4° to -16.9°] versus -11.2° [-15.3° to -7.0°], P=.001, respectively). There were 54 AIEs in 44 IBDs in 42 patients (AIE in 13.3% of IBD systems), requiring 35 reinterventions (median time to event 41 days; median time to reintervention 153 days). There were 18 endoleaks, 29 occlusions, and five device constrictions. There were no strong associations between anatomic measurements and AIE overall, though internal iliac diameter was inversely associated with AIE in nitinol devices (nAIE,nitinol=8). ConclusionsPurpose-built iliac branch devices effectively treat aortoiliac disease, including that with tortuous anatomy, with a high patency rate (91.5%) and low reintervention rate (9.1%) at four years. Anatomic predictors of AIE are limited.

Laparoscopic Gastrojejunostomy Versus Endoscopic Stenting as a Palliative Treatment for Gastric Outlet Obstruction.

Introduction: Gastric outlet obstruction (GOO) is a common complication in advanced stage upper gastrointestinal malignancies. The symptoms of severe nausea and protracted vomiting can lead to a decline in quality of life and cachexia. Symptoms of GOO can be effectively managed with either operative or nonoperative palliative interventions. In our article, we aim to compare laparoscopic gastrojejunostomy (GJ) to endoscopic stenting as palliative interventions for GOO. Methods: We retrospectively evaluated the charts of patients who underwent palliative procedure for gastric outlet obstruction. Group I included patients who underwent endoscopic stenting, and group II patients underwent Laparoscopic GJ. The groups' demographics (age, gender), length of procedure, length of stay, days to oral intake, overall survival, complications rate, and 30-day mortality rates were compared. Results: Overall, 38 patients were included in the study. Nineteen patients underwent endoscopic stenting and 19 underwent laparoscopic GJ. Comparing the groups, no significant differences were noted. Surgical time was significantly longer than the endoscopic procedures (83 minutes versus 25 minutes, P = .001). No significant differences were noted in days of oral intake initiation, overall survival and 30-day mortality rates. Five patients in the stenting group had complications (26.3%) versus none in the surgical group (P = .046). No postoperative complications were noted. Conclusion: Laparoscopic GJ is a safe and feasible treatment for GOO, demonstrating early resumption of oral intake. The relative short hospital stay, combined with an encouraging postoperative complications profile and low reintervention rate, should be kept in mind especially among patients with longer life expectancy.

P-393 Operative hysteroscopy versus vacuum aspiration for missed miscarriage in women undergoing in vitro fertilization, a propensity score-matched cohort study

Abstract Study question Is operative hysteroscopy, compared to vacuum aspiration, associated with increased success rates in the subsequent frozen embryo transfer of women who experienced missed miscarriage? Summary answer Operative hysteroscopy does not show advantages in terms of live birth rate in the subsequent frozen embryo transfer compared to women who underwent vacuum aspiration. What is known already As hysteroscopy to remove retained product of conception is performed under direct visualization control, it may theoretically reduce risks to the uterine cavity and therefore improve future fertility. With the advancements in hysteroscopy technology, an increasing number of women with missed miscarriage are choosing operative hysteroscopy over conventional vacuum aspiration. However, there is currently insufficient research available to determine whether use of operative hysteroscopy to remove retained tissues within the uterus effectively increases the success rate of subsequent frozen embryo transfer. Study design, size, duration This was a propensity score-matched cohort study on women who had experienced an missed miscarriage at 5 to 16 gestational weeks during an IVF cycle in Peking University Third Hospital from 2015 to 2022. Participants/materials, setting, methods We aimed to focus on a specific group of patients who had experienced missed miscarriage during IVF and subsequently underwent frozen embryo transfer. Logistic regression models were used to compare the effect of operative hysteroscopy versus vacuum aspiration, after propensity score matching with a 1:1 ratio. Non-linear interaction was tested on gestational weeks and treatment effect on live birth rate. The primary outcome was the live birth rate in the subsequent frozen embryo transfer. Main results and the role of chance Out of the 3,722 fresh embryo transfer cycles and 5,948 frozen embryo transfer cycles resulting in miscarriage, a total of 2,562 women who underwent vacuum aspiration and 347 women who underwent operative hysteroscopy were included in the analysis. After propensity score matching at a 1:1 ratio, 324 women were included in each group. Compared to women who underwent vacuum aspiration, those who underwent operative hysteroscopy were associated with a lower rate of live birth in the propensity-based matched cohort (29% vs 22%, aOR = 0.67 (0.47, 0.96)). The result was further confirmed by several sensitivity analysis, including using non-imputed data, varying calliper widths for propensity score matching, and matching covariates associated with treatment assignment or pregnancy outcomes. No statistical difference was detected on the biochemical pregnancy rate, clinical pregnancy rate, multiple pregnancy rate, and miscarriage rate. No interaction was detected between the gestational week and the relative treatment effect on live birth (p = 0.75). There was no significant difference in the rate of neonatal outcomes between the vacuum aspiration and operative hysteroscopy groups. 11 women experienced surgery reintervention in the vacuum aspiration group (0.4%), while no one required surgery reintervention in the operative hysteroscopy group. Limitations, reasons for caution The retrospective design and inability to analyze certain confounding factors are notable limitations, despite achieving covariate balance through matching. Our dataset did not capture several important outcomes, including cumulative pregnancies and severe complications after surgery. Future randomised trials are warranted to provide more robust insights into our results. Wider implications of the findings Women may benefit from operative hysteroscopy with a lower rate of reintervention compared to vacuum aspiration. However, this advantage may come at the expense of lower rates of live birth. Our results should be further tested by randomised trials. Trial registration number NA

Poster 295: Evidence Suggesting Beneficial Effects of Platelet-Rich Plasma Over Alternative Injections for Knee Osteoarthritis Is Fairly Robust: A Systematic Review and Statistical Fragility Index-Based Meta-Analysis of Randomized Controlled Trials

Objectives: Based in part on the results of randomized controlled trials (RCTs) that suggest a beneficial effect over alternative treatment options, the use of platelet-rich plasma (PRP) for the management of knee osteoarthritis (OA) is widespread and increasing. However, the extent to which these studies are vulnerable to slight variations in the outcomes of patients remains unknown. The purpose of this study is to evaluate the statistical fragility of conclusions from RCTs that reported outcomes of patients with knee OA who were treated with PRP versus alternative nonoperative management strategies. Methods: All RCTs comparing PRP to alternative nonoperative treatment options for knee OA were identified. The fragility index (FI) and reverse fragility index (RFI) were applied to assess the robustness of conclusions regarding the efficacy of PRP for knee OA. Meta-analyses were performed to determine the minimum number of patients from one or more trials included in the meta-analysis for which a modification on the event status would change the statistical significance of the pooled treatment effect. Results: In total, this analysis included outcomes from 1993 patients with a mean (± standard deviation) age of 58.0 ± 3.8 years. The mean number of events required to reverse significance (FI) was 4.57 ± 5.85. This corresponded to a fragility quotient of 0.060 ± 0.075, meaning the significance of the results was contingent on 6 events per 100 participants. For non-significant outcome events, the mean number of events required to reverse statistical nonsignificance (RFI) was 4.41 ± 2.22. This corresponded to a reverse fragility quotient of 0.065 ± 0.056, meaning the non-significance of the results was contingent on 6.5 events per 100 participants (Figure 1). Based on random-effects meta-analyses, PRP demonstrated a significantly higher rate of successful outcomes when compared to hyaluronic acid (p = 0.002, odds ratio 95% CI = 2.19 [1.33-3.62]) (Figure 2) as well as higher rates of patient-reported symptom relief (p = 0.019, odds ratio [95% CI] = 1.55 [1.07-2.24]) (Figure 3), not requiring a reintervention after the initial injection treatment (p = 0.002, odds ratio [95% CI] = 2.17 [1.33-3.53]) (Figure 4), and achieving the minimal clinically important difference (MCID) for pain improvement (p = 0.007, odds ratio [95% CI] = 6.19[1.63-23.42]) when compared to all alternative nonoperative treatments. Overall, the mean number of events per meta-analysis required to change the statistical significance of the pooled treatment effect was 8.67 ± 4.50. Conclusions: Individual RCTs evaluating PRP for knee OA possess slight robustness. Upon meta-analysis, PRP demonstrated a significant advantage over HA as well as improved symptom relief, lower rates of reintervention, and more frequent achievement of the MCID for pain improvement when compared to alternative, nonoperative treatment options. Statistically significant pooled treatment effects evaluating PRP for knee OA are more robust than approximately half of all comparable meta-analyses in medicine and healthcare. Future RCTs and meta-analyses should consider reporting fragility indices and quotients to facilitate interpretation of results in their proper context. In addition, the robustness of these findings suggests that reconsideration of the American Academy of Orthopaedic Surgeons clinical practice guidelines around the use of PRP for knee OA may be warranted.

Evaluation of custom-made Relay® stent-grafts for aortic arch landing zones 0 and I: experience from two high-volume aortic centres.

To report experience with a Relay® stent-graft custom-made platform in treating different aortic arch pathology in 2 high-volume aortic centres. A retrospective analysis of all patients treated between July 2016 and July 2023 with custom-made Relay® stent-graft (custom-made device). Underlying aortic arch pathology was an aneurysm, penetrating aortic ulcer, and dissection. Three custom-made device designs were used: proximal scallop, fenestrations, and inner branches. The endpoints were technical success, perioperative stroke, death, and reintervention rate. Thirty-five patients (89% males) with a mean age of 70 ± 11 years were treated.Indication for treatment was penetrating aortic ulcer in 14 patients (40%), aneurysm in 11 patients (31%) and aortic dissection in 10 patients (29%). The technical success rate was 100%. Twenty-eight patients (80%) had proximal sealing in zone 0, and 7 (20%) had proximal sealing in zone 1. Nine patients (25.6%) had proximal scallops, 9 (25.6%) had 1 big fenestration and 17 (48.8%) had a branched device; 1 with single branch, 15 with double branches and 1 with triple branches. Thirty patients (86%) had previous or simultaneous left subclavian artery revascularization. No patient died during 30 days. Two patients (5.7%) had stroke postoperatively; both recovered without disabling deficits. The mean follow-up was 35 ± 26 months. Six patients (17.1%) died during follow-up. One patient required reinforcement of the bridging stent in the left common carotid artery and one additional vascular plugging of the left subclavian artery. Three patients received distal extension. The Relay® stent-graft custom-made platform showed a good performance in our study with a high technical success rate, low perioperative stroke and mortality, and low reintervention rates during the follow-up.

Long-term outcomes of total arch replacement with bilateral antegrade cerebral perfusion using the "arch first" approach.

To report outcomes of total arch replacement (TAR) with hypothermic circulatory arrest and bilateral antegrade cerebral perfusion (bACP) using an "arch first" approach for acute Type A aortic dissection (ATAAD). The "arch first" approach involved revascularization of the aortic arch branch vessels with uninterrupted ACP, before lower body circulatory arrest, while the patient was cooling. This was an observational study of aortic surgeries from 2010 to 2021. All patients who underwent TAR with bACP for ATAAD were included. Short-term and long-term outcomes were reported utilizing descriptive statistics and Kaplan-Meier survival estimation. A total of 215 patients were identified who underwent TAR + bACP for ATAAD. Age was 59.0 [49.0-67.0] years and 35.3% were female. 73 patients (34.0%) underwent a concomitant aortic root replacement, 188 (87.4%) had aortic cannulation, circulatory arrest time was 37.0 [26.0-52.0] minutes, and nadir temperature was 20.8 [19.4-22.5] degrees Celsius. 35 patients (16.3%) had operative mortality (STS definition), 17 (7.9%) had a new stroke, 79 (36.7%) had prolonged mechanical ventilation (>24h), 35 (16.3%) had acute renal failure (by RIFLE criteria), and 128 (59.5%) had blood product transfusions. One-year survival was 77.1%, while 5-years survival was 67.1%. During follow-up, there were 23 (10.7%) reinterventions involving the descending thoracic aorta - either thoracic endovascular aortic repair or open thoracoabdominal aortic replacement. Among patients with ATAAD, short-term postoperative outcomes after TAR + bACP using the "arch first" approach are acceptable. Moreover, this operative strategy may furnish long-term durability, with a reasonably low reintervention rate and satisfactory overall survival.

Alternative treatments of adenomyosis - an update in procedural management and clinical outcomes.

Adenomyosis is a common cause of abnormal uterine bleeding (AUB), dysmenorrhea, and pelvic pain. Definitive diagnosis and treatment have historically been by uterine histopathology at time of hysterectomy; however, advances in imaging have supported earlier diagnosis and subsequent conservative treatment. This review aims to update the evidence supporting the uterine-sparing, procedural management options with a focus on clinical outcomes. Uterine artery embolization (UAE), radiofrequency ablation (RFA), high-intensity focused ultrasound (HIFU), percutaneous microwave ablation (PMWA), and adenomyomectomy are minimally invasive interventions proven to be effective in reducing AUB and dysmenorrhea due to adenomyosis. Symptom improvement is associated with a decrease in uterine volume. Studies support the use of alternative treatment options given the overall low rates of symptom recurrence and reintervention. Combination therapy may be more effective than monotherapy. This review provides the current evidence for use of alternative treatment options for adenomyosis. Access to ablative therapies in the USA is limited and primarily off label, given lack of FDA approval. High-quality prospective and randomized controlled trials are needed in order to further delineate treatment comparisons, efficacy, safety, and ideal patient selection for these treatments. More data are needed to assess safety and utility in those desiring future fertility.

Inside stent placement is suitable for preoperative biliary drainage in patients with perihilar cholangiocarcinoma

Background/PurposeEndoscopic biliary stenting (EBS) is commonly used for preoperative drainage of localized perihilar cholangiocarcinoma (LPHC). This study retrospectively compared the utility of inside stent (IS) and conventional stent (CS) for preoperative EBS in patients with LPHC.MethodsEBS was performed in 56 patients with LPHC. EBS involved the placement of a CS (n = 32) or IS (n = 24). Treatment outcomes were compared between these two groups.ResultsPreoperative recurrent biliary obstruction (RBO) occurred in 23 patients (71.9%) in the CS group and 7 (29.2%) in the IS group, with a significant difference (p = 0.002). The time to RBO (TRBO) was significantly longer in IS than in CS (log-rank: p < 0.001). The number of stent replacements was significantly lower in IS than CS [0.38 (0–3) vs. 1.88 (0–8), respectively; p < 0.001]. Gemcitabine-based neoadjuvant chemotherapy (NAC) was administered to 26 patients (46.4%). Among patients who received NAC, TRBO was longer in IS than in CS group (log-rank: p < 0.001). The IS group had a significantly shorter preoperative and postoperative hospital stay than the CS group (20.0 vs. 37.0 days; p = 0.024, and 33.5 vs. 41.5 days; p = 0.016). Both the preoperative and the postoperative costs were significantly lower in the IS group than in the CS group (p = 0.049 and p = 0.0034, respectively).ConclusionCompared with CS, IS for preoperative EBS in LPHC patients resulted in fewer complications and lower re-intervention rates. The fact that the IS group had shorter preoperative and postoperative hospital stays and lower costs both preoperatively and postoperatively compared to the CS group may suggest that the use of IS has the potential to benefit not only the patient but also the healthcare system.

Comparison of total percutaneous in situ microneedle puncture and chimney technique for left subclavian artery fenestration in thoracic endovascular aortic repair for type B aortic dissection.

To compare the outcomes of totally percutaneous in situ microneedle puncture for left subclavian artery (LSA) fenestration (ISMF) and chimney technique in type B aortic dissection (TBAD) during thoracic endovascular aortic repair (TEVAR). Data on patients who underwent either chimney-TEVAR (n = 89) or ISMF-TEVAR (n = 113) from October 2018 to April 2022 were analyzed retrospectively. The primary outcomes were mortality and major complications at 30 days and during follow-up. The technical success rate was 84.3% in the chimney group and 93.8% in the ISMF group (p = 0.027). The incidence of immediate endoleakage was significantly higher in the chimney than ISMF group (15.7% vs 6.2%, respectively; p = 0.027). The 1- and 3-year survival rates in the chimney and ISMF groups were 98.9% ± 1.1% vs 98.1% ± 0.9% and 86.5% ± 6.3% vs 92.6% ± 4.1%, respectively (log-rank p = 0.715). The 3-year rate of cumulative freedom from branch occlusion in the chimney and ISMF group was 95.4% ± 2.3% vs 100%, respectively (log-rank p = 0.023). Both ISMF-TEVAR and chimney-TEVAR achieved satisfactory short- and mid-term outcomes for the preservation of the LSA in patients with TBAD. ISMF-TEVAR appears to offer better clinical outcomes with higher patency and lower reintervention rates. However, ISMF-TEVAR had longer operation times with higher procedure expenses. When LSA revascularization is required during TEVAR, in situ, fenestration, and chimney techniques are all safe and effective methods; in situ, fenestration-TEVAR appears to offer better clinical outcomes, but takes longer and is more complicated. LSA revascularization during TEVAR reduces post-operative complication rates. Both in situ ISMF-TEVAR and chimney-TEVAR are safe and effective techniques for the preservation of the LSA during TEVAR. The chimney technique is associated with a higher incidence of endoleakage and branch occlusion, but ISMF-TEVAR is a more complicated and expensive technique.