Neoadjuvant nivolumab plus chemotherapy in resectable non-small-cell lung cancer in Japanese patients from CheckMate 816.

In the open-label, phase III CheckMate 816 study (NCT02998528), neoadjuvant nivolumab plus chemotherapy demonstrated statistically significant improvements in event-free survival (EFS) and pathological complete response (pCR) versus chemotherapy alone in patients with resectable non-small-cell lung cancer (NSCLC). Here we report efficacy and safety outcomes in the Japanese subpopulation. Patients with stage IB-IIIA, resectable NSCLC were randomized 1:1 to nivolumab plus chemotherapy or chemotherapy alone for three cycles before undergoing definitive surgery within 6 weeks of completing neoadjuvant treatment. The primary end-points (EFS and pCR) and safety were assessed in patients enrolled at 16 centers in Japan. Of the Japanese patients randomized, 93.9% (31/33) in the nivolumab plus chemotherapy arm and 82.9% (29/35) in the chemotherapy arm underwent surgery. At 21.5 months' minimum follow-up, median EFS was 30.6 months (95% confidence interval [CI], 16.8-not reached [NR]) with nivolumab plus chemotherapy versus 19.6 months (95% CI, 8.5-NR) with chemotherapy; hazard ratio, 0.60 (95% CI, 0.30-1.24). The pCR rate was 30.3% (95% CI, 15.6-48.7) versus 5.7% (95% CI, 0.7-19.2), respectively; odds ratio, 7.17 (95% CI, 1.44-35.85). Grade 3/4 treatment-related adverse events were reported in 59.4% versus 42.9% of patients, respectively, with no new safety signals identified. Neoadjuvant nivolumab plus chemotherapy resulted in longer EFS and a higher pCR rate versus chemotherapy alone in Japanese patients, consistent with findings in the global population. These data support nivolumab plus chemotherapy as a neoadjuvant treatment option in Japanese patients with resectable NSCLC.

A standard procedure for rapid toxicity evaluation of carbon dots both in vitro and in vivo.

Carbon dots (CDs) are an emerging class of fluorescent quantum dot nanomaterials that have attracted considerable scientific attention for biomedical or bioimaging applications due to their physicochemical and biochemical properties. With the emergence of massive novel synthetic CDs applying to biomedical fields of science, evaluating their biosafety before any biological application is essential. However, there is no universal protocol or routine procedures for toxicity detection and biosafety assessment of CDs in general biological environments. Herein, we provide an ideal and fast operating system to detect the biotoxicity of CDs, which has been preliminary practiced. Briefly, the obtained CDs will be evaluated by in vitro cytotoxicity assay using cell counting kit-8, lactate dehydrogenase assay kit, and flow cytometry. Meanwhile, the model creature zebrafish is employed to perform in vivo evaluation by measuring body length, hatching rate, heart rate, and morphological observation. Our operating procedure condenses previous scattered biosafety detection methods into a rapid standard evaluation protocol that can be applied to early biotoxicity screening of CDs. This protocol will accelerate CDs biological exploitation and guide future industrialized biosafety assessment in large-scale applications.

Viewpoint: Lupus anticoagulant detection and interpretation in antiphospholipid syndrome.

Lupus anticoagulant (LA) is a well-established risk factor for the clinical manifestations of antiphospholipid syndrome (APS). Accurate LA detection is an essential prerequisite for optimal diagnosis and management of patients with APS or aPL carriers. Variability remains a challenge in LA testing, with reliable detection influenced by multiple factors, including pre-analytical conditions, anticoagulation treatment, choice of tests and procedures performed, as well as interpretation of results, that can lead to false-positives or negatives. A standardised approach to LA testing, following current guidance, based on published data and international consensus, and with attention to detail, is required to underpin accurate detection of LA. Future work should focus on better characterisation of the nature of LA, which may ultimately lead to improved diagnosis and management of patients with APS and aPL carriers. This article reviews current practice and challenges, providing an overview on detection of LA.

Laparoscopic Total Pancreatectomy After Laparoscopic Whipple.

BACKGROUND: The incidence of a second de novo pancreatic ductal adenocarcinoma (PDAC) among patients with prior cancer has been reported to be 6%.1,2 however, as survival increases through improvements in systemic therapy, this incidence of a de novo PDAC after prior PDAC may become more prevalent.3-8 In this context, a structured and stepwise approach to a total pancreatectomy for a second de novo PDAC after a prior PDAC treated with a pancreaticoduodenectomy is detailed. PATIENTS: We present two similar cases. The first patient was a 71-year-old female with de novo body PDAC, and the second was a 50-year-old female with de novo tail PDAC. To rule out recurrence, immunohistochemical staining as well as the review of biopsies by two experienced pathologists were employed. Both patients had undergone a laparoscopic pancreatoduodenectomy for PDAC 4 and 3 years prior. Each patient received four cycles of neoadjuvant chemotherapy and underwent a safe laparoscopic total pancreatectomy. TECHNIQUE: Prior to surgery, three-dimensional anatomic and port site modeling is performed to optimize the understanding of the spatial relationship between the tumor, blood vessels, and adjacent organs involved. The port site modeling (including pneumoperitoneum simulation) focuses on the optimal port set-up for dissecting the biliopancreatic limb off the portal vein. Following complete mobilization of the biliopancreatic limb, the biliopancreatic limb is staple-divided between the hepatico- and pancreaticojejunostomy. Great care must be taken to avoid accidental staple injury to the hepatic artery or celiac trunk. The remainder of the dissection is akin to a standard distal pancreaticosplenectomy. CONCLUSION: Virtual pancreatectomy modeling facilitates an optimal set-up for the critical step of this case, i.e. dissection of the pancreaticojejunostomy off the portal vein. Early division of the biliopancreatic limb between hepatico- and pancreatojejunostomy is crucial to facilitating the remainder of the dissection. Laparoscopic total pancreatectomy for a de novo PDAC after laparoscopic pancreaticoduodenectomy may become more common as survival of patients with prior PDAC improves over time.

Impact of Imaging-Guided Localization on Performance of Tailored Axillary Surgery in Patients with Clinically Node-Positive Breast Cancer: Prospective Cohort Study Within TAXIS (OPBC-03, SAKK 23/16, IBCSG 57-18, ABCSG-53, GBG 101).

BACKGROUND: Tailored axillary surgery (TAS) is a novel surgical concept for clinical node-positive breast cancer. It consists of the removal of the sentinel lymph nodes (LNs), as well as palpably suspicious nodes. The TAS technique can be utilized in both the upfront and neoadjuvant chemotherapy (NACT) setting. This study assessed whether/how imaging-guided localization (IGL) influenced TAS. PATIENTS AND METHODS: This was a prospective observational cohort study preplanned in the randomized phase-III OPBC-03/TAXIS trial. IGL was performed at the surgeon's discretion for targeted removal of LNs during TAS. Immediate back-up axillary lymph node dissection (ALND) followed TAS according to TAXIS randomization. RESULTS: Five-hundred patients were included from 44 breast centers in six countries, 151 (30.2%) of whom underwent NACT. IGL was performed in 84.4% of all patients, with significant variation by country (77.6-100%, p < 0.001). No difference in the median number of removed (5 vs. 4, p = 0.3) and positive (2 vs. 2, p = 0.6) LNs by use of IGL was noted. The number of LNs removed during TAS with IGL remained stable over time (p = 0.8), but decreased significantly without IGL, from six (IQR 4-6) in 2019 to four (IQR 3-4) in 2022 (p = 0.015). An ALND was performed in 249 patients, removing another 12 (IQR 9-17) LNs, in which a median number of 1 (IQR 0-4) was positive. There was no significant difference in residual nodal disease after TAS with or without IGL (68.0% vs. 57.6%, p = 0.2). CONCLUSIONS: IGL did not significantly change either the performance of TAS or the volume of residual nodal tumor burden. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03513614.

Real-world evidence demonstrates an appropriate atrial fibrillation population for hybrid convergent approach versus stand-alone cryoballoon ablation: A long-term safety and efficacy study.

INTRODUCTION: A hybrid convergent approach (endocardial and epicardial ablation) demonstrated superior effectiveness in a recent randomized study for long-standing persistent atrial fibrillation (LSPAF). Yet, there is a lack of real-world, long-term evidence as to which patients are best candidates for a hybrid convergent approach compared to standard endocardial cryoballoon pulmonary vein isolation (CB PVI). METHODS AND RESULTS: This single-center, retrospective analysis spanning from 2010 to 2015 compared two distinctly different atrial fibrillation (AF) cohorts; one treated with stand-alone cryoablation and one treated with a hybrid convergent approach. Baseline characteristics described candidates for each approach. The following criteria were utilized to determine CB PVI candidacy: (1) paroxysmal AF (PAF) (stage 3A) with failed class I/III antiarrhythmic drug (AAD) or (2) persistent/LSPAF (stage 3B/3C/3D) with failed class I/III AAD unwilling to undergo hybrid procedure. Selection criteria for the hybrid procedure included: (1) PAF refractory to both class I/III AAD and prior CB PVI (stage 3D) or (2) persistent/LSPAF (stage 3B/3C/3D) with failed class I/III AAD agreeable to hybrid procedure. Prior sternotomy was excluded. Serial electrocardiograms and continuous monitoring evaluated primary efficacy outcome of time-to-first recurrence of atrial arrhythmia after a 90-day blanking period. Secondary outcomes were procedure-related complications and AAD use (at discharge, 12, and 36 months). Kaplan-Meier methods evaluated arrhythmia recurrence. Of 276 patients, 197 (64.2 ± 10.6 years old; 66.5% male; 74.1% 3A-PAF; 18.3% 3B/3D-persistent AF; 1.0% 3C-LSPAF; 6.6% undetermined) underwent CB PVI and 79 (61.4 ± 8.1 years old; 83.5% male; 41.8% 3D-PAF; 45.5% 3B/3D-persistent AF; 12.7% 3C/3D-LSPAF) underwent hybrid procedure. Arrhythmia freedom through 36 months was 55.2% for CB PVI and 50.4% for hybrid (p = .32). Class I AAD utilization at discharge occurred in 38 (19.3%) patients in the CB PVI group and 5 (6.3%) patients in the hybrid group (p = .01). CB PVI class I AAD utilization at 12 months occurred in 14 (9.0) patients versus 0 patients for hybrid convergent (p = .004). Patients with one or more adverse event were as follows: two (1.0%) in the CB PVI group (both transient phrenic nerve palsy) and three (3.7%) in the hybrid group (two with significant bleeding and one with wound infection) (p = .14). CONCLUSION: This study demonstrated that patients with more complex forms of AF (3D-PAF or 3B/3C/3D-persistent/LSPAF) could be well managed with a convergent approach. In a real-world evaluation, outcomes match safety and efficacy thresholds achieved for patients with earlier, less complex AF etiologies treated by CB PVI alone.

Comparison of clinical outcomes between transthoracic echocardiography- and X-ray-guided left bundle branch pacing for bradycardia: A randomized controlled trial.

INTRODUCTION: Left bundle branch pacing (LBBP) is a physiological pacing modality. However, the long procedure and fluoroscopy time of LBBP is still a problem. This study aims to compare the clinical outcomes between transthoracic echocardiography (TTE)- and X-ray-guided LBBP. METHODS: This is a single-center, prospective, randomized controlled study. Consecutive patients who underwent LBBP in our team from June 2022 to November 2022 were enrolled. Procedure and fluoroscopy time, pacing parameters, electrophysiological and echocardiographic characteristics, as well as complications were recorded at implantation and during follow-up. RESULTS: In this study, 60 patients were enrolled and divided into two groups: 30 patients were allocated to the X-ray group and the remaining 30 to the TTE group. There was no significant difference in the success rate between the two groups (86.7% vs. 76.7%, p = .317). The procedure time of TTE group was comparable to that of the X-ray group (9.0 vs. 12.0 min, p = .063). However, the fluoroscopy time in the TTE group was significantly lower than that of the X-ray group (2.5 vs. 5.0 min, p = .002). There were no statistically significant differences in pacing parameters, electrophysiological and echocardiographic characteristics, or complications between the two groups at implantation and during follow-up. CONCLUSION: TTE-guided LBBP is a feasible and safe method. Compared with X-ray, TTE showed a comparable success rate and procedure time, but it could significantly reduce the fluoroscopy time of LBBP.

Reinterventions and sac dynamics after fenestrated endovascular aortic repair with physician-modified endografts for index aneurysm repair and following proximal failure of prior endovascular aortic repair.

OBJECTIVE: The high frequency of reinterventions after fenestrated endovascular aortic repair (FEVAR) with physician-modified endografts (PMEGs) has been well-studied. However, the impact of prior EVAR on reinterventions and sac behavior following these procedures remains unknown. We analyzed 3-year rates of reinterventions and sac dynamics following PMEG for index aneurysm repair compared with PMEG for prior EVAR with loss of proximal seal. METHODS: We performed a retrospective analysis of 122 consecutive FEVARs with PMEGs at a tertiary care center submitted to the United States Food and Drug Administration in support of an investigational device exemption trial. We excluded patients with aortic dissection (n = 5), type I to III thoracoabdominal aneurysms (n = 13), non-elective procedures (n = 4), and prior aortic surgery other than EVAR (n = 8), for a final cohort of 92 patients. Patients were divided into those who underwent PMEG for index aneurysm repair (primary FEVAR) and those who underwent PMEG for rescue of prior EVAR with loss of proximal seal (secondary FEVAR). The primary outcomes were freedom from reintervention and sac dynamics (regression as ≥5 mm decrease, expansion as ≥5 mm increase, and stability as <5 mm increase or decrease) at 3 years. Secondary outcomes were perioperative mortality and 3-year survival. RESULTS: Of the 92 patients included, 56 (61%) underwent primary FEVAR and 36 (39%) underwent secondary FEVAR. Secondary FEVAR patients were older (78 years [interquartile range (IQR), 74.5-83.5 years] vs 73 years [IQR, 69-78.5 years]; P < .001), more frequently male (86% vs 68%; P = .048), and had larger aneurysms (72.5 mm [IQR, 65.5-81 mm] vs 59 mm [IQR, 55-65 mm]; P < .001). Perioperative mortality was 1.8% for primary FEVAR and 2.7% for secondary FEVAR (P = .75). At 3 years, overall survival was 84% for primary FEVAR and 71% for secondary FEVAR (P = .086). Freedom-from reintervention was significantly higher for primary FEVAR than secondary FEVAR, specifically 82% vs 38% at 3 years (P < .001). Primary FEVAR also had more desirable sac dynamics relative to secondary FEVAR at 3 years (primary: 54% stable, 46% regressed, 0% expanded vs secondary: 33% stable, 28% regressed, and 39% expanded; P = .038). CONCLUSIONS: FEVAR for primary aortic repair and FEVAR for rescue of prior EVAR with loss of proximal seal are two distinct entities. Following primary FEVAR, less than a quarter of patients have undergone reintervention at 3 years, and sac expansion was not seen in our cohort. Comparatively, 3 years after secondary FEVAR, over one-half of patients have undergone reintervention and over one-third have had ongoing sac expansion. Vigilant surveillance and a low threshold for further interventions are crucial following secondary FEVAR.

Comparison of open and endovascular left subclavian artery revascularization for zone 2 thoracic endovascular aortic repair.

OBJECTIVE: In patients undergoing elective thoracic endovascular aortic repair (TEVAR) and left subclavian artery (LSA) coverage, routine preoperative LSA revascularization is recommended. However, in the current endovascular era, the optimal surgical approach is debated. We compared baseline characteristics, procedural details, and perioperative outcomes of patients undergoing open or endovascular LSA revascularization in the setting of TEVAR. METHODS: Adult patients undergoing TEVAR with zone 2 proximal landing and LSA revascularization between 2013 and 2023 were identified in the Vascular Quality Initiative. We excluded patients with traumatic aortic injury, aortic thrombus, or ruptured presentations, and stratified based on revascularization type (open vs any endovascular). Open LSA revascularization included surgical bypass or transposition. Endovascular LSA revascularization included single-branch, fenestration, or parallel stent grafting. Primary outcomes were stroke, spinal cord ischemia (SCI), and perioperative mortality (Pearson's χ2 test). Multivariable logistic regression was used to evaluate associations between revascularization type and primary outcomes. Secondarily, we studied other in-hospital complications and 5-year mortality (Kaplan-Meier, multivariable Cox regression). Sensitivity analyses were performed in patients undergoing concomitant LSA revascularization to TEVAR. RESULTS: Of 2489 patients, 1842 (74%) underwent open and 647 (26%) endovascular LSA revascularization. Demographics and comorbidities were similar between open and endovascular cohorts. Compared with open, endovascular revascularization had shorter procedure times (median, 135 minutes vs 174 minutes; P < .001), longer fluoroscopy times (median, 23 minutes vs 16 minutes; P < .001), lower estimated blood loss (median, 100 mL vs 123 mL; P < .001), and less preoperative spinal drain use (40% vs 49%; P < .001). Patients undergoing endovascular revascularization were more likely to present urgently (24% vs 19%) or emergently (7.4% vs 3.4%) (P < .001). Compared with open, endovascular patients experienced lower stroke rates (2.6% vs 4.8%; P = .026; adjusted odds ratio [aOR], 0.50 [95% confidence interval (CI), 0.25-0.90]), but had comparable SCI (2.9% vs 3.5%; P = .60; aOR, 0.64 [95% CI, 0.31-1.22]) and perioperative mortality (3.1% vs 3.3%; P = .94; aOR, 0.71 [95% CI, 0.34-1.37]). Compared with open, endovascular LSA revascularization had lower rates of overall composite in-hospital complications (20% vs 27%; P < .001; aOR, 0.64 [95% CI, 0.49-0.83]) and shorter overall hospital stay (7 vs 8 days; P < .001). After adjustment, 5-year mortality was similar among groups (adjusted hazard ratio, 0.85; 95% CI, 0.64-1.13). Sensitivity analyses supported the primary analysis with similar outcomes. CONCLUSIONS: In patients undergoing TEVAR starting in zone 2, endovascular LSA revascularization had lower rates of postoperative stroke and overall composite in-hospital complications, but similar SCI, perioperative mortality, and 5-year mortality rates compared with open LSA revascularization. Future comparative studies are needed to evaluate the mid- to long-term safety of endovascular LSA revascularization and assess differences between specific endovascular techniques.

Midterm outcomes of endovascular repair for abdominal aortic aneurysm using the cuff-first technique to prevent type II endoleaks.

OBJECTIVE: The aim of this study was to evaluate the initial and midterm outcomes of endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) using the cuff-first technique (CFT) to prevent type II endoleak (T2EL). METHODS: CFT involves deploying an aortic cuff inside the AAA to cover the ostium of the aortic side branch vessels before deploying the main body. We performed a retrospective review of all patients undergoing EVAR with CFT or side branch embolization (SBE) for AAAs at The Jikei University Hospital between 2016 and 2022. Primary endpoint was the rate of aneurysm sac shrinkage. Secondary endpoints were procedure time, radiation exposure, technical and clinical success rates, occurrence of T2EL, and freedom from reintervention or aneurysm-related death. RESULTS: Of 406 patients who underwent EVAR for AAAs, CFT was utilized in 56 (CFT group) and SBE in 35 (SBE group); all 91 patients were included in this study. There were no differences in patient demographics between groups, but there were differences in patency rate of the inferior mesenteric artery and absent intraluminal thrombus. The technical success rate per target vessel in the CFT and SBE group was 97.8% and 91.8%, and the clinical success rate was 91.0% and 100%, respectively. The median procedure time was shorter for CFT than for SBE: CFT, 10 (interquartile range [IQR], 6-14) minutes vs SBE, 25 (IQR, 18.5-45) minutes; P < .05), and median radiation exposure was lower for CFT than for SBE (CFT, 1455 (IQR, 840-2634) mGy vs SBE, 2353 (IQR, 1552-3586) mGy; P < .05). During the median follow-up of 25 months (IQR, 12.5-47 months), sac shrinkage occurred at similar rates in both groups (CFT, 37.5% vs SBE, 40.0%; P = .812), and there were no differences in freedom from reintervention (CFT, 96.2% and 91.4% at 12 and 36 months vs SBE, 100% and 89.5% at 12 and 36 months; log-rank P = .761) and freedom from aneurysm-related death (100% at 36 months in both groups; log-rank P = .440). The odds ratio of CFT vs SBE for sac regression was calculated by adjusting for inferior mesenteric artery patency and absent intraluminal thrombus, resulting in no statistical significance (odds ratio, 1.231; 95% confidence interval, 0.486-3.122). CONCLUSIONS: CFT is feasible with a shorter procedure time and lower radiation exposure than SBE and comparable mid-term outcomes, including sac shrinkage rate, compared with SBE. We believe that CFT, if anatomically suitable, is an alternative to SBE for the prevention of T2EL during EVAR.

Insufficient Ablation is Associated with Atrial Fibrillation Recurrence after Combining Ablation and Left Atrial Appendage Closure.

Background: The combination of left atrial appendage closure (LAAC) and catheter ablation (CA) in a single procedure is a safe and effective form of treatment for atrial fibrillation (AF). However, several findings have argued that LAAC might increase the risk of AF recurring. Therefore, this study investigated the impact of insufficient ablation on AF recurrence after the hybrid procedures of CA and LAAC. Methods: We reviewed 107 consecutive patients with AF who received the CA and LAAC hybrid procedures (combined group). In the case-control study, another 107 patients who underwent only CA (ablation group) were successfully matched using propensity score matching. After correcting the insufficient ablation, 107 consecutive patients were enrolled prospectively. During the follow-up period, postprocedural 24-hour monitor recordings and a portable electrocardiogram (ECG) monitoring device were used to detect AF recurrence. Transesophageal echocardiography was used to evaluate LAAC. Results: The combined group showed an increase in the risk of AF recurrence after 539.2 ± 304.4 days of follow-up (29.9% vs. 15.9%, p < 0.05). Interestingly, the duration of the procedure was not significantly prolonged when LAAC was added after CA in the combined group, while there was a higher number of ablating attempts, duration of ablation, and additional ablation in the ablation group for both radiofrequency and cryoballoon ablation. After correcting for the insufficient ablation, the corrected group showed a significant decrease in AF recurrence after 420.4 ± 204.8 days of follow-up. Conclusions: Insufficient ablation is common when combining CA and LAAC and may lead to the recurrence of atrial fibrillation. It should be corrected intentionally by sufficient ablation of the pulmonary vein antrum and additional ablation. Clinical Trial Registration: The prospective study is a sub-study of our CAGEDAF study that has already been registered (ChiCTR2000039746).

Joint EANM/EANO/RANO/SNMMI practice guideline/procedure standards for diagnostics and therapy (theranostics) of meningiomas using radiolabeled somatostatin receptor ligands: version 1.0.

PURPOSE: To provide practice guideline/procedure standards for diagnostics and therapy (theranostics) of meningiomas using radiolabeled somatostatin receptor (SSTR) ligands. METHODS: This joint practice guideline/procedure standard was collaboratively developed by the European Association of Nuclear Medicine (EANM), the Society of Nuclear Medicine and Molecular Imaging (SNMMI), the European Association of Neurooncology (EANO), and the PET task force of the Response Assessment in Neurooncology Working Group (PET/RANO). RESULTS: Positron emission tomography (PET) using somatostatin receptor (SSTR) ligands can detect meningioma tissue with high sensitivity and specificity and may provide clinically relevant information beyond that obtained from structural magnetic resonance imaging (MRI) or computed tomography (CT) imaging alone. SSTR-directed PET imaging can be particularly useful for differential diagnosis, delineation of meningioma extent, detection of osseous involvement, and the differentiation between posttherapeutic scar tissue and tumour recurrence. Moreover, SSTR-peptide receptor radionuclide therapy (PRRT) is an emerging investigational treatment approach for meningioma. CONCLUSION: These practice guidelines will define procedure standards for the application of PET imaging in patients with meningiomas and related SSTR-targeted PRRTs in routine practice and clinical trials and will help to harmonize data acquisition and interpretation across centers, facilitate comparability of studies, and to collect larger databases. The current document provides additional information to the evidence-based recommendations from the PET/RANO Working Group regarding the utilization of PET imaging in meningiomas Galldiks (Neuro Oncol. 2017;19(12):1576-87). The information provided should be considered in the context of local conditions and regulations.

Focused ultrasound versus the loop electrosurgical excision procedure to treat women with cervical high-grade squamous intraepithelial lesions under 40: a retrospective study.

BACKGROUND: This study aimed to compare the efficacy of focused ultrasound (FUS) and the loop electrosurgical excision procedure (LEEP) for the treatment of cervical high-grade squamous intraepithelial lesions (HSILs) among women of reproductive age. METHODS: Case records of patients aged < 40 years who were treated for cervical HSILs using either FUS or LEEP from September 1, 2020 to May 31, 2022 were retrospectively reviewed. Patients were followed up for cure, recurrence, human papillomavirus (HPV) clearance, and complications within 1 year of treatment. Odds ratios and 95% confidence intervals were determined using univariate and multivariate logistic regression models to analyze the association between disease evidence or HPV clearance and treatment modalities or other covariates. RESULTS: Of the 1,054 women who underwent FUS or LEEP, 225 met our selection criteria. Among the selected women, 101 and 124 received FUS and LEEP, respectively. There was no significant difference between the FUS and LEEP groups in the cure rate during the 3-6 months of follow-up (89.11% vs. 94.35%, P = 0.085) and recurrence rate during the 6-12 months follow-up (2.22% vs. 1.71%, P = 0.790). Both groups exhibited enhanced cumulative HPV clearance rates; however, the rates were not significantly different between the FUS and LEEP groups (74.23% vs. 82.79%, P = 0.122 during the 3-6 months follow-up; 84.95% vs. 89.17%, P = 0.359 during the 6-12 months follow-up). Furthermore, the incidence of complications caused by the FUS and LEEP techniques was comparable (5.0% vs. 5.6%, P = 0.818). CONCLUSIONS: We found that FUS and LEEP have similar efficacy, safety, and reliability in treating women (aged < 40 years) with HSILs.

Near total head resection of pancreas in patients with chronic pancreatitis - Outcome of a novel surgical technique.

BACKGROUND: Chronic pancreatitis (CP) is characterized by debilitating pain which affects patients' quality of life. Early surgical intervention has been shown to mitigate pain and prevent a decline in quality of life. The present study evaluated the impact of bile duct and duodenum preserving pancreatic head resection (BDPPHR), an innovative technique, on pain relief, functional outcomes, postoperative morbidity, and mortality in patients with CP. METHODS: Between March 2019 and July 2022, a total of 37 patients underwent bile duct and duodenum preserving pancreatic head resection (BDPPHR) for pain relief in patients with CP. Post-operative outcomes were assessed by Izbicki pain score, exocrine insufficiency, endocrine insufficiency, and return to work. The safety of the surgical procedure was determined by evaluation of postoperative morbidity and mortality as per Clavien-Dindo scores. RESULTS: BDPPHR showed a significant reduction in Izbicki pain scores with 30 (81 %) patients experiencing complete or partial pain relief up to 18 months of follow up. 32(86 %) patients ceased narcotic use by the end of the 18-month follow-up period. 33 (89 %) patients were able to resume regular work at the end of 18 months. There were no significant alterations in both exocrine and endocrine statuses post-surgery. The median duration of hospital stay was 4.5 days (3-11). Major complications occurred in 2 (5 %) patients. There was no post-operative mortality. CONCLUSION: BDPPHR is a novel and safe technique of near total head resection which results in very good pain relief in 81 % of patients.

Balloon predilation or direct valve implantation in TAVI for women: Insights from the DIRECTAVI study.

BACKGROUND: The randomized DIRECTAVI trial demonstrated safety and feasibility of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) using SAPIEN 3 balloon-expandable devices. However, the female population with smaller anatomy may have potential higher risk of residual gradient and/or mismatch. PURPOSE: We assessed the impact of BAV on the procedural success rate and clinical outcomes in the female population of the DIRECTAVI trial. METHODS: Between May 2016 and May 2018, 91 of the 250 patients included in the DIRECTAVI trial were women (38.6%), 45 of them (49.5%) were enrolled in the BAV group and 46 of them (50.5%) in the direct TAVI group. The primary endpoint was procedural success rate in women (Valve Academic Research Consortium-2 criteria). The secondary endpoint included evaluation of PPM and 1-month major adverse events according to the implantation stategy in women and comparison between men and women regarding major endpoints. RESULTS: The primary endpoint occurred in 29 women (64.4%) in the BAV group and in 34 women (73.9%) in the direct TAVI group (mean difference 9.47%; 95% confidence interval: 6.5%-25.4%; p = 0.045 for non-inferiority of the direct strategy). One-month major adverse events were similar between the 2 women groups. Procedural success was lower in women vs men (p = 0.01) due to higher incidence of moderate mismatches in women (p = 0.001) but with no significant difference regarding the implantation strategy (p = 0.4). CONCLUSION: Direct implantation of the balloon-expandable SAPIEN 3 valve was non-inferior to predilatation on procedural success in women. Incidence of moderate mismatch was higher in women but was not related to the implantation strategy.

Minimally invasive procedures for right side infective endocarditis: A targeted literature review.

INTRODUCTION: Right-side infective endocarditis (RSIE) is caused by microorganisms and develops into intracardiac and extracardiac complications with high in-hospital and 1-year mortality. Treatments involve antibiotic and surgical intervention. However, those presenting with extremes e.g. heart failure, or septic shock who are not ideal candidates for conventional medical therapy might benefit from minimally invasive procedures. OBJECTIVE: This review summarizes existing observational studies that reported minimally invasive procedures to debulk vegetation due to infective endocarditis either on valve or cardiac implantable electronic devices. METHODS: A targeted literature review was conducted to identify studies published in PubMed/MEDLINE, EMBASE, and Cochrane Central Database from January 1, 2015 to June 5, 2023. The efficacy and/or effectiveness of minimally invasive procedural interventions to debulk vegetation due to RSIE were summarized following PRISMA guidelines. RESULTS: A total of 11 studies with 208 RSIE patients were included. There were 9 studies that assessed the effectiveness of the AngioVac system and 2 assessed the Penumbra system. Overall procedure success rate was 87.9%. Among 8 studies that reported index hospitalization, 4 studies reported no death, while the other 4 studies reported 10 deaths. CONCLUSIONS: This study demonstrates that multiple systems can provide minimally invasive procedure options for patients with RSIE with high procedural success. However, there are mixed results regarding complications and mortality rates. Further large cohort studies or randomized clinical trials are warranted to assess and/or compare the efficacy and safety of these systems.

Eugen Bogdan Aburel, a pioneer of fertility sparing surgery.

Eugen Bogdan Aburel was pioneer of the fertility sparing surgery in early cervical cancer in young women desiring to preserve their childbearing potential. He graduated in Romania but started specializing in obstetrics and gynecology in Paris, where he had the chance to work with the most prominent professors of the time and do research at Sorbonne, the most famous French higher education institution. Most of his discoveries date from the time he spent in Paris hospitals, proving that a good medical school can generate remarkable physicians. The fertility sparing surgery he created after returning to Romania did not have the same chance to be known and spread to the international medical world because of the Cold War isolation, Romania belonging to the Eastern Communist bloc. However, his pioneering work in this field of surgery is fully recognized today.

Robot-assisted nephroureterectomy: surgical and mid-term oncological outcomes in over 1100 patients (ROBUUST 2.0 collaborative group).

OBJECTIVE: To analyse surgical, functional, and mid-term oncological outcomes of robot-assisted nephroureterectomy (RANU) in a contemporary large multi-institutional setting. PATIENTS AND METHODS: Data were retrieved from the ROBotic surgery for Upper tract Urothelial cancer STtudy (ROBUUST) 2.0 database, an international, multicentre registry encompassing data of patients with upper urinary tract urothelial carcinoma undergoing curative surgery between 2015 and 2022. The analysis included all consecutive patients undergoing RANU except those with missing data in predictors. Detailed surgical, pathological, and postoperative functional data were recorded and analysed. Oncological time-to-event outcomes were: recurrence-free survival (RFS), metastasis-free survival (MFS), cancer-specific survival (CSS), and overall survival (OS). Survival analysis was performed using the Kaplan-Meier method, with a 3-year cut-off. A multivariable Cox proportional hazard model was built to evaluate predictors of each oncological outcome. RESULTS: A total of 1118 patients underwent RANU during the study period. The postoperative complications rate was 14.1%; the positive surgical margin rate was 4.7%. A postoperative median (interquartile range) estimated glomerular filtration rate decrease of -13.1 (-27.5 to 0) mL/min/1.73 m2 from baseline was observed. The 3-year RFS was 59% and the 3-year MFS was 76%, with a 3-year OS and CSS of 76% and 88%, respectively. Significant predictors of worse oncological outcomes were bladder-cuff excision, high-grade tumour, pathological T stage ≥3, and nodal involvement. CONCLUSIONS: The present study contributes to the growing body of evidence supporting the increasing adoption of RANU. The procedure consistently offers low surgical morbidity and can provide favourable mid-term oncological outcomes, mirroring those of open NU, even in non-organ-confined disease.

Surgical procedure and recurrence of upper urinary tract stone: a national-wide study based on hospitalized patients.

PURPOSE: This study aimed to investigate the influence of surgical intervention on recurrence risk of upper urinary tract stone and compare the medical burden of various surgical procedures. METHODS: This study analyzed data from patients with upper urinary tract stone extracted from a national database of hospitalized patients in China, from January 2013 to December 2018. Surgical recurrence was defined as patients experience surgical procedures for upper urinary tract stone again with a time interval over 90 days. Associations of surgical procedures with surgical recurrence were evaluated by Cox regression. RESULTS: In total, 556,217 patients with upper urinary tract stone were included in the present analysis. The mean age of the population was 49.9 ± 13.1 years and 64.1% were men. During a median follow-up of 2.7 years (IQR 1.5-4.0 years), 23,012 patients (4.1%) had surgical recurrence with an incidence rate of 14.9 per 1000 person-years. Compared to patients receiving open surgery, ESWL (HR, 1.59; 95% CI 1.49-1.70), URS (HR, 1.38; 95% CI 1.31-1.45), and PCNL (HR, 1.11; 95% CI 1.06-1.18) showed a greater risk for surgical recurrence. Patients receiving ESWL had the shortest hospital stay length and the lowest cost among the 4 procedures. CONCLUSIONS: Compared with open surgery, ESWL, URS, and PCNL are associated with higher risks of surgical recurrence for upper urinary tract stone, while ESWL showed the least medical burden including both expenditure and hospital stay length. How to keep balance of intervention efficacy and medical expenditure is an important issue to be weighed cautiously in clinic practice and studied more in the future.

Quality indicators for appropriate in-hospital pharmacotherapeutic stewardship: An international modified Delphi study.

AIMS: In-hospital prescribing errors may result in patient harm, such as prolonged hospitalisation and hospital (re)admission, and may be an emotional burden for the prescribers and healthcare professionals involved. Despite efforts, in-hospital prescribing errors and related harm still occur, necessitating an innovative approach. We therefore propose a novel approach, in-hospital pharmacotherapeutic stewardship (IPS). The aim of this study was to reach consensus on a set of quality indicators (QIs) as a basis for IPS. METHODS: A three-round modified Delphi procedure was performed. Potential QIs were retrieved from two systematic searches of the literature, in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement. In two written questionnaires and a focus meeting (held between the written questionnaire rounds), potential QIs were appraised by an international, multidisciplinary expert panel composed of members of the European Association for Clinical Pharmacology and Therapeutics (EACPT). RESULTS: The expert panel rated 59 QIs and four general statements, of which 35 QIs were accepted with consensus rates ranging between 79% and 97%. These QIs describe the activities of an IPS programme, the team delivering IPS, the patients eligible for the programme and the outcome measures that should be used to evaluate the care delivered. CONCLUSIONS: A framework of 35 QIs for an IPS programme was systematically developed. These QIs can guide hospitals in setting up a pharmacotherapeutic stewardship programme to reduce in-hospital prescribing errors and improve in-hospital medication safety.