Incidence Of Severe Complications Research Articles

Tolerability of perioperative chemotherapy for gastric cancer in real clinical practice

Background. The choice of the optimal scheme of perioperative chemotherapy of locally advanced gastric cancer is an urgent problem in real clinical practice. Aim. To analyze therapy tolerability in this cohort of patients. Materials and methods. Perioperative chemotherapy of gastric cancer was performed in 90 patients in the Chemotherapy Department of the Oncology Center №1 of the Yudin City Clinical Hospital from January 2021 to February 2024. Results. The incidence of severe complications at the preoperative stage was 41.9% for the FOLFOX regimen and 40.7% for the FLOT regimen, at the adjuvant stage – 17.4 and 43.2%, respectively. Operative treatment was successfully performed in 79 (87.8%) patients, and the full scope of combined treatment of locally advanced gastric cancer was completed in 59 (65%) patients. 80.8% of pathomorphologic responses in the FOLFOX group and 67.9% in the FLOT group were TRG3-4, with complete response noted in only one patient. Conclusion. High toxicity rates in elderly and comorbid patients on the FOLFOX regimen require the development of an individualized approach to the treatment of this group of patients.

Prognostic impact of a 3-week multimodal prehabilitation program on frail elderly patients undergoing elective gastric cancer surgery: a randomized trial.

Research indicates that prehabilitation is effective in optimizing physical status before surgery, although this method may be considered "aggressive" for frail elderly patients. This study aimed to evaluate whether multimodal prehabilitation decreases postoperative complications and improves functional recovery in frail elderly patients undergoing gastric cancer surgery, in comparison to usual clinical care. This study was a single-center, single-blind, randomized controlled trial. Patients over 65 years old with a Fried Frailty Index of 2 or higher, scheduled for gastric cancer surgery, were considered for inclusion. Eligible participants were randomized in a 1:1 ratio to either the intervention or control group. The intervention group underwent a 3-week multimodal prehabilitation program prior to surgery, in addition to perioperative care guided by ERAS protocols. The control group received only the latter. The primary outcome was the comprehensive complications index (CCI) measured at 30 days after surgery. Secondary outcomes included 30-day overall complications, functional walking capacity as assessed by 6-minute walking distance (6MWD) at 4 weeks postoperatively, and 3-month postoperative quality of life. This study was registered at ClinicalTrials.gov (No. NCT06510088). Among the 112 eligible patients, the median age was 74 years, with 58 (52.7%) being female.No between-group difference was found in the primary outcome measure, 30-day CCI. The Median (Q1-Q3) CCI for the intervention and control groups was 0 (0-12.2) and 0 (0-22.6) (P = 0.082), while the mean (SD) CCI was 6.1 (15.8) and 9.8 (12.7), respectively (P = 0.291). Notably, the incidence of severe complications (CCI > 20) was significantly lower in the intervention group compared to the control group (11.1% vs. 25.9%, P = 0.046), particularly in terms of medical complications (12.3% vs. 29.3%, P = 0.025). Preoperatively, 27 patients (47.4%) in the intervention group exhibited an increase in the 6MWD of at least 20m, compared to 16 patients (27.6%) in the control group (P = 0.028). At 4 weeks postoperatively, more patients in the intervention group returned to their baseline 6MWD levels (63.2% vs. 43.1%, P = 0.031). Secondary parameters of functional capacity in the postoperative period generally favored the multimodal prehabilitation approach. In frail elderly patients undergoing elective gastric cancer surgery, a prehabilitation program did not affect the 30-day postoperative complication rate or CCI but reduced severe complications and improved perioperative functional capacity. [ClinicalTrials.gov], [NCT06510088], [07/15/2024], [Retrospectively registered].

Outcomes after revisional surgery for paraesophageal hernias at a high-volume tertiary care center.

Although recurrences after repair of giant paraesophageal hernias (PEH) are common, revisional procedures are challenging and associated with higher complication rates than primary repair. Therefore, repair of recurrent PEH is often avoided except in symptomatic patients. Data describing operative outcomes in these infrequent cases is lacking. Therefore, this study aimed to report and compare peri-operative outcomes of revisional PEH repair to similar patients undergoing primary surgery. A single-institution, retrospective cohort study was conducted on all adult patients undergoing primary repair of Type II-IV PEH and any revisional surgery for recurrent hiatal hernia after previous primary PEH repair (2012-2019). Patient and operative characteristics and post-operative outcomes were extracted from medical records. Patients were grouped into revisional (rPEH) and primary repair (pPEH). Coarsened exact matching was performed to create balanced cohorts. A total of 347 cases were identified. The matched cohort included 234 patients (rPEH: 46, pPEH: 188). Patient sex and comorbidities were well balanced, while those who underwent revisions were younger (64 ± 13 vs. 69 ± 11years; p = 0.01). Median time between primary and rPEH was 40[17-121] months. Incidence of emergency repair were similar among groups (rPEH: 9(15%), pPEH: 14(8%); p = 0.10). All revisional cases commenced laparoscopically with 7(15%) requiring conversion to open. The conversion rate was higher for rPEH than primary surgery (7(15%) vs. 3(2%); p < 0.01), with the most common reasons being adhesions and gastric fundus injury. Intra-operative complications occurred in 12(26%) revisional cases, of which 58% were gastric fundus injuries. Median length of stay was longer for rPEH than pPEH (2[1-5] vs. 1[1-2] day; p = 0.02). Incidence of severe complications (rPEH: 5(11%), pPEH: 11(6%); p = 0.23) and reoperations (rPEH: 2(4%), pPEH: 7(4%); p = 0.84) were similar between groups. There were no peri-operative deaths. In a high-volume tertiary care center, repair of recurrent giant paraesophageal hernias can be performed successfully laparoscopically in the majority of cases with acceptable morbidity and peri-operative outcomes in comparison to primary surgery.

Impact of antenatal corticosteroids-to-delivery interval on very preterm neonatal outcomes: a retrospective study in two tertiary centers in Japan

BackgroundAntenatal corticosteroids (ACS) are administered to prevent neonatal complications and death in women at risk of imminent preterm birth. Internationally, the optimal interval from ACS to delivery (ACS-to-delivery interval) is within seven days; however, evidence in Asian populations specifically is limited. This study aimed to investigate the association between ACS-to-delivery interval and the incidence of neonatal complications in Japan.MethodsThis retrospective observational study enrolled singleton neonates born preterm at < 32 weeks of gestational age between 2012 and 2020 at two tertiary centers. A total of 625 neonates were divided into the following four groups according to the timing of ACS (measured in days): no ACS (n = 145), partial ACS (n = 85), ACS 1–7 (n = 307), and ACS ≥ 8 (n = 88). The following outcomes were compared between the groups: treated respiratory distress syndrome (RDS), severe intraventricular hemorrhage (IVH), treated patent ductus arteriosus (PDA), necrotizing enterocolitis, sepsis, bronchopulmonary dysplasia (BPD), treated retinopathy of prematurity (ROP), periventricular leukomalacia, and death discharge.ResultsThe ACS 1–7 group had significantly decreased adjusted odds ratios (ORs) for treated RDS (0.37 [95% confidence interval: 0.23, 0.57]), severe IVH (0.21 [0.07, 0.63]), treated PDA (0.47 [0.29, 0.75]), and treated ROP (0.50 [0.25, 0.99]) compared with the no ACS group. The ACS ≥ 8 group also showed significantly reduced adjusted ORs for RDS (0.37 [0.20, 0.66]) and treated PDA (0.48 [0.25, 0.91]) compared with the no ACS group. However, the adjusted ORs for BPD significantly increased in both the ACS 1–7 (1.86 [1.06, 3.28]) and ACS ≥ 8 groups (2.94 [1.43, 6.05]) compared to the no ACS group.ConclusionsAn ACS-to-delivery interval of 1–7 days achieved the lowest incidence of several complications in preterm neonates born at < 32 weeks of gestational age. Some of the favorable effects of ACS seem to continue even beyond ≥ 8 days from administration. In contrast, ACS might be associated with an increased incidence of BPD, which was most likely to be prominent in neonates delivered ≥ 8 days after receiving ACS. Based on these findings, the duration of the effect of ACS on neonatal complications should be studied further.

Influence of smoking and socioeconomic status on labor analgesia: a nationwide register-based study in Finland

PurposeLabor pain can be treated by medical and non-medical analgesia. Smoking during pregnancy has been shown to increase the incidence of several complications and may influence analgesic effectiveness. Previous studies have linked socioeconomic status to the use of epidurals for labor analgesia. We aimed to determine whether smoking and socioeconomic status influence the use of labor analgesia in Finland.MethodsFrom January 1, 2004 to December 31, 2018, we collected data from the national Finnish Medical Birth Register on smoking status, labor analgesia, and socioeconomic status during pregnancy. These categorized variables were presented as absolute numbers and percentages. We included data on singleton pregnancies and excluded any data on pregnancies that missed smoking or socioeconomic status.Results71,603 women smoked during the first trimester, 42,079 women continued to smoke after the first trimester, and 641,449 were non-smokers. The four most used labor analgesia were nitrous oxide, epidural, other medical analgesia, and non-medical analgesia. The most frequently used analgesia was nitrous oxide, which was used by 60.8% of the group of smokers after the first trimester, 58.8% of smokers during the first trimester, and 54.5% of non-smokers. There were no substantial differences between socioeconomic status classes and labor analgesia used.ConclusionWomen who continued smoking after the first trimester used labor analgesia more often than non-smokers. There were no clear differences between socioeconomic status classes and labor analgesia used. These findings highlight the need to reduce maternal smoking during pregnancy, and universal social healthcare systems should promote equality in labor analgesia.

The incidence of severe complications in acanthamoeba keratitis: Qualitative and quantitative systematic assessment

Acanthamoeba keratitis (AK) is a rare, sight-threating corneal infection. The disease is challenging to diagnose and treat, and the amoeba can rapidly encyst, persisting in the tissue and causing recurrences. Medical therapy is conventionally considered the first line treatment, but advanced cases could require more invasive treatments like a “chaud” corneal transplant. We review the incidence of severe complications in patients affected by AK. Of 439 reports screened, 158 met our inclusion criteria. Incidence of severe complications was low, with 2.21 % patients developing perforation, 1 % requiring evisceration/enucleation and less than 1 % developing endophthalmitis. Corneal transplantation was required in 16.68 % of the cases. According to our results, and considering the reported incidences of these complications in other infectious keratitis, AK patients have an overall low risk of developing perforation, endophthalmitis, and enucleation/evisceration. Nevertheless, data available in the literature remain poor, and further randomized control trials are needed to confirm our findings.

Severe Periprocedural Complications After Ablation for Atrial Fibrillation: An International Collaborative Individual Patient Data Registry

BackgroundCatheter ablation for atrial fibrillation (AF) including pulmonary vein isolation and possibly further substrate ablation is the most common electrophysiological procedure. Severe complications are uncommon, but their detailed assessment in a large worldwide cohort is lacking. ObjectivesThe aim of this study was to determine the incidence of periprocedural severe complications and to provide a detailed characterization of the diagnostic evaluation and management of these complications in patients undergoing AF ablation. MethodsIndividual patient data were collected from 23 centers worldwide. Limited data were collected for all patients who underwent catheter ablation, and an expanded series of data points were collected for patients who experienced severe complications during periprocedural follow-up. Incidence, predictors, patient characteristics, management details, and overall outcomes of patients who experienced ablation-related complications were investigated. ResultsData were collected from 23 participating centers at which 33,879 procedures were performed (median age 63 years, 30% women, 71% radiofrequency ablations). The incidence of severe complications (n = 271) was low (tamponade 6.8‰, stroke 0.97‰, cardiac arrest 0.41‰, esophageal fistula 0.21‰, and death 0.21‰). Age, female sex, a dilated left atrium, procedure duration, and the use of radiofrequency energy were independently associated with the composite endpoint of all severe complications. Among patients experiencing tamponade, 13% required cardiac surgery. Ninety-three percent of patients with complications were discharged directly home after a median length of stay of 5 days (Q1-Q3: 3-7 days). ConclusionsThis large worldwide collaborative study highlighted that tamponade, stroke, cardiac arrest, esophageal fistula, and death are rare after AF ablation. Older age, female sex, procedure duration, a dilated left atrium, and the use of radiofrequency energy were associated with severe complications in this multinational cohort. One in 8 patients with tamponade required cardiac surgery.

Abstract PO4-22-11: Study to Compare the Safety of Immediate One-stage IBBR With Expander-Implant Two-stage IBBR Augmented With TiLoop® Bra(COSTA)

Abstract Background: The use of TiLOOP@ Bra in implant-based breast reconstruction (IBBR) becomes standard of care in mainland China. But evidence is limited about complication of one-stage and two-stage IBBR using TiLOOP@ Bra. A prospective randomized trial was conducted to compare the safety of immediate IBBR with that of immediate-delayed IBBR, both with TiLOOP@ Bra. Methods: We did an open label, randomized, controlled trial in eleven hospitals in the mainland China. Inclusion criteria: Women aged above 18 with cT0-T2N0M0 breast carcinoma which requires to undergo nipple or skin-sparing mastectomy (NSM or SSM) and immediate IBBR. Randomization was done electronically, stratified per center and in blocks of four of six to achieve approximately balanced groups of patients assigned to undergo one-stage or two-stage IBBR. Both procedures were undergone pectoralis major and TiLOOP@ Bra to build pockets. The primary endpoint of the present study was the incidence of postoperative complications (within 90 days after surgery), while the secondary endpoints were the quality of life at 18 months after surgery, satisfaction with breast appearance, aesthetic scores of reconstructed breasts, type of reoperation and TiLOOP@ Bra angiopathological assessment. This study is registered at clinicaltrials.gov, number NCT03589924. Findings: Between June 2018 and May 2022, a total of 418 eligible patients were randomly assigned to either two-stage implant reconstruction (n=194) group or immediate one-stage implant reconstruction (n=224) group. In terms of surgical procedures, NSM was more commonly (72.7%) chosen, with the two-stage implant reconstruction group having a lower proportion compared to the immediate one-stage implant reconstruction (66.3% vs. 78.3%; p=0.010). At 3 months after breast reconstruction surgery, the incidence of complications was lower in the two-stage implant reconstruction group than that in the immediate one-stage implant reconstruction group, with significant difference of 14.5% vs 23%; p=0.038. The incidence of nipple or areola necrosis was lower in the two-stage implant reconstruction group compared to the immediate one-stage implant reconstruction group, with statistically significant difference of 9.8% vs 17.1%; p=0.048. The implant loss rate was only 0.7%. It was discovered that the incidence of severe complications was lower in the two-stage implant reconstruction group than in the immediate one-stage implant reconstruction group (2.6% vs. 3.7%), and the difference was not statistically significant. Patients who experienced complications had a higher proportion of chemotherapy (69.2% vs. 38.9%; p&amp;lt; 0.001), endocrine therapy (74.4% vs. 53.9%; p=0.002), and targeted therapy (24.4% vs. 9.6%; p=0.001), and the differences were statistically significant. In terms of surgical procedures, 67 (85.9%) patients who experienced complications underwent NSM, while the proportion of NSM in patients who did not experience complications was lower at 69.6%, which were 231 patients, and the difference was statistically significant (p=0.011). In addition, the complication incidence of patients who received implants sizes of 300-400ml was higher than that of the group that did not (32.1% vs. 17.8%; p=0.012). Conclusion: Both one-stage and two-stage TiLOOP@-assisted IBBR demonstrated perioperative safety. The complication rate within three month of two-stage is lower than one-stage. The implant loss rate was only 0.7% perioperatively. Our results suggest that use of TiLOOP@ Bra be considered carefully for one-stage NSM with IBBR but can be considered for SSM patients. Citation Format: Benlong Yang, Jian Liu, Haibo Wang, Yiding Chen, Cuizhi Geng, Nanyan Rao, Siyuan Han, Antai Zhang, Jinping Shi, Qiang Zhang, Wenhe Zhao, Jiong Wu. Study to Compare the Safety of Immediate One-stage IBBR With Expander-Implant Two-stage IBBR Augmented With TiLoop® Bra(COSTA) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-22-11.

Effect of robotic versus open pancreaticoduodenectomy on postoperative length of hospital stay and complications for pancreatic head or periampullary tumours: a multicentre, open-label randomised controlled trial

The flexibility of the robotic system in resection and reconstruction provides potential benefits in pancreaticoduodenectomy. Increasingly, robotic pancreaticoduodenectomy (RPD) has been reported with favourable outcomes, but high-level evidence is still scarce. We aimed to compare the short-term postoperative outcomes of RPD with those of open pancreaticoduodenectomy (OPD), and hypothesised that postoperative length of hospital stay would be shorter after RPD than after OPD. This multicentre, open-label randomised controlled trial was conducted at three high-volume hospitals in China. Patients were considered for participation in this trial if they were aged 18-75 years, had a resectable benign, premalignant, or malignant tumour in the pancreatic head or periampullary region; and were suitable for both RPD and OPD. Patients with distant metastases were excluded. Block randomisation was done with random block sizes of four, stratified by centre. Allocation was concealed via individual, sequentially numbered, opaque sealed envelopes. Eligible patients were randomly assigned to the RPD group or the OPD group in a 1:1 ratio by a masked research assistant. Surgeons and patients were not masked to trial group, but data collectors, postoperative outcome assessors, and data analysts were. All patients underwent RPD or OPD according to previously reported techniques. Participating surgeons had surpassed the learning curves of at least 40 RPD and 60 OPD procedures. The primary outcome was postoperative length of hospital stay, which was analysed in the modified intention-to-treat (mITT) population. This trial is registered with the Chinese Clinical Trial Registry (ChiCTR2200056809) and is complete. Between March 5 and Dec 20, 2022, 292 patients were screened for eligibility, of whom 164 were enrolled and randomly assigned to the RPD group (n=82) or the OPD group (n=82). 161 patients who underwent surgical resection were included in the mITT analysis (81 in the RPD group and 80 in the OPD group). 94 (58%) participants were male and 67 (42%) were female. Postoperative length of hospital stay was significantly shorter in the RPD group than in the OPD group (median 11·0 days [IQR 9·0 to 19·5] vs 13·5 days [11·5 to 18·0]; median difference -2·0 [95% CI -4·0 to 0·0]; p=0·029). During a follow-up period of 90 days, six (7%) of 81 patients in the RPD group and five (6%) of 80 patients in the OPD group required readmission. Reasons for readmission were intra-abdominal haemorrhage (one in each group), vomiting (two in the RPD group and one in the OPD group), electrolyte disturbance (one in each group), and fever (two in each group). There were two (1%) in-hospital deaths within 90 days of surgery, one in each group. The postoperative 90-day mortality rate (difference -0·02% [-5·6 to 5·5]; p=1·00) and the incidence of severe complications (ie, Clavien-Dindo grade ≥3; difference -1·5% [-14·5 to 11·4]; p=0·82) were similar between the two groups. For surgeons who had passed the learning curve, RPD was safe and feasible with the advantage of shorter postoperative length of hospital stay than OPD. Future research should focus on the medium-term and long-term outcomes between RPD and OPD. None.

USE OF REPOURPOSED DRUGS LOSARTAN AND IVERMECTIN IN PATIENTS WITH CANCER FOR PREVENTION OF COVID-19 SERIOUS EVENTS DURING PANDEMIC. A randomized, double-blind, placebo-controlled phase II study.

Introduction: Cancer patients are at higher risk of COVID-19 severe complications and also demonstrated a lower antibodies conversion after vaccination. Therefore, therapeutic approaches after COVID-19 infection are needed in this population. Repurposing drugs has emerged as an appealing strategy during pandemic, and drugs such as angiotensin 2 antagonists and ivermectin may have a role against COVID-19. Objective: This trial evaluated losartan plus ivermectin aimed at decreasing the incidence of severe outcomes due to coronavirus infection among cancer patients. Methods: This was a randomized, double-blind, and placebo-controlled phase II study. Cancer patients with recent diagnosis of mild to moderate COVID-19 were randomized to receive 50 mg of losartan for 15 days plus a single dose of 12 mg of ivermectin or placebo. The primary endpoint was the incidence of severe complications, defined as a need for admission to the intensive care unit (ICU), need for mechanical ventilation (MV), or death. Secondary endpoints were safety and adherence. Results: Thirty-five patients were randomized to intervention arm and 34 to placebo arm. Seven (20%) patients in the losartan + ivermectin arm experienced severe outcomes versus 8 (23.5%) patients in the placebo arm (p = 1.00). No difference was observed in the need for intensive care unit (17.1% versus 17.6%; p = 1.00) or in the need for mechanical ventilation (17.1% versus 11.8%; p = 0.73). Four patients died in the losartan + ivermectin arm, while 3 in the placebo arm (11.4% versus 8.8%; p = 1.00). Severe adverse events and adherence were similar between groups. Conclusions and Relevance: The combination of losartan and ivermectin did not improve severe COVID-19 outcomes among cancer patients. This is the first study registered on ClinicalTrials.gov that evaluates active treatment for COVID-19 exclusively for cancer patients. and more studies should be performed for a more aggressive approach in this high-risk population.

Safety of the stent-based diverting technique after low anterior resection in patients with rectal cancer

&lt;p&gt;Given that anastomotic leakage (AL) is a severe complication of low anterior resection (LAR) for rectal cancer, ileostomy is the most common method for reducing the severity of AL, which in turn has stoma-related side effects. A self-developed technique named the stent-based diverting technique (SDT) not only protects the anastomosis but also avoids the stoma. From December 2021 to March 2023, 80 patients were randomized into the ileostomy arm (n = 43) or the SDT arm (n = 37). Demographic characteristics, laboratory test results, surgical outcomes, and oncological features were compared between the groups. For the primary endpoint, the incidence of severe complications was 14.0% in the ileostomy arm and 8.1% in the SDT arm (relative risk=0.58, 95% confidence interval=0.156-2.163, p=0.494). For the second endpoint, the incidences of mild and total complications were comparable. The shorter the hospital stay, the lower the cost and quality of life, which could be improved by the SDT procedure. This prospective randomized clinical trial preliminarily evaluated the usefulness of SDT after LAR for patients with rectal cancer, suggesting that SDT might be an alternative operation for patients who need to receive ileostomy after rectal surgery.&lt;/p&gt;

Trophic ulcers of venous etiology and their treatment tactics by endovasal laser coagulation

The main goal of the study was to identify a unified and pathogenetically justified method of surgical treatment of patients with trophic ulcers of venous etiology, as well as an algorithm for preoperative preparation of such patients for minimally invasive intervention. The article presents the results of the treatment of trophic ulcers of venous etiology by endovenous laser coagulation. In a comparative aspect, modern data on its effectiveness are presented, the success of this operation is 93–100 %. When comparing the results of using lasers with different wavelengths and energies, the incidence of severe complications (deep vein thrombosis, thrombophlebitis, pulmonary embolism, skin burn) ranges from 0.1 to 2.4 %. In the analysis of the literature, no evidence was found that the wavelength affects the clinical outcome, but the power of the laser energy used matters. The main elements of preparation and performance of operative interventions aimed at elimination of venous blood reflux in lower extremities are indicated, and therapeutic tactics for healing of soft tissue defect in postoperative period are determined.

Second free jejunum transfer after flap loss does not affect oral intake: A retrospective case-control study

Free jejunum transfer is one of the standard procedures for restoring oral intake after total pharyngo-laryngo-esophagectomy. Flap loss leading to a second free jejunum transfer rarely occurs. This study investigated the impact of a second free jejunum transfer on post-operative oral intake. A retrospective review was conducted on patients who underwent a first free jejunum transfer between July 1998 and December 2019. A total of 367 patients were included in the study. Among them, 17 patients who underwent a second free jejunum transfer because necrosis constituted the second free jejunum transfer group, whereas 350 patients who did not require a second free jejunum transfer formed the first free jejunum transfer group. The incidence of dysphagia requiring tube feeding and post-operative complications was compared between the two groups. Moreover, risk factors for dysphagia and complications were estimated. There were no statistically significant differences in the incidence of dysphagia post-operation between the two groups. A second free jejunum transfer was a statistically significant factor for complications at 2- and 6-months post-operation; however, there were no significant differences in complication rates at the 12-month follow-up. Furthermore, there were no significant differences in the incidence of severe complications between the two groups. Although a second free jejunum transfer increases early complications, it is not associated with major complications and does not negatively impact oral intake. These findings support the conclusion that free jejunum transfer is safe and helps maintain post-operative quality of life.

Open or Not Open the Retroperitoneum: A Pandora's Box for Blunt High-Grade Pancreatic Trauma?

IntroductionThe optimal management strategy for pancreatic trauma remains unclear. We aimed to determine whether the initial nonoperative management (NOM) strategy based on percutaneous drainage combined with endoscopic retrograde cholangiopancreatography guided stent placement would improve outcomes for blunt high-grade pancreatic trauma. MethodsPatients with blunt abdominal trauma who were hemodynamically stable without signs of diffuse peritonitis were consecutively enrolled at a high-volume center. The primary outcome was the occurrence of severe complications (Clavien‒Dindo classification ≥ Ⅲb) for patients who underwent initial laparotomy (LAP) versus NOM. Modified Poisson regression was used to model the primary outcome. Propensity score matching and weighting models were included into a regression-based sensitivity analysis. ResultsOf 119 patients with grade III/IV pancreatic trauma, 29 patients underwent initial NOM, and 90 underwent initial LAP. The incidence of severe complications in the LAP group was higher than that in the NOM group (65/90 [72.2%] versus 9/29 [31.0%], P < 0.001). In the multivariable modified Poisson regression model, the relative risk for severe complications was decreased in the NOM group (relative risk, 0.52; 95% confidence interval, 0.30-0.90; P = 0.020). The results of the sensitivity analysis were consistent with those of the multivariable analysis. The mean number of reinterventions per patient was 1.8 in the NOM group and 2.6 in the LAP group (P = 0.067). ConclusionsFor blunt high-grade pancreatic trauma patients with stable hemodynamics and no diffuse peritonitis, the NOM strategy was associated with a lower risk of severe complications (Clavien‒Dindo classification ≥ Ⅲb) and did not require more invasive reintervention procedures. In high-volume centers with sufficient expertise, percutaneous drainage combined with endoscopic retrograde cholangiopancreatography guided stent placement may serve as an initial reasonable option for selected patients.

Retrospective study of propionic acidemia using natural language processing in Mayo Clinic electronic health record data

BackgroundPropionic acidemia (PA) is a rare autosomal recessive organic acidemia that classically presents within the first days of life with a metabolic crisis or via newborn screening and is confirmed with laboratory tests. Limited data exist on the natural history of patients with PA describing presentation, treatments, and clinical outcomes. ObjectiveTo retrospectively describe the natural history of patients with PA in a clinical setting from a real-world database using both structured and unstructured electronic health record (EHR) data using novel data extraction techniques in a unique care setting. Design/MethodsThis retrospective study used EHR data to identify patients with PA seen at the Mayo Clinic. Unstructured clinical text (medical notes, pathology reports) were analyzed using augmented curation natural language processing models to enhance analysis of data extracted by structured data fields (International Classification of Diseases 9th or 10th revision [ICD-9/−10] codes, Current Procedural Terminology [CPT] codes, and medication orders). De-identified health records were also manually reviewed by clinical scientists to ensure data accuracy and completeness. The index date was defined as the patient's date of PA diagnosis at the Mayo Clinic. Results were reported as aggregate descriptive statistics relative to patients' index dates. Complications, therapeutic interventions, laboratory tests, procedures, and hospitalization encounters related to PA were described at and within 6 months of the patient's index date, and from medical history available before the index date. ResultsIn total, 13 patients with PA were identified, with visits occurring from 1998 to 2022. Age at diagnosis ranged from birth to 3 years; age at initial evaluation at the Mayo Clinic ranged from 3 days to 28 years. The mean number of Mayo Clinic outpatient visits was 31 (median duration of care, 2 years). PA-related complications were documented in 85% of patients and included nutritional difficulties (46%), metabolic decompensation events (MDEs; 38%), neurologic abnormalities (38%), and cardiomyopathy (7%). One pair of affected siblings had mild symptoms and no complications or MDEs. All 5 patients with a history of MDEs presented with developmental delays. Among patients with MDEs, the mean frequency of outpatient clinical care visits was 10 per year, and 3 patients required inpatient hospitalization (mean duration, 16 days). The incidence of severe complications was higher among patients with MDEs than those without MDEs. Of the patients with MDEs, 2 experienced crises while receiving treatment at the Mayo Clinic, with 9 total MDEs occurring between the 2 patients. Symptoms at presentation included hyperammonemia (78%), fever and/or decreased nutritional intake (67%), hyperglycemia/hypoglycemia (56%), intercurrent upper respiratory infection and/or lethargy (44%), constipation (33%), altered mental status (33%), and cough (33%). ConclusionsThis study highlights the range and frequency of clinical outcomes experienced by patients with PA and demonstrates the clinical burden of MDEs.

Prospective minimally invasive pancreatic resections from the IGOMIPS registry: a snapshot of daily practice in Italy on 1191 between 2019 and 2022

This retrospective analysis of the prospective IGOMIPS registry reports on 1191 minimally invasive pancreatic resections (MIPR) performed in Italy between 2019 and 2022, including 668 distal pancreatectomies (DP) (55.7%), 435 pancreatoduodenectomies (PD) (36.3%), 44 total pancreatectomies (3.7%), 36 tumor enucleations (3.0%), and 8 central pancreatectomies (0.7%). Spleen-preserving DP was performed in 109 patients (16.3%). Overall incidence of severe complications (Clavien–Dindo ≥ 3) was 17.6% with a 90-day mortality of 1.9%. This registry analysis provided some important information. First, robotic assistance was preferred for all MIPR but DP with splenectomy. Second, robotic assistance reduced conversion to open surgery and blood loss in comparison to laparoscopy. Robotic PD was also associated with lower incidence of severe postoperative complications and a trend toward lower mortality. Fourth, the annual cut-off of ≥ 20 MIPR and ≥ 20 MIPD improved selected outcome measures. Fifth, most MIPR were performed by a single surgeon. Sixth, only two-thirds of the centers performed spleen-preserving DP. Seventh, DP with splenectomy was associated with higher conversion rate when compared to spleen-preserving DP. Eighth, the use of pancreatojejunostomy was the prevalent reconstruction in PD. Ninth, final histology was similar for MIPR performed at high- and low-volume centers, but neoadjuvant chemotherapy was used more frequently at high-volume centers. Finally, this registry analysis raises important concerns about the reliability of R1 assessment underscoring the importance of standardized pathology of pancreatic specimens. In conclusion, MIPR can be safely implemented on a national scale. Further analyses are required to understand nuances of implementation of MIPR in Italy.

Can modified frailty index predict postoperative complication after lung cancer surgery?

The impact of the modified frailty index (mFI) on postoperative complications after lung cancer surgery was investigated. Patients who underwent lung cancer surgery in 2017 were included. 30-day postoperative mortality and morbidity were evaluated according to their Clavien-Dindo classification. mFI values are presented as the sum of values of 11 included items. Logistic regression was used to assess the effect of mFI on postoperative severe complication incidence. Among 190 patients considered, severe postoperative complications (Grade 3 or more) were observed in 30 (16%). No patients died within 30days of surgery. The incidence of severe complications was 3.6% in patients with mFI of 0, 16.2% in patients with mFI of 1, 23.4% in patients with mFI of 2, and 31.6% in patients with mFI of 3 or more, and was correlated with the grade of mFI. Univariate and multivariate analyses showed that the high mFI was significantly predictive of postoperative complications. Frail patients of mFI ≥ 2 were at 3.0-fold greater risk of severe complications than non-frail patients of mFI 0 or 1. mFI was associated with morbidity after lung cancer surgery. Preoperative frailty assessment and appropriate intervention to frail patients would be required to improve postoperative outcomes.

Use of the MynxGrip vascular closure device in patients undergoing interventional diagnosis or treatment: The PANDA multicenter, open-label, randomized controlled trial.

MynxGrip is a non-suture, balloon catheter- and extravascular sealant-based vascular closure device designed to help hemostasis after an arterial puncture. This study evaluated the efficacy and safety of MynxGrip versus manual compression for femoral artery access closure in patients undergoing diagnostic or interventional procedures. The PANDA multicenter, parallel-group, open-label, randomized controlled trial enrolled patients undergoing a diagnostic or interventional procedure through femoral artery access between April 2019 and September 2020 at six centers in China. The participants were randomized 2:1 to the MynxGrip group and the manual compression group. Time to hemostasis and incidence of severe complications were the primary efficacy and safety endpoints, respectively. A total of 304 consecutive participants were included. The baseline characteristics were similarly distributed in the MynxGrip (n = 203) versus manual compression (n = 101) groups. Compared with the manual compression group, the median time to hemostasis and time to ambulation were significantly shorter (3.0 (interquartile range: 2.0, 4.0) vs 18.0 (11.0, 22.0) min, and 479.0 (275.0, 932.0) vs 1410.3 (1121.0, 1476.0) min, respectively; both p = 0.0001) in the MynxGrip group, with similar procedural success rate, and without severe complications in either group. The incidence of device-related adverse events was 11.8% in the MynxGrip group, most possibly or definitely unrelated. Compared with manual compression, the MynxGrip vascular closure device significantly shortens the times to hemostasis and ambulation without severe complications after diagnostic or interventional procedures through the femoral artery access.

Feasibility and learning curve for robotic surgery in a small hospital: A retrospective cohort study.

Robotic surgery rates, typified by the use of the da Vinci Surgical System, have increased in recent years. However, robotic surgery is mostly performed in large hospitals and has not been fully implemented in small hospitals. Therefore, we aimed to verify the feasibility of robotic surgery in small hospitals and verify the number of cases in which perioperative preparation for robotic surgery is stable by creating a learning curve in small hospitals. Forty robot-assisted rectal cancer surgeries performed in large and small hospitals by a surgeon with extensive experience in robotic surgery were validated. Draping and docking times were recorded as perioperative preparation times. Unexpected surgical interruptions, intraoperative adverse events, conversion to laparoscopic or open surgery, and postoperative complications were recorded. Cumulative sum analysis was used to derive the learning curve for perioperative preparation time. Draping times were significantly longer in the small hospital group (7 vs 10 minutes, P = .0002), while docking times were not significantly different (12 vs 13 minutes, P = .098). Surgical interruptions, intraoperative adverse events, and conversions were not observed in either group. There were no significant differences in the incidence of severe complications (25% [5/20] vs 5% [1/20], P = .184). In the small hospital group, phase I of the draping learning curve was completed in 4 cases, while phase I of the docking learning curve was completed in 7 cases. Robotic surgery is feasible for small hospitals, and the preoperative preparation time required for robotic surgery stabilizes relatively early.

Severe complications after pulmonary vein isolation for atrial fibrillation: a worldwide collaborative registry

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): Swiss Heart Foundation Background Pulmonary vein isolation (PVI) is the most commonly performed electrophysiological procedure. Severe complications such as tamponade, stroke, cardiac arrest and death are believed to be uncommon but detailed assessment of these complications in very large worldwide cohorts is lacking. Purpose To investigate the incidence, predictors, patient characteristics, management details and outcome of severe complications (cardiac tamponade, stroke, cardiac arrest, death) after PVI in a large worldwide collaborative registry with comprehensive patient-level data. Methods We contacted electrophysiologists from an established PVI-collaborative network and invited further center to participate, thereby gathering individual patient-data from 23 centers worldwide. Few datapoints were collected for the overall patients and exhaustive details were entered in a dedicated database for patients experiencing a severe complication. Results From the 23 participating centers a total of 33,889 procedures could be collected (median age 63 y.o., 30% female, 27% cryoballoon ablations). The incidence of severe complications was low (tamponade 0.7% (7/1000 PVIs), stroke 0.089% (&amp;lt;1/1000 PVIs) or cardiac arrest (0.035%, &amp;lt;1/1000PVIs)), and death was extremely rare (1.18/10,000 PVIs), Figure panel A). Female sex (OR 1.7 95%-CI [1.3-2.2], p&amp;lt;0.001), a dilated left atrium (OR 1.9 95%-CI [1.4-2.8], p&amp;lt;0.001) and the use of radiofrequency (OR 1.8 95%-CI [1.3-2.7], p=0.002) appeared as strong predictors for the composite endpoint of all severe complications (Figure panel B). Critical steps during the ablation were transseptal puncture and energy delivery and 14% of all tamponades led to procedure abortion (Figure panel C). Among the patients experiencing a tamponade, 13% required cardiac surgery and perforations were predominantly found in the left atrial appendage and in the PVs during surgery (Figure panel D). Patient outcomes despite a severe complication were good with 93% of patients discharged directly home after a median length of stay of 5 days (IQR 3-7). Conclusion This very large worldwide collaborative study highlighted that tamponade, stroke, cardiac arrest or death are rare after PVI. Female sex and the use of radiofrequency catheters were associated with a higher risk of severe complications. A non-negligible percentage of patients required cardiac surgery after tamponade, where a perforation was most commonly found in the left atrial appendage and PVs.