Complication Classification System Research Articles

Case Volume Is Not Associated With Outcomes After Adrenalectomy Performed by Urologic Surgeons.

Our goal was to compare outcomes of adrenalectomy performed by low-volume and high-volume academic urologists with extensive experience in renal surgery. A single-center retrospective review identified patients undergoing adrenalectomy by urologists from 2009 to 2023. Data were gathered on demographics, tumor characteristics, surgeon volume, surgical outcomes including length of procedure, estimated blood loss, length of stay, and complications identified by the Clavien-Dindo complication classification system. Bivariable and multivariable analyses adjusting for BMI, size of mass, age, and surgical approach compared outcomes between low- and high-volume adrenalectomy surgeons. A total of 304 adrenalectomies were performed by 7 urologic surgeons during the study period. One surgeon was high volume, with an average of 15 adrenalectomies per year during the study period. The remaining 6 surgeons ranged from < 1 to 4 adrenalectomies per year on average during the study period and were considered low volume. On multivariable analysis, the rate of any complication was found to be significantly different between the groups (5.3% vs 13.5%, P = .01). However, on analysis of Clavien 3 or higher complications, the rate was not found to be different (1% vs 4%, P = .22). Procedure time (130 vs 134 minutes, P = .33), estimated blood loss (30 vs 50 mL, P = .86), positive margin rate (11% vs 7%, P = .35), and length of stay (2 days vs 2 days, P = .22) were not different when the surgery was performed by a high-volume or low-volume urologist. Surgical volume may not affect outcomes of adrenalectomy when performed by urologists experienced in retroperitoneal surgery at a high-volume, specialized center.

Effects of sarcopenia and nutritional status on surgical outcomes for metastatic spinal tumors: In the perspective of peri-operative complications and performance improvement.

With the advancement of cancer treatment, appropriate treatment for musculoskeletal problems is becoming more important as it extends the patient's lifespan and improves the quality of life. In surgical treatment for metastatic spine tumors (MST), various efforts are being considered to obtain a good prognosis. The purposes of this study are to analyze prognostic factors for postoperative ambulation and perioperative complications in patients surgically treated for MST with neurologic symptoms. Seventy five cases of patients who underwent surgery for MST with neurologic symptoms were enrolled between December 2016 and January 2023. Postoperative ambulatory function and medical complications were assessed for each patient in this study. The endpoint of ambulatory function was defined as the best function among entire periods of follow-up outpatient visits. We defined the improvement of ambulatory function as improvement in Eastern Cooperative Oncology Group (ECOG) scale. For complications, we applied complication classification system for orthopaedic surgery. Perioperative complications were defined as those requiring changes of treatment compared with routine postoperative treatment during patient's admission. Confirmed complications included expire, delirium, urinary tract infection (UTI), pneumonia, sepsis, bacteremia, acute kidney injury (AKI), chylothorax. Prognostic factors were collected and analyzed for relationship by logistic regression. Of the 75 cases, postoperatively 42 (56%) cases of patients were improved in Nurick grade, 36 (48%) cases of patients in ECOG performance. And 21 (28%) cases of patients were treated in intensive care unit (ICU) and 15 (20%) cases of patients suffered from major perioperative complications. Regression analysis showed that clinical factors such as ECOG, psoas muscle index (PMI) and prognostic nutritional index (PNI) were related to the improvement of ambulatory function and incidence of perioperative complications. On multivariate analysis, improvement of ambulatory function was associated with PMI (p = 0.014) and incidence of perioperative complications was associated with PNI (p = 0.045). Preoperative nutritional status and sarcopenia are related factors in the outcome of surgical treatment for MST, and preoperative efforts to improve these may be a way to obtain better clinical results.

Classification and Treatment of Complications Related to Titanium and Biodegradable Miniplates Using the Lip-Split Transmandibular Approach for Oral and Oropharyngeal Oncological Surgery.

There is a lack of classified definitions and corresponding treatment principles for complications related to titanium miniplate (TMP) and biodegradable miniplate (BMP). This study proposes a classification system for complications related to TMP and BMP osteosynthesis and evaluates the effectiveness of the classification system in the treatment of the complications. One hundred forty-two patients with advanced-stage oral cavity and oropharynx squamous cell carcinoma (SCC) underwent oncological surgery via lip-split transmandibular (LTM) approach including midline, paramedian, stair-step, and triangle. 54.9% of patients were treated with TMP, and 45.1% were treated with BMP for osteosynthesis. The classification of complications is divided into grades 0, 1, 2, and 3. Grade 0 is defined as having no complications. The evaluation criteria for treating complications were significant improvement, partial improvement, and no improvement. All patients underwent en bloc resection of the tumor with histologically negative margins via the LTM approach. The overall success rate of the flap is 98.6%. 25.3%, 48.6%, 14.8%, and 11.3% of patients were treated with midline, paramedian, stair-step, and triangular osteotomy approaches, respectively. A significant increase in the number of paramedian osteotomies was observed compared with other types of osteotomy (P < 0.05). Grades 0, 1, 2, and 3 developed in 54.2%, 12.0%, 14.8%, and 19.0% of patients, respectively. No significant differences in the grade of complications were observed between the TMP group and the BMP group. Sixty-five patients with complications, grades 1, 2, and 3 occurred in 26.2%, 32.3%, and 41.5% of patients. The midline, paramedian, stair-step, and triangle osteotomy approaches were used in 26.1%, 47.7%, and 10.8%, respectively. The incidence of complications in the paramedian osteotomy was significantly higher than that in the other osteotomy (P < 0.05). 83.1% of patients showed significant improvement, 10.8% showed partial improvement, and 6.1% showed no improvement. No significant differences in the treatment outcomes were observed between the TMP group and the BMP group. The incidence of complications in paramedian osteotomy is also significantly higher than 3 types of osteotomy, and 83.1% of patients showed significant improvement in complications. The complication classification system related to TMP and BMP osteosynthesis are easy to implement and feasible in clinical practice.

Complications of Laparoscopic and Open Donor Hepatectomy for Living Donor Liver Transplantation: Single Center Experience.

Donor hepatectomy is a major surgery with a relatively safeprofile anda reportedcomplication rate of ~20%. Most complications are non-life threatening and are resolved with conservative measures. However, rare complications may need invasive precautions, ranging from percutaneous interventions to surgeries. We retrospectively analyzed all living donor hepatectomies at our center. Donors were divided into 2 groups: laparoscopic and open procedures. We collected preoperative, intraoperative and postoperative data of donors.Donor complications were recorded separately intraoperatively and postoperatively according to the Clavien-Dindo postoperative complication classification system. Between July 2018 and April 2023, 215 living donors had hepatectomies, including 48 laparoscopic and 167 open donor hepatectomies. Among donors, 91 were female donors (42.3%) and 124 were male donors (57.7%).The meanage of alldonorswas 33.5±8.1 years, and the mean body mass index (in kilogram divided by meters squared) was 24.6 ± 3.8. Among donors, 124 underwent right and 91 underwent left or left lateral hepatectomies. The mean operative time for all donors was 301 ± 83 minutes, the mean hospital stay was 5.8 ± 1.4 days, and the mean follow-up was 31.9 ± 15.8 months. Four patients (1.8%) had intraoperative complications, including 2 cases of bleeding, 1 diaphragm perforation, and 1 portal vein stenosis. Fourteen patients (7.4%) had major postoperative complications, with 5 patients requiring surgical intervention. Donor hepatectomy is a complicated surgery that requires extensive preoperative preparation and appropriate donor selection. Postoperative donor complications can be diagnosed early with close follow-up, and a multidisciplinary approach is essential for complication management.

Two AIS Cases, 2 Surgeons, 1 Operating Room, 1 Day: Faster and Safer Than 1 Case in a Day.

To lessen surgical times for patients with adolescent idiopathic scoliosis (AIS) undergoing posterior spinal instrumentation and fusion (PSIF), our department developed a quality improvement initiative where 2 AIS cases were completed in 1 day by the same 2 surgeons operating together in 1 operating room (OR). We describe the results of this initiative, comparing operative times and outcomes to cases of these surgeons operating individually. From 2017 to 2023, patients aged 10 to 18 years with AIS undergoing PSIF were prospectively enrolled for "Two Spine Tuesday." Patients were matched by age, sex, curve severity, and number of levels fused to historical AIS controls. Outcomes included surgery time, total OR time, estimated blood loss (EBL), volume of cell saver transfused, allogenic blood transfusion, length of stay, 90-day readmissions, Clavien-Dindo-Sink Complication Classification System complication rates, and percentage who achieved the minimal clinically important difference (MCID) for SRS-22. Fifty-five patients composing the 2-spine group (group 2) were compared with 55 historical sex-matched and age-matched controls (group 1). Major coronal curve and average number of levels fused were similar between groups. Overall surgery time (203 vs. 296min, P <0.001), total OR time ( P <0.001), and EBL (400 vs. 550mL, P <0.001) were lower for group 2. Group 2 had fewer complications [n=17 (31%) vs. n=28 (51%), P =0.03]. Performing 2 AIS cases in 1 OR by 2 surgeons the same day resulted in shorter surgery times, less total time in the operating room, lower complication rates, and less blood loss compared with single-surgeon matched controls. Level III-retrospective comparative study.

Efficiency of Orthopaedic Audits in a Level-1 Trauma Centre Using a Modified Clavien–Dindo Complications Classification

Background: Complications are an inevitable part of orthopaedic surgery, and how one defines complications can have an impact on the ability to learn from them. There have been issues with a commonly used classification system first outlined by Clavien and Dindo. Our aim was to evaluate a modification of this classification system developed for use in our department, with our hypothesis being that this could make our audit presentations more efficient. Methods: A modified Clavien–Dindo Classification was prospectively applied to all complications recorded in the orthopaedic departmental audits at our institution for a 12-month period. The audit discussion was recorded and analysed and compared with the complication audits for the preceding 12-month period. Results: We analysed eight audit presentations before and eight audit presentations after the introduction of a modified Clavien–Dindo classification to our orthopaedic complications over a 2-year period. The number of PowerPoint™ slides (103 vs. 84, p = 0.03) and the time spent on each presentation (88 vs. 71 min, p = 0.02) decreased significantly with the introduction of the modified classification. The novel system was found to have high inter-observer reliability. Conclusions: The modified Clavien–Dindo classification system is a reproducible classification system for orthopaedic complications. It made our audit presentations more efficient.

International Classification System for Ocular Complications of Anti-VEGF Agents in Clinical Trials

Complications associated with intravitreal anti-VEGF therapies are reported inconsistently in the literature, thus limiting an accurate evaluation and comparison of safety between studies. This study aimed to develop a standardized classification system for anti-VEGF ocular complications using the Delphi consensus process. Systematic review and Delphi consensus process. Twenty-five international retinal specialists participated in the Delphi consensus survey. A systematic literature search was conducted to identify complications of intravitreal anti-VEGF agent administration based on randomized controlled trials (RCTs) of anti-VEGF therapy. A comprehensive list of complications was derived from these studies, and this list was subjected to iterative Delphi consensus surveys involving international retinal specialists who voted on inclusion, exclusion, rephrasing, and addition of complications. Furthermore, surveys determined specifiers for the selected complications. This iterative process helped to refine the final classification system. The proportion of retinal specialists who choose to include or exclude complications associated with anti-VEGF administration. After screening 18 229 articles, 130 complications were categorized from 145 included RCTs. Participant consensus via the Delphi method resulted in the inclusion of 91 complications (70%) after 3 rounds. After incorporating further modifications made based on participant suggestions, such as rewording certain phrases and combining similar terms, 24 redundant complications were removed, leaving a total of 67 complications (52%) in the final list. A total of 14 complications (11%) met exclusion thresholds and were eliminated by participants across both rounds. All other remaining complications not meeting inclusion or exclusion thresholds also were excluded from the final classification system after the Delphi process terminated. In addition, 47 of 75 proposed complication specifiers (63%) were included based on participant agreement. Using the Delphi consensus process, a comprehensive, standardized classification system consisting of 67 ocular complications and 47 unique specifiers was established for intravitreal anti-VEGF agents in clinical trials. The adoption of this system in future trials could improve consistency and quality of adverse event reporting, potentially facilitating more accurate risk-benefit analyses. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Prognostic factors for overall survival and safety of trans-arterial chemoembolization (TACE) with irinotecan-loaded drug-eluting beads (DEBIRI) in patients with colorectal liver metastases.

Transarterial chemoembolisation with irinotecan-loaded drug-eluting beads (DEBIRI TACE) can be considered in patients with unresectable colorectal cancer liver metastases (CRLM) who progress after all approved standard therapies or in patients unsuitable for systemic therapy. Between September 2010 and March 2020, thirty patients (22 men and 8 women; mean age 66.8 ± 13.2) were included in this retrospective study. DEBIRI TACE was conducted in 43% of patients unsuitable for systemic therapy as a first-line treatment and 57% as salvage therapy after the progression of systemic therapy. All the patients had liver-limited disease. In the case of unilobar disease, two treatments were performed at four-week intervals, and in the case of bilobar disease, four treatments were performed at two-week intervals. All patients were premedicated and monitored after the procedure. Adverse events were graded according to the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) classification system for complications. The median overall survival (OS) from the beginning of DEBIRI TACE in the salvage group was 17.4 months; in the group without prior systemic therapy, it was 21.6 months. The median overall survival of all patients was 17.4 months (95% confidence interval [CI]: 10.0-24.7 months), and progression-free survival (PFS) was 4.2 months (95% CI: 0.9-7.4 months). The one-year survival rate after the procedure was 61%, and the two-year rate was 25%. Univariate analysis showed better survival of patients with four or fewer liver metastases (p = 0.002). There were no treatment-related deaths or grade 4 and 5 adverse events. Nonserious adverse events (Grades 1 and 2) were present in 53% of patients, and Grade 3 adverse events were present in 6% of the patients. DEBIRI TACE is a well-tolerated treatment option for patients with liver metastases of colorectal cancer. Patients with four or fewer liver metastases correlated with better survival.

Are adverse events during surgery for benign prostatic hyperplasia device related? A review of the MAUDE database.

The Manufacturer and User Facility Device Experience database contains anonymous, voluntary medical device reports. A review of device-related adverse events associated with Benign Prostatic Hyperplasia surgeries was completed. The objective was to evaluate the occurrence and contributing factors to clinically significant complications in a cohort of patients electing to undergo surgical intervention for Benign Prostatic Hyperplasia. The Manufacturer and User Facility Device Experience database was queried for "Aquablation, Greenlight Laser, Holmium Laser, Morcellator, Water Vapor Thermal Therapy, Loop Resection, and Prostatic Urethral Lift" from 2018 through 2021. A complication classification system (Level I-IV) based on the Clavien-Dindo system was used to categorize events. These events were then correlated with procedural technology malfunctions and classified as "device related" and "non-device related." Chi squared analysis was performed to identify associations between procedural technology and complication classification distribution. A total of 873 adverse events were identified. The adverse events were classified into level I (minimal harm) versus levels II-IV (clinically significant). Aquablation (p < 0.017) and Water Vapor Thermal Therapy (p < 0.012) were associated with a higher proportion of reports with Level II-IV complications compared with other procedure types. Level II-IV complications were not associated with a reported device related malfunction. Aquablation and water vapor thermal therapy demonstrated noteworthy clinically significant complications which were not driven by device-related malfunctions.

Modified Clavien-Dindo-Sink Classification System for operative complications in adult spine surgery.

Currently there is no standardized mechanism to describe or compare complications in adult spine surgery. Thus, the purpose of the present study was to modify and validate the Clavien-Dindo-Sink complication classification system for applications in spine surgery. The Clavien-Dindo-Sink complication classification system was evaluated and modified for spine surgery by four fellowship-trained spine surgeons using a consensus process. A distinct group of three fellowship-trained spine surgeons completed a randomized electronic survey grading 71 real-life clinical case scenarios. The survey was repeated 2 weeks after its initial completion. Fleiss' and Cohen's kappa (κ) statistics were used to evaluate interrater and intrarater reliabilities, respectively. Overall, interobserver reliability during the first and second rounds of grading was excellent with a κ of 0.847 (95% CI 0.785-0.908) and 0.852 (95% CI 0.791-0.913), respectively. In the first round, interrater reliability ranged from good to excellent with a κ of 0.778 for grade I (95% CI 0.644-0.912), 0.698 for grade II (95% CI 0.564-0.832), 0.861 for grade III (95% CI 0.727-0.996), 0.845 for grade IV-A (95% CI 0.711-0.979), 0.962 for grade IV-B (95% CI 0.828-1.097), and 0.960 for grade V (95% CI 0.826-1.094). Intraobserver reliability testing for all three independent observers was excellent with a κ of 0.971 (95% CI 0.944-0.999) for rater 1, 0.963 (95% CI 0.926-1.001) for rater 2, and 0.926 (95% CI 0.869-0.982) for rater 3. The Modified Clavien-Dindo-Sink Classification System demonstrates excellent interrater and intrarater reliability in adult spine surgery cases. This system provides a useful framework to better communicate the severity of spine-related complications.

A retrospective study of irreversible electroporation for tumors adjacent to perihepatic important structure.

Irreversible electroporation has been proved as a feasible and safe method against tumor in liver. However, few studies focused on tumors adjacent to perihepatic important structure like vessels, biliary system and gall bladder. These structures limit the effectiveness of conventional treatments. The aim of this article is to analyze the clinical outcomes of patients with hepatic tumors at the special sites who received IRE treatment and provide reliable evidence for broadening the scope of IRE's clinical application. The clinical information of patients who underwent IRE ablation for tumors adjacent to perihepatic important structure between February 2017 and December 2021 was collected and retrospectively analyzed. All patients underwent contrast-enhanced CT or MRI for further evaluation at the 1-month follow-up and every 3 months thereafter. Post-ablation complications, recurrence, progression-free survival and overall survival were evaluated to analyze the prognosis of IRE ablation adjacent to perihepatic important structure. Categorical variables are presented as numbers followed by percentages. Continuous data are presented as the mean ± deviation. The tumor size and IRE ablation size were evaluated by the maximum diameters. Thirty-two patients who underwent IRE ablation for tumor adjacent to perihepatic important structure were studied in this research. There were 39 lesions in 32 patients treated with IRE ablation. Fourteen of them (35.9%) were located adjacent to the porta hepatis, and 8 of them (20.5%) were located adjacent to the hepatocaval confluence. Subcapsular lesions accounted for 15.4% (6 of 39 lesions). The other 11 lesions were in the para gallbladder (5 of 39 lesions, 12.8%), the caudate lobe (5 of 39 lesions, 12.8%) and the colonic hepatic flexure (1 of 39 lesions, 2.6%). According to the Clavien-Dindo classification system for complications, all relative patients with cancer experienced complications below class III except one patient who developed postoperative hemorrhagic shock and improved after timely treatment. Recurrence in situ was observed in 5 of 32 (15.6%) patients. The median PFS of the patients who received IRE ablation was 384 days, and the median OS was 571 days. IRE ablation is a feasible and safe treatment strategy for tumors adjacent to perihepatic important structure. With improved equipment, optimized therapeutic parameters and long-term clinical trials, IRE will play an increasingly important role in the treatment of tumors in liver.

The ISSG-AO Complication Intervention Score, but Not Major/Minor Designation, is Correlated With Length of Stay Following Adult Spinal Deformity Surgery.

Retrospective review. The International Spine Study Group-AO (ISSG-AO) Adult Spinal Deformity (ASD) Complication Classification System was developed to improve classification, reporting, and study of complications among patients undergoing ASD surgery. The ISSG-AO system classifies interventions to address complications by level of invasiveness: grade zero (none); grade 1, mild (e.g., medication change); grade 2, moderate (e.g., ICU admission); grade 3, severe (e.g., reoperation related to surgery of interest). To evaluate the efficacy of the ISSG-AO ASD Complication Classification System, we aimed to compare correlations between postoperative length of stay (LOS) and complication severity as classified by the ISSG-AO ASD and traditional major/minor complication classification systems. Patients age ≥18 in a multicenter ASD database who sustained in-hospital complications were identified. Complications were classified with the major/minor and ISSG-AO systems and correlated with LOS using an ensemble-based machine learning algorithm (conditional random forest) and a generalized linear mixed model. 490 patients at 19 sites were included. 64.9% of complications were major, and 35.1% were minor. By ISSG-AO classification, 20.4%, 66.1%, 6.7%, and 6.7% were grades 0-3, respectively. ISSG-AO complication grading demonstrated significant correlation with LOS, whereas major/minor complication classification demonstrated inverse correlation with LOS. In conditional random forest analysis, ISSG-AO classification had the greatest relative importance when assessing correlations across multiple variables with LOS. The ISSG-AO system may help identify specific complications associated with prolonged LOS. Targeted interventions to avoid or reduce these complications may improve ASD surgical quality and resource utilization.

Hip Manipulation Under Anesthesia for Post-Hip Arthroscopy Pericapsular Scarring: Indications and Techniques

Hip arthroscopy has become an increasingly common procedure with expanding indications over the last several decades. With the increase in number of procedures performed a complication profile has emerged, although there is yet to be a formal classification system for complications. The most cited complications include lateral femoral cutaneous nerve neuropraxia, other sensory deficits, chondral or labral iatrogenic damage, superficial infection and deep vein thrombosis. One complication that has not yet been well documented in the literature is pericapsular scarring/adhesions resulting in decreased hip range of motion and function. If this complication is noted to persist after adequate impingement resection and a rigorous post-operative physical therapy regimen, the senior author has addressed this with a hip manipulation under anesthesia. Therefore, this techniques paper aims to describe pericapsular scarring as a post hip-arthroscopy condition which may cause pain and demonstrate our technique to address this diagnosis through hip manipulation under anesthesia.

SP28. The Risk Analysis Index Has Superior Frailty Discrimination Than the Modified Frailty Index-5 for Predicting Poor Cranioplasty Outcomes

PURPOSE: Cranioplasty is a common surgical procedure where autologous or synthetic materials are used to repair cranial defects and although considered simple and low-risk, it is surprisingly associated with significant morbidity and mortality. Although increased patient age has been shown to be a predictor of poor postoperative outcomes, no studies have evaluated frailty’s impact on cranioplasty outcomes. This study examined the association between frailty and cranioplasty by comparing effect sizes of the Risk Analysis Index-Administrative (RAI-A), Modified Frailty Index-5 (mFI-5), and increasing patient age on the primary outcome of 30-day mortality and secondary outcomes of non-home discharge rates and postoperative complications, as measured by the Clavien-Dindo (CD) complication classification system: (CD I: surgical site infection, CD II: postoperative bleeding or transfusion(s), CD IIIb: reoperation under general anesthesia, CD IV: sepsis, septic shock, pulmonary embolism, myocardial infraction, ventilator status, 30-day mortality). METHODS: The American College of Surgeons National Surgical Quality Improvement Program (NSQIP) was queried for all patients undergoing cranioplasty between 2012-2020. Data for baseline demographics, comorbidities, operative characteristics, and postoperative outcomes were evaluated. Statistical analysis was performed on IBM SPSS Statistics ver. 28.0 (IBM Co., Armonk, NY, USA). The discriminatory thresholds of RAI-A, mFI-5, and increasing patient age on 30-day mortality were evaluated using receiver operating characteristics (ROC) curve analysis. The area under the curve (AUC) is represented as a C-statistic with a 95% confidence interval (CI). Two distinct multivariable analyses were conducted for RAI-A and mFI-5 to measure the independent relationships between frailty and outcomes. Covariates controlled for included race, BMI, primary procedure, cranial defect size, and material type. Additionally, the mFI-5 model was age-adjusted, allowing for direct comparison of effect sizes between age and frailty. We excluded age from the model for RAI-A to prevent any collinearity, since age contributes to the total RAI-A score. RESULTS: There were 2,864 included study patients with a median age of 57 years (IQR, 44-67), and a higher proportion of patients were female (57.0%), and white (68.5%). The RAI-A demonstrated better predictive ability for 30-day mortality (C-Statistic: 0.741, 95% CI: 0.678-0.804) compared to mFI-5 (C-Statistic: 0.574, 95% CI: 0.489-0.659) and increasing patient age (C-Statistic: 0.671, 95% CI: 0.610-0.732). On multivariable analyses, RAI-A demonstrated superior independent associations with mortality, NHD, CDII, and CDIII when compared to mFI-5 and increasing patient age. (p<0.05). CONCLUSIONS: The RAI-A demonstrated superior discrimination than the mFI-5 and increasing patient age in predicting poor outcomes following cranioplasty. The high rates of operative morbidity (5.0-36.5%) and mortality (0.4-3.2%) after cranioplasty highlight the importance of being able to predict which patients are at increased risk for poor cranioplasty outcomes, so that shared decision making regarding the potential risk and benefits of treatment can occur. Multivariable Analyses for Postoperative Outcomes

Palliative Arterial Embolization for Metastases of the Sternum

To investigate the safety and efficacy of palliative arterial embolization for metastases of the sternum. This study included 10 consecutive patients (5M, 5 F; mean age 58.1; range 37-70) with metastases of the sternum from different primary tumors, treated with palliative arterial embolization using NBCA-Lipiodol between January 2007 and June 2022. Four patients received a second embolization at the same site, for a total of 14 embolizations. Data on technical and clinical success, as well as changes in tumor size, were collected. All embolization-related complications were evaluated according to the CIRSE classification system for complications. Post-embolization angiography showed occlusion of more than 90% of the pathological feeding vessels in all procedures. Pain score and analgesic drug consumption were reduced by 50% in all 10 patients (100%, p < 0.05). The mean duration of pain relief was 9.5months (range 8 to 12months, p < 0.05). Metastatic tumor size was reduced from a mean of 71.5 cm3 (range 41.6 to 90.3 cm3) pre-embolization to a mean of 67.9 cm3 (range 38.5 to 86.1 cm3) at the 12-month follow-up (p < 0.05). None of the patients experienced embolization-related complications. Arterial embolization is safe and effective as a palliative treatment for patients with metastases of the sternum who did not benefit from radiation therapy or experienced recurrence in symptoms.

PD41-08 DEVICE-RELATED ADVERSE EVENTS DURING BENIGN PROSTATIC HYPERTROPHY SURGERY: REVIEW OF THE MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE DATABASE

You have accessJournal of UrologyCME1 Apr 2023PD41-08 DEVICE-RELATED ADVERSE EVENTS DURING BENIGN PROSTATIC HYPERTROPHY SURGERY: REVIEW OF THE MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE DATABASE Daniel Heidenberg, Ethan Nethery, Nathanael Judge, Kevin Wymer, Scott Cheney, and Mitchell Humphreys Daniel HeidenbergDaniel Heidenberg More articles by this author , Ethan NetheryEthan Nethery More articles by this author , Nathanael JudgeNathanael Judge More articles by this author , Kevin WymerKevin Wymer More articles by this author , Scott CheneyScott Cheney More articles by this author , and Mitchell HumphreysMitchell Humphreys More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003346.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Benign prostatic hyperplasia (BPH) affects most men over 60 years old. The Manufacturer and User Facility Device Experience (MAUDE) database is an FDA maintained public database that contains anonymous, voluntary medical device reports. Herein, we review device-related adverse events reported in the MAUDE database associated with BPH surgeries. METHODS: The MAUDE database was queried for “Aquablation, Rezum, Loop Resection, Morcellator, Greenlight Laser, Holmium Laser, and Urolift” from 2018 through 2021. A complication classification system (Level 1-4) based on the Clavien-Dindo system was used to categorize events based on outcomes. These events were then correlated with device malfunctions and classified as “product related” and “non-product related.” Chi squared analysis was performed to identify associations between BPH surgery type and complication classification distribution. RESULTS: A total of 873 device related events were identified. The entries by surgical subtype included: rezum 304 (35%), urolift 33 (4%), TURP 134 (15%), HOLEP 40 (4%), Aquablation 294 (34%), Greenlight laser 68 (8%). 553 complications (63%) were Level I (mild/none), 138 (16%) were Level II (medical management), 164 (19%) were Level III (surgical management), and 16 (2%) was Level IV (life threatening). The most common level II-IV complications by BPH surgery type: aquablation - hematuria (50%), rezum - lower urinary tract symptoms (23%), HOLEP – retained adenoma (23%), urolift – acute urinary retention (12%), greenlight laser – urethral necrosis (2%), transurethral resection of prostate – bladder perforation (3%). Using chi squared analysis, aquablation (p<0.017) and Rezum (p<0.012) were associated with the highest risk of Level II-IV complications compared with other device classes. Overall, “product related” malfunctions were not associated with level II-IV complications. CONCLUSIONS: Aquablation and rezum were associated with a higher proportion of level II-IV complications. However, this difference is not accounted for by “product related” malfunctions, which highlights surgeon experience or other unknown factors as potential sources for adverse events with newer products. A limitation of this study is the total complications per surgical subtype are not fully captured. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1061 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Daniel Heidenberg More articles by this author Ethan Nethery More articles by this author Nathanael Judge More articles by this author Kevin Wymer More articles by this author Scott Cheney More articles by this author Mitchell Humphreys More articles by this author Expand All Advertisement PDF downloadLoading ...

Development of a classification system for equine postoperative complications and its application in a cohort of 190 horses undergoing emergency laparotomy.

Accurate reporting of postoperative complications is paramount to understanding procedural outcomes, comparing procedures and assuring quality improvement. Standardising definitions of complications in equine surgeries will improve the evidence of their outcomes. To this end, we proposed a classification for postoperative complications and applied it to a cohort of 190 horses undergoing emergency laparotomy. A classification system for postoperative complications in equine surgery was developed. Medical records of horses that underwent equine emergency laparotomy and recovered from anaesthesia were analysed. Reported complications pre-discharge were classified as per the new classification system, and the cost and days of hospitalisation were correlated with the equine postoperative complication score (EPOCS). Of the 190 horses that underwent emergency laparotomy, 14 (7.4%) did not survive to discharge (class 6 complications), and 47 (24.7%) did not develop complications. The remaining horses were classified as follows: 43 (22.6%) had class 1 complications, 30 (15.8%) had class 2, 42 (22%) had class 3, 11 (5.8%) had class 4; and three (1.5%) had class 5. The proposed classification system and EPOCS correlated with the cost and length of hospitalisation. This was a single-centre study and the definition of scores was arbitrary. Reporting and grading all complications will help surgeons better understand the patients' postoperative course, thereby reducing subjective interpretation.

The Frequency and Severity of Complications in Surgical Treatment of Osteochondral Lesions of the Talus: A Systematic Review and Meta-Analysis of 6,962 Lesions.

The primary aim was to determine and compare the complication rate of different surgical treatment options for osteochondral lesions of the talus (OLTs). The secondary aim was to analyze and compare the severity and types of complications. A literature search was performed in MEDLINE (PubMed), EMBASE (Ovid), and the Cochrane Library. Methodological quality was assessed using the Methodological Index for Non-Randomized Studies (MINORS). Primary outcome was the complication rate per surgical treatment option. Secondary outcomes included the severity (using the Modified Clavien-Dindo-Sink Complication Classification System for Orthopedic Surgery) and types of complications. The primary outcome, the severity, and the sub-analyses were analyzed using a random effects model. A moderator test for subgroup-analysis was used to determine differences. The types of complications were presented as rates. In all, 178 articles from the literature search were included for analysis, comprising 6,962 OLTs with a pooled mean age of 35.5 years and follow-up of 46.3 months. Methodological quality was fair. The overall complication rate was 5% (4%-6%; treatment group effect, P = 0.0015). Analysis resulted in rates from 3% (2%-4%) for matrix-assisted bone marrow stimulation to 15% (5%-35%) for metal implants. Nerve injury was the most observed complication. In 1 out of 20 patients treated surgically for an OLT, a complication occurs. Metal implants have a significantly higher complication rate compared with other treatment modalities. No life-threatening complications were reported.

Complication rates in rigid vs. flexible endoscopic foreign body removal in children.

While foreign body aspiration remains a frequent and preventable cause of morbidity and mortality in children, recommendations on the appropriate removal technique do often not match the lived practice and expertise of the performing examiners. As there is a scarcity of data regarding success and complication rates of the procedure, the aim of this study was to set up a classification system for procedure-related complications, prospectively record and analyze them. Specialists in the field of foreign body removal contributed cases anonymously. Information regarding procedural details of the bronchoscopy, type, and severity of complications as well as patient characteristics were classified and recorded. Correlations were calculated using Pearson's Chi Square test. A total of 314 rigid and 178 flexible bronchoscopies were compared. Complications were categorized and their severity was defined by the anesthesiologist's assessment of whether to interrupt or terminate the procedure. The overall complication rate was similar in rigid vs. flexible bronchoscopy (19.1% vs. 24.2%, p=0.232), while respiratory complications occurred significantly less frequent during rigid bronchoscopy (9.2% vs. 16.3%, p=0.025). This is the largest pediatric case collection recording and comparing complications between rigid and flexible foreign body removal. The higher rate of respiratory complications in flexible bronchoscopy has been shown for the first time and validates some of the concerns about its use for foreign body removal. Flexible bronchoscopy is a safe procedure when extended respiratory monitoring and the possibility of an immediate switch to a secured airway are assured.

USE OF A MODIFIED CLAVIEN-DINDO CLASSIFICATION SYSTEM FOR ORTHOPAEDIC COMPLICATIONS IN A LEVEL 1 TRAUMA CENTRE

Complications are an inevitable part of orthopaedic surgery, how one defines complications can have an impact on the ability to learn from them. A group of general surgeons headed by Clavien and Dindo et al.1 have previously published their classification system for surgical complications based on the type of therapy required to correct the complication.Our aim was to evaluate a modification of this classification system and its use over a 12-month period at our institution via our departmental audits, our hypothesis being that this would direct appropriate discussion around our complications and hence learning and institutional change.A modified Clavien-Dindo Classification was prospectively applied to all complications recorded in the Orthopaedic departmental quarterly audits at our institution for a 12-month period (4 audits). The audit discussion was recorded and analysed and compared with the quarterly complication audits for the preceding 12-month period.The modified Clavien-Dindo classification for surgical complications was applicable and reproducible to Orthopaedic complications in our level 1 trauma centre. It is a transparent system, objective in its interpretation and avoids the tendency to down-grade serious complications. It was easy to apply and directed discussion appropriately at our quarterly audit meetings on complications where there was a preventable outcome or important learning point. In particular modifications to VTE and Death classes allowed the unit to focus discussion on cases where complication was preventable or unexpected.The modified Clavien-Dindo classification system is an easy to use and reproducible classification system for Orthopaedic complications in our unit it directed audit discussion towards cases where complications were preventable or had a learning point.