Surgical Outcome Reporting. Moving From a Comic to a Tragic Opera?

OBJECTIVES: To assess the current quality of surgical outcome reporting in the medical literature and to provide recommendations for improvement. BACKGROUND: In 1996, The Lancet labeled surgery as a "comic opera" mostly referring to the poor quality of outcome reporting in the literature impeding improvement in surgical quality and patient care. METHODS: We screened 3 first-tier and 2 second-tier surgical journals, as well as 3 leading medical journals for original articles reporting on results of surgical procedures published over a recent 18-month period. The quality of outcome reporting was assessed using a prespecified 12-item checklist. RESULTS: Six hundred twenty-seven articles reporting surgical outcomes were analyzed, including 125 randomized controlled trials. Only 1 (0.2%) article met all 12 criteria of the checklist, whereas 356 articles (57%) fulfilled less than half of the criteria. The poorest reporting was on cumulative morbidity burden, which was missing in 94% of articles (n=591) as well as patient-reported outcomes missing in 83% of publications (n=518). Comparing journal groups for the individual criterion, we found moderate to very strong statistical evidence for better quality of reporting in high versus lower impact journals for 7 of 12 criteria and strong statistical evidence for better reporting of patient-reported outcomes in medical versus surgical journals ( P <0·001). CONCLUSIONS: The quality of outcomes reporting in the medical literature remains poor, lacking improvement over the past 20 years on most key end points. The implementation of standardized outcome reporting is urgently needed to minimize biased interpretation of data thereby enabling improved patient care and the elaboration of meaningful guidelines.

Surgeon-Scientists Going Extinct - Last Call for Action or Too Late?

OBJECTIVE: To define the concept of surgeon-scientists and identify the root causes of their decline in number and impact. The secondary aim was to provide actionable remedies. BACKGROUND: Surgeons who conduct research in addition to patient care are referred to as «surgeon-scientists¼. While their value to society remains undisputed, their numbers and associated impact have been plunging. While reasons have been well identified along with proposals for countermeasures, their application have largely failed. METHODS: We conducted a systematic review covering all aspects of surgeon-scientists together with a global online survey among 141 young academic surgeons. Using gap analysis, we determined implementation gaps for proposed measures. Then, we developed a comprehensive rescue package. RESULTS: A surgeon-scientist must actively and continuously engage in both patient care and research. Competence in either field must be established through protected training and criteria of excellence, particularly reflecting contribution to innovation. The decline of surgeon-scientists has reached unprecedented magnitude. Leadership turning hospitals into «profit-factories¼ is one reason, a flawed selection process not exclusively based on excellence another. Most importantly, the appreciation for the academic mission has vanished. Along with fundamentally addressing these root causes, surgeon-scientists' path to excellence must be streamlined, and their continuous devotion for innovation cherished. CONCLUSION: The journey of the surgeon-scientist is at crossroads. As society, we either adapt and shift our priorities again towards innovation or capitulate to the greed for profit, permanently losing these invaluable professionals. Successful rescue packages must not only involve hospitals and universities but also the political sphere.

Revolutionizing Liver Transplantation: Transitioning to an Elective Procedure via ex situ Normothermic Machine Perfusion - A Benefit Analysis.

OBJECTIVE: To assess the impact of Normothermic Machine Perfusion (NMP) on patients, medical teams, and costs by gathering global insights and exploring current limitations. BACKGROUND: NMP for ex-situ liver graft perfusion is gaining increasing attention for its capability to extend graft preservation. It has the potential to transform liver transplantation (LT) from an urgent to a pure elective procedure, which could revolutionize LT logistics, reduce burden on patients and healthcare providers, and decrease costs. METHODS: A 31-item survey was sent to international transplant directors to gather their NMP experiences and vision. Additionally, we performed a systematic review on cost-analysis in LT and assessed studies on cost-benefit in converting urgent-to-elective procedures. We compared the costs of available NMPs and conducted a sensitivity analysis on NMP's cost benefits. RESULTS: Of 120 transplant programs contacted, 64 (53%) responded, spanning North America (31%), Europe (42%), Asia (22%), and South America (5%). Sixty percent had adopted NMP, with larger centers (>100 transplants/year) in North America and Europe more likely to use it. Main NMP systems were OrganOx-metra (39%), XVIVO (36%), and TransMedics-OCS (15%). Despite NMP adoption, 41% of centers still perform >50% of LTs at nights/weekends. Centers recognized NMP's benefits, including improved work satisfaction and patient outcomes, but faced challenges like high costs and machine complexity. 16% would invest $100'000-500'000, 33% $50'000-100'000, 38% $10'000-50'000, and 14% <$10'000 in NMP. These results were strengthened by a cost analysis for NMP in emergency-to-elective LT transition. Accordingly, while liver perfusions with disposables up to $10'000 resulted in overall positive net balances, this effect was lost when disposables' cost amounted to >$40'000/organ. CONCLUSION: The adoption of NMP is hindered by high costs and operational complexity. Making LT elective through NMP could reduce costs and improve outcomes, but overcoming barriers requires national reimbursements and simplified, automated NMP systems for multi-day preservation.

Milestones in Surgical Complication Reporting. Clavien-Dindo Classification 20 Years & Comprehensive Complication Index (CCI®) 10 Years.

OBJECTIVE: To provide improved guidance for the consistent application of the Clavien-Dindo classification (CDC) and Comprehensive Complication Index (CCI®) in challenging clinical scenarios. BACKGROUND: Standardized outcome reporting is key for proper assessment of surgical procedures. A recent consensus conference recommended the CDC and the CCI® for assessing postoperative morbidity. Several challenging scenarios for grading complications still require evidence-based guidance, and the use of the two metrics in RCTs remains unexplored. METHODS: We assessed the use of the CDC and CCI® as an outcome measure in a systematic literature search. Additionally, we asked 163 international surgeons to critically evaluate and independently grade complications in 20 complex clinical scenarios. Finally, a core group of five experts used this information to develop consistent recommendations. RESULTS: Until July 2023, 1327 RCTs selected the CDC and/or CCI® to assess morbidity. Annual use was steadily increasing with now over 200 new RCTs per year. However, only a third (n=335) of published RCTs provided the complete range of CDC grades, including all subgrades. Eighty-nine out of 163 surgeons (response rate 55%) completed the questionnaire that served as basis for the recommendations: Repetitive interventions that are required to treat one complication, complications followed by further complications, complications occurring prior to referral, and expected and unrelated complications to the original procedure should all be counted separately and included in the CCI®. Invasive blank diagnostic interventions should not be considered a complication. CONCLUSION: The increasing use of the CDC and CCI® in RCTs highlights the importance of their standardized application. The current consensus on various difficult scenarios may offer novel guidance for the consistent use of the CDC and CCI®, aiming to improve complication reporting, and better-quality control, ultimately benefiting all healthcare stakeholders, and first and foremost, all patients.

Recommendations on Robotic Hepato-Pancreato-Biliary Surgery. The Paris Jury-Based Consensus Conference.

OBJECTIVE: To establish the first consensus guidelines on the safety and indications of robotics in Hepato-Pancreatic-Biliary (HPB) surgery. The secondary aim was to identify priorities for future research. SUMMARY BACKGROUND DATA: HPB robotic surgery is reaching the IDEAL 2b exploration phase for innovative technology. An objective assessment endorsed by the HPB community is timely and needed. METHODS: The ROBOT4HPB conference developed consensus guidelines using the Zurich-Danish model. An impartial and multidisciplinary jury produced unbiased guidelines based on the work of ten expert panels answering predefined key questions and considering the best-quality evidence retrieved after a systematic review. The recommendations conformed with the GRADE and SIGN50 methodologies. RESULTS: Fifty-four experts from 20 countries considered 285 studies, and the conference included an audience of 220 attendees. The jury (n=10) produced recommendations or statements covering five sections of robotic HPB surgery: technology, training and expertise, outcome assessment, and liver and pancreatic procedures. The recommendations supported the feasibility of robotics for most HPB procedures and its potential value in extending minimally invasive indications, emphasizing however the importance of expertise to ensure safety. The concept of expertise was defined broadly, encompassing requirements for credentialing HPB robotics at a given center. The jury prioritized relevant questions for future trials and emphasized the need for prospective registries, including validated outcome metrics for the forthcoming assessment of HPB robotics. CONCLUSION: The ROBOT4HPB consensus represents a collaborative and multidisciplinary initiative, defining state-of-the-art expertise in HPB robotics procedures. It produced the first guidelines to encourage their safe use and promotion.

Liver transplantation as an alternative for the treatment of neuroendocrine liver metastasis: Appraisal of the current evidence.

BACKGROUND: Liver transplantation (LT) for neuroendocrine liver metastases (NELM) is still in debate. Studies comparing LT with liver resection (LR) for NELM are scarce, as patient selection is heterogeneous and experience is limited. The goal of this review was to provide a critical analysis of the evidence on LT versus LR in the treatment of NELM. DATA SOURCES: A scoping literature search on LT and LR for NELM was performed with PubMed, including English articles up to March 2023. RESULTS: International guidelines recommend LR for NELM in resectable, well-differentiated tumors in the absence of extrahepatic metastatic disease with superior results of LR compared to systemic or liver-directed therapies. Advanced liver surgery has extended resectability criteria whilst entailing increased perioperative risk and short disease-free survival. In highly selected patients (based on the Milan criteria) with unresectable NELM, oncologic results of LT are promising. Prognostic factors include tumor biology (G1/G2) and burden, waiting time for LT, patient age and extrahepatic spread. Based on low-level evidence, LT for low-grade NELM within the Milan criteria resulted in improved disease-free survival and overall survival compared to LR. The benefits of LT were lost in patients beyond the Milan NELM-criteria. CONCLUSIONS: With adherence to strict selection criteria especially tumor biology, LT for NELM is becoming a valuable option providing oncologic benefits compared to LR. Recent evidence suggests even stricter selection criteria with regard to tumor biology.

Glucose controls lipolysis through Golgi PtdIns4P-mediated regulation of ATGL.

Metabolic crosstalk of the major nutrients glucose, amino acids and fatty acids (FAs) ensures systemic metabolic homeostasis. The coordination between the supply of glucose and FAs to meet various physiological demands is especially important as improper nutrient levels lead to metabolic disorders, such as diabetes and metabolic dysfunction-associated steatohepatitis (MASH). In response to the oscillations in blood glucose levels, lipolysis is thought to be mainly regulated hormonally to control FA liberation from lipid droplets by insulin, catecholamine and glucagon. However, whether general cell-intrinsic mechanisms exist to directly modulate lipolysis via glucose sensing remains largely unknown. Here we report the identification of such an intrinsic mechanism, which involves Golgi PtdIns4P-mediated regulation of adipose triglyceride lipase (ATGL)-driven lipolysis via intracellular glucose sensing. Mechanistically, depletion of intracellular glucose results in lower Golgi PtdIns4P levels, and thus reduced assembly of the E3 ligase complex CUL7FBXW8 in the Golgi apparatus. Decreased levels of the E3 ligase complex lead to reduced polyubiquitylation of ATGL in the Golgi and enhancement of ATGL-driven lipolysis. This cell-intrinsic mechanism regulates both the pool of intracellular FAs and their extracellular release to meet physiological demands during fasting and glucose deprivation. Moreover, genetic and pharmacological manipulation of the Golgi PtdIns4P-CUL7FBXW8-ATGL axis in mouse models of simple hepatic steatosis and MASH, as well as during ex vivo perfusion of a human steatotic liver graft leads to the amelioration of steatosis, suggesting that this pathway might be a promising target for metabolic dysfunction-associated steatotic liver disease and possibly MASH.

Peritransplant Varicosis After Simultaneous Pancreas and Kidney Transplantation Is an Uncommon Cause of Late-Onset and Recurrent Gastrointestinal Bleeding.

Ectopic peritransplant varicosis represents an uncommon cause of late-onset gastrointestinal (GI) bleeding after simultaneous pancreas and kidney transplantation (SPK). We report on a 53-year-old female patient who suffered from recurrent upper GI bleeding seven years after SPK with persistent graft function. Upper endoscopy revealed perianastomotic angiodysplasias, treated by clipping and Argon-Plasma-Coagulation. Repeated endoscopy showed no signs of anastomotic ulcer. With persistent symptoms, computed tomography and angiography revealed extensive ectopic varicosis around the pancreas and duodenal graft. With no signs of portal hypertension, pancreas graft venous outflow impairment or arterio-venous fistula, the origin of variceal formation remained unknown. The extended finding did not allow for endovascular treatment by embolization. Surgery with extensive variceal ligation led to persistent cessation of hemorrhage and maintained stable graft function. In patients with unclear recurrent upper GI bleeding after SPK, one should consider ectopic peritransplant varicosis as an exceptional bleeding cause. If endoscopic treatments fail, angiography should be performed to rule out unusual causes of vascular complications. In case of extensive peritransplant varicosis, surgery may remain the only successful therapy, whenever possible including graft preservation in well-functioning grafts.

Minimally invasive versus open pancreatic surgery: meta-analysis of randomized clinical trials.

BACKGROUND: Widespread implementation of the minimally invasive technique in pancreatic surgery has proven to be challenging. The aim of this study was to compare the perioperative outcomes of minimally invasive (laparoscopic and robotic) pancreatic surgery with open pancreatic surgery using data obtained from RCTs. METHODS: A literature search was done using Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Web of Science; all available RCTs comparing minimally invasive pancreatic surgery and open pancreatic surgery in adults requiring elective distal pancreatectomy or partial pancreatoduodenectomy were included. Outcomes were mortality rate, general and pancreatic surgery specific morbidity rate, and length of hospital stay. RESULTS: Six RCTs with 984 patients were included; 99.0 per cent (486) of minimally invasive procedures were performed laparoscopically and 1.0 per cent (five) robotically. In minimally invasive pancreatic surgery, length of hospital stay (-1.3 days, -2 to -0.5, P = 0.001) and intraoperative blood loss (-137 ml, -182 to -92, P < 0.001) were reduced. In the subgroup analysis, reduction in length of hospital stay was only present for minimally invasive distal pancreatectomy (-2 days, -2.3 to -1.7, P < 0.001). A minimally invasive approach showed reductions in surgical site infections (OR 0.4, 0.1 to 0.96, P = 0.040) and intraoperative blood loss (-131 ml, -173 to -89, P < 0.001) with a 75 min longer duration of surgery (42 to 108 min, P < 0.001) only in partial pancreatoduodenectomy. No significant differences were found with regards to mortality rate and postoperative complications. CONCLUSION: This meta-analysis presents level 1 evidence of reduced length of hospital stay and intraoperative blood loss in minimally invasive pancreatic surgery compared with open pancreatic surgery. Morbidity rate and mortality rate were comparable, but longer duration of surgery in minimally invasive partial pancreatoduodenectomy hints that this technique in partial pancreatoduodenectomy is technically more challenging than in distal pancreatectomy.

Long-term patency of arteriovenous fistulas for hemodialysis: A decade's experience in a transplant unit.

BACKGROUND: The heterogeneous quality of studies on arteriovenous fistulas outcome, with variable clinical settings and large variations in definitions of patency and failure rates, leads to frequent misinterpretations and overestimation of arteriovenous fistula patency. Hence, this study aimed to provide realistic and clinically relevant long-term arteriovenous fistula outcomes. METHODS: We retrospectively analyzed all autologous arteriovenous fistulas at our center over a 10-year period (2012-2022). Primary and secondary patency analysis was conducted using the Kaplan-Meier method; multivariate analysis of variance was used to detect outcome predictors. Vascular access-specific endpoints were defined according to the European guidelines on vascular access formation. FINDINGS: Of 312 arteriovenous fistulas, 57.5% (n = 181) were radio-cephalic (RC_AVF), 35.2% (n = 111) brachio-cephalic (BC_AVF), and 6.3% (n = 20) brachio-basilic (BB_AVF). 6, 12, and 24 months follow-up was available in 290 (92.1%), 282 (89.5%), and 259 (82.2%) patients, respectively. Primary patency rates at 6, 12, and 24 months were 39.5%, 34.8%, and 27.2% for RC_AVF, 58.3%, 44.4%, and 27.8% for BC_AVF, and 40.0%, 42.1%, and 22.2% for BB_AVF (p = 0.15). Secondary patency rates at 6, 12, and 24 months were 65.7%, 63.8%, and 59.0% for RC_AVF, 77.7%, 72.0%, and 59.6% for BC_AVF, and 65.0%, 68.4%, and 61.1% for BB_AVF (p = 0.29). Factors associated with lower primary and secondary patency were hemodialysis at time of arteriovenous fistula formation (p = 0.037 and p = 0.024, respectively) and higher Charlson Comorbidity Index (p = 0.036 and p < 0.001, respectively). Previous kidney transplant showed inferior primary patency (p = 0.005); higher age inferior secondary patency (p < 0.001). DISCUSSION: Vascular access care remains challenging and salvage interventions are often needed to achieve maturation or maintain patency. Strict adherence to standardized outcome reporting in vascular access surgery paints a more realistic picture of arteriovenous fistula patency and enables reliable intercenter comparison.

Screening for mitochondrial function before use-routine liver assessment during hypothermic oxygenated perfusion impacts liver utilization.

BACKGROUND: To report on a concept of liver assessment during ex situ hypothermic oxygenated perfusion (HOPE) and its significant impact on liver utilization. METHODS: An analysis of prospectively collected data on donation after circulatory death (DCD) livers, treated by HOPE at our institution, during a 11-year period between January 2012 and December 2022. FINDINGS: Four hundred and fifteen DCD Maastricht III livers were offered during the study period in Switzerland, resulting in 249 liver transplants. Of those, we performed 158 DCD III liver transplants at our institution, with 1-year patient survival and death censored graft survival (death with functioning graft) of 87 and 89%, respectively, thus comparable to benchmark graft survivals of ideal DBD and DCD liver transplants (89% and 86%). Correspondingly, graft loss for primary non-function or cholangiopathy was overall low, i.e., 7/158 (4.4%) and 11/158 (6.9%), despite more than 82% of DCD liver grafts ranked high (6-10 points) or futile risk (>10 points) according to the UK-DCD score. Consistently, death censored graft survival was not different between low-, high-risk or futile DCD III livers. The key behind these achievements was the careful development and implementation of a routine perfusate assessment of mitochondrial biomarkers for injury and function, i.e., release of flavin mononucleotide from complex I, perfusate NADH, and mitochondrial CO2 production during HOPE, allowing a more objective interpretation of liver quality on a subcellular level, compared to donor derived data. INTERPRETATION: HOPE after cold storage is a highly suitable and easy to perform perfusion approach, which allows reliable liver graft assessment, enabling surgeons to make a fact based decision on whether or not to implant the organ. HOPE-treatment should be combined with viability assessment particularly when used for high-risk organs, including DCD livers or organs with relevant steatosis. FUNDING: This study was supported by the Swiss National Foundation (SNF) grant 320030_189055/1 to PD.