Solid Organ Transplant Litigation at One of Europe's Largest University Hospitals.

Due to its intrinsic complexity and the principle of collective solidarity that governs it, solid organ transplantation (SOT) seems to have been spared from the increase in litigation related to medical activity. Litigation relating to solid organ transplantation that took place in the 29 units of the Assistance Publique-Hôpitaux de Paris and was the subject of a judicial decision between 2015 and 2022 was studied. A total of 52 cases of SOT were recorded, all in adults, representing 1.1% of all cases and increasing from 0.71% to 1.5% over 7 years. The organs transplanted were 25 kidneys (48%), 19 livers (37%), 5 hearts (9%) and 3 lungs (6%). For kidney transplants, 11 complaints (44%) were related to living donor procedures and 6 to donors. The main causes of complaints were early post-operative complications in 31 cases (60%) and late complications in 13 cases (25%). The verdicts were in favour of the institution in 41 cases (79%). Solid organ transplants are increasingly the subject of litigation. Although the medical institution was not held liable in almost 80% of cases, this study makes a strong case for patients, living donors and their relatives to be better informed about SOT.

Refining Auxiliary Orthotopic Liver Transplantation (AOLT) Improves Outcomes in Adult Patients With Acute Liver Failure.

OBJECTIVE: To investigate whether and how experience accumulation and technical refinements simultaneously implemented in auxiliary orthotopic liver transplantation (AOLT) may impact on outcomes. BACKGROUND: AOLT for acute liver failure (ALF) provides the unique chance of complete immunosuppression withdrawal after adequate native liver remnant regeneration but is a technically demanding procedure. Our department is a reference center for ALF and an early adopter of AOLT. METHODS: This is a single-center retrospective before/after study of a prospectively maintained cohort of 48 patients with ALF who underwent AOLT between 1993 and 2019. In 2012, technical refinements were implemented to improve outcomes: (i) favoring the volume of the graft rather than that of the native liver, (ii) direct anastomosis of graft hepatic artery with recipient right hepatic artery instead of the use of large size vessels, (iii) end-to-side hepaticocholedocostomy instead of bilioenteric anastomosis. Early experience (1993-2011) group (n=26) and recent experience (2012-2019) group (n=22) were compared. Primary endpoint was 90-day severe morbidity rate (Clavien-Dindo≥IIIa) and secondary endpoints were overall patient survival and complete immunosuppression withdrawal rates. RESULTS: Compared with the earlier experience group, the recent experience group was associated with a lower severe complication rate (27% vs 65%, P <0.001), as well as less biliary (18% vs 54%, P =0.017) and arterial (0% vs 15%, P =0.115) complications. The 1-, 3-, and 5-year patient survival was significantly improved (91%, 91%, 91% vs 76%, 61%, 60%, P =0.045). The rate of complete immunosuppression withdrawal increased to 94% vs 70%, ( P =0.091) with no need of long-term graft explant. CONCLUSION: These technical refinements favoring the liver graft and reducing morbidity may promote AOLT implementation among LT centers.

The role of preoperative psychosocial counseling on the improvement of the recipient compliance and speed of recovery after liver transplantation - A systematic review of the literature and expert panel recommendations.

BACKGROUND: Psychosocial disorders ranging from anxiety to severe psychiatric diseases and active alcohol/substance abuse are frequent in liver transplant candidates and potentially associated with worse post- transplant outcomes. Therefore, psychosocial evaluation is mandatory to optimize success after liver transplantation. However, how to carry out this evaluation, the type of intervention needed and its potential impact on patient outcome remain unclear. OBJECTIVES: To investigate whether psychosocial assessment may help in predicting risks of poor outcome; and to investigate whether psychosocial interventions may mitigate these risks and improve posttransplant outcomes, in particular compliance and speed of recovery. DATA SOURCES: Ovid MEDLINE, Embase, Scopus, Google Scholar, and Cochrane Central. METHODS: Systematic review following PRISMA guidelines and recommendations using the GRADE approach derived from an international expert panel. The protocol was registered on PROSPERO CRD42021238361. Main outcomes assessed were mortality, alcohol relapse, rejection, and medication compliance. RESULTS: Fifteen studies were analyzed including five observational comparative and ten observational noncomparative studies. Preoperative psychosocial evaluation of LT candidates was associated with higher concordance with the treatment plan (i.e., higher adherence to treatment and lower alcohol relapse) and lower rates of rejection. Psychosocial assessment tools were used in some studies to guide the evaluation, but their predictive ability remains debated, and they should not be used in isolation. Most of the interventions were studied in patients with alcohol related issues. In this context, support by specialized teams was associated with better posttransplant outcome, especially through a decrease in post-transplant alcohol relapse. CONCLUSIONS: Preoperative psychosocial assessment should be provided in order to detect patients at increased risk of poorer post-transplant outcome, in particular in terms of concordance to the treatment plan (Quality of Evidence; Low | Grade of Recommendation; Strong/For). The experts suggest that, when possible, provision of preoperative psychological assessment and concomitant interventions aimed at improving the concordance to treatment plans will positively impact the success of liver transplantation. (Quality of Evidence; Very Low | Grade of Recommendation; Strong/For].

[Connected health objects and medical devices]. / Objets de santé et dispositifs médicaux connectés.

Connected health objects and medical devices.A clear distinction is required between connected devices which change patient's care and those intended to im¬prove his well-being. Connected devices with a medical objective must obtain a CE mark assessing the technical reliability of both the physical piece and the associated software, but also ensuring the control of the hosting of data. Those who demonstrate individual or collective improvement in the diagnosis or treatment of a disease may be financed by the community. This reimbursement is the main tool in France expecting to reduce the digital divide.

Objets de santé et dispositifs médicaux connectés.L'expansion des objets connectés impose de distinguer ceux qui modifient la prise en charge d'un malade, à finalité médicale et ceux destinés à améliorer son bien-être. Les dispositifs connectés ayant une finalité médicale doivent obtenir un marquage CE pour évaluer la fiabilité technique de l'objet physique et du logiciel associé mais aussi pour garantir le contrôle de l'hébergement des données. Ceux qui démontrent une amélioration indivi¬duelle ou collective du diagnostic ou du traitement d'une maladie peuvent être pris en charge par la collectivité. Ce soutien financier représente en France le principal outil pour limiter la fracture numérique.

[Robots set up in the operating theater]. / Les robots s'installent au bloc opératoire.

"Robots set up in the operating theater. The patient's benefit after a minimally invasive approach stimulated the robotic approach of abdominal and thoracic surgical procedures. Although much more expensive, the robots improve the vision of the operating field, the precision of the gestures with a faster training course for the surgeon who operates more comfortably. Surgeons eager for technological progress quickly adopted this technique in urology and gynecology and then in thoracic and digestive procedures. In France, the support for this innovation by academic and medical institutions is limited by several factors including the supremacy of Intuitive which imposes its prices, the absence of scientifically proven superiority, the absence of surveys under the responsibility of scientific societies and the lack of criteria concerning the surgeon training."

"Les robots s'installent au bloc opératoire. Les bénéfices de l'approche mini-invasive abdominale et thoracique ont stimulé l'approche robotique. Bien que beaucoup plus coûteux, les robots améliorent la vision du champ opératoire, la précision des gestes avec un apprentissage plus rapide pour le chirurgien qui opère plus confortablement. Les chirurgiens avides de progrès technologiques s'emparent rapidement de cette technique en urologie et en gynécologie puis en thoracique et en digestif. Le monopole imposé par la société Intuitive qui impose ses prix, l'absence de supériorité démontrée scientifiquement, de registres sous la responsabilité de sociétés scientifiques et de critères concernant la formation des chirurgiens à cette nouvelle technique ne favorise pas le soutien des institutions françaises pour accompagner cette innovation."

Liver resection for octogenarians in a French center: prolonged hepatic pedicle occlusion and male sex increase major complications.

PURPOSE: The prolonged life expectancy and increase in aging of the population have led surgeons to propose hepatectomy in the elderly population. In this study, we evaluate the surgical outcome of octogenarians in a single French center. METHODS: Between 2000 and 2020, 78 patients over 80 years old were retrospectively analyzed. The risk factors of major complications (Clavien-Dindo ≥ grade IIIa) and patient performance after surgery by using textbook outcome (TO) (no surgical complications, no prolonged hospital stay (≤ 15 days), no readmission ≤90 days after discharge, and no mortality ≤90 days after surgery) were studied. RESULTS: The main surgical indication was for malignancy (96%), including mainly colorectal liver metastases (n = 41; 53%) and hepatocellular carcinoma (n = 22; 28%), and major hepatectomy was performed in 28 patients (36%). There were 6 (8%) postoperative mortalities. The most frequent complications were pulmonary (n = 22; 32%), followed by renal insufficiency (n = 22; 28%) and delirium (n = 16; 21%). Major complications occurred in 19 (24%) patients. On multivariate analysis, the main risk factors for major complications were the median vascular clamping time (0 vs 35; P = 0.04) and male sex (P = 0.046). TO was ultimately achieved in 30 patients (38%), and there was no prognostic factor for achievement of TO. CONCLUSIONS: Hepatectomy in octogenarians is associated with acceptable morbidity and mortality. Meanwhile, prolonged hepatic pedicle clamping should be avoided especially if hepatectomy is planned in a male patient.

Up-to-down open and laparoscopic liver hanging maneuver: an overview.

BACKGROUND: The liver hanging maneuver (LHM) was described by Belghiti et al. to facilitate liver resection and is done classically by creating a space between the caudate lobe and the inferior vena cava starting on the edge of caudate lobe and extending cranially, in a para-caval fashion, towards the space between the right and middle hepatic veins. LHM facilitates liver transection, guides anatomical resections, decreases blood loss, facilitates harvesting of the liver graft in live donors, and also has oncological advantages. STUDY DESIGN: We describe a new approach named "up-to-down" to perform LHM in open and laparoscopic liver resections. This approach was mainly used in obese patients, in laparoscopic liver resections and in cases of failure of the classic approach. The advantages/disadvantages, complications, and different modalities of LHM are also summarized. RESULTS: The peritoneal layer between the liver capsule and the infrahepatic vena cava is opened, and a short blind dissection is initiated on the right anterolateral aspect of the inferior vena cava to the left of the hepatic vein of segment VI. The suprahepatic vena cava is exposed, and the space between the right and middle hepatic veins and the vena cava is created by gentle dissection. A 16-Fr nasogastric tube is positioned in the space between the right and middle hepatic vein, pointing inferiorly, and pushed downwards, in a para-caval manner caudally until it is seen inferiorly. The results of this approach are given. CONCLUSION: LHM facilitates liver resection, and many variations have been described worldwide in open and laparoscopic liver surgery. The up-to-down approach should be part of the surgical armamentarium in order to offer a safer way to achieve LHM in some patients.

Microcirculatory changes in the liver of patients with refractory ascites and their relationship with diabetes and alcohol.

OBJECTIVES: The determinants of refractory ascites have not been fully characterized. The aims of this study were to assess liver histopathological alterations associated with refractory ascites and their relationship with comorbidities. METHODS: Consecutive patients with cirrhosis who underwent liver transplantation were retrospectively included. Patients' characteristics at the time of listing were analysed. The native livers were reviewed and lesions associated with refractory ascites were examined. RESULTS: Out of the 89 patients included, 30 had refractory ascites and 59 did not (including 35 without ascites and 24 with diuretic-sensitive ascites). Patients with and without refractory ascites had a similar amount of fibrous tissue and features of fatty liver disease. By contrast, microvascular changes, namely sinusoidal dilatation (P < 0.001), diffuse perisinusoidal fibrosis (P = 0.001), hepatic venous thromboses (P = 0.004) and vascular proliferation (P = 0.01) were more frequently observed in the livers of patients with refractory ascites. Diabetes (57% vs. 31%, P = 0.02) and alcohol as a causal factor for cirrhosis (80% vs. 42%, P = 0.001) were more frequent in patients with refractory ascites than in those without. By multivariate analysis, refractory ascites was independently associated with diabetes mellitus [odds ratio (OR) (95% confidence interval, CI) 6.15 (1.47-25.71); P = 0.01], alcohol as a causal factor for cirrhosis [OR (95% CI) 4.63 (1.07-20.02); P = 0.04], higher Model For End Stage Liver Diseases [OR (95% CI) 1.21 (1.05-1.38); P = 0.008] and lower serum sodium [OR (95% CI) 0.87 (0.78-0.98); P = 0.03]. CONCLUSION: Liver microcirculatory changes are associated with refractory ascites. Diabetes and alcohol may explain refractory ascites by causing microangiopathy.

Pancreatic fistula following laparoscopic distal pancreatectomy is probably unrelated to the stapler size but to the drainage modality and significantly decreased with a small suction drain.

INTRODUCTION: Risk factors of postoperative pancreatic fistula (POPF) after laparoscopic distal pancreatectomy (LDP) are not well known and were studied, including the stapler cartridge size and drainage modality. METHODS: Between January 2008 and December 2016, 181 LDP were performed and the pancreas was sectioned by stapler in 130 patients (72%). Patients received white (2.5 mm), blue (3.5 mm), or green (4.1 mm) staplers and the size was not based on any pre or peroperative randomization. As primary analysis of the first 84 patients (28 in each group) showed no effect of stapler size on POPF, we decided to use the white (total = 47) or blue and finally the blue (total = 55) of medium size for standardization. Drainage was obtained by multi-tubular drain (first, 79) and a small suction drain (last, 102). Risk factors of POPF were studied and grades B and C were compared to grade A or no POPF. RESULTS: POPF (n = 66; 36%) was of grade A (n = 25, 14%), grade B (n = 32, 18%), and grade C (n = 9, 5%). The comparison of the three groups of staplers showed that the blue stapler was used more with a small suction drain (85 vs 23%, p < 0.0001), had lower rate of grade B POPF (p = 0.028), and a shorter hospital stay (p = 0.004). On multivariate analysis, only the use of a small suction drain was associated with significant decrease in grades B and C POPF (6 vs 44%, odds ratio 7.385 (1.919-28.418); p = 0.004). CONCLUSION: The occurrence of POPF following LDP is influenced by the type of drainage alone and is significantly decreased with a small suction drain.

R1 Resection for Colorectal Liver Metastases: a Survey Questioning Surgeons about Its Incidence, Clinical Impact, and Management.

BACKGROUND: A ≥ 1-mm margin is standard for resection of colorectal liver metastases (CLM). However, R1 resection is not rare (10-30%), and chemotherapy could mitigate its impact. The possibility of detaching CLM from vessels (R1 vascular margin) has been described. A reappraisal of R1 resection is needed. METHODS: A 19-question survey regarding R1 resection for CLM was sent to hepatobiliary surgeons worldwide. Seven clinical cases were included. RESULTS: In total, 276 surgeons from 52 countries completed the survey. Ninety percent reported a negative impact of R1 resection (74% local recurrence, 31% hepatic recurrence, and 36% survival), but 50% considered it sometimes required for resectability. Ninety-one percent of responders suggested that the impact of R1 resection is modulated by the response to chemotherapy and/or CLM characteristics. Half considered the risk of R1 resection to be an indication for preoperative chemotherapy in patients who otherwise underwent upfront resection, and 40% modified the chemotherapy regimen when the tumor response did not guarantee R0 resection. Nevertheless, 80% scheduled R1 resection for multiple bilobar CLM that responded to chemotherapy. Forty-five percent considered the vascular margin equivalent to R0 resection. However, for lesions in contact with the right hepatic vein, right hepatectomy remained the standard. Detachment from the vein was rarely considered (10%), but 27% considered detachment in the presence of multiple bilobar CLM. CONCLUSIONS: A negative margin is still standard for CLM, but R1 resection is no longer just a technical error. R1 resection should be part of the modern multidisciplinary, aggressive approach to CLM.

Hemorrhage of hepatocellular adenoma: a complication that can be treated by conservative management without surgery.

BACKGROUND: Hemorrhage is the main complication of hepatocellular adenoma (HCA). The aim of this study was to describe a single center's evolving management of patients with hemorrhagic HCA. METHOD: Between 1990 and 2013, all patients with hemorrhagic HCA were included. During the study period, the management evolved from urgent surgery (period <2004) to arterial embolization with (period, 2004-2010) or without (period > 2010) delayed resection. RESULTS: A total of 56 patients were identified. The median (range) size of HCA and the hematoma was 80 mm (35-160) and 50 mm (10-160). Patients were treated by urgent resection (group 1, n = 6), delayed resection with or without embolization (group 2, n = 43) and systematic embolization without surgery (group 3, n = 7). Embolization was performed in 0/6, 15/43 and 7/7 in groups 1, 2 and 3. Urgent resection was associated with higher morbidity (p < 0.001). Complete necrosis was observed in 0/6, 13/43 and 3/7 patients, and on histology it was associated with embolization (p = 0.001), a hematoma-tumor ratio > 60% (p = 0.046) and a cystic non-viable lesion before surgery (p < 0.001). CONCLUSION: Hemodynamic stability can be achieved in patients presenting with hemorrhagic HCA by none surgical means. Subsequent surgery can be completely avoided with such an approach in up to 40% of patients.

Polycystic liver disease: Hepatic venous outflow obstruction lesions of the noncystic parenchyma have major consequences.

In patients with polycystic liver disease (PLD), development of cysts induces hepatic venous outflow obstruction (HVOO) and parenchymal modifications, challenging the paradigm of a normal noncystic liver parenchyma. The aims were to reappraise the pathology of the noncystic parenchyma, by focusing on HVOO lesions; and to investigate the association with outflow obstruction at imaging and perioperative course after liver resection. This is a retrospective study conducted in one tertiary center between 1993 and 2014. PLD patients (n = 125) who underwent resection (n = 90) or transplantation (n = 35) were included. HVOO parenchymal lesions were assessed for all patients and a liver congestion score was built. Imaging was analysed for 45 patients with computed tomography scan, and perioperative course was assessed in resected patients. At pathology, 92% of patients had HVOO lesions, with sinusoidal dilatation being the most common feature. HVOO was more severe in patients who underwent transplantation compared to liver resection, as assessed by the congestion score. At imaging, all patients had HVOO with at least two hepatic veins involved. Mosaic enhancement pattern of the parenchyma was associated with the severity of hepatic vein obstruction (P = 0.045) and the compression of the inferior vena cava (P = 0.014). In case of liver resection, intraoperative course was characterized by hemorrhage, related to HVOO at imaging. Ascites (44%) and liver failure (9%) in the postoperative period were associated with blood losses and transfusions. CONCLUSION: Hepatic venous outflow obstruction, including development of venous collaterality and parenchymal changes, is frequent in PLD and has major consequences on intraoperative bleeding and postoperative ascites and liver failure. Hepatic venous outflow obstruction should be taken into account to choose the most appropriate surgical treatment. (Hepatology 2017).

Reconstruction of Bile Duct Injury and Defect with the Round Ligament.

Lateral injury of the bile duct can occur after cholecystectomy, bile duct dissection, or exploration. If direct repair is not possible, conversion to bilioenteric anastomosis can be needed with the risk of long-term bile duct infections and associated complications. We developed a new surgical technique which consist of reconstructing the bile duct with the round ligament. The vascularized round ligament is completely mobilized until its origin and used for lateral reconstruction of the bile duct to cover the defect. T tube was inserted and removed after few months. Patency of the bile duct was assessed by cholangiography, the liver function test and magnetic resonance imaging (MRI). Two patients aged 33 and 59 years old underwent lateral reconstruction of the bile duct for defects secondary to choledocotomy for stone extraction or during dissection for Mirizzi syndrome. The defects measured 2 and 3 cm and occupied half of the bile duct circumference. The postoperative course was marked by low output biliary fistula resolved spontaneously. In one patient, the T tube was removed at 3 months after surgery and MRI at 9 months showed strictly normal aspect of the bile duct with normal liver function test. The second patient is going very well 2 months after surgery and the T tube is closed. Lateral reconstruction of the bile duct can be safely achieved with the vascularized round ligament. We will extend our indications to tubular reconstruction.

The Largest European Single-Center Experience: 300 Laparoscopic Pancreatic Resections.

BACKGROUND: Although laparoscopic pancreatic resection (LPR) has become routine, large single-center series are still lacking. Our aim was to analyze the results of a large European single-center series of LPR. STUDY DESIGN: Between January 2008 and September 2015, 300 LPRs were performed and studied prospectively, including 165 (55%) distal pancreatectomies, 68 (23%) pancreaticoduodenectomies (PDs), 30 (10%) enucleations, 35 (11%) central pancreatectomies, and 2 (1%) total pancreatectomies. RESULTS: Mean age was 54 ± 15.4 years old (range 17 to 87 years), and most patients were women (58%). Laparoscopic pancreatic resection was performed for malignancy (46%), low potential malignant (44%), or benign (10%) diseases. The mean operative durations were 211 ± 102 minutes (range 30 to 540 minutes) for the entire population and 351 ± 59 minutes (range 240 to 540 minutes) for PD, and decreased with the learning curve. Mean blood loss was 229 ± 269 mL (range 0 to 1,500 mL), and 13 patients (4%) received transfusions. Conversion to an open procedure was required in 12 patients (4%), and only 5 in the last 250 patients (14% vs 2%; p < 0.001). Mortality occurred in 4 (1.3%) patients and only after PD (5.8%). Common complications were pancreatic fistula (n = 124, 41%), bleeding (n = 35, 12%), and reoperation (n = 28, 9%). The postoperative outcomes were less favorable in procedures with a reconstruction phase (n = 105) than in those without (n = 195), with increased mortality (3.8% vs 0%; p = 0.04), overall morbidity (76% vs % 52%; p < 0.001), and mean hospital stay (26 ± 15 days vs 16 ± 10 days; p < 0.001). CONCLUSIONS: Laparoscopic pancreatic resection without a reconstruction phase has excellent outcomes; LPR with a reconstruction phase, especially PD, has less favorable outcomes, and further randomized studies are required to draw conclusions on the safety and benefits of this approach.

Laparoscopic Repair of Post-cholecystectomy Bile Duct Injury: an Advance in Surgical Management.

Despite widespread advances in laparoscopic surgery, laparoscopic repair of post-cholecystectomy bile duct injury (BDI) has rarely been reported related mainly to technical difficulty. We describe three cases of BDI treated laparoscopically with one illustrated by a video. With our gained experience in hepatic pedicle dissection during laparoscopic pancreaticoduodenectomy, we decided to perform laparoscopic repair of BDI in patients with an intact biliary confluence without vascular injury. Three patients were operated including two women: one was re-operated by subcostal incision for peritonitis and two had undergone cholecystectomy without conversion. Surgical technique is detailed in the manuscript and the video. Laparoscopic repair was performed between 45 and 300 days after cholecystectomy. Surgery lasted between 250 and 270 min with no conversion and no transfusion. The postoperative course was uneventful with a hospital stay ranging from 7 to 9 days. After a mean follow-up of 9-33 months, patients were symptom free with normal liver function tests. The laparoscopic approach can be safely and effectively proposed to a subgroup of patients with BDI. This approach has the advantages of the laparoscopic approach and represents the main new surgical advancement in the management of this complication.

Surgical procedures in liver transplant patients: A monocentric retrospective cohort study.

BACKGROUND: Pre-existing chronic liver diseases and the complexity of the transplant surgery procedures lead to a greater risk of further surgery in transplanted patients compared to the general population. The aim of this monocentric retrospective cohort study was to assess the epidemiology of surgical complications in liver transplanted patients who require further surgical procedures and to characterize their post-operative risk of complications to enhance their medical care. PATIENTS AND METHODS: From January 1997 to December 2011, 1211 patients underwent orthotropic liver transplantation in our center. A retrospective analysis of prospectively collected data was performed considering patients who underwent surgical procedures more than three months after transplantation. We recorded liver transplantation technique, type of surgery, post-operative complications, time since the liver transplant and immunosuppressive regimens. RESULTS: Among these, 161 patients (15%) underwent a further 183 surgical procedures for conditions both related and unrelated to the transplant. The most common surgical procedure was for an incisional hernia repair (n = 101), followed by bilioenteric anastomosis (n = 44), intestinal surgery (n = 23), liver surgery (n = 8) and other surgical procedures (n = 7). Emergency surgery was required in 19 procedures (10%), while 162 procedures (90%) were performed electively. Post-operative mortality and morbidity were 1% and 30%, respectively. According to the Dindo-Clavien classification, the most common grade of morbidity was grade III (46%), followed by grade II (40%). CONCLUSION: Surgical procedures on liver transplanted patients are associated with a significantly high risk of complications, irrespective of the time elapsed since transplantation.