Applying international organization for standards 9001 to create an effective surgical quality committee

BackgroundEfforts to improve surgical safety are limited by several factors and no consensus exists regarding the most effective way to improve surgical quality. The use of ISO 9001 quality standards within healthcare is recognized but has not been widely applied for improving surgical outcomes.MethodsA surgical quality committee was created using ISO 9001:2015 standards. Quality objectives were assessed to understand how any suggested changes will be impacted due to risks and opportunities inherent in the system.ResultsThe initial quality focus was on surgical site infections in 5 services. Change in surgical infection ratio from 2018 to 2019 showed significant improvement: coronary bypass 1.288 vs. 0.901; Colon 1.359 vs. 0.589; Hysterectomy 2.119 vs. 1.022; Knee 1.391 vs. 0.306; Hip 0 vs. 0.302.ConclusionsThis is one of the first studies using ISO 9001 to improve surgical quality. The results indicate both acceptance and success of applying continual improvement strategies.     

Diffuse glomerular basement membrane lamellation in renal allografts from pediatric donors to adult recipients

The transplantation of kidneys from pediatric cadaveric donors into adult recipients is performed in many centers. However, some studies indicate that the outcome of such renal transplants may be inferior compared with that of adult donors, particularly if the donor is an infant. Morphologic studies of failed pediatric donor kidneys in adult recipients describe various degrees of segmental or global glomerular sclerosis. The authors have performed ultrastructural examinations on such transplants and have identified six cases with diffuse irregular lamellation of the glomerular basement membrane (GBM), a change that may develop as early as 10 weeks after transplantation. The age of all donors was < or =6 years; three were infants. The incidence of the lesion was 9% at our institution in renal transplant patients who received a graft from donors <10 years old. Diffuse GBM lamellation has not been found in renal transplants from adult donors. Light microscopy showed various degrees of diffuse mesangial expansion, usually with segmental glomerular sclerosis. The patients had severe proteinuria. While recurrent focal segmental glomerular sclerosis (FSGS) has to be excluded, such diffuse GBM lamellation is generally not seen in recurrent FSGS cases. The pathogenesis of the lesion is most likely related to hyperperfusion injury of small pediatric donor kidneys grafted into adult recipients.     

The Safety and Efficacy of Approaches to Liver Resection: A Meta-Analysis

Background:The aim of this study is to compare the safety and efficacy of conventional laparotomy with those of robotic and laparoscopic approaches to hepatectomy.Database:Independent reviewers conducted a systematic review of publications in PubMed and Embase, with searches limited to comparative articles of laparoscopic hepatectomy with either conventional or robotic liver approaches. Outcomes included total operative time, estimated blood loss, length of hospitalization, resection margins, postoperative complications, perioperative mortality rates, and cost measures. Outcome comparisons were calculated using random-effects models to pool estimates of mean net differences or of the relative risk between group outcomes. Forty-nine articles, representing 3702 patients, comprise this analysis: 1901 (51.35%) underwent a laparoscopic approach, 1741 (47.03%) underwent an open approach, and 60 (1.62%) underwent a robotic approach. There was no difference in total operative times, surgical margins, or perioperative mortality rates among groups. Across all outcome measures, laparoscopic and robotic approaches showed no difference. As compared with the minimally invasive groups, patients undergoing laparotomy had a greater estimated blood loss (pooled mean net change, 152.0 mL; 95% confidence interval, 103.3–200.8 mL), a longer length of hospital stay (pooled mean difference, 2.22 days; 95% confidence interval, 1.78–2.66 days), and a higher total complication rate (odds ratio, 0.5; 95% confidence interval, 0.42–0.57).Conclusion:Minimally invasive approaches to liver resection are as safe as conventional laparotomy, affording less estimated blood loss, shorter lengths of hospitalization, lower perioperative complication rates, and equitable oncologic integrity and postoperative mortality rates. There was no proven advantage of robotic approaches compared with laparoscopic approaches.     

Early inhibition of the renin‐angiotensin system improves the long‐term graft survival of single pediatric donor kidneys transplanted in adult recipients

Transplanting single pediatric donor kidneys into adult recipients has an increased risk of hyperfiltration injury and graft loss. It is unknown if renin‐angiotensin system (RAS) blockers are beneficial in this setting. We retrospectively analyzed 94 adults who received single kidneys from donors <10 years old during 1996–2009. The recipients were divided into group 1 with RAS blockers (n = 40) and group 2 without RAS blockers (n = 54) in the first year of transplant. There was no significant difference in any donor/recipient demographic between the two groups. Graft function, incidence of delayed graft function, acute rejection, and persistent proteinuria were not statistically different either. Kaplan–Meier estimated death‐censored graft survivals were significantly better in group 1 than in group 2: 95 vs. 81.2%, 82.4 vs. 61.2%, 72.6 vs. 58.5%, and 68.5 vs. 47.2% at 1, 3, 5, and 7 years, respectively (log rank P = 0.043). Multivariable analysis found persistent proteinuria was a risk factor for graft loss (OR 2.70, 95% CI 1.33–5.49, P = 0.006), while RAS blockers reduced the risk of graft loss (OR 0.38, 95% CI 0.18–0.79, P = 0.009). Early RAS blockade therapy in the first year of transplant is associated with superior long‐term graft survival among adults transplanted with single pediatric donor kidneys.     

Budd-Chiari syndrome: current management options

OBJECTIVE: To assess the outcomes of current treatment strategies for Budd-Chiari syndrome. SUMMARY BACKGROUND DATA: Budd-Chiari syndrome, occlusion or obstruction of hepatic venous outflow, is a disease traditionally managed by portal or mesenteric-systemic shunting. The development of other treatment options, such as catheter-directed thrombolysis, transjugular portosystemic shunting (TIPS), and liver transplantation, has expanded the therapeutic algorithm. METHODS: The authors reviewed the medical records of all patients diagnosed with Budd-Chiari syndrome at the Johns Hopkins Hospital during the past 20 years. RESULTS: A total of 54 patients were identified: 13 (24%) male patients and 41 (76%) female patients, ranging in age from 2 to 76 years (median 33 years). Twenty-one (39%) had polycythemia vera, 3 (5.6%) used estrogens, 11 (20%) had a myeloproliferative or coagulation disorder, and in 7 (13%) the cause remained unknown. Forty-three patients were treated with surgical shunting, 24 mesocaval and 19 mesoatrial. Actuarial survival rates at 1, 3, and 5 years after shunting were 83%, 78%, and 75%, respectively. Of 33 patients surviving more than 4 years, 28 (85%) had relief of clinical symptoms. Five patients required shunt revision and eight had radiologic procedures to maintain shunt patency. Primary and secondary shunt patency rates were 46% and 69% respectively for mesoatrial shunts and 70% and 85% respectively for mesocaval shunts. Clot lysis was successful as primary treatment in seven patients. TIPS was performed in three patients, one after a failed mesocaval shunt. During an average of 4 years of follow-up, these patients required multiple procedures to maintain TIPS patency. Six patients underwent liver transplantation. Of these, three had previous shunt procedures. Five of the transplant recipients are alive with follow-up of 2 to 9 years (median 6). CONCLUSIONS: Both shunting and transplantation can result in a 5-year survival rate of at least 75%, and other treatment modalities may be appropriate for highly selected patients. Optimal management requires that treatment be directed by the predominant clinical symptom (liver failure or portal hypertension) and anatomical considerations and be tempered by careful assessment of surgical risk.     

High body mass index and short- and long-term renal allograft survival in adults

BACKGROUND: The effect of recipient obesity on kidney allograft survival remains enigmatic. The purpose of this study was to evaluate the effect of donor and recipient body mass index on graft survival. METHODS: Retrospective study of 193 consecutive, adult renal transplants, with at least six months follow-up (mean 24+/-14.1 months). Patients were divided into two groups based upon body mass index (BMI), [weight (kg)/height (m)]: normal (<30.0, n=137) and obese (> or =30.0, n=56). Endpoints were graft loss, defined as either total loss of graft function (return to dialysis) or patient death with a functional graft. Unadjusted and adjusted multivariate analysis techniques, including Kaplan-Meier and Cox proportional hazards regression were used. RESULTS.: Individuals with a BMI > or =30 were not more likely to experience graft loss (O.R. 0.93, 95% C.I. 0.50, 1.72). Rates of acute rejection were not increased in obese recipients. While mortality was not increased in the BMI > 30 group, morbidity, especially surgical, had an increased incidence. The ratio of recipient to donor BMI did not influence graft survival. CONCLUSION: Obese recipients (BMI > or =30.0) were not at increased risk for graft failure. Additionally, matching donor and recipient BMI's would not appear to substantially improve transplant outcome. Obese recipients do have increased posttransplant morbidity and risk all the known health consequences associated with obesity. Careful evaluation and clinical management of obese patients allows for successful kidney transplantation with results equivalent to normal BMI patients.     

Hand-assisted laparoscopic donor nephrectomy: a low rate of complications

BACKGROUND: Laparoscopic donor nephrectomy is associated with a higher incidence of ureteral complications. Hand-assisted dissection minimizes the use of instruments for intraoperative retraction and handling of periureteric tissue, and may reduce posttransplant complications. OBJECTIVE: To assess the outcome of hand-assisted laparoscopic donor nephrectomy, in particular ureteral complications. METHODS: Records of 143 kidney transplant recipients who received allografts removed using the hand-assisted laparoscopic technique were retrospectively studied. RESULTS: Total operating time was 2.0 +/- 0.55 (range 1.08-4) hours. Warm ischemia time was 1.45 +/- 0.60 (range 0.58-3.00) minutes. Length of artery, vein, and ureter was 2.4 +/- 0.5 cm, 3.0 +/- 0.5 cm, and 10.3 +/- 2.1 cm, respectively. Estimated blood loss averaged 86.3 +/- 55.6 mL. Intraoperative suction was not needed in 65% of patients. Two donors developed incisional hernias and 1 had a postoperative ileus. Four of 143 (2.8%) recipients developed ureteral complications: reoperations for ureteral necrosis (1), stenting for ureteral stenosis (2), and urethral catheterization for ureterovesical leak (1). Graft loss in the first year after transplantation occurred because of renal vein thrombosis, thrombosis of revised arterial anastomosis, arterial thrombosis due to myocardial infarction, vasculitis, focal segmental glomerulosclerosis, and chronic rejection. Delayed graft function developed in 3 recipients. The acute rejection rate was 14.6%. Mean serum creatinine levels at 1 and 3 years were 134 +/- 61 micromol/L (1.52 +/- 0.69 mg/dL) and 121 +/- 35 micromol/L (1.37 +/- 0.40 mg/dL), respectively. CONCLUSIONS: Hand-assisted laparoscopic donor nephrectomy is associated with a low incidence of ureteral complications; may reduce the technical difficulty of the operation and minimize retraction with instruments, resulting in fewer complications for donors and recipients; and minimizes donor blood loss.