Utility of Preoperative [(18)]F Fluorodeoxyglucose–Positron Emission Tomography Scanning in High-Risk Melanoma Patients

Background [(18)]F Fluorodeoxyglucose-positron emission tomography (PET) scanning provides functional imaging based on glucose uptake by tumors. Melanoma is a glucose-avid malignancy, and preoperative PET scanning in melanoma patients has the potential to guide appropriate treatment. Methods We performed a prospective trial to evaluate the clinical utility of whole-body fluorine 18–labeled deoxyglucose-PET scanning used in addition to standard imaging (contrast-enhanced computed tomographic [CT] imaging of the chest, abdomen, and pelvis) in preoperative stage IIC (T4N0M0), III (any T, N1 to N3, M0), and IV (any T, any N, M1) melanoma patients. Pathologic or clinical follow-up within 4 to 6 months of the imaging studies was used to determine the accuracy of preoperative PET and CT scan findings. Results Preoperative imaging findings led to a change in clinical management in 36 (35%) of 103 patients. In 32 (89%) of these patients, the information was accurate. Findings on PET scan alone (14 of 36; 39%) or in combination with CT (20 of 36; 56%) resulted in a treatment change in most patients (34 of 36; 94%). The most common decision was to cancel the operation (19 of 36; 53%). PET scanning was more sensitive than CT scanning in detecting occult disease (68% vs. 48%; P = .05), but both tests were highly specific (92% vs. 95%; P = .7, PET vs. CT). Conclusions PET scanning facilitates the appropriate management of high-risk melanoma patients being considered for operative intervention. PET imaging in addition to CT scanning should be strongly considered before operation in patients at high risk for occult metastatic disease. Presented in part at the Annual Meeting of the American Society of Clinical Oncology, New Orleans, Louisiana, June 7, 2004.     

Cost–Utility Estimations of Palliative Care in Patients With Pancreatic Adenocarcinoma: A Retrospective Analysis

Background

We earlier reported cost–utility estimates in patients who undergo resection aimed at cure for pancreatic carcinoma. The present study describes similar information on patients with unresectable tumors who experienced palliative care only.

Methods

A population-based cohort of patients with exocrine pancreatic adenocarcinoma during 1998–2005 was evaluated retrospectively (n = 444). Total direct health care costs at departments of surgery and oncology, for primary health care, and at hospice were achieved. Self-estimated health-related quality of life (HRQL) was assessed by the SF-36. A single preference-based utility index, SF-6D, was derived from SF-36 items to estimate quality-adjusted life years (QALYs). Results were compared to similar findings in a previously reported group of patients with pancreatic carcinoma resected for cure (n = 31).

Results

Palliative care patients (n = 305) had impaired HRQL particularly related to physical domains. The mean preference-based health utility index at diagnosis was 0.65 ± 0.02 [95 % confidence interval (CI) 0.61–0.69] compared to 0.77 ± 0.02 (95 % CI 0.75–0.79) in healthy reference individuals. Total direct health care costs were 50 % in patients on palliative care compared to costs for surgical R0 resections (23,701 and 50,950€, respectively). QALYs for 1 year from diagnosis were 0.2 (95 % CI 0.17–0.23) in patients on palliative care and 0.48 (95 % CI 0.44–0.54) in resection patients. Costs per QALY were 118,418€ and 106,146€, respectively (95 % CI 103,048–139,418€ and 94,352–115,795€).

Conclusions

Optimized palliative care of patients with exocrine pancreatic carcinoma had costs per achieved utility similar to those for surgical resections aimed at cure.     

Prospective Evaluation of Endoluminal Venous Stents in the Treatment of the May–Thurner Syndrome

The May–Thurner syndrome is an acquired stenosis of the left common iliac vein causing pain, edema, or deep venous thrombosis (DVT). The patency and behavior of endoluminal venous stents for this condition was evaluated in this study. Patients with the May–Thurner lesion treated with endoluminal stenting from 1997 to 2000 were evaluated according to an institutional review board–approved protocol. Wallstents (n = 14) or Smart stents (n = 1) were placed into the left common iliac. Patency was evaluated with duplex ultrasonography using a 5 mHz linear array probe (HP 4500) at 6-month intervals. Our results showed that treatment of the May–Thurner syndrome with endoluminal stenting is associated with low morbidity and high patency rates. Longitudinal evaluation of this group of patients is ongoing to confirm these findings.     

Association of Type O Blood with Pancreatic Neuroendocrine Tumors in Von Hippel–Lindau Syndrome

Background

ABO blood type antigens are expressed not only on human red blood cells, but also throughout the gastrointestinal tract and in normal pancreatic tissue. Previous studies have identified an association between ABO blood type and various malignancies. We analyzed the association of ABO blood type with pancreatic neuroendocrine tumors (PNETs) in a high-risk cohort of patients with Von Hippel?CLindau (VHL) syndrome.

Methods

A retrospective review was performed of 798 patients with VHL syndrome. Blood type was confirmed for 181 patients. Fisher??s exact test and Mehta??s modification to Fisher??s exact test were used to test for an association between ABO blood type and manifestations of VHL syndrome.

Results

We found a strong trend for association between O blood type and pancreatic disease manifestation in patients with VHL syndrome (P?=?0.047). More importantly, there was a significant association of O blood type with solid pancreatic lesions consistent with PNETs (P?=?0.0084). Patients with solid pancreatic lesions who met criteria for surgical resection at the National Institutes of Health also had a higher rate of O blood type than those who did not require surgery (P?=?0.051).

Conclusions

Our findings suggest an association between O blood type and pancreatic manifestation of disease in patients with VHL syndrome, especially for PNETs. Screening and surveillance approaches for pancreatic lesions in patients with VHL syndrome should also consider patient blood type. The possibility of A, B, H misexpression in PNETs should also be explored to determine whether the serologic association with disease translates into a relationship with tissue pathology.     

Is Geographic Socioeconomic Disadvantage Associated with the Rate of THA in Medicare-aged Patients?

BackgroundDisparities in THA use may lead to inequitable care. Prior research has focused on disparities based on individual-level and isolated socioeconomic and demographic variables. To our knowledge, the role of composite, community-level geographic socioeconomic disadvantage has not been studied in the United States. As disparities persist, exploring the potential underlying drivers of these inequities may help in developing more targeted recommendations on how to achieve equitable THA use.Questions/purposes(1) Is geographic socioeconomic disadvantage associated with decreased THA rates in Medicare-aged patients? (2) Do these associations persist after adjusting for differences in gender, race, ethnicity, and proximity to hospitals performing THA?MethodsIn a study with a cross-sectional design, using population-based data from five-digit ZIP codes in Maryland, USA, from July 1, 2012 to March 31, 2019, we included all inpatient and outpatient primary THAs performed in individuals 65 years of age or older at acute-care hospitals in Maryland, as reported in the Health Services Cost Review Commission database. This database was selected because it provided the five-digit ZIP code data necessary to answer our study question. We excluded THAs performed for nonelective indications. We examined the annual rate of THA in our study population for each Maryland ZIP code, adjusted for differences across areas in distributions of gender, race, ethnicity, and distance to the nearest hospital performing THAs. Four hundred fourteen ZIP codes were included, with an overall mean ± SD THA rate of 371 ± 243 per 100,000 persons 65 years or older, a rate similar to that previously reported in individuals aged 65 to 84 in the United States. Statistical significance was assessed at α = 0.05.ResultsTHA rates were higher in more affluent areas, with the following mean rates per 100,000 persons 65 years or older: 422 ± 259 in the least socioeconomically disadvantaged quartile, 339 ± 223 in the second-least disadvantaged, 277 ± 179 in the second-most disadvantaged, and 214 ± 179 in the most-disadvantaged quartile (p < 0.001). After adjustment for distributions in gender, race, ethnicity, and hospital proximity, we found that geographic socioeconomic disadvantage was still associated with THA rate. Compared with the least-disadvantaged quartile, the second-least disadvantaged quartile had 63 fewer THAs per 100,000 people (95% confidence interval 12 to 114), the second-most disadvantaged quartile had 136 fewer THAs (95% CI 62 to 211), and the most-disadvantaged quartile had 183 fewer THAs (95% CI 41 to 325).ConclusionGeographic socioeconomic disadvantage may be the underlying driver of disparities in THA use. Although our study does not determine the “correct” rate of THA, our findings support increasing access to elective orthopaedic surgery in disadvantaged geographic communities, compared with prior research and efforts that have studied and intervened on the basis of isolated factors such as race and gender. Increasing access to orthopaedic surgeons in disadvantaged neighborhoods, educating physicians about when surgical referral is appropriate, and educating patients from these geographic communities about the risks and benefits of THA may improve equitable orthopaedic care across neighborhoods. Future studies should explore disparities in rates of appropriate THA and the role of density of orthopaedic surgeons in an area.Level of EvidenceLevel III, therapeutic study.     

Pancreatic Lesions in von Hippel–Lindau Disease? A Systematic Review and Meta-synthesis of the Literature

Background

von Hippel?CLindau (vHL) disease is a rare condition that leads to characteristic lesions within many different body systems. Pancreatic manifestations of vHL cover a wide spectrum of pathologies, and thus, accurate characterization and management is critical.

Methods

A comprehensive and systematic text word and MeSH search of the medical literature was performed to identify studies where information regarding the prevalence, clinical characteristics, and management recommendations could be extracted.

Results

Eleven studies were identified but 2 studies utilized the same data set. Of the 10 remaining studies, a total of 1,442 patients with vHL were available for analysis. Four hundred and twenty patients were examined for any type of pancreatic lesion, 362 for simple cysts or serous cystadenomas (SCAs), and 1,442 for neuroendocrine tumors (NETs). Of the 420 assessed for any pancreatic manifestation of vHL, 252 (60%) had a pancreatic lesion identified. Simple cysts that present as the sole manifestation of pancreatic disease were common and found in 169 of 362 (47%) patients. These are usually asymptomatic and do not normally require intervention. SCAs were reported in 39 of 362 (11%) patients and followed a similar benign course; resection is acceptable in symptomatic patients. NETs were identified in 211 of 1,442 (15%) patients, and 27 of 1,442 (2%) lesions behaved malignantly. Management of NETs depends on size, doubling time, and underlying genetics. Renal cell carcinoma is a characteristic in vHL, but there were no cases of pancreatic metastases identified from the included studies. Adenocarcinomas of the pancreas are not pathogenically linked to vHL.

Conclusions

This review highlights the wide spectrum and high prevalence of pancreatic lesions in vHL. Simple cysts and SCAs are benign, but NETs require careful observation due to their malignant potential.     

Evaluation of the Role of the SQSTM1 Gene in Sporadic Belgian Patients with Paget’s Disease

A positional cloning effort in French Canadian families with Pagets disease of bone (PDB) resulted in the identification of a mutation in the sequestosome1 (SQSTM1) gene in a subset of both familial and sporadic PDB cases. This was confirmed in samples of mainly United Kingdom (UK) origin. In this study, we performed both mutation analysis and association studies in order to evaluate the role of this gene in a collection of isolated Belgian PDB patients. A mutation in the SQSTM1 gene was found in only 6 of 111 patients (5.4%). In all cases it involves the P392L mutation, previously shown to be common in both familial and sporadic cases. To perform association studies, we selected 8 single nucleotide polymorphisms (SNPs) and looked for linkage disequilibrium (LD) between these. Haplotype analysis indicated that typing of 3 Tag SNPs (IVS1+633A/C, IVS5–23A/G, and 976A/G) enables us to identify the most common haplotypes. Association studies for the 3 selected SNPs, based on 105 PDB cases without a SQSTM1 mutation and 159 control individuals, did not support a possible influence of natural variants in the SQSTM1 gene either on the pathogenesis of PDB or on the disease severity. In conclusion, our study confirms that the P392L mutation is a recurrent mutation causing PDB in different populations. We were not able to show an association between SQSTM1 polymorphisms and PDB in our population but this clearly needs to be extended to other populations. The presented identification of haplotype Tag SNPs will be of major help for such studies.     

Does the Mechanism of Lymph Node Invasion Affect Survival in Patients with Pancreatic Ductal Adenocarcinoma?

Background  

Lymph node metastases are prognostically significant in pancreatic ductal adenocarcinoma. Little is known about the significance of direct lymph node invasion.     

Nɛ–homocysteinyl–lysine Isopeptide is Associated with Progression of Peripheral Artery Disease in Patients Treated with Folic Acid

ObjectiveFolic acid (FA) administration can reduce plasma total homocysteine (tHcy); however, it fails to decrease cardiovascular events and progression of peripheral artery disease (PAD). N?–homocysteinyl–lysine isopeptide (N?–Hcy–Lys) is formed during catabolism of homocysteinylated proteins. We sought to investigate factors that determine the presence of N?–Hcy–Lys in PAD patients with hyperhomocysteinemia receiving FA.Patients and methodsWe studied 131 consecutive PAD patients with tHcy > 15 μmol l^?1 taking FA 0.4 mg d^?1 for 12 months. Serum N?–Hcy–Lys was determined by high-performance liquid chromatography (HPLC). We also measured interleukin-6 (IL-6), plasminogen activator inhibitor-1 (PAI-1), asymmetric dimethylarginine (ADMA) and 8-iso-prostaglandin F_2α (8-iso-PGF_2α).ResultsFA administration resulted in a 70.5% decrease in tHcy (p < 0.0001). However, serum N?–Hcy–Lys was detectable in 28 (21.4%) patients on FA who were more frequently current smokers and survivors of ischaemic stroke (p < 0.001). They had higher tHcy by 46.0%, PAI-1 by 51.7%, 8-iso-PGF_2α by 59.1% and ADMA by 26.4% (all, p < 0.0001). The presence of N?–Hcy–Lys was associated with lower ankle-brachial index (ABI) values (p < 0.001) and higher prevalence of cardiovascular events (p < 0.001) following therapy.ConclusionThe presence of N?–Hcy–Lys in one-fifth of hyperhomocysteinemic individuals with PAD despite FA treatment is associated with progression of PAD and with increased ADMA formation, oxidative stress and hypofibrinolysis.     

Comparison of RIFLE and AKIN Criteria in the Evaluation of the Frequency of Acute Kidney Injury in Post–Liver Transplantation Patients

BackgroundAcute renal dysfunction is presented quite often after orthotopic liver transplantation (LT), with a reported incidence of 12–64%. The “RIFLE” criteria were introduced in 2004 for the definition of acute kidney injury (AKI) in critically ill patients, and a revised definition was proposed in 2007 by the Acute Kidney Injury Network (AKIN), introducing the AKIN criteria. The aim of this study was to record the incidence of AKI in patients after LT by both classifications and to evaluate their prognostic value on mortality.MethodsWe retrospectively evaluated the records of patients with LT over 2 years (2011–2012) and recorded the incidence of AKI as defined by the RIFLE and AKIN criteria. Preoperative and admission severity of disease scores, duration of mechanical ventilation, intensive care unit length of stay, and 30- and 180-day survivals were also recorded.ResultsSeventy-one patients were included, with an average age of 51.78 ± 10.3 years. The incidence of AKI according to the RIFLE criteria was 39.43% (Risk, 12.7%; Injury, 12.7%; Failure, 14.1%), whereas according to the AKIN criteria it was 52.1% (stage I, 22.5%; stage II, 7%; stage II 22.55%). AKI, regardless of the classification used, was related to the Model for End-Stage Liver Disease score, the volume of transfusions, the duration of mechanical ventilation, and survival. The presence of AKI was related to higher mortality, which rose proportionally with the severity of AKI as defined by the stages of either the RIFLE or the AKIN criteria.ConclusionsAKI classifications according to the RIFLE and AKIN criteria are useful tools in the recognition and classification of the severity of renal dysfunction in patients after LT, because they are associated with higher mortality, which rises proportionally with the severity of renal disease.     

Searching for Indicators of Malignancy in Pancreatic Intraductal Papillary Mucinous Neoplasms: The Value of 18FDG–PET Confirmed

Background

Malignancy in intraductal papillary mucinous neoplasms (IPMN) of the pancreas may be predicted on the basis of a number of clinical and radiologic features, which have raised sensitivity but result in a specificity as low as 20?C50%. We sought to confirm the additional value of ¹⁸F-18-fluorodeoxyglucose?Cpositron emission tomography (¹⁸FDG?CPET) in diagnostic accuracy of imaging-based IPMN malignancy assessment.

Methods

This prospective uncontrolled case series contained 44 patients with IPMN undergoing comprehensive diagnostic evaluation, including magnetic resonance cholangiopancreatography and ¹⁸FDG?CPET. Average follow-up time was 39.3?months (range 3?C97?months). Diagnostic performance regarding the diagnosis of malignancy was evaluated for the classic preoperative assessment, including clinical signs, CA 19-9, imaging (computed tomography and magnetic resonance cholangiopancreatography), and International Consensus Guidelines criteria, as well as ¹⁸FDG?CPET scan.

Results

Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 100, 22, 32, 100, and 43%, and 83, 100, 100, 94, and 96%, respectively, for comprehensive assessment without and with ¹⁸FDG?CPET [maximum standardized uptake value (SUV_max) cutoff of 2.5?MBq]. Elevated CA 19-9 values and positive PET scan were the only independent prognostic factors for malignancy (odds ratio 2.11, 95% confidence interval 1.15?C2.74 and 5.49, 95% confidence interval 3.98?C21.44, respectively).

Conclusions

¹⁸FDG?CPET is useful for detection of malignancy in IPMN, improving the differential diagnosis with benign cases by functional data. The choice of SUV_max cutoff should maximize specificity.     

The Clinical Utility of DCISionRT® on Radiation Therapy Decision Making in Patients with Ductal Carcinoma In Situ Following Breast-Conserving Surgery

Background

The role of radiation therapy (RT) following breast-conserving surgery (BCS) in ductal carcinoma in situ (DCIS) remains controversial. Trials have not identified a low-risk cohort, based on clinicopathologic features, who do not benefit from RT. A biosignature (DCISionRT^®) that evaluates recurrence risk has been developed and validated. We evaluated the impact of DCISionRT on clinicians’ recommendations for adjuvant RT.

Methods

The PREDICT study is a prospective, multi-institutional, observational registry in which patients underwent DCISionRT testing. The primary endpoint was to identify the percentage of patients where testing led to a change in RT recommendations.

Results

Overall, 539 women were included in this study. Pre DCISionRT testing, RT was recommended to 69% of patients; however, post-testing, a change in the RT recommendation was made for 42% of patients compared with the pre-testing recommendation; the percentage of women who were recommended RT decreased by 20%. For women initially recommended not to receive an RT pre-test, 35% had their recommendation changed to add RT following testing, while post-test, 46% of patients had their recommendation changed to omit RT after an initial recommendation for RT. When considered in conjunction with other clinicopathologic factors, the elevated DCISionRT score risk group (DS > 3) had the strongest association with an RT recommendation (odds ratio 43.4) compared with age, grade, size, margin status, and other factors.

Conclusions

DCISionRT provided information that significantly changed the recommendations to add or omit RT. Compared with traditional clinicopathologic features used to determine recommendations for or against RT, the factor most strongly associated with RT recommendations was the DCISionRT result, with other factors of importance being patient preference, tumor size, and grade.

     

Reoperative Intervention in Patients with Mesh at the Hiatus is Associated with High Incidence of Esophageal Resection—A Single-Center Experience

Background

Mesh hiatoplasty is a widely debated topic among foregut surgeons. While short-term outcomes tout decreased recurrence rates, an increase in mesh-related complications has been reported. The aim of this study is to present a single-center experience with reoperative intervention in patients with previous mesh at the hiatus.

Methods

After institutional review board approval, a prospectively maintained database was retrospectively queried to identify patients who underwent reoperative intervention between 2003 and spring of 2013 and had mesh placed at a previous hiatal hernia procedure. Patient charts were reviewed and data variables collected.

Results

Twenty-six patients (mean age of 56.7?±?18.3; 19 females) who underwent 27 procedures met the inclusion criteria. Synthetic mesh was placed in 15 (56 %) procedures, while the remaining 12 had biologic mesh. The mean interval between reoperative intervention and previous surgery was 33 months. Dysphagia (56 %) was the most common presentation, while three patients had mesh erosion. Recurrent hiatus hernia (2 to 7 cm) was noted in 19 (70 %) patients. Eight patients (30 %) underwent redo fundoplication, six patients (22 %) were converted to Roux-en-Y gastrojejunostomy, two patients (7.4 %) underwent distal esophagectomy with esophagojejunostomy, five patients (19 %) had subtotal esophagectomy with gastric pull-up, and one patient underwent substernal gastric pull-up for esophageal bypass with interval esophagectomy. The mean operative time was 252?±?71.7 min, and the median blood loss was 150 ml (range, 50–1,650 ml). There was no postoperative mortality.

Conclusion

Reoperative intervention in patients with mesh at the hiatus is associated with a high need for esophageal resection. More than two thirds of the patients also had a recurrent hiatal hernia.     

Utility of ¹⁸F-FDG PET/CT in identifying penile squamous cell carcinoma metastatic lymph nodes

ObjectivesDue to the significant potential morbidity of inguinal and pelvic lymphadenectomy, the search for an imaging modality that can accurately identify penile squamous cell carcinoma (SCCA) lymphatic metastases continues. Initial ¹⁸F-FDG PET/CT studies have reported 80% sensitivity and 100% specificity in the detection of inguinal and obturator lymph node metastasis. We review a single institutional experience of ¹⁸F-FDG PET/CT imaging of SCCA of the penis to assess for accuracy and potential impact on clinical management.MethodsThree patients diagnosed with penile SCCA at a single institution underwent staging ¹⁸F-FDG PET/CT and went on to subsequent inguinal lymph node dissection. The ¹⁸F-FDG PET machine was a Philips Gemini Time-of-Flight PET with LYSO crystals with 4.7 mm spatial resolution. The CT was a 16-slice helical CT with 5 mm slice widths. ¹⁸F-FDG PET/CT findings were compared with the histologic findings of these procedures. Decision to proceed with lymphadenectomy was based on clinical judgment of a single urologist and all fused ¹⁸F-FDG PET/CT imaging was assessed by a single experienced radiologist.ResultsNo patient received chemotherapy or radiation before the ¹⁸F-FDG PET/CT or surgery. The first patient was obese (BMI > 30), clinically node negative, and the ¹⁸F-FDG PET/CT showed inflammation. Histologic examination showed a positive 2 cm right inguinal metastatic node. The second patient's ¹⁸F-FDG PET/CT showed a suspicious 1 cm left inguinal node. Histologically, the suspicious lymph node was positive for SCCA as was a second positive 2 cm lymph node not identified on preoperative ¹⁸F-FDG PET/CT. Clinical exam of this patient was negative. The third patient was ¹⁸F-FDG PET/CT and clinically negative but subsequently developed a palpable lymph node approximately 1 month later, which was suspicious on repeat ¹⁸F-FDG PET/CT and positive for SCCA on histological examination.Conclusions¹⁸F-FDG PET/CT has shown initial promise in the staging of penile SCCA. However, our review shows that false negative studies occur at alarmingly high rates, and ¹⁸F-FDG PET/CT is poor in detection of micro-metastasis. Thus, close follow-up in these patients is imperative.     

A Prospective Evaluation of a Variant of Biliopancreatic Diversion with Roux-en-Y Reconstruction in Mega-obese Patients (BMI ≥ 70 kg/m2)

BACKGROUND: Super-obese patients with BMI > or = 70 kg/m(2) present a special subgroup among the obese population due to the higher incidence of severe comorbidities and increased technical difficulties in perioperative management. The optimal surgical approach still remains controversial. METHODS: From January 2002 to October 2007, 68 super-obese patients with BMI > or = 70 kg/m(2) (75.7 +/- 5.61) and various comorbidities (mean 1.45 +/- 1, range 0-5), underwent a variant of biliopancreatic diversion with Roux-en-Y reconstruction (BPD-RYGBP) at our institution. The mean age was 39.6 +/- 9.5 years, and the excess weight was 146.1 +/- 24.5 kg. The safety and the effectiveness of the procedure were prospectively evaluated. RESULTS: Thirty-one patients have completed their second postoperative year. Mean BMI after 2 years follow-up was 35 +/- 5.33 kg/m(2) (p < 0.001) and mean %EWL was 79.9% (range 57.17-149.89). Significant improvement in preexisting comorbidities was also observed (mean 0.95 +/- 0.1, range 0-2; p < 0.001). Early major postoperative complications included one case of acute renal failure (1.47%), three anastomotic leaks (4.41%), four pulmonary embolisms (5.88%), one hemorrhage requiring reoperation (1.47%), and three cases of pneumonia (4.41%), resulting in a total morbidity rate of 8.82% and a mortality rate of 8.82%. Late complications included small bowel obstruction in four patients (5.88%), pulmonary embolism in one patient (1.47%), severe hypoalbuminemia requiring artificial nutrition support in six patients (8.82%), and incisional hernia in 23 patients (33.8%). Late morbidity was 41.1%, and there was no late mortality. CONCLUSION: BPD-RYGBP appears to be an effective procedure in patients with BMI > or = 70 kg/m(2) providing adequate weight loss and improvement of co-existing comorbidies after 2 years. Nevertheless, it is associated with higher morbidity and mortality rates compared to patients with BMI < 70 kg/m(2) undergoing the same surgical procedure.