Prevalence of Upper Gastrointestinal Pathology in Patients with Obesity on Preoperative Endoscopy.

BACKGROUND AND OBJECTIVES: The preoperative work up for bariatric surgery is variable and not all centers perform a preoperative upper gastrointestinal endoscopy. A study was undertaken to determine the frequency of clinically significant gross endoscopic and pathological diagnoses in a large sample of patients with obesity undergoing work-up for bariatric surgery. METHODS: Routine endoscopy was performed on all preoperative bariatric patients. A retrospective chart review of 1000 consecutive patients was performed. Patients were divided into three groups: Group A (no endoscopic findings), Group B (clinically insignificant findings), Group C (clinically significant findings). RESULTS: Patients had a mean body mass index (BMI) of 49 kg/m2 and 79% were female. In this sample one finding was found on preoperative EGD in 95.2% of patients, 33.9% had at least two diagnoses, and 29.9% had three or more diagnoses. Group A (no findings) consisted of 4.8% of patient, 52.5% in Group B (clinically insignificant findings), and 42.7% were in Group C (clinically significant findings). Clinically significant findings included hiatal hernia 23.5%, esophagitis 9.5%, H. pylori 7.1%, gastric erosions 5.7%, duodenitis 3.7%, Barrett's esophagus 3.1%, and Schatzki ring 1.2%. There was no significant correlation between preoperative BMI and any endoscopic findings (all p-value 0.05). Patients in Group C were statistically older than Groups A and B. CONCLUSION: Upper gastrointestinal pathology is highly common in patients with obesity. There is a significant rate of clinically significant endoscopy findings and all bariatric surgery patients should undergo preoperative endoscopy.

Reoperations for Long-Term Complications Following Laparoscopic Adjustable Gastric Banding: Analysis of Incidence and Causality.

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) gained popularity in the early 2000s as a purely restrictive procedure with modest weight loss. The potential for complications requiring reoperation has since become evident. A retrospective review was performed to determine the incidence of long-term complications and predictive factors requiring surgical reintervention after LAGB. METHODS: Institutional review board approval was obtained, and a retrospective review of 200 consecutive patients undergoing LAGB over a period of six years was conducted at a single institution with American Society of Metabolic and Bariatric Surgery Center of Excellence designation. Data were collected on patient characteristics, comorbid conditions and complications requiring reintervention. Statistical analysis was performed using SPSS Statistics software (IBM Corp., Armonk, NY). RESULTS: Of the 200 patients, 176 (90.7%) were female with an average age of 53.6 years and preoperative body mass index (BMI) of 44.2 kg/m2. The average follow-up was 46 months. Complications occurred in 55 (28.4%) patients with band slippage/prolapse as the most common need for reoperation. Younger age, lack of comorbidities and diet/exercise compliance were associated with reintervention. CONCLUSIONS: LAGB has a high rate of reoperation secondary to complications associated with younger age. Alternative bariatric procedures may be more appropriate in these patients who have fewer comorbid conditions and are motivated to improve his or her health.

Laparoscopic Inguinal Hernia Repair Using ProGrip Self-Fixating Mesh: Technical Learning Curve and Mid-Term Outcomes.

PURPOSE: Self-fixating mesh has been introduced to further improve the quality results already seen with laparoscopic inguinal hernia repair. An observational study was undertaken to evaluate the technical learning curve and mid-term outcomes associated with the use of ProGrip (Medtronic, Minneapolis, MN, USA) laparoscopic self-fixating mesh in transabdominal preperitoneal (TAPP) inguinal herniorrhaphy. METHODS: Patients who underwent elective laparoscopic TAPP inguinal herniorrhaphy by a single surgeon using ProGrip laparoscopic self-fixating mesh within a one-year period were studied. The primary outcome measures included the time from mesh introduction to the final position (MI-FP), surgical complications, and pain scores. Demographic and other perioperative outcome data were collected and analyzed. RESULTS: Forty hernias were repaired in 29 patients with a laparoscopic TAPP approach. The average MI-FP was 249.4 seconds for the first 20 repairs, and 118.6 seconds (p < 0.001) for the final 20. Minor post-operative surgical complications were reported by 13.8% of patients; there were no major surgical complications. The average pain score on a scale of 0 to 5 was 0.9 (SD = 0.67, range 0-3). CONCLUSIONS: Surgeons with reasonable laparoscopic experience can expect to become fully proficient in the manipulation of self-fixating mesh after 15 to 20 repairs. Use of this product yielded low intraoperative and mid-term postoperative complication rates as well as low postoperative pain.

Urinary Bladder Matrix Reinforcement for Laparoscopic Hiatal Hernia Repair.

BACKGROUND AND OBJECTIVES: Synthetic mesh reinforcement during laparoscopic hiatal hernia repair (LHHR) reduces recurrence. Biologically derived mesh is also associated with reduced recurrence. Urinary bladder matrix (UBM), a biologically derived extracellular matrix mesh, has shown clinical success. We wanted to determine the safety and efficacy of LHHR with porcine UBM reinforcement. METHODS: This retrospective, single-surgeon study reviewed clinical data on patients who underwent LHHR from August 2009 through May 2014, with diaphragmatic reinforcement with porcine UBM mesh. Primary outcomes were (1) recurrence-a >2-cm defect above the diaphragm at 3 months; (2) intra- and postoperative complications; (3) pre- and postoperative esophageal reflux (GERD) or dysphagia; and (4) cessation of proton pump inhibitor (PPI). RESULTS: Sixty-two patients who had LHHR with UBM mesh were studied (mean age, 62 years, 53 women, mean body mass index 32.7 kg/m2) Before surgery 98% had GERD, 19% had dysphagia, and 98% were on PPI. Postoperative UGIS was performed on 66% 3 months after surgery, and 19% had a recurrence of >2 cm; 56% remained on PPI, and 16% (P < .001) remained symptomatic. Dysphagia improved in 75% (P = .05). No intraoperative complications were recorded. One postoperative mortality occurred secondary to an unrelated cardiac event. CONCLUSIONS: UBM mesh was effective and safe for LHHR. In addition to reducing the rate of recurrence compared to unreinforced primary repair, the properties of UBM, including site-specific constructive tissue remodeling, may add benefits over other biologic products. This study represents an evaluation of UBM mesh in a large cohort of patients who underwent LHHR.

A pilot study on the biomechanical assessment of obstructive sleep apnea pre and post bariatric surgery.

Obesity is a major risk factor for obstructive sleep apnea patients. In obese patients the severity of this risk can be reduced by bariatric surgery. This pilot study investigates the perioperative effects of bariatric surgery on obstructive sleep apnea and on the physical and biomechanical characteristics of the upper airway. Polysomnography and computer tomography data for 10 morbid obese patients promoted for bariatric surgery were conducted before surgery and at 6 and 12 months postoperatively for assessment of the oropharyngeal anatomy, and subsequent three-dimensional modelling of the airway. Mean values for the apnea/hypopnea index and body mass index significantly reduced after surgery. To combine the effect of changes in the upper airway volume and body mass index, a new volume body mass index is introduced. This index increases with a successful bariatric surgery. Although bariatric surgery leads to an effective weight reduction for all age groups, for obstructive sleep apnea patients it may be effective for middle age, less effective for 50-60 years, and further less effective for patients over the age of 60 years.

Laparoscopic Roux-en-Y Gastric Bypass: Surgical Technique and Perioperative Care.

Obesity is a global epidemic with multiple associated comorbid conditions. The laparoscopic Roux-en-Y gastric bypass is the gold standard operation in the fight against obesity. This review outlines the common technical aspects of the procedure, as well as the evidence based recommendations for preoperative and postoperative care.

Liver disease in the morbidly obese: a review of 1000 consecutive patients undergoing weight loss surgery.

BACKGROUND: Liver disease among the morbidly obese is increasingly prevalent, contributing to significant morbidity. Obesity-related liver pathologies including nonalcoholic steatohepatitis (NASH) have become a leading cause for liver transplant. However, risk factors for developing severe liver disease in the morbidly obese remain unknown. The objective of this study was to determine the frequency of abnormal liver pathology and any relationship to patient-related factors. METHODS: One thousand consecutive patients undergoing weight loss surgery were reviewed. All patients had a liver biopsy at the time of surgery. Frequency of benign pathology, steatosis, NASH, and fibrosis on pathologic examination of liver biopsy specimens were recorded. Pathologic findings were compared and analyzed to age and body mass index (BMI) of all patients. RESULTS: All patients in the study population had a BMI>35 kg/m2. Of these patients, 80.2% had liver disease related to obesity on pathology, including 65.9% with steatosis (grade 1-3), and 14.3% with NASH and/or fibrosis. Mean BMI of patients with liver disease was 48.1 compared to a BMI of 47.7 with benign pathology (P=.523). Mean age of patients with and without abnormal pathology was 48.3 and 47.3, respectively (P=.294). CONCLUSION: Liver disease is highly prevalent in the obese, but is not associated with increased age or BMI. Although all morbidly obese patients appear at significant risk for developing severe liver pathology, further risk factors are unknown.

Two-trocar cholecystectomy by strategic laparoscopy for improved cosmesis (SLIC).

BACKGROUND AND OBJECTIVES: Until the advent of singleincision laparoscopic surgery, few advances were aimed at improving cosmesis with laparoscopic cholecystectomy. Criticisms of the single-incision laparoscopic surgery technique include a larger incision and increased incidence of wound-related complications. We present our initial experience with a novel technique aimed at performing strategic laparoscopy for improved cosmesis (SLIC) for cholecystectomy. METHODS: Twenty-five patients with biliary symptoms were selected for SLIC cholecystectomy. Access to the abdomen was obtained with a 5-mm optical trocar in the left upper quadrant and a 5-mm trocar in the umbilicus. Retraction was performed by a transabdominal suture in the dome of the gallbladder and a needlescopic grasper. Age, American Society of Anesthesiologists score, body mass index, operative time, length of stay, pathology results, and short-term complications at follow-up were prospectively recorded. RESULTS: The 25 female patients had a mean age of 34.3 years and mean body mass index of 24 kg/m(2). American Society of Anesthesiologists scores ranged from 1 to 3. The mean operative time was 51.3 minutes. Pathology revealed chronic cholecystitis in all patients. All procedures were performed on an outpatient basis. The only complication was one ultrasonography-documented deep vein thrombosis. All 25 planned SLIC cholecystectomies were successfully completed. CONCLUSIONS: SLIC cholecystectomy is feasible and safe. This technique decreases the cumulative incision length, as well as the number of incisions, leading to very desirable cosmetic results in patients with a favorable body habitus and surgical history.

Age and gender exert differential effects on blood lipids in patients after LAGB and LRYGB.

BACKGROUND: Although bariatric surgery is known to exert favorable effects on dyslipidemia, few studies have systematically considered how the demographic variables might modulate the outcomes. The aim of the present study was to examine the interactive effects of gender, age, and surgery type on dyslipidimia in bariatric surgery patients at a tertiary hospital in the United States. METHODS: In a retrospective review of 294 patients who had undergone laparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic adjustable gastric bypass (LAGB), we examined the changes in lipid profiles and antihyperlipidemic use for ≤4 years postoperatively. The data were analyzed using longitudinal mixed modeling methods, in which the effects on lipid concentrations and medication use were tested in models with gender, surgery type, age, postoperative duration, and all possible interactions entered as factors. RESULTS: Significant 2-way interactions of surgery type*time were found for total cholesterol and high-density lipoprotein cholesterol, gender*time for high-density lipoprotein cholesterol, and age*time for triglycerides. A 3-way interaction of surgery type*age*time was noted for low-density lipoprotein cholesterol. For older patients, low-density lipoprotein cholesterol was reduced by 20% from baseline in the LRYGB group but did not lessen significantly in the LAGB group. In the younger patients, however, decreases from the preoperative concentrations were not evident in either surgery group. An interaction of surgery type*time on antihyperlipdemic medication use, in which values changed significantly from baseline was found in both groups. However, the pattern in the LRYGB patients opposed that in the LAGB patients. CONCLUSION: Our results have demonstrated that bariatric surgery imparts a pronounced improvement in the blood lipid profile of recipients; however, these effects might be moderated by other factors, such as age and gender, independently of the baseline weight status of the patients.

Laparoscopic revision of failed fundoplication and hiatal herniorraphy.

OBJECTIVE: The aim of this study was to evaluate the mechanisms of failure after laparoscopic fundoplication and the results of revision laparoscopic fundoplication. BACKGROUND: Laparoscopic Nissen fundoplication has become the most commonly performed antireflux procedure for the treatment of gastroesophageal reflux disease, with success rates from 90 to 95%. Persistent or new symptoms often warrant endoscopic and radiographic studies to find the cause of surgical failure. In experienced hands, reoperative antireflux surgery can be done laparoscopically. We performed a retrospective analysis of all laparoscopic revision of failed fundoplications done by the principle author and the respective fellow within the laparoscopic fellowship from 1992 to 2006. METHODS: A review was performed on patients who underwent laparoscopic revision of a failed primary laparoscopic fundoplication. RESULTS: Laparoscopic revision of failed fundoplication was performed on 68 patients between 1992 and 2006. The success rate of the laparoscopic redo Nissen fundoplication was 86%. Symptoms prior to the revision procedure included heartburn (69%), dysphagia (8.8%), or both (11.7%). Preoperative evaluation revealed esophagitis in 41%, hiatal hernia with esophagitis in 36%, hiatal hernia without esophagitis in 7.3%, stenosis in 11.74%, and dysmotility in 2.4%. The main laparoscopic revisions included fundoplication alone (41%) or fundoplication with hiatal hernia repair (50%). Four gastric perforations occurred; these were repaired primarily without further incident. An open conversion was performed in 1 patient. Length of stay was 2.5 +/- 1.0 days. Mean follow-up was 22 months (range, 6-42), during which failure of the redo procedure was noted in 9 patients (13.23%). CONCLUSION: Laparoscopic redo antireflux surgery, performed in a laparoscopic fellowship program, produces excellent results that approach the success rates of primary operations.

Laparoscopic repair of incarcerated diaphragmatic hernia with mesh.

Diaphragmatic hernias are now being approached laparoscopically. Incarcerated diaphragmatic hernia poses a special problem due to concerns about contamination. We describe a laparoscopic repair of such a hernia with the use of prosthetic mesh.

Laparoscopic Roux-en-Y Gastric bypass utilizing the triple stapling technique.

OBJECTIVE: To evaluate the outcomes of a single surgeon's experience with laparoscopic Roux-en-Y gastric bypass (LRYGB) utilizing the triple stapling technique for creation of the jejunojejunostomy. METHODS: A retrospective review of patients who underwent LRYGB utilizing the triple stapling technique for creation of the jejunojejunostomy (JJ) between 10/01 and 12/04 was performed. RESULTS: LRYGB was performed in 435 consecutive patients. The mean age was 41 years (range, 14 to 68), and 82% were female. Mean initial body mass index was 50 (range, 35 to 91). One conversion to open (0.2%) was necessary. Mean operating time was 144+/-26 minutes. Mean length of stay was 2.3+/-1.5 days. There were 3 leaks at the gastrojejunostomy anastomosis (0.7%). No leaks occurred at the JJ anastomosis. One patient underwent revision of the JJ (0.2%) secondary to obstruction of the JJ on upper gastrointestinal study. Intraluminal bleeding occurred in 21 patients (4.8%). Patients required blood transfusion of 2.2+/-1.1 units (range, 0 to 5), but none required surgical or endoscopic intervention. Mortality occurred in 2 patients (0.5%). Mean excess body weight loss was 72% at 1 year. CONCLUSION: Construction of the jejunojejunostomy utilizing the triple stapling technique is expeditious, safe, and associated with minimal complication.

Postoperative gastrointestinal complaints after laparoscopic Nissen fundoplication.

OBJECTIVES: Approximately 80% of patients complain of various symptoms immediately after laparoscopic Nissen fundoplication. These symptoms typically are treated medically without an extensive evaluation to identify the cause. We reviewed our experience of laparoscopic Nissen fundoplication to determine the course of postoperative symptomatology in our patient population, and present a rational approach to this problem. METHODS: Over a 10-year period, 628 patients underwent primary laparoscopic Nissen fundoplication for gastroesophageal reflux disease; patients were evaluated with a standard set of questions for postoperative gastrointestinal complaints. Three- and 6-month follow-up data were compared by using the chi square test. RESULTS: One-year follow-up data were available for 615 patients (98%). All of these patients had symptoms during the first 3 postoperative months. Early satiety (88%), bloating/flatulence (64%), and dysphagia (34%) were the most common; however, 94% of patients had resolution of their symptoms by the 1-year follow-up visit, and most had resolved after 3 months. Patients with persistent reflux or dysphagia after 3 months typically had an anatomic failure of the operation. CONCLUSIONS: Most patients who have undergone laparoscopic Nissen fundoplication for gastroesophageal reflux disease will have gastrointestinal complaints during the initial 3 postoperative months. Nearly all of these patients will have resolved their symptomatology after 3 months. Those with persistent symptoms after 3 months warrant evaluation for operative failure.

L5-S1 laparoscopic anterior interbody fusion.

OBJECTIVE: We evaluated our experience with laparoscopic L5-S1 anterior lumbar interbody fusion (ALIF). METHODS: This represents a retrospective analysis of consecutive patients who underwent L5-S1 laparoscopic ALIF between February 1998 and August 2003. RESULTS: Twenty-eight patients underwent L5-S1 LAIF (15 males and 13 females). The mean age was 43 years (range, 26 to 67). Mean operative time was 225 minutes (range, 137 to 309 minutes). No conversions to an open procedure were necessary. Twenty-four (85.7%) patients underwent successful bilateral cage placement. Four patients (14.3%) in whom only a single cage could be placed underwent supplementary posterior pedicle screw placement. Mean length of stay (LOS) was 4.1 days (range, 2-to 15). Two patients underwent reoperation subacutely secondary to symptomatic lateral displacement of the cage. One patient developed radiculopathy 6 months postoperatively and required reoperation. One patient developed a small bowel obstruction secondary to adhesions to the cage requiring laparoscopic reoperation. Fusion was achieved in all patients. Visual analogue scale scores for back pain were significantly improved from 8.6+/-0.8 to 2.8+/-0.8 (P<0.0001) at 1 year. CONCLUSION: L5-S1 LAIF is feasible and safe with all the advantages of minimally invasive surgery. Fusion rates and pain improvement were comparable to those with an open repair.

Effect of body mass index on nonalcoholic fatty liver disease in patients undergoing minimally invasive bariatric surgery.

The risk factors for nonalcoholic fatty liver disease in patients undergoing bariatric surgery are under study. We wanted to determine the correlation between nonalcoholic fatty liver disease and patient factors such as obesity and liver function tests. A retrospective analysis was performed on 177 nonalcoholic morbidly obese patients who underwent laparoscopic Roux-en-Y gastric bypass with liver biopsy, to identify risk factors for nonalcoholic fatty liver disease. The histologic grade of liver disease was compared with preoperative body mass index, age, and liver function tests. Simple steatosis and steatohepatitis were present in 90% and 42% of patients, respectively. Elevated transaminase levels were an independent risk for liver disease. Body mass index and liver disease were not correlated with univariate analysis. Regression analysis performed on age, body mass index, and liver disease demonstrated that the risk for liver disease increased with body mass index in the younger (<35 years old) age group and decreased with body mass index in the older (>45 years old) age group. There was a high incidence of steatosis and steatohepatitis in these nonalcoholic bariatric patients, and elevated transaminase level was indicative of disease. Body mass index was a positive risk factor for liver disease in younger patients but a negative risk factor in the older patients.

Minimally invasive surgery for achalasia: a 10-year experience.

Minimally invasive esophagomyotomy for achalasia has become the preferred surgical treatment; the employment of a concomitant fundoplication with the myotomy is controversial. Here we report a retrospective analysis of 53 patients with achalasia treated with laparoscopic Heller myotomy; fundoplication was used in all patients except one, and 48 of the fundoplications were complete (floppy Nissen). There were no deaths or reoperations, and minor complications occurred in three patients. Good-to-excellent long-term results were obtained in 92% of the subjects (median follow-up 3 years). Two cases (4%) of persistent postoperative dysphagia were documented, one of which was treated with dilatation. Postoperative reflux occurred in five patients, four of whom did not receive a complete fundoplication; these patients were well controlled with medical therapy. We suggest that esophageal achalasia may be successfully treated with laparoscopic Heller myotomy and floppy Nissen fundoplication with an acceptable rate of postoperative dysphagia.

Laparoscopic transgastric esophageal mucosal resection for high-grade dysplasia.

BACKGROUND: High-grade dysplasia of the esophageal mucosa has been shown to be a precursor to adenocarcinoma. In addition to esophagectomy, multiple ablative endoscopic techniques have evolved for the management of this condition. As a surgical alternative to esophagectomy, we describe for the first time a new option in the treatment of high-grade dysplasia. MATERIALS AND METHODS: Two patients with a history of gastroesophageal reflux disease (GERD) underwent upper gastrointestinal endoscopy which demonstrated high-grade dysplasia of the distal esophagus. The first patient had a short segment (0.5-1.0 cm), and the second patient had a longer (2 cm) segment of dysplasia. The patient is placed in the modified lithotomy position. Five trocars are placed as if to perform a fundoplication. A complete circumferential mobilization of the esophagus is performed. The short gastric vessels are divided with the harmonic scalpel, to free up the fundus of the stomach. An anterior horizontal gastrotomy is performed three to four centimeters below the gastroesophageal junction. A solution of epinephrine and normal saline (1:100,000) is injected into the mucosa at the Z-line and, utilizing specially designed hook electrocautery, the mucosa is incised circumferentially around a lighted bougie. Using blunt dissection the mucosa is undermined, elevated, and excised in four quadrants. Three centimeters of the distal esophageal mucosa are resected. The gastrotomy is then closed using a linear stapler, and a 360 degrees fundoplication is performed around a 50 Fr bougie. RESULTS: High-grade dysplasia was identified in the specimens from both patients; however, neither patient was found to have carcinoma in situ or invasive esophageal cancer. Our first patient has been followed for twenty months, the second for ten months. Both patients underwent routine upper gastrointestinal endoscopy for surveillance of the healing process. At eight months, the mucosa of the first patient showed complete regeneration of squamous epithelium. Our most recent patient appears to be progressing without complications and has also demonstrated normal squamous epithelium at ten months postoperatively, without changes of Barrett's epithelium. CONCLUSION: The technique of laparoscopic transgastric esophageal mucosal resection is feasible and may be proven to be an alternative to esophagectomy for the management of high-grade dysplasia.

Endoluminal reconstruction of the canine common biliary duct.

PURPOSE: Extrahepatic biliary duct injuries such as transections, stenoses, and biliary leaks are well-known complications of upper abdominal surgeries. The popularization of laparoscopic cholecystectomies in the early 1990's resulted in an increase in the numbers of these reported injuries. The surgical repair of these injuries may be challenging. In this feasibility study, we were presented with the opportunity to evaluate a novel polytetrafluoroethylene (PTFE) covered stent graft that could be useful in common bile duct reconstructions. The long-term goal of this research is to offer the surgeon a new technique for reconstructing the biliary duct or repairing biliary strictures.John G. Zografakis MD, was the first place winner in the Basic Sciences Resident Competition at the Ohio American College of Surgeons meeting. METHODS: Seven dogs were originally enrolled in the study. After general endotracheal anesthesia and open cholecystectomy, the common bile duct was identified in each dog. A guide wire was then passed through the neck of the cystic duct, anterograde into the common bile duct, through the Ampulla of Vater and into the duodenum. A stent graft delivery system was placed over the wire, and the covered stent graft was deployed within the lumen of the common bile duct. Study outcomes included graft patency and assessment of the bio-incorporation of the graft and the effectiveness of the graft to drain the biliary system as determined by liver enzyme tests. RESULTS: Three implants were harvested at 1 month, and 2 grafts were harvested each at 3 months and 6 months postoperatively. All of the stent grafts were patent. Liver enzyme tests revealed that all dogs had increased serum levels of alkaline phosphatase, alanine aminotransferase (ALT) serum glutamate pyruvate transaminase (SGPT) and aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT). Four dogs had increased total bilirubin. These increases were all measured in the immediate postoperative period. Peak levels for each measure were reached between 4 and 10 days and then gradually trended toward baselines by 1 month postoperatively. We did not observe meaningful changes in serum albumin or total protein. One dog suffered a tear in the common bile duct due to balloon overinflation. This tear was suture repaired when the graft was implanted. However, bile leakage was found when the graft was harvested at 1 month postoperatively. There appeared to be minimal bio-incorporation of the stent-grafts into the biliary duct wall, and there was no pronounced inflammatory response found in the duct wall or surrounding tissues. CONCLUSIONS: We are encouraged by these early results. Additional studies are planned to evaluate a self-expanding PTFE covered stent graft and a percutaneous delivery system.