Analysis of the Final DENALI Trial Data: A Prospective, Multicenter Study of the Denali Inferior Vena Cava Filter.

PURPOSE: To report the final 2-year data on the efficacy and safety of a nitinol retrievable inferior vena cava (IVC) filter for protection against pulmonary embolism (PE). MATERIALS AND METHODS: This was a prospective multicenter trial of 200 patients with temporary indications for caval filtration who underwent implantation of the Denali IVC filter. After filter placement, all patients were followed for 2 years after placement or 30 days after filter retrieval. The primary endpoints were technical success of filter implantation in the intended location and clinical success of filter placement and retrieval. Secondary endpoints were incidence of clinically symptomatic recurrent PE, new or propagating deep vein thrombosis (DVT), and filter-related complications including migration, fracture, penetration, and tilt. RESULTS: Filter placement was technically successful in 199 patients (99.5%). Filters were clinically successful in 190 patients (95%). The rate of PE was 3% (n = 6), with 5 patients having a small subsegmental PE and 1 having a lobar PE. New or worsening DVT was noted in 26 patients (13%). Filter retrieval was attempted 125 times in 124 patients and was technically successful in 121 patients (97.6%). The mean filter dwell time at retrieval was 200.8 days (range, 5-736 d). There were no instances of filter fracture, migration, or tilt greater than 15° at the time of filter retrieval or during follow-up. CONCLUSIONS: The Denali IVC filter exhibited high success rates for filter placement and retrieval while maintaining a low complication rate in this clinical trial.

The DENALI Trial: an interim analysis of a prospective, multicenter study of the Denali retrievable inferior vena cava filter.

PURPOSE: To assess safety and effectiveness of a nitinol retrievable inferior vena cava (IVC) filter in patients who require caval interruption to protect against pulmonary embolism (PE). MATERIALS AND METHODS: Two hundred patients with temporary indications for an IVC filter were enrolled in this prospective, multicenter clinical study. Patients undergoing filter implantation were to be followed for 2 years or for 30 days after filter retrieval. At the time of the present interim report, all 200 patients had been enrolled in the study, and 160 had undergone a retrieval attempt or been followed to 6 months with their filter in place. Primary study endpoints included technical and clinical success of filter placement and retrieval. Patients were also evaluated for recurrent PE, new or worsening deep vein thrombosis, and filter migration, fracture, penetration, and tilt. RESULTS: Clinical success of placement was achieved in 94.5% of patients (172 of 182), with a one-sided lower limit of the 95% confidence interval of 90.1%. Technical success rate of filter placement was 99.5%. Technical success rate of retrieval was 97.3%; 108 filters were retrieved in 111 attempts. In two cases, the filter apex could not be engaged with a snare, and one device was engaged but could not be removed. Filter retrievals occurred at a mean indwell time of 165 days (range, 5-632 d). There were no instances of filter fracture, migration, or tilt greater than 15° at the time of retrieval or 6-month follow-up. CONCLUSIONS: In this interim report, the nitinol retrievable IVC filter provided protection against pulmonary embolism, and the device could be retrieved with a low rate of complications.

Management of infections of polytetrafluoroethylene-based mesh.

BACKGROUND: Mandatory removal of infected expanded polytetrafluoroethylene (ePTFE) mesh has been advocated, leading to a high rate of hernia recurrence. Although salvage of infected mesh has been reported, the feasibility, efficacy, and long-term outcomes of this practice remain unclear. The purpose of this study was to delineate a protocol for salvaging infected ePTFE mesh. METHODS: We reviewed retrospectively the records of patients with infections of ePTFE-based mesh placed for complex abdominal hernias at a tertiary referral center from October 1997 to September 2005. RESULTS: Twenty-two patients were treated for ePTFE-based mesh infections. Fifteen patients had undergone laparoscopic repair, and seven patients had undergone open repair. The median time of presentation after repair was 70 days (range 10-480 days). Fourteen patients had an extensive mesh infection and underwent mesh excision, with twelve patients having attempted fascial closure; hernias recurred in all twelve patients. Two patients underwent mesh excision and repair with a biologic mesh. Eight patients had a limited area of mesh involvement; six of these patients underwent surgical debridement, partial excision of the mesh, re-approximation of the remaining mesh with non-absorbable suture and drains, and application of a vacuum-assisted closure system to the open portion of the wound. These patients received four weeks of antibiotics with delayed wound closure. Two patients underwent percutaneous drainage of a perigraft abscess. There was no hernia recurrence in seven patients with a mean follow-up of approximately three years. CONCLUSIONS: Infections of ePTFE-based mesh can present in early or delayed fashion. Although mesh with extensive infection could not be salvaged, limited mesh infections could be managed successfully with percutaneous or open drainage and prolonged antibiotic courses.

Laparoscopic ventral hernia repair in obese patients: a new standard of care.

HYPOTHESIS: Ventral abdominal hernias represent a frequent and often formidable clinical problem, especially in obese patients. Because laparoscopic ventral hernia repair (LVHR) results in few complications and a low recurrence rate, the use of minimally invasive techniques in this subgroup of patients may minimize perioperative complications and failure rates. DESIGN: Retrospective review of prospectively collected data. SETTING: Tertiary care hospital. PATIENTS: One hundred sixty-three obese patients (body mass index [calculated as weight in kilograms divided by the square of height in meters], > or =30) who underwent LVHR at our institution between July 1, 1998, and December 31, 2003. INTERVENTION: Laparoscopic ventral hernia repair with an expanded polytetrafluoroethylene mesh. MAIN OUTCOME MEASURES: Patient age, sex, body mass index, size of fascial defect and mesh, operating time, operative blood loss, length of hospitalization, complications, and hernia recurrences. RESULTS: Ninety-eight women and 65 men, with a mean body mass index of 38, underwent LVHR. Twenty patients (12.3%) had 21 postoperative complications. There was no perioperative mortality. The mean length of hospital stay was 2.6 days. The recurrence rate was 5.5% at a mean follow-up of 25 months (range, 1-73 months). CONCLUSIONS: A low rate of conversion to laparotomy, minimal perioperative morbidity, and the absence of perioperative mortality in this series indicate the safety of LVHR in obese patients with complex hernias. In addition, a success rate of more than 94.5% suggests improved efficacy of LVHR compared with the historical rates among control subjects undergoing open surgery. In experienced hands, LVHR may be the approach of choice for most patients with a body mass index of 30 or more.

Laparoscopic approach to open gastric bypass.

BACKGROUND: Gastric bypass is a successful tool in the treatment of morbid obesity. In recent years, laparoscopic Roux-en-Y gastric bypass has gained popularity. However, open bypass is sometimes more suitable for patients who are "superobese." Laparoscopic instrumentation can be used during an open gastric bypass to facilitate dissection, formation of the gastric pouch, and creation of the gastrojejunostomy. METHODS: We describe the use of laparoscopic ultrasonic coagulating shears for dissection during open gastric bypass. Additionally, laparoscopic gastrointestinal anastomosis and end-to-end anastomosis staplers are used for creating bowel anastomoses. CONCLUSIONS: Laparoscopic instrumentation can be useful in the setting of open procedures. Their long handles and jaw design make them ideal for working in the depths of a superobese abdomen.

Successful salvage of infected PTFE mesh after ventral hernia repair.

Rates of hernia recurrence following repair of abdominal wall hernia defects have been shown to be lower when prosthetic biomaterials are used, but their presence may be associated with a higher rate of infectious complications. Traditional surgical teaching has advocated removal of contaminated or exposed prosthetics, although the morbidity of these revisions is high. The case presented involves a ventral hernia repair complicated by methicillin-resistant Staphylococcus aureus infection and exposed polytetrafluoroethylene mesh. The open abdominal wound was successfully managed with a combination of intravenous antibiotics, local wound debridement, vacuum-assisted closure, and soft tissue coverage of the mesh. Eighteen months following surgical closure of the wound, no hernia recurrence or infection was evident.