The Clinical Efficacy of Balloon-Assisted Maturation of Autogenous Arteriovenous Fistulae.

BACKGROUND: Delayed maturation of arteriovenous fistulae (AVF) among patients who require hemodialysis (HD) can lead to catheter sepsis with its resultant morbidity and mortality. Some have proposed that sequential balloon-assisted maturation (BAM) may accelerate the maturation times of these accesses. On the other hand, serial balloon angioplasty of normal vein may result in stenosis and delay maturation. Although the safety of BAM has been shown, direct comparison to nonmatured AVF has not been explored. Therefore, we conducted a retrospective analysis of our prospectively maintained vascular access database to compare the duration of period to AVF maturation between patients who received BAM and those who were not referred for BAM at our institution. METHODS: Prospectively collected data over a 3-year period in 194 patients who underwent AVF creation at our institution were retrospectively analyzed. The duration to maturation of the AVF was determined by comparing the period between the creation of the fistula and the first successful cannulation of the fistula. Only patients on HD were included. Patients who underwent BAM or placement of AVF at an outside institution were excluded. Follow-up consisted reviewing of postoperative AVF duplex for patency, hospital and clinic databases, HD center databases, and telephone interviews. RESULTS: Of the 194 patients who had AVF placement, 172 patients were on HD within 2 weeks of AVF placement, whereas 22 patients had AVF placed in anticipation of the need for HD. Of the 172 patients on HD within 2 weeks, 54 patients had BAM performed at our institution and 4 patients had BAM at an outside institution, whereas 114 patients were not referred for BAM. Thirty-three of these 114 patients were age and gender matched to compare to the patients who underwent BAM at our institution. At the time of this analysis, of the 54 patients who had BAM, 30 had functional AVF (19 men, 11 women; mean age, 62 years; range, 26-86 [standard deviation, SD ± 18] years). In the BAM group of functioning AVF, n = 30, the total number of procedures was 125 (range, 1-8, average 4). The overall average duration to maturation of the AVF was 119 days (SD ± 84 days) and 146 days (SD ± 157 days) P = 0.73, for BAM and non-BAM, respectively. CONCLUSIONS: These preliminary data suggest the role of BAM did not decrease maturation times of AVF and that BAM warrants further scrutiny before further adoption.

Prospective randomized study comparing the clinical outcomes between inferior vena cava Greenfield and TrapEase filters.

OBJECTIVE: Although anticoagulation remains the mainstay of treatment for deep venous thrombosis, the use of inferior vena cava (IVC) filters when anticoagulation has failed or when contraindicated remains a safe and effective treatment. Greenfield (Boston Scientific, Natick, Mass) and TrapEase (Cordis, Bridgewater, NJ) filters are arguably among the most popular filtration devices. The Greenfield filter (12F introducer) has been in use for >30 years and has been well studied. The TrapEase filter (6F introducer) has been used since 2000, with a limited number of studies. Good guidelines to help determine which filter to use in any given situation are lacking; therefore, this randomized study prospectively compared the clinical outcomes (access-site thrombosis, filter thrombosis, and symptomatic pulmonary embolism [PE]) between these filters. METHODS: Between July 2006 and November 2008, 156 patients (63 men, 93 women; mean age, 75 years; range, 38-101 years) were randomized: 84 to Greenfield and 72 to TrapEase IVC filter insertion in the infrarenal position using angiographic guidance. Postoperative follow-up comprised serial lower extremity and IVC/iliac vein (IV) duplex imaging (78.2%) at day 1, week 1, every 3 months for the first year, and every 6 months for the second year; clinical evaluation, and clinic visits. During this period, 349 patients (143 men, 206 women; mean age, 75 years; range, 24-96 years) were not randomized. RESULT: The indications for filter placement, in the 156 randomized patients, were gastrointestinal bleeding, 37; intracranial hemorrhage, 12; free-floating clot, 19; failure of anticoagulation, 29; PE, 27; prophylactic, 4; and others, 32. During a mean 12-month follow-up (range, 0-39 months), symptomatic IVC/IV thrombosis developed in five patients (6.94%) in the TrapEase group and none in the Greenfield group (P = .019). No filter migration, access-site thrombosis, misplacement, or IVC perforation occurred. Recurrent PE was suspected in one of the five patients with IVC/IV thrombosis. Overall mortality was 42.3% (66 patients), and 30-day mortality was 13.5% (21 patients: 10 TrapEase, 11 Greenfield). The study was initially designed to recruit 360 patients in both TrapEase and Greenfield filters in 2 years to demonstrate any statistical significance but was prematurely concluded due to the interim results. CONCLUSION: A higher rate of symptomatic IVC/IV thrombosis is associated with TrapEase filter placement. However, the TrapEase filter still has a selective clinical role in the prevention of thromboembolism in selected patients who are coagulopathic. This is the first randomized prospective study comparing IVC filters since their inception in 1967.

Superior vena cava perforation following the placement of a superior vena cava filter in males less than 60 years of age.

Although the utility of the superior vena cava (SVC) filter remains controversial, the safety and efficacy of SVC filters in patients with upper extremity deep venous thrombosis in whom anticoagulation is contraindicated or ineffective have been well described. However, few complications have been reported. Herein we describe a series of three cases of SVC perforation in three young males following the placement of SVC filters. All three patients had deep venous thrombosis on upper extremity duplex ultrasonography and contraindication to anticoagulation (n = 1) or failure of anticoagulation (n = 2). Cardiac tamponade was demonstrated on transthoracic echocardiography in all three cases. The pericardial effusion was evacuated with either median sternotomy or pericardiocentesis in two cases. One of the patients died of cardiac arrest, and an autopsy showed aortic perforation in addition to the SVC perforation. This patient underwent chest compression following the cardiac arrest. One patient was lost to follow-up, and the other patient remained asymptomatic at the 1-year follow-up. This is the first case of SVC perforation that is associated with aortic perforation after the placement of an SVC filter. Owing to this occurrence, one has to be aware of these life-threatening complications when placing an SVC filter, especially in males less than 60 years of age.

Long-term follow-up for superior vena cava filter placement.

The short-term effectiveness and safety placement of superior vena cava (SVC) filter in the treatment of upper extremity deep venous thrombosis in patients with contraindication to anticoagulation have been well documented. However, as opposed to the numerous reported experiences with inferior vena cava filter placement and its complications, there has been no documented long-term follow-up on SVC filter placement. We, therefore, reviewed our experience with SVC filter placement. A retrospective review was performed of the 154 cases of patients who underwent SVC filter placement between January 1994 and August 2005 at our institution. Seven additional patients had unsuccessful SVC filter placement due to widespread deep venous thrombosis. The data were evaluated for both insertion complications (pneumothorax, hemorrhage, filter misplacement) and long-term complications (pulmonary embolism, migration, caval occlusion). The follow-up included review of serial chest radiographs to evaluate for filter migration in patients who lived at least 60 days after filter insertion and had chest radiography performed (n = 40), patients' charts, clinic visits, and telephone contacts, hospital databases, city death records, and national databases. There were 69 males and 85 females with a mean age of 73.6 years (range, 16-96 years; +/-15.3 [SD] years). Follow-up ranged from 1 day to 3750 days (256.3 +/- 576 days [mean +/- SD]) and 5 patients were lost to follow-up. Of the 154 patients, 58 survived longer than 60 days with mean follow-up of 628.4 days. All SVC filters (TrapEase, n = 38; Greenfield, n = 116) were successfully deployed in the 154 patients. During the follow-up, 114 (74.0% mortality) of the patients died of chronic illness or from cancer complications. There were three cases of pericardial tamponade (1.9%), and one case of misplaced filter in innominate vein. There were no known cases of symptomatic pulmonary embolism, caval occlusion, pneumothorax, or filter migration. SVC filter placement is associated with a low incidence of complications with long-term follow-up. These data help to reaffirm the safety and effectiveness of SVC filter placement. However, SVC perforation in young males remains a significant issue.