Final Two-Year Outcomes for the Sentry Bioconvertible Inferior Vena Cava Filter in Patients Requiring Temporary Protection from Pulmonary Embolism.

PURPOSE: To report final 2-year outcomes with the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE). MATERIALS AND METHODS: In a prospective multicenter trial, the Sentry filter was implanted in 129 patients with documented deep vein thrombosis (DVT) and/or PE (67.5%) or who were at temporary risk of developing DVT/PE (32.6%). Patients were monitored and bioconversion status ascertained by radiography, computed tomography (CT), and CT venography through 2 years. RESULTS: The composite primary 6-month endpoint of clinical success was achieved in 97.4% (111/114) of patients. The rate of new symptomatic PE was 0% (n = 126) through 1 year and 2.4% (n = 85) through the second year of follow-up, with 2 new nonfatal cases at 581 and 624 days that were adjudicated as not related to the procedure or device. Two patients (1.6%) developed symptomatic caval thrombosis during the first month and underwent successful interventions without recurrence. No other filter-related symptomatic complications occurred through 2 years. There was no filter tilting, migration, embolization, fracture, or caval perforation and no filter-related deaths through 2 years. Filter bioconversion was successful for 95.7% (110/115) of patients at 6 months, 96.4% (106/110) of patients at 12 months, and 96.5% (82/85) of patients at 24 months. Through 24 months of follow-up, there was no evidence of late-stage IVC obstruction or thrombosis after filter bioconversion or of thrombogenicity associated with retracted filter arms. CONCLUSIONS: The Sentry IVC filter provided safe and effective protection against PE, with a high rate of intended bioconversion and a low rate of device-related complications, through 2 years of follow-up.

Utility of a Power Aspiration-Based Extraction Technique as an Initial and Secondary Approach in the Treatment of Peripheral Arterial Thromboembolism: Results of the Multicenter PRISM Trial.

PURPOSE: To investigate the safety and initial efficacy of XTRACT, a power aspiration-based extraction technique for treatment of peripheral arterial thromboembolism with the use of the Penumbra/Indigo system. MATERIALS AND METHODS: A total of 79 patients were enrolled: 39 (49.4%) underwent XTRACT as the initial therapy and 40 (50.6%) underwent XTRACT after failed catheter-directed thrombolysis or other mechanical intervention or for removal of distal emboli that occurred during an intervention. Occlusion locations were as follows: 36.7% (n = 29) in the profunda, common, or superficial femoral artery; 35.4% (n = 28) in the popliteal artery; 15.2% (n = 12) in the tibial artery; 7.6% (n = 6) in the peroneal artery; and the remainder in the common iliac (n = 1), external iliac (n = 1), sciatic (n = 1), and brachial (n = 1) arteries. RESULTS: Complete or near-complete revascularization (Thrombolysis In Myocardial Infarction [TIMI] grade 2/3 flow) was achieved in 87.2% of patients (68 of 78) immediately after the XTRACT procedure and before any other intervention. Successful revascularization was achieved in 79.5% of patients (31 of 39) as an initial treatment and in 92.5% (37 of 40) as salvage or secondary therapy. After additional adjunctive endovascular interventions, TIMI grade 2/3 flow was achieved in 96.2% of patients (76 of 79). Complete thrombus removal and restoration of normal flow (TIMI grade 3) was achieved in 77.2% of patients (61 of 79) after all endovascular treatment was completed. No patients required surgical revascularization. No device-related adverse events occurred. CONCLUSIONS: XTRACT was safe and effective for revascularization of acute or subacute peripheral arterial occlusions as a primary therapy or as a secondary therapy after other endovascular techniques had failed.

One-Year Analysis of the Prospective Multicenter SENTRY Clinical Trial: Safety and Effectiveness of the Novate Sentry Bioconvertible Inferior Vena Cava Filter.

PURPOSE: To prospectively assess the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE). MATERIALS AND METHODS: At 23 sites, 129 patients with documented deep vein thrombosis (DVT) or PE, or at temporary risk of developing DVT or PE, unable to use anticoagulation were enrolled. The primary end point was clinical success, including successful filter deployment, freedom from new symptomatic PE through 60 days before filter bioconversion, and 6-month freedom from filter-related complications. Patients were monitored by means of radiography, computerized tomography (CT), and CT venography to assess filtering configuration through 60 days, filter bioconversion, and incidence of PE and filter-related complications through 12 months. RESULTS: Clinical success was achieved in 111 of 114 evaluable patients (97.4%, 95% confidence interval [CI] 92.5%-99.1%). The rate of freedom from new symptomatic PE through 60 days was 100% (n = 129, 95% CI 97.1%-100.0%), and there were no cases of PE through 12 months for either therapeutic or prophylactic indications. Two patients (1.6%) developed symptomatic caval thrombosis during the first month; neither experienced recurrence after successful interventions. There was no filter tilting, migration, embolization, fracture, or caval perforation by the filter, and no filter-related death through 12 months. Filter bioconversion was successful for 95.7% (110/115) at 6 months and for 96.4% (106/110) at 12 months. CONCLUSIONS: The Sentry IVC filter provided safe and effective protection against PE, with a high rate of intended bioconversion and a low rate of device-related complications, through 12 months of imaging-intense follow-up.

Vacuum-assisted thrombectomy device (AngioVac) in the management of symptomatic iliocaval thrombosis.

Three patients with complete iliocaval thrombosis causing symptomatic leg swelling failed initial treatment with standard pharmacomechanical techniques. The occluded segments of the inferior vena cava and iliac veins were subsequently treated with the AngioVac Cannula (AngioDynamics, Latham, New York) and extracorporeal venous bypass circuit. In each patient, symptoms improved after treatment. This report discusses potential benefits and ancillary techniques of using the AngioVac device for iliocaval venous thrombosis.

An online survey of pelvic congestion support group members regarding comorbid symptoms and syndromes.

OBJECTIVES: Patients with pelvic congestion syndrome (PCS) often report overlapping somatic symptoms and syndromes. The objective of this study was to explore the prevalence of co-existing symptoms and self-reported syndrome diagnoses among women with PCS and to inform future research hypotheses. METHODS: A brief online survey was offered to members of a PCS support group website. Responses were assessed for self-reported co-existing symptoms and formal diagnoses, including: chronic fatigue syndrome, fibromyalgia, postural tachycardia syndrome, irritable bowel syndrome, migraines, interstitial cystitis, and temporomandibular joint dysfunction. RESULTS: Of a total of 6000 members, there were 398 respondents; 232 (59%) had not yet been treated for PCS. Among these, the most prevalent co-existing symptoms were as follows: severe fatigue (72%), dizziness (63%), IBS symptoms (61%), brain fog (33%), migraines (49%), polyuria or dysuria (41%), excessive sweating (31%), TMJ pain (31%), and loose skin or lax joints (18%). These are much higher than reported for the general female population. The most commonly self-reported comorbid syndrome diagnoses for the overall group of 398 were: irritable bowel syndrome (29%), fibromyalgia (13%), spinal nerve problems (18%), interstitial cystitis (10%), postural tachycardia syndrome (9%), hypertension (11%), chronic fatigue syndrome (10%), and Ehlers-Danlos syndrome (6%). Other than with hypertension, these rates are variably higher than in the general population. CONCLUSION: Several self-reported co-existing symptoms and syndromes are more prevalent in members of a PCS support group relative to the reported prevalence in the general population. More formal investigation is warranted to evaluate this finding and to investigate potential etiologic links. Ehlers-Danlos Syndrome appears to be common in self identifying PCS women.

Treatment of Chronic Total Occlusions Using the Avinger Ocelot Crossing Catheter.

Peripheral arterial disease is becoming more prevalent as the population ages. In addition, the severity of the disease seems to be progressing from simple narrowing of vessels to chronic total occlusions (CTOs). Treatment of CTOs of the infrainguinal peripheral arteries remains a challenge even for experienced endovascular specialists. Many crossing techniques have been described ranging from standard guidewire and catheter-based techniques including subintimal recanalization to specialized CTO crossing devices. One of the newest technologies, the Avinger Ocelot catheter (Avinger, Inc., Redwood City, CA), employs optical coherence tomography imaging on the tip of a rotating crossing catheter to allow visual confirmation of luminal passage. This article will review this new technology for crossing CTOs, review the results of the multicenter CONNECT II trial, and discuss the potential benefits of direct visualization while crossing occlusions.

Percutaneous vertebroplasty: new treatment for vertebral compression fractures.

Interventional radiologists have been performing image-guided spinal procedures for many years. Percutaneous vertebroplasty is a newer technique in which a medical grade cement is injected though a needle into a painful fractured vertebral body. This stabilizes the fracture, allowing most patients to discontinue or significantly decrease analgesics and resume normal activity. The impact of this procedure on the morbidity and expense associated with symptomatic osteoporotic vertebral compression fractures in the United States may be significant. Patients who are unresponsive to conservative therapy of bed rest, analgesics, and back bracing should be considered for vertebroplasty. This procedure is contraindicated in patients with active infection, untreated coagulopathy, and certain types of fracture morphology. Because many patients have multiple chronic fractures, there should be a strong correlation between the physical examination signs, symptoms, and cross-sectional imaging findings. The success rate for this procedure in treating osteoporotic fractures is 73 to 90 percent. Vertebroplasty can effectively treat aggressive hemangiomas of the vertebral body and may be palliative in patients with malignant pathologic fractures. Significant complications of the procedure are less than 1 percent.