The ABCs of the FDA: A Primer on the Role of the United States Food and Drug Administration in Medical Device Approvals and IR Research.

The role of the US Food and Drug Administration (FDA) in medical device regulation is important to device-driven specialties such as interventional radiology. Whether it is through industry-sponsored trials during the approval process for new devices or investigator-initiated research prospectively evaluating the role of existing devices for new or established procedures, interaction with the FDA is an integral part of performing significant research in interventional radiology. This article reviews the potential areas of interface between the FDA and interventional radiology, as understanding these areas is necessary to continue the innovation that is the hallmark of this specialty.

Management of splenic trauma: a single institution's 8-year experience.

BACKGROUND: Management of splenic trauma has evolved, with current practice favoring selective angiographic embolization and non-operative treatment over immediate splenectomy. Defining the optimal selection criteria for the appropriate management strategy remains an important question. METHODS: This retrospective registry review was conducted at a Level I trauma center. The patient population consisted of 20,561 patients in the State Trauma Registry from April 2004 to May 2012. Splenectomy, angiography, splenic embolization, nonoperative, and noninterventional (NI) observation were the management strategies under study. Morbidity and mortality were the outcome measures. Morbidity and mortality by management strategy. RESULTS: During the 8-year study period, 926 (4.5%) patients sustained splenic injury. Observational management increased over time despite the similar distribution of splenic injury grade over the study period: grade I/II (50%), grade III (24.2%), and grade IV/V (25.8%). Mortality rates associated with each management strategy were the following: immediate splenectomy (IS; 25%), splenic embolization (SE; 3.9%), and angiography only or observation, that is, NI (6.5%) management. Injury severity score (ISS) was highest in IS (36.1 ± 1.3) compared with SE (29.1 ± 1.0, P = .001) and NI (21.6, P < .001). Splenectomy was required in 5 of the 129 (3.9%) patients managed with SE and 9 of the 677 (1.3%) patients managed by NI. Mortality was significantly lower among those managed by SE (odds ratio .12, 95% confidence interval: .05 to .32) or NI (odds ratio .21, 95% confidence interval: .12 to .35). This survival benefit was explained by the association of IS with systolic blood pressure <90, high ISS, low GCS at presentation, ISS, development of shock, need for transfusion, and multiorgan failure. CONCLUSIONS: In this large 8-year single institution study, we observed an increase in nonoperative management by an increased application of angiography and embolization. An aggressive utilization of SE in patients with appropriate indications will result in low failure rates and improved mortality.

A prospective postmarket study to evaluate the safety and efficacy of a new peripherally inserted central catheter stabilization system.

An initial postmarket study of the SecurAcath used with 5 Fr peripherally inserted central catheters (PICCs) was conducted with 68 adult patients at 3 different institutions in the United States. PICCs were placed in both outpatients and inpatients, with patients in critical care and medical/surgical units, home care, and extended care facilities. Sixty-two (91.2%) of the patients completed therapy without a securement-related device malfunction or device-related adverse event associated with the securement system. The device was readily accepted by both patients and nursing staff. The SecurAcath represents a novel, safe, and effective method for catheter securement.

Catheter venography and endovascular treatment of chronic cerebrospinal venous insufficiency.

Multiple sclerosis (MS) is a disorder characterized by damage to the myelin sheath insulation of nerve cells of the brain and spinal cord affecting nerve impulses which can lead to numerous physical and cognitive disabilities. The disease, which affects over 500,000 people in the United States alone, is widely believed to be an autoimmune condition potentially triggered by an antecedant event such as a viral infection, environmental factors, a genetic defect or a combination of each. Chronic cerebrospinal venous insufficiency (CCSVI) is a condition characterized by abnormal venous drainage from the central nervous system that has been theorized to have a possible role in the pathogenesis and symptomatology of MS (1). A significant amount of attention has been given to this theory as a possible explanation for the etiology of symptoms related to MS patients suffering from this disease. The work of Dr. Zamboni, et al, who reported that treating the venous stenoses causing CCSVI with angioplasty resulting in significant improvement in the symptoms and quality of life of patients with MS (2) has led to further interest in this theory and potential treatment. The article presented describes endovascular techniques employed to diagnose and treat patients with MS and CCSVI.

Internet-based social networking and its role in the evolution of chronic cerebrospinal venous insufficiency.

The Internet is being seen as a growing resource for health-related information for a large number of patients. It is undeniable that its widespread presence has led to the growth of awareness that chronic cerebrospinal venous insufficiency (CCSVI) as an entity that may contribute to the symptoms experienced by patients with multiple sclerosis (MS). Social networking and file-sharing Web sites have brought patients with MS together from all over the world and have facilitated the distribution of personal experiences and information derived from medical research as it relates to CCSVI. As a result, there has been an accelerated growth in the number of patients seeking treatment for this syndrome in light of the possibility that it may improve their present condition. This article will review this phenomenon, the Internet-based resources available to MS patients seeking information about CCSVI, and the responsibilities of physicians as they participate in these online discussions.

Safety of endovascular treatment of chronic cerebrospinal venous insufficiency: a report of 240 patients with multiple sclerosis.

PURPOSE: To evaluate the safety of outpatient endovascular treatment in patients with multiple sclerosis (MS) and chronic cerebrospinal venous insufficiency (CCSVI). MATERIALS AND METHODS: A retrospective analysis was performed to assess complications occurring within 30 days of endovascular treatment of CCSVI. The study population comprised 240 patients; 257 procedures were performed over 8 months. The indication for treatment in all patients was symptomatic MS. Of the procedures, 49.0% (126 of 257) were performed in a hospital, and 51.0% (131 of 257) were performed in the office. Primary procedures accounted for 93.0% (239 of 257) of procedures, and repeat interventions accounted for 7% (18 of 257). For patients treated primarily, 87% (208 of 239) had angioplasty, and 11% (26 of 239) had stent placement; 5 patients were not treated. Of patients with restenosis, 50% (9 of 18) had angioplasty, and 50% (9 of 18) had stent placement. RESULTS: After the procedure, all but three patients were discharged within 3 hours. Headache after the procedure was reported in 8.2% (21 of 257) of patients; headache persisted > 30 days in 1 patient. Neck pain was reported in 15.6% (40 of 257); 52.5% (21 of 40) of these patients underwent stent placement. Three patients experienced venous thrombosis requiring retreatment within 30 days. Sustained intraprocedural arrhythmias were observed in three patients, and two required hospital admission. One of these patients, who was being retreated for stent thrombosis, was hospitalized because of a stress-induced cardiomyopathy. CONCLUSIONS: Endovascular treatment of CCSVI is a safe procedure; there is a 1.6% risk of major complications. Cardiac monitoring is essential to detect intraprocedural arrhythmias. Ultrasonography after the procedure is recommended to confirm venous patency and to identify patients experiencing acute venous thrombosis.

Review of venous anatomy for venographic interpretation in chronic cerebrospinal venous insufficiency.

Chronic cerebrospinal venous insufficiency (CCSVI) represents a recently described condition that may potentially contribute to the symptoms experienced by patients with multiple sclerosis. The evaluation of a prospective patient for CCSVI often involves an invasive evaluation with venography of the internal jugular and azygos veins. The purpose of this article is to review the normal anatomy of the internal jugular, vertebral, and azygos veins, as an understanding of these veins is necessary for appropriate interpretation of the venograms obtained to evaluate patients for CCSVI.

Comparison of the efficacy of the embolic agents acrylamido polyvinyl alcohol microspheres and tris-acryl gelatin microspheres for uterine artery embolization for leiomyomas: a prospective randomized controlled trial.

OBJECTIVE: To evaluate the efficacy of acrylamido polyvinyl alcohol microspheres (a-PVAM) as an embolic agent for uterine artery embolization (UAE) compared with Tris-acryl gelatin microspheres (TAGM). DESIGN, SETTING, PARTICIPANTS: Prospective randomized double-blind noninferiority trial. Conducted at two sites both with regional UAE practices. Forty-six women with symptomatic leiomyomas. INTERVENTION: UAE procedure was performed with either of the two embolic agents. Either 700-900-µm a-PVAM or 500-700-µm TAGM was used. MAIN OUTCOME MEASURES: Changes in leiomyoma perfusion, overall uterine volume, and dominant leiomyomas volume measured by contrast-enhanced magnetic resonance imaging at 1 week, 3 months, and 6 months after UAE by a reader blinded to the embolic agent used. Changes in Uterine Fibroid Symptoms and Quality of Life questionnaire scores were measured at 3, 6, and 12 months after UAE. RESULTS: Forty-six patients were randomized and treated under the study protocol (a-PVAM n=22, TAGM n=24). There were no procedure-related complications. Two patients were excluded from analysis (one technical failure of the procedure, one withdrawal from study). Successful (>90%) leiomyoma devascularization was observed in 81% of subjects at 1 week after UAE, 97% at 3 months after UAE, and 95% at 6 months after UAE. No significant differences were observed in 14 of 15 outcome measurements, consistent with noninferiority. TAGM was slightly superior to a-PVAM on one comparison (overall quality of life at 3 months after UAE).

Leiomyoma infarction after uterine artery embolization: a prospective randomized study comparing tris-acryl gelatin microspheres versus polyvinyl alcohol microspheres.

PURPOSE: To determine the degree of leiomyoma infarction after uterine artery embolization (UAE) performed with tris-acryl gelatin microspheres or polyvinyl alcohol (PVA) microspheres. MATERIALS AND METHODS: Patients determined to be candidates and scheduled for UAE were randomized prospectively to receive tris-acryl gelatin microspheres or PVA microspheres. The manufacturers' recommended technique was used for both products during the UAE procedures (including the recently described refined protocol for PVA microspheres). All patients underwent magnetic resonance (MR) imaging of the pelvis with contrast agent enhancement before and after the UAE procedure. On the postprocedural MR study, the degree of tumor infarction was assessed on postcontrast images. These findings were classified as follows: 100% infarction, 90%-99% infarction, 50%-89% infarction, and less than 50% infarction. Treatment failure was defined by enhancement of more than 10% of a patient's entire tumor burden. RESULTS: A total of 53 patients were enrolled in this study. Twenty-seven (mean age, 44.9 years) received PVA microspheres and 26 (mean age, 45.1 years) received tris-acryl gelatin microspheres. There were no significant differences in the preprocedural uterine volume, dominant tumor volume, location of dominant tumor, and presenting symptoms between populations. In the PVA microsphere group, treatment failure was seen in eight patients (29.6%). In the tris-acryl gelatin microsphere group, treatment failure was seen in one patient (3.8%), which was a significant difference between groups (P < or = .025). CONCLUSIONS: There was a significantly greater degree of tumor infarction in patients treated with tris-acryl gelatin microspheres during UAE than in patients who received PVA microspheres administered in accordance with a newly refined protocol. Given the known risk of recurrence in patients with persistent tumor enhancement after UAE, it is concluded that tris-acryl gelatin microspheres should be the preferred agent for UAE at this time.

Uterine artery embolization and infertility.

As the acceptance of uterine artery embolization as a treatment option for uterine fibroids grows among patients and physicians, it appears that new questions are being asked about the patient selection criteria used for this procedure. In particular, patients with infertility issues or concerns about preserving fertility after fibroid treatment are often being evaluated for uterine artery embolization. This article was prepared to summarize the available literature regarding fertility preservation after both myomectomy and uterine artery embolization and to provide the reader with an algorithm for evaluating these patients and making literature-based treatment decisions.