Curtis A. Lewis

Quality Improvement Guidelines for Percutaneous Management of the Thrombosed or Dysfunctional Dialysis Access

John E. Aruny, MD, Curtis A. Lewis, MD, John F. Cardella, MD, Patricia E. Cole, PhD, MD, Andrew Davis, MD, Alain T. Drooz, MD, Clement J. Grassi, MD, Richard J. Gray, MD, James W. Husted, MD, Michael Todd Jones, MD, Timothy C. McCowan, MD, Steven G. Meranze, MD, A. Van Moore, MD, Calvin D. Neithamer, MD, Steven B. Oglevie, MD, Reed A. Omary, MD, Nilesh H. Patel, MD, Kenneth S. Rholl, MD, Anne C. Roberts, MD, David Sacks, MD, Orestes Sanchez, MD, Mark I. Silverstein, MD, Harjit Singh, MD, Timothy L. Swan, MD, Richard B. Towbin, MD, Scott O. Trerotola, MD, Curtis W. Bakal, MD, MPH, for the Society of Interventional Radiology Standards of Practice Committee

Quality Improvement Guidelines for Percutaneous Permanent Inferior Vena Cava Filter Placement for the Prevention of Pulmonary Embolism

PULMONARY embolism (PE) continues to be a major cause of morbidity and mortality in the United States. Estimates of the incidence of nonfatal PE range from 400,000 to 630,000 cases per year, and 50,000 to 200,000 fatalities per year are directly attributable to PE (1–4). The current preferred treatment for deep venous thrombosis and PE is anticoagulation therapy. However, as many as 20% of these patients will have recurrent PE (1,5,6). Interruption of the inferior vena cava (IVC) for the prevention of PE was first performed in 1893 with use of surgical ligation (7). Over the years, surgical interruption took many forms (ligation, plication, clipping, or stapling) but IVC thrombosis was a frequent complication after these procedures. Endovascular approaches to IVC interruption became a reality in 1967 after the introduction of the Mobin-Uddin filter (8). Many devices have since been developed for endoluminal caval interruption but, currently, there are six devices commercially available in the United States. These devices are designed for permanent placement. For detailed information regarding each of these filters, the reader is referred to several published reviews (9–12). Selection of a device requires knowledge of the clinical settings in which filters are used, evaluation of the clot trapping efficiency of the device, occlusion rate of the IVC and access vein, risk of filter migration, filter embolization, structural integrity of the device, and ease of placement. Percutaneous caval interruption can be performed as an outpatient or inpatient procedure. However, practically speaking, most filter placements will occur in the inpatient population because of ongoing medical therapy for acute thromboembolic disease or underlying illness. The IVC should be assessed with imaging before placement of a filter, and the current preferred imaging method is vena cavography. Before filter selection and placement, the infrarenal IVC length and diameter should be measured, the location and number of renal veins determined, IVC anomalies (eg, duplication) defined, and intrinsic IVC disease such as preexisting thrombus or extrinsic compression excluded. The ideal placement for the prevention of lower extremity and pelvic venous thromboembolism is the infrarenal IVC. The apex or superior aspect of any filtration device should be at or immediately inferior to the level of the renal veins according to the manufacturers’ recommendations. In specific clinical circumstances, other target locations may be appropriate. Percutaneous caval interruption is commonly accomplished through right femoral and right internal jugular vein approaches; however, other peripheral and central venous access sites can be used. Filters can be placed in veins other than the vena cava to prevent thromboembolism. Implant sites have included iliac veins, subclavian veins, superior vena cava, and IVC (suprarenal and infrarenal). This document will provide quality improvement guidelines for filter placement within the inferior vena cava because of the limited data available for implantation sites other than the IVC. The patient’s clinical condition, the type of filter available, the alternative access sites available, and the expertise of the treating physician should always be considered when the decision to place an IVC filter has been made. These guidelines are written to be used in quality improvement programs to assess percutaneous interruption of the IVC to prevent pulmonary embolism. The most important processes of care are (a) patient selecThis article first appeared in J Vasc Interv Radiol 2001; 12:137–141.

Quality Improvement Guidelines for Percutaneous Transhepatic Cholangiography and Biliary Drainage

PERCUTANEOUS transhepatic cholangiography is a safe and effective technique for evaluating biliary abnormalities. It reliably demonstrates the level of abnormalities and sometimes can help diagnose their etiologies. Percutaneous transhepatic biliary drainage is an effective method for the primary or palliative treatment of many biliary abnormalities demonstrated with cholangiography. Participation by the radiologist in patient follow-up is an integral part of percutaneous transhepatic biliary drainage and will increase the effectiveness of the procedure. Close follow-up, with monitoring and management of the patients’ drainage-related problems, is appropriate for the interventional radiologist. These guidelines are written to be used in quality improvement programs to assess percutaneous biliary procedures. The most important processes of care are (a) patient selection, (b) performing the procedure, and (c) monitoring the patient. The outcome measures or indicators for these processes are indications, success rates, and complication rates. Outcome measures are assigned threshold levels.

Reporting Standards for Endovascular Treatment of Lower Extremity Deep Vein Thrombosis

Suresh Vedantham, MD, Clement J. Grassi, MD, Hector Ferral, MD, Nilesh H. Patel, MD, Patricia E. Thorpe, MD, Vittorio P. Antonacci, MD, Bertrand M. Janne d’Othée, MD, Lawrence V. Hofmann, MD, John F. Cardella, MD, Sanjoy Kundu, MD, Curtis A. Lewis, MD, MBA, Marc S. Schwartzberg, MD, Robert J. Min, MD, and David Sacks, MD, for the Technology Assessment Committee of the Society of Interventional Radiology

Quality improvement guidelines for transjugular intrahepatic portosystemic shunts.

Ziv J. Haskal, MD, Louis Martin, MD, John F. Cardella, MD, Patricia E. Cole, PhD, MD, Alain Drooz, MD,Clement J. Grassi, MD, Timothy C. McCowan, MD, Steven G. Meranze, MD, Calvin D. Neithamer, MD,Steven B. Oglevie, MD, Anne C. Roberts, MD, David Sacks, MD, Mark I. Silverstein, MD,Timothy L. Swan, MD, Richard B. Towbin, MD, and Curtis A. Lewis, MD, MBA, for the Society ofInterventional Radiology Standards of Practice Committee

Position Statement on the Use of the Ankle Brachial Index in the Evaluation of Patients with Peripheral Vascular Disease A Consensus Statement Developed by the Standards Division of the Society of Interventional Radiology

PERIPHERAL vascular disease (PVD), also known as peripheral arterial disease, affects more than 8–10 million Americans, and its incidence is growing annually (1). PVD is a risk marker for coronary disease, cerebrovascular disease, aneurysmal disease, diabetes, hypertension, and many other conditions. Patients with objectively documented PVD have a fourto six-fold increase in cardiovascular mortality rate over healthy age-matched individuals (2). Fifty percent of people with PVD are symptomatic (3). One of the simplest and most useful parameters to objectively assess lower extremity arterial perfusion is the ankle-brachial index (ABI). The ABI helps to define the severity of the disease and successfully screens for hemodynamically significant disease. The Society of Interventional Radiology (SIR) recommends that all patients being evaluated for peripheral vascular disease should have their ABI measured. The following methodology is recommended: With the patient placed in a supine position, the brachial and ankle systolic pressure measurements are obtained. The higher systolic pressure of the anterior tibial or posterior tibial measurement for each foot is divided by the highest brachial systolic pressure to obtain an ankle brachial pressure ratio. For example, to obtain the left ABI, first measure the systolic brachial pressure in both the left and the right arm. Select the higher of these two values as the brachial artery pressure measurement. There should be a difference of less than 10 mm Hg between each brachial pressure measurement. Next, measure the left anterior tibial and posterior tibial arterial systolic pressures. Select the higher of these two values as the ankle pressure measurement. Then, divide the selected ankle pressure measurement by the previously selected brachial artery systolic pressure measurement. This will give the ABI. ABIs as high as 1.10 are normal; abnormal values are those less than 1.0. The majority of patients with claudication have ABIs ranging from 0.3 to 0.9. Rest pain or severe occlusive disease typically occurs with an ABI lower than 0.50. Indexes lower than 0.20 are associated with ischemic or gangrenous extremities. In patients with diabetes and heavily calcified vessels, the arteries are frequently incompressible. This results in an artifactually elevated ankle pressure, which can underestimate disease severity. In these patients, toe pressure determinations more accurately reflect perfusion.

Quality improvement guidelines for percutaneous nephrostomy.

The membership of the Society of Cardiovascular & Interventional Radiology (SCVIR) Standards of Practice Committee represents experts in a broad spectrum of interventional procedures from both the private and academic sectors of medicine. Generally, Standards of Practice Committee members dedicate the vast majority of their professional time to performing interventional procedures; as such, they represent a valid, broad expert constituency of the subject matter under consideration for standards production.

Quality Improvement Guidelines for Percutaneous Transcatheter Embolization

Alain T. Drooz, MD, Curtis A. Lewis, MD, Timothy E. Allen, MD, Steven J. Citron, MD, Patricia E. Cole, PhD, MD, Neil J. Freeman, MD, James W. Husted, MD, Patrick C. Malloy, MD, Louis G. Martin, MD, A. Van Moore, MD, Calvin D. Neithamer, MD, Anne C. Roberts, MD, David Sacks, MD, Orestes Sanchez, MD, Anthony C. Venbrux, MD, Curtis W. Bakal, MD, MPH, for the Society of Interventional Radiology Standards of Practice Committee

SIR Reporting Standards for the Treatment of Acute Limb Ischemia with Use of Transluminal Removal of Arterial Thrombus

ACUTE limb ischemia is any sudden decrease or worsening in limb perfusion that causes a potential threat to limb viability (1). Acute peripheral arterial occlusion may be caused by in situ thrombosis or embolus. In this article, the term “thrombus” will be used to describe arterial occlusion caused by in situ thrombosis or embolus. Percutaneous or “open” surgical techniques can be used to remove the thrombus. Current percutaneous methods for transluminal removal of thrombus (TRT) include thrombolytic therapy (ie, catheter-directed, pharmacomechanic), percutaneous aspiration thrombectomy (PAT), and percutaneous mechanical thrombectomy (PMT). These methods may be used in combination. Surgical techniques entail an “open” procedure that necessitates an arteriotomy for the removal of thrombus. Of the various TRT methods used to treat acute limb ischemia, catheterdirected thrombolytic therapy with urokinase has been the most widely studied. Catheter-directed thrombolytic therapy has at least three theoretical and practical advantages over surgical thromboembolectomy: less endothelial trauma, angiographic visualization of the underlying lesion(s) and runoff vessels, and, in many cases, ready access for definitive transluminal therapies that address the underlying lesion (1,2). In addition, it has been suggested that gradual, lowpressure reperfusion may offer certain advantages over sudden, high-pressure reperfusion associated with surgical revascularization (1,3,4). Recently, the Food and Drug Administration recalled urokinase (Abbokinase; Abbott Laboratories, Abbott Park, IL). As a result, a critical evaluation of alternate methods to treat acute limb ischemia with use of other thrombolytic drug strategies, PAT and/or PMT, will be needed. Reporting standards for the treatment of peripheral arterial disease (PAD) and practice guidelines for thrombolytic therapy for acute limb ischemia have been published (1,2,5– 7). However, there is insufficient evidence in the literature to determine the best therapy in a given case of acute limb ischemia. This is because the literature is replete with individual or institutional reports of surgical and thrombolytic therapy that are either biased or lack concurrent controls and standardized reporting practices (1). The purpose of this document is to establish reporting standards for subsequent studies pertaining to TRT in the treatment of acute limb ischemia. Consistent data reporting is needed to help precisely define the safety, efficacy, and long-term outcome of TRT procedures (1,8,9). Only then can the appropriate treatment be determined for patients presenting with acute limb ischemia.

Quality Improvement Guidelines for Image-guided Percutaneous Biopsy in Adults

PERCUTANEOUS biopsy has become established as a safe, effective procedure. Successful percutaneous needle biopsy has been applied in most organ systems with excellent results and few complications (1–19). The key to these procedures has been the use of imaging guidance, which allows for the safe passage of a needle into an organ or mass, to obtain tissue for cytologic or histologic examinations. Imageguided percutaneous biopsy is less invasive than open exploration to obtain these same tissues. Because of the lower morbidity and mortality of the noninvasive procedures, they can be applied to patients who are too ill to undergo surgery or who wish to avoid convalescence from large diagnostic laparotomy procedures. In most settings percutaneous biopsy is the first approach to diagnosis. Follow-up, with postprocedure monitoring and management of the patient, is appropriate for the radiologist and will increase the effectiveness of the procedure. These guidelines are written for use in a quality improvement program that monitors percutaneous biopsy procedures (20). The most important processes of care in this area are: (a) patient selection, (b) performing the procedure, and (c) monitoring the patient. The outcome measures or indicators for these processes are indications, success rates, and complication rate.