Clement J. Grassi

Image-guided tumor ablation: standardization of terminology and reporting criteria.

The field of interventional oncology with use of image-guided tumor ablation requires standardization of terminology and reporting criteria to facilitate effective communication of ideas and appropriate comparison between treatments that use different technologies, such as chemical (ethanol or acetic acid) ablation, and thermal therapies, such as radiofrequency (RF), laser, microwave, ultrasound, and cryoablation. This document provides a framework that will hopefully facilitate the clearest communication between investigators and will provide the greatest flexibility in comparison between the many new, exciting, and emerging technologies. An appropriate vehicle for reporting the various aspects of image-guided ablation therapy, including classification of therapies and procedure terms, appropriate descriptors of imaging guidance, and terminology to define imaging and pathologic findings, are outlined. Methods for standardizing the reporting of follow-up findings and complications and other important aspects that require attention when reporting clinical results are addressed. It is the groups intention that adherence to the recommendations will facilitate achievement of the groups main objective: improved precision and communication in this field that lead to more accurate comparison of technologies and results and, ultimately, to improved patient outcomes. The intent of this standardization of terminology is to provide an appropriate vehicle for reporting the various aspects of image-guided ablation therapy.

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.

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

Observations on the use of thrombolytic agents for thrombotic occlusion of infrainguinal vein grafts

Vein graft failure remains a major challenge for the vascular surgeon. Thrombolysis of occluded vein grafts has shown promising short-term results in restoring vein graft patency, however, the long-term results are not established. This study examines the long-term patency and limb salvage after successful thrombolysis and revision of 22 thrombosed vein grafts in 21 patients. There were 17 men and four women with an average age of 60 years (38 to 77 years). Failed vein grafts had an average primary patency of 19 months (1 to 84 months) and included eight in situ grafts and 14 non-in situ grafts. Twelve grafts were to the popliteal level, whereas 10 were infrapopliteal. Thrombolytic agents used included urokinase (15), tissue plasminogen activator (5), and streptokinase (2). After successful thrombolysis, 19 grafts underwent 26 additional procedures including percutaneous transluminal angioplasty (9), vein patch angioplasty (4), vein interposition or jump extension graft (9), or other procedures (4). Three patients had no additional procedure, but one was placed on sodium warfarin (Coumadin). After successful initial vein graft salvage, life-table analysis revealed a 36.6% +/- 11.9% patency at 1 year and a 22.9% +/- 11.6% patency at 3 years. After secondary failure six patients had further interventions contributing to an improved limb salvage of 66.9% +/- 11.6% at 1 year and 60.3% +/- 19.0% at 3 years. The results suggest that thrombosed vein grafts initially salvaged with thrombolysis and revision do not have a favorable long-term patency, and that a premium must be placed on the detection of the failing vein graft before thrombosis.

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

Risks and benefits of femoropopliteal percutaneous balloon angioplasty

PURPOSE The purpose of this study was to evaluate the efficacy of angioplasty in the treatment of femoropopliteal arterial disease. METHODS From 1980 to 1991, 126 angioplasty procedures were performed in 131 limbs of 106 patients with 175 femoropopliteal lesions (26 common femoral, 118 superficial femoral, and 31 popliteal). Critical ischemia was present in 55 limbs (42%), and claudication was present in 76 (58%). Angioplasty was performed for a single lesion in 87 limbs (66%) and for multiple lesions in 44 (34%). In 13 limbs (10%) the most severe lesion was an occlusion; in 118 (90%) all lesions were stenoses. Distal runoff was good (2 or 3 vessels patent) in 72 limbs (55%) and poor (0 or 1 vessel patent) in 59 (45%). RESULTS Death within 30 days occurred in 0.8%, nonfatal systemic morbidity in 7.1%, and local morbidity in 1.6% of procedures. Multivariate analysis revealed that indication and age were predictive of increased morbidity and mortality rates. Immediate success was achieved in 95% of limbs treated. Mean follow-up time was 2.0 years. The overall 5-year cumulative primary patency rate was 45% (+/- 5%). In a proportional hazards model indication and lesion type were predictive (p < 0.01) of long-term failure, with relative risks of 2.0 (1.2 to 3.3) and 2.7 (1.3 to 5.6), respectively. The 5-year primary patency rate after angioplasty for stenoses and claudication was 55% (+/- 7%), for stenoses and critical ischemia it was 29% (+/- 11%), and for occlusions it was 36% (+/- 14%). CONCLUSION These results suggest that femoropopliteal angioplasty is a low-risk procedure with acceptable long-term results in patients with claudication and stenoses.

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.

Early operative intervention after thrombolytic therapy for primary subclavian vein thrombosis: An effective treatment approach

PURPOSE Effective treatment of primary subclavian vein thrombosis focuses on restoration of venous patency, relief of intrinsic stenosis, and decompression of the thoracic inlet. The appropriate method and timing for surgery, however, have not been not well defined. We conducted a study to determine an acceptable treatment approach. METHODS A retrospective review evaluated 11 patients seen at our institution in an 8-year period. Seven patients were male and four were female, with an average age of 30 years (range 15 to 54 years). Two patients who had symptomatic stenosis without occlusion were omitted from the study. All patients with occlusion received urokinase therapy and underwent surgical decompression within 5 days of thrombolytic therapy. Five percutaneous transluminal angioplasties were attempted before operative intervention. Eleven decompressions were performed, including nine first-rib resections and two scalenectomies. Five operative venous procedures, consisting of thrombectomy with patch closure (n = 3) and bypass (n = 2), and seven venolysis procedures were performed. All patients received coumadin for 3 to 6 months after the operation. RESULTS Urokinase therapy established wide venous patency in nine of the 11 extremities treated, with the remaining two requiring thrombectomy for residual thrombus at the time of operation. One patient who underwent transluminal angioplasty before the operation had rethrombosis, and the remaining four showed no improvement in venous stenosis after the intervention. Eight of nine extremities treated by first-rib resection and one of two treated by scalenectomy were free of residual symptoms at follow-up. CONCLUSIONS Preoperative use of percutaneous balloon angioplasty is ineffective and should be avoided in this setting. Surgical intervention within days of thrombolysis obviates the need for interim oral anticoagulation and enables patients to return to normal activity sooner.

Reporting Standards for Inferior Vena Caval Filter Placement and Patient Follow-up: Supplement for Temporary and Retrievable/Optional Filters

THIS Standards document is intended as a Supplement to the Recommended Reporting Standards for Vena Cava Filter Placement and Patient Followup, published in 1999 (1). Since 1999, there has been increased interest in non-permanent vena cava filters, with both increased research and clinical use of these devices. Several such devices are now approved for use in Europe, Canada, and the United States. The previous Standards did address several issues related specifically to non-permanent filters: this document contains additional issues that have arisen in the interval. Although there is a large number of publications regarding vena cava filters, the literature is generally limited, with few good prospective studies, and even fewer randomized controlled trials (2). A randomized trial published in 1998 (3) demonstrated the “initial efficacy of filters for the prevention of pulmonary embolism.” However, prevention of pulmonary embolism (PE) appeared to be shortlived, and was counterbalanced by an increased risk of recurrent deep-vein thrombosis (DVT) in the patients receiving filters (3). The data published in this trial, which was based on 2-year follow-up, resulted in increased interest in non-permanent filters. Of note, further follow-up data from the same trial showed continued filter protection against PE with no increase in post-thrombotic syndrome at 8 years (4).