Steven F. Millward

Transcatheter Therapy for Hepatic Malignancy: Standardization of Terminology and Reporting Criteria

The field of interventional oncology includes tumor ablation as well as the use of transcatheter therapies such as embolization, chemoembolization, and radioembolization. Terminology and reporting standards for tumor ablation have been developed. The development of standardization of terminology and reporting criteria for transcatheter therapies should provide a similar framework to facilitate the clearest communication among investigators and provide the greatest flexibility in comparing established and emerging technologies. An appropriate vehicle for reporting the various aspects of catheter directed therapy is outlined, including classification of therapies and procedure terms, appropriate descriptors of imaging guidance, and terminology to define imaging and pathologic findings. Methods for standardizing the reporting of outcomes toxicities, complications, and other important aspects that require attention when reporting clinical results are addressed. It is the intention of the group that adherence to the recommendations will facilitate achievement of the groups main objective: improved precision and communication for reporting the various aspects of transcatheter management of hepatic malignancy that will translate to more accurate comparison of technologies and results and, ultimately, to improved patient outcomes.

Society of Interventional Radiology Position Statement on Chemoembolization of Hepatic Malignancies

PRIMARY and secondary malignancies in the liver present one of the most challenging problems in clinical oncology. Hepatocellular carcinoma (HCC) is one of the most common fatal malignancies worldwide, with more than 530,000 new cases diagnosed annually (1). The prevalence of hepatoma in the United States is rapidly increasing as a result of the spread of chronic infection with hepatitis C. Currently 10,000–15,000 cases of HCC are diagnosed annually in the United States. It is estimated that this number will more than double to 34,000 cases of HCC per year by 2019 (2). Colorectal cancer is the second leading cause of cancer-related death in the United States, with liver metastases accounting for approximately half these deaths. More than 56,000 patients died from colon cancer in 2002 and it is predicted that there will be more than 145,000 new cases of colorectal cancer diagnosed in the United States in 2005 (3). Other tumors that frequently develop fatal hepatic metastases despite a treatable primary tumor include ocular melanoma, neuroendocrine tumors, and gastrointestinal sarcoma. Chemoembolization combines hepatic artery embolization with simultaneous infusion of a concentrated dose of chemotherapeutic drugs followed by embolization particles. Hepatic artery embolization refers to infusion of particles into tumor-feeding arteries without chemotherapeutic agents. Embolization by either technique renders the tumor ischemic, depriving it of nutrients and oxygen. When chemotherapy is used, tumor drug concentrations are one to two orders of magnitude greater than are achieved by infusion alone, and the dwell time of the chemotherapy agent is markedly prolonged, with measurable drug levels present as long as 1 month later (4–7). Because most of the drug is retained in the liver, systemic toxicity is reduced (8). Embolization and chemoembolization lead to ischemia of the tumor by blockade of the nutrient supply. An advantage of embolization is that the ischemia induced by embolization helps to overcome drug resistance by causing metabolically active cell membrane pumps to fail, thereby increasing intracellular retention of the chemotherapeutic drugs (9). Recent research has demonstrated that ischemia can increase angiogenesis in tumor cells, possibly spurring tumor growth (10–12). These molecular changes raise questions about whether chemoembolization or hepatic arterial embolization is the better method to perform endovascular hepatic arterial therapy. To date, no study has demonstrated a difference in survival between the two techniques (10,13).

Reporting Standards for Endovascular Treatment of Pulmonary Embolism

From the Division of Interventional Radiology (F.B.) and the Departments of Radiology (D.C.B.) and Surgery (D.M.L.), Georgetown University Hospital, 3800 Reservoir Rd, NW, Washington, DC 20007; the Division of Vascular and Interventional Radiology, Stanford University Medical Center, Stanford, California (W.T.K.); the Department of Radiology, Division of Interventional Radiology, Emory University School of Medicine, Emory University Hospital, Atlanta, Georgia (L.G.M.); the Department of Radiology, University of Western Ontario, London, and Peterborough Regional Health Centre, Peterborough, Ontario, Canada (S.F.M.); the Department of Interventional Radiology, New York University School of Medicine, NYU Medical Center, New York, New York (T.W.I.C.); Scarborough General Hospital, Toronto, Ontario, Canada (S.K.); the Division of Vascular and Interventional Radiology, Department of Medical Imaging, University of Toronto, University Health Network, Toronto, Ontario, Canada (D.K.R.); The Reading Hospital and Medical Center, Advanced Interventional Radiology, West Reading, Pennsylvania (D.S.); and Geisinger Health System, Danville, Pennsylvania (J.F.C.). Received September 1, 2009; accepted September 28, 2009. Address correspondence to F.B.; E-mail: banovac@isis.georgetown.edu

Society of Interventional Radiology Position Statement on Percutaneous Radiofrequency Ablation for the Treatment of Liver Tumors

Focal tumor ablation--whether applied percutanously, laparoscopically, or by means of open surgery--is an effective therapy for selected liver tumors. The choice of liver ablation as well as the choice between percutaneous and surgical approaches is dependent on tumor factors, patient factors, and other viable treatment options. Currently, the largest cumulative reported experience is with radiofrequency (RF) ablation of hepatocellular carcinoma and colorectal metastases. This document is a position statement of the Interventional Oncology Task Force and the Standards Division of the Society of Interventional Radiology regarding the use of percutaneous RF ablation for the treatment of liver tumors.

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).

Preliminary Clinical Experience with the Gunther Temporary Inferior Vena Cava Filter

PURPOSE The authors describe their preliminary clinical experience with the Gunther temporary inferior vena cava (IVC) filter. PATIENTS AND METHODS Seven women and 10 men, mean age 52 years (range, 19-85 years), were treated with the temporary IVC filter. Indications for filter placement were pulmonary embolism (PE) in four patients and iliofemoral deep venous thrombosis in six. In these patients anticoagulation was contraindicated because of planned major surgery. Filters were placed in four patients following massive PE and in three for prophylaxis following cranial trauma. Four patients had underlying malignant disease. Filters were introduced through the right common femoral vein in 14 patients, the left common femoral vein in two, and the left internal jugular vein in one. RESULTS No patient developed recurrent PE with the filter in place. All filters were removed without complication 3-14 days (mean, 7 days) after placement. Two of the patients with underlying malignant disease required placement of a permanent filter. Two patients developed IVC thrombosis with the filter in place, and both developed recurrent PE after filter removal. Two patients developed insertion vein thrombosis. One patient developed a bleeding disorder that caused a massive hematoma at the insertion vein site, which may have contributed to her death. CONCLUSION The Gunther temporary filter can be used in selected patients; however, patients with underlying malignant disease may be more appropriately treated with a permanent filter. The temporary filter does not appear to reduce the rate of insertion vein and IVC thrombosis.

LGM (Vena Tech) Vena Caval Filter: Experience at a Single Institution

PURPOSE The authors describe their experience with LG-Medical (LGM [Vena Tech]) filter placement and follow-up. PATIENTS AND METHODS LGM vena cava filters were placed in 63 patients. Follow-up was obtained by means of duplex sonography of the introduction vein and inferior vena cava (IVC) and abdominal radiography in 50 patients, and by means of autopsy in an additional four patients. In eight, only clinical follow-up was obtained and one patient was lost to follow-up. RESULTS Major complications of placement occurred in three patients, all when the right internal jugular vein was used for introduction: In one patient a filter was inadvertently placed in the right renal vein and in two the filter failed to open fully. No serious complications of placement occurred when either the right or left common femoral veins were used. Pulmonary embolism (PE) recurred in four patients (6%) and was fatal in one. Septicemia from an infected filter was the probable cause of death in another patient. Introduction vein thrombosis occurred in five patients (8%) and was symptomatic in two (3%). Occlusion of the IVC occurred in 15 patients (24% of the total patient group, but 28% of those with objective follow-up) and was symptomatic in 12 (19%). Two patients with IVC occlusion had recurrent PE. CONCLUSION These data suggest that the rate of IVC occlusion is higher than most previous reports have suggested and that IVC occlusion may be a potentially serious complication.

Reporting Standards for Percutaneous Thermal Ablation of Renal Cell Carcinoma

WITH the increasing incidence of renal cell carcinoma (RCC) in the United States and the increasing proportion of patients with tumors detected at an early stage (1–5), nephron-sparing approaches are becoming more popular. These alternatives to radical nephrectomy include partial nephrectomy, wedge resection, and, more recently, in situ thermal ablation. Five-year survival rates after partial nephrectomy are equivalent to those after radical nephrectomy (6–8), supporting the rationale of in situ tumor destruction to further reduce morbidity and invasiveness. In situ thermal destruction of RCC uses techniques that destroy tumor tissue through heating (eg, radiofrequency [RF] ablation, microwave ablation, laser interstitial therapy, high-intensity focused ultrasound [US]) or freezing (eg, cryotherapy). Each of these techniques relies on controlled energy delivery to minimize collateral damage to normal renal parenchyma and other surrounding structures. In the United States, RF ablation and cryoablation are currently the most widely used techniques for in situ RCC destruction. Thermal ablation of RCC may be performed percutaneously, laparoscopically, or through open surgery. Our current understanding of the role of percutaneous thermal ablation in the management of primary RCC is limited by a paucity of prospective studies (9,10). Given the relative newness of this technology, most series to date report short-term or midterm outcomes, with no reports extending to 5 years of survival outcomes. No randomized trials have been performed to date comparing thermal ablation against a gold standard (ie, partial nephrectomy) or against other thermal ablation techniques. The optimal size range of RCC amenable to thermal ablation has not been clearly defined and is closely related to anatomic factors that influence the ability to deposit sufficient thermal dose to coagulate tissue, including proximity to major vessels and the urinary collecting system, which can act as a heat sink. The kidney has approximately four times the blood flow of the liver, so convective heat loss during thermal ablation is potentially significant (11). The role of percutaneous thermal ablation compared with laparoscopic or open thermal ablation also remains a topic of controversy. The combination of thermal ablation with other imageguided therapies (eg, transcatheter embolization) and adjuvant therapies such as chemotherapy and antiangiogenic agents for larger RCCs in patients who are poor operative candidates is another potential use of this technique. Although most recent reports of percutaneous RCC ablation have involved RF ablation, other ablation technologies are now available with percutaneous applicators (eg, cryoablation, microwave, laser interstitial therapy), and reporting standards should be uniform for all forms of energy-based ablation. This document provides recommended reporting standards for physicians performing percutaneous thermal ablation of primary RCC and will serve as a template in the design of clinical trials to further evaluate this technology. From the Section of Vascular and Interventional Radiology, Department of Radiology (T.W.I.C.), New York University School of Medicine, New York, New York; Department of Radiology (S.F.M.), University of Western Ontario, Peterborough Regional Health Center, Peterborough, Ontario, Canada; Department of Radiology, Gastrointestinal/Genitourinary Division (D.A.G.), Massachusetts General Hospital; Department of Radiology (S.N.G.), Beth Israel Deaconess Medical Center, Boston; Department of Radiology (C.J.G.), Lahey Clinic Medical Center, Burlington; Department of Radiology (D.A.P.), University of Massachusetts Memorial Health Care, Worcester, Massachusetts; Department of Radiology (T.B.K.), University of California San Diego Medical Center, San Diego, California; Department of Radiology (D.S.), The Reading Hospital and Medical Center, Reading, Pennsylvania; and Department of Radiology (J.F.C.), University of Colorado Health Sciences Center, Denver, Colorado. Received June 19, 2006; revision requested June 19; final revision received June 29; and accepted July 3. Address correspondence to T.W.I.C., c/o Tricia McClenny, Society of Interventional Radiology, 3975 Fair Ridge Dr, Suite 400 North, Fairfax, VA 22033; E-mail: mcclenny@sirweb.org

Multi-society consensus quality improvement guidelines for the treatment of lower-extremity superficial venous insufficiency with endovenous thermal ablation from the Society of Interventional Radiology, Cardiovascular Interventional Radiological Society of Europe, American College of Phlebology and Canadian Interventional Radiology Association.

Neil M. Khilnani, MD, Clement J. Grassi, MD, Sanjoy Kundu, MD, FRCPC, Horacio R. D’Agostino, MD, Arshad Ahmed Khan, MD, J. Kevin McGraw, MD, Donald L. Miller, MD, Steven F. Millward, MD, Robert B. Osnis, MD, Darren Postoak, MD, Cindy Kaiser Saiter, NP, Marc S. Schwartzberg, MD, Timothy L. Swan, MD, Suresh Vedantham, MD, Bret N. Wiechmann, MD, Laura Crocetti, MD, John F. Cardella, MD, and Robert J. Min, MD, for the Cardiovascular Interventional Radiological Society of Europe, American College of Phlebology, and Society of Interventional Radiology Standards of Practice Committees

LGM (Vena Tech) Vena Cava Filter: Clinical Experience in 64 Patients

LG-Medical (LGM) vena cava filters were inserted percutaneously in 64 patients. Each case was followed after the filter insertion. Clinical follow-up was available in all patients; in 11 patients it was the only form of follow-up. Findings were available from autopsies in seven patients, plain abdominal radiographs in 42, and duplex sonograms of the insertion vein and inferior vena cava (IVC) in 46. A filter was inserted without major complication in all patients. The filter failed to open fully in four patients and was tilted in the IVC in 15. Recurrent pulmonary embolism was found in two patients (fatal in one), and inconsequential filter migration occurred in 11. Introduction vein thrombosis occurred in four patients. IVC thrombosis, demonstrated at autopsy or sonography, was found in 14 patients (22%) and was symptomatic in six (9%). This report suggests that the LGM filter is easy to introduce, and few complications are associated with insertion. The rate of caval thrombosis, however, may be higher than previously reported.