Interventional Radiology Practice Research Articles

Abstract No. 260: The MAUDE database: Friend, foe, or just misunderstood

To illustrate the utility of the FDA-sponsored Manufacturer and User Facility Device Experience (MAUDE) database for post market surveillance of interventional devices using the Starclose (Abbott) device as an example. Post-market surveillance is an essential aspect of establishing the safety of new medicines or devices in clinical practice. Pre-market clinical trials may not reveal all the potential complications associated with a device without prohibitive large or lengthy trials. As such the FDA designed the MAUDE database for post-marketing surveillance of medical devices through voluntary reporting of device-related adverse events. As there is an ever-expanding array of devices approved by the FDA with a considerably lower threshold than for pharmaceuticals, the potential value of the MAUDE database is tremendous. The reality is that MAUDE provides a useful starting point for post-market evaluation of device complications, however there are significant shortcomings that limit the utility of this resource. In this educational exhibit we will describe the MAUDE database and illustrate how it can be used to track device complications using the Starclose vascular device as an example. The strengths and the limitations of this database for tracking device complications are reviewed. - Post-market evaluation of devices may increasingly impact interventional radiology practice given the proliferation of new devices.

The Practice of Pediatric Interventional Radiology

There is a stark contrast between adult and pediatric interventional radiology practice. The essential elements of this all relate to working with children, including a need for greater procedural sedation and anesthesia; the psychology of working with children and their families; a skill set based around smaller bodies; and technology for smaller and growing humans. Interventional radiology departments that cater to children need to accommodate these factors so that sick children can access minimally invasive image-guided therapy in a safe and nonthreatening environment.

The Radiologist as a Palliative Care Subspecialist: Providing Symptom Relief When Cure Is Not Possible

The purpose of this study was to determine the percentage of patients referred to an interventional radiology (IR) practice who need palliative care and to examine the training required for a diplomate of the American Board of Radiology (ABR) to qualify for the hospice and palliative medicine certifying examination. This retrospective study reviewed all patient referrals to an academic vascular and IR practice during the month of August 2009. The demographics, underlying diagnosis, and the type of procedures performed were ascertained from the electronic medical record. The requirements for a diplomate of the ABR to obtain certification as a hospice and palliative medicine subspecialist were evaluated and summarized. Two-hundred eighty-two patients were referred to the IR service and underwent a total of 332 interventional procedures. Most of the patients (229 [81.2%]) had underlying diagnoses that would warrant consultation with a hospice and palliative medicine subspecialist; these patients were significantly older (58.5 vs 44.7 years; p < 0.01) and underwent more procedures (1.21 vs 1.02; p < 0.01). To obtain a subspecialty certification in hospice and palliative medicine, a radiologist needs certification by the ABR, an unrestricted medical license, 2 years of subspecialty training in hospice and palliative medicine, 100 hours of interdisciplinary hospice and palliative medicine team participation, active care of 50 terminally ill adult patients, and successful performance on the certification examination. Procedures related to palliative care currently compose the majority of our IR cases. Certification in hospice and palliative medicine can be achieved with a modest investment of time and clinical training.

Outpatient Vascular and Interventional Radiology Practice from 2001–2008

To describe experience with an outpatient vascular interventional radiology (IR) practice with respect to number of patients seen, number of procedures performed, and number of imaging studies ordered in follow-up. The outpatient vascular IR practice at the authors' institution was established in 2001 with two physicians spending one half-day per week; a third physician joined in 2004. A retrospective review was done of all patients seen by an interventional radiologist from 2001 to July 2008. The following data were collected for each physician per year: the number of new and established patients seen, the number and type of procedures performed, and the number and type of imaging studies ordered. Data are presented as mean ± standard deviation per physician per year and total number. In 2001, the average number of new patients seen was 61 ± 11 (total number = 122), which peaked in 2006 at 127 ± 28 (total number = 380). A similar trend occurred with the established patients. In 2001, the procedure performed with the greatest frequency was abdominal aortogram with stent placement, which started at 18 ± 2 (total number = 35) and peaked by 2006 at 37 ± 23 (total number = 122). The number of ancillary imaging studies ordered by each physician increased each year and by 2006 was nearly 93 ± 77 (total number = 278). A robust outpatient IR practice in vascular disease can be developed in 3-5 years with downstream imaging studies being ordered for the radiology department.

Prophylactic Antibiotic Guidelines in Modern Interventional Radiology Practice

Modern interventional radiology practice is continuously evolving. Developments include increases in the number of central venous catheter placements and tumor treatments (uterine fibroid therapy, radio- and chemoembolization of liver tumor, percutaneous radiofrequency and cryoablation), and new procedures such as abdominal aortic aneurysm stent-graft repair, vertebroplasty, kyphoplasty, and varicose vein therapies. There have also been recent advancements in standard biliary and urinary drainage procedures, percutaneous gastrointestinal feeding tube placement, and transjugular intrahepatic portosystemic shunts. Prophylactic antibiotics have become the standard of care in many departments, with little clinical data to support its wide acceptance. The rise in antibiotic-resistant strains of organisms in all hospitals worldwide have forced every department to question the use of prophylactic antibiotics. The authors review the evidence behind use of prophylactic antibiotics in standard interventional radiology procedures, as well as in newer procedures that have only recently been incorporated into interventional radiology practice.

Prevention of Contrast-Induced Nephropathy (CIN) in Interventional Radiology Practice

Contrast-induced nephropathy (CIN) is a widely recognized and clinically significant problem in patients undergoing an increasing number of minimally invasive procedures that require contrast administration. Contrast-induced nephropathy is the third most common cause of hospital-acquired renal failure and has significant prognostic implications on patient outcomes. Interventional practitioners are faced with challenging decisions regarding prophylaxis and patient management. The major risk factor for developing CIN is preexisting renal dysfunction, particularly in association with diabetes. Patients are considered to be at risk when estimated glomerular filtration rate (eGFR) or estimated creatinine clearance (eC(Cr)) is less than 60. The cornerstone of prevention of CIN is appropriate risk stratification, intravenous hydration with normal saline or sodium bicarbonate, appropriate withholding of nephrotoxic medications, use of low or iso-osmolar contrast media, and various intraprocedural methods for iodinated contrast dose reduction. Although N-acetylcysteine administration is popular, it remains unproven. Practitioners must be familiar with prevention strategies and diagnosis of CIN to minimize its clinical impact.

Tratamento endovascular: o papel do radiologista

A fast search on the PubMed site in September 29, 2010 with the words “Cardiovascular imaging”, covering a ten-year period, revealed 12,560 articles. By limiting the search to 2010 alone, 1,489 scientific articles were found. With these surprising figures, one can conclude that this is the greatest advance in developments in the field of cardiovascular imaging ever achieved in medicine. This increasing interest is based on three factors as follows: a) major companies invest in this field placing their bets on the expectations that technological success will yield incalculable profits; b) research laboratories seek to improve technical procedures, endoprosthesis materials and patients’ prognosis in the process of validating clinical studies; and c) physicians, clinics and hospitals, whether public or private, that must understand the struggle between profit and “reality”. We could take advantage of the present editorial to describe the different aspects of such developments, however it will only be focused on the radiologist’s role. In 2003, Mavroforou et al. highlighted the relevance of good practice in interventional radiology, based on compliance with the legislation and on the discussion of all the aspects with the patients and their families. Thus, those practicing non-invasive radiology, besides the patient himself, will face constant interference of the assisting physician in the practice, which will pose dilemma situations between common sense and medical ethics. The radiologist must dedicate himself to deeply understand the physiology and pathology of every disease, but currently the control of the effects of the human interference in this process is fundamental. The attempt to change the natural course of a vascular disease with interventional radiology may be successful or not. Thus, those who qualify to investigate cardiovascular diseases must understand the relevant role of noninvasive imag-

More Than a Procedure

AJR:195, October 2010 of the disease entity itself. You need to talk the talk. Your colleagues should rely on you to highlight new published studies in your field or the development of new techniques. It is quite obvious to others when a member either is passive and not a true contributor or is just “blowing smoke.” These groups do not suffer fools lightly. Many years ago, Charles T. Dotter, the founder of interventional radiology, warned us about being too focused on the technical aspects of the procedures. In time, anyone can learn how to do a specific procedure. It’s about being a doctor first and then a proceduralist. Intake and follow-up clinics have been emphasized over the past two decades for interventional radiologists. Drs. Trerotola and Pyeritz and the University of Pennsylvania HHT Center of Excellence have expanded on this concept with coordinated care from multiple subspecialty groups whose members share an interest in, common approach to, and broad knowledge of this complex disease entity. Their approach emphasizes the fact that an interventional radiology practice is more than a procedure. Matthew A. Mauro AJR Section Editor Vascular and Interventional Radiology The Ernest H. Wood Distinguished Professor and Chair Department of Radiology University of North Carolina School of Medicine Chapel Hill, NC m_mauro@med.unc.edu DOI:10.2214/AJR.10.5320

Renewing Focus on Resident Education: Increased Responsibility and Ownership in Interventional Radiology Rotations Improves the Educational Experience

To enhance the educational experience among residents rotating through interventional radiology (IR) by encouraging ownership and responsibility. In May 2006, the authors implemented changes in resident education in IR that included increased clinical responsibilities, structured didactics, and greater hands-on experience, including call. Residents were assigned as first assistants, ownership of cases was encouraged, and assignment to a week on the consult service was instituted to help residents better understand all aspects of IR practice. Additional faculty recruitment and program expansion ensured the same high level of training for the fellowship program. Evaluations were reviewed every year (July 1, 2007-June 30, 2009) for hands-on training, daily teaching, didactic conferences, and overall effectiveness of the clinical service. A graduated scale of 1-5 was used. In 2009, 3 years after the curricular changes were made, the quality of hands-on training, daily case reviews and consults, didactics, and overall education had markedly improved with 89%, 71%, 65%, and 82% of the residents rating these respective aspects of the training as "above expectations" (4 on a scale of 5) or "superior" (5 on a scale of 5) compared with 77%, 23%, 20%, and 60% in 2005-2006. Three years after the changes, the impact of these changes on recruitment patterns also showed improvement, with 28.6% of the class of 2010 pursuing a fellowship in IR. Increasing resident ownership, responsibility, and hands-on experience improves resident education in IR, which, in turn, promotes interest in the field.

2010 Annual Convention

The 29th Annual Convention of the Association for Radiologic & Imaging Nursing (ARIN) was held on March 14e17 in Tampa, FL, at the Marriott Waterside. This year’s convention theme was Achieving Success through Knowledge and Networking. Typical of early spring in the South, we had some torrential rains, some blowing winds, and some great Florida sunshined occasionally all in the same hour or two. More than a few of the attendees left sporting bright red sunburns (TIPdminimum SPF 15, don’t leave home without it!). The Imaging Nurse Review Course (formerly known as certification preparation) was presented on March 12e13 by master faculty Kathy Scheffer, MN, RN, CRN, and Ellen Lash, RN, C, CRN. The preconvention program was well attended with almost 50 participants, several of whom sat for the CRN exam at the end of the convention on March 17th. Chris Cavanaugh, BSN, RN, CRNI, presented the PICC Fundamentals workshop on Saturday, March 13. Having decreased the length of the convention and eliminating the joint daywithAVIR, theARINPlanning Committee did a wonderful job compiling a wide variety of topics and presenters inclusive of all members of the Interventional Radiology (IR) team. Physicians, advanced practice registered nurses, registered nurses, and radiology technologists spoke on an array of subjects, from patient safety in the IR setting to the ‘‘business’’ of IR and collaborative practice opportunities that encourage the IR service to be an identifiable option for the health care consumer. OnSunday,K. LynnWieck, PhD,RN, gave the opening address entitled ‘‘Keys to a Successful Workplace:

Abstract No. 352: The outpatient vascular and interventional radiology practice from 2001-2008

To describe our experience with our outpatient vascular interventional radiology (IR) practice with respect to number of patients seen, number of procedures performed, and number of imaging studies ordered in follow-up. Our outpatient vascular IR practice was established in 2001 with two physicians spending 0.1 FTE per year with a third physician joined in 2004. We retrospectively reviewed from all patients seen by an interventional radiologist 2001 to July 2008. The following data were collected for each IR physician per year: the number of new and established patients seen, the number and type of procedures performed, and the number and type of imaging studies ordered. Data are presented as mean ± standard deviation/IR physician/year. In 2001, the average number of new patients seen was 61 ± 11 which peaked by 2006 at 127 ± 28. A similar trend occurred with the established patients. In 2001, the procedure performed with the greatest frequency was abdominal aortogram with stent placement, which started at 18 ± 2 and peaked by 2006 at 37 ± 23. In addition, the number of ancillary imaging ordered by each physician grew each year and by 2006–2007 it was nearly 93 ± 77. A robust outpatient IR practice in vascular disease can be developed in 3–5 years. The interventional radiologist can successfully consult on vascular patients and gradually grow a practice in procedural volume along with downstream imaging studies being ordered for the diagnostic radiology department.

Introduction

Six years ago, the Journal of Vascular and Interventional Radiology (JVIR) published a supplement based on the many documents developed to that point by the Standards Division of the Society of Interventional Radiology (SIR). These documents were products of a laudable intent on the part of SIR leadership to improve the quality of clinical care and published research relevant to the practice of interventional radiology. As is clear from the supplement you are now reading, the Standards Division has resisted any tendency to stand still since publication of the initial collection, and has continued to develop new content as well as to revise older documents as appropriate. The output has been prodigious in terms of both volume and quality, and SIR should be justly proud of the Standards Division efforts. I wish to acknowledge and personally thank the many members of the Standards Division for the tremendous amount of thought and labor that has gone into these documents. In particular, I would like to express my gratitude to John F. Cardella, MD, FSIR, FACR, FAHA, the Standards Division Councilor, who has shepherded these documents through their development, and who serves as the guest editor for this supplement. By way of introduction, in the Table of Contents to this supplement, readers will notice three new icons used to designate specific types of articles. The CPG icon refers to Clinical Practice Guidelines under which fall Quality Improvement Guidelines, Safety Guidelines, Consensus Documents, Credentialing Statements, and Policy and Position Statements. The SIR develops Clinical Practice Guidelines in an attempt to define practice principles that generally should assist in producing high quality patient care. The RS icon refers to Reporting Standards, which are developed by the SIR Technology Assessment Committee. Reporting Standards serve as important guidelines for industry and the FDA in the evaluation of new devices during pre-market trials and development. Finally, the ET icon refers to Emerging Technologies, documents written about new and emerging technologies used in the practice of interventional radiology. These icons will appear in future regular issues of the journal to help readers readily identify articles. Sincerely,

Society of Interventional Radiology clinical practice guidelines.

WELCOME to the 2009 edition of the Society of Interventional Radiology (SIR) Clinical Practice Guidelines Supplement of JVIR, which we hope you will find useful and informative for your day-to-day practice of interventional radiology (IR). Since the last Clinical Practice Guidelines Supplement was published in 2003, there have been many changes in IR practice leading to the publication of new documents from the SIR Standards Division. The intent of coalescing the documents from the Standards Division into one edition is to help members have the Clinical Practice Guidelines in one convenient reference source for daily reference and to bring them to the attention of SIR members and JVIR readers and authors.

Three-dimensional C-arm Cone-beam CT: Applications in the Interventional Suite

C-arm cone-beam computed tomography (CT) with a flat-panel detector represents the next generation of imaging technology available in the interventional radiology suite and is predicted to be the platform for many of the three-dimensional (3D) roadmapping and navigational tools that will emerge in parallel with its integration. The combination of current and unappreciated capabilities may be the foundation on which improvements in both safety and effectiveness of complex vascular and nonvascular interventional procedures become possible. These improvements include multiplanar soft tissue imaging, enhanced pretreatment target lesion roadmapping and guidance, and the ability for immediate multiplanar posttreatment assessment. These key features alone may translate to a reduction in the use of iodinated contrast media, a decrease in the radiation dose to the patient and operator, and an increase in the therapeutic index (increase in safety-vs-benefit ratio). In routine practice, imaging information obtained with C-arm cone-beam CT provides a subjective level of confidence factor to the operator that has not yet been thoroughly quantified.

Quality Improvement Guidelines for Preventing Wrong Site, Wrong Procedure, and Wrong Person Errors: Application of the Joint Commission “Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery” to the Practice of Interventional Radiology

THE membership of the Society of Interventional Radiology (SIR) 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.

Reimbursement Trends for Outpatient Interventional Radiology Procedures: Comparison of Hospital and Freestanding Physician Office Sites of Service

The aim of this study was to compare trends in reimbursement rates between hospital outpatient departments and freestanding physician offices for commonly performed interventional radiology procedures from 2006 through 2010. Using final rules data from the 2006 and 2008 Hospital Outpatient Prospective Payment System for Medicare and Medicare Physician Fee Schedule, reimbursement rates were calculated for a sample of procedures commonly performed by interventional radiologists in the outpatient setting. Hospital and freestanding reimbursement rates for 2006, 2008, and 2010 (projected) were adjusted for inflation to 2008 dollars and weighted by relative procedure frequency using Medicare Part B claims data. Reimbursements for the entire sample of procedures were compared year to year, by site of service, and by payment system. Individual procedure reimbursements were also trended. In 2006, reimbursements for the entire procedure sample were 6% less in hospital outpatient departments than in freestanding offices. In 2008 and 2010, they are projected to be 3% and 23% greater, respectively, in hospital outpatient departments than in freestanding offices. Over the 4-year interval, reimbursements are projected to fall by 36% in freestanding offices and by 16% in hospital outpatient departments. Reimbursements to hospitals for facility costs are projected to decrease by 14%. Reimbursements to physicians for work done in hospital outpatient departments are projected to decrease by 23%. Substantial reductions in calculated outpatient interventional radiology practice expenses being phased in between 2006 and 2010 under the Medicare Physician Fee Schedule seem to be dramatically reducing reimbursements for interventional procedures performed on outpatients, especially in freestanding offices. The impact of these practice expense reductions on interventional radiology seems to far outweigh that of the Deficit Reduction Act and other recent Medicare reimbursement changes.

Estimating Radiation Doses to the Skin from Interventional Radiology Procedures for a Patient Population with Cancer

To estimate the peak radiation skin doses for interventional radiology cases performed at a cancer center, identify procedure types likely to result in skin doses exceeding the American College of Radiology's 3 Gy follow-up level, and determine a kerma area product (P(KA)) for use in monitoring. A single-center retrospective study was performed to estimate doses from consecutive procedures performed during 2006. Of 6,598 procedures, 3,925 (60%) had P(KA) recorded and were included. Forty-three procedure types are represented. The median estimated peak skin dose was 39 mGy (third quartile, 205 mGy). In 2.6% of the cases, the estimated skin dose exceeded 3 Gy. No procedures resulted in skin doses greater than 15 Gy, and 94% of the cases resulted in skin doses less than 1 Gy. Procedure types with instances of skin doses greater than 1 Gy included hepatic, portal, and other arterial embolizations; diagnostic arteriography; biliary drainages; stent placements and catheter exchanges; nephrostomy/nephroureterostomy; urinary catheter exchanges; inferior vena cava filters; foreign body retrieval; abscess drainage; catheter exchange; and fistulography. Hepatic embolizations, nonhepatic arterial embolizations, and biliary drain/stent procedures were most likely to result in skin doses greater than 1 Gy. Significant variations in skin dose were noted within the same procedure type. No patients were noted to have developed any sequelae from radiation. It is unlikely that typical cases in an oncologic interventional radiology practice would exceed the Joint Commission's "reviewable sentinel event" skin dose level of 15 Gy. A P(KA) trigger of 300 Gy cm(2) could be used in the authors' clinic to identify follow-up requirements.

Abstract No. 279 EE: Implementing the Balanced Scorecard Strategic Assessment Tool in Interventional Radiology

To introduce the balanced scorecard as a strategic assessment tool at an academic medical center. The balanced scorecard is a strategic assessment and planning tool used to align professional activities with a defined strategy. Its use can help improve internal and external communications and monitor a division/group's performance against strategic goals. Scorecards should address four key elements: learning and growth, business processes, customer, and financial. Each practice must define strategic goals prior to considering components of their scorecard. Subsequent metrics should be simple and directly address the defined strategy. HI-IQ software can be used to monitor and collect the data, which can then be easily exported to a spreadsheet program. Learning and growth can be tracked via diligent measurement of complications and near misses. Procedural and process improvements can be input for each patient following relevant cases. Procedure time and inventory management are important factors easily gleaned. Patient and referring physician surveys can be monitored on HI-IQ with reminders for office staff conducting the phone or mail questionnaires. Financial metrics regarding inventory management can be obtained using the program and should be a part of the financial strategy. 1) The balanced scorecard can help interventional radiology practices align ongoing learning, business processes, customer satisfaction, and financial metrics with their strategic goals. 2) HI-IQ can be an effective tool to help monitor and track key metrics. 3) Care must be taken to keep the process simple with overly complicated measurements detracting from the beauty of the balanced scorecard tool.

Abstract No. 102: Quality Improvement in Inventory Management

To improve inventory management in interventional radiology at an academic medical center by standardizing processes and stored inventory in IR suites and the stock room. A team of physicians, technologists, and nurses participated in a 100 day quality improvement project as part of the Mayo Clinic Quality Academy. A value stream map was constructed followed by a Kaizen event to test improvement interventions. Pre and post- time studies and financial metrics were used to assess improvement and sustainability of change. Average retrieval time by laboratory assistants for 8 standard products decreased from 5 to 2 minutes in IR suites and from 5 to 1 minute in the store room. Expired product also decreased from $51,736 in quarter 1 (Q1) 2007 to $22,971 in Q1 2008 with a similar outcome in Q2. However, device stock-outs remained high and unchanged at 250 for September 2007 year to date (YTD) and September 2008 YTD. Five vendors were responsible for 80% of stock-outs. Inventory management is an important driver of practice and financial performance for interventional radiology practices. Use of value stream mapping and Kaizen events are examples of quality improvement techniques that can result in improvements in employee efficiency, and can lead to improved patient care. Additionally, small process changes can lead to significant financial rewards. Finally, initiating a QI program for inventory management will likely uncover several problem areas worthy of improvement.

The Clinical Practice of Interventional Radiology: A European Perspective

The purpose of this study was to determine the current clinical environment in which interventional radiology (IR) is practiced throughout Europe. A survey, comprising 12 questions on IR clinical practice, was sent to 1800 CIRSE members. Members were asked to return one survey per department. Two hundred seventy-four departments returned completed questionnaires, 22% from the United Kingdom (n = 60), 11% from Germany (n = 30), 8% from Austria (n = 23), and the remainder spread over Europe. Experts, with more than 10 years of IR experience, comprised 74% of the survey group. Almost one-third of the radiologists dedicated more than 80% of their clinical sessions to IR alone (27%; n = 75), with two-thirds practicing in a university teaching hospital setting (66%; n = 179). Few institutions have dedicated IR inpatient hospital beds (17%; n = 46), however, to compensate, day case beds are available (31%), IR admitting rights are in place (64% overall, 86% for in-patients, and 89% for day cases), and elective IR admissions can be made through other clinicians (87%). IR outpatient clinics are run at 26% of departments, with an average of two sessions per week. Dedicated nurses staff the majority of IR suites (82%), but clinical junior doctors are lacking (46%). Hospital management's refusing access to beds was the most commonly cited reason for not developing a clinical IR service (41%). In conclusion, there is marked variation across European centers in the current practice of IR. Half do not have dedicated junior doctors and only a small minority have inpatient hospital beds. If IR is to be maintained as a dedicated clinical specialty, these issues need to be addressed urgently.