Catheter thrombectomy for peripheral arterial clot removal

Transcription

1 Procedure 32 Clinical PRIVILEGE WHITE PAPER Background Catheter thrombectomy for peripheral arterial clot removal It is estimated that one in every 20 Americans over age 50 has peripheral vascular disease, a condition caused by the accumulation of fatty deposits on arterial walls, according to the National Institutes of Health. These deposits can narrow the arteries, restricting or blocking blood flow. And when these fatty deposits become brittle or inflamed, they can rupture, creating a dangerous clot that stops blood flow completely. If the condition isn t treated, the patient may lose a limb or experience other complications. In the past, the only way to treat a clot was through the use of clot-dissolving drugs or by removing it surgically. But now physicians also have another option using less invasive catheter thrombectomy devices. The advantage of catheter thrombectomy procedures is that they are minimally invasive and rapidly restore blood flow to the affected area. In contrast, drug therapy can take too much time in acute situations and can also cause bleeding complications. To perform catheter thrombectomy procedures, the physician makes a small hole in the skin, approximately the size of a pencil point. Using x-ray guidance, he or she inserts a catheter, advancing it to the area where the clot is located. The physician uses a mechanical device to break up and remove the clot. There are a number of clot-removal devices on the market and they work in different ways. One type of device loosens the clot using a stream of saline and then vacuums the particles back up the catheter. These devices are sometimes used in combination with drugs designed to help dissolve the clots. Involved specialties Interventional radiologists, vascular surgeons, and cardiologists Positions of specialty boards ABIM The American Board of Internal Medicine (ABIM) grants certification in cardiovascular disease. To become certified in the subspecialty of cardiovascular disease, physicians must: Be previously certified in internal medicine by the ABIM Satisfactorily complete the requisite graduate medical education fellowship training

2 Demonstrate clinical competence, procedural skills, and moral and ethical behavior in the clinical setting Hold a valid, unrestricted, and unchallenged license to practice medicine Pass the Cardiovascular Disease Certification Examination Cardiovascular disease fellowship training must be accredited by the Accreditation Council for Graduate Medical Education (ACGME), the Royal College of Physicians and Surgeons of Canada (RCPSC), or the Professional Corporation of Physicians of Quebec. Candidates for certification must also complete 36 months of training, including 24 clinical months in the following procedures: Advanced cardiac life support, including cardioversion Electrocardiography, including ambulatory monitoring and exercise testing Echocardiography Arterial catheter insertion Right-heart catheterization, including insertion and management of temporary pacemakers Left-heart catheterization and diagnostic coronary angiography ABR The American Board of Radiology (ABR) does not publish requirements specific to catheter thrombectomy for peripheral arterial clot removal, but it grants certification in vascular/interventional radiology. The ABR requires that candidates for certification complete one year of fellowship training (after residency) in a vascular and interventional radiology program accredited by the ACGME or by the RCPSC. The ABR also requires an additional year of practice or approved training. Candidates must spend one-third of that year in vascular and interventional radiology. Candidates can apply for certification within 10 years of completing the subspecialty training. ABS The American Board of Surgery (ABS) grants certification in vascular surgery. Successful completion of the Vascular Surgery Qualifying and Certifying Examinations is required for board certification in vascular surgery. In order to take the certifying examination, applicants must: Have a currently registered full and unrestricted license to practice medicine in the United States or Canada. Applicants are required to immediately inform the ABS of any conditions or restrictions in force on any active medical license they hold. Have satisfactorily completed a program in vascular surgery accredited by the ACGME or the RCPSC. Have successfully completed either the General Surgery Qualifying Examination 2

3 or the Surgical Principles Examination. Have obtained increasing levels of responsibility during the course of vascular surgery training, including serving as chief resident for a 12-month period. Have acquired no fewer than 48 weeks of full-time surgical experience in each residency year. Have performed all vascular surgery training at the same institution, except for applicants who complete the pathway. Applicants from programs may complete their vascular surgery training at no more than two programs, with the final 18 months at the same institution. Be actively and primarily engaged in the practice of vascular surgery as indicated by holding full surgical privileges in this discipline in approved hospitals, or be currently engaged in pursuing additional graduate education in another recognized surgical specialty. Have submitted for the ABS review a report of operative experience as surgeon and assistant surgeon that is deemed acceptable to the ABS, not only as to volume, but also spectrum and complexity of cases. This includes the performance of at least 250 major vascular reconstructions. Cases must be from the applicant s vascular surgery residency or fellowship and verified by the program director. Adhere to the ABS Ethics and Professionalism Policy. Applicants to the 2014 Vascular Surgery Qualifying Examination and after will be required to possess the Registered Physician Vascular Interpretation (RPVI ) credential. This credential is obtained by successfully completing the Physicians Vascular Interpretation Examination, which evaluates knowledge and skills commonly used in a vascular laboratory setting. More information about RPVI is available at AOBR The American Osteopathic Board of Radiology (AOBR) does not publish requirements specific to catheter thrombectomy for peripheral arterial clot removal, but it does offer a certificate of advanced qualifications in vascular and interventional radiology. To qualify, a candidate must meet the following standards: Be a diplomate of the AOBR in diagnostic radiology. Have completed a period of one year of formal concentrated study approved by the American Osteopathic Association (AOA) in the specific area of examination. Have AOA approval of all completed training. Be licensed to practice in the state where his or her practice is conducted. Be able to show evidence of conformity to the standards set forth in the AOA Code of Ethics. Be a member in good standing of the AOA or the Canadian Osteopathic Association for the two years immediately prior to the date of certification. Have successfully completed the diagnostic radiology certification examination. 3

4 AOBS The American Osteopathic Board of Surgery (AOBS) does not publish requirements specific to catheter thrombectomy for peripheral arterial clot removal, but it awards certification in general vascular surgery. Candidates for certification must meet the following requirements: Graduated from an AOA-accredited college of osteopathic medicine. Be licensed or credentialed to practice in the state or military jurisdiction where practice is conducted and provide documentary evidence of an unrestricted license prior to taking an examination. Conform to the standards set forth in the AOA Code of Ethics. Be a member in good standing of the AOA or the Canadian Osteopathic Association throughout the certification process. Following the examination process, if a candidate is found to be delinquent in his or her maintenance of membership and/or payment of membership dues, certification may be delayed. Have satisfactorily completed an AOA-approved internship year. Completed four years of training in general surgery followed by one year of training in general vascular surgery, except: Candidates who began their residency training with the required OGME-1R internship year effective in the academic year 2008 must complete five years of training in general surgery followed by one year in general vascular surgery. Positions of societies, academies, colleges, and associations ACC/ACP/SCAI/SVMB/SVS The American College of Cardiology (ACC), American College of Physicians (ACP), Society for Cardiovascular Angiography and Interventions (SCAI), Society for Vascular Medicine and Biology (SVMB), and the Society for Vascular Surgery (SVS) published a statement called ACC/ACP/SCAI/SVMB/SVS Clinical Competence Statement on Vascular Medicine and Catheter-Based Peripheral Vascular Interventions. The document outlines the training and skills that a physician should have to perform catheter-based peripheral vascular interventions. Physicians performing these procedures should have specific knowledge about vascular biology and vascular diseases in addition to the technical skills needed to perform the procedures. The vascular interventionalist should be knowledgeable about each of the following: Mechanisms that regulate blood vessel function and hemostasis Pathophysiology, clinical manifestation, natural history, evaluation, and treatment of peripheral arterial disease, renal artery stenosis, mesenteric ischemia, extracranial cerebrovascular disease, aneurysmal disease, arterial dissection, and arterial and venous thromboembolism 4

5 Noninvasive vascular tests such as segmental blood pressure measurements, arterial and venous duplex ultrasonography, and CT and magnetic resonance angiography Accuracy and limitations of diagnostic tests Radiation physics, safety, and radiographic imaging equipment Principles of image acquisition and display Advantages, disadvantages, and potential complications of iodinated and noniodinated contrast agents Advantages, disadvantages, potential outcomes, and complications of interventional procedures Indications, alternatives, and contraindications for catheter-based interventions They must also have sufficient technical skills and have knowledge of radiation physics and safety and skills in operating radiographic imaging equipment. The technical skills necessary for vascular interventions include the ability to perform catheter-directed thrombolysis/thrombectomy, as well as the following: Safely gain vascular access from multiple sites (femoral, popliteal, and upper extremity arteries, as well as femoral, upper extremity, and neck veins) Obtain hemostasis, including application of compression and vascular closure devices Manipulate guide wires and catheters Place and deploy angioplasty equipment (e.g., balloons, atherectomy devices, stents, distal protection devices) Recognize and treat procedure-related complications (e.g., dissection, pseudoaneurysms, embolism, vessel perforation or occlusion, stent thrombosis, adverse hemodynamic events) Perform vascular interventions in each of the following: aorta and lower extremity arteries, brachiocephalic and upper extremity arteries, mesenteric and renal arteries, central and peripheral veins, and pulmonary arteries Physicians performing these procedures should also able to discuss results and recommendations for future care with the patient and family members, and to discharge the patient from the hospital with appropriate follow-up arrangements. Achieving the skill level needed to perform catheter-based interventions requires cognitive and technical training and experience. Training should include the following elements: A formal, preferably ACGME-approved program Mentoring by experienced, qualified physicians Hands-on experience, under supervision, as secondary and primary operator Documentation of the number of procedures, success and failure rates, complication rates, and outcomes For cardiovascular physicians, the document says that the ACC Core Cardiology Training Symposium document provides guidelines for training in catheter-based 5

6 peripheral interventions. For the fellow wishing to acquire competence as a peripheral vascular interventionalist, a minimum of 12 months of training is recommended, in addition to the 24-month core cardiology training and eight months in diagnostic cardiac catheterization in an ACGME-accredited fellowship program. The trainee should participate in a minimum of 100 diagnostic peripheral angiograms and 50 noncardiac peripheral vascular interventional cases during the interventional training period. At least 50 of the diagnostic angiograms and 25 of the interventional cases should be as supervised primary operator. The case mix should be evenly distributed among the different vascular beds. Supervised cases of thrombus management for limb ischemia and venous thrombosis, utilizing percutaneous thrombolysis or thrombectomy, should be included. Advanced training in peripheral vascular intervention can be undertaken concurrently with advanced training for coronary interventions. The year devoted to interventional training should include at least one month on an inpatient vascular medicine consultation service, one month in a noninvasive vascular diagnostic laboratory, and one-half to one full day per week in the longitudinal care of outpatients with vascular disease. According to the ACC/ACP/SCAI/SVMB/SVS Clinical Competence Statement on Vascular Medicine and Catheter-Based Peripheral Vascular Interventions, the pathway for interventional radiologists should include completion of an ACGME-approved training program in vascular and interventional radiology. In addition, the interventional radiologist should be eligible for or have received the Certificate of Added Qualification (CAQ) given by the ABR, as well as maintain recertification requirements. After finishing a fellowship, trainees who are ABR-certified in diagnostic radiology are CAQ eligible in vascular and interventional radiology. At the time of CAQ examination, the trainee must have had documented direct participation in a minimum of 700 procedures, of which 10 must be catheter-directed thrombolysis/thrombectomy. The case mix should be evenly distributed among the different vascular beds. A minimum of 12 months of training in catheter-based intervention is required. This is in addition to the general radiology residency, which includes several months of interventional radiology. During the ACGME-approved fellowship, the trainee must have direct participation in a minimum of 500 procedures that encompass the full range of vascular and interventional procedures. The year devoted to interventional training should also include time dedicated to the clinical evaluation, treatment, and follow-up of patients with vascular disease; to noninvasive vascular evaluation, treatment, and follow-up of patients with vascular disease; and to noninvasive vascular studies (e.g., ultrasound, magnetic resonance angiography, CT angiography, physiological arterial studies, stress tests). 6

7 Vascular surgeons should complete an ACGME-accredited residency (fellowship) after an ACGME-accredited residency in surgery. Although the ACGME only requires one year for vascular surgery training, a second year is permitted and the vast majority of training programs are of two years duration, according to the statement. The increasing importance and use of catheter-based procedures has been recognized by the ACGME, which has made training in endovascular techniques a required component of vascular surgery programs. Therefore, training in peripheral catheter-based intervention is one of the major determinants for the second fellowship year. Vascular fellows may obtain this training in one year or throughout both years of a fellowship program. Required numbers of endovascular procedures have not yet been implemented by the ACGME, but beginning in 2004, each vascular fellow was required to perform a minimum of 100 diagnostic and 50 therapeutic endovascular procedures plus five to 10 aortic aneurysm endovascular grafting procedures. The case mix should be evenly distributed among the different vascular beds. Supervised cases of thrombus management for limb ischemia and venous thrombosis, utilizing percutaneous thrombolysis or thrombectomy, should be included. These requirements are consistent with recommendations and guidelines for endovascular training and hospital credentialing developed and published by the AAVS and SVS. The knowledge and experience for interventionalists should be similar to those standards for new trainees. Vascular interventionalists must acquire the cognitive and clinical knowledge requisite to understand vascular diseases, including the fundamental biology, clinical manifestations, diagnostic tools, pharmacotherapies, and indications and contraindications to intervention. Knowledge of radiation physics and skills in operating imaging equipment is also necessary. They should perform at least 100 diagnostic peripheral angiograms, and no less than 50 peripheral interventional procedures. The physician should attend category 1 postgraduate education courses in peripheral vascular intervention and hospital conferences including endovascular mortality and morbidity, as well as document self-directed education. Appropriate documentation of the trainee s experience is required. The case mix should be evenly distributed, so as to ensure exposure to diagnosis and intervention in a variety of vascular beds. Experience heavily weighted toward treatment of one specific site (e.g., renal) to the exclusion of other venues (e.g., infrainguinal) may not provide adequate expertise for the latter. To achieve a balanced experience required for competence, the physician s experience should include no fewer than 20 diagnostic/10 interventional individual supervised cases in each of the vascular territories described in the ACC/ACP/ SCAI/SVMB/SVS statement, including aortoiliac and brachiocephalic; abdominal visceral and renal; and infrainguinal. In addition, the physician should perform a minimum of five catheter-directed peripheral thrombolytic/thrombectomy cases. 7

8 Physicians who have previously completed training in interventional cardiology or vascular surgery may elect to develop competence in only a subset of anatomic areas. Physicians who desire competence in more than three anatomic areas should pursue training for the full range of procedures in the manner outlined in the preceding paragraph. In order to maximize patient safety, physicians desiring competence in a subset of procedures require, as a minimum, proficiency in the aortoiliac arteries as the foundation for endovascular procedures in other anatomic beds. For physicians seeking to develop competence in a subset of procedures, no fewer than 30 diagnostic/15 interventional cases in any one anatomic area are necessary when seeking selective credentialing in a stepwise fashion, up to a maximum of two additional anatomic areas. Training should be performed under the proctorship of a peripheral vascular interventionalist who is credentialed to perform the full range of procedures described in this document. The cases should be accumulated over a period of not more than 24 months. The physician should demonstrate evidence of adequate didactic and clinical training in the anatomy, pathophysiology, diagnosis, and medical management of peripheral vascular diseases and in endovascular techniques, which may be achieved by acquiring experience in supervised inpatient and outpatient vascular consultation settings, noninvasive vascular laboratories, and angiography/ interventional laboratories. The physician should attend category 1 postgraduate education courses in peripheral vascular intervention and hospital conferences including endovascular mortality and morbidity, as well as document self-directed education. In all of the situations described, clinical outcomes of procedures should be documented and comparable to published quality improvement guidelines for vascular interventions. In addition, after fulfilling initial requirements for competence, the log of cases should be continued for at least two years, with appropriate analysis of outcomes and quality assurance, to enable ongoing evaluation of competence. The numbers of procedures proposed in the guideline represent a minimum threshold for achieving competence and some individuals may require more training. Maintenance of competence in catheter-based peripheral vascular interventions is an ongoing process that ensures continuity and growth of the cognitive, clinical, and technologic skills acquired during training. The physician s cognitive knowledge base in peripheral vascular disease management and techniques must remain up to date. The physician must commit to ongoing education and lifelong learning and document attendance at CME activities. He or she should also perform self-assessments. Physicians should perform at least 25 peripheral vascular intervention cases annually, with documentation of favorable outcomes and minimal complications. 8

9 Physicians should also document that they have current medical licenses and credentials/privileges in the areas of expertise at the local hospital and/ or practice level. The physician should also document appropriate board certification and recertification. SIR The Society of Interventional Radiology (SIR) participated in the process of creating ACC/ACP/SCAI/SVMB/SVS Clinical Competence Statement on Vascular Medicine and Catheter-Based Peripheral Vascular Interventions, but the organization ultimately disagreed with the guideline. The SIR issued a statement outlining its reasons for dissension, Response to the ACC/ACP/SCAI/SVMB/SVS Clinical Competence Statement on Catheter-based Peripheral Vascular Interventions, in which it stated that it would instead stand by its earlier statement, Training Standards for Physicians Performing Peripheral Angioplasty and Other Percutaneous Peripheral Vascular Interventions. This document states that physician applicants should have extensive clinical training in the diagnosis and treatment of patients with peripheral vascular disease. The body of knowledge necessary includes the anatomy, natural history, and clinical manifestations of peripheral vascular disease; noninvasive assessment of peripheral vascular disease; indications and contraindications for angioplasty; risks and benefits of angioplasty; recognition of complications; alternative therapies; principles of thrombolytic techniques; and technical aspects and usage of x-ray equipment needed for diagnostic peripheral angiography and percutaneous transluminal angioplasty. A basic training requirement must be met by each physician applicant and should include at least one of the following: ABR eligibility or certification ABIM eligibility or certification with additional completion of a fellowship in vascular medicine ABIM certification with additional eligibility or certification in cardiovascular medicine ABS eligibility or certification with additional completion of a general vascular surgery residency The applicant should also have training and experience in the use of thrombolytic therapy in peripheral arteries, having participated in 10 such cases. These requirements would normally be met during a formal subspecialty training program of at least one year s duration, completed after at least one of the basic training requirements listed in the previous section has been met. However, they may be met in part or in total during initial residency or fellowship. In all instances, complete and detailed documentation of the aforementioned procedural training should be available. 9

10 An applicant may also qualify by having extensive previous experience in peripheral angiographic diagnosis and percutaneous transluminal angioplasty with acceptable complication and success rates. This experience must include performance of a minimum of 100 diagnostic angiograms and 50 percutaneous transluminal angioplasties of the peripheral arteries, and for at least half of these procedures, the applicant must be primary operator. The applicant should participate in at least 10 cases that involve the use of thrombolytic therapy in peripheral arteries. According to the SIR, physicians may become qualified based on apprenticeship. These physicians must be prepared to demonstrate knowledge of the recommended principles of diagnosis and therapy of peripheral and visceral v ascular disease. The apprenticeship should be thoroughly documented and should include a minimum of 10 peripheral arterial thrombolysis procedures. A qualified physician preceptor must supervise the procedures. The applicant must have been the primary operator for at least half of these procedures. Clear understanding of the method of diagnostic angiography must be demonstrated, including knowledge of appropriate radiographic equipment, catheters and catheter techniques, and radiation safety associated with diagnostic and interventional procedures. The SIR recommends that physicians attend postgraduate courses for a total of at least 50 Category 1 CME credits in diagnostic peripheral angiography and percutaneous peripheral vascular interventional techniques. Maintenance of privileges requires ongoing experience in performing these procedures with acceptable success and complication rates. The determination of a minimum number of procedures per year is at the discretion of the credentials or clinical privileges committee of each hospital. Whether a minimum number is specified, maintenance of privileges is also dependent on the physician s active participation in the institution s quality improvement program that monitors indications, success rates, and complications. This data may be used within the individual institution in considering renewal of clinical privileges. All physicians performing these procedures must participate in the quality improvement program and will be evaluated using the same criteria. All new applicants for hospital privileges in vascular surgery should have completed an ACGME-accredited vascular surgery residency and should obtain ABS board certification within three years of completion of their training. The renewal of privileges for surgeons currently privileged to perform vascular surgery should be granted on the basis of an analysis of their outcomes in comparison with local and regional standards. 10

11 For nonvascular certified physicians lacking noninvasive vascular laboratory training and wishing to obtain privileges interpreting studies, supervised experience is required. Forty hours of relevant CME should be obtained in a three-year period, and a minimum number of cases should be interpreted under supervision, with the same number of cases that apply to vascular residents applying to these individuals. Obtaining an RPVI credential from the ARDMS should be construed as having fulfilled the requirements for vascular laboratory credentialing because the ARDMS requires a specific number of cases and experience before allowing physicians to sit for the examination. ACGME The ACGME Program Requirements for Graduate Medical Education in Vascular and Interventional Radiology states that an educational program in the subspecialty of vascular and interventional radiology must provide comprehensive, fulltime training and supervision in the evaluation and management of patients potentially requiring diagnostic vascular imaging-guided interventional procedures. Training must include the following: A supervised experience in performance of imaging-guided diagnostic and interventional procedures used to treat a variety of disorders Knowledge of the application of all forms of imaging to the performance and interpretation of vascular and interventional procedures Knowledge of the signs and symptoms of disorders amenable to diagnosis and/ or treatment by percutaneous techniques Proficiency in taking a history and in the performance of an appropriate physical exam Understanding of the signs and symptoms, as well as the pathophysiology and natural history of the disorders The indications for, contraindications to, and risks of vascular and interventional procedures, and an understanding of the medical and surgical alternatives to those procedures A complete understanding of imaging methods used to guide percutaneous procedures Participation in appropriate follow-up care, including inpatient rounds and longitudinal management of outpatients via clinic visits The technical aspects of percutaneous procedures The fundamentals of radiation physics, radiation biology, and radiation protection Opportunities for research into new technologies and evaluation of the clinical outcomes of interventional radiology The ACGME also publishes ACGME Program Requirements for Graduate Medical Education in Cardiovascular Disease (Internal Medicine), which outlines training 11

12 requirements for cardiovascular disease programs. Subspecialty training in cardiology must provide sufficient experience in evaluating a wide variety of patients with acute and chronic cardiovascular conditions. The three-year training program must include 24 months of clinical training, including patient and special experiences. Trainees must also have instruction and clinical experience, and have worked with patients in a number of areas including peripheral vascular disease. They must also have instruction and clinical experience in performing percutaneous transluminal coronary angioplasty and other interventional procedures. The ACGME publishes ACGME Program Requirements for Graduate Medical Education in Vascular Surgery, which outlines training requirements for vascular surgery programs. The ACGME does not specify the number of catheter thrombectomies fellows must perform, but it does state that fellows should perform a minimum of 500 procedures. AOA The AOA publishes Specific Basic Standards for Osteopathic Fellowship Training in Cardiology. During training, fellows must complete: Nine months of hospital-based general cardiology experience Three months of hospital-based general cardiology experience in the ICU/CCU Four months of cardiac catheterization experience Three months of echocardiographic experience Four months of nuclear medicine experience Two months of electrophysiology experience One month of vascular medicine experience The AOA does not publish a specific number of catheter thrombectomies that cardiology fellows must complete. The AOA also publishes Basic Standards for Fellowship Training in Neuroradiology, Pediatric Radiology, and Vascular and Interventional Radiology. According to the guidelines, vascular and interventional training programs must include a minimum of one year of concentrated study during which the trainee must participate in 500 procedures. Trainees must also be taught the following: Use of needles, catheters, and guide wires Physical properties and physiologic responses of all short- and long-term implantable devices as they pertain to interventional radiology Clinical aspects of patient assessment, clinical indications, risks, and limitation to vascular and interventional procedures Physiologic monitoring devices, their interpretations, as well as proper 12

13 interpretation of noninvasive tests as they pertain to vascular and interventional radiology Administration and monitoring of conscious sedation The AOA also publishes Basic Standards for Residency Training in Surgery and the Surgical Subspecialties, which includes standards for general vascular surgery. The AOA does not list specific requirements regarding catheter thrombectomies, but it states that residents should complete a minimum of 200 major vascular surgery procedures performed as surgeon or first assistant and under supervision. Positions of subject matter experts Jerry Goldstone, MD, FACS, FRCSEd (hon) Cleveland Jerry Goldstone, MD, FACS, FRCSEd (hon), professor of surgery and emeritus chief in the Division of Vascular Surgery and Endovascular Therapy at Case Western Reserve University School of Medicine University Hospitals Case Medical Center, says in the past, in order to remove a clot, surgeons needed to open the actual vessel, or one nearby to mechanically extract the clot. Today physicians have a less invasive option. There are several catheter-based mechanical thrombectomy devices that can be used to remove peripheral clots. These devices work in different ways, from shooting out a high stream of saline to loosen the clot and then sucking the particles back up the catheter, to using a combination of clot-busting drugs and mechanical removal. Most often the physician performing this procedure is an interventional radiologist, but it is also frequently performed by vascular surgeons and less frequently by cardiologists. Any physician performing these procedures should have appropriate training in their specialty and they should also have sufficient experience in endovascular skills, which involve puncturing the arteries, gaining access to the arteries, stenting, and balloon angioplasty. Experience with the use of fluoroscopy is also required. Manufacturers of catheter thrombectomy devices typically offer courses at meetings and will also come to individual facilities to provide physicians support for the first few cases upon request. In general, a physician should perform at least five of these procedures to obtain the necessary skill to perform the procedure safely and should perform three or four additional procedures each year to maintain their skill. This procedure uses a similar skill set to other endovascular procedures, but the instruments are slightly different. When credentialing a physician to perform 13

14 these procedures, it s important to be certain that he or she possesses these basic endovascular skills. Cathy Keck Anderson Warrendale, Pa. Cathy Keck Anderson, a representative in the public policy and communications department for MEDRAD, Inc., which manufacturers the AngioJet Rheolytic Thrombectomy System and other tools to remove clots, says that physicians performing catheter-based thrombectomy should have general endovascular skills and a knowledge of endovascular techniques in order to use the AngioJet in all indicated areas. Other procedures such as PTCA, stenting, and CDL require similar skills to those needed to operate the AngioJet device. We currently provide in-service training to all physicians and staff on the use of AngioJet prior to the initial use of the device. We offer a coronary, peripheral, and AV declot combined CEU program for the lab staff and physicians, says Keck Anderson. The in-service covers all device specifics, including: Indications Contraindications Warnings Overview of thrombus Use of the AngioJet products to remove thrombus using endovascular techniques The in-service also covers the use of the Power Pulse Spray in a peripheral use. It s important that staff and physicians understand how to operate the device and its indications before using the device, but there is no preceptorship required to use the AngioJet. However, physicians and staff members often request that a MEDRAD team member be present during the case to observe and help with setup if needed. The AngioJet is a simple-to-use device that works with the tools that an endovascular-trained physician uses in daily practice. The AngioJet operates over a or guide wire similar to other interventional tools. It is important to understand the operation and method of action of the AngioJet device along with the run times and possible side effects of its use. All of these are covered during the in-service and are included in the discussion of operation, indications, contraindications, and warnings. 14

15 Positions of accreditation bodies CMS CMS has no formal position concerning the delineation of privileges for catheter thrombectomy for peripheral arterial clot removal. However, the CMS Conditions of Participation (CoP) define a requirement for a criteria-based privileging process in (c)(6) stating, The bylaws must include criteria for determining the privileges to be granted to individual practitioners and a procedure for applying the criteria to individuals requesting privileges (a)(6) states, The governing body must assure that the medical staff bylaws describe the privileging pro cess. The process articulated in the bylaws, rules or regula tions must include criteria for determining the privileges that may be granted to individual practitioners and a procedure for applying the criteria to individual practitioners that considers: Individual character Individual competence Individual training Individual experience Individual judgment The governing body must ensure that the hospital s bylaws governing medical staff membership or the granting of privileges apply equally to all practitioners in each professional category of practitioners. Specific privileges must reflect activi ties that the majority of prac titioners in that category can perform competently and that the hospital can support. Privileges are not granted for tasks, procedures, or activities that are not conducted within the hospital, regardless of the practitioner s ability to perform them. Each practitioner must be individually evaluated for requested privileges. It cannot be assumed that every practitioner can perform every task, activity, or privilege specific to a specialty, nor can it be assumed that the practitioner should be automatically granted the full range of privileges. The individual practitioner s ability to perform each task, activity, or privilege must be individually assessed. CMS also requires that the organization have a process to ensure that practitioners granted privileges are work ing within the scope of those privileges. CMS CoPs include the need for a periodic appraisal of practitioners appointed to the medical staff/granted medical staff privileges ( [a][1]). In the absence of a state law that establishes a time frame for the periodic appraisal, CMS recommends that an appraisal be conducted at least every 24 months. The purpose of the periodic appraisal is to determine whether clinical privileges or membership should be continued, discontinued, revised, or otherwise changed. 15

16 The Joint Commission The Joint Commission has no formal position concerning the delineation of privileges for catheter thrombectomy for peripheral arterial clot removal. However, in its Comprehensive Accreditation Manual for Hospitals, The Joint Commission states, The hospital collects information regarding each practitioner s current license status, training, experience, competence, and ability to perform the requested privilege (MS ). In the introduction for MS , The Joint Commission states that there must be a reliable and consistent system in place to process applications and verify credentials. The organized medical staff must then review and evaluate the data collected. The resultant privilege recommendations to the governing body are based on the assessment of the data. The Joint Commission introduces MS by stating, The organized medical staff is respon sible for planning and implementing a privileging process. It goes on to state that this process typically includes: Developing and approving a pro cedures list Processing the application Evaluating applicant-specific information Submitting recommendations to the governing body for applicant-specific delineated privileges Notifying the applicant, relevant personnel, and, as required by law, external entities of the privi leging decision Monitoring the use of privileges and quality-of-care issues MS further states, The decision to grant or deny a privilege(s) and/or to renew an existing privilege(s) is an objective, evidence-based process. The EPs for standard MS include several requirements as follows: The need for all licensed independent practitioners who provide care, treatment, and services to have a current license, certification, or registration, as required by law and regulation Established criteria as recommended by the organized medical staff and approved by the governing body with specific evaluation of current licensure and/or certification, specific relevant training, evidence of physical ability, professional practice review data from the applicant s current organization, peer and/or faculty recommendation, and a review of the practitioner s performance within the hospital (for renewal of privileges) Consistent application of criteria A clearly defined (documented) procedure for processing clinical privilege requests that is approved by the organized medical staff Documentation and confirmation of the applicant s statement that no health problems exist that would affect his or her ability to perform privileges requested 16

17 A query of the NPDB for initial privileges, renewal of privileges, and when a new privilege is requested Written peer recommendations that address the practitioner s current medical/clinical knowledge, technical and clinical skills, clinical judgment, interpersonal skills, communication skills, and professionalism A list of specific challenges or concerns that the organized medical staff must evaluate prior to recommending privileges (MS , EP 9) A process to determine whether there is sufficient clinical performance information to make a decision related to privileges A decision (action) on the completed application for privileges that occurs within the time period specified in the organization s medical staff bylaws Information regarding any changes to practitioners clinical privileges, updated as they occur The Joint Commission further states, The organized medical staff reviews and analyzes information regarding each requesting practitioner s current licensure status, training, experience, current competence, and ability to perform the requested privilege (MS ). In the EPs for standard MS , The Joint Commission states that the information review and analysis process is clearly defined and that the decision process must be timely. The organization, based on recommendations by the organized medical staff and approval by the governing body, develops criteria that will be considered in the decision to grant, limit, or deny a request for privileges. The criteria must be consistently applied and directly relate to the quality of care, treatment, and services. Ultimately, the governing body or delegated governing body has the final authority for granting, renewing, or denying clinical privileges. Privileges may not be granted for a period beyond two years. Criteria that determine a practitioner s ability to provide patient care, treatment, and services within the scope of the privilege(s) requested are consistently evaluated. The Joint Commission further states, Ongoing professional practice evaluation information is factored into the decision to maintain existing privilege(s), to revise existing privileges, or to revoke an existing privilege prior to or at the time of renewal (MS ). In the EPs for MS , The Joint Commission says there is a clearly defined process facilitating the evaluation of each practitioner s professional practice, in which the type of information collected is determined by individual departments and approved by the organized medical staff. Information resulting from the ongoing professional practice evaluation is used to determine whether to continue, limit, or revoke any existing privilege. 17

18 HFAP The Healthcare Facilities Accreditation Program (HFAP) has no formal position concerning the delineation of privileges for catheter thrombectomy for peripheral arterial clot removal. The bylaws must include the criteria for determining the privileges to be granted to the individual practitioners and the procedure for applying the criteria to individuals requesting privileges ( ). Privileges are granted based on the medical staff s review of an individual practitioner s qualifications and its recommendation regarding that individual practitioner to the governing body. It is also required that the organization have a process to ensure that practitioners granted privileges are working within the scope of those privileges. Privileges must be granted within the capabilities of the facility. For example, if an organization is not capable of performing open-heart surgery, no physician should be granted that privilege. In the explanation for standard related to membership selection criteria, HFAP states, Basic criteria listed in the bylaws, or the credentials manual, include the items listed in this standard. (Emphasis is placed on training and competence in the requested privileges.) The bylaws also define the mechanisms by which the clinical departments, if applicable, or the medical staff as a whole establish criteria for specific privilege delineation. Periodic appraisals of the suitability for membership and clinical privileges is required to determine whether the individual practitioner s clinical privileges should be approved, continued, discontinued, revised, or otherwise changed ( ). The appraisals are to be conducted at least every 24 months. The medical staff is accountable to the governing body for the quality of medical care provided, and quality assessment and performance improvement ( ) information must be used in the process of evaluating and acting on re- privileging and reappointment requests from members and other credentialed staff. DNV DNV has no formal position concerning the delineation of privileges for catheter thrombectomy for peripheral arterial clot removal. MS.12 Standard Requirement (SR) #1 states, The medical staff bylaws shall include criteria for determining the privileges to be granted to individual practitioners and a procedure for applying the criteria to those individuals that request privileges. 18

19 The governing body shall ensure that under no circumstances is medical staff membership or professional privileges in the organization dependent solely upon certification, fellowship, or membership in a specialty body or society. Regarding the Medical Staff Standards related to Clinical Privileges (MS.12), DNV requires specific provisions within the medical staff bylaws for: The consideration of automatic suspension of clinical privileges in the following circumstances: revocation/restriction of licensure; revocation, suspension, or probation of a DEA license; failure to maintain professional liability insurance as specified; and noncompliance with written medical record delinquency/ deficiency requirements Immediate and automatic suspension of clinical privileges due to the termination or revocation of the practitioner s Medicare/Medicaid status Fair hearing and appeal The Interpretive Guidelines also state that core privileges for general surgery and surgical subspecialties are acceptable as long as the core is properly defined. DNV also requires a mechanism (outlined in the bylaws) to ensure that all individuals provide services only within the scope of privileges granted (MS.12, SR.4). Clinical privileges (and appointments or reappointments) are for a period as defined by state law or, if permitted by state law, not to exceed three years (MS.12, SR.2). Individual practitioner performance data must be measured, utilized, and evaluated as a part of the decision-making for appointment and reappointment. Although not specifically stated, this would apply to the individual practitioner s respective delineation of privilege requests. CRC draft criteria The following draft criteria are intended to serve solely as a starting point for the development of an institution s policy regarding catheter thrombectomy for peripheral arterial clot removal. Minimum threshold criteria for requesting privileges for catheter thrombectomy for peripheral arterial clot removal Minimal formal training: Successful completion of an ACGME- or AOAaccredited fellowship in vascular surgery, cardiology, or interventional radiology that included training in percutaneous thrombolysis/thrombectomy or completion of a hands-on CME course. Required current experience: Demonstrated current competence and evidence of the performance of at least six percutaneous thrombolysis/ thrombectomy procedures in the past 12 months or completion of training in the past 12 months. 19

20 References If the applicant is recently trained, a letter of reference should come from the director of the applicant s training program. Alternatively, a letter of reference may come from the applicable department chair and/or clinical service chief at the facility where the applicant most recently practiced. Reappointment Reappointment should be based on unbiased, objective results of care according to a hospital s quality assurance mechanism, as well as demonstrated current competence and evidence of the performance of at least 12 catheter thrombectomies in the past 24 months based on results of ongoing professional practice evaluation and outcomes. In addition, continuing education related to catheter thrombectomy for peripheral arterial clot removal should be required. For more information Accreditation Council for Graduate Medical Education 515 North State Street, Suite 2000 Chicago, IL Telephone: Website: American Board of Internal Medicine 510 Walnut Street, Suite 1700 Philadelphia, PA Telephone: Website: American Board of Radiology 5441 East Williams Boulevard, Suite 200 Tucson, AZ Telephone: Website: American Board of Surgery 1617 John F. Kennedy Boulevard, Suite 860 Philadelphia, PA Telephone: Website: 20