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Endovascular Training Program Endorsement Essentials - Guidelines from EV-PEEC

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Guiding Philosophy
Institutional Requirements
Teaching Staff
Environment and Resources
Educational Program
Endorsement Process

 

The following endovascular training guidelines apply to graduates of vascular fellowship training programs and are specifically not intended to apply to non-vascular surgeons.

I.  GUIDING PHILOSOPHY

A.  Vascular surgeons should be trained to achieve full competence in the diagnosis and operative and endoluminal treatment of peripheral vascular disorders, defined as all vascular disease exclusive of the coronary and intracerebral circulations.

As such, to be endorsed, an endovascular training program MUST encompass all accepted diagnostic and therapeutic endovascular procedures in all peripheral vascular territories in numbers roughly proportional to their prevalence in vascular surgical practice.

B.  Endovascular training encompasses both the body of knowledge relevant to the appropriate procedure    selection and application, as well as, training in the technical aspects of endovascular procedures to ensure technical competence.

As such, endorsement will require a program of teaching experiences designed to review the fundamental body of knowledge about the endovascular treatment of vascular disease, as well as illustrative cases, to develop clinical judgment pertaining to endovascular therapies. These teaching experiences may be integrated into the overall vascular fellowship training experience in programs where both exist.

C.  Although collaborative arrangements with other interventionalists may have been developed in some institutions, endovascular training is best provided under the guidance of vascular surgeons, as they will serve as role models with expertise in both open and endovascular procedures.

As such, while experience under non-surgeon interventionalists will be considered when assessing the adequacy of case volume, program endorsement will require that at least 50% of the SVS credentialing minimums for catheterizations and interventions (reference below) will be performed under the direct tutelage of vascular surgeons.  This minimum MUST encompass all accepted diagnostic and therapeutic endovascular procedures in all peripheral vascular territories in numbers roughly proportional to their prevalence in vascular surgical practice.  Furthermore, the committee must be satisfied that the non-surgeon interventionalists are fully integrated into the vascular service and that endovascular training received under the tutelage of any non-surgeon interventionalists is authentic and comprehensive.

D.  The previously adopted SVS endovascular credentialing guidelines (J. Vasc Surg 1999; 29:177-186) define the minimal case experience required to attain technical competence, though they may not be assumed to assure competence on an individual basis.

As such, endorsement will only be granted to programs that can provide that volume of training within the designated length of time specified for the fellowship.

E.  Endovascular diagnostic and therapeutic procedures should be performed in the venue best suited to the safe and efficacious completion of the procedure.

As such, in order to achieve endorsement, vascular surgeons at the program must have access to a dedicated angiographic facility providing digital subtraction angiography capabilities, in addition to portable fluoroscopic imaging in the operating room.  Purely percutaneous procedures should be performed in a dedicated angiographic facility, while hybrid procedures requiring open vascular access may be performed in the operating room under portable fluoroscopy.

II.  INSTITUTIONAL REQUIREMENTS

A.  Sponsoring Institution
Vascular surgery is a discipline of great breadth, and is often consultative in nature.  In order to insure exposure to the full spectrum of vascular disease and therapeutic options, including open surgical alternatives, the program should be conducted in institutions accredited by the Joint Commission on Accreditation of Healthcare Organizations, or its equivalent, and be classified as general hospitals.  Ideally, to insure a balanced approach to vascular disease and to meet educational requirements of the endovascular fellow (to follow), institutions would also be sponsoring vascular surgery fellowships.

B.  Participating Institutions
1.   The endovascular training institution should provide sufficient resources and clinical material to provide an adequate case experience, currently being defined as one which meets the endovascular credentialing guidelines of the SVS (J Vasc Surg 1999; 29:177-186).  The facilities should occur in either the parent institution or an institution associated by an affiliation agreement.

Facility requirements include the following:
a. Access to contemporary fixed radiographic peripheral interventional rooms
b. A radiographic image archival system using films, tapes, or electronic media
c. A dictation system for case documentation
d. An adequate quantity of suitable radiation protection equipment
e. A mechanism of ongoing radiation exposure monitoring and education

2.   Affiliated institutions must promote the educational goals of the program, rather than simply enlarge the program, and must not be added primarily for the purpose of meeting service needs.

C.  Vascular Service
1.  The institution, department, or service accredited to conduct a program of graduate education in endovascular therapy must be able to provide a sufficient number and variety of patients with vascular disease to ensure that fellows have an adequate exposure to a wide spectrum of endovascular cases.

2.  To provide an effective training program, a vascular surgery service must be organized as an identifiable unit, even if it is within the framework of a larger administrative entity such as a department of surgery, general surgery, or thoracic surgery.  It is highly desirable that all patients with vascular disease who are available for teaching purposes be admitted to this unit so that the patients may be centralized and utilized most efficiently for teaching.

3.   Privileges on the endovascular surgery teaching service should be granted to surgeons who have full peripheral endovascular credentials, and only then with the understanding that their patients are to be available for coordinated graduate education of fellows.

III. TEACHING STAFF

The establishment of an inquiring and scholarly environment in the parent and integrated institution(s) is the primary responsibility of the teaching staff in a vascular surgery and endovascular training program.  There must be a single program director responsible for the endovascular therapy training program.  The program director and teaching staff must prepare and comply with written educational goals for the program.

A.  Qualifications of the Program Director
      1.   Documented qualification in catheter-based procedures, requisite administrative abilities and experience, and dedication to surgical education and scholarship, as evidenced by his or her curriculum vitae.
     
      2.   Certification in vascular surgery (Special or Added Qualifications) by the American Board of Surgery.

B.  Responsibilities of the Program Director
      1.   Prepare a written statement outlining the educational goals of the endovascular program with respect to knowledge, skills, and other accomplishments of the fellow graduates.  This statement must be distributed to fellows and members of the teaching staff and should be available for review.
     
      2.   Designate other vascular surgeons and/or non-surgeon interventionalists well qualified in endovascular techniques to assist in the supervision of the endovascular fellow, but maintain continuous responsibility and authority for administrative and teaching policies of the service. 
 
      3.   Select fellows for appointment to the program in accordance with institutional and departmental policies and procedures, make fellow assignments, and be responsible for the proper conduct of the educational activities; namely, for their supervision, direction, and administration in all participating institutions.

      4.   Provide fellows with explicit written descriptions of supervisory lines of responsibility for the care of patients.  Such guidelines must be communicated to all members of the program staff.  Fellows must be provided with prompt, reliable systems for communication and interaction with supervisory physicians.

C.  Other Teaching Staff
1.   There must be a sufficient number of teaching staff with documented qualifications to instruct and supervise the fellows in the endovascular program.  In addition to the program director, for each approved fellowship position there should be at least one geographic full-time teaching staff member whose major function is to support the fellowship program.  While the program director MUST be a vascular surgeon, other teaching staff may be non-surgeon interventionalists.  All members of the teaching staff must be able to devote sufficient time to meet their supervisory and teaching responsibilities.

2.   A member of the teaching staff of each participating institution must be designated to assume responsibility for the day-to-day activities of the program at that institution, with overall coordination by the program director.

3.   The teaching staff must be organized and have regular documented meetings to review program goals and objectives as well as program effectiveness in achieving them.

4.   The teaching staff should periodically evaluate the utilization of the resources available to the program, the contribution of each institution participating in the program, the financial and administrative support of the program, the volume and variety of patients available to the program for educational purposes, the performance of members of the teaching staff, and the quality of supervision of fellows.

D.  Faculty Scholarship Activity
      1.   Scholarly activity of the faculty at the parent and integrated institutions is of paramount importance to the program.  Adequate documentation of scholarly activity on the part of the program director and the teaching staff at the parent and integrated institutions must be submitted at the time of the program review.

      2.   Documentation of scholarly activity is based on participation in continuing surgical education, participation in regional or national surgical scientific societies, presentation and publication of scientific studies and participation in clinical trials evaluating new endovascular techniques.

      3.   While not all members of a teaching staff can be investigators, ideally, clinical and/or basic science vascular research would be ongoing at the parent and integrated institution(s) to provide the endovascular fellow with exposure to innovative new technologies.

IV.  ENVIRONMENT AND RESOURCES

A.  Facilities
1.   Endovascular faculty and fellows must have access to and privileges for using a radiographic imaging suite, which is a permanent structure with fixed imaging capabilities such as an angiography suite, catheterization laboratory, or operating room with a ceiling or wall-mounted image intensifier.

2.   Utilization of portable C-arm fluoroscopy for appropriately selected procedures may be an integral component in the training process; however, sole reliance on portable C-arm fluoroscopy for the entirety of the fellowship experience is not acceptable.

3.   In addition to tutorial instruction covering the technical aspects involved with operation of angiographic equipment, instruction must be provided regarding radiation safety, contrast media, and their injection parameters.  Continuous monitoring for cumulative radiation exposure must be performed and evaluated monthly.  Levels must fall within institutional guidelines.

B.  Working Environment and Hours
      1.   Graduate education in endovascular surgery requires a commitment to continuity of patient care. This continuity of care must take precedence—without regard to the time of day, day of the week,
number of hours already worked, or on-call schedules.  At the same time, patients have a right to expect a healthy, alert, responsible, and responsive physician dedicated to delivering effective and appropriate care.

2.   The program director must establish an environment that is optimal for both fellowship education and for patient care, while ensuring that undue stress and fatigue among fellows are avoided.  It is his or her responsibility to ensure assignment of appropriate in-hospital duty hours, so those fellows are not required to perform excessively difficult or prolonged duties regularly.  Call schedules are left to the discretion of the program directors.  However, it is desirable on average (excluding exceptional patient care needs) that fellows have at least one day out of seven free of routine responsibilities.  A distinction must be made between on-call time in the hospital and on-call availability at home and their relation to actual hours worked.  The ratio of hours worked to on-call time will vary each week and therefore necessitates flexibility.  There must be adequate backup so that patient care is not jeopardized during or following assigned periods of duty.

C.  Library
      1.   Endovascular surgery fellows must have ready access to a medical library, either at the institution where the fellows are located or through arrangement with convenient nearby institutions.

      2.   Ideally, Internet access for electronic retrieval of information from medical databases would be readily available.

      3.   There must be access to an on-site library or to a collection of appropriate texts and journals in each institution participating in a fellowship program.  On-site libraries and/or collections of texts and journals must be readily available during nights and weekends.

D.  Logistics
      During in-hospital on-call hours, fellows should be provided with adequate sleeping lounge and food facilities.  Support services must be such that fellows do not spend an inordinate amount of time in non-educational activities that can be discharged properly by other personnel.

V.  EDUCATIONAL PROGRAM

A.  Curriculum
      1.   The curriculum for the endovascular training program should include all portions of the vascular system, both arterial and venous.  The program should include didactic instruction in the basic concepts of:
a. Imaging equipment, radiation physics, and safety
b. Diagnostic arteriography and venography
c. Guide wire and catheter skills
d. Percutaneous vascular access
e. Intravascular ultrasound
f. Percutaneous transluminal angioplasty (PTA)
g. Intravascular stents
h. Pharmacologic and mechanical thrombolytic therapy
i. Stent-grafts for endovascular repair of abdominal aortic aneurysms
j. Coil embolization (to facilitate endovascular AAA repair)
k. Closure of percutaneous access sites
l. Accepted intra-arterial and intracaval filtering devices

      2.   In addition, because of the device-related nature of endovascular therapy, specific technical instruction should be provided in the following:
a. Devices to facilitate and close vascular access
b. Endovascular guide wires
c. Diagnostic catheters
d. Balloons for percutaneous transluminal angioplasty
e. Intravascular stents
f. Percutaneous thrombectomy/thrombolysis devices or agents
g. Endovascular grafts
h. Coil and/or particulate embolization

      3.    The curriculum should be taught through hands-on, supervised training, and though regularly scheduled educational meetings of at least one hour per week.  These conferences should include a review of interesting and complex cases, morbidity and mortality, new technologies, and literature.  The trainee should be integrally involved in the planning and conduct of these educational conferences.

      4.    In addition to performing procedures, the trainee will be actively involved in out-patient evaluation (pre-treatment), in-patient management (including management of complications), and out-patient follow-up.  Integration with the non-invasive vascular laboratory is a desirable facet of the endovascular fellowship experience.

      5.    Scholarly activity by the endovascular trainee is strongly encouraged.

B.  Volume and Complexity
1. Technical skill in endovascular procedures can only be gained through hands-on experience in progressively increasing degrees of independence, under the supervision of an experienced mentor.  The ultimate goal of the trainee is independent practice in endovascular surgery.

2.   The program must provide sufficient experience to allow for development of independent operators in the following core areas:
a. Percutaneous vascular access via femoral and brachial approaches
b. Diagnostic arteriography of all peripheral vascular vessels including the carotid, renal/mesenteric aortoiliac, and upper and lower extremity vessels
c. Percutaneous transluminal angioplasty and stenting of all peripheral arterial lesions for which this is accepted therapy
d. Endovascular repair of abdominal aortic aneurysms (AAA)
e. Coil embolization to facilitate endovascular AAA repair
f. Catheter-directed and/or mechanical thrombolysis 
    
3.   Although not required, additional experience in the following areas is desirable:
a. Carotid angioplasty & stenting
b. Intravascular ultrasound
c. Supraselective microcoil embolization of endoleaks
d. Translumbar AAA sac embolization
      
4.    Allowing for differences in individual capability and rate of progress, the endovascular trainee should be provided progressively increasing experience as the primary operator in endovascular procedures.  At completion of the program, the trainee should meet those requirements for case numbers as defined in the endovascular credentialing guidelines for vascular surgeons (J Vacs Surg 1999; 29:177-186).  It is the trainee’s responsibility to document his/her experience in an ongoing case log, copies of which will be maintained by the sponsoring institution.  At the completion of the SVS-endorsed endovascular training program, the program director will document in a letter to the trainee the number and types of endovascular procedures he/she performed during the endovascular fellowship training.  This document will further assist the trainee in the credentialing process at their institution.

 C. Evaluation of Endovascular Fellows
      1.   There must be adequate ongoing evaluation of the knowledge, competency, attitudes, and performance of the endovascular fellows. Written evaluation of each fellow’s knowledge, skills, professional growth and performance (using appropriate criteria and procedures), must be documented.  This assessment must include cognitive, motor, and interpersonal skills as well as endovascular judgment, and should verify that the endovascular fellow has demonstrated sufficient professional ability to practice endovascular therapy competently and independently.  For programs of three months or less in duration, this evaluation should be performed at the completion of the endovascular training experience.  For programs longer than three months, this evaluation should be performed at the mid-point of the training experience as well as upon completion of the endovascular fellowship.

     2. The program must maintain a permanent record of evaluation for each fellow and have it accessible to the fellow and other authorized personnel.

     3. A system for documentation of fellows’ experiences must be utilized to monitor the education experience and to provide documentation for future hospital privileges.

 D.  Evaluation of the Program and Faculty
The educational effectiveness of a program must be evaluated in a systematic manner.  In particular, the quality of the curriculum, and the extent to which the fellows have met the educational goals, must be assessed.  All teaching faculty must also be evaluated on a regular basis, including teaching ability, attitudes, scholarly contributions, interpersonal skills, and communication abilities.  Written evaluations by fellows of the program and faculty should be utilized in this process.  Fellow feedback should be anonymous if feasible, and under no circumstance should it result in any negative program or faculty response directed toward the fellows.

VI.  ENDORSEMENT PROCESS

A.  Application Process
Applications for EV-PEEC endorsement, which can be obtained from the SVS website, should be completed per the accompanying instructions and returned to the listed address with a non-refundable check for $500.00.  The EV-PEEC will have 60 days to distribute and review the application and arrive at a decision about granting a site inspection.  If, upon review by the EV-PEEC, it appears that the program meets the requirements for endorsement, a site inspection will be offered.  After submission of all fees an inspection date will be arranged by mutual consent with the designated EV-PEEC site reviewer.

B.  Site Inspection and Committee Review
Initial site visits will be made by one of the EV-PEEC vascular surgeons, with the expressed purpose of examining the facilities, interviewing faculty, fellows, and hospital administrators, and reviewing supporting documentation for the program.  It would be anticipated that this could be accomplished in one working day, travel excluded.  If accepted for a site inspection the institution will be required to pay a fee of $3,000.00 to cover the expenses associated with travel, lodging, administrative costs, and a stipend for the inspector.  The site inspector will prepare a final summary report of the program, which, once reviewed by the entire committee, will lead to a judgment about the program’s endorsement within 60 days of the date of inspection.  Three types of recommendations are possible:

• Full endorsement:  Complete endorsement of the endovascular training program with no major deficiencies being noted and no corrective action required.  The program would be due for re-inspection in 3-5 years.

• Provisional endorsement:  Endorsement, but with noted deficiencies which MUST be corrected within ONE year, or the provisional endorsement status will be lost and re-inspection, or possibly re-application, will be required.  This category of endorsement would typically be granted to programs with deficiencies that the EV-PEEC feels are relatively minor, but worthy of bringing to the attention of the program and its applicants, and that the EV-PEEC feels are likely to be correctable within one year.  It would be anticipated that documentation of the correction of most deficiencies could be achieved without an additional site visit.  Once documentation of corrective action has been received, provisionally endorsed programs could promote themselves as being fully endorsed.  Until that time, however, they would be required to use the term “provisionally endorsed.”

• Non-endorsement:  The program has failed to win a simple majority of votes for endorsement from the EV-PEEC because of fundamental or major deficiencies.  A report will be prepared for the program explaining its deficiencies and inviting an application for re-inspection after one year with appropriate documentation of the correction of the deficiencies.  A re-inspection fee of $2,000.00 would be required.  Programs receiving a non-endorsement decision will have up to 60 days to appeal that determination and provide refuting documentation of evidence that the cited deficiencies are erroneous, have been, or are actively being addressed.

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