Practice Standards for Stent Grafting of Thoracic Aortic Aneurysms
Equipment and personnel
- A DSA apparatus must be installed in an operating room or an angiography room with proper hygiene where emergency surgery can be provided; in addition, the facility must have a system that allows aortic surgery (see Note 1).
Surgical performance (see Note 2)
- A minimum of 30 vascular surgeries and/or endovascular treatments, including 10 thoracic aortic aneurysm repairs, must be performed per year.
Cooperation of surgeons
- The cooperation of full-time surgeons who have had experience of at least 5 surgeries for ruptured thoracic aortic aneurysm or acute aortic dissection must be immediately available (surgeons: board-certified cardiovascular surgeons or surgeons at facilities where board-certified cardiovascular surgeons are on staff).
- Must have completed a training program for each type of stent graft to be used.
- Must have experience as an operator or assistant in a minimum of 10 thoracic aortic aneurysm repairs (surgery or stent grafting).
- Must have experience of a minimum of 10 stent grafts to treat abdominal aortic aneurysms as an operator, or a minimum of 20 endovascular iliac artery repairs (5 as an operator and 15 as a first assistant) and 5 stent grafts for thoracic aortic aneurysms as a first assistant under the guidance of a supervising surgeon.
- Must have experience as an operator in a minimum of 5 abdominal aortic/iliac artery surgeries.*
- Must have experience as an operator in a minimum of 5 surgeries or endovascular repairs of aortic arch branches. *
- (* If the surgeon does not have experience as an operator, other surgeons experienced with the procedure must participate in the surgery.)
- Must have carried out successful endografting for each type of stent graft to be used in a minimum of 2 cases as an operator under the guidance of a supervising surgeon.
- Must have experience of a minimum of 20 thoracic stent graftings (including handmade stent grafts) as an operator.
- Must have experience as an operator of a minimum of 10 stent graftings with the relevant stent graft. For those who have a certificate as a supervising surgeon regarding other types of thoracic stent grafts, experience with a minimum of 5 cases is required.
- Must be qualified as one of the following: a physician certified by the Japanese Association of Cardiovascular Intervention and Therapeutics, specialist certified by the Japanese Society of Interventional Radiology, board-certified cardiovascular surgeon, or surgeon certified by the Japan Surgical Society at a facility where board-certified cardiovascular surgeons are on staff. (IVR: Interventional Radiology)
Determination of indication
- Seek the advice of a supervising surgeon in determining the indication and selecting the device based on imaging for the first 10 cases.
Surveillance (see Note 3)
- Follow-up surveillance must be conducted at the facility.
- The Stent-graft Management Committee shall analyze the follow-up surveillance data and disclose the results of the analysis when necessary.
- Note 1: The system referred to here includes the participation of anesthesiologists, nurses and clinical engineers in aortic surgery using a heart-lung machine.
- Note 2: Surgical performance is the measure of whether the institution regularly performs vascular surgery.
- Note 3: The surveillance system referred to here includes the surveillance cooperative system for safety management and efficacy, and cooperation for the follow-up surveillance conducted by The Japanese Committee for Stent-graft Management is required.
- Additional Note: These practice standards should be reviewed every three years on the basis of results of the analysis of follow-up surveillance data.