Practice Standards for Stent Grafting of Abdominal Aortic Aneurysms

Equipment and personnel

• A DSA apparatus must be installed in an operating room or an angiography room.
• The facility must have a system that facilitates aortic surgery (see Note 1).

Surgical performance (see Note 2)

• A minimum of 30 vascular surgeries and/or endovascular treatments, including 10 abdominal aortic aneurysm repairs, must be performed per year.

Cooperation of surgeons

• The cooperation of full-time surgeons who have had experience of at least 3 ruptured abdominal aortic aneurysm surgeries must be immediately available. (Surgeons: board-certified cardiovascular surgeons or surgeons at facilities where board-certified cardiovascular surgeons are on staff.)

Training requirements

• Must have completed a training program for each type of stent graft to be used.

Basic experience

• Must have experience of a minimum of 20 endovascular iliac artery repairs (5 as an operator and 15 as a first assistant).
• Must have experience as an operator of a minimum of 10 aorto-iliac aneurysms (surgery or stent graft).

Operator experience

• Must have achieved successful endograting for each type of stent graft to be used in a minimum of 2 cases as an operator under a supervising surgeon.

Performance

• Must have experience of a minimum of 30 stent graftings (incl. handmade stent grafts) as an operator or first assistant surgeon.

Training requirements

• Must have completed a training program for each type of stent graft to be used.

Operator experience

• Must have experience of a minimum of 10 stent graftings with the relevant stent graft. For those who have a certificate as a supervising surgeon in other types of stent grafts, experience in a minimum of 5 cases is required.

Academic qualifications

• 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.

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.

Imaging

• Diagnosis must be made on the basis of CT images (slice thickness, 3 mm or less).

Surveillance (see Note 3)

• The facility must conduct follow-up surveillance.

Information disclosure

• The Stent-graft Management Committee shall analyze the follow-up surveillance data and disclose the results of the analysis when necessary.