Preparation process of practice standards:

Preparation process of "Practice Standards for Stent Grafting of Aortic Aneurysms"

In August 2005, when industrially made stent graft was approved for the first time by the Ministry of Health, Labour and Welfare (MHLW) in Japan, the Japanese Society for Vascular Surgery (JSVS) acknowledged the necessity of prescribing certain standards for facilities and physicians for the purpose of safe and effective introduction of the new technology. Therefore, the JSVS established the “Stent Graft Standards Preparatory Board (board), set up as an advisory board to the chief director of the JSVS.

On December 2, 2005, drafts of standards for facilities, practicing surgeons and supervising surgeons were discussed at the board meeting. The board attendees concluded that "joint standards should be developed by a group of relevant academic associations and meetings related to endovascular therapy," which will be based on the preliminary drafts prepared by the JSVS. Thus, the JSVS decided to request extensive participation of associations in relevant fields (internal medicine, surgery, radiology).

On December 5, 2005, in response to the above-mentioned proposal of the board, the JSVS judged that it was appropriate to request the Japanese College of Angiology (a comprehensive academic association covering various relevant fields) to take charge of the preparation and management of the joint standards in the future.

On May 1, 2006, the Evaluation & Licensing Division of the Drug & Food Safety Bureau of the Ministry of Health, Labour & Welfare requested nine related academic associations (Note 1) to cooperate with the establishment of efficacy and safety of stent grafting of abdominal aortic aneurysms.

On May 31, 2006, in response to the proposal of the Japanese College of Angiology (a comprehensive academic association of the vascular field), the "Committee to Prepare the Draft of Practice Standards for Stent Grafting" consisting of representative members recommended by the 10 academic associations (all associations listed in Note 1 plus the Japanese Society of Phlebology; Note 2) was held to make the draft of "Practice Standards for Stent Grafting of Abdominal Aortic Aneurysms."

On July 11, 2006, an industrially made stent graft gained MHLW approval for clinical use, and its use was made a subject of reimbursement by health insurance as a specific medical material in January 2007. In this reimbursement, a provision that "the use of this device should be in compliance with the practice standards for stent grafting prepared by the relevant academic associations" was added as a caution related to the payment setting for the medical material.

On December 21, 2006, a meeting to discuss the "management of practice standards for stent grafting of abdominal aortic aneurysms" was jointly held by the above-mentioned 10 academic associations. At that time, the "Practice Standards for Stent Graft of Abdominal Aortic Aneurysms" draft, approved by the board of directors of all 10 associations, was established, and then, they discussed several issues concerning observance of the practice standards. These 10 associations plus the Japanese Association for Thoracic Surgery (Note 3) founded the "Japanese Committee for Stentgraft Management ("Management Committee") to cope with stent grafting of thoracic aortic aneurysms, which was expected to be introduced in the future. Prof. Hiroshi Shigematsu (Department of Vascular Surgery, Tokyo Medical University) was elected as Chairperson of the committee.

On August 3, 2007, the Japanese Ministry of Health, Labour & Welfare requested the relevant 11 academic associations that comprise the Management Committee to plan the requirements of the system for appropriate use of stent grafting of thoracic aortic aneurysm. In response to their request, the management committee consolidated the enforcement systems for the stent grafting of thoracic aortic aneurysm and prepared the "Practice Standards for Stent Grafting of Thoracic Aortic Aneurysm (draft)" at a meeting held on November 8, 2007.

On December 20, 2007, the chief directors of 11 academic associations that form the management committee approved and established the "Practice Standards for Stent Grafting of Thoracic Aortic Aneurysms."

On July 4, 2009, the Japanese Society of Interventional Cardiology and the Japanese Association of Cardiovascular Catheterization Therapeutics were merged and became the Japanese Association of Cardiovascular Intervention. Thus, the number of academic associations that form the management committee became 10 (Note 4).

On March 1, 2010, the basic skill set required for performing the stent graft procedure, prescribed in the Practice Standards for Stent Grafting of Thoracic Aortic Aneurysms and Abdominal Aortic Aneurysms, was amended.

• Note 1: Japanese College of Angiology, Japanese Circulation Society, Japanese Association of Cardiovascular Catheterization Therapeutics, Japanese Society of IVR (Interventional Radiology), Japanese Society for Vascular Surgery, Japanese Society for Cardiovascular Surgery, Japanese Society of Endovascular Intervention, Japanese Society of Interventional Cardiology, Japanese Society for Artificial Organs.
• Note 2: Japanese College of Angiology, Japanese Circulation Society, Japanese Association of Cardiovascular Catheterization Therapeutics, Japanese Society of IRV (Interventional Radiology), Japanese Society for Vascular Surgery, Japanese Society for Cardiovascular Surgery, Japanese Society of Phlebology, Japanese Society of Endovascular Intervention, Japanese Society of Interventional Cardiology, Japanese Society for Artificial Organs.
• Note 3: Academic associations that form the Japanese Committee for Stentgraft Management.
  Japanese College of Angiology, Japanese Circulation Society, Japanese Association of Cardiovascular Catheterization Therapeutics, Japanese Society of IVR (Interventional Radiology), Japanese Society for Vascular Surgery, Japanese Society for Cardiovascular Surgery, Japanese Society of Phlebology, Japanese Society of Endovascular Intervention, Japanese Society of Interventional Cardiology, Japanese Society for Artificial Organs, Japanese Association for Thoracic Surgery.
• Note 4: Japanese College of Angiology, Japanese Circulation Society, Japanese Society of IVR (Interventional Radiology), Japanese Society for Vascular Surgery, Japanese Society for Cardiovascular Surgery, Japanese Society of Phlebology, Japanese Society of Endovascular Intervention, Japanese Association of Cardiovascular Intervention and Therapeutics, Japanese Society for Artificial Organs, Japanese Association for Thoracic Surgery.