Case Implementation Process

4Starting Robot-Assisted Cardiac Surgery

Starting Robot-Assisted Cardiac Surgery

  • After certification by the Council, robot-assisted surgery can be performed as self-pay treatment.
  • To perform robot-assisted valvuloplasty surgery (valve replacement surgery) as an insurance-covered procedure, notification to the Regional Bureau of Health and Welfare as a specified medical treatment fee is required

Preparation for Case Initiation

  • Team case observation is recommended before starting (observation can be divided among personnel).
    The above case observation is conducted in accordance with each implementing facility's regulations.
  • It is desirable to start surgery as soon as possible after case observation.
  • Conduct dry runs in the operating room.
  • Conduct emergency roll-out training assuming intraoperative emergencies (bleeding, equipment malfunctions).

Precautions When Starting da Vinci-Assisted Surgery

  • When performing da Vinci-assisted cardiac surgery, explain in preoperative informed consent what to do in case of equipment malfunction
  • When starting da Vinci-assisted cardiac surgery, obtain approval from the facility's High-Difficulty New Technology Committee or equivalent for each surgical procedure
  • Ensure that equipment used for da Vinci-assisted cardiac surgery is properly maintained
  • Cooperate in understanding surgical outcomes, complication occurrence rates, etc. by registering all cases preoperatively in JCVSD (NCD)
※If more than six months have passed between completion of training and the start of robot-assisted surgery, attend the retraining program provided by the company

Proctoring

When performing robot-assisted surgery for the first time, at least 3 cases must be conducted under the guidance of a proctor approved by the Council. Except when there is a full-time proctor at the same facility, new surgeons must receive guidance from an external proctor even at facilities that have already started robot-assisted surgery.
The proctor must submit a guidance report to the Council.
The Council will review whether the surgeon is appropriate as an independent console surgeon based on the guidance report.

Proctor Report [Excel file 16KB]

※Guidance by the same proctor is preferable.
Confirm with the proctor in advance whether the proctoring case is appropriate as an initial case (surgical difficulty, anatomical issues, etc.) and be sure to submit detailed surgical case information (including echocardiography, CT, and other images) to the proctor. Perform only cases that have been approved.

Notification of Specified Medical Treatment Fees to the Regional Bureau of Health and Welfare (Insurance Coverage)

※Approval Requirements at the Regional Bureau of Health and Welfare (New Approval Requirements)

In the 2024 insurance revision, it was revised that thoracoscopic valvuloplasty and video-assisted valve replacement must be performed at least 20 times annually at the applicable facility. (Effective from June 2024)
Each facility should thoroughly confirm the notification requirements from the Ministry of Health, Labour and Welfare's Health Insurance Bureau regarding the start of insurance coverage
(For details on notification, contact the Regional Bureau of Health and Welfare)

Notification Form 87-11 [PDF file 67KB]

Submit notification to the Regional Bureau of Health and Welfare after performing the initial 5 cases as self-pay (or hospital-paid) treatment.
Insurance reimbursement becomes available from the 6th case after approval.

When performing additional procedures and techniques in combination with valvuloplasty, it is desirable to have sufficient experience with robot-assisted mitral valvuloplasty before doing so.

Council Policy

Robot-assisted valve replacement should be performed at facilities that have performed at least 3 robot-assisted valvuloplasties
Proctoring is not required for robot-assisted valve replacement, but when starting, follow the guidelines of the facility's High-Difficulty New Technology Committee or equivalent

Reporting of Serious Complication Cases

If a death occurs in cardiac surgery initiated using a robot, promptly report it to the Council and JCVSD (NCD). The Council may investigate such cases.