Guidelines for Live Presentations of Cardiovascular Surgery (Revised)
Guidelines for Live Presentations of Thoracic and Cardiovascular Surgery were established August 10, 2007 through the cooperation of the Japanese Society for Cardiovascular Surgery, the Japanese Association for Thoracic Surgery, and the Japanese Society for Vascular Surgery. The guidelines were developed to specify the goals of live surgery and to promote its safety and educational impact. Since 2007 and up until December 2012, a total of 33 reports on “live surgery” have been submitted and reviewed. While considerable effort has been shown by surgeons and institutions to abide by the guidelines, deficiencies in the 33 reports have been identified:
- Delayed report submission. Fourteen reports were submitted less than two weeks before the scheduled date of live surgery or had no specified date
- No program submitted. Seven reports failed to include a printed program of the live presentation.
- No Approval by Local Ethics Committee. Five programs did not obtain prior approval from their local Ethics Committee, or failed to mention such in their report.
- No report of local program committee. Thirty programs did not include reports of the meeting of the local program committee.
- No postoperative followup. Sixteen programs failed to provide a postoperative followup report on the operated patients.
Of note, during this time, an intraoperative accident occurred during one case of televised surgery in August 2012 and led to the death of the patient.
Pros and Cons of Live Surgery
In cardiovascular surgery, unexpected circumstances may arise intraoperatively that challenge the operative surgeon’s judgement and management skills. The ability of the surgeon to manage those scenarios is key to good clinical outcomes. Live surgery has the potential to instruct audiences on such management, and can marked educational impact, consequently contributing to the quality of surgery for future patients.
Live surgery imparts additional stress on the operating surgeon and may interfere with the surgeon’s ability to use his/her skills as effectively as they usually do. This may endanger the patient, and for this reason, it is crucial to give priority to patient safety and to ensure sufficient educational benefit during cases of live cardiovascular surgery. To that end, the above-mentioned guidelines have been revised. The revised version addresses cardiovascular surgery but excludes thoracic (respiratory and esophageal) surgery.
I.Goals of live surgery
Live surgery aims to provide opportunities to learn diverse operative techniques related to cardiovascular surgery, rather than serve as a display of a masterful surgical performance or to satisfy an audience’s voyeuristic desires. Therefore, its scope should be limited to typical surgical procedures in which advanced operative techniques are used. Ideally, the surgical procedures should be performed in a standardized fashion familiar to both the operating surgeon and host operative team. In addition to demonstration of surgical techniques, the educational program should include appropriate strategies, such as indications, surgical equipment and instruments, and support systems, such as anesthesia.
II. Requirements of live surgery
1) Surgical procedures
- In the field of cardiovascular surgery, some surgical procedures are appropriate for live surgery, but others are not. In terms of the protection of patients’ rights, those involving higher risks of complications or death should be excluded, as it is likely to be difficult to determine whether the liver surgery or the disease itself were responsible in the evident of an accident or untoward outcome.
- Diseases for which appropriate surgical procedures have not yet been determined are inappropriate for live surgery. Intraoperative discussions about surgical approaches may distract surgeon from their task, and interfere with optimal treatment.
- New surgical instruments or devices (limited to those approved in Japan) may be used for live surgery only when such use is appropriate and has academic value. To conform to the COI (conflict-of-interest) policy, live surgery for commercial purposes should not be permitted even if there is no compensation from industry.
2) Operating surgeons
The surgeon performing each live surgical procedure should be appointed by the academic society or study group responsible for the meeting. The surgeon should meet the following requirements:
- Having sufficient knowledge and experience to perform the relevant surgical procedure and actually performing it on a daily basis
- Fully understanding the objective of live surgery and being able to provide appropriate education
- (In the case of Japanese) Being certified as an advisor or specialist of related academic societies
- In principle, live surgery should be performed in facilities where operating surgeons belong. When performing it in other facilities, it is necessary to organize a team consisting of a team assembled specific for the live case, including assistants and scrub nurses.
- It is also necessary for operating surgeons to specify the presence/absence of possible COI (conflicts of interest) before the initiation of surgery.
3) Live surgery facilities
Live surgery should be performed in facilities meeting all the following requirements:
- Maintaining social transparency in all aspects and addressing information disclosure
- Sufficiently training all medical professionals involved, such as surgeons, anesthesiologists, related medical departments, nurses, and clinical engineers, so as to be familiar with the relevant surgical procedure, and enabling them to work cooperatively, particular in the case of unexpected events.
- The hospital director should also fully understand and agree with the objective of live surgery
- Live surgery facilities should be certified as those for education and training by related academic societies
In principle, audiences should be medical professionals, such as doctors, nurses, and engineers, who are members of relevant academic societies or study groups. It is also necessary for them to understand the objective of live surgery and to respect patients’ rights. The general public and media should be excluded; however, based on the organizer’s judgment, those involved with medical services, such as medical companies, may participate as observers. In live surgery, it is desirable to register and appropriately manage such participants.
III. Ethical issues
While live surgery principally is design to teach surgical techniques, it is also inextricably related to the patient’s treatment. Therefore, it is important to establish an agreement between the surgical team and patient based on mutual trust. In line with this, it is essential to obtain the patients’ informed consent after detailed explanation and discussion about how they will undergo surgery in a special live environment. It is also essential that consent be obtained without pressure on the patient, with attentions to these points:
- After explaining the objective, content, and problematic issues of live surgery with patients, it is necessary to confirm that the patient understands such explanations and expressly agrees to the procedure under the circumstances of “live surgery.”
- It is also necessary to explain to patients that, although the educational effect of live surgery may benefit future patients, it does not benefit the patient in question, and may indeed increase risk in some cases. Mention should be made that live surgery performed in front of a large number of audiences presents additional stress on the operating surgeon and may affect the surgeon’s judgement, possibly preventing effective use of surgical skills otherwise used.
- These explanations should be provided personally by the operating surgeon before obtaining written consent. When live surgery is performed in an external facility, the informed consent procedure may be obtained by the doctor in charge of (person responsible for) the live surgery facility.
The Ethics Committee of the live surgery facility should be familiar with these guidelines and confirmed that the planned surgery conforms the guidelines before the planned surgery. It is desirable for the committee to submit records of proceedings to document the process of such approval. The appropriateness of each planned live surgery should be discussed within the committee, even if similar procedures are performed routinely at that institution.
3) Patients’ privacy
The privacy of patients undergoing live surgery should be strictly protected by appropriately management of their personal information. Distribution of videos should be carefully limited and monitored.
IV. Live surgery safety measures
1)Planning of live surgery
As previously mentioned, surgical procedures with high risk of complications or death should be avoided in live surgery. Sufficient time for completion of the procedure should be allotted, including time for surgeon’s participation in a review meeting to be held immediately after the surgery.
2) Safety in live surgery facilities
In terms of safety management, it strongly recommended that live surgery be performed in the facilities where the operating surgeon routines performs surgery. Familiar operating rooms and surgical instruments are indispensable to ensure surgical safety, and established systems for cooperation with other medical professionals and related departments gives the best chance for successful management of unexpected events.
3) Coordinator (in the operating room) and chairman (at the live surgery venue)
In addition to the operating surgeon, a coordinator should be present within the operating room during surgery. The coordinator plays an important role, namely to provide communication between the operating surgeon, moderator, and audience without interfering with operation. It is also necessary for the coordinator to facilitate smooth progress of the live surgery, by summarizing audience questions and presenting them to the operating surgeon at the appropriate time. The chairman at the live surgery venue should prevent questions and comments that might distract the operating surgeon by determining their appropriateness and the appropriate times to present the question during the surgery.
Filming of live surgery to obtain high quality images should not interfere with the safe practice of the operation. It is inappropriate for the operating surgeon to alter or prolong the operation for the purpose of filming. The coordinator and chairman should take appropriate measures to prevent filming from disturbing surgical performance.
2.Discontinuation of live streaming
If an untoward clinical event occurs during live surgery, live streaming should be discontinued immediately in order to make all efforts to save the patient’s life. The chairman or coordinator bears the responsibility for making such judgments.
V. Reporting obligations
All case of live surgery should be reported, to assure safe practice and for the development and refinement of future guidelines. The organizer of each live surgery or person responsible for the live surgery facility (such as the hospital director) bears the responsibility for such reporting.
Before each live surgery, a report should be submitted to the Medical Safety Management Committee of the Japanese Society for Cardiovascular Surgery (addressed to the Chairman). This committee is entrusted with management of such reports. After receiving a report, the committee should promptly forward it to the Medical Safety Management Committees of the Japanese Association for Thoracic Surgery and Japanese Society for Vascular Surgery. Each report should be submitted by 2 weeks before the scheduled date of live surgery, with the following documents:
- ①Written preoperative report (specifying the details of the planned live surgery, such as the purpose, content, operating surgeon, and facility)
- ③Report from the Ethics Committee of the live surgery facility (with records of proceedings whenever possible)
- ④Completed live surgery checklist (the signature of the person responsible for reporting is necessary)
It should be noted that each facility, rather than the Medical Safety Management Committee that receives such reports, bears the responsibility for approving each live surgery.
Reports after live surgery should be submitted to the same place as 1. Each report should be submitted approximately 1 to 2 months after the surgery, with the following documents:
- ①Written postoperative report
- ②Follow-up documents, such as discharge summaries
However, in the event of an intraoperative accident or negative postoperative outcome, it is necessary to report them as soon as possible, with details of the circumstances of the negative event. If serious complications or fatal accidents occur, systems to ensure fairness and transparency through the evaluation conducted by external bodies should be established, while organizing the Medical Accident Investigation Committee within the hospital.
VI. Evaluation of live surgery
1)Review meetings immediately after surgery
Immediately after surgery, a review meeting should be held to evaluate the live surgical event. The meeting should include debaters and audience members and provide them an opportunity to present questions to the operating surgeon. Such review meetings are indispensable for education. If the operating surgeon cannot participate in the review meeting due to a long distance between the locations of the academic society (or study group) and live surgery facility, the internet may be used for online participation.
2)Analysis of postoperative reports
The 3 academic societies that developed these guidelines should analyze the submitted postoperative reports within a certain period of time, and, based on the results of such analysis, cooperate to develop future perspectives on live surgery together.
The main purpose of live surgery is to provide opportunities to learn surgical techniques. Observing operating surgeons’ appropriate judgments and management of unexpected intraoperative events can be very instructive to the surgical audience. However, the highest priority must be given to patient safety; all organizers, operating surgeons, live surgery facilities, and participants (audiences) should acknowledge and respect this priority, even above the goals of education. Well edited videos can be more educationally effective than live surgery, although the real-time aspect is not present. The Japanese Society for Cardiovascular Surgery, Japanese Association for Thoracic Surgery, and Japanese Society for Vascular Surgery hope that all live surgery procedures will be safely and appropriately implemented, conforming to these guidelines (revised).Postscript
The external committee members who cooperated with the revision of these guidelines made the following comments on live surgery:
- The necessity of live surgery has not yet been fully discussed. It may also be possible to sufficiently study individual cases with edited or unedited videos.
- It is still difficult to confirm that patients voluntarily consent only after fully understanding the content of explanations and based on their own intentions.
- If it is determined ultimately that live surgery imposes significant risks to patients, it should be completely prohibited.
- Considering the purposes of live surgery and the above transparency policy, the media’s participation may be permitted if they fully understand such purposes and apply for participation prior to the surgery.
Established on June 12, 2014
Japanese Society for Cardiovascular Surgery
Japanese Association for Thoracic Surgery
Japanese Society for Vascular Surgery
Yuji Miyamoto (Chair), Yuichi Ueda, Ryuzo Sakata, Tetsuro Miyata, Hideo Adachi, Kiyoyuki Eishi, Norihiko Shiiya, Tadashi Tashiro, Hiroshi Nishida, Kazuhiro Hashimoto, Satoshi Maemura, Yoshio Kato, and Ikuko Yamaguchi
The members of committee appreciate Duke Cameron, M.D., for his generous support for English version of the Guideline.