Live Case Demonstration of Interventional Cardiology Procedures A Regulatory Perspective

Office of Device Evaluation, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
JACC. Cardiovascular Interventions (Impact Factor: 7.35). 02/2012; 5(2):225-7. DOI: 10.1016/j.jcin.2011.11.006
Source: PubMed
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    ABSTRACT: Live surgery is an important part of surgical education, with an increase in the number of live surgery events (LSEs) at meetings despite controversy about their real educational value, risks to patient safety, and conflicts of interest. To provide a European Association of Urology (EAU) policy on LSEs to regulate their organisation during urologic meetings. The project was carried out in phases: a systematic literature review generating key questions, surveys sent to Live Surgery Panel members, and Internet- and panel-based consensus finding using the Delphi process to agree on and formulate a policy. The EAU will endorse LSEs, provided that the EAU Code of Conduct for live surgery and all organisational requirements are followed. Outcome data must be submitted to an EAU Web-based registry and complications reported using the revised Martin criteria. Regular audits will take place to evaluate compliance as well as the educational role of live surgery. This policy represents the consensus view of an expert panel established to advise the EAU. The EAU recognises the educational role of live surgery and endorses live case demonstration at urologic meetings that are conducted within a clearly defined regulatory framework. The overriding principle is that patient safety must take priority over all other considerations in the conduct of live surgery. Controversy exists regarding the true educational value of live surgical demonstrations on patients at surgical meetings. An EAU committee of experts developed a policy on how best to conduct live surgery at urologic meetings. The key principle is to ensure safety for every patient, including a code of conduct and checklist for live surgery, specific rules for how the surgery is organised and performed, and how each patient's results are reported to the EAU. For detailed information, please visit
    European Urology 01/2014; 66(1). DOI:10.1016/j.eururo.2014.01.028 · 13.94 Impact Factor
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    ABSTRACT: Live case demonstration as an educational tool is widely used to rapidly and effectively disseminate information on surgical and interventional techniques. The risks and benefits of live case transmission for investigational devices, however, are in question. Transcatheter Aortic Valve Intervention-Live Transmission (VERITAS) is a case-control study of 60 patients from 5 centers who were treated with transcatheter aortic valve replacement (TAVR) during live- or recorded transmission; of which 42 have matched Control subjects from five sites. Case and Control subjects were matched by valve type, access strategy (Edwards SAPIEN transfemoral, Edwards SAPIEN transapical, CoreValve transfemoral), Society of Thoracic Surgeons (STS) score, date of TAVR procedure, and primary operator. The Case and Control groups' baseline characteristics were similar, with average ages of 84 and 82 years, and STS scores of 6.54±3.22 and 6.46±3.20, respectively. The number of operators, fluoroscopy time, contrast volume and length of hospital stay were also similar between groups. Overall, 91.7% of the cases had TAVR via a transfemoral approach; 72% of these patients received a closure device. The final valve position was adequate in 91.2% of the Case patients and in 97% of the Control patients, with no cases of valve migration or coronary obstruction. The Case patients had longer procedure times (130.2±50.6 versus 100.6±43.7min; p=0.006). The Valve Academic Research Consortium in-hospital complications were similar between groups. Four Case patients and 1 Control patient required additional valve implantation. Data support the notion that live transmission of TAVR procedures, when performed by experienced operators, can be done safely with similar outcomes when compared to non-transmitted cases.
    Cardiovascular revascularization medicine: including molecular interventions 03/2014; 15(2):63-8. DOI:10.1016/j.carrev.2014.01.005
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    ABSTRACT: Background Live surgical demonstrations are commonly performed for surgical conferences. These live procedures have recently come under great scrutiny; in particular with issues pertaining to patient safety. This systematic review therefore aimed to: 1. Explore the evidence for live surgery as a training tool. 2. Investigate the safety of live surgical broadcasts. 3. Identify guidelines provided for live surgery. Methods PubMed, EMBASE, MEDLINE and the Cochrane Library databases were searched utilising a predefined search strategy from 1980 to October 2013. Specialty societies and primary colleges of surgeons were searched for guidelines or position statements on live surgical teaching. Results Educational value criteria demonstrated for live surgery included feasibility, acceptability, construct and concurrent validity. Complication rates during live procedures were not compromised in the majority of studies; however, patient safety may be affected during live procedures due to success rates found to be lower in some studies. Only cardiothoracic, urology and vascular surgical societies currently offer guidelines on conducting live surgical demonstrations. Conclusions Little evidence exists on the educational value and safety of live surgery with few studies of high quality conducted on the subject. Guidance on live procedures is scarce with only three major surgical specialties offering any guidance. More needs to be done to establish international pan-speciality guidelines with a central governing body that can regulate these demonstrations. Furthermore, awareness and adherence to already established guidelines must be raised.
    British Journal of Surgery 12/2014; 101(13):1637-1643. DOI:10.1002/bjs.9635 · 5.54 Impact Factor


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