Abstract
Background
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.
Methods
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.
Results
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 ± 43.7 min; 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.
Conclusion
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.
1
Introduction
With advanced technologies in patient care and in the telecommunications field, the broadcasting of live cases into medical professional meetings, or recently via the Web, has become an integral part of medical education. Live transmissions that demonstrate new devices and operating techniques enable the rapid, worldwide dissemination of new information with the potential to improve quality of care. Live case transmission can be especially valuable for operators who require continued exposure to new technologies and techniques and for referral physicians as a way to increase awareness of new technologies and their implications on patient care.
There is criticism, however, with respect to patient safety during a live broadcast: the operators may be disrupted by the camera; the large audience may stress the operator; and comments/interactive discussion during a complicated procedure may be distracting . While it is widely believed that patient safety is not compromised during a live broadcast, the procedure is under a time constraint, and the environment is entirely different from that of a non-transmitted procedure, so it is legitimate to question the outcomes and complication rates of live procedures. Interestingly, this question has never been studied prospectively, and the literature reports on only a small series of live-broadcast procedures and suggests no major concern with regard to safety. Others have raised ethical concerns with regard to patient consent, awareness of procedural risk during a live broadcast, and patient satisfaction . The additional educational value of live cases has also been challenged.
Professional surgical societies recommend against live case transmission, while subspecialty cardiology societies advocate for the potential educational benefits. A consensus document written by cardiovascular society representatives focused on patient safety during live cases but did not determine if the educational benefits of live case demonstrations outweigh any potential negative consequences .
The aim of the Transcatheter Aortic Valve Intervention-Live Transmission (VERITAS) Study is to assess the safety of patients treated with transcatheter aortic valve replacement (TAVR) during a live case or videotaped transmission as compared to those treated with TAVR without live or recorded transmission. It was hypothesized that the major complication rate for TAVR patients from the live case or videotaped transmission would be similar to that of patients treated without transmission, and that the procedural parameters would be similar between the groups.
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