News | May 13, 2013

VERITAS Trial Confirms Safety of Live Transmission of TAVR Cases

Live Transmission of TAVR Cases Safety SCAI 2013 Scientific Sessions

May 13, 2013 — Live demonstration, transmission or recording of transcatheter aortic valve replacement (TAVR) has been found feasible and safe, even for the typically high-risk patients who undergo the procedure. Results of the VERITAS late-breaking clinical trial, presented at the SCAI 2013 Scientific Sessions, confirmed via comparison of on- and off-camera case studies that recording procedures did not pose any additional risk or complications to patients. 

The risk and value of live case demonstrations as a tool for physician education has been the subject of debate for some time. Proponents of broadcast or recorded procedures say such education provides valuable insights, helping train physicians in new technology and sharpening their awareness of the intricacies of specific techniques. Some medical societies, however, now discourage and have even considered banning live transmission of cardiovascular procedures due to questions about ethics and patient safety, especially for technologies considered to be high-risk, such as cardiac surgery or for the use of investigational devices. In 2010, several medical societies, including SCAI, published an expert consensus document, stating that data were insufficient to properly assess the risk presented by live dissemination of cardiothoracic surgery and interventions.

The VERITAS trial was designed to assess the safety of transmitting live TAVR cases. TAVR is a minimally invasive procedure approved in late 2011 for marketing in the United States in patients who have severe aortic valve stenosis and are not eligible for open-heart surgical aortic valve replacement. Ron Waksman, M.D., Washington Hospital Center, Washington, D.C., presented the VERITAS results during a late-breaking clinical-trial session here at SCAI.

Researchers recruited 64 patients across six different centers worldwide to undergo live or recorded TAVR, of which 46 patients were matched to a control patient who had almost identical procedures without live or recorded transmission. Matched subjects were of similar age, averaging 83 years; and they had similar valve types, which included two devices: the Edwards Sapien Transcatheter Heart Valve and a device approved for marketing in Europe called the Medtronic CoreValve Transcatheter Aortic Valve. Researchers also matched minimally invasive arterial access sites, either transfemorally (through a small incision in the femoral artery) or transapically (directly through the heart muscle wall without invasive surgery). In both groups, access was guided by catheter-based instruments and advanced imaging.

In VERITAS, patients undergoing live transmitted or recorded treatment experienced longer procedure times, about 129 minutes, versus approximately 101 minutes for matched controls not on camera (p=0.007). Final positioning of the aortic valve device was successful in 100 percent of both the live case and control patients. Four patients in the live or recorded cases group (8.7%) required additional implantation compared with one patient in the non-transmitted group (2.2%). Valve migration or obstruction was not experienced by either group.

Resulting complications were similar in both demonstration and control groups. The rates of death and end-organ failure were the same in both groups (2.2%, p=1). The live transmission group was associated with a lower percentage of complications than the control group for acute kidney injury (4.3% to 2.2%, p=1), post valve heart attack (2.2% to 0%, p=1) and of major and minor vascular complications (6.5% to 13%, p=0.485 and 13% to 23.9%, p=0.283, respectively). None of these variations were found to be statistically significant.

Based on these results, Waksman recommended that the medical community should renew its confidence in live case transmission and conduct it more frequently. He cautioned that live disseminations should be performed only by experienced, high-volume operators.

“Live case transmission is a very effective teaching tool that allows physicians to be informed in a very clear demonstration about degree of disease, complexity of cases and everything that the procedure entails,” Waksman said. “Our recommendation is that live cases should continue as a part of physician education.”

“Transparency is very important in these procedures,” he added. “If you don’t perform them live, you don’t present all of the details and you don’t have complete transparency, which is the primary benefit and power of live case transmissions for our community of physicians and for the public.”

Waksman indicated that further studies may be warranted with larger sample sizes. The VERITAS study was partially supported by the U.S. Food and Drug Administration (FDA).

For more information:

Related Content

Societies Issue New Performance and Quality Measures for Treating Patients with Heart Attack
News | Cath Lab| October 17, 2017
The American College of Cardiology and the American Heart Association recently released updated clinical performance...
First Patient Enrolled in U.S. Arm of ALIVE Pivotal Heart Failure Trial
News | Heart Failure| October 17, 2017
October 17, 2017 — BioVentrix Inc. recently announced enrollment of the first patient in the U.S.
Appropriate Use Criteria Published for Valvular Heart Disease Imaging Tests
News | Clinical Decision Support| October 16, 2017
The American College of Cardiology (ACC), along with several partnering societies, recently released appropriate use...
Dee Dee Wang runs Henry Ford Hospital's 3D printing lab for its complex structural heart cardiology program.

Dee Dee Wang, M.D., runs Henry Ford Hospital's 3-D printing lab that supports its complex structural heart program.

Feature | 3-D Printing| October 13, 2017 | Dave Fornell
Three-dimensional (3-D) printed anatomic models created from a patient’s computed tomography (CT), magnetic resonance...
Low Mortality and Stroke Risks Displayed for Minimally Invasive Aortic Valve Replacements
News | Heart Valve Technology| October 11, 2017
An analysis of more than 1,000 minimally invasive aortic valve replacements and more than 400 additional associated...
Videos | Chronic Total Occlusion (CTO)| October 09, 2017
Bill Lombardi, M.D., director of complex coronary artery interventions at the University of Washington, discusses the
BTG Acquires Roxwood Medical
News | Business| October 05, 2017
BTG plc announced it has acquired Roxwood Medical, provider of advanced cardiovascular specialty catheters used in the...
TVA Medical Receives CE Mark for Next-Generation EverlinQ 4 EndoAVF System
News | Vascular Access| October 04, 2017
TVA Medical Inc. announced that its everlinQ 4 endoAVF System has received CE Mark in the European Union. The...
Reflow Medical's Wingman Crossing Catheter Receives FDA Clearance for Coronary Indication
News | Catheters| October 02, 2017
October 2, 2017 — Reflow Medical Inc. announced that the company has received 510(k) clearance from the U.S.
Medtronic Announces Post-Market Study for CoreValve Evolut Pro System
News | Heart Valve Technology| October 02, 2017
Medtronic plc recently announced a new post-market clinical study to evaluate its CoreValve Evolut Pro valve in...
Overlay Init