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

Ancora Heart Announces Positive Interim Analysis of AccuCinch Ventricular Repair System for Heart Failure
News | Heart Valve Technology | September 24, 2018
Ancora Heart Inc. announced positive clinical data from the company’s recently expanded U.S. early feasibility study...
Medtronic Announces TAVR Study of Aortic Stenosis Patients With Bicuspid Valves
News | Heart Valve Technology | September 19, 2018
The U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) to initiate a new...
4C Medical's AltaValve First-in-Human Experience to be Presented at TCT 2018
News | Heart Valve Technology | September 17, 2018
September 17, 2018 — 4C Medical Technologies Inc.
Gore Acquires Pipeline Medical Technologies Inc.
News | Heart Valve Technology | September 06, 2018
W. L. Gore & Associates Inc. (Gore) announced the acquisition of Pipeline Medical Technologies Inc., a privately...
The Edwards Lifesciences Cardioband Tricuspid Valve Reconstruction System received the European CE mark approval in May.

The Edwards Cardioband Tricuspid Valve Reconstruction System received the European CE mark approval in May, becoming the first transcatheter tricuspid repair device to be approved in the world.

Feature | Heart Valve Technology | August 21, 2018 | Jeff Zagoudis
The tricuspid valve has been dubbed “the forgotten valve” by many practitioners in the interventional cardiology spac
Earlier Intervention for Mitral Valve Disease May Lead to Improved Outcomes
News | Heart Valve Technology | July 26, 2018
The number of patients undergoing mitral valve operations are at an all-time high, and new research suggests many...
The Abbott Tendyne transcatheter mitral valve replacement (TMVR) system  is being tested in the SUMMIT Trial.

The Abbott Tendyne transcatheter mitral valve replacement (TMVR) system.

Feature | Heart Valve Technology | July 26, 2018
July 26, 2018 — The pivotal clinical study in the U.S.
A CoreValve TAVR valve seen in a CT scan looking down from the aortic arch into the left ventricle using reconstruction software from TeraRecon.

A CoreValve TAVR valve seen in a CT scan looking down from the aortic arch into the left ventricle using reconstruction software from TeraRecon.

Feature | Heart Valve Technology | July 26, 2018
July 26, 2018 — A new multi-societal expert consensus document has been released that summarizes the position of thes
Abbott Receives FDA Approval for Third-Generation MitraClip Device
Technology | Heart Valve Technology | July 18, 2018
July 18, 2018 — Abbott announced it received approval from the U.S.
Videos | Heart Valve Technology | July 18, 2018
Jonathon Leipsic, M.D., FSCCT, professor of radiology and cardiology at the University of British Columbia, Vancouver
Overlay Init