VERITAS: Live TAVR transmission safe when performed by high-volume operators
WASHINGTON — Live broadcasting of transcatheter aortic valve replacement performed by high-volume operators was found safe and resulted in similar rates of complications compared with nontransmitted cases, according to results of the VERITAS trial presented here.
“Live or taped transmission of TAVR procedures should be utilized for the introduction of technology and for initial training of the procedural techniques,” trial investigator Ron Waksman, MD, course chairman of the Cardiovascular Research Technologies, and of MedStar Washington Hospital Center, Washington, D.C., said during his presentation. “To ensure adequate exposure to new techniques and devices for TAVR, live case transmission of investigational devices should be utilized more frequently within the [investigational device exemption] studies to ensure transparency of new device techniques.”
For the VERITAS trial, Waksman and colleagues enrolled 42 live transmission or taped TAVR cases and matched them with a control group of TAVR cases that were not transmitted live or taped. They also enrolled 18 cases from a registry that were transmitted live or taped.
Patients who underwent TAVR were aged older than 18 years and received the Sapien valve (Edwards Lifesciences) via the transfemoral or transapical approach or the CoreValve (Medtronic) via the transfemoral approach.
According to Waksman, sites conducted a retrospective chart review to collect data for all case and control patients and matched control patients to the case patients by specified criteria. Several safety endpoints — including in-hospital death and post-procedural stroke — and procedural safety endpoints — including procedure time, fluoroscopy time and length of hospital stay — were examined in the trial.
Overall, patients had similar baseline demographics and medical history.
Intraprocedural complications were similar between all three groups, as were Valve Academic Research Consortium (VARC) complications, which included death (case, 2.4% vs. control, 2.4%), cardiac death (case, 0% vs. control, 2.4%) and stroke (case, 0% vs. control, 0%; P for all was nonsignificant). Additionally, all procedural variables, with the exception of procedure time (case, 130.2 ± 50.6 minutes vs. control, 100.6 ± 43.6 minutes; P=.006), were similar between the groups.
These data led Waksman to conclude that live transmissions of TAVR procedures, when performed by doctors who perform high volumes of cases, are safe and similar with respect to events as nontransmitted cases.
For more information:
Waksman R. iMPACT Trials Session 1. The impact of live case transmission on patient outcomes during transcatheter aortic valve replacement: results from the VERITAS study. Presented at: Cardiovascular Research Technologies; Feb. 23-26, 2013; Washington, D.C.
Disclosure: Waksman reported that the trial received partial grant support from the FDA.