The transition of transcatheter aortic valve replacement (TAVR) from a procedure performed at an initial 17 clinical trial sites with highly trained physicians to almost 250 facilities in the U.S. appears to be going smoothly, the registry leaders reported in the Nov. 20 issue of JAMA.
The Centers for Medicare & Medicaid Services requires TAVR centers to participate in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry in order to receive reimbursement for procedures on inoperable and high-risk patients with severe aortic stenosis who undergo TAVR. The determination followed the FDA’s approval of the Sapien valve (Edwards Lifesciences) for TAVR in inoperable patients in November 2011 and for high-risk patients in September 2012, based on results from the pivotal PARTNER Part A and B trial.
Broadening the opportunity for clinical practices to perform this complex procedure beyond operators and sites that followed a trial protocol raised concerns about safety and effectiveness. The registry group, with Michael J. Mack, MD, of the Heart Hospital Baylor Plano in Texas as lead author, evaluated data collected in the registry to determine all-cause mortality and stroke rates since FDA approval. They reported trends through May 2013.
The analysis included 7,710 procedures in 224 hospitals that provided full data. The median age of patients was 84 years and 51 percent were men. Twenty percent of patients were considered inoperable and the rest high-risk, with an STS predicted risk of operative mortality score of 7 percent.
Most cases used transfemoral access (64 percent), followed by transapical (29 percent) and other (7 percent). More than a quarter of inoperable cases involved a nonfemoral access approach, which Mack et al noted was off-label. The device success rate was 92 percent.
The in-hospital mortality rate was 5.5 percent. In-hospital rates of complications ranged from 2 percent for stroke to 6.4 percent for major vascular injury and 3.5 percent for major bleeding. Six percent of patients experienced new-onset atrial fibrillation and 6.6 percent needed a new pacemaker or implantable cardioverter-defibrillator. Patients deemed inoperable or with nontransfemoral access had a higher incidence of adverse events.
The median hospital length of stay was six days.
Fifty-one percent of hospitals provided sufficient 30-day outcomes. Their data showed a mortality rate of 7.6 percent, with 52 percent due to noncardiac causes. The 30-day stroke rate was 2.8 percent. Patients showed a significant improvement in heart function.
The researchers found no difference in mortality outcomes for hospitals that reported less complete follow-up data.
“[P]ostapproval commercial introduction of this new technology with an early-generation device has yielded success rates and complication patterns that are similar to those documented in carefully performed randomized trials,” Mack et al wrote. The results also are in line with findings in international registries, they added.
They credited sharing of knowledge about the devices and procedures through international exchanges as well as help from experienced U.S. investigators for shortening the learning curve at newer sites. Device manufacturers have played a role in educating operators and facilities, too. Patients in the analysis also tended to have a lower risk profile than the PARTNER high-risk cohort.