More Than 1 in 10 Patients in US TAVR Registry Treated Off-Label
More than 1 in 10 US patients have undergone TAVR for an off-label indication since the first devices were approved for use, new data show. These patients—all of whom had at least 1 condition that would have excluded them from participating in the pivotal RCTs—appear to have a higher risk of death within the first 30 days but similar mortality at 1 year vs those treated on-label.
Ravi Hira, MD, of University of Washington, Seattle, and colleagues presented their analysis of the STS/ACC Transcatheter Valve Therapy (TVT) Registry as a poster at the American Heart Association 2015 Scientific Sessions.
“Even though these patients have not been studied in the past, it seems like they have reasonable outcomes,” Hira told TCTMD. “These patients need to be evaluated before … commercial use, but it seems that they stand to benefit and their results appear to be on par with the on-label indications.”
Almost 24,000 patients from 328 centers were enrolled in the TVT registry between November 2011 and September 2014. Among them, 2682 (11.2%) were found to have received TAVR off-label, defined as a procedure in a patient with bicuspid or unicuspid valve, failing bioprosthetic aortic valve, moderate aortic stenosis, severe mitral or aortic regurgitation, or subaortic stenosis. With the exception of failing bioprosthetic valves, these are all listed in the label as conditions for which the device has not been tested.
In the past year, both of the TAVR devices commercially available in the United States have been granted an expanded indication that permits their use for valve-in-valve procedures. These cases, however, represented just 303 (1.3%) of the off-label implants in the data-set, Hira clarified, adding that he and his co-investigators are currently redoing their analysis with the valve-in-valve cases omitted.
According to investigators, severe aortic or mitral regurgitation were the most common off-label criteria, seen in 71.4% of the off-label group. People treated off-label were more likely to be younger, male, receive care in urban teaching hospitals with higher TAVR volumes, have higher STS scores than on-label patients, and be less likely to have elective procedures.
Hira et al then linked patient outcomes with mortality data from the Centers for Medicare & Medicaid Services, available for 15,394 patients. They report that at 30 days, mortality was higher in the off-label group than the on-label group (7.7% vs 6.2%; P = .02). At 1 year, however, mortality, ranging from 22 to 24%, did not differ between groups.
Hira said he and his colleagues have not yet looked at whether outcomes were better or worse depending on the specific off-label condition. “I think in general there might be some patients with a particular off-label indication who do much worse, and other patients with a particular off-label use who do much better, so teasing that out is what we’re in the process of doing right now,” he commented.
Hira RS, Virani SS, Vemulapalli S, et al. Trends, predictors, and outcomes of off-label use of transcatheter aortic valve replacement (TAVR). Presented at: American Heart Association Scientific Sessions 2015; November 8, 2015; Orlando, FL.
- The study was supported in part by the ACCF NCDR registry and the STS National Database.
- Hira reports no relevant disclosures.