Discussions on transcatheter aortic valve replacement (TAVR) at last week’s Transcatheter Valve Therapies (TVT) meeting in Chicago were upbeat on the prospect of landing an intermediate-risk indication later this year, despite turbulence around reports of complications and questions of long-term success.
The good news: Back in April, PARTNER 2 investigators suggested that TAVR is non-inferior to surgery in a lower risk population. The bad news: a separate study soon emerged describing the long-term degeneration of TAVR valves.
Those worrying findings from May’s EuroPCR conference still resonated with attendees of TVT, where physicians discussed the issue of durability.
“It re-emphasizes the need for long-term data,” John Carroll, MD, of University of Colorado in Aurora, said in an interview. “We should not use TAVR broadly in low risk patients with decades of life expectancy until we have durability data … We know from the surgical literature what the rate of deterioration is for specific valves. We have to apply the same yardstick and method to TAVR,” he added, which will be “a slow process from a regulatory standpoint.”
TAVR thrombosis rates at two European centers were reported by Azeem Latib, MB BCh, — 1.4% (15 of 1,057 patients) at his institution, Italy’s San Raffaele Hospital, and 2.8% at a center in Bad Segeberg, Germany. The rates at his institution varied from 0.3% for CoreValve to 1.6% for Direct Flow and 1.9% for Sapien/Sapien XT/S3 up to 4.7% for Lotus.
Latib suggested that leaflet thrombosis is still under-recognized and under-diagnosed, with a variable onset time ranging from 3 days to 3 years. For now, multi-slice CT is the best modality for its diagnosis but shouldn’t be done routinely if there aren’t reasons for suspicion of valve dysfunction or thromboembolism, he suggested.
If asymptomatic leaflet thrombosis is confirmed, then what? Raj Makkar, MD, of Cedars-Sinai Medical Center in Los Angeles, who first reported the problem, noted that treatment with warfarin carries a nontrivial bleeding risk and that it’s unclear what to do with TAVR patients with that contraindication.
Sharing concerns about infective endocarditis in TAVR recipients was Bernard Prendergast, MD, of Guy’s and St. Thomas’ Hospitals in London. He cited 1-year mortality rates of 38% to 75% in TAVR patients who develop infective endocarditis.
Prendergast noted that under-reporting and diagnosing difficulties remain challenges in fighting infection, as do the limited recommendations for antibiotic prophylaxis.
The silver lining in the cloud? Infective endocarditis does not seem to be any more common after TAVR than surgery, he noted, while suggesting more aggressive treatment algorithms.