The study looked at 704 patients who had a TAVR procedure between April 2002 and May 2011, following 378 of them for up to 10 years. In the 100 patients who survived for at least 5 years, there were 35 cases of valve degeneration, with a significant number showing deterioration between 5 and 7 years after TAVR implantation. The study’s authors estimated that the 8-year rate of degeneration was roughly 50%.
“Physicians performing [TAVR] in younger patients and in those expected to survive long after the procedure should be aware that the long-term rate of [transcatheter heart valve] degeneration is not negligible, at least for first-generation THV devices,” lead author Dr. Danny Dvir, of Vancouver’s St. Paul’s Hospital, said in prepared remarks. “Physicians must be mindful of the limitations of the THV they implant and whether patients can be safely treated by another transcatheter approach, such as valve-in-valve, if a THV fails years later.”
“This is extremely important data and addresses the concerns that many people had when transcatheter heart valve were introduced: Will they last as long as surgical bioprostheses? Can we therefore expand the indication to younger patients?” added Dr. Pieter Kappetein of Rotterdan’s Erasmus Medical Center. “Hopefully, the new generation of [TAVR] will last longer and there might also be a need for self-regenerating tissue-engineered heart valves. Expansion of [TAVR] indication should only take place in the confines of a randomized trial.”
The valves implanted in the study were all earlier versions of devices made by Edwards Lifesciences (NYSE:EW): The Sapien (50%), Sapien XT (36%) and Cribier-Edwards (14%). Leerink Partners analysts noted that the 2nd-generation Sapien XT showed a 50% lower rate of deterioration compared with the 1st-generation Sapien device, suggesting that the 3rd-generation Sapien 3 and Medtronic‘s (NYSE:MDT) CoreValve could show even lower rates of degeneration.
“Based on our conversations [with physicians from Germany, Holland and France], we believe poor TAVR durability as demonstrated in yesterday’s presentation is more noise than anything that will fundamentally impact near-to-medium term growth,” the Leerink analysts wrote. “While the surgeons believe TAVR may need longer-term durability data to drive rapid adoption in low risk patients – largely defined as 75 and younger by these physicians – the cardiologists believe industry will have this longer-term durability by the time low risk is a reality. Clearly this will be an issue to watch, as it is the surgeon’s last line of defense in preserving his surgical valve patient population. But – at least for now – this durability issue seems to us to be highly unproven and largely noise.
“At just 378 patients, the study was small relative to the 1,000+ randomized controlled trials looking at 1 and 2 year outcomes for EW’s Sapien 3 and MDT’s CoreValve,” they wrote. “Even the cardiac surgeons – one of whom expressed exceeding caution as it relates to TAVR in both intermediate and low risk based on yesterday’s presentation – noted that penetration into these less sick patient populations will depend on the clinical data from large randomized controlled trials, clinical guidelines, and patient preference. While the surgeons believe TAVR may need longer-term durability data to drive rapid adoption in low risk patients – largely defined as 75 and younger by these physicians – the cardiologists believe industry will have this longer-term durability by the time low risk is a reality. Clearly this will be an issue to watch, as it is the surgeon’s last line of defense in preserving his surgical valve patient population. But – at least for now – this durability issue seems to us to be highly unproven and largely noise.”
The news spooked investors into a selloff of EW shares, which are down -4.0% to $99.82 apiece since the study dropped May 17.
The post EuroPCR 2016: Study casts doubt on long-term TAVR durability appeared first on MassDevice.
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