Janarthanan Sathanathan (Center for Heart Valve Innovation, St Paul’s Hospital, Vancouver, Canada) and others report in Catheterization & Cardiovascular Interventions that the 10-year rate of bioprosthetic structural valve failure and valve failure was low in patients who had undergone transcatheter aortic valve implantation (TAVI) with an early-generation balloon-expandable device. They say that these findings provide “insights into the long-term performance of transcatheter heart valves”.
Sathanathan et al observe that when TAVI was first introduced, for inoperable and high-risk patients, “there was no expectation of 10-year survival, let alone the possibility of assessing late durability”. However, they add that as TAVI has become a more accepted therapy for lower-risk populations, the issue of durability has become a more pertinent issue. “While transcatheter heart valve durability to five to eight years appears favourable, the long-term performance of transcatheter heart valves ≥10 years is unknown,” they note. Therefore, the authors reviewed the rate of structural valve deterioration and bioprosthetic valve failure following TAVI with an early-generation valve.
Of 235 patients who underwent TAVI at the Center for Heart Valve Innovation (Vancouver, Canada) between 2005 and 2009, 19 patients were still alive at 10 years—including three patients who had undergone valve-in-valve TAVI during follow-up. The mean of age of these survivors was 78.2±11 years, 42.1% had a Society of Thoracic Surgeons (STS) score of >8%, 89.5% received a Sapien valve (Edwards Lifesciences) and 10.5% received a Cribier-Edwards valve. Overall, at 10-year follow-up, the mean age of patients was 88.5±11.2 years.
Of the total cohort, according to the authors, 15 patients had evidence of structural valve deterioration “with a cumulative incidence at 10-years at 6.5%”. “The rate of structural valve deterioration/bioprosthetic valve failure at four, six, eight, and 10 years was 0.4%, 1.7%, 4.7%, and 6.55, respectively,” Sathanathan et al explain. They add that the median time to develop structural valve deterioration/bioprosthetic valve failure was 6.7 years. Furthermore, nine patients had moderate structural valve deterioration and six had severe deterioration. Of the six cases of severe deterioration, one was identified at the 10-year follow-up echocardiogram. The deterioration was managed with redo TAVI using a Sapien 3 valve. “At 30-day follow-up, the patient was symptomatically well with New York Heart Association (NYA) class I symptoms and an echocardiogram that demonstrated a mean gradient of 10mmHg,” Sathanathan et al comment.
The authors note that their findings provide insights into the long-term performance of transcatheter heart valves, but state that “patient and device factors must be considered when interpreting these results”. “Although the long-term transcatheter heart valve performance documented here is promising, poor late survival due to comorbidities does not allow for speculation in the larger group as a whole,” they comment. Sathanathan et al also make the observation that the valves reviewed in their study are “not identical to currently available balloon expandable frames of today”. “Ultimately, the performance of each transcatheter heart valve design and iteration must be assessed individually,” they conclude.
John Webb (Center for Heart Valve Innovation, St Paul’s Hospital, Vancouver, Canada) told Cardiovascular News: “We now know that these newer transcatheter valves can last as long as surgical valves. The choice between transcatheter and surgical valve replacement should be based on the other factors important to an individual.”