BARCELONA, SPAIN — The growing population of nonagenarians can safely and effectively undergo transcatheter aortic-valve implantation (TAVI) for severe aortic stenosis, results of a registry study suggest[1].
Presented as a poster at the European Society of Cardiology (ESC) 2017 Congress, the observational “real-world” study of more than 800 patients treated over 7 years showed that, while there were increases in adverse outcomes in the immediate postoperative period, rates of stroke, all-cause death, and major adverse cardiac events (MACE) were almost identical at 2 years.
Dr Adriano Caixeta
Speaking at a press conference here, Dr Adriano Caixeta (Hospital Israelita Albert Einstein, São Paolo, Brazil) said that he and his colleagues were “surprised” that, despite being sicker than the other patients, nonagenarians had rates of all-cause mortality and MACE at 2 years that were “pretty much the same or similar.”
However, he pointed out that, as nonagenarians are underrepresented in clinical trials, “it’s hard to say” how many patients aged over 90 years of age can undergo TAVI safely and effectively and therefore how many could be considered for the procedure.
Asked how applicable the findings are to, for example, Europe or the US, Caixeta told theheart.org | Medscape Cardiology that his is a developing country and “the life expectancy in Brazil is only 70 years,” which is why only just over 10% of the patients in their registry were nonagenarians, compared with the 16% one would expect to see in a US population.
Consequently, he is looking forward to cooperating with both developing and developed countries to see whether or not their results will be repeated in nonagenarians treated with this kind of procedure.
Caixeta noted that “another very important point is regarding our valve,” as they used second-generation devices in their study, not the newer third-generation valves.
“Also we’ve been treating patients, in general, in Brazil with local anesthesia and conscious sedation,” he added, “so we are expecting even better results with nonagenarian patients in the future.”
“The life expectancy of newborn baby will be 85 years, at least in the Spanish population, and the expectancy of life of a person who already has 90 years of age is 5 or 6 years,” Dr Rosa Ana Hernandez Antolin (Universidad de Alcalá de Henares, Madrid, Spain), who was not involved in the study, told theheart.org | Medscape Cardiology.
She said that, therefore, “these patients have still some way to go” in life, and “so this is why we shouldn’t restrict elderly people from having these kinds of procedures.”
Consequently, for Hernandez Antolin, the study “is very interesting and highlights that these patients are still candidates for the procedure.”
Although TAVI is a well-established and standard treatment for the majority of patients with aortic stenosis, there is an ongoing debate as to whether the technique should be used in groups traditionally seen as very high risk, including nonagenarians.
To determine the early and long-term clinical outcomes of TAVI in this age group, the researchers studied 819 patients enrolled in the Brazilian TAVI Registry, who underwent the procedure for severe aortic stenosis between January 2008 and February 2015.
Of the patients, 735 were aged less than 90 years and 84 were nonagenarians. As expected, there was a significant difference in average age between the groups, at 80.12 years vs 92.45 years, respectively (P<0.001).
In addition, nonagenarians were significantly more likely than younger patients to have renal insufficiency, at 96.4% vs 74.7% (P<0.001), and the older age group had a significantly higher mean Society of Thoracic Surgeons scores, at 13.19 vs 9.87 among younger participants (P<0.001).
Older patients also had a significantly lower average body mass index than those aged less than 90 years, at 24.61 vs 26.49 (P=0.001), and a significantly higher Euro score, at 27.65 vs 19.67 (P<0.001).
There were, however, no significant echocardiographic findings between the two groups.
The types of prosthesis used in the sets of patients were also similar, with 69.0% of nonagenarians and 73.3% of younger patients receiving CoreValve (Medtronic) and the remaining patients in each group given the Sapien XT (Edwards Lifesciences) valve.
The patients were followed up for 5 years, at which time nonagenarians had, in line with expectations, higher rates of all-cause death, cardiovascular death, and major adverse cardiac events (MACE).
However, when the team focused on the first 2 years of follow-up, they found that rates of adverse outcomes were remarkably similar between the older and younger patients.
For example, rates of all-cause death at 30 days were 15.6% and 8.4% in nonagenarians and younger patients, respectively (P=0.03), rising to 20.9% and 21.8%, respectively, at 1 year (P=0.81), and 27.3% and 30.7%, respectively, at 2 years (P=0.95).
Stroke was recorded in 2.4% of nonagenarians and 4.0% of younger patients at 30 days (P=0.53), in 5.3% and 7.4% of patients, respectively, at 1 year (P=0.65), and in 5.3% and 8.5% of patients, respectively, at 2 years (P=0.76).
For MACE, the rate at 30 days among nonagenarians was 19.1% vs 12.0% in younger patients (P=0.06). MACE was then recorded in 27.0% of nonagenarians and 25.8% of younger patients at 1 year (P=0.48) and in 33.7% of older and 34.4% of younger patients at 2 years (P=0.64).
Overall, the hazard ratio (HR) for all-cause death among nonagenarians vs younger patients after 5 years of follow-up was 1.72 (95% CI 1.21–3.25, P=0.09). The HR for cardiovascular death was 1.99 (95% CI 1.25–5.02, P=0.03), while that for major bleeding was 0.83 (95% CI 0.21–3.20, P=0.62).
For stroke, the HR among nonagenarians vs younger patients at 5 years was 1.02 (95% CI 0.30–3.45, P=0.63), while the HR for MACE over the same time period was 1.37 (95% CI 0.87–2.39, P=0.71).
Caixeta concluded that, although nonagenarians experienced worse short-term outcomes than younger patients following TAVI, they had similar long-term clinical outcomes and that using TAVI to treat symptomatic severe aortic stenosis is this group is a “nonfutile approach.”
The authors declared no relevant financial relationships.
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