Key result
TAVI for severe AS in nonagenarians yields mortality rates similar to younger patients.
Why the study?
Does TAVI improve mortality and quality of life in nonagenarians with severe aortic stenosis?
Does TAVI improve mortality and quality of life in nonagenarians with severe aortic stenosis?
TAVI is a viable and effective treatment option for nonagenarians with severe aortic stenosis, offering similar mortality and quality of life improvements as in younger patients, provided careful patient selection is performed.
Supports individualized TAVI decisions in nonagenarians; leaves open confirmation from prospective randomized trials.
Introduction The prevalence of cardiovascular diseases increases as the general population ages, presenting the cardiologist with ‘complex’ elderly patients, in whom frailty, comorbidities and disabilities complicate diagnostic and therapeutic choices. Aortic stenosis is the main cause of morbidity and mortality in the elderly, and it is appraised that, in patients over 75 years of age, more than 4.6% are affected with severe aortic stenosis. It is well known that after symptoms onset the 1- and 5-year survival is 60 and 32%, respectively.1 Nonetheless, in the past a significant proportion of these patients received only medical treatment, just because of the advanced age and the comorbidities. During the last decade, the introduction of trans-catheter aortic valve implantation (TAVI) modified the therapeutic approach to patients inoperable and at too high surgical risk (PARTNER 1),2 becoming in a few years a valuable alternative to surgical treatment. The multifactorial increase in life expectancy is such that an ever-increasing number of elderly with severe aortic stenosis are actually in their 90s, creating the need for a therapeutic strategy specifically designed for them. Several studies demonstrated the feasibility and safety of TAVI as treatment for severe aortic stenosis in the nonagenarians.3–6 The question then arises as to which patients should be recommended for TAVI, or percutaneous aortic valvuloplasty (PAV), or optimal medical therapy (OMT). Considering that the prevalence of patients over 90 is limited in the studies presently available, it is questionable whether the surgical risk score (STS score and EuroScore II) should be used for the selection of the best available treatment (TAVI versus PAV versus OMT). In fact, these risk assessment algorithms do not include some factors, often crucial, in the therapeutic decision for these patients, such as frailty, senile dementia, concurrent clinical problems, the patient's psychological status (willingness to live), and his/her level of activity and involvement. In addition to these factors, the diagnostic pre-TAVI screening (iliac-femoral and cardiac CT angiogram and/or cardiac MRI and transesophageal echography) is paramount for a good outcome of the procedure. It is likely that the feasibility of TAVI in nonagenarians will increase in the next few years with the development of lower profile and more performing devices, which could contribute to make this the procedure of choice in these patients also. Surgical aortic valve replacement The risk assessment scores are objective, but have limitations in their applicability in the individual patient, such that a personalized approach is more suitable. Each variable has its weight on the final score, but in clinical practice this weight could be misinterpreted. An example is the patient with exactly the same clinical characteristics who has two completely different Euroscore II whether 80 or 90 years old: 3.66 and 4.80%, respectively. The operative risk is substantially different. Age has an important weight on the total score, so that the immediate surgical risk increases with age (the operation itself, the extracorporeal circulation, the general anesthesia, etc.), as well as the postoperative risk (prolonged bed ridden). Accordingly, surgical aortic valve replacement is rarely if ever considered in patients over 90 years of age (and now also for those over 80 years of age). Percutaneous aortic valvuloplasty PAV, one of the available treatments for symptomatic aortic stenosis, was introduced in 1986 by Cribier7 for surgical inoperable or too high-risk patients. This is a simple procedure, safe and effective, but with a high rate of recurrent (>80%) stenosis after 6–12 months, and with a limited impact on survival and disease progression.8 In octogenarians and nonagenarians the rate of major adverse events is around 15% per year, and the mortality 1–2%.9–10 PAV is then used as a palliative measure, for patients with severe aortic stenosis inoperable both surgically and with TAVI. Presently, another use for PAV is as a bridge before TAVI. In patients not suitable for TAVI (advanced heart failure, too frail or malnourished, or with life expectancy of <1 year), PAV as a bridge to TAVI could provide for hemodynamic stabilization, with an improvement is the general health status, possibly leading to positive reevaluation for TAVI.11 Trans-catheter aortic valve implantation and the selection process for nonagenarians There is still uncertainty as to the individual benefit of TAVI in nonagenarians. To appropriately select patients for this procedure, two aspects seems to take center stage, also considering the cost/benefit ratio of the procedure in an era of cost containment demands. Quality of life: Several observational studies reported a significant improvement in NYHA class of patients older than 85 years after TAVI.12,13 Most of the patients moved from an NYHA class III or IV to class I or II. Furthermore, the exercise capacity also improved, as assessed by the 6-minute walking test (6MWT).14 The PARTNER-EU registry reported that 82% of the patients after TAVI experienced a clear improvement in their NYHA class (≈87% of the patients were NYHA class I or II after the procedure).15 The patients’ quality of life was assessed with several clinical questionnaires like the Short Form 36 (SF-36), Kansas City Cardiomyopathy Questionnaire (KCCQ), EuroQuol-5D (EQ-5D), and the Duke Activity Status Index. The PARTNER-EU registry reported a substantial improvement in 73% of the patients evaluated with the KCCQ questionnaire. Concepts expressed by QALY (Quality-Adjusted Life Year) and DALY (Disability-Adjusted Life Year)16–18 (years of life in good health and years of life in disability, respectively) are difficult to extend to nonagenarians, because calculation of life expectancy over 90 years is uncertain. Hence, the necessity for new studies, in addition to the promising data of the Partner Trial,2 which only addressed patients with a mean age less than 90 years. Frailty: Several studies investigated the effect of various frailty indices on the outcome of patients after TAVI. Despite the fact that these measures were heterogeneous, there was a clear increase in the mortality rate and hospital stay as compared with patients thought to be nonfrail.14,18–20 Until 2013, there had been no common agreed upon definition of frailty; since then, a consensus document has been released defining physical frailty, and considering not only the physical impairment (loss of muscular mass, strength and weight), the decrease endurance, lack of balance and mobility, slowing of activities, and inactivity, but also the decreased cognitive, psychological and social functions.21 Frailty could be physical, psychological or both, and is a dynamic condition which could potentially improve or worsen with time. Results of TAVI (mortality and complications) in nonagenarians are variable and not always comparable. This procedure in patients over 90 years should be considered more for its impact on the quality rather than the quantity of life. One of the most recent studies included a cohort of nonagenarians extrapolated from the TVT registry,3 and analyzed the outcome of 3773 patients older than 90 years (15.7% of the registry total population) comparing them to patients less than 90 years of age. Mortality, both at 30 days and at 1 year, was higher for nonagenarians. These patients had a higher STS score (age carries a considerable weight in determining the total score), but the mortality adjusted for life expectancy was similar among the two groups. There were also no differences in the rate of stroke and myocardial infarction, and both groups experienced an improved quality of life at 1 year. Accordingly, it can be inferred that older patients had a longer recovery after TAVI, but after 1 year both groups enjoyed a similar improvement in quality of life. The FRANCE-2 registry,4 which preceded the TVT registry, analyzed the results of 2254 patients after TAVI divided in three groups according to the patients age [80–84 years (867 patients); 85–89 years (1064 patients); >90 years (349 patients)]. As far as mortality and complications the three groups had similar results. Unfortunately, the study did not consider quality of life changes pre and postprocedure. Recently, Escárcega et al.22 reported the results at 30 days and 1 year of 654 patients (n = 107, >90 years and n = 547, <90 years) after TAVI, outlining the factors leading to a higher mortality for nonagenarians at 1 year: residual, more than moderate, post TAVI aortic incompetence (HR 6.87, 95% CI 2.32–20.3, P = 0.001), and peripheral arterial disease (HR 2.35, 95% CI 1.03–5.38, P = 0.042). The 30-day (12.1% versus 7.1%, P = 0.07) and 1-year mortality (25 versus 21%, P = 0.35) was similar among the groups. The authors inferred that age alone should not discriminate against the procedure, because the nonagenarians were expected to have as good results after TAVI as their younger counterparts. Accordingly, the procedure is a valid option for the treatment of severe aortic stenosis regardless of the age of the patient. Abramowitz et al.5 found that mortality rates at 1 month and 1 year were similar for patients less than 90 or more than 90 years of age, likely because patients less than 90 had more baseline risk factors, even though they had a lower STS and frailty score, and lower rate of renal insufficiency and atrial fibrillation. Nonagenarians had a higher rate of peripheral vascular complications, but similar procedural success rates, and 30 days’ and 6 months’ mortality (96 versus 100%; P = 0.58, 6 versus 15%; P = 0.22; 14 versus 27%; P = 0.14, respectively). Lastly, at the 6-month follow-up the clinical status of the two groups was similar (89 versus 84% in class NYHA II or inferior, P = 0.68), as well as the cumulative survival (mean 13.4 ± 8.0 months, follow-up). In nonagenarians it is of interest to evaluate the results of TAVI also considering the approach to the procedure. A subanalysis of the PARTNER I study23 compared the results in patients over 90 years (n = 531) who underwent TAVI via the trans-femoral (n = 329) or transapical (n = 202) approach. Mortality at 30 days was 4% and 12%, and at 3 years 48 and 54%, respectively (P-log range <0.005). Accordingly, the trans-femoral approach seems to be better suited for nonagenarians. Conclusion TAVI is a well tolerated and effective treatment regardless of the age of the patient. The results are promising and mortality in nonagenarians is similar to the younger counterparts. The indication for this treatment in patients over 90 years of age should be reached after a careful comprehensive and individualized evaluation, which includes the assessment by the heart team (clinical and interventional cardiologist, anesthesiologist and cardiac surgeon), and the surgical and frailty score. PAV is an alternative to TAVI, and when it induces a clear improvement in the patient's clinical conditions, it could constitute an intermediate step toward TAVI. Finally, it is important to recognize that when life expectancy is limited, a procedure, such as PAV or TAVI, could represent mere therapeutic obstinacy. A close discussion with the patient's family so as to share the reasons for recommending the sole medical treatment is then paramount. Acknowledgements Conflicts of interest There are no conflicts of interest.
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Pilato et al. (2018) studied this question. Transcatheter aortic valve implantation is an effective treatment for severe aortic stenosis in nonagenarians, demonstrating mortality rates similar to those of younger patients.
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