Severe aortic valve stenosis (AS) is the most common valvular disease in the elderly (1). Current therapeutic options are primarily based on surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI). SAVR allows implementation of either a mechanical or biological valve prosthesis, while TAVI is feasible only with a biological prosthesis. The decision on which strategy to apply depends on several factors, with patient age and the presence of comorbidities being the primary considerations. Initially, TAVI was preferred in elderly (>80 years) patients at high surgical risk; presently, patients at low (2, 3) or intermediate (4) surgical risk are considered suitable for TAVI.

The majority of studies comparing SAVR and TAVI have focused on outcome measures related to mortality and major complications (such as stroke, heart failure, and re-hospitalization). From an indications viewpoint, there is presently a discrepancy between the European (5) and US (6) guidelines for the management of AS: European guidelines recommend SAVR for patients <70 years in the absence of major comorbidities; conversely, US guidelines suggest SAVR for patients <65 years. Given this discrepancy and considering the differences between SAVR and TAVI in terms of costs, resource utilization, and invasiveness, it is reasonable to include assessment of health-related quality of life (HRQL) in the decision-making process when deciding whether to refer a patient to SAVR or TAVI. This consideration is especially important in patients with limited life expectancy, for whom achieving increased HRQL within a reasonable postprocedural timeframe is mandatory. Data on HRQL are available but limited to studies with relatively short follow-up durations (3, 7–9), selected patient populations (3, 7, 10), and small sample sizes (7, 9).

In 2018, under the auspices of the Italian Ministry of Health and within the Cardiac Network of the Italian Clinical Research Hospitals (IRCCS), data on SAVR and TAVI procedures began to be collected in a national registry (OUTcomes evaluation of current therapeutic STrategies for severe Aortic valve steNosis and the ageING population in ITALY: OUTSTANDING-ITALY). The purpose of the OUTSTANDING-ITALY registry is to prospectively collect data on SAVR and TAVI procedures to offer a real-world assessment of procedural outcomes. Within this registry, several institutions collected data on HRQL and cognitive function to test the hypothesis that the patient-reported outcome (PRO) of HRQL does not differ between SAVR and TAVI at long-term follow-up. A secondary endpoint was to verify the hypothesis that early cognitive impairment after SAVR or TAVI procedures may constitute a risk factor for subsequent worsening in the mental component of HRQL.

All patients were enrolled prospectively according to the study design of the OUTSTANDING-ITALY registry, which is funded by the Italian Ministry of Health. The study was approved by the local ethics committee of San Raffaele Hospital (OSR 14/12/2017, protocol number 298/2017) and subsequently amended to include the assessment of neurocognitive function. All patients provided written informed consent for participation.

Overall, 806 patients underwent a preprocedural assessment of HRQL between September 18, 2018 and November 24, 2024. Of this patient population, 306 patients failed to complete any of the HRQL follow-up assessments after discharge from the hospital. Patients lost to follow-up included 220 in the TAVI group (42%) and 86 in the SAVR group (31%). The final study population therefore comprised 500 patients (179 SAVR and 321 TAVI), whose characteristics are reported in Table 1. As expected, patients in the TAVI group exhibited a significantly more severe profile than those in the SAVR, including older age, lower left ventricular ejection fraction, and a higher prevalence of risk conditions such as prior cerebrovascular accident and prior vascular or percutaneous interventions. HRQL was significantly (P = 0.001) worse in the physical domain among TAVI patients, whereas no differences were observed in the mental domain.

The main results of our study are as follows: a.

At 1 year after the procedure, no differences were observed in HRQL between SAVR and TAVI in both the mental and physical domains, with similar proportions of patients showing improvement, no change, or deterioration. In both groups, the incidence of worsening was higher for the mental component than for the physical component of HRQL.

Previous studies have addressed changes in HRQL after SAVR and TAVI procedures. Amonn and colleagues (7) examined a selected population of high-risk patients undergoing transapical TAVI compared with those receiving SAVR, with treatment allocation decided by the heart team. HRQL was assessed before treatment and at a mean follow-up of 15 months (with a high standard deviation of 10 months). One hundred patients completed follow-up, and no differences were observed between groups in terms of mental health and other scales of the SF-36; however, the general health subscale was significantly lower in the TAVI group. Given the large difference in baseline conditions, this difference was no longer significant after adjustment for potential confounders. Surman and colleagues (8) investigated three groups of patients undergoing SAVR, TAVI, or coronary surgery, for a total of 331patients consecutively enrolled at a single institution. At 12-month follow-up, no differences in HRQL were found among the groups. Tokarek and colleagues (9) conducted a prospective study including 173 patients divided into four groups: SAVR (via sternotomy, mini-sternotomy, or mini-thoracotomy) and TAVI. Allocation to TAVI or SAVR was based on clinical decision-making. At 12-month follow-up, HRQL was significantly better in the TAVI group compared with all SAVR subgroups. Baron and colleagues (3) analyzed 1,000 low-risk patients randomized to TAVI or SAVR using the Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ), the SF-36, and the EuroQoL instruments. Follow-up evaluations at 1, 6, and 12 months showed a higher rate of excellent outcomes (survival without a significant decline in quality of life) in the TAVI arm. Finally, the most important study (10) was a randomized controlled trial that included 2,032 patients and had a follow-up period of 5 years. In this trial, quality of life (assessed using the KCCQ) did not differ significantly between SAVR and TAVI at 5-year follow-up or at any intermediate time point.

Our results are in line with these previous studies with regard to the mental component of HRQL; conversely, we observed a higher rate of worsening of the physical component in the TAVI group. Various possible interpretations may account for this difference. a.

All previous studies have addressed changes in HRQL using a continuous variable (points). Conversely, we applied the RCI, a well-validated tool often used in psychological studies to determine the clinical relevance of changes. This dichotomization, based on an objective statistical criterion, allowed us to perform adequate analyses based on the cumulative risk of HRQL worsening and to account for the possibility that worsening might be transient. Actually, this is what happened to the SAVR group, which had a recovery rate almost twice that of the TAVI group. As a result, despite similar rates of events at 12 months, the cumulative risk was significantly lower in the SAVR group. It could be argued that, years after the procedure, TAVI patients might have experienced the effects of older age as a determinant of a greater decrease in HRQL in the physical domain. However, even in a propensity-matched analysis in which both groups had the same age at the time of procedure, the results obtained in the overall patient population were confirmed.

An additional finding of our study is that patients who experience early cognitive deterioration are more likely to develop worsening of the mental component of HRQL at 1-year follow-up compared with those without cognitive deterioration. The present study was not designed to address the role of SAVR and TAVI in determining cognitive dysfunction. Briefly, SAVR has been associated with air micro-embolism and the deleterious effects of cardiopulmonary bypass, whereas TAVI is associated with embolization of calcium debris. These mechanisms have already been addressed in a previous study (14). A potentially important consequence of our finding is that patients with neurocognitive dysfunction may benefit from targeted neurocognitive rehabilitation aimed at preventing long-term, probably irreversible worsening of the mental component of HRQL. Therefore, a routine cognitive assessment may be considered for patients undergoing both SAVR and TAVI. Notably, the relationship between early cognitive dysfunction and worsening of the SF-12 MCS at 1 year remains unaffected by the type of procedure (SAVR or TAVI).

There are limitations in our study. An important one is the proportion of patients lost to follow-up, which was 38%. However, loss to follow-up proportions of 30% are quite common in non-randomized studies comparing SAVR and TAVI (7). Notably, the proportion of patients lost to follow-up was higher in the TAVI group, probably due to the older age in this group. A second limitation is the relatively low sample size of the subgroup receiving both MOCA and SF-12 after the first year of follow-up. The propensity matching method may suffer from the common problem of missing variables, despite 23 variables being considered. The strength of our study lies in the assessment of the clinical relevance of changes in HRQL and neurocognitive function using an objective and well-validated tool (RCI).

In conclusion, our study challenges the concept of interchangeability between SAVR and TAVI and highlights the importance of life expectancy in the decision-making process. Extending the observation period beyond 1 year appears essential to reveal the potential long-term effects of one procedure compared to the other. Therefore, the more restrictive European approach, particularly with respect to age thresholds for referral of patients to TAVI, presently appears more adequate than the more liberal strategy advocated by US guidelines.