Abstract

Transcatheter aortic valve implantation (TAVI) is a tremendous therapeutic advance for patients with severe aortic stenosis and high-surgical risk. Since TAVI-treated patients are elderly with multiple co-existing conditions, limited life expectancy and disproportionate health-care expenditures, the aspect of the health-related quality of life (HRQoL) benefits becomes of fundamental importance. Based on recent evidence, TAVI appears to improve significantly HRQoL measures compared with optimal standard care, which are restored to age-adjusted population norms over time.

Introduction

As population is ageing, aortic stenosis (AS) creates a major health problem both for the individual and the society [1]. Advancing age is not only associated with reduced responsiveness to medical therapy for AS, such as beta-blockers, but could also be considered a contraindication in some cases [2]. On the other hand, conventional aortic valve replacement (AVR) is associated with higher morbidity and mortality rates in the elderly compared with younger patients [3]. Transcatheter aortic valve implantation (TAVI) is a therapeutic alternative for high-risk elderly patients with severe symptomatic AS [1, 4]. The clinical results of TAVI are promising, with over 90% procedural success rates and superior 1-year survival, when compared with medical treatment but with similar rates, when compared with surgery [1, 4]. Sustained favourable outcomes have recently been reported at 2- and 3-year post-TAVI from large national registries and randomised trials [5, 6]. Appropriate pre-procedural selection of patients and careful planning strategy for TAVI is crucial to optimise procedural success and ultimate outcome [6]. The impact of any new medical intervention on the health-related quality of life (HRQoL) should also be taken into serious consideration in the decision-making process, particularly if this is associated with high complication risks and costs [7].

It would be a great challenge to achieve a consensus on ideal HRQoL assessment or interpretation in elderly patients with AS undergoing TAVI for several reasons. First, old age is an independent prognostic indicator of high mortality and morbidity [3]. Secondly, TAVI population is a heterogeneous group with different lifespans, comorbidities and disabilities, which complicate risk stratification and further management [1, 4–6]. Thirdly, previous clinical trials have excluded elderly patients, limiting the available evidence to guide treatment in this population [3].

So far, 12 studies assessed the HRQoL outcome after TAVI compared with baseline in patients with the same disease status (i.e. symptomatic severe AS needed treatment) [8–19]. Only one was a randomised, multi-centre study of TAVI versus optimal standard care (PARTNER trial Cohort B) or versus surgical valve replacement (PARTNER trial Cohort A) [1, 4].

HRQoL evaluation instruments for patients with TAVI

Currently, there is no comprehensive and standardised HRQoL instrument specific for patients with AS undergoing TAVI. Such instrument should have the ability to serve four goals: evaluation, discrimination, quantification and prediction. A proper evaluation of the overall burden, which this chronic severe disease imposes on the elderly, is essential [20]. HRQoL measures must indicate the best method of therapy among individuals at a certain point of time, providing additional information not achievable with conventional clinical measures (i.e. an improvement in haemodynamic performance may not be reflected in changes of everyday activities). The assessment of HRQoL may be a useful tool for estimating the benefit of this specialist intervention over a time period and for predicting the patient-centred outcome [21].

The Short Form-36 (SF-36) questionnaire is a validated measure of overall physical and mental health status, but it is not disease specific (i.e. there are no questions relating to symptoms or functional limitations from valve disease) [22]. The SF-12 health survey is a shortened and simplified tool, which emerged form the discovery that SF-36 physical and mental component summary scales capture about 85% of the reliable variance in the SF-36 health profile [22]. Most studies examining HRQoL after TAVI used the SF-12 questionnaire, because of its brevity, high feasibility and the considerably lower rate of floor and ceiling effects; however, this may be at the cost of losing detailed information about separate health-status domains [10, 13, 15, 16, 18].

The Minnesota Living with Heart Failure questionnaire (MLHFQ) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) have also been suggested in the evaluation of the quality of life with TAVI [8, 12, 14, 16]. However, the clinical domains of both questionnaires were developed to quantify-specific HRQoL concerns of heart failure patients, which may not be adequately reflected in TAVI-treated patients with preserved left ventricular function [21, 23].

The Eurocol instrument (EQ-5D) allows comparisons to be made with the effect of other health-care interventions by assessing the seriousness of conditions and it is usually recommended for multi-national use [24]. Because of its low sensitivity, EQ-5D should be used as a complementary instrument and not as a substitute for other instruments.

Baseline HRQoL assessment in patients undergoing TAVI

All studies have unanimously reported TAVI patients to be a full two standard deviations below the average of the general population regarding HRQoL assessment at baseline [10, 13, 17, 18]. The co-existence of a chronic disease along with multiple other morbidities is mainly responsible for this enormous decline in pre-procedural HRQoL levels similar to those following a major stroke. High prevalence of concomitant coronary artery disease with a history of percutaneous or surgical revascularisation, renal insufficiency, chronic lung disease and cerebrovascular disease may contribute to the low baseline HRQoL scores (Table 1) [8–19]. Although the physical component was severely limited compared with age-matched healthy population before TAVI, there are contradictory results regarding the mental component [10, 13]. Differences in study population characteristics (i.e. sex composition, specific cognitive disorders) or even regional differences may affect the perceived mental faculties.

Table 1.

Baseline characteristics of patients undergoing transcatheter aortic valve implantation

 Gotzmann et al. [8], n = 44 Krane et al. [9], n = 99 Ussia et al. [10], n = 30 Bekeredjian et al. [11], n = 80 Gonçalves et al. [12], n = 74 Georgiadou et al. [13], n = 36 Gotzmann et al. [14], n = 51 Ussia et al. [15], n = 143 Reynolds et al. [16], n = 179 Cohen et al. [17], n = 348 Fairbairn et al. [18], n = 99 Krane et al [19], n = 186 
Age, years 79.1 ± 7 81 ± 6 81.7 ± 4.7 86 ± 2.9 82 ± 8 80.5 ± 5.9 78 ± 6.6 81 ± 4.6 83 ± 9 84 ± 7 80 ± 6 80.8 ± 6.8 
Female, n (%) 22 (50) 58 (58.6) 17 (57) 47 (59) 40 (54.1) 15 (42) 26 (51) 85 (59) 97 (54) 139 (42.4) 51 (51) 118 (63) 
Log Euroscore or STS score, % 18.3 ± 12.4 20 25.3 ± 8.1 24 ± 15.1 19.3 ± 9.9 29.7 ± 13.7 19.6 ± 11.3 23.4 ± 14.7   20 ± 13 19.7 ± 12 
   18.1 ± 10.2   9.3 ± 4.8 7.9 ± 4 11.2 ± 5.8 11.8 ± 3.4  6.5 ± 6.5 
Prior MI, n (%) 15 (34) 8 (8.1) 10 (33) 0 (0)  8 (23.5) 13 (26) 30 (21) 33 (18.6) 90 (27.4) 39 (39) 69 (37) 
Prior PCI/CABG, n (%) 25 (57) 21 (21.2) 20 (67) 29 (36) 25 (33.8) 25 (69.4) 26 (51) 56 (39) 67 (37.4) 140 (42.7) 28 (28)  
CVD, n (%)  11 (11.1) 3 (10) 11 (14)  7 (19.4) 4 (8) 23 (16) 49 (27.4) 88 (26.8) 9 (9) 27 (15) 
COPD, n (%) 17 (39) 17 (17.2) 5 (17) 23 (29) 30 (40.5) 15 (41.7) 19 (37) 31 (21.7) 38 (21.2) 30 (9.1) 23 (23) 37 (20) 
Chronic renal insufficiency, n (%) 24 (55) 18 (18.4) 14 (47) 9 (11) 22 (29.7) 6 (17.1) 33 (65) 32 (22.4) 10 (5.6)  9 (9) 33 (18) 
 Gotzmann et al. [8], n = 44 Krane et al. [9], n = 99 Ussia et al. [10], n = 30 Bekeredjian et al. [11], n = 80 Gonçalves et al. [12], n = 74 Georgiadou et al. [13], n = 36 Gotzmann et al. [14], n = 51 Ussia et al. [15], n = 143 Reynolds et al. [16], n = 179 Cohen et al. [17], n = 348 Fairbairn et al. [18], n = 99 Krane et al [19], n = 186 
Age, years 79.1 ± 7 81 ± 6 81.7 ± 4.7 86 ± 2.9 82 ± 8 80.5 ± 5.9 78 ± 6.6 81 ± 4.6 83 ± 9 84 ± 7 80 ± 6 80.8 ± 6.8 
Female, n (%) 22 (50) 58 (58.6) 17 (57) 47 (59) 40 (54.1) 15 (42) 26 (51) 85 (59) 97 (54) 139 (42.4) 51 (51) 118 (63) 
Log Euroscore or STS score, % 18.3 ± 12.4 20 25.3 ± 8.1 24 ± 15.1 19.3 ± 9.9 29.7 ± 13.7 19.6 ± 11.3 23.4 ± 14.7   20 ± 13 19.7 ± 12 
   18.1 ± 10.2   9.3 ± 4.8 7.9 ± 4 11.2 ± 5.8 11.8 ± 3.4  6.5 ± 6.5 
Prior MI, n (%) 15 (34) 8 (8.1) 10 (33) 0 (0)  8 (23.5) 13 (26) 30 (21) 33 (18.6) 90 (27.4) 39 (39) 69 (37) 
Prior PCI/CABG, n (%) 25 (57) 21 (21.2) 20 (67) 29 (36) 25 (33.8) 25 (69.4) 26 (51) 56 (39) 67 (37.4) 140 (42.7) 28 (28)  
CVD, n (%)  11 (11.1) 3 (10) 11 (14)  7 (19.4) 4 (8) 23 (16) 49 (27.4) 88 (26.8) 9 (9) 27 (15) 
COPD, n (%) 17 (39) 17 (17.2) 5 (17) 23 (29) 30 (40.5) 15 (41.7) 19 (37) 31 (21.7) 38 (21.2) 30 (9.1) 23 (23) 37 (20) 
Chronic renal insufficiency, n (%) 24 (55) 18 (18.4) 14 (47) 9 (11) 22 (29.7) 6 (17.1) 33 (65) 32 (22.4) 10 (5.6)  9 (9) 33 (18) 

STS score, society of thoracic surgeon; MI, myocardial infarction; PCI, percutaneous coronary intervention; CABG, coronary artery by-pass grafting; CVD, cerebrovascular disease; COPD, chronic obstructive pulmonary disease; chronic renal insufficiency-serum creatinine >1.8 g/dl.

Short-term HRQoL after TAVI

Elderly patients with severe symptomatic AS, who are treated with TAVI, report a significant improvement in HRQoL even in 1 month after the procedure (Table 2) [8, 18]. The immediacy of HRQoL improvement after TAVI has also been demonstrated as early as 1 month in the landmark PARTNER trial. Cohort B randomised 358 patients with severe ‘inoperable’ AS to receive either TAVI or standard therapy (including balloon valvuloplasty in approximately 80%). The largest effect sizes were observed in the KCCQ social limitation and QoL components not only within the TAVI group compared with baseline (mean difference, 26 points, 95% CI: 18.6–33.5, P < 0.001 and 31.4, 95% CI: 26.5–36.4, P < 0.001, respectively), but also between the two study arms at 1 month (mean difference, 16.1 points, 95% CI: 8.1–24.1, P < 0.001 and 14.8, 95% CI: 8.6–21, P < 0.001, respectively) [16]. The elderly patients undergoing TAVI seem to perceive the impact of their disease on their general health and interpersonal relations much more seriously than physical health. The SF-12 physical health was substantially enhanced between and within-groups at 1 month but with a marked change in mental health seen only within the TAVI group at 1 month and between groups at 6 months [16].

Table 2.

Summary of studies assessing health-related quality of life in patients undergoing transcatheter aortic valve implantation

Author Type of aortic valve Duration of follow-up, months QoL instrument (s) Main findings 
Short-term 
 Gotzmann et al. [8Transarterial CoreValve 18 F MLHFQ A substantial enhancement in the overall MLHFQ score 
 Krane et al. [973 transarterial CoreValve 18 F and 26 transapical Edwards Sapien SF-36 A significant improvement in physical functioning, bodily pain, general health, vitality—no changes in role-physical, social functioning, and mental health—a marked impairment in role emotional—a high degree of independence 
 Ussia et al. [10Transarterial CoreValve 18 F SF-12v2 A marked increase in the eight health subscales—A severe impairment of pre-procedural summary scores compared with general population, which were restored after the procedure 
 Bekeredjian et al. [11Transfemoral CoreValve 18 F SF-36 A significant increase in all eight health components, with the greatest gain in physical functioning and the lowest in bodily pain, along with a significant improvement in neurohormonal activation 
 Gonçalves et al. [1221 transfemoral CoreValve, 28 transfemoral and 25 transapical Edwards Sapien 6.5 MLHFQ A striking improvement in global MLHFQ scores as well as in physical and emotional dimensions—a large majority of patients living independently and reaffirming their decision to have TAVI 
Mid-term 
 Georgiadou et al. [13Transarterial CoreValve 18 F 11.3 ± 4.9 SF-36 and SF-12v2 A significant improvement in all domains and the summary scale scores, which were higher than those of general population norms 
 Gotzmann et al. [14Transarterial CoreValve 18 F 12 ± 1 MLHFQ Persistent beneficial effects on MLHFQ Score, exercise capacity and neurohormonal activation 
 Ussia et al. [15Transarterial CoreValve 18 F or Edwards Sapien 12 SF-12v2 A remarkable improvement in post-procedural summary scores, which were similar to general population norms 
 Reynolds et al. [16Transarterial Edwards Sapien 12 KCCQ and SF-12 A larger benefit of KCCQ and SF-12 summary scores were observed at 12 months 
 Fairbairn et al. [18Transarterial CoreValve 18 F 12 SF-2v2 and EQ-5D A sustained marked increase in physical health score compared with baseline with no change in mental health score 
 Krane et al. [19Transarterial or transapical CoreValve or Edwards Sapien 12 SF-36 A significant increase in physical scores with a minor change in mental scores but both comparable with age-matched population post-TAVI 
Author Type of aortic valve Duration of follow-up, months QoL instrument (s) Main findings 
Short-term 
 Gotzmann et al. [8Transarterial CoreValve 18 F MLHFQ A substantial enhancement in the overall MLHFQ score 
 Krane et al. [973 transarterial CoreValve 18 F and 26 transapical Edwards Sapien SF-36 A significant improvement in physical functioning, bodily pain, general health, vitality—no changes in role-physical, social functioning, and mental health—a marked impairment in role emotional—a high degree of independence 
 Ussia et al. [10Transarterial CoreValve 18 F SF-12v2 A marked increase in the eight health subscales—A severe impairment of pre-procedural summary scores compared with general population, which were restored after the procedure 
 Bekeredjian et al. [11Transfemoral CoreValve 18 F SF-36 A significant increase in all eight health components, with the greatest gain in physical functioning and the lowest in bodily pain, along with a significant improvement in neurohormonal activation 
 Gonçalves et al. [1221 transfemoral CoreValve, 28 transfemoral and 25 transapical Edwards Sapien 6.5 MLHFQ A striking improvement in global MLHFQ scores as well as in physical and emotional dimensions—a large majority of patients living independently and reaffirming their decision to have TAVI 
Mid-term 
 Georgiadou et al. [13Transarterial CoreValve 18 F 11.3 ± 4.9 SF-36 and SF-12v2 A significant improvement in all domains and the summary scale scores, which were higher than those of general population norms 
 Gotzmann et al. [14Transarterial CoreValve 18 F 12 ± 1 MLHFQ Persistent beneficial effects on MLHFQ Score, exercise capacity and neurohormonal activation 
 Ussia et al. [15Transarterial CoreValve 18 F or Edwards Sapien 12 SF-12v2 A remarkable improvement in post-procedural summary scores, which were similar to general population norms 
 Reynolds et al. [16Transarterial Edwards Sapien 12 KCCQ and SF-12 A larger benefit of KCCQ and SF-12 summary scores were observed at 12 months 
 Fairbairn et al. [18Transarterial CoreValve 18 F 12 SF-2v2 and EQ-5D A sustained marked increase in physical health score compared with baseline with no change in mental health score 
 Krane et al. [19Transarterial or transapical CoreValve or Edwards Sapien 12 SF-36 A significant increase in physical scores with a minor change in mental scores but both comparable with age-matched population post-TAVI 

Pts, patients; y, years; F, French; MLHFQ, Minnesota Living with Heart Failure Questionnaire; SF, Short Form; KCCQ, Kansas City Cardiomyopathy Questionnaire.

At 3-month follow-up, Krane et al. reported a significant increase in a SF-36 physical health summarised score after TAVI consistent with high patient's degree of independence [9, 19]. Of interest, there was no change in a SF-36 mental health score, mainly due to a remarkable reduction in role emotional and social functioning. The inclusion of patients referred to trans-apical TAVI may have led to this negative result. Further, the SF-36 may not be sufficiently effective in detecting changes in individuals after TAVI over short periods of time. The use of such generic measure is more suitable for large-study populations or studies comparing patients with AS and healthy persons [21].

The benefits of physical functioning are not only sustained but further improved at 5 and 6 months after TAVI. In a patient population of the most advanced age, Bekeredjian et al. observed a significant improvement of all SF-36 health components, with the greatest gain observed in physical functioning 6 months after the procedure [11]. These findings were consistent with those reported by Ussia et al. [10]. Fairbairn et al. observed the greatest change in physical component to be obtained at 30 days but with further significant improvement to 6 months [18]. Gonçalves et al. also suggested the presence of significant peripheral vascular disease as a significant determinant of lower improvement in HRQoL [12]. Likewise, Reynolds et al. showed a higher positive impact on SF-12 physical summary scores at 6 months within the TAVI group. Regarding KCCQ, the extent of improvement was greater after TAVI compared with controls at 6 months than that at 1 month (mean between-group difference 21 versus 13 points). The KCCQ social limitation and QoL components were still the major contributors to these changes [16].

Mid-term HRQoL after TAVI

Seven studies, so far, have showed a substantial enhancement in HRQoL at 1 year after TAVI compared with baseline [13–19]. The physical health scores declined insignificantly between 6 months and 1 year in all surveys, reflecting worsening health, which could gradually become significant over longer follow-up periods (Table 2), (Figure 1). Conflicting results exist regarding the 1-year mental evaluation component. Reports suggesting mental health improvement have also shown the lowest benefit in this domain (Figure 1). In the PARTNER trial Cohort B, TAVI therapy has persistent beneficial effects on a global KCCQ summary score by 20–25 points at 1 year, corresponding to an average improvement of two levels of New York Heart Association class [16]. One-year post-procedural SF-12 physical and mental health scores were favourable with mean differences of 5.7 and 6.4 points (P < 0.001), compared with the standard care (Figure 1), [16]. The physical improvement was suggested to be roughly comparable with a 10-year reduction in effective age.

Figure 1.

Summary of SF-12 scores in patients after transcatheter aortic valve implantation. PCS, physical component summary; MCS, mental component summary.

Figure 1.

Summary of SF-12 scores in patients after transcatheter aortic valve implantation. PCS, physical component summary; MCS, mental component summary.

The 1-year health of TAVI population has been consistently shown to become similar to age-matched general population norms; except from Greek patients who scored higher compared with the anticipated of the standard population, indicating the relative higher perception of their health probably due to lower expectations [13,15,18,19]. Among patient- and procedural-related characteristics assessed, the male sex and the operator experience have been identified as independents predictors of post-procedural HRQoL improvement [18].

In terms of health economic benefit of TAVI, a health-utility analysis has recently been published based on the PARTNER trial. By projecting survival data and costs beyond the trial period in the cohort of inoperable patients, the cost-effectiveness analysis for TAVI suggested an incremental cost-effectiveness ratio below of $62,000 per quality-adjusted life years gained, which is well within the accepted values for typically used cardiovascular technologies [25]. Although follow-up costs were lower with TAVI versus standard care—mainly due to reduced cardiovascular hospitalisations—the overall 1-year costs remained substantially higher with TAVI because of the high index admission costs [25, 26]. A recent report from Belgium supported that this economic benefit is restricted only to the anatomic inoperable patients and not to those inoperable for medical reasons [27].

HRQoL assessment after TAVI versus surgical AVR

Surgical AVR has been shown to improve HRQoL scores, comparable with those of general population, even among octogenarians at 1 year after surgery [28]. However, surgical candidates included in these studies were in a less compromised preoperative status than TAVI patients. In the only available randomised PARTNER trial Cohort A, high-risk patients with severe AS were assigned to TAVI (n = 348, 84 ± 7 years) performed via transfemoral (n = 244) or transapical approach (n = 104) or AVR (n = 300, 84 ± 6 years). Over 1-year follow-up, all patients experienced a marked improvement in HRQoL assessed by KCCQ, SF-12 and EQ-5D questionnaires. Transfemoral TAVI resulted in substantial HRQoL benefits compared with surgical AVR at 1 month with similar benefits at later time points; these findings indicate a higher rate of early recovery after TAVI, despite its association with increased procedural complication risks. However, there was no HRQoL improvement after transapical TAVI over AVR at any time point and quality of life tended to be better with surgical AVR both at 1 and 6 months [17]. A recent small study with longer follow-up (15 ± 10 months) also showed no significant difference in HRQoL assessed by SF-36 between patients undergoing transapical TAVI and surgical AVR after adjustment for baseline characteristics [29].

A cost-effectiveness analytic model comparing data from TAVI and AVR registries showed a small health benefit of TAVI over AVR (1.78 versus 1.72 quality-adjusted life years) and underscored the importance of considering both mortality and stroke rates in the selection of the favoured strategy, since variations in the probabilities of these parameters changed the estimations of this model [30].

Shortcomings and future perspectives

Except from the PARTNER trial, all the other were single-centre studies with small sample sizes. In design, all these studies were biased due to deaths or patients who failed to complete the questionnaires at the follow-up period, which may result in a study cohort, largely composed by patients who benefited from TAVI. Further, the studies comparing HRQoL changes between TAVI and surgical AVR were unblinded and therefore, a placebo-like effect cannot be excluded; a blinded study would be more informative but this would require a broadened indication of TAVI for patients with lower surgical risk.

It is important to use quantitative methods to complement standardised HRQoL instruments in order to adequately capture the totality of survivor's experience. The development of an optimal set of HRQoL measures, the identification of specific predictors of future HRQoL, a longer-term follow-up and further refinements regarding the access sites would provide more comprehensive understanding of TAVI patient's journey.

Conclusion

Along with the positive performance and durability data, TAVI appears to maximise both symptom reduction and HRQoL for elderly ‘inoperable’ patients. This aspect becomes of paramount importance in the context of the high risks and costs involved in this procedure. TAVI yields early substantial HRQoL benefits compared with baseline or standard treatment, which accrue for at least a year. These advantages of TAVI but only via a transfemoral approach occur at 1 month compared with conventional surgery and are diminished at later time points. The ultimate value of TAVI will depend on careful selection of patients who are not surgical candidates, and yet do not have extreme co-morbidities that overwhelm the benefits of TAVI.

Key points

  • General and disease-specific HRQoL are improved with TAVI over standard care among inoperable patients at 1, 6 and 12 months.

  • A substantial enhancement in physical functioning has been unanimously reported, comparable with a 10-year reduction in effective age.

  • Both surgical and transcatheter AVR resulted in marked improvement in HRQoL over 1-year follow-up with greater benefits at earlier time points in the transfemoral TAVI group.

  • No significant benefit was observed in HRQoL after transapical TAVI over surgical AVR at any time point.

  • The penetration of this technology in the broad group of elderly patients with multiple co morbidities and severe AS will depend on the optimal patient selection and the continuing evolution of the technology.

Conflicts of interest

None declared.

Funding

No funding was received for this work.

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