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      Assessment of cognitive functions and quality of life in patients scheduled for transcatheter aortic valve implantation: a pilot study

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          Abstract

          Transcatheter aortic valve implantation (TAVI) is an innovative and effective treatment for patients with symptomatic severe aortic stenosis (AS). In particular, TAVI offers a treatment option for elderly patients with very high surgical risk, who are disqualified from surgical aortic valve replacement (SAVR) [1]. An improvement in long-term outcomes and quality of life (QoL) after TAVI has been confirmed by several studies [2–6]. Importantly, an exponential increase in the number of TAVIs is expected over the next decade. It is related to the aging of the population in Europe and the growing number of geriatric patients who will be possible candidates for TAVI. Apart from mortality, QoL and both mental and functional status are important instruments in assessing patient-specific outcomes of therapeutic interventions, especially in the population with limited life expectancy [7]. Measures of morbidity and mortality are not able to elucidate life-specific information on physical, emotional, and mental well-being but can be supplemented with the patient’s perception of recovery after the intervention [7]. However, there are specific changes in cognitive functioning, connected with aging [8]. Neuropsychological evaluation of cognitive functions and QoL assessment are helpful in the qualification process concerning clinical decisions and choice of treatment method. Furthermore, well-adjusted questionnaires are able to exclude those patients who cannot cooperate well enough during diagnostic procedures because of dementia. Identification of such patients would allow the Heart Team and treating physicians to better inform patients of their likely individual benefits from this procedure. Therefore, comprehensive medical and psychological evaluation of elderly patients seems to be necessary. We sought to evaluate QoL in regard to both mental and functional status among patients with symptomatic severe AS scheduled for TAVI. Here we summarize our initial results of 100 consecutive patients with symptomatic severe AS and high surgical risk or contraindications for SAVR. The periprocedural risk was evaluated with the STS PROM scale and EuroSCORE II. Patients were admitted for TAVI qualification to the Second Department of Cardiology and Cardiovascular Interventions in Krakow between 2016 and 2017. Patient screening and selection were performed by a multidisciplinary Heart Team. The study is planned to be held in three steps: assessment before the treatment, 2 weeks and 6 months after TAVI. The full data (2-week and 6-month steps) are in the process of collection. Due to the time-consuming procedure, the necessity to create appropriate methods of patient qualification, and some difficulties with fast data collection, we decided to present the first step results in this paper. An evaluation of a larger population with 6-month follow-up is planned. Exclusion criteria included: lack of informed consent, severe dementia, severe somatic state preventing participation in the study, eyesight deficits which make it impossible to fill in the questionnaires, and hearing deficits which make it impossible to answer the questions asked during the interview. During the qualification process, all the procedures were performed by an experienced cardiologist. In addition, each patient was examined by a neuropsychologist highly qualified in work with cardiologic patients. Patients were asked to take part in a psychological interview concerning demographic data, previous mental problems, family life and current life situation with a special interest in everyday life skills and abilities. The Mini-Mental State Examination Scale (MMSE), self-reported EQ-5D-3L questionnaire, and the Lawton Instrumental Activities of Daily Living (IADL) scale were collected. MMSE was used for cognitive function evaluation with typical cut points [8]. The differences in QoL between patients with stable ((MMSE) ≥ 24 points) and decreased (MMSE ≤ 23 points) cognitive functioning were examined. All patients provided written informed consent to participate in the study. The protocol was approved by the local ethics committee (decision no. 122.6120.39.2015). The study followed the ethical principles for clinical research based on the Declaration of Helsinki with later amendments. Standard descriptive statistics were used. Quantitative variables were described using mean and standard deviation. Categorical variables were presented as counts and percentages. The level of statistical significance was set at p < 0.05. The Mann-Whitney U test (for non-normal distribution of data) or unpaired (two-sample) Student’s t-test (for normally distributed data) was applied for continuous variables. The χ2 test was used for categorical (nominal and dichotomous) variables. The association between the values of MMSE and IADL was assessed by Pearson’s correlation coefficients. All analyses were carried out with Statistica 12 (StatSoft, Inc. Tulsa, OK, USA). A total of 100 consecutive patients (66 males and 34 females; mean age: 82 ±5 years) with symptomatic severe AS and very high surgical risk or contraindications for SAVR were enrolled. Mean MMSE score in the group with stable cognitive functioning was 26.9 ±1.9 points while in the group with dementia symptoms it was 19.2±3.1 points. Patients with MMSE ≥ 24 were younger (81.2 ±5.3 vs. 84.2 ±4.0 years, p = 0.001), with longer education (10.5 ±5.3 vs. 6.6 ±2.9 years, p = 0.001) and better orientation in time and place (9.5 ±0.8 vs. 6.6 ±2.8 points, p = 0.001). In patients with decreased MMSE, memory skills (3.6 ±1.5 vs. 5.3 ±0.9 points, p = 0.001) and language functions (3.15 ±1.1 vs. 3.8 ±0.6 points, p = 0.001) were lower in comparison to patients with preserved mental status. There was no difference between groups in QoL assessment using the EQ-5D-3L questionnaire and the VAS scale (Table I). Therefore, general evaluation of self-care, usual activities, pain and discomfort, anxiety and depression is not enough to describe and differentiate patients’ abilities to cope with treatment duties and tasks in the context of the mental state. Also, patients’ subjective point of view in the context of their well-being (assessed with the VAS) is not a sufficient predictor of differences in patients’ functioning between the group with stable and decreased cognitive functioning. Such daily activities as using the phone, walking, cooking, managing medications and managing finances are distinctive for patients’ ability to be independent in everyday life and well adapted to treatment situations. These factors are evaluated in the IADL scale and can be helpful in qualification procedures for TAVI. Particular results of these dimensions describing daily functioning are presented in Table I. A moderate positive correlation between MMSE and the IADL scale was observed (r = 0.45, p = 0.006) (Figure 1). It proves that mental state is an important factor connected with daily activities. Patients with higher scores in the MMSE have a higher chance of returning to their daily activities and coping well with self-care after TAVI treatment, too. Figure 1 Correlation between IADL and MMSE total points (r = 0.45, p = 0.006) Table I EQ-5D-3L Questionnaire and IADL scale mean values in comparison between patients with stable (MMSE ≥ 24 points) and decreased (MMSE ≤ 23 points) cognitive functioning level Variable MMSE ≥ 24 points MMSE ≤ 23 points P-value Mobility EQ-5D-3L: 0.3  None (0) 20.37% 22.58%  Moderate (1) 75.93% 64.52%  Extreme (2) 3.70% 12.90% Self-care EQ-5D-3L: 0.2  None (0) 75.93% 61.29%  Moderate (1) 22.22% 38.71%  Extreme (2) 1.85% 0.00% Usual activities EQ-5D-3L: 0.3  None (0) 55.56% 41.94%  Moderate (1) 42.59% 51.61%  Extreme (2) 1.85% 6.45% Pain/discomfort EQ-5D-3L: 0.2  None (0) 25.93% 16.13%  Moderate (1) 62.96% 58.06%  Extreme (2) 11.11% 25.81% Anxiety/depression EQ-5D-3L: 0.9  None (0) 44.44% 38.71%  oderate (1) 42.59% 48.39%  Extreme (2) 12.96% 12.90% Total score EQ-5D-3L [points] 3.3 ±1.6 3.6 ±2.3 0.4 EQ Visual Analogue Scale 50.6 ±19.6 54.4 ±18.1 0.4 IADL using phone: 0.005  Dependent (1) 0.00% 21.88%  Need help (2) 12.96% 21.88%  Independent (3) 87.04% 56.25% IADL walking: 0.001  Dependent (1) 14.81% 40.63%  Need help (2) 31.48% 34.38%  Independent (3) 53.7% 25.00% IADL shopping: 0.2  Dependent (1) 24.07% 31.25%  Need help (2) 18.52% 31.25%  Independent (3) 57.41% 37.5% IADL cooking: 0.007  Dependent (1) 0.00% 6.25%  Need help (2) 12.96% 34.38%  Independent (3) 87.04% 59.37% IADL basic house work: 0.02  Dependent (1) 11.11% 21.88%  Need help (2) 31.48% 40.63%  Independent (3) 57.41% 37.5% IADL laundry: 0.06  Dependent (1) 9.43% 21.88%  Need help (2) 24.53% 37.50%  Independent (3) 66.04% 40.62% IADL managing medications: 0.007  Dependent (1) 5.56% 25.00%  Need help (2) 11.11% 21.88%  Independent (3) 83.33% 53.12% IADL managing finance: 0.002  Dependent (1) 0.00% 21.88%  Need help (2) 14.81% 9.38%  Independent (3) 85.19% 68.74%  IADL total score [points] 20.8 ±3.1 16.1 ±6.3 0.007  IADL using phone 0% 100% 0.003  IADL walking 38.1% 61.9% 0.007  IADL shopping 56.52% 43.48% 0.5  IADL cooking 0% 100% 0.06  IADL basic house work 46.15% 53.85% 0.2  IADL laundry 46.15% 53.85% 0.2  IADL managing medications 27.27% 72.73% 0.009  IADL managing finance 0% 100% 0.003 MMSE – Mini Mental State Examination. EQ-5D-3L – The questionnaire is composed of 5 questions, each scoring 0–2 points. A higher score represents a lower quality of life. The Visual Analogue Scale was scored 0–100% – the higher the score, the higher the quality of life. IADL (Instrumental Activities of Daily Living) questionnaire was scored 1–3 points – the higher the score, the fewer the problems with a particular activity. We confirmed that the MMSE test is appropriate for general cognitive functioning measurement in elderly patients with severe symptomatic AS qualified for TAVI. The differences between patients with cognitive decline (MMSE ≤ 23 points) in orientation in time and place, memory skills and language functions are consistent with the previous studies [9, 10]. Thus, MMSE can be used in the qualification process for TAVI. However, the method of MMSE data interpretation requires a detailed analysis. In some studies functional independence was related to the level of education: a higher level of education corresponded to a higher level of self-reliance [8]. We found in our study that the algorithm for the calculation of results in the MMSE proposed by previous studies is probably inadequate [11]. The correction for age and education suggested by the authors of the algorithm gave statistically false results. Years of education did not accurately represent the mental state of our patients. A possible reason is that in our study many of the patients were not educated enough due to World War II to use this algorithm appropriately. Thus, we decided to evaluate the raw results, which is recommended in some cases [12]. Furthermore, chronic heart failure (CHF) as a result of severe AS could have an influence on the value of MMSE [13]. The association between cognitive impairment and stage of CHF seems to have clinical importance [13]. Mental status decline affects both the QoL and clinical evolution of the stage of CHF [13]. Furthermore, it has a detrimental effect on the interaction between physician and patients as well as compliance with recommended treatment. Evaluation of QoL seems to be an important index as frequently not a reduction in mortality but an improvement in daily life comfort is considered most desirable by the patients themselves. Regarding QoL and daily living, the IADL questionnaire was found to be relevant and useful. On the other hand, EQ-5D-3L, which is a standardized generic measure of health state widely used in diverse patient populations, showed low sensitivity, which potentially influenced the results. Therefore the use of EQ-5D-3L in our further studies seems to be debatable as the IADL questionnaire may provide more comprehensive information about the patients’ functioning. Our results showed which aspects of QoL are an easy and quick way to evaluate patients who will profit from the treatment and a group of patients who will not gain any benefits. Furthermore, in the follow-up, we plan to assess whether TAVI influences cognitive functions and QoL in time. Both functional and cognitive assessment can provide objective data to assist with targeting individualized diagnostic needs and the plan for treatment. Most of the proposed mental state and QoL indices confirmed predictive ability in the process of qualification for TAVI. Our results are consistent with recent reports on the impact of frailty on 12-month mortality after TAVI [14]. Such assessments can help to identify a group of patients who will not benefit from TAVI and who should receive conservative treatment instead. Mental and QoL evaluation can also guide the physicians to focus on the patient’s baseline capabilities, facilitating early recognition of changes and symptoms that may signify a need for a medical work-up [15]. Comprehensive medical and psychological evaluation is useful in selection of patients for TAVI. Multidisciplinary evaluation in the qualification process gives the fullest description of the clinical situation of the candidate for TAVI. An important aspect for further consideration is the postulate that the psychologist should always be a member of the TAVI qualification team. The most important limitation of this single-center prospective observational study is the relatively small sample size. On the other hand, this study represents a comprehensive analysis of consecutive “real-world” patients undergoing TAVI. There are limitations linked to the tool for QoL assessment. EQ-5D-3L is questionnaire with low sensitivity. Also, the analysis did not include disease-specific questionnaires; only generic instruments were used. In conclusion, we confirm the relationship between mental health and QoL in patients scheduled for TAVI. Thus, it may stress the value of the assessment of cognitive and everyday life functioning with validated methods during qualification for TAVI. A comprehensive evaluation may be useful to avoid futility of TAVI and to predict outcomes

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          Most cited references15

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          Population-based norms for the Mini-Mental State Examination by age and educational level.

          To report the distribution of Mini-Mental State Examination (MMSE) scores by age and educational level. National Institute of Mental Health Epidemiologic Catchment Area Program surveys conducted between 1980 and 1984. Community populations in New Haven, Conn; Baltimore, Md; St Louis, Mo; Durham, NC; and Los Angeles, Calif. A total of 18,056 adult participants selected by probability sampling within census tracts and households. Summary scores for the MMSE are given in the form of mean, median, and percentile distributions specific for age and educational level. The MMSE scores were related to both age and educational level. There was an inverse relationship between MMSE scores and age, ranging from a median of 29 for those 18 to 24 years of age, to 25 for individuals 80 years of age and older. The median MMSE score was 29 for individuals with at least 9 years of schooling, 26 for those with 5 to 8 years of schooling, and 22 for those with 0 to 4 years of schooling. Cognitive performance as measured by the MMSE varies within the population by age and education. The cause of this variation has yet to be determined. Mini-Mental State Examination scores should be used to identify current cognitive difficulties and not to make formal diagnoses. The results presented should prove to be useful to clinicians who wish to compare an individual patient's MMSE scores with a population reference group and to researchers making plans for new studies in which cognitive status is a variable of interest.
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            Impact of frailty on mortality after transcatheter aortic valve implantation.

            We sought to investigate the relation between frailty indices and 12-month mortality after transcatheter aortic valve implantation (TAVI).
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              Clinical outcomes of patients with severe aortic stenosis at increased surgical risk according to treatment modality.

              The aim of this study was to assess the role of transcatheter aortic valve implantation (TAVI) compared with medical treatment (MT) and surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (AS) at increased surgical risk. Elderly patients with comorbidities are at considerable risk for SAVR. Since July 2007, 442 patients with severe AS (age: 81.7 ± 6.0 years, mean logistic European System for Cardiac Operative Risk Evaluation: 22.3 ± 14.6%) underwent treatment allocation to MT (n = 78), SAVR (n = 107), or TAVI (n = 257) on the basis of a comprehensive evaluation protocol as part of a prospective registry. Baseline clinical characteristics were similar among patients allocated to MT and TAVI, whereas patients allocated to SAVR were younger (p 80 years, p = 0.01), peripheral vascular disease (<0.001), and atrial fibrillation (p = 0.04) were significantly associated with all-cause mortality at 30 months in the multivariate analysis. At 1 year, more patients undergoing SAVR (92.3%) or TAVI (93.2%) had New York Heart Association functional class I/II as compared with patients with MT (70.8%, p = 0.003). Among patients with severe AS with increased surgical risk, SAVR and TAVI improve survival and symptoms compared with MT. Clinical outcomes of TAVI and SAVR seem similar among carefully selected patients with severe symptomatic AS at increased risk. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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                Author and article information

                Journal
                Postepy Kardiol Interwencyjnej
                Postepy Kardiol Interwencyjnej
                PWKI
                Postępy w Kardiologii Interwencyjnej = Advances in Interventional Cardiology
                Termedia Publishing House
                1734-9338
                1897-4295
                25 September 2017
                2017
                : 13
                : 3
                : 258-262
                Affiliations
                [1 ]2 nd Department of Cardiology and Cardiovascular Interventions, University Hospital, Krakow, Poland
                [2 ]Department of Medical Psychology, Chair of Psychiatry, Jagiellonian University Medical College, Krakow, Poland
                [3 ]Department of Interventional Cardiology, Jagiellonian University Medical College, Krakow, Poland
                [4 ]2 nd Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland
                Author notes
                Corresponding author: Katarzyna Olszewska MD, PhD, 2 nd Department of Cardiology and Cardiovascular Interventions, University Hospital, 17 Kopernika St, 31-501 Krakow, Poland, phone: +48 12 424 71 81. e-mail: katarzyna.olszewska5@ 123456wp.pl
                Article
                30624
                10.5114/aic.2017.70199
                5644045
                29056999
                0beb3cae-2df6-45f4-82e0-9fab363acfe3
                Copyright: © 2017 Termedia Sp. z o. o.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0) License, allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.

                History
                : 25 June 2017
                : 31 August 2017
                Categories
                Short Communication

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