"Be Your Own Doctor" Experiences of Patients With Transcatheter Aortic Valve Implantation During the Pandemic: A Qualitative Study.

Background and Purpose: Although patients have had reduced access to healthcare institutions due to the COVID-19 pandemic and the related preventive measures, there is no current data on how the pandemic has affected patients who underwent transcatheter aortic valve implantation (TAVI), despite their need for close follow-up.This study investigated TAVI patients' experiences with self-care management during the pandemic. Methods: This study adopted a descriptive qualitative design. The sample consisted of 24 patients recruited using purposive sampling. Data were collected by telephone and analyzed using inductive content analysis. Results: The data were grouped under three themes: "vulnerability," "worsening of psychological condition," and "expectations." The most challenging self-care behaviors reported by TAVI patients were determined to be doing regular physical activity, managing their symptoms, complying with treatment, and attending regular check-ups. They also reported experiencing psychological problems such as fear, concern, and abandonment and stated a need for better communication and follow-up at home during the pandemic. Implications for Practice: The pandemic has more than ever demonstrated the importance of effective self-care for cardiovascular patients. Nurses should plan individualized interventions regarding the problems in self-care management that we identified in this study. In this regard, the use of secure digital applications such as telerehabilitation can be effective. Also, nurses should develop community-based and political initiatives to allow sustainable self-care management to be effectively implemented in special patient groups in extraordinary circumstances such as pandemics.

Quality of life after transcatheter or surgical aortic valve replacement using the Toronto Aortic Stenosis Quality of Life Questionnaire.

BACKGROUND: The Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) is a validated instrument for assessing quality of life (QoL) in patients with severe aortic stenosis (AS). In this study, we evaluated health status outcomes, based on the TASQ, in patients with severe AS undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). METHODS: The TASQ registry was a prospective observational registry. Patients with severe AS from nine centres in Europe and one in Canada underwent either SAVR or transfemoral TAVR. Patients completed the TASQ, Kansas City Cardiomyopathy Questionnaire and Short Form-12 V.2 prior to the intervention, predischarge, and at 30-day and 3-month follow-ups. Primary end point was the TASQ score. RESULTS: In both the TAVR (n=137) and SAVR (n=137) cohorts, significant increases were observed in all three scores. The overall TASQ score improved as did all but one of the individual domains at 3 months after the intervention (p<0.001). TASQ health expectations were the only domain which worsened (p<0.001). Across TASQ subscores, significant changes were evident from the time of discharge in the TAVR and 30-day follow-up in the SAVR cohort. In a categorical analysis of the TASQ, 39.7% of the TAVR group and 35.0% of the SAVR group had a substantially improved health status at 3 months compared with baseline. CONCLUSIONS: The TASQ captured changes in QoL among patients with severe AS who were treated with TAVR or SAVR. QoL improved substantially after either intervention, as indicated by changes in the TASQ overall score at 3 months. TRIAL REGISTRATION NUMBER: NCT03186339.

Aortic valve replacement among patients with Alzheimer's disease and related dementias.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has made palliation from aortic stenosis more broadly available to populations previously thought to be too high risk for surgery, such as those with Alzheimer's disease and related dementias (ADRD); however, its safety and effectiveness in this context are uncertain. METHODS: We performed a retrospective cohort study of national Medicare beneficiaries, aged 66 and older with Parts A and B, between 2010 and 2016. Patients undergoing AVR were identified, and follow-up was available through 2017. Multivariable regression was used to measure the independent association between having a diagnosis of ADRD at the time of AVR, stratified by TAVR and surgery, and outcomes (mortality and Medicare institutional days at 1 year after AVR). RESULTS: The average rate of increase in AVR per year was 17.5 cases per 100,000 ADRD and 8.4 per 100,000 non-ADRD beneficiaries, largely driven by more rapid adoption of TAVR. Adjusted mortality following AVR declined significantly between those treated in 2010 and 2016, from 13.5% (95% CI 10.2%-17.7%) to 6.3% (95% CI 5.2%-7.6%) and from 13.7% (95% CI 12.7%-14.7%) to 6.3% (95% CI 5.8%-6.9%) in those with and without ADRD, respectively. The sharpest decline was noted for patients undergoing TAVR between 2011 and 2016, with adjusted mortality declining from 19.9% (95% CI 11.2%-32.8%) to 5.2% (95% CI 4.1%-6.5%) and from 12.2% (95% CI 9.3%-15.8%) to 5.0% (95% CI 4.4%-5.6%) in patients with and without ADRD, respectively. Similar declines were evident for Medicare institutional days in the year after AVR in both patient groups. CONCLUSIONS: Rates of AVR in those with ADRD increased during the past decade largely driven by the diffusion of TAVR. The use of TAVR in this vulnerable population did not come at the expense of increasing Medicare institutional days or mortality at 1-year.

Impact of Severe Sarcopenia on Rehospitalization and Survival One Year After a TAVR Procedure in Patients Aged 75 and Older.

BACKGROUND: Transcatheter aortic-valve replacement (TAVR) reduces mortality and improves quality of life in patients with severe aortic valve stenosis. One third of patients have no benefit one year after TAVR. Sarcopenia, an age-related loss of skeletal muscle mass, is associated with increased physical disability and mortality. The main purpose was to evaluate the impact of severe sarcopenia on rehospitalization one year after TAVR in older patients. METHODS: All patients aged ≥75 referred for a TAVR in 2018 were included. Severe sarcopenia was defined by a loss of skeletal muscle mass defined on CT-scan measurement associated with a gait speed ≤0.8m/s. The main outcome was rehospitalization one year after TAVR. RESULTS: Median age of the 182 included patients was 84, and 35% had an unplanned hospitalization at one year. Severe sarcopenia was diagnosed in 9 patients (4.9%). Univariable analysis showed that gait speed was a factor associated with readmission [HR=0.32, 95% CI (0.10-0.97), p=0.04] but not severe sarcopenia. In multivariable analysis, only diabetes was significantly associated with rehospitalization [HR=2.06, 95% CI (1.11-3.84), p=0.02]. Prevalence of severe sarcopenia varied according to different thresholds of skeletal muscle mass on CT-scan. CONCLUSION: Even though severe sarcopenia was not correlated with rehospitalization and mortality at one year after TAVR, our results emphasize the changes in the prevalence according to cutoff used. It highlights the need to define standardized methods and international threshold for sarcopenia diagnosis by CT-scan measurements, in general population and for patients with valvular heart disease.

Patient values and preferences on valve replacement for aortic stenosis: a systematic review.

The review aims to summarise evidence addressing patients' values, preferences and practical issues on deciding between transcatheter aortic valve insertion (TAVI) and surgical aortic valve replacement (SAVR) for aortic stenosis. We searched databases and grey literature until June 2020. We included studies of adults with aortic stenosis eliciting values and preferences about treatment, excluding medical management or palliative care. Qualitative findings were synthesised using thematic analysis, and quantitative findings were narratively described. Evidence certainty was assessed using CERQual (Confidence in the Evidence from Reviews of Qualitative Research) and GRADE (Grading of Recommendations Assessment, Development and Evaluation). We included eight studies. Findings ranged from low to very low certainty. Most studies only addressed TAVI. Studies addressing both TAVI and SAVR reported on factors affecting patients' decision-making along with treatment effectiveness, instead of trade-offs between procedures. Willingness to accept risk varied considerably. To improve their health status, participants were willing to accept higher mortality risk than current evidence suggests for either procedure. No study explicitly addressed valve reintervention, and one study reported variability in willingness to accept shorter duration of known effectiveness of TAVI compared with SAVR. The most common themes were desire for symptom relief and improved function. Participants preferred minimally invasive procedures with shorter hospital stay and recovery. The current body of evidence on patients' values, preferences and practical issues related to aortic stenosis management is of suboptimal rigour and reports widely disparate results regarding patients' perceptions. These findings emphasise the need for higher quality studies to inform clinical practice guidelines and the central importance of shared decision-making to individualise care fitted to each patient.

Cerebral Blood Flow in Patients with Severe Aortic Valve Stenosis Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a minimally invasive, life-saving treatment for patients with severe aortic valve stenosis that improves quality of life. We examined cardiac output and cerebral blood flow in patients undergoing TAVI to test the hypothesis that improved cardiac output after TAVI is associated with an increase in cerebral blood flow. DESIGN: Prospective cohort study. SETTING: European high-volume tertiary multidisciplinary cardiac care. PARTICIPANTS: Thirty-one patients (78.3 ± 4.6 years; 61% female) with severe symptomatic aortic valve stenosis. MEASUREMENTS: Noninvasive prospective assessment of cardiac output (L/min) by inert gas rebreathing and cerebral blood flow of the total gray matter (mL/100 g per min) using arterial spin labeling magnetic resonance imaging in resting state less than 24 hours before TAVI and at 3-month follow-up. Cerebral blood flow change was defined as the difference relative to baseline. RESULTS: On average, cardiac output in patients with severe aortic valve stenosis increased from 4.0 ± 1.1 to 5.4 ± 2.4 L/min after TAVI (P = .003). The increase in cerebral blood flow after TAVI strongly varied between patients (7% ± 24%; P = .41) and related to the increase in cardiac output, with an 8.2% (standard error = 2.3%; P = .003) increase in cerebral blood flow per every additional liter of cardiac output following the TAVI procedure. CONCLUSION: Following TAVI, there was an association of increase in cardiac output with increase in cerebral blood flow. These findings encourage future larger studies to determine the influence of TAVI on cerebral blood flow and cognitive function.

Rationale and design of a prospective, randomized, controlled, multicenter study to evaluate the safety and efficacy of transcatheter heart valve replacement in female patients with severe symptomatic aortic stenosis requiring aortic valve intervention (Randomized researcH in womEn all comers wIth Aortic stenosis [RHEIA] trial).

BACKGROUND: Limited data suggest that transcatheter (TAVR) as compared with surgical aortic valve replacement (SAVR) may be more effective in female than male patients. To date, most evidence is derived from subgroup analyses of large trials, and a dedicated randomized trial evaluating whether there is a difference in outcomes between these interventions in women is warranted. The RHEIA trial will compare the safety and efficacy of TAVR with SAVR in women with severe symptomatic aortic stenosis requiring aortic valve intervention, irrespective of surgical risk. METHODS/DESIGN: The RHEIA trial is a prospective, randomized, controlled study that will enroll up to 440 patients across 35 sites in Europe. Women with severe symptomatic aortic stenosis, with any but prohibitive surgical risk status, will be randomized 1:1 to undergo aortic valve intervention with either transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra device or SAVR and followed up for 1 year. The objective is to determine whether TAVR is non-inferior to SAVR in this patient population and, if this is fulfilled whether TAVR is actually superior to SAVR. The primary safety/efficacy endpoint is a composite of all-cause mortality, all stroke, and re-hospitalization (for valve or procedure-related symptoms or worsening congestive heart failure) at 1 year post-procedure. Other outcomes (assessed at 30 days and/or 1 year) include all-cause mortality; bleeding, vascular, cardiac, cerebrovascular and renal complications; aortic valve prosthesis and left ventricular function; cognitive function, health status, and quality of life. DISCUSSION: The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk. The results will be the first to provide specific randomized evidence to guide treatment selection in female patients with severe symptomatic aortic stenosis. TRIAL REGISTRATION: clinicaltrials.gov: NCT04160130.

Quality of life in sexagenarians after aortic biological vs mechanical valve replacement: a single-center study in China.

OBJECTIVE: This article aimed to study the quality of life and anxiety of sexagenarian patients who underwent aortic biological vs mechanical valve replacement in a single center in China. METHODS: The clinical data of 78 patients aged 60 to 70 years who underwent aortic prosthetic valve replacement were retrospectively analyzed in our hospital from June 2017 to February 2018. Patients were divided into two groups depending on the type of prosthetic valve they received (biological valve group vs mechanical valve group). The SF-36 was completed by all patients at discharge and at one-year follow-up, and the cardiac anxiety questionnaire (CAQ) was also completed at one-year follow-up. RESULTS: There was no statistically significant difference between the two groups in general clinical data or SF-36 score at discharge. However, at one-year follow-up, the SF-36 scores were significantly higher in the biological valve group than in the mechanical valve group, and the CAQ scores in fear and anxiety, avoidance and attention in the mechanical valve group were significantly higher than those in the biological valve group. CONCLUSIONS: Based on the postoperative quality of life and anxiety scores of sexagenarian patients who underwent biological vs mechanical valve replacement in this study, a biological valve has more value than a mechanical valve for sexagenarians undergoing aortic valve replacement.

Toronto aortic stenosis quality of life questionnaire (TASQ): validation in TAVI patients.

BACKGROUND: Aortic stenosis (AS) is a common cardiac condition whose prevalence increases with age. The symptom burden associated with severe aortic stenosis (AS) can introduce significant lifestyle disruptions and if left untreated can lead to a poor prognosis. Quality of life (QoL) is an important consideration in these patients. The TASQ is a QoL tool that was developed for aortic stenosis patients. We evaluated the psychometric properties of this specific questionnaire in patients who underwent transcatheter aortic valve implantation (TAVI), which is a therapeutic option for patients with severe aortic stenosis (AS). METHODS: The properties of the TASQ in measuring QoL were evaluated in AS patients undergoing TAVI. Patients presenting for the TAVI procedure (N = 62) were evaluated pre-TAVI, at discharge, 1-month, and 3-month follow-ups. Demographic information as well as caregiver status, and daily activities were recorded. In addition to the TASQ, they completed the KCCQ (Kansas City Cardiomyopathy Questionnaire) and the IIRS (Illness Intrusiveness Rating Scale). RESULTS: The TASQ is a 16-item self-administered questionnaire that assesses AS-specific QoL across five domains: physical symptoms; physical limitations; emotional impact; social limitations, and health expectations. TASQ subscales are internally consistent (α = 0.74-0.96) and showed significant improvements from baseline across assessments (p < 0.001). Construct validity evidence was demonstrated by correlations consistent with theoretically derived hypotheses across time points. CONCLUSIONS: The TASQ is a brief measure of AS-specific QoL that is sensitive to change in patients undergoing TAVI. Items on the TASQ capture important QoL concerns reported by AS patients, suggesting this is a measure of relevant and meaningful outcomes for this patient population. Detection of early improvements in QoL by the TASQ is promising, with important implications for the evaluation of procedural outcomes in this population.

Efficiency, Safety, and Quality of Life After Transcatheter Aortic Valve Implantation Performed With Moderate Sedation Versus General Anesthesia.

There is growing interest in "minimalist" transcatheter aortic valve implantation (M-TAVI), performed with conscious sedation instead of general anesthesia (GA-TAVI). We assessed the impact of M-TAVI on procedural efficiency, long-term safety, and quality of life (QoL) in 477 patients with severe aortic stenosis (82 years, women 50%, STS 5.0), who underwent M-TAVI (n = 278) or GA-TAVI (n = 199). M-TAVI patients were less likely to have NYHA Class ≥3, valve-in-valve TAVI, and receive self-expanding valves. M-TAVI was completed without conversion to GA in 269 (97%) patients. M-TAVI was more efficient that GA-TAVI including shorter lengths of stay (2 vs 3 days, p <0.0001), higher likelihood of being discharged home (87% vs 72%, p <0.0001), less use of blood transfusions (10% vs 22%, p = 0.0008), inotropes (13% vs 32%, p <0.0001), contrast volume (50 vs 90 ml, p <0.0001), fluoroscopy time (20 vs 24 minute, p <0.0001), and need for >1 valves (0.4 vs 5.5%, p = 0.0004). At 1-month, death/stroke (M-TAVI vs GA-TAVI 4.0 vs 6.5%) and a "safety composite" end point (death, stroke, transient ischemic attack, myocardial infarction, new dialysis, major vascular complication, major or life-threatening bleeding, and new pacemaker: 17.6% vs 21.1%) were similar (p = NS for both). At a median follow-up of 365 days, survival curves showed similar incidence of death/stroke as well as the safety composite end point between the groups. QoL scores were similar at baseline and 1-month after TAVI. In multivariable analyses, M-TAVI showed significant improvements in all parameters of procedural efficiency. In conclusion, M-TAVI is more efficient than GA-TAVI, with similar safety at 1-month and long-term, and similar QoL scores at 1 month.

The Learning Curve for Shared Decision-making in Symptomatic Aortic Stenosis.

Importance: Shared decision-making (SDM) is widely advocated for patients with valvular heart disease yet is not integrated into the heart team model for patients with symptomatic aortic stenosis. Decision aids (DAs) have been shown to improve patient-centered outcomes and may facilitate SDM. Objective: To determine whether the repeated use of a DA by heart teams is associated with greater SDM, along with improved patient-centered outcomes and clinician attitudes about DAs. Design, Setting, and Participants: This mixed-methods study included a nonrandomized pre-post intervention and clinician interviews. It was conducted between April 30, 2015, and December 7, 2017, with quantitative analysis performed between January 12, 2017, and May 26, 2017, within 2 academic medical centers in northern New England among 35 patients with symptomatic aortic stenosis who were at high to prohibitive risk for surgery. The qualitative analysis was performed between August 6, 2018, and May 7, 2019. The Severe Aortic Stenosis Decision Aid was delivered by 6 clinicians, with patients choosing between transcatheter aortic valve replacement and medical management. Main Outcomes and Measures: Clinician SDM performance was measured using the Observer OPTION5 scale with dual-independent coding of audiotaped clinic visits. Previsit and postvisit surveys measured the patient's knowledge, satisfaction, and decisional conflict. Audiotaped clinician interviews were coded, and qualitative thematic analysis was performed. Results: Six male clinicians and 35 patients (19 of 34 women [55.9%; 1 survey was missing]; mean [SD] age, 85.8 [7.8] years) participated in the study. Shared decision-making increased stepwise with repeated use of the DA (mean [SD] Observer OPTION5 scores: usual care, 17.9 [7.6]; first use of a DA, 60.5 [30.9]; fifth use of a DA, 79.0 [8.4]; P < .001 for comparison between usual care and fifth use of DA). Multiple uses of the DA were associated with increased patient knowledge (mean difference, 18.0%; 95% CI, 1.2%-34.8%; P = .04) and satisfaction (mean difference, 6.7%; 95% CI, 2.5%-10.8%; P = .01) but not decisional conflict (mean [SD]: usual care, 96.0% [9.4%]; first use of DA, 93.8% [12.5%]; fifth use of DA, 95.0% [11.2%]; P = .60). Qualitative analysis of clinicians' interviews revealed that clinicians perceived that they used an SDM approach without DAs and that the DA was not well understood by elderly patients. There was infrequent values clarification or discussion of stroke risk. Conclusion and Relevance: In a mixed-methods pilot study, use of a DA for severe aortic stenosis by heart team clinicians was associated with improved SDM and patient-centered outcomes. However, in qualitative interviews, heart team clinicians did not perceive a significant benefit of the DA, and therefore sustained implementation is unlikely. This pilot study of SDM clarifies new research directions for heart teams.

Illness perception in overweight and obese patients with cardiovascular diseases.

OBJECTIVE: This study explored the relationship of illness perception with different aspects of cardiac anxiety, general anxiety and depression in a sample of male and female overweight and obese patients with cardiovascular diseases (CVD). STUDY DESIGN: The clinical sample included 165 adults (113 males) aged from 32 to 89 years. The patients were admitted to the Department of Cardiology and Cardiac Rehabilitation for a major cardiovascular event, acute myocardial infarction or myocardial revascularization. MEASUREMENTS: Psychological measurement included questionnaires of illness perception, cardiac anxiety, general anxiety and depression. RESULTS AND CONCLUSIONS: Illness perception and cardiac anxiety in patients with CVD were associated with anxiety and depression. Regression analysis showed that illness perception accounts for a significant proportion of the variance in both anxiety and depression for males, but not for females. Gender-specific interrelations between perceptions of CVD and indices of mental health have an implication for interventions to maximize the effect of therapy with these patients. LEVEL OF EVIDENCE: Level V, Descriptive study.

Periprocedural Changes in Cognitive Function After Transcatheter and Surgical Aortic Valve Replacement: Results From a Pilot Study Assessing Cognition in Elderly Veterans.

BACKGROUND: There is paucity of data comparing periprocedural changes in cognitive function between surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). METHODS: We enrolled patients with severe aortic stenosis scheduled to undergo TAVR or SAVR at the discretion of the heart team. Participants completed a cognitive battery before and 3 months after TAVR or SAVR, including the Montreal Cognitive Assessment (MoCA), phonemic (letter) verbal fluency, semantic (category) verbal fluency, and the Trail Making test (TMT) A and B. Periprocedural differences in cognition were compared within (pre/post procedure) and between groups using the paired-samples or independent-sample t-test, respectively. The Wilcoxon test was used for non-normally distributed data. RESULTS: Of the 63 patients (95% men) included, a total of 43 underwent TAVR and 20 underwent SAVR. Patients undergoing TAVR were older than SAVR patients (78 ± 8 years vs 70 ± 7 years, respectively; P<.001), but had similar STS surgical risk scores (4.9% vs 4.7%, respectively; P=.79). At baseline, there were no differences in cognition. At 3 months post TAVR or SAVR, there were no significant differences for MoCA blind score (16 ± 3 vs 16 ± 3, respectively; P=.61), correct responses in semantic fluency (15 ± 5 vs 15 ± 6, respectively; P=.93), correct responses in phonemic fluency (30 ± 12 vs 28 ± 15, respectively; P=.87), TMT A completion time (54 sec [IQR, 42-65 sec] vs 31 sec [IQR, 28-69 sec], respectively; P=.07), or TMT B completion time (161 sec [IQR, 118-300 sec] vs 173 sec [IQR, 110-300 sec], respectively; P=.87). CONCLUSIONS: In this pilot observational study, we observed no significant differences in cognition at baseline or 3 months between SAVR and TAVR groups.

Preoperative left atrial minimum volume as a surrogate marker of postoperative symptoms in senile patients with aortic stenosis who underwent surgical aortic valve replacement.

BACKGROUND: Previous reports have shown that postoperative symptoms despite successful surgical aortic valve replacement (AVR) are not uncommon depending on severity of myocardial fibrosis in patients with aortic stenosis (AS). Left atrial minimum volume (LAVmin) at end-diastole determined by direct exposure of left ventricular end-diastolic pressure may be useful as a surrogate marker of postoperative symptoms in patients with AS undergoing AVR. METHODS AND RESULTS: We studied 75 patients with AS who underwent AVR and were followed up to 600 days after AVR. We examined the postoperative symptomatic status which occurred between 60 days to 600 days after AVR. The study patients were divided into 2 groups: 19 patients (25%) with postoperative symptoms (symptomatic group) and 56 without symptoms (asymptomatic group). There were no significant differences in preoperative left ventricular volumes and ejection fraction and AS severity by echocardiography between the two groups. There were significant differences in preoperative echocardiographic LAVmin index (LAVImin) between symptomatic group and asymptomatic group (45±15 vs. 28±11ml/m2). Using receiver operating characteristic curve analysis, LAVImin≥30ml/m2 detected postoperative symptoms with the large area under the curve (0.84) (sensitivity 94% and specificity 68%). In the multivariate analysis, preoperative LAVImin was the independent predictor of the postoperative symptomatic status after AVR (odds ratio: 1.11; 95% CI: 1.04-1.18). CONCLUSIONS: The preoperative echocardiographic LAVImin measurement is useful as a surrogate marker of symptomatic status after AVR in patients with AS.

Cognitive assessment using the revised Hasegawa's dementia scale to determine the mid-term outcomes following transcatheter aortic valve replacement.

BACKGROUND: Several predictors are available to guide patient selection for transcatheter aortic valve replacement (TAVR) to achieve better outcomes, and cognitive function is one of these predictors. This study investigated whether the revised Hasegawa's dementia scale (HDS-R) could independently predict mid-term outcomes following TAVR. METHODS: The study population comprised 455 patients with severe aortic stenosis who underwent TAVR at the Sakakibara Heart Institute between 2010 and 2018. The primary endpoint was all-cause mortality following TAVR. Patients were dichotomized into two groups according to the receiver operating characteristic analysis (HDS-R ≤23 and >23). RESULTS: Patients with HDS-R ≤23 were older, were more frail, were more likely to have peripheral artery disease, had lower serum albumin levels, had lower ejection fractions, and had smaller aortic valve areas than those with HDS-R >23. By definition, 81 of the 455 patients (17.8%) were considered to have dementia (HDS-R ≤20) before TAVR. The discriminatory performance for predicting all-cause mortality at 3 years was greater for dichotomization with 23/24 than that with 20/21 [area under the curve (AUC): 0.63, 95% confidence interval (CI): 0.50-0.76, p=0.047 vs. AUC: 0.52, 95% CI: 0.39-0.65, p=0.713]. From the Kaplan-Meier analysis, patients with HDS-R ≤23 had higher mortality rates than those with HDS-R >23 (86.8±3.3% and 75.4±4.7% at 3 years, respectively; log-rank p=0.001). The multivariate Cox regression analysis found that the HDS-R was independently associated with all-cause mortality (hazard ratio 2.11, 95% CI 1.21-3.69, p=0.008). CONCLUSIONS: Patients with HDS-R ≤23 were sicker and more frail and had greater cognitive impairment. Additionally, HDS-R could independently predict mid-term outcomes following TAVR.

Patients and informal caregivers' experience of surgical and transcatheter aortic valve replacement: Real-world data contributing to establish value-based medicine in Denmark.

BACKGROUND: The concept of value-based medicine (VBM) is increasingly implemented in therapeutic decision-making processes, but only few data on patient-perceived values are available in the field of aortic stenosis treatment. HYPOTHESIS: This study aimed to deliver data on patient-perceived values and health-related quality of life (HR-QoL) following surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) in a real-world, all-comers patient population. METHODS: Questionnaires were sent to 637 patients who had undergone elective AVR 12 to 24 months earlier in the period September 2015 to August 2016. The questionnaires were specifically designed to assess physical and mental impact of the entire AVR process on patients and their nearest relative and to capture HR-QoL. RESULTS: Questionnaires were completed by 429 patients (SAVR: N = 265; TAVR: N = 164). Both physical and mental impact of the intervention and its recovery period were experienced more stressful by SAVR as compared with TAVR patients. Also, nearest relatives of SAVR patients experienced the entire process mentally more stressful and enduring than relatives of TAVR patients. In both groups, 10% of patients reported no change in HR-QoL, whereas HR-QoL improved in 76% vs 83% (P = 0.092) and worsened in 14% vs 7% (P = 0.040) of the SAVR and TAVR populations, respectively. CONCLUSION: The perioperative experience tends to be more stressful for SAVR as compared with TAVR patients; however, HR-QoL finally improves to a similar degree in both groups. Given the increasing importance of VBM, patient-perceived values will have to be considered in future decision-making processes, both at individual and public policy-making level.

Effect of transcatheter aortic valve implantation on health-related quality of life in older adults with multimorbidity.

PURPOSE: The purpose of this study was to determine the effect of transcatheter aortic valve implantation on health-related quality of life in older adults with multimorbidity and to evaluate the predictive factors for postoperative quality of life impairment in such patients. MATERIAL AND METHOD: This study included 141 older adults with severe aortic stenosis scheduled for elective transcatheter aortic valve implantation. Quality of life was examined in all patients using the Short-Form 36 Health Survey Questionnaire, before and 2 years after surgery. Comorbidity was assessed using the Charlson Comorbidity Index. RESULTS: In older adult patients with aortic stenosis and multimorbidity, transcatheter aortic valve implantation significantly improved both physical and mental components of quality of life 2 years after surgery. A Charlson Comorbidity Index ≥5 points was independently associated with the absence of positive dynamics in Physical Health score [odds ratio (OR) 0.38 (0.20-0.75), p = 0.007]. Charlson Comorbidity Index ≥5 points [OR 0.31 (0.19-0.58), p = 0.026] and new-onset arrhythmia [OR 0.54 (0.38-0.78), p = 0.017] were independent predictors of the absence of positive dynamics in Mental Health score after transcatheter aortic valve implantation. CONCLUSIONS: High-level comorbidity (Charlson Comorbidity Index ≥5 points) predicts both Physical and Mental Health scores for quality of life impairment following transcatheter aortic valve implantation in older adults, and new-onset arrhythmia predicts the Mental Health score for quality of life impairment following transcatheter aortic valve implantation in these patients.

Transforming the experience of aortic valve disease in older patients: A qualitative study.

AIM AND OBJECTIVES: To explore patients' lived experiences of daily life and coping with recovery after transcatheter aortic valve implantation (TAVI). BACKGROUND: Transcatheter aortic valve implantation is increasingly used to treat older patients with severe aortic stenosis with high surgical risk. This novel treatment has been shown to be effective in relieving symptoms, improving survival and prognosis, but its impact on patients' daily life has been sparsely explored. DESIGN: Qualitative design. METHODS: Qualitative interviews were conducted in a purposeful sample of ten patients three-four months after TAVI. A phenomenological hermeneutical approach comprised an epistemological stance and Ricoeur's work inspired the qualitative methodological foundation. The study adhered to the COREQ guidelines. RESULTS: This study is illuminating patients' perception of recovery after TAVI. The patients experienced a transformation of bodily sensations, a changed bodily attention and enhanced physical possibilities to cope with life. Undergoing TAVI changed the pre-treatment symptoms that limited daily activities, allowing the patients to resume or participate in activities that were previously impossible. TAVI gives patients the feeling that they can do more than before, which strengthens their faith in the body's possibilities and means that they can live a more self-reliant and independent life. CONCLUSION: For older patients, TAVI can serve to bolster a sense of trusting their own body again. A clear distinction between pre- and post-TAVI is recognised. Patients may be able to resume everyday activities following TAVI. The recovery process, however, must take into account the individual patient's own resources. RELEVANCE TO CLINICAL PRACTICE: The impact of TAVI on daily life activities should be communicated to the patient in decision-making. Recovery depends on the patient's own effort, why identification of the patients who need support for recovery after TAVI as well as differentiated rehabilitation is required. Walking as a parameter should be integrated in the recovery trajectory.

[Dynamics of Quality of Life in Patients With Aortic Stenosis After Aortic Valve Replacement With a Biological or Mechanical Prosthesis].

OBJECTIVE: To assess dynamics of the quality of life (QOL) in patients of the older age group of with initial aortic stenosis in 1, 3, and 5 years after replacement of the aortic valve (AV) with biological or mechanical prosthesis. MATERIALS AND METHODS: QOL was assessed in 282 patients who underwent aortic valve replacement with a biological or mechanical prosthesis. Criterion for inclusion in this retrospective single-center study was primary and elective nature of the operation. Patients with repeated interventions (early postoperative resternotomy, reosteosynthesis, repeat aortic valve surgery) were not included. Using the method of Propensity Score Matching, we distributed 151 patients in whom the long-term results of AV replacement were analyzed according to age, gender, body mass index into groups of AV replacement with biological (group 1, n=74) and mechanical (group 2, n=77) prosthesis. RESULTS: In the early period after operation, there was no significant difference between groups in parameters of quality of life. During the observation period up to 3 years significant increases of parameters bodily pain (BP), vitality (VT), and mental health (MH) occurred in patients with biological prostheses, while physical functioning (PF) was higher in patients with mechanical prostheses. At follow-up to 5 years, indicators such as BP and role emotional functioning (RE) became higher in patients with mechanical prostheses. According to the conducted regression analysis the type of prosthesis affected the quality of life. CONCLUSIONS: 1) AV replacement with mechanical prostheses was associated with lowering of the physical component of health by 81.1%, and of the mental health component - by 56.6% per month; 2) significant difference in QOL between groups of patients with mechanical and biological prostheses could be detected only in 3 years after the operation: parameters BP, VT and MH were significantly higher in patients with biological prostheses, while PF was higher in patients with mechanical prostheses; 3) in the longer observation period (up to 5 years) parameters BP and RE became higher in patients with mechanical prostheses.