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.

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.

Health Status Benefits of Transcatheter vs Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Intermediate Surgical Risk: Results From the PARTNER 2 Randomized Clinical Trial.

Importance: In patients with severe aortic stenosis (AS) at intermediate surgical risk, treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) results in similar 2-year survival. The effect of TAVR vs SAVR on health status in patients at intermediate surgical risk is unknown. Objective: To compare health-related quality of life among intermediate-risk patients with severe AS treated with either TAVR or SAVR. Design, Setting, and Participants: Between December 2011 and November 2013, 2032 intermediate-risk patients with severe AS were randomized to TAVR with the Sapien XT valve or SAVR in the Placement of Aortic Transcatheter Valve 2 Trial and were followed up for 2 years. Data analysis was conducted between March 1, 2016, to April 30, 2017. Main Outcomes and Measures: Health status was assessed at baseline, 1 month, 1 year, and 2 years using the Kansas City Cardiomyopathy Questionnaire (KCCQ) (23 items covering physical function, social function, symptoms, self-efficacy and knowledge, and quality of life on a 0- to 100-point scale; higher scores indicate better quality of life), Medical Outcomes Study Short Form-36 (36 items covering 8 dimensions of health status as well as physical and mental summary scores; higher scores represent better health status), and EuroQOL-5D (assesses 5 dimensions of general health on a 3-level scale, with utility scores ranging from 0 [death] to 1 [ideal health]). Analysis of covariance was used to examine changes in health status over time, adjusting for baseline status. Results: Of the 2032 randomized patients, baseline health status was available for 1833 individuals (950 TAVR, 883 SAVR) who formed the primary analytic cohort. A total of 1006 (54.9%) of the population were men; mean (SD) age was 81.4 (6.8) years. Over 2 years, both TAVR and SAVR were associated with significant improvements in both disease specific (16-22 points on the KCCQ-OS scale) and generic health status (3.9-5.1 points on the SF-36 physical summary scale). At 1 month, TAVR was associated with better health status than SAVR, but this difference was restricted to patients treated via transfemoral access (mean difference in the KCCQ overall summary [KCCQ-OS] score, 14.1 points; 95% CI, 11.7 to 16.4; P < .01) and was not seen in patients treated via transthoracic access (mean difference in KCCQ-OS, 3.5 points; 95% CI, -1.4 to 8.4; P < .01 for interaction). There were no significant differences between TAVR and SAVR in any health status measures at 1 or 2 years. Conclusions and Relevance: Among intermediate-risk patients with severe AS, health status improved significantly with both TAVR and SAVR through 2 years of follow up. Early health status improvement was greater with TAVR, but only among patients treated via transfemoral access. Longer term follow-up is needed to assess the durability of quality-of-life improvement with TAVR vs SAVR in this population. Trial Registration: clinicaltrials.gov Identifier: NCT01314313.

Assessment of quality of life in patients after surgical and transcatheter aortic valve replacement.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) and minimally invasive aortic valve replacement (mini-thoracotomy, mini-sternotomy, MIAVR) have become an appealing alternative to conventional surgical (SAVR) treatment of severe aortic stenosis (AS) in high-risk patients. BACKGROUND: Aim of the study was to evaluate the quality of life (QoL) in patients with AS and treated with transfemoral TAVI, SAVR, mini-thoracotomy and mini-sternotomy. METHODS: One hundred and seventy-three patients with symptomatic AS were enrolled in 2011-2013. TAVI group consisted of 39 patients (22.5%), mini-sternotomy was performed in 44 patients (25.5%), mini-thoracotomy in 50 (29%), and AVR in 40 patients (23%). QoL was assessed perioperatively, 12 and 24 months after aortic valve replacement (AVR) by Minnesota Living with Heart Failure Questionnaire (MLHFQ) and EQ-5D-3L. RESULTS: Median follow-up was 583.5 (IQR: 298-736) days. Improvement of health status after procedure in comparison with pre-operative period was significantly more often reported after TAVI in perioperative period (90.3%; P = 0.004) and 12 months after procedure (100%, P = 0.02). Global MLHFQ, physical and emotional dimension score at 30-day from AVR presented significant improvement after TAVI in comparison with surgical methods (respectively: 8.3(±8.6), P = 0.003; 4.1(±5.9), P = 0.01; 1.5(±2.6), P = 0.005). Total MLHFQ score was significantly lower (better outcome) in TAVI patients 1 year after procedure (4.8(±6.8), P = 0.004), no differences in somatic and emotional component were found. No differences were found in MLHFQ score 24 months after AVR. Data from EQ-D5-3L questionnaire demonstrated significant improvement of QoL at 30-day follow-up after TAVI in comparison with surgical methods (1.2(±1.7), P = 0.0008). CONCLUSIONS: TAVI improves QoL in perioperative and 12 months observation in comparison with mini-thoracotomy, mini-sternotomy and SAVR. Improvement in QoL was obtained in both generic and disease specific questionnaires. © 2016 Wiley Periodicals, Inc.

Use of the Kansas City Cardiomyopathy Questionnaire for monitoring health status in patients with aortic stenosis.

BACKGROUND: Improving functional status and quality of life are important goals of treatment for patients with severe aortic stenosis. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a heart failure health status measure and has been used in studies of patients with aortic stenosis. However, its psychometric properties have not yet been evaluated in these patients. METHODS AND RESULTS: We analyzed data from 955 patients, enrolled in the PARTNER trial of transcatheter aortic valve replacement, to evaluate the reliability, responsiveness, validity, and prognostic importance of the KCCQ in patients with severe aortic stenosis. The KCCQ was administered at baseline and at 1, 6, and 12 months after randomization to medical therapy, transcatheter aortic valve replacement, or surgical valve replacement. Among clinically stable patients, there were only small changes in the KCCQ domain scores over time (mean differences 0.1-4.2 points), and the intraclass correlation coefficients showed good agreement between paired assessments (0.65-0.76). However, the domain scores of patients who underwent transcatheter aortic valve replacement showed large changes after treatment (mean differences 13-30 points). Construct validity was demonstrated by comparing each domain against a relevant reference measure (Spearman correlations 0.46-0.69). Finally, among 157 patients randomized to medical management, lower KCCQ overall summary scores at baseline were strongly associated with an increased risk of mortality during the following 12 months. CONCLUSIONS: The KCCQ is a highly reliable, responsive, and valid measure of symptoms, functional status, and quality of life in patients with severe, symptomatic aortic stenosis.

Lack of social participation or religious strength and comfort as risk factors for death after cardiac surgery in the elderly.

The purpose of this study was to examine the relationship of social support and religion to mortality after elective open heart surgery in older patients. Of the 232 patients included in the study, 21 died within 6 months of surgery. Three biomedical variables were significant predictors of mortality and selected as adjustment variables for a multivariate analysis: history of previous cardiac surgery; greater impairment in presurgery basic activities of daily living; and older age. Among the social support and religion variables, two were consistent predictors of mortality in the multivariate analyses: lack of participation in social or community groups and absence of strength and comfort from religion. These results suggest that in older persons lack of participation in groups and absence of strength and comfort in religion are independently related to risk for death during the 6-month period after cardiac surgery.