Five-Year Clinical and Quality of Life Outcomes From the CoreValve US Pivotal Extreme Risk Trial

2021 ◽  
Author(s):  
Suzanne V. Arnold ◽  
George Petrossian ◽  
Michael J. Reardon ◽  
Neal S. Kleiman ◽  
Steven J. Yakubov ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Kansas City ◽  
Severe Aortic Stenosis ◽  
Summary Score ◽  
Kansas City Cardiomyopathy Questionnaire ◽  
Surgical Risk ◽  
Extreme Risk ◽  
Major Stroke

Background: Older adults with comorbidities who are at extreme risk for surgical aortic valve replacement may be appropriate candidates for transcatheter aortic valve replacement (TAVR). We present the 5-year clinical, echocardiographic, and health status outcomes of such patients treated with CoreValve self-expanding supra-annular TAVR. Methods: The CoreValve US Extreme Risk Pivotal Trial was a prospective, nonrandomized, single-arm clinical trial of TAVR at 41 sites in the United States. The primary outcome was all-cause mortality or major stroke. Secondary outcomes included echocardiographic parameters and patient-reported health status, assessed with the Kansas City Cardiomyopathy Questionnaire. Results: Between February 2011 and August 2012, 639 patients with severe aortic stenosis at extreme surgical risk underwent attempted TAVR (mean age 82.8±8.4 years, 53% women, mean Society of Thoracic Surgeons Predicted Risk of Mortality 10.4±5.6%, 77% iliofemoral access). The 5-year Kaplan-Meier rate of death or major stroke was 72.6% ([95% CI, 68.4%–76.7%]; death 71.6%, major stroke 11.5%), with no significant differences according to access site. Among patients who survived 5 years, mean transvalvular gradient was 7.5±5.9 mm Hg, and 3.1% had moderate or severe aortic regurgitation. Health status measures improved significantly by 1 month after TAVR through 1 year (mean change in Kansas City Cardiomyopathy Questionnaire–Overall Summary score 24.8 points [95% CI, 22.4–27.2]). Beyond 1 year, the Kansas City Cardiomyopathy Questionnaire–Overall Summary score decreased gradually but remained significantly improved from pre-TAVR through 5 years of follow-up among surviving patients (mean change from baseline, 14.3 points [95% CI, 10.7–17.9]). Conclusions: Patients with severe aortic stenosis at extreme surgical risk who are treated with self-expanding supra-annular TAVR have high 5-year mortality. However, the short-term benefits of TAVR in terms of valve hemodynamics and quality of life are mostly preserved among surviving patients at 5 years, thereby supporting the continued use of TAVR in these challenging patients. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01240902.

Abstract 27: Impact of Telemonitoring on Health Status in Patients with Heart Failure

2013 ◽  
Vol 6 (suppl_1) ◽  
Author(s):  
Natalie Jayaram ◽  
Harlan M Krumholz ◽  
Sarwat I Chaudhry ◽  
Jennifer Mattera ◽  
Fengming Tang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Health Status ◽  
Usual Care ◽  
Primary Endpoint ◽  
Kansas City ◽  
Summary Score ◽  
Care Group ◽  
Patients With Heart Failure

Background: Although telemonitoring in patients with heart failure is not effective in reducing mortality or hospitalizations, less is known regarding its effect on patients’ health status, their symptoms, functioning and quality of life. Methods: The TeleHF study randomized 1,653 patients with recent heart failure hospitalization to telephonic monitoring (n=826) or usual care (n=827). Patients in the telemonitoring arm phoned in daily and responded to a series of automated questions regarding their symptoms and daily weight. Health status information, using the Kansas City Cardiomyopathy Questionnaire (KCCQ), was collected at baseline, 3 months, and at 6 months. The primary endpoint was change in KCCQ score from baseline to 3 and 6 months. Results: The baseline characteristics of the two treatment arms were similar; 42% were female and 39% were black. At baseline, there were no significant differences in KCCQ scores between the telemedicine and the usual care group. Both groups reported significant quality of life limitations with median KCCQ score of 59.9, and median scores of 75.0, 87.5 and 56.3 on the physical limitation, self-efficacy and social limitation subscales respectively. At 3 and 6 month follow-up, there were no significant differences between the two treatment groups with respect to the primary endpoint, change in KCCQ overall summary score or subscale scores from baseline (see table). Conclusion: Telemonitoring in a large group of patients with heart failure did not improve health status when compared to usual care. Failure to improve readmission or mortality rates combined with lack of effect on quality of life suggests that alternative solutions for management of this complex population should be sought.

scholarly journals Empagliflozin, Health Status, and Quality of Life in Patients with Heart Failure and Preserved Ejection Fraction: The EMPEROR-Preserved Trial

Circulation ◽  
2021 ◽  
Author(s):  
Javed Butler ◽  
Gerasimos Filippatos ◽  
Tariq Jamal Siddiqi ◽  
Martina Brueckmann ◽  
Michael Böhm ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Health Status ◽  
Ejection Fraction ◽  
Kansas City ◽  
Cardiovascular Death ◽  
Summary Score ◽  
Preserved Ejection Fraction ◽  
Patients With Heart Failure

Background: Patients with heart failure and preserved ejection fraction (HFpEF) have significant impairment in health-related quality of life (HRQoL). In EMPEROR-Preserved, we evaluated the efficacy of empagliflozin on HRQoL in patients with HFpEF and whether the clinical benefit observed with empagliflozin varies according to baseline health status. Methods: HRQoL was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, 12, 32 and 52 weeks. Patients were divided by baseline KCCQ Clinical Summary Score (CSS) tertiles and the effect of empagliflozin on outcomes were examined. The effect of empagliflozin on KCCQ-CSS, Total Symptom Score (TSS) and Overall Summary Score (OSS) were evaluated. Responder analyses were performed to compare the odds of improvement and deterioration in KCCQ related to treatment with empagliflozin. Results: The effect of empagliflozin on reducing the risk of time to cardiovascular death or HF hospitalization was consistent across baseline KCCQ-CSS tertiles (HR 0.83 [0.69-1.00], HR 0.70 [0.55-0.88] and HR 0.82 [0.62-1.08] for scores <62.5, 62.5-83.3 and ≥83.3, respectively; P trend=0.77). Similar results were seen for total HF hospitalizations. Patients treated with empagliflozin had significant improvement in KCCQ-CSS versus placebo (+1.03, +1.24 and +1.50 at 12, 32 and 52 weeks, respectively P<0.01); similar results were seen for TSS and OSS. At 12 weeks, patients on empagliflozin had higher odds of improvement ≥5 points (OR 1.23; 95%CI 1.10, 1.37), ≥10 points (1.15; 95%CI 1.03, 1.27), and ≥15 points (1.13; 95%CI 1.02, 1.26) and lower odds of deterioration ≥5 points in KCCQ-CSS (0.85; 95%CI 0.75, 0.97). A similar pattern was seen at 32 and 52 weeks, and results were consistent for TSS and OSS. Conclusions: In patients with HFpEF, empagliflozin reduced the risk for major HF outcomes across the range of baseline KCCQ scores. Empagliflozin improved HRQoL, an effect that appeared early and was sustained for at least one year.

Abstract 131: Shared Medical Appointments for Heart Failure Patients Improve Cardiac Health Status

2015 ◽  
Vol 8 (suppl_2) ◽  
Author(s):  
Sandesh Dev ◽  
Kathryn E Williams ◽  
Helen M Hatseras ◽  
Matthew Weyer ◽  
Sona S Hepfinger ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Health Status ◽  
Physical Function ◽  
Summary Score ◽  
Shared Medical Appointments ◽  
Group Visits ◽  
Average Change ◽  
Specific Health

Objective: Heart Failure Shared Medical Appointments (HF SMAs) are group visits in which several HF patients are treated by a clinician(s) at the same time. This intervention is a system redesign that addresses growing health system and patient care burdens in chronic HF management. Group visits have been associated with greater adherence to select HF medications and hospitalization-free survival during the intervention. However, there is little data on patient-reported outcomes such as HF-specific health status, an important outcome that quantifies the impact of the patient’s HF on his or her life. The objective of this pilot study is to determine whether HF SMA is associated with a change in HF-specific health status. The short version Kansas City Cardiomyopathy Questionnaire (KCCQ-12) measures HF-specific health status, including symptoms, physical and social function, and quality of life. Methods: We retrospectively collected patient characteristics by review of medical records for all patients in a VA hospital that completed the full HF SMA intervention (4 visits across 8 weeks). Each patient completed the KCCQ-12 at the beginning of each clinic visit. The primary outcome was change in KCCQ Summary Score(range 0 to 100; higher scores indicate better health status; 5 points is a clinically meaningful change). The secondary outcome was change in KCCQ subscales. Results: Twenty-eight patients (median age 64, median LVEF 35%) completed all four HF SMA visits. The mean KCCQ at baseline was 51. From pre- to post-SMA, the average change in KCCQ-12 Summary Score was +8 (p=0.001). The Quality of Life Subscale was associated with the greatest change (average change,+15, p=0.0003), followed by Symptom Scale (average change +10, p=0.002). There was no significant change in Social Limitation (average change +6, p=0.08) or Physical Function (average change +2, p=0.48). Conclusions: Preliminary findings suggest that a novel group intervention in patients with HF is associated with mild to moderate clinically significant changes in HF-specific health status. Further, HF SMA appears to specifically improve quality of life and symptoms more than physical function. Future clinical trials will be required to determine how these improvements compare to usual care.

scholarly journals Quality of life and disease experience in patients with heart failure with reduced ejection fraction in Spain: a mixed-methods study

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e053216
Author(s):  
Raül Rubio ◽  
Beatriz Palacios ◽  
Luis Varela ◽  
Raquel Fernández ◽  
Selene Camargo Correa ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Ejection Fraction ◽  
Kansas City ◽  
Mixed Methods Study ◽  
Kansas City Cardiomyopathy Questionnaire ◽  
Reduced Ejection Fraction ◽  
Patients With Heart Failure ◽  
Disease Experience

ObjectivesTo gather insights on the disease experience of patients with heart failure (HF) with reduced ejection fraction (HFrEF), and assess how patients’ experiences and narratives related to the disease complement data collected through standardised patient-reported outcome measures (PROMs). Also, to explore new ways of evaluating the burden experienced by patients and caregivers.DesignObservational, descriptive, multicentre, cross-sectional, mixed-methods study.SettingSecondary care, patient’s homes.ParticipantsTwenty patients with HFrEF (New York Heart Association (NYHA) classification I–III) aged 38–85 years.MeasuresPROMs EuroQoL 5D-5L (EQ-5D-5L) and Kansas City Cardiomyopathy Questionnaire and patient interview and observation.ResultsA total of 20 patients with HFrEF participated in the study. The patients’ mean (SD) age was 72.5 (11.4) years, 65% were male and were classified inNYHA functional classes I (n=4), II (n=7) and III (n=9). The study showed a strong impact of HF in the patients’ quality of life (QoL) and disease experience, as revealed by the standardised PROMs (EQ-5D-5L global index=0.64 (0.36); Kansas City Cardiomyopathy Questionnaire total symptom score=71.56 (20.55)) and the in-depth interviews. Patients and caregivers often disagreed describing and evaluating perceived QoL, as patients downplayed their limitations and caregivers overemphasised the poor QoL of the patients. Patients related current QoL to distant life experiences or to critical moments in their disease, such as hospitalisations. Anxiety over the disease progression is apparent in both patients and caregivers, suggesting that caregiver-specific tools should be developed.ConclusionsPROMs are an effective way of assessing symptoms over the most recent time period. However, especially in chronic diseases such as HFrEF, PROM scores could be complemented with additional tools to gain a better understanding of the patient’s status. New PROMs designed to evaluate and compare specific points in the life of the patient could be clinically more useful to assess changes in health status.

scholarly journals Quality of life status determinants in hypertrophic cardiomyopathy as evaluated by the Kansas City Cardiomyopathy Questionnaire

2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Razvan Capota ◽  
Sebastian Militaru ◽  
Alin Alexandru Ionescu ◽  
Monica Rosca ◽  
Cristian Baicus ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Hypertrophic Cardiomyopathy ◽  
Pulmonary Artery ◽  
Kansas City ◽  
Nyha Class ◽  
Systolic Pressure ◽  
Pulmonary Artery Systolic Pressure ◽  
Kansas City Cardiomyopathy Questionnaire ◽  
Health Related

Abstract Purpose The present study evaluated how heart failure (HF) negatively impacts health-related quality of life (HRQoL) in hypertrophic cardiomyopathy (HCM) patients and explored the major clinical determinants associated with HRQoL impairment in this population. Methods This was a cross-sectional single-center study of health-related HRQoL that included 91 consecutive patients with HCM. Evaluation was performed based on a comprehensive protocol that included the recommended diagnostic studies, as well as administration of the translated validated version of the Kansas City Cardiomyopathy Questionnaire (KCCQ) (CV Outcomes Inc) as a health status measure. Results The cohort included 52 (57%) males, median age 58 (20–85) years. The median global KCCQ score was 67 (12.5–100) corresponding to a moderate impairment in HRQoL. There was an inverse correlation between the median global KCCQ score and NYHA class (Kendall’s tau b coefficient r − 0.33, p = 0.001). Patients with pulmonary hypertension (PHT), defined as resting pulmonary artery systolic pressure of ≥ 45 mmHg, presented a significantly worse HRQoL as compared to those without PHT (median KCCQ score 56.2 vs 77.5, p = 0.013). The KCCQ score mildly correlated with age (r − 0.18, p = 0.014), history of syncope (r − 0.18, p = 0.045), estimated glomerular filtration rate (eGFR) (r 0.31, p < 0.001), plasmatic creatinine (r − 0.18, p = 0.017) and urea levels (r − 0.27, p < 0.001), left ventricular (LV) end-systolic dimensions (r − 0.18, p = 0.014), maximal provoked intraventricular gradient (r 0.20, p = 0.039), LV ejection fraction (r 0.15, p = 0.04), average E/e′ (r − 0.16, p = 0.039), pulmonary acceleration time (r 0.21, p = 0.007), pulmonary artery systolic pressure (r − 0.20, p = 0.016). In ordinal regression, the independent predictors of HRQoL were NYHA class and eGFR. Conclusions Patients with HCM and HF present a moderate degree of alteration in HRQoL. This is especially true for patients with PHT and more severe functional impairment. Renal failure and NYHA class are potential markers of HRQoL in clinical practice.

4071Early changes in quality of life after transcatheter aortic valve replacement: One-year results from the 3M TAVR Study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Lauck ◽  
D A Wood ◽  
S J Baron ◽  
B Borregaard ◽  
H Wijeysundera ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Kansas City ◽  
Clinical Pathways ◽  
Summary Score ◽  
Transcatheter Aortic Valve

Abstract Background In patients with severe calcific aortic stenosis, transcatheter aortic valve replacement (TAVR) has been shown to significantly improve quality of life (QOL). However, changes in QOL at early follow-up (<1 month), and following next-day discharge are poorly understood. Methods A total of 411 patients at 13 centers were enrolled in the Multimodality, Multidisciplinary but Minimalist TAVR (3M TAVR) study in 2015–2017. QOL was evaluated using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) in participants with a baseline score and at least one score at 2 weeks, 30 days and 1 year. Study endpoints were change in (1) KCCQ-Overall Summary Score (KCCQ-OS) and (2) minimal clinically important differences (MCID). Mixed effects models were used to explore patterns of change from baseline, with fixed terms for time, status at 1-year and their interaction terms, and a random intercept for subject to account for within subject correlation. Descriptive statistics were used to report MCID. Results Data were available for 358 (87.1%) participants. 216 (60.3%) were men with a median age 84.0 and STS 5.0 There was significant increase in QOL 2 weeks after TAVR (p≤0.01), and further significant improvement at the 1-month timepoint (p<0.01) for participants who were alive at 1 year. Sex, age category, and STS score category did not have a significant effect on the change in QOL (p>0.05). In the first 2 weeks, moderate (10–20 points) and large (>20 points) improvements were observed in 19.9% and 49.0% of the surviving patients, respectively; at 1-year, similar MCID were seen in 14.6% and 64.0% respectively. Figure 1 Conclusion This is the first study to report significant increase in QOL 2 weeks after TAVR, with sustained improvement during the first year in patients treated with the Vancouver TAVR Clinical Pathway with a goal of next-day discharge. Further studies are necessary to determine whether alternative TAVR clinical pathways yield similar findings. Acknowledgement/Funding Investigator-initiated unrestricted research grant, Edwards

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