Disease-specific Health Status Research Articles

Health Status Changes and Outcomes in Patients With Heart Failure and Mitral Regurgitation: COAPT Trial

BackgroundIn the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial, transcatheter mitral valve repair (TMVr) with the MitraClip rapidly improved health status and reduced the long-term risks for death and heart failure (HF) hospitalization in patients with HF and severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated guideline-directed medical therapy (GDMT). ObjectivesThe aim of this study was to examine if early health status changes were associated with long-term clinical outcomes in the COAPT population. MethodsThe association between change in health status (Kansas City Cardiomyopathy Questionnaire overall summary score [KCCQ-OS]) from baseline to 1 month and the composite rate of death or HF hospitalization between 1 month and 2 years in the COAPT trial were evaluated, and whether treatment (TMVr or GDMT alone) modified this association was tested. ResultsAmong 551 patients with HF and severe secondary mitral regurgitation who were alive at 1 month, those randomized to TMVr were more likely than those randomized to GDMT alone to achieve a ≥10-point improvement in KCCQ-OS from baseline to 1 month (TMVr, 58%; GDMT alone, 26%). Early improvement in KCCQ-OS was inversely associated with the risk for death or HF hospitalization between 1 month and 2 years (p < 0.001). When analyzed as a continuous variable, a 10-point increase in KCCQ-OS was associated with a 14% lower risk for death or HF hospitalization (hazard ratio: 0.86; 95% confidence interval: 0.81 to 0.92; p < 0.001), with no significant interaction with treatment group (pinteraction = 0.17). After adjusting for demographic and clinical factors, the association between change in KCCQ-OS and outcomes was strengthened (hazard ratio: 0.79; 95% confidence interval: 0.73 to 0.86; p < 0.001). ConclusionsIn patients with HF and severe secondary mitral regurgitation, a short-term change in disease-specific health status was strongly associated with the subsequent long-term risk for death or HF hospitalization. These findings reinforce the prognostic utility of serial KCCQ-OS assessments to identify patients at risk for poor long-term clinical outcomes in this population. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial]; NCT01626079)

Can Nose Scale Be Used as a Predictor of Successful Surgery in Patients Undergoing Septoplasty.

The complaint of nasal obstruction or difficulty in nasal breathing is highly subjective. The benefits of surgery vary depending upon patient perception and satisfaction. Along with objective methods like nasal endoscopy improvement in subjective score of patients symptoms is definitely an important outcome parameter of management. Assessing the disease specific quality of life outcomes of patients undergoing septoplasty by means of a questionnaire using nose scale and correlating it with diagnostic nasal endoscopic findings and clinical examination thirty patients above 17years of age, with anatomical deviation of the nasal septum as the sole cause of obstruction and symptoms persisting for more than 3months, underwent septoplasty. Degree of septal deviation was classified as per Mladina classification. Patients Nasal Obstruction & Symptom Evaluation (NOSE) score were documented preoperatively and postoperatively and analysed. In our study it was found that there was significant improvement in nose scores which correlated with the improvement in nasal endoscopic findings. Use of NOSE score will help in letting the patient know his expected outcome following septoplasty and can be used as a predictor of successful surgery/an adjunct to clinical examination and nasal endoscopy in patients undergoing septoplasty. Disease specific health status instruments like Nose scale are needed along with objective outcome measures to compare disease-specific health status and symptom severity in patients before and after treatment. Similarly it could be used to assess differences in outcome when different surgical techniques are used. These subjective scales like nose scale can be used as along with to clinical examination and nasal endoscopy in the management of patients undergoing septoplasty.

Economic Analysis of Surgical and Interventional Treatments for Patients with Complex Coronary Artery Disease: Insights from a One-Year Single-Center Study

BackgroundSurgical treatment methods for patients with complex coronary artery disease (CAD) who have undergone vascular reconstruction mainly include coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI). The purpose of the study aimed to compare a 1-year follow-up for the patient clinical outcomes and costs between PCI and CABG treatment.Material/MethodsThere were 840 patients enrolled in this study from July 2015 to September 2016. Among the study participants, 420 patients underwent PCI treatment and 420 patients underwent off-pump CABG. Patients costs were assessed from the perspective of the China healthcare and medical insurance system. EuroQOL 5-dimension 3 levels (EQ-5D-3L) questionnaire was used to evaluate the general health status, and the Seattle Angina Questionnaire (SAQ) was used to assess the disease-specific health status.ResultsAfter a 1-year follow-up, the all-cause mortality (P=0.0337), the incidence of major adverse cardiac and cerebrovascular events (P<0.001), and additional revascularization (P<0.001) in PCI group were significantly higher than those in CABG group. Both groups have significant sustained benefits in the SAQ subscale. The CABG group had a higher score on the frequency of angina than the PCI group. In addition, the quality-adjusted life year value of PCI and CABG resulted was 0.8. The average total cost for PCI was $14 643 versus CABG cost of $13 842 (P=0.0492).ConclusionsIn the short-term, among the CAD patients with stable triple-vessel or left-main, costs and clinical outcomes are substantially higher for CABG than PCI. Long-term, economic, and health benefits analysis, is warranted.

Does the Reflux Symptom Index Predict Increased Pharyngeal Events on HEMII-pH Testing and Correlate with General Quality of Life?

To determine the ability of the reflux symptom index (RSI) to predict objective impedance and pH-probe testing, and to examine the relationship between disease-specific and general health status in patients diagnosed with laryngopharyngeal reflux (LPR). Adults presenting to a tertiary care academic center with a primary voice complaint completed the RSI and the Patient-Reported Outcomes Measurement Information System 10-item global health instrument (PROMIS). An RSI score ≥13 was considered abnormal. Objective testing for LPR was performed using hypopharyngeal-esophageal multichannel intraluminal impedance catheter with dual pH (HEMII-pH) testing; a positive test was defined as more than one pharyngeal impedance events over 24 hours. Spearman rho analyses were applied, and the sensitivity and specificity of the RSI to detect HEMII-pH findings were determined. One hundred four patients underwent HEMII-pH testing. Mean scores were 16.7 (95%CI 15.1-18.3) for RSI. Sixty-three (60.6%) patients were diagnosed with LPR by HEMII-pH testing. RSI scores were moderately correlated with PROMIS physical (Spearman rho 0.43, P < 0.0001), social (Spearman rho 0.33, P < 0.0001) and mental health (Spearman rho 0.33, P < 0.0001) scores. The RSI has a sensitivity and specificity of 66.7% and 31.7%, respectively, for detecting pharyngeal events on HEMII-pH testing. There is moderate sensitivity and lack of specificity of the RSI for detecting increased pharyngeal reflux events. Reflux-specific and general health status instruments are correlated. Further investigation could assess the diagnostic ability of RSI compared proximal reflux events on HEMII-pH, as well as whether health status instruments can be used to detect clinically meaningful change in the LPR population.

Association Between Diastolic Dysfunction and Health Status Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement

ObjectivesThe aim of this study was to assess the association of baseline left ventricular diastolic dysfunction (LVDD) with health status outcomes of patients undergoing transcatheter aortic valve replacement (TAVR). BackgroundAlthough LVDD in patients with aortic stenosis is associated with higher mortality after TAVR, it is unknown if it is also associated with health status recovery. MethodsIn a cohort of 304 patients with interpretable echocardiograms, undergoing TAVR, LVDD was categorized at baseline as absent (grade 0), mild (grade 1), moderate (grade 2), or severe (grade 3). Disease-specific health status was assessed using the 12-item Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) at baseline and at 1-month and 12-month follow-up. Association of baseline LVDD with health status at baseline and follow-up after TAVR was assessed using a linear trend test, and association with health status recovery (change in KCCQ-OS) was examined using a linear mixed model adjusting for baseline KCCQ-OS. ResultsTwenty-four (7.9%), 54 (17.8%), 186 (61.2%), and 40 (13.2%) patients had LVDD grades of 0, 1, 2, and 3, respectively. Baseline KCCQ-OS was 61.3 ± 22.7, 51.0 ± 26.1, 44.7 ± 25.7, and 44.4 ± 21.9 (p = 0.004) in patients with LVDD grades of 0, 1,2 and 3. At 1 and 12 months after TAVR, LVDD was not associated with KCCQ-OS. Recovery in KCCQ-OS after TAVR was substantial and similar in patients across all severities of LVDD. ConclusionsAlthough LVDD is associated with health status prior to TAVR, patients across all severities of LVDD have similar recovery in health status after TAVR.

Effects of Dapagliflozin on Biomarkers, Symptoms and Functional Status in Patients with Heart Failure with Reduced Ejection Fraction with and without Diabetes - The Define-HF Trial

Background Three large cardiovascular outcome trials of patients with type 2 diabetes (T2D) found a reduction in hospitalizations for heart failure (HF) in patients treated with SGLT2i. However, a majority of patients in these trials did not have manifest HF, and those that did were not well characterized. Consequently, the effects of SGLT-2i in patients with established HF, specifically HF with reduced ejection fraction (HFrEF), including those with and without T2DM, have not been examined in a dedicated trial. Methods The effects of dapagliflozin on biomarkers, symptoms, and functional status in patients with HFrEF (DEFINE-HF) is a 12-week multi-center, randomized, double-blind, placebo-controlled trial. From March 2016 to March 2019, 263 patients from 26 US centers were randomized 1:1 to dapagliflozin 10 mg or matching placebo. Patients with or without T2D, with LVEF ≤40%, EGFR ≥30 mL/min/m2, and NTproBNP ≥400 pg/mL were eligible for inclusion. Co-primary end points were (1) change in NTproBNP and (2) composite of proportion of patients with ≥ 5point increase in the HF disease-specific health status (assessed using KCCQ) or ≥ 20% decrease in NTproBNP over 12 weeks. Key secondary endpoints included functional status based on 6-minute walk test, and change in KCCQ. Exploratory endpoints included hospitalizations for HF and urgent HF visits. Results Enrollment in DEFINE-HF was completed in March 2019, with last visit scheduled in June. Baseline characteristics are consistent with other trials of high risk HFrEF patients, and are shown in the Table. Topline study results will be available in July 2019, in time for presentation at HFSA 2019. Conclusion DEFINE-HF is the first dedicated multi-center randomized double-blind placebo-controlled trial of SGLT-2i in patients with established HFrEF with and without T2D. It will assess whether the SGLT2i dapagliflozin improves HF biomarkers, symptoms and functional status in this high-risk patient population.

Financial barriers in accessing medical care for peripheral artery disease are associated with delay of presentation and adverse health status outcomes in the United States.

Patient-reported difficulties in affording health care and their association with health status outcomes in peripheral artery disease (PAD) have never been studied. We sought to determine whether financial barriers affected PAD symptoms at presentation, treatment patterns, and patient-reported health status in the year following presentation. A total of 797 United States (US) patients with PAD were identified from the Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) study, a prospective, multicenter registry of patients presenting to vascular specialty clinics with PAD. Financial barriers were defined as a composite of no insurance and underinsurance. Disease-specific health status was measured by Peripheral Artery Questionnaire (PAQ) and general health-related quality of life was measured by EuroQol 5 (EQ5D) dimensions at presentation and at 3, 6, and 12 months of follow-up. Among 797 US patients, 21% (n = 165) of patients reported financial barriers. Patients with financial barriers presented at an earlier age (64 ± 9.5 vs 70 ± 9.4 years), with longer duration of symptoms (59% vs 49%) (all p ⩽ 0.05), were more depressed and had higher levels of perceived stress and anxiety. After multivariable adjustment, health status was worse at presentation in patients with financial barriers (PAQ: -7.0 [-10.7, -3.4]; p < 0.001 and EQ5D: -9.2 [-12.74, -5.8]; p < 0.001) as well as through 12 months of follow-up (PAQ: -8.4 [-13.0, -3.8]; p < 0.001 and EQ5D: -9.7 [-13.2, -6.2]; p < 0.001). In conclusion, financial barriers are associated with later presentation as well as poorer health status at presentation and at 12 months. ClinicalTrials.gov Identifier: NCT01419080.

125. The use of combinatorial supervised machine learning and wearable sensors to objectively measure activities of daily living from the Oswestry Disability Index

BACKGROUND CONTEXT Disease specific health status is measured using survey-based patient-reported outcomes (PROs) (eg, Oswestry Disability Index, ODI) including questions about walking, sitting, standing, traveling (driving) and sleeping (lying down). However, survey data are difficult to collect routinely and subject to multiple biases. Multiple sensor and rules-based algorithms have shown positive predictive values (PPV) greater than 85% for key functional metrics such as walking, jogging, sitting and lying down in a laboratory setting, suggesting the potential to assess measured function rather than reported function. The purpose of this study is to test the predictive capability of a single wearable sensor containing a high-end inertial measurement unit (IMU) for core elements of the ODI survey in a real-world setting. PURPOSE To determine the feasibility of using a single wearable sensor in a real-world environment to measure a subset of activities in the ODI. STUDY DESIGN/SETTING Technology feasibility. PATIENT SAMPLE Five healthy volunteers willing to wear a sensor and undergo a 60-minute activity protocol. OUTCOME MEASURES Sensor generated predictions of activity measured at the 5 ms boundary. METHODS Training data were generated from five healthy volunteers wearing a single navigation-grade IMU (SBG Systems Ellipse2-N) for 60 minutes in a real-world environment. Volunteers were asked to sit, stand, lie supine, drive and walk in an unscripted manner. Data were continuously recorded at 200Hz. A combinatorial learning approach utilized multinomial logistic regression (MLR) to classify posture and sleeping results before feeding into a layer of support-vector-machines (SVM). Twenty percent of the data were held out for testing. RESULTS A total of 1,989,878 data points were analyzed from five healthy volunteers. After the two layers (MLR followed by SVM), accuracy was found to be 98.6% across all activities. Positive predictive values were 98.4% for walking, 97.8% for sitting, 98.5% for driving, 100% for lying and 97.9% for standing. CONCLUSIONS The use of a high-end IMU combined with machine learning algorithms to classify a subset of ODI activities in a real-world setting achieved greater accuracy than multiple sensors and rules-based algorithms reported in prior studies. This type of technology offers the potential for measured function to replace or supplement patient-reported function for key patient-centric activities routinely considered reflective of health status. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

710-P: The Relationship between Health Literacy, Cardiovascular Disease Knowledge, and Diabetes Prevention Knowledge in Middle Eastern Patients at a Free Clinic

This study's purpose was to investigate the level of health literacy, cardiovascular disease (CVD) knowledge and diabetes prevention knowledge, as well as the relationship among them, in the Middle Eastern population. A survey was conducted among the Middle Eastern patients of a free health clinic to obtain information on the health literacy and knowledge of these patients. A total of 73 surveys were collected and analyzed in this study. Print literacy and numeracy were strongly correlated with each other (r=0.4949, P&amp;lt;0.0001). Both print literacy and numeracy were significantly correlated with the Diabetes Prevention knowledge score (print literacy: r=0.2764, P=0.0179; numeracy: r=0.4110, P=0.0003), but not with the CVD knowledge score. The Diabetes Prevention knowledge score had a high correlation with the CVD knowledge score (r=0.6980, P&amp;lt;0.0001). Furthermore, print literacy was significantly associated with self-reported health status (r=0.2637, P=0.0242). Our results support that health literacy was associated with some disease-specific knowledge and self-reported health status in the Middle Eastern population. Future research that includes measures of health behaviors and objective measure of health status could help provide more insight into the interactions between these variables in this understudied population. Disclosure C. Kawata: None. L. Jiang: None.

Thirty-Day Hospital Readmission After Acute Myocardial Infarction in China.

Background Readmission after acute myocardial infarction in low- and middle-income countries like China is not well characterized. Methods and Results We approached consecutive patients with acute myocardial infarction hospitalized within 24 hours of symptom onset and discharged alive from 53 geographically diverse hospitals in China. We described rates of unplanned 30-day readmission, their timing and admitting diagnoses, and fit Cox proportional hazards models to identify factors associated with readmission. Among 3387 patients, median (interquartile range) age was 61 (52-69) years, and 76.9% were men. The index median length of stay was 11 (8-14) days. Unplanned 30-day readmission occurred in 6.3% of the cohort; most readmissions (77.7%) were for cardiovascular diagnoses. Nearly half (41.9% of all-cause readmissions; 44.3% of cardiovascular readmissions) occurred within 5 days of discharge. Mini-Global Registry of Acute Coronary Events scores at admission (hazard ratio [HR], 1.15 for every 10-point increase; 95% CI, 1.05-1.25), longer length of stay (HR, 1.03; 95% CI, 1.00-1.06 for each extra day), and in-hospital recurrent angina (HR, 1.40; 95% CI, 1.04-1.89) were associated with higher unplanned all-cause readmission. Revascularization during the index hospitalization (70.2% of the cohort) was associated with lower risks of all-cause readmission (HR, 0.27; 95% CI, 0.18-0.42). In addition, left ventricular ejection fraction <0.4 (HR, 1.79; 95% CI, 1.05-3.07) and in-hospital complication (HR, 1.20; 95% CI, 1.03-1.39) were associated with higher risk of unplanned cardiovascular readmission, and ST-segment-elevation myocardial infarction (HR, 0.60; 95% CI, 0.36-0.98) was associated with lower risk of unplanned cardiovascular readmission. Sex, family income, depression, stress level, lower social support, disease-specific health status, and medications were not associated with readmission. Conclusions In China, most readmissions are for cardiovascular events, and almost half occur within 5 days of discharge. Clinical factors identify patients at higher and lower unplanned readmissions. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT01624909.

A Prospective Cohort Study on the Effects of Geriatric Rehabilitation Following Acute Exacerbations of COPD

ObjectivesOlder patients with chronic obstructive pulmonary disease (COPD), hospitalized for an acute exacerbation, often do not receive recommended post-acute pulmonary rehabilitation. This underuse might be related to the impaired clinical and functional status of these patients, who are more likely to present with frailty, comorbidities, and disability. Having developed and implemented a geriatric rehabilitation program for these patients (GR_COPD), the primary aim of this study was to investigate the effectiveness of this program. Design and interventionA prospective cohort study with a 3-month follow-up period. Patients who declined the GR_COPD program were considered as controls. Setting and participantsThe study was conducted at the pulmonary department of 2 hospitals. Patients were eligible when hospitalized as a result of an acute exacerbation of COPD and indicated for the GR_COPD program based on standardized criteria. MethodsPrimary outcome was defined as change in disease-specific health status measured with the clinical COPD questionnaire (CCQ), secondary outcome as the exacerbation rate ratio during follow-up. To balance potential confounders between the intervention and control group, propensity score–based weighted linear regression analyses were performed. ResultsOf the 158 included patients [78 (49.4%) male, mean age 70.8 (±8.1) years, mean forced expiratory volume in 1 second: 35.5 (±12.8) as % of predicted], 78 received the GR_COPD program. The results of the CCQ showed a significant and clinically relevant treatment effect of −0.56 points [95% confidence interval (CI) −0.89, −0.23; P = .001). Patients in the control group had 2.77 times more exacerbations compared with the intervention group (95% CI 2.13, 3.58; P < .001). Conclusions/ImplicationsThis study shows a clinically relevant effect of the GR_COPD program on disease-specific health status and exacerbation rate. Implementation of the program for older patients with severe COPD hospitalized for an acute exacerbation is recommended.

The China Patient-centred Evaluative Assessment of Cardiac Events (PEACE) prospective heart failure study design

IntroductionChina faces the prospect of a large growth in the prevalence of heart failure (HF). However, there is limited knowledge about outcomes in patients after HF hospitalisations, including patient-reported outcomes...

Association of Transcatheter Mitral Valve Repair With Quality of Life Outcomes at 30 Days and 1 Year

Improvements in symptoms, functional capacity, and quality of life are among the key goals of edge-to-edge transcatheter mitral valve repair (TMVR) for mitral regurgitation. To examine health status outcomes among patients undergoing TMVR in clinical practice and the factors associated with improvement. This cohort study used the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, which contains data on patients with severe mitral regurgitation treated with TMVR from 2013 through 2017 in 217 US hospitals. Change in disease-specific health status (Kansas City Cardiomyopathy Questionnaire-Overall Summary score [KCCQ-OS]; range 0-100 points, with higher scores indicating better health status) at 30 days and 1 year after TMVR. We also examined factors associated with health status at 30 days after TMVR, by means of multivariable linear regression using a generalized estimating equations approach to account for clustering of patients within sites. The KCCQ data were available in 81.2% at baseline, 69.3% of survivors at 30 days, and 47.4% of survivors at 1 year. Among 4226 patients who underwent TMVR, survived 30 days, and completed the KCCQ at baseline and follow-up, the KCCQ-OS increased from 41.9 before TMVR to 66.7 at 30 days (mean change 24.8 [95% CI, 24.0-25.6] points; P < .001), representing a large clinical improvement. The KCCQ scores remained stable from 30 days to 1 year after TMVR, with no further significant increase or decline. On multivariable analysis, atrial fibrillation (-2.2 [95% CI, -3.7 to -0.6] points; P = .01), permanent pacemaker (-2.1 [95% CI, -3.7 to -0.4] points; P = .01), severe lung disease (-3.9 [95% CI, -6.2 to -1.5] points; P = .001), home oxygen (-2.7 [95% CI, -4.9 to -0.4] points; P = .02), and lower KCCQ scores at baseline (3.9 points for each 10-point increase [95% CI, 3.6-4.2]; P < .001) were independently associated with lower 30-day KCCQ-OS scores. In-hospital renal failure was uncommon but was also associated with significant reductions in 30-day KCCQ-OS scores (-7.3 [95% CI -13.3 to -1.2] points). In estimates calculated with inverse probability weighting, after 1 year after TMVR, 54.2% (95% CI 52.2%-56.1%) of patients were alive and well; 23.0% had died, 21.9% had persistently poor health status (KCCQ-OS <60 points), 5.5% had a health status decline from baseline, and 4.6% had both poor health status and health status decline. In a national cohort of US patients undergoing edge-to-edge TMVR in clinical practice, health status was impaired prior to the procedure, improved within 30 days, and remained stable through 1 year among surviving patients with available data. While long-term mortality remains high, most surviving patients demonstrate improvements in symptoms, functional status, and quality of life, with only modest differences by patient-level factors.

Long-term Outcomes After Surgery Involving the Pelvic Floor in Rectal Cancer: Physical Activity, Quality of Life, and Health Status

PurposeThis study has aimed to evaluate the effects of surgery on physical activity (PA), quality of life (QoL), and disease-specific health status, by analyzing the differences between sphincter-preserving surgery (low anterior resection (LAR)) and abdominoperineal resection (APR) among rectal cancer survivors. MethodsIndividuals who were diagnosed with rectal cancer and who underwent an APR or a LAR between 2000 and 2009 were included. The different questionnaires on QoL, disease-specific health status, and physical activity began their surveys in 2010. Differences in QoL, health status, and physical activity were analyzed between the APR group and the LAR group. ResultsThe study included 905 rectal cancer survivors (LAR, 632; APR, 273). Besides a higher rate of radiotherapy treatment in the APR group (94% vs. 75%, p < 0.001), there were no differences in clinical characteristics or in comorbid conditions between the LAR group and APR group. No significant differences were found in PA level between the patients who had undergone an APR vs. a LAR. Regarding QoL, APR patients did report a worse physical (p = 0.009) and role functioning (p = 0.03), as well as a worse body image (p = 0.001), compared to patients who had undergone a LAR. However, they reported fewer constipation (p = 0.02) and gastrointestinal problems (p = 0.009). Finally, compared to patients who had undergone a LAR with a permanent ostomy, APR patients reported a better body image (p = 0.048) and less stoma-related problems (p = 0.001). ConclusionsThis study showed no differences in PA level among the patients who had undergone an APR versus a LAR. With respect to their QoL, their physical and role functioning seemed to be worse in the APR patients. However, these differences in outcomes resolved when comparing the APR group with patients after a LAR with a permanent ostomy.

Sex differences in health outcomes at one year following acute myocardial infarction: A report from the China Patient-Centered Evaluative Assessment of Cardiac Events prospective acute myocardial infarction study.

We examined sex differences in long-term health outcomes following acute myocardial infarction in China, including mortality, major adverse cardiac events and health status (symptoms, functioning, quality of life). A total of 3415 acute myocardial infarction patients (23.2% women) aged ⩾18 years were enrolled across 10 geographic regions in China (2012-2014) in the China Patient-Centered Evaluative Assessment of Cardiac Events (PEACE) study. Clinical data was abstracted from medical records. Generic (Euro-Quality of Life Scale) and disease-specific (Seattle Angina Questionnaire) health status was obtained through interviews at baseline and one year. At one year, women with acute myocardial infarction had a higher risk of death from all causes ( p<0.001), but had similar rates of major adverse cardiac events ( p=0.2). Women had lower mean generic (Euro-Quality of Life Scale utility index score: 0.90±0.13 vs 0.94±0.11) and disease specific health scores indicating poorer functioning (Seattle Angina Questionnaire summary score: 75.3±11.4 vs 78.4±9.7) and higher rates of daily/weekly angina (Seattle Angina Questionnaire angina frequency score ⩽60 vs >60: 9.1% vs 4.7%; all p<0.001). In multivariable analysis, there was a significant association between female sex and mortality (β=0.45, standard error=0.21, p=0.03) but not for major adverse cardiac events (β=-0.02, standard error=0.14, p=0.89). The association between female sex and worse generic health status persisted (β=-0.02, standard error=0.01, p=0.003), but was no longer significant between sexes for disease-specific health status (β=-0.82, standard error=0.58, p=0.154) or daily/weekly angina (odds ratio=1.39; 95% confidence interval 0.88-2.21). Women in China have higher crude rates of all-cause/cardiovascular death versus men, as well as worse generic/disease specific health status at one-year post-acute myocardial infarction. The association between female sex and worse generic health status persisted following adjustment.

TCT-45 Quality of Life Outcomes after Transcatheter Mitral Valve Repair in an Unselected Population. A Report from the STS/ACC TVT RegistryTM

Improvements in heart failure symptoms, functional capacity, and quality of life are the primary benefits of transcatheter mitral valve repair (TMVR) for mitral regurgitation. To date, no large studies have examined disease-specific health status among unselected patients who underwent TMVR or the

The physical, mental, and social impact of COPD in a population-based sample: results from the Longitudinal Aging Study Amsterdam

Chronic obstructive pulmonary disease (COPD) is associated with substantial health impact that may already become apparent in early disease. This study aims to examine the features of subjects with COPD in a Dutch population-based sample and compare their physical status, mental status, and social status to non-COPD subjects. This study made use of Longitudinal Aging Study Amsterdam (LASA) data. Demographics, clinical characteristics, self-reported diseases, post-bronchodilator spirometry, physical, mental, and social status were assessed. A number of 810 subjects (50.5% male, mean age 60.5 ± 2.9 years) were included. Subjects with COPD (n = 68, mean FEV1 67.6 [IQR 60.4–80.4] %.) had a slower walking speed than non-COPD subjects, p = 0.033. When compared to non-COPD subjects, COPD subjects gave a lower rating on their health (physical subscale of SF-12: 15 [IQR 16.0–19.0] vs. 18 [IQR 11.0–17.0] points) and life (EQ5D VAS: 75 [IQR 70.0–90.0] vs. 80 points [IQR 65.0–85.5]) surveys. COPD subjects also had a more impaired disease-specific health status (CAT: 9.5 ± 5.9 vs. 6.7 ± 5.2, respectively), were less likely to have a partner (69% vs. 84%, respectively) and received emotional support less often (24% vs. 36%, respectively) compared to non-COPD subjects (All comparisons p < 0.001). In a population-based sample, subjects with COPD had a reduced physical performance, a more impaired disease-specific health status and were more socially deprived compared to non-COPD subjects. These impairments need to be taken into consideration when setting up a management program for patients with mild COPD.

Telephone-based mindfulness training to reduce stress in women with myocardial infarction: Rationale and design of a multicenter randomized controlled trial

BackgroundElevated stress is associated with adverse cardiovascular disease outcomes and accounts in part for the poorer recovery experienced by women compared with men after myocardial infarction (MI). Psychosocial interventions improve outcomes overall but are less effective for women than for men with MI, suggesting the need for different approaches. Mindfulness-based cognitive therapy (MBCT) is an evidence-based intervention that targets key psychosocial vulnerabilities in women including rumination (i.e., repetitive negative thinking) and low social support. This article describes the rationale and design of a multicenter randomized controlled trial to test the effects of telephone-delivered MBCT (MBCT-T) in women with MI. MethodsWe plan to randomize 144 women reporting elevated perceived stress at least two months after MI to MBCT-T or enhanced usual care (EUC), which each involve eight weekly telephone sessions. Perceived stress and a set of patient-centered health outcomes and potential mediators will be assessed before and after the 8-week telephone programs and at 6-month follow-up. We will test the hypothesis that MBCT-T will be associated with greater 6-month improvements in perceived stress (primary outcome), disease-specific health status, quality of life, depression and anxiety symptoms, and actigraphy-based sleep quality (secondary outcomes) compared with EUC. Changes in mindfulness, rumination and perceived social support will be evaluated as potential mediators in exploratory analyses. ConclusionsIf found to be effective, this innovative, scalable intervention may be a promising secondary prevention strategy for women with MI experiencing elevated perceived stress.

Validation of the Seattle angina questionnaire in women with ischemic heart disease

BackgroundAlthough the Seattle Angina Questionnaire (SAQ) has been widely used to assess disease-specific health status in patients with ischemic heart disease, it was originally developed in a predominantly male population and its validity in women has been questioned. MethodsUsing data from 8892 men and 4013 women across 2 multicenter trials and 5 registries, we assessed the construct validity, test–retest reliability, responsiveness to clinical change, and predictive validity of the SAQ Summary Score (SS) and its 5 subdomains (Physical Limitation (PL), Anginal Stability (AS), Angina Frequency (AF), Treatment Satisfaction (TS), and Quality of Life (QoL)) separately in men and women. ResultsComparable correlations of the SAQ SS with Canadian Cardiovascular Society class was demonstrated in both men and women (−0.48 for men, −0.46 for women). Similar correlations between the SAQ PL scale with treadmill exercise duration and Short Form-12 (SF-12) Physical Component Summary were observed in women and men (0.34–0.63 and 0.40–0.63, respectively). SAQ AS scores were significantly lower for both men and women with acute syndromes compared with 1 month later. The SAQ AF scale was strongly correlated with daily angina diaries (0.62 for men and 0.66 for women). The SAQ QoL scores were moderately correlated with the EQ5D visual analog scale and SF-12 general health question in men (0.43–0.50) and women (0.33–0.39). All SAQ scales demonstrated excellent reliability (intraclass correlation ≥0.78) in both men and women with stable CAD and were very sensitive to change after percutaneous coronary intervention (≥15-point difference in scores, standardized response mean ≥ 0.67). The SAQ SS was similarly predictive of 1-year mortality and cardiac re-hospitalizations for both men and women. ConclusionThe SAQ demonstrates similar psychometric properties in men and women with CAD. These findings provide evidence for validity of the SAQ in assessing women with IHD.

Long-term clinical and quality of life outcomes after stenting of femoropopliteal artery stenosis: 3-year results from the STROLL study.

To evaluate the clinical and health status outcomes of patients undergoing superficial femoral artery (SFA) revascularization using the Shape Memory Alloy Recoverable Technology (S.M.A.R.T.®) nitinol self-expanding stent through 3 years of follow-up. Limited long-term data are available describing the durability of benefits after femoropopliteal revascularization. In a multicenter, prospective, core-lab adjudicated study, 250 subjects with de novo or restenotic femoropopliteal arterial lesions were treated with the S.M.A.R.T.® stent. The primary endpoint of target vessel patency, a composite of ultrasound-assessed patency and freedom from clinically driven target lesion revascularization (TLR), was evaluated through 3 years. Secondary endpoints included stent fracture and health status. Health status was measured using generic and disease-specific instruments, including the Peripheral Artery Questionnaire (PAQ). At 3-year follow-up, Kaplan-Meier estimated target vessel patency was 72.7%, freedom from clinically driven TLR was 78.5%, and the incidence of stent fracture was 3.6%. The PAQ summary score was markedly impaired at baseline (mean 37.3 ± 19.6 points) and improved substantially at 1 month (mean change from baseline of 31.4 points, 95% CI: 28.5-34.3; P < 0.001). Disease-specific health status benefits assessed by the PAQ were largely preserved through 3 years of follow-up (mean change from baseline, 28.0 points, 95% CI: 24.3-31.7; P < 0.0001). In patients undergoing revascularization for moderately complex SFA disease, use of the self-expanding S.M.A.R.T® stent was associated with a high rate of target vessel patency through 3 years and led to substantial and sustained health status benefits.