Hypertrophic Cardiomyopathy: A Heart Burden and Challenging Diagnosis

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score weighting technique was applied to balance the demographic characteristics between the groups.  Results: The weighted prevalence of hypertension in US 2012 was estimated to be 20.8% (unweighted: 7019/38974), 14.9% of which also reported depression (unweighted: 936/7019). Hypertensives with depression were associated with worse health status [PCS:-3.97 (17.9% reduction) and MCS: -9.14 (9% reduction)], higher utilizations [outpatient visits: 6.4 (63.8% higher), nights of hospitalization: 0.9 (100% higher), and medication prescription: 22.59 (76.8% higher)], and higher health care expenditures [inpatient: $1953.22 (72% higher) and prescription drugs $1995.46 (82% higher)], all with statistical significance (p< 0.01).  Conclusions: Hypertension patients with depression have a worse health status and higher health costs as compared to those without depression. Our study findings emphasizes on the potential benefit of screening for depression among hypertensive patients. A depression screening program would significantly reduce healthcare burden and improve health among patients with both hypertension and depression. PCV71 Health-Related Quality of Life of Patients Suffering an Acute Coronary Syndrome: An Analysis Using Multinational Eq-5d Outcomes from the Pgrx-3 Real-World Dataset Cuervo J1, Nordon C2, Rossignol M3, Morisot N2, Worsfold A4, Benichou J5, Danchin N6, Abenhaim L4, Grimaldi L2 senior consultant, Oviedo, Spain, 2LASER Analytica, Paris, France, 3McGill University, Montreal, QC, Canada, 4LASER Analytica, London, UK, 5Centre Hospitalier Universitaire de Rouen, Paris, France, 6Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France

1HEOR

Objectives: Recent research has remarked the importance of the HRQoL as a predictor of mortality in individuals suffering an acute coronary syndrome (ACS). The aim of this study was to analyze the HRQoL of ACS patients undergoing one or more events and to establish comparisons with the respective population norms. Methods: ACS cases were prospectively recruited via the Pharmacoepidemiology General Research eXtension information system (PGRx-3), which employs a transversal study design. Comprehensive real-world physician and patient data captured serves to describe targeted diseases, their management and estimate the related burden of illness. Treating physicians from UK, France, Italy, Germany, Spain and the USA provide clinical information on recruited patients. Additionally, patients also complete various validated self-administered instruments (EQ-5D 5L included). Differences in EQ-5D (VAS and index scores) according to key clinical variables (i.e. socio-demographic, time since last ACS, diagnosis, number of episodes) were contrasted (parametric and non-parametric tests). Reported outcomes were compared with the populations of reference following EuroQol Group recommendations.  Results: The PGRx-3 ACS sample included 1048 ACS cases registered, of which 678 patients (69.8% males, mean age-SD-= 66.1611.26-) fulfilled the EQ-5D: no differences in socio-demographic and other key variables were found between responders and non-responders, p> 0.05. According to the time since ACS, at short-term (< 6months), 21.1% of patients experienced problems in self-care domain versus 13.4% at long-term (6 to 24months), p= 0.023. Conversely, higher proportions of patients reported slight to extreme affectation in pain/discomfort and anxiety/depression at long-term (50.8%vs60.9%-p= 0.026and 37.8%vs46.5%- p= 0.061-, respectively). Overall, mean VAS and index values found across all countries were systematically lower than those values published in the respective population norms, revealing a considerable impact on patients’ well-being.  Conclusions: A significant humanistic burden of disease has been highlighted in ACS patients from EU and USA. Finally, a differential affectation is observed according to clinical variables. PCV72 Reported Psychological Symptoms and Quality of Life in Patients Suffering an Acute Coronary Syndrome: New Insights from the Pgrx-3 Real-World Dataset Cuervo J1, Nordon C2, Rossignol M3, Morisot N2, Worsfold A4, Benichou J5, Danchin N6, Abenhaim L4, Grimaldi L2 senior consultant, Oviedo, Spain, 2LASER Analytica, Paris, France, 3McGill University, Montreal, QC, Canada, 4LASER Analytica, London, UK, 5Centre Hospitalier Universitaire de Rouen, Paris, France, 6Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France

1HEOR

Objectives: Depressive symptoms are of interest after an acute coronary syndrome (ACS) due to its association with increased cardiovascular morbidity and mortality and impact on health care utilisation and costs. The objective was to analyse the psychological distress and health-related quality of life (HRQoL) of incident and recurrent ACS patients registered in the Pharmacoepidemiology General Research eXtension System (PGRx-3).  Methods: PGRx-3 comprises multi-national prospective real world datasets designed to identify risk factors of multiple diseases, describe their management and quantify the associated burdens. To this end, patients from UK, France, Italy, Germany, Spain and US are being recruited by their physicians. Information from medical records is complemented with a set of validated self-administered measures. The ACS sample for this study included 1048 patients classified according to the number of ACS events registered in their clinical records. Responses to the EQ-5D 5L ‘Anxiety/depression’ domain were used to identify moderate to extreme affectation. Bivariate tests and multivariate models to control the effect of sensitive variables (i.e age, country) were used to analyze HRQoL of ACS patients (EQ-5D VAS and index scores).  Results: A total of 678 patients (69.8% male, mean age-SD-= 66.16-11.26-, 50.6% with non-ST elevated myocardial infarction) completed the EQ-5D (no significant differences in age or gender between responders and non-responders were found). Incident cases (n= 434) were slightly younger than recurrent patients: 65.18-11.48- vs. 67.85-10.66-; p=  0.01. Moderate to extreme symptoms of anxiety/depression were reported in 17.8% of incident and 19.8% of recurrent patients (p= 0.606). The presence of these emotional symptoms was not associated with the time since last ACS episode (p> 0.1). Finally, adjusted EQ-5D index scores and VAS values were higher in incident patients

(p<  0.05).  Conclusions: A substantial presence of psychological symptoms have been highlighted in both incident and recurrent ACS patients. However, incident patients showed higher levels of HRQoL. PCV73 Development and Content Validation of a Patient-Reported Outcome Measure to Evaluate Statin Intolerance in the Real World Jacobson T1, Edelman S2, Davidson M3, Galipeau N4, Shields A4, Mallya UG5, Koren A5 1Emory University, Atlanta, GA, USA, 2University of California San Diego, San Diego, GA, USA, 3The University of Chicago Medicine, Chicago, IL, USA, 4Adelphi Values USA, Boston, MA, USA, 5Sanofi US, Inc., Bridgewater, NJ, USA

Objectives: The National Lipid Association encourages improved understanding and assessment of patient-reported statin intolerance (SI). We sought to develop a patient-reported outcome questionnaire to assess real-world patient SI experience.  Methods: Questionnaire development was informed by (1) a literature review (n= 41 articles, n= 3 drug labels), interviews with expert providers (n= 5), and patient concept elicitation interviews (CEIs; n= 20); (2) concept selection and questionnaire construction; and (3) cognitive debriefing with experts (n= 5) and patients (n= 15). Rigorous methodology was employed to identify concepts most relevant to patients experiencing SI and create a content-valid tool for measuring SI-related concepts perceived as useful by patients and providers.  Results: Results identified 3 areas of measurement: SI symptoms, impacts, and medication behavior. Musclerelated symptoms, and associated physical impacts, were commonly reported in the literature (85.4% of articles) and by experts (n= 5, 100%). In CEIs, patients with SI also commonly reported muscle-related symptoms (n= 17, 85.0%) in addition to non–muscle-related symptoms (n≤ 3, 15.0%). In the resulting 17-item questionnaire, instructions, items, and response options were positively reviewed by patients and experts during the cognitive interviews but resulted in some modifications and a 15-item questionnaire. Nausea and headache were removed based on irrelevance to SI according to some experts (n= 2, 40.0%) and patients (not relevant to 12/15 [80.0%] and 7/15 [46.7%], respectively). The Statin Experience Assessment Questionnaire (SEAQ) assesses the severity and impact of 6 SI symptoms (muscle aches, muscle pain, muscle cramps, muscle weakness, tiredness, and joint pain) on an 11-point numeric scale in the 30 days before assessment. Statin discontinuation and the likelihood of discontinuation due to symptoms are also assessed on yes/no and Likert scales, respectively.  Conclusions: The SEAQ is a content-valid questionnaire that can be used in clinical settings to facilitate patient/provider communications about SI. Additional research is recommended to validate the SEAQ in real-world settings. PCV74 Hypertrophic Cardiomyopathy: A Heart Burden and Challenging Diagnosis Salberg L1, Schroeder E2, McKinley G3 Cardiomyopathy Association (HCMA), Denville, NJ, USA, 2Medical Writer, San Mateo, CA, USA, 3MyoKardia, South San Francisco, CA, USA

1Hypertrophic

Objectives: Hypertrophic cardiomyopathy (HCM), a chronic genetic disease characterized by thickening heart muscle, affects about 1 in 500 people. HCM symptoms are highly variable, complicating diagnosis and estimation of burden on patients’ lives. This research explores the diagnostic process and symptoms in HCM patients.  Methods: An 80-question survey was distributed online to members of the Hypertrophic Cardiomyopathy Association, an advocacy, education, and support group. Responses were collected between August-October 2015.  Results: 444 respondents had been diagnosed with HCM, equally divided by gender. Of these patients, 43% were initially diagnosed with an innocent heart murmur. The most common age of HCM diagnosis was 41-55 years (39%). Many patients (37%) were diagnosed within three months after visiting a physician due to symptoms. However, 25% were not diagnosed for three years or more. General cardiologists diagnosed 73% of patients. Most patients reported experiencing tiredness (74%), shortness of breath upon exertion (73%), light-headedness (70%), and palpitations (64%). Using the New York Heart Association (NYHA) scale, 42% of patients rated their symptoms as Class II (mild), 31% as Class III, and 6% as Class IV (severe). Obstruction developed in 58% of patients. In the 37% of patients who had undergone myectomy to reduce obstruction, 45% rated their symptoms as NYHA Class II, 38% as Class III and 6% as Class IV. Patients also reported experiencing atrial fibrillation (34%) and TIA or stroke (6%). Since diagnosis, HCM symptoms have increased or interfered with life in 85% of patients.  Conclusions: Despite moderate prevalence, HCM can be challenging to diagnose. Patients experience diverse symptoms that vary in severity. Progression and burden of these symptoms on patients’ quality of life may be underestimated. Although the group described here may experience symptoms more severe than the general HCM population, these results highlight the challenges of HCM diagnoses and the broad range of HCM-related symptoms. PCV75 Clinical Outcomes and Quality of Life After Off-Pump Versus On-Pump Coronary Artery Bypass Grafting in Armenia Minasyan K1, Thompson ME2, Abrahamyan L3 1American University of Armenia, Yerevan, Armenia, 2University of North Carolina at Charlotte, Charlotte, NC, USA, 3University of Toronto, Toronto, ON, Canada

Objectives: Coronary artery bypass grafting (CABG), one of the treatment approaches for coronary artery disease, can be conducted with (on-pump) or without (off-pump) the use of a heart-lung machine. The long-term benefits of off-pump versus on-pump (traditional) CABG are debatable. This study compared on-pump and off-pump 5 year event-free survival from major cardiac and cerebrovascular events (MACCE) and quality of life of patients who underwent on-pump versus off-pump CABG surgery.  Methods: This retrospective cohort study included all patients who underwent CABG at Nork Marash Medical Center (NMMC), Armenia from 2009 to 2010. Data were collected from patient telephone surveys (March 2015), the NMMC electronic surgical database, and medical records. Results: Among 528 patients, 407 (77.1%) underwent on-pump and 121 (22.9%) off-pump