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Heart Failure Symptom Survey: Validity and Reliability
S100 Journal of Cardiac Failure Vol. 12 No. 6 Suppl. 2006 323 Tissue ACE Inhibitors Decrease the Risk of Hospitalization for Heart Failure and Cardiovascular Morbidity and Mortality in Patients with Cardiovascular Disease and Preserved Ventricular Function e A Pooled Meta-Analysis Sandeep A. Saha1, Janos Molnar1, Rohit R. Arora1; 1Internal Medicine and Cardiology, The Chicago Medical School, Rosalind Franklin University of Medicine & Science, North Chicago, IL Introduction: Although the role of angiotensin converting enzyme (ACE) inhibitors in patients with depressed left ventricular function is well established, their role in patients with preserved ventricular function is uncertain. We conducted a meta-analysis of recent clinical trials to evaluate the role of tissue-specific ACE inhibitors in secondary prevention of cardiovascular disease in patients with normal left ventricular function. Study Selection: Randomized placebo-controlled clinical trials of at least 12 months duration, which included patients who had experienced an acute cardiovascular event or were at high risk for cardiovascular events. Data Synthesis and Analysis: A total of 31,555 patients from 4 selected trials were analyzed. Relative risk estimations were made using pooled data from these 4 trials. Statistical significance was determined using the Chi-square test (two-sided alpha error !0.05). The number of patients needed to treat (NNT) was also calculated. Results: When compared to placebo, the use of tissue ACE inhibitors was associated with significant relative risk reductions in cardiovascular mortality (p ! 0.001), fatal and non-fatal myocardial infarction (p ! 0.001), stroke (p ! 0.001), as well as hospitalization for congestive heart failure (p 5 0.001). The number of patients needed to treat (NNT) with tissue ACE inhibitors to prevent one hospitalization for heart failure is 168, while the number to prevent one cardiovascular death is 115, over a period of 4.5 years. Conclusions: Tissue ACE inhibitors significantly reduce the risk of hospitalization for heart failure, as well as cardiovascular mortality and morbidity in patients at high cardiovascular risk with preserved left ventricular systolic function.
medication than patients without a spouse regardless of depression level and NYHA class. Thus, interventions aimed at improving medication adherence of married patients should target both the patient and spouse. Patients without a spouse require alternative support interventions.
325 Heart Failure Symptom Survey: Validity and Reliability Bunny Pozehl, Kathy Duncan, Melody Hertzog; College of Nursing, University of Nebraska Medical Center, Lincoln, NE Purpose: The purpose of this study was to evaluate the reliability and validity of the Heart Failure Symptom Survey (HFSS). Sample: A random sample of 300 subjects was obtained from a midwestern heart failure (HF) clinic. Surveys were mailed to subjects and 138 subjects responded with complete data for a return rate of 46%. The sample respondents were 33 women and 105 men with a mean age of 70.6 6 9.7 years and a mean EF of 34 6 10.9%. The majority of subjects were NYHA Class II (38.1%) and Class III (51.8%) with 66.2% having ischemic HF and 33.8% with nonischemic HF. Methods: The HFSS is a 14 item, investigator developed instrument to measure frequency and severity of symptoms experienced by HF patients in the past seven days. Frequency and severity were measured on a 0e10 scale (0 5 never, 10 5 very frequently or very severe). Interference with physical activity and enjoyment of life were also assessed on a 0e10 scale (0 5 no interference, 10 5 great deal of interference) for each of the 14 symptoms. Internal consistency reliability estimates were obtained for the HFSS. The Kansas City Cardiomyopathy Questionnaire (KCCQ) was utilized to evaluate construct validity. The KCCQ has a total symptom score that assesses frequency and burden of dyspnea and fatigue. Results: Frequency, severity, interference with physical activity and interference with enjoyment of life were treated as individual HFSS subscales and Cronbach alpha coefficients were .80, .87, .88, and .88, respectively. Convergent validity was indicated by the Pearson correlations between the HFSS subscales and subscales of the KCCQ (See Table 1). Higher scores on the HFSS indicate greater symptomology while lower scores on the KCCQ indicate greater impairment. Known group validity was also assessed for HFSS frequency and severity according to NYHA class. Mean frequency [F (3,127) 5 9.57, p ! .001] and severity of symptoms [F (3,128) 5 7.42, p ! .001] increased significantly from NYHA Class I to Class IV. Conclusions: Findings indicate the HFSS is a valid and reliable instrument for assessment of common symptoms experienced by HF patients. Implications: A valid and reliable measure of HF symptoms is necessary in order to evaluate and document HF patient symptom status over time. Pearson Correlations Between HFSS and KCCQ
324 Presence of a Spouse Improves Adherence to Medication in Patients with Heart Failure Misook L. Chung1, Debra K. Moser1, Terry A. Lennie1, Barbara J. Riegel2; 1College of Nursing, University of Kentucky, Lexington, KY; 2School of Nursing, University of Pennsylvania, Philadelphia, PA Background: Nonadherence to prescribed medications is a primary cause of rehospitalization in patients with heart failure (HF). Although positive spousal support is related to long-term outcomes in HF patients, the direct effect of having a spouse on medication adherence is unknown. The purpose of this study was to examine the impact of patients’ marital status on medication adherence. Methods: Adherence to medication was assessed in 89 HF patients (male 61%; ejection fraction 32 6 14%; mean age of 60 years; married 60%) using the electronic Medication Event Monitoring System (MEMS). Adherence rate was calculated as the percent of the prescribed number of doses taken over an average of 94 days. Data on patients’ knowledge of medications and beliefs about adherence were also collected using a structured questionnaire. To rule out the potential confound of depression level, we assessed patients’ depression using the Beck Depression Inventory-II. Results: MEMS data revealed that, on average, patients took 87% of prescribed doses; only 67% of medication doses were taken on time. There was no difference in age, education, number of prescribed medication, or depression level between patients with and without a spouse. Compared to patients without a spouse, patients with a spouse took more prescribed doses (90% vs. 80%, p ! .05) and took more doses on schedule (70% vs. 49%, p ! .01). Patients with a spouse expressed greater agreement with the importance of taking medication on time (9.8 vs. 9.3, p ! .05). They were more knowledgeable about names (7.7 vs. 5.8, p ! .05) and doses (8.4 vs. 6.7, p ! .05) of medications. In a test of a multiple logistic regression model consisting of marital status, depression, and NYHAclass, patients with a spouse were 3.1 times more likely to be adherent (took O 85% of medication doses as prescribed) to medication taking than patients without a spouse (95% CI 5 1.06e9.0). The strength of this relationship was equal to that between depression and adherence (odds ratio 5 3.2; 95% CI 5 1.02-9.8). NYHA class was not a significant predictor of medication adherence. Conclusion: Married patients had substantially better adherence to
HFSS Frequency HFSS Severity HFSS Interference with Physical Activity HFSS Interference with Enjoyment of Life
KCCQ Total Symptoms
KCCQ Clinical Summary
KCCQ Physical Limitation
KCCQ Quality of Life
.78* .74* .69*
.76* .73* .68*
.66* .65* .62*
.69* .63* .62*
.69*
.69*
.64*
.65*
*p ! .001.
326 Robotic Epicardial Left Ventricular Lead Is Superior to Endovascular Implantation in Cardiac Resynchronization Therapy Responders Ajay S. Shah1, Rawa Sarji1, Eftekhari Hossein1, Bilal Ayub1, Madhuri Devabhaktuni1, Ramya S. Suryadevara1, Joseph DeRose1, Jonnathan S. Steinberg1, Farooq A. Chaudhry1; 1Cardiology, St Lukes-Roosevelt Hospital Center, New York, NY Background: Cardiac resynchronization therapy (CRT) has been shown to improve systolic function and cause reverse-remodeling in patients with advanced heart failure (HF). Robotically implanted epicardial lead placement is a rescue therapy in patients with failed endovascular implants. The relative efficacy of robotically implanted epicardial lead placement versus endovascular lead placement in responders has not been examined. A superior lead placement offers the theoretical benefit of ideal anatomical site for lead placement. Methods: Thirty seven patients (54% male) with advanced HF (NYHA-3.4 6 0.3, EF-19 6 8%) and optimized medical therapy, undergoing CRT (51% endovascular, 49% epicardial) formed the study cohort. Responders were defined by improvement in left ventricular ejection fraction (LVEF) $15% from baseline. Clinical improvement was assessed by changes in NYHA class and Minnesota living with Heart Failure (QoL) questionnaire. Reverseremodeling was assessed by changes in follow-up (7.7 6 2 months) 2D-trans thoracic echocardiographic parameters of left ventricular ejection fraction (LVEF), LV end-diastolic index (LVEDI), LV end diastolic volume index (LVEDVI) and Dyssynchrony index (Ts-SD 12)with Tissue Synchronization Imaging were quantitatively evaluated. Results: There were 30 responders out of 37 patients (Robotic CRT 16/18 and Endovascular CRT 14/19). Responders to CRT who received robotically implanted epicardial CRT demonstrated significant improvement in symptoms, increased LVEF, decreased LVEDI, decreased LVEDVI and better resynchronization compared to
medication than patients without a spouse regardless of depression level and NYHA class. Thus, interventions aimed at improving medication adherence of married patients should target both the patient and spouse. Patients without a spouse require alternative support interventions.
325 Heart Failure Symptom Survey: Validity and Reliability Bunny Pozehl, Kathy Duncan, Melody Hertzog; College of Nursing, University of Nebraska Medical Center, Lincoln, NE Purpose: The purpose of this study was to evaluate the reliability and validity of the Heart Failure Symptom Survey (HFSS). Sample: A random sample of 300 subjects was obtained from a midwestern heart failure (HF) clinic. Surveys were mailed to subjects and 138 subjects responded with complete data for a return rate of 46%. The sample respondents were 33 women and 105 men with a mean age of 70.6 6 9.7 years and a mean EF of 34 6 10.9%. The majority of subjects were NYHA Class II (38.1%) and Class III (51.8%) with 66.2% having ischemic HF and 33.8% with nonischemic HF. Methods: The HFSS is a 14 item, investigator developed instrument to measure frequency and severity of symptoms experienced by HF patients in the past seven days. Frequency and severity were measured on a 0e10 scale (0 5 never, 10 5 very frequently or very severe). Interference with physical activity and enjoyment of life were also assessed on a 0e10 scale (0 5 no interference, 10 5 great deal of interference) for each of the 14 symptoms. Internal consistency reliability estimates were obtained for the HFSS. The Kansas City Cardiomyopathy Questionnaire (KCCQ) was utilized to evaluate construct validity. The KCCQ has a total symptom score that assesses frequency and burden of dyspnea and fatigue. Results: Frequency, severity, interference with physical activity and interference with enjoyment of life were treated as individual HFSS subscales and Cronbach alpha coefficients were .80, .87, .88, and .88, respectively. Convergent validity was indicated by the Pearson correlations between the HFSS subscales and subscales of the KCCQ (See Table 1). Higher scores on the HFSS indicate greater symptomology while lower scores on the KCCQ indicate greater impairment. Known group validity was also assessed for HFSS frequency and severity according to NYHA class. Mean frequency [F (3,127) 5 9.57, p ! .001] and severity of symptoms [F (3,128) 5 7.42, p ! .001] increased significantly from NYHA Class I to Class IV. Conclusions: Findings indicate the HFSS is a valid and reliable instrument for assessment of common symptoms experienced by HF patients. Implications: A valid and reliable measure of HF symptoms is necessary in order to evaluate and document HF patient symptom status over time. Pearson Correlations Between HFSS and KCCQ
324 Presence of a Spouse Improves Adherence to Medication in Patients with Heart Failure Misook L. Chung1, Debra K. Moser1, Terry A. Lennie1, Barbara J. Riegel2; 1College of Nursing, University of Kentucky, Lexington, KY; 2School of Nursing, University of Pennsylvania, Philadelphia, PA Background: Nonadherence to prescribed medications is a primary cause of rehospitalization in patients with heart failure (HF). Although positive spousal support is related to long-term outcomes in HF patients, the direct effect of having a spouse on medication adherence is unknown. The purpose of this study was to examine the impact of patients’ marital status on medication adherence. Methods: Adherence to medication was assessed in 89 HF patients (male 61%; ejection fraction 32 6 14%; mean age of 60 years; married 60%) using the electronic Medication Event Monitoring System (MEMS). Adherence rate was calculated as the percent of the prescribed number of doses taken over an average of 94 days. Data on patients’ knowledge of medications and beliefs about adherence were also collected using a structured questionnaire. To rule out the potential confound of depression level, we assessed patients’ depression using the Beck Depression Inventory-II. Results: MEMS data revealed that, on average, patients took 87% of prescribed doses; only 67% of medication doses were taken on time. There was no difference in age, education, number of prescribed medication, or depression level between patients with and without a spouse. Compared to patients without a spouse, patients with a spouse took more prescribed doses (90% vs. 80%, p ! .05) and took more doses on schedule (70% vs. 49%, p ! .01). Patients with a spouse expressed greater agreement with the importance of taking medication on time (9.8 vs. 9.3, p ! .05). They were more knowledgeable about names (7.7 vs. 5.8, p ! .05) and doses (8.4 vs. 6.7, p ! .05) of medications. In a test of a multiple logistic regression model consisting of marital status, depression, and NYHAclass, patients with a spouse were 3.1 times more likely to be adherent (took O 85% of medication doses as prescribed) to medication taking than patients without a spouse (95% CI 5 1.06e9.0). The strength of this relationship was equal to that between depression and adherence (odds ratio 5 3.2; 95% CI 5 1.02-9.8). NYHA class was not a significant predictor of medication adherence. Conclusion: Married patients had substantially better adherence to
HFSS Frequency HFSS Severity HFSS Interference with Physical Activity HFSS Interference with Enjoyment of Life
KCCQ Total Symptoms
KCCQ Clinical Summary
KCCQ Physical Limitation
KCCQ Quality of Life
.78* .74* .69*
.76* .73* .68*
.66* .65* .62*
.69* .63* .62*
.69*
.69*
.64*
.65*
*p ! .001.
326 Robotic Epicardial Left Ventricular Lead Is Superior to Endovascular Implantation in Cardiac Resynchronization Therapy Responders Ajay S. Shah1, Rawa Sarji1, Eftekhari Hossein1, Bilal Ayub1, Madhuri Devabhaktuni1, Ramya S. Suryadevara1, Joseph DeRose1, Jonnathan S. Steinberg1, Farooq A. Chaudhry1; 1Cardiology, St Lukes-Roosevelt Hospital Center, New York, NY Background: Cardiac resynchronization therapy (CRT) has been shown to improve systolic function and cause reverse-remodeling in patients with advanced heart failure (HF). Robotically implanted epicardial lead placement is a rescue therapy in patients with failed endovascular implants. The relative efficacy of robotically implanted epicardial lead placement versus endovascular lead placement in responders has not been examined. A superior lead placement offers the theoretical benefit of ideal anatomical site for lead placement. Methods: Thirty seven patients (54% male) with advanced HF (NYHA-3.4 6 0.3, EF-19 6 8%) and optimized medical therapy, undergoing CRT (51% endovascular, 49% epicardial) formed the study cohort. Responders were defined by improvement in left ventricular ejection fraction (LVEF) $15% from baseline. Clinical improvement was assessed by changes in NYHA class and Minnesota living with Heart Failure (QoL) questionnaire. Reverseremodeling was assessed by changes in follow-up (7.7 6 2 months) 2D-trans thoracic echocardiographic parameters of left ventricular ejection fraction (LVEF), LV end-diastolic index (LVEDI), LV end diastolic volume index (LVEDVI) and Dyssynchrony index (Ts-SD 12)with Tissue Synchronization Imaging were quantitatively evaluated. Results: There were 30 responders out of 37 patients (Robotic CRT 16/18 and Endovascular CRT 14/19). Responders to CRT who received robotically implanted epicardial CRT demonstrated significant improvement in symptoms, increased LVEF, decreased LVEDI, decreased LVEDVI and better resynchronization compared to