Primary Results of the Patient-Centered Disease Management (PCDM) for Heart Failure Study: A Randomized Clinical Trial.

IMPORTANCE: Heart failure (HF) has a major effect on patients' health status, including their symptom burden, functional status, and health-related quality of life. OBJECTIVE: To determine the effectiveness of a collaborative care patient-centered disease management (PCDM) intervention to improve the health status of patients with HF. DESIGN, SETTING, AND PARTICIPANTS: The Patient-Centered Disease Management (PCDM) trial was a multisite randomized clinical trial comparing a collaborative care PCDM intervention with usual care in patients with HF. A population-based sample of 392 patients with an HF diagnosis from 4 Veterans Affairs centers who had a Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score of less than 60 (heavy symptom burden and impaired functional status and quality of life) were enrolled between May 2009 and June 2011. INTERVENTIONS: The PCDM intervention included collaborative care by a multidisciplinary care team consisting of a nurse coordinator, cardiologist, psychiatrist, and primary care physician; home telemonitoring and patient self-management support; and screening and treatment for comorbid depression. MAIN OUTCOMES AND MEASURES: The primary outcome was change in the KCCQ overall summary score at 1 year (a 5-point change is clinically significant). Mortality, hospitalization, and depressive symptoms (Patient Health Questionnaire 9) were secondary outcomes. RESULTS: There were no significant differences in baseline characteristics between patients randomized to the PCDM intervention (n=187) vs usual care (n=197); baseline mean KCCQ overall summary scores were 37.9 vs 36.9 (P=.48). There was significant improvement in the KCCQ overall summary scores in both groups after 1 year (mean change, 13.5 points in each group), with no significant difference between groups (P=.97). The intervention was not associated with greater improvement in the KCCQ overall summary scores when the effect over time was estimated using 3-month, 6-month, and 12-month data (P=.74). Among secondary outcomes, there were significantly fewer deaths at 1 year in the intervention arm (8 of 187 [4.3%]) than in the usual care arm (19 of 197 [9.6%]) (P = .04). Among those who screened positive for depression, there was a greater improvement in the Patient Health Questionnaire 9 scores after 1 year in the intervention arm than in the usual care arm (2.1 points lower, P=.01). There was no significant difference in 1-year hospitalization rates between the intervention arm and the usual care arm (29.4% vs 29.9%, P=.87). CONCLUSIONS AND RELEVANCE: This multisite randomized trial of a multifaceted HF PCDM intervention did not demonstrate improved patient health status compared with usual care. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00461513.

Patient-centered disease management (PCDM) for heart failure: study protocol for a randomised controlled trial.

BACKGROUND: Chronic heart failure (HF) disease management programs have reported inconsistent results and have not included comorbid depression management or specifically focused on improving patient-reported outcomes. The Patient Centered Disease Management (PCDM) trial was designed to test the effectiveness of collaborative care disease management in improving health status (symptoms, functioning, and quality of life) in patients with HF who reported poor HF-specific health status. METHODS/DESIGN: Patients with a HF diagnosis at four VA Medical Centers were identified through population-based sampling. Patients with a Kansas City Cardiomyopathy Questionnaire (KCCQ, a measure of HF-specific health status) score of < 60 (heavy symptom burden and impaired quality of life) were invited to enroll in the PCDM trial. Enrolled patients were randomized to receive usual care or the PCDM intervention, which included: (1) collaborative care management by VA clinicians including a nurse, cardiologist, internist, and psychiatrist, who worked with patients and their primary care providers to provide guideline-concordant care management, (2) home telemonitoring and guided patient self-management support, and (3) screening and treatment for comorbid depression. The primary study outcome is change in overall KCCQ score. Secondary outcomes include depression, medication adherence, guideline-based care, hospitalizations, and mortality. DISCUSSION: The PCDM trial builds on previous studies of HF disease management by prioritizing patient health status, implementing a collaborative care model of health care delivery, and addressing depression, a key barrier to optimal disease management. The study has been designed as an 'effectiveness trial' to support broader implementation in the healthcare system if it is successful. TRIAL REGISTRATION: Unique identifier: NCT00461513.

Comparison of tissue Doppler and propagation velocity to invasive measures for measuring left ventricular filling pressures.

The utility of tissue Doppler and propagation velocity in identifying patients with abnormal left ventricular filling pressures was assessed in 50 patients who underwent catheterization and echocardiography on the same day. The ratios of the peak velocity of early mitral inflow to early mitral annular velocity (E/Ea) and the velocity of propagation (E/Vp) were compared with invasive measurements of pre-A-wave left ventricular pressures. Echocardiography measures were 77% to 92% accurate in identifying patients with a pre-A-wave pressure >15 mm Hg. Tissue Doppler imaging is more accurate than propagation velocity.

Effect of chronic total coronary occlusion on treatment strategy.

In a registry analysis of 8,004 consecutive patients presenting for diagnostic catheterization at a single institution from 1990 to 2000, chronic total occlusion (CTO) was found in 52% of patients with significant (> or = 70% diameter stenosis) coronary artery disease. Peripheral vascular disease was the strongest clinical predictor of the presence of a CTO. In a multivariate analysis, CTO was the strongest predictor against the selection of percutaneous coronary intervention (PCI) as a treatment strategy, indicating that efforts to improve the success rate of PCI in CTO may have a significant impact on management of coronary disease.

Estimation of the end of ejection in aortic stenosis: an unreported source of error in the invasive assessment of severity.

BACKGROUND: All indices of aortic stenosis (AS) rely on measurements of mean transvalvular pressure gradient (DeltaP) and flow rate. Because the gradient is reversed during late ejection, the late systolic left ventricular (LV)-aortic pressure crossover may be an erroneous landmark of end-ejection. The aortic incisura should be a better reference to calculate indices of AS invasively. METHODS AND RESULTS: The accuracy of the pressure crossover and the incisura to define end-ejection was assessed in a chronic AS experimental model (9 dogs) with the use of an implantable flowmeter and Doppler echocardiography as reference. In 288 hemodynamic recordings analyzed (aortic valve area [AVA]: 0.74+/-0.46 cm2), ejection ended 37+/-29 ms after the pressure crossover but almost simultaneously with the incisura (2+/-17 ms). Pressure crossover error accounted for significant errors in the measurement of DeltaP (95% limits of agreement, +0 to +7 mm Hg) and AVA (-0.1 to +0.2 cm2). These errors were reduced to less than half with the use of the incisura to define end-ejection. Additionally, the agreement with Doppler-derived AS indices was best with use of the incisura. Pressure crossover error was maximal in situations of higher output, moderate orifice narrowing, higher arterial compliance, and lower vascular resistance. In 32 consecutive patients undergoing cardiac catheterization for AS, the pressure crossover induced a clinically important overestimation of the DeltaP from +22 to +50%. Errors in AVA estimation were considerably smaller (-2% to +6%) because of simultaneous and offsetting errors in the measurements of DeltaP and flow. CONCLUSIONS: The aortic incisura and not the second pressure crossover should be used to obtain invasive indices of AS.