Microsoft Word - Roth MPV in Heart Failureand Thérèse Stukel
Medical Practice Variations
Health Services Research
10.1007/978-1-4899-7573-7_81-1
Medical Practice Variations in Heart Failure Gregory A Roth1 , Jeremiah Brown2 and David J. Malenka3
(1)Division of Cardiology & Institute for Health Metrics and Evaluation, University of Washington School of Medicine, Seattle, WA 98121, USA
(2)The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth, One Medical Center Drive, HB 7505, Lebanon, NH 03756, USA
(3)The Dartmouth Institute, Lebanon, NH, USA
Gregory A Roth Assistant Professor (Corresponding author) Email: rothg@uw.edu
Jeremiah Brown Email: jeremiah.r.brown@dartmouth.edu
David J. Malenka Email: david.j.malenka@hitchcock.org
Abstract There is substantial regional variation in hospitalization and mortality due to heart failure in the United States that is not explained by disease severity. Significant variation also exists in medical care for heart failure in the United States. Underprescribing of medical therapy for heart failure has been widely documented, and the use of recommended behavioral counseling, diagnostic imaging, and implanted defibrillators varies across the country. Treatment of advanced heart failure is changing rapidly due to broadening indications and availability of mechanical support devices and increases in the use of hospice services. There are disparities in heart failure care including evidence that African- American race correlates with factors leading to early readmission and that the regions with highest rates of readmission vary by race. Regional variation is partly explained by differences in hospital quality and local patterns of medical practice, including providers’ experience, training and specialization, willingness to implant devices in those with advanced disease, and local availability of resources. Multicenter quality improvement programs appear to have slightly reduced readmission and mortality due to heart failure despite the fact that best practices are only sometimes adopted and the effect of broadly adopted quality metrics remains to be seen. Medical practice variation remains an active area of research in the face of rising costs and hospitalizations due to heart failure.
Background
Heart failure is a condition that burdens people around the world and is estimated to affect more than six million adults in the United States (Roger et al. 2011). This chapter describes medical practice variation in the care of people with heart failure. There are four sections. The first section provides background on heart failure, including its definition, pathophysiology, clinical presentation, treatment, and epidemiology in the United States. The second section describes variation in medical practice as it relates to heart failure. Medical practice variation is defined broadly to include regional differences in the utilization of medical services for heart failure as well as change over time, including variation in medical therapy, diagnostic imaging, implanted medical devices, heart transplant, and palliative care. The third section explores the possible causes of this observed variation, focusing first on patient- and provider-level factors. The fourth section considers the goal of reducing practice variation in the medical care of heart failure. Though some European studies are referenced, the primary focus is practice variation in the United States.
What Is Heart Failure?
Heart failure is a clinical syndrome in which cardiac dysfunction leads to inadequate delivery of oxygen to organs and pulmonary and systemic venous congestion (Heart Failure Society of America 2010). It is the result of deterioration of the pumping function of the heart muscle related to inadequate contraction (heart failure with reduced ejection fraction) and/or relaxation (heart failure with preserved ejection fraction, known as HFpEF or diastolic heart failure). Heart failure may involve the left, right, or both sides of the heart such that fluid accumulates in the lungs or the periphery of the body. Congestive heart failure (CHF) is often used as a synonym for heart failure, though congestion is better understood as a result of some types of left-sided heart failure during which fluid accumulates in the lungs. Rather than a single disease, heart failure is a final common pathway for a wide range of diseases that affect the heart. Many conceptual models have been applied to heart failure in an attempt to account for this heterogeneity and encapsulate the wide-ranging hemodynamic, cardiorenal, neurohormonal, and molecular aspects of the disease (Braunwald’s Heart Disease 2012). In general, heart failure is a
 
 
 
 
 
 
 
 
 
 
 
 
 
reactive protein levels in the blood (>7.0 mg/L), abnormal ankle-arm blood pressure index, internal carotid artery wall thickness >1.88 mm, diabetes, abnormal pulmonary function testing, decreased kidney function (creatinine >1.4 mg/dl), and a range of ECG abnormalities (Gottdiener et al. 2000).
Heart Failure as a Clinical Syndrome
Clinical heart failure is a diagnosis based on a patient’s reported symptoms, a health-care provider’s
physical examination, and a range of diagnostic tests. Patients may report decreased exercise tolerance, fatigue, weakness, shortness of breath, and edema. Physical examination findings include pulmonary congestion, peripheral edema, and low blood pressure. Laboratory findings can include abnormal electrolytes and reduced kidney function. Chest x-ray and electrocardiograms can be abnormal but are relatively insensitive to the condition. Echocardiography plays an important role in the diagnosis of heart failure syndromes. Imaging of depressed cardiac function often serves to confirm an initial suspicion of heart failure. Echocardiograms are also essential in identifying possible reversible or progressive causes, including valvular heart disease, cardiac tamponade, and infiltrative diseases of the myocardium. Perhaps the most important role for echocardiography in clinical practice is to differentiate between heart failure with decreased ejection fraction (i.e., left ventricular systolic dysfunction) and heart failure with preserved ejection fraction (i.e., diastolic dysfunction). Approximately half of heart failure cases have preserved ejection fraction (Senni et al. 1998). This distinction is essential for guiding therapeutic decision-making, though both types of heart failure have been shown to have similarly poor prognosis (Bhatia et al. 2006). An ongoing challenge for the study of medical practice variation in heart failure is the fact that large administrative data sets, where diagnosis is based on codes for billing, do not reliably differentiate between heart failure with and without preserved ejection fraction.
Heart Failure Epidemiology
Heart failure is estimated to affect more than six million adults in the United States (Roger et al. 2011). Incidence of heart failure is associated with age, sex, and race, with African-Americans having a high rate (4.6 per 1,000 person-years) and Chinese Americans having a relatively low rate (1.0 per 1000 person-years). Over the past 50 years, the incidence of heart failure has fallen for women but not for men (Levy et al. 2002). Left ventricular dysfunction is common in the general population. In Olmstead County, 28 % of asymptomatic individuals had some degree of diastolic dysfunction and 6 % had systolic dysfunction (Redfield 2003). Heart failure is frequently reported on death certificates, with one in nine death certificates mentioning it (Roger et al. 2011). Mortality is high with post- hospitalization mortality of 4–15 % at 30 days and 33–68 % at 5 years (Levy et al. 2002). In Olmstead
County, 5-year mortality rates have improved slightly from 43 % in 1979–1984 to 52 % from 1996 to 2000 (Roger 2004). Heart failure remains the second most common reason for hospitalizing an adult, after pneumonia, and the fifth most expensive in total cost ($10.7 million in 2009), following only septicemia, osteoarthritis, coronary atherosclerosis, and acute myocardial infarction (Figures 2009).
Heart Failure Disease Management
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Common behavioral recommendations include dietary sodium restriction, exercise training, smoking cessation, control of traditional cardiovascular risk factors, careful medication adherence, and maintenance of a healthy body weight. The medications that were found to have a mortality benefit for those with heart failure with left ventricular systolic dysfunction include certain types of beta blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, aldosterone receptor blockers (spironolactone or eplerenone), and hydralazine combined with nitrates. Right heart failure may be treated with pulmonary vasodilators. Traditionally, the symptoms of heart failure have been effectively managed with loop and thiazide diuretics, digoxin, and sometimes nitrates. Recently, medical devices have played an increasingly important role in the care of heart failure, including implantable cardioverter-defibrillators and pacemakers that provide for cardiac resynchronization (biventricular pacing). Revascularization, either with percutaneous coronary intervention or coronary artery bypass grafting, is often pursued for patients with heart failure, coronary artery disease, and reversible myocardial ischemia. Valve surgery or transcatheter valve replacement may be recommended. Advanced heart failure may be treated with temporary intra-aortic balloon pumps, inotrope infusions, ventricular assist devices, or cardiac transplantation.
The Role of Hospitalization in the Care of Heart Failure
While heart failure is ideally treated in an ambulatory setting, heart failure is the second most common reason for an adult to be admitted to a hospital. This usually occurs because of dyspnea due to pulmonary edema that is no longer responsive to oral diuretic therapy. A hospital admission allows for the administration of parental loop diuretics and effective decongestion while simultaneously optimizing other important medications. Increasingly, hospital admissions are opportunities to educate patients on disease management, address home care needs, and offer palliative care services. A large- scale national effort is currently underway to reduce 30-day readmissions for heart failure and improve transitions from hospital to home for patients with heart failure.
Medical Practice Variation in Heart Failure
Regional Variation in HF-Related Hospitalization and Mortality in the United States
 
 
 
 
 
 
region. In order to understand the independent role that medical practice variation plays in determining hospitalization rates, it is necessary to account not only for age but also patient-level risk factors for heart failure like sex and hypertension as well as comorbid health conditions that can cause heart failure like coronary artery disease. These concerns might reasonably be extended to include race, levels of education, and socioeconomic class. Some researchers have also considered area-level influences such as neighborhood characteristics (Gerber et al. 2010). Multivariate and hierarchical models may be used to help measure the variation in hospitalization rates that is independent of the factors which are correlated with heart failure.
Geographic Variation in Heart Failure-Related Hospitalization
Casper et al. calculated county-specific, age-adjusted, and spatially smoothed heart failure hospitalization rates for patients older than 65 years using Medicare data collected from 2000 to 2006 (Casper et al. 2010). They showed that hospitalization rates were highest in the Southeastern United States, including along the lower Mississippi and Ohio River Valleys, Appalachia, northern and southern Texas, and part of Oklahoma (Fig. 1). These regions represented the highest quintile of admission rates (25–60 hospitalizations per 1,000 beneficiaries) which was more than 4 times larger
 
 
 
 
Fig. 1 Heart failure hospitalization rates among medicare beneficiaries, age ≥65 years, 2000–2006 (Reprinted from Journal of the American college of Cardiology (JACC), 55/4, Michele Casper, Isaac Nwaise, Janet B. Croft, Yuling Hong, Jing Fang, Sophia Greer, Geographic Disparities in Heart Failure Hospitalization Rates Among Medicare Beneficiaries, 294–299, 2010, with permission from Elsevier)
As stated above, geographic variation in heart failure hospitalization rates may represent differences in the incidence and severity of heart failure in the local population rather than variation in medical practice patterns. Several investigators have used data available in Medicare administrative files to estimate risk-adjusted hospitalization rates in order to account for differences in the incidence and severity of heart failure between regions of the country. These studies adopted the Center for Medicare & Medicaid Services (CMS) heart failure 30-day mortality measure used for profiling hospitals (developed, in part, by the same investigators), which include age, sex, history of cardiovascular conditions and procedures, and common serious comorbidities identified by billing codes (Keenan et al. 2008). Using this approach, an analysis of trends in heart failure hospitalization and death from 1998 to 2008 examined heart failure at the US state level (Chen et al. 2011). Among Medicare beneficiaries older than 65 years in 2008, risk-standardized hospitalization rates ranged from 1149/100,000 person-years (Vermont) to 2931/100,000 person-years (Wyoming). This analysis documented significant variation in adjusted rates at the state level that persisted over time despite overall improvement in national rates of hospitalization. For example, the mean number of unique hospitalizations for heart failure in the United States fell from 2014/100,000 person-years to 1462/100,000 person-years over 10 years. At the same time, four states in 1998 and two states in 2008 have risk-standardized heart failure hospitalization rates significantly higher than the national mean (Nevada, Mississippi, Illinois, and West Virginia in 1998 and Wyoming and West Virginia in 2008). While the researchers do not report exact estimates for each state, overall, their map shows higher rates of hospitalization around the Mississippi and Ohio River Valleys, Appalachia, and parts of Texas and Oklahoma. Analyses of such large geographic areas frequently mask important variation occurring within them. Hospital referral regions (HRR) are smaller geographic areas defined by referral patterns for tertiary services such as cardiac and neurosurgery. The 306 HRRs usually contain at least one major referral center and represent the major market for tertiary care (Dartmouth Health Atlas 2013). Very large variation in the prevalence of heart failure and rates of hospitalization is observed at the level of HRR. In 2011, the prevalence of heart failure within HRR ranges from 8.1 % of fee-for-service Medicare beneficiaries around Grand Junction, CO, to 22.7 % around Dearborn, MI (New Data on Geographic Variation – Institute of Medicine 2011). Bernheim et al. examined heart failure 30-day mortality and
   
 
 
 
 
 
 
Fig. 2 Regional distribution of heart failure adjusted readmission rate by quintile of performance (Bernheim et al. 2010)
Regional variation in medical practice is easiest to measure when there is good agreement among health-care professionals about when a condition exists and how to treat it. For example, hip fractures and myocardial infarctions are reliably diagnosed by readily available and specific tests, and there is general agreement that they require a hospitalization for treatment (Lewis 1969). Heart failure poses particular challenges for the study of medical practice variation because it is an extremely heterogeneous condition with a broad array of diagnostic definitions and available treatments. Furthermore, broadly representative administrative and billing data do not contain the detailed clinical information, such as left ventricular ejection fraction, required to accurately estimate disease severity. Despite these challenges, considerable efforts have been made to provide a comprehensive picture of geographic variation in the burden of heart failure in the United States. The available studies support five main conclusions about regional variation in heart failure. First, there is substantial geographic variation in heart failure hospitalization rates in the United States. Second, hospitalization rates are highest in the Midwest, South, and South Central states. Third, this variation exists both for all admission and 30-day readmission rates. Fourth, analyses of larger geographic areas frequently mask important variation occurring within them. Finally, risk adjustment methods using administrative data may not fully account for variation in the severity of heart failure. Thus, observed variation in adjusted hospitalization rates may reflect, at least in part, differences in the variation in heart failure severity across the United States.
Geographic Variation in Heart Failure-Related Mortality
 
 
 
 
 
Just as regional variation in hospitalization may reflect underlying disease severity in a particular community and not necessarily unwarranted medical practice variation, regional variation in heart failure mortality may reflect either local disease severity or local quality of care. For example, risk factors for heart failure such as hypertension vary greatly in prevalence across the country (Avery et al. 2012; Ezzati et al. 2008). Therefore, risk adjustment for hypertension and other comorbidities associated with heart failure can help account for regional variation and make it more reasonable to infer unwarranted variation in health-care delivery from mortality patterns. For example, Chen et al. have reported a risk-standardized 1-year mortality rate following heart failure hospitalization of 32 % in 2008 among older Medicare beneficiaries. Notably, there was significant variation by state, ranging from a risk-standardized 1-year mortality rate of 29.1 % in Maine to 35.2 % in Arizona (Chen et al. 2011). Unlike hospitalization rates described above, standardized 1-year mortality rates fell only slightly over the preceding decade (from 31.7 % in 1999 to 29.6 % in 2008). The mortality rate remained significantly higher than the national average in three states for both 1999 and 2008 (Arizona, Oklahoma, and Oregon). At the HRR level, standardized 30-day mortality after an admission for heart failure also shows significant geographic variation (median 10.8 % with a 5 % difference between hospitals in the 5th and 95th percentile) (Bernheim et al. 2010). Patterns of mortality after heart failure hospitalization show a much broader distribution of regions with higher rates than when examining hospitalization rates alone. Unlike hospitalization due to heart failure, some of the highest death rates due to heart failure are found in the Western United States. In the West, intriguing variation exists between a region with elevation in both 30-day and 1-year mortality (Oregon) compared with a region where 1-year mortality is high but 30-day mortality is lower (Arizona). There is a need for further studies that examine both early and late mortalities from heart failure using similar methods. However, both studies demonstrate large regional variation in heart failure-related mortality that is likely independent of variation in disease severity.
Variation in the Use of Optimal Medical Therapy for HF
 
   
 
of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE-HF) included over 15,000 adults with documented LV systolic dysfunction at 197 clinics in the United States (Fonarow et al. 2007b). The study was based on representative sampling of medical records at each clinic for each assessment period. At baseline, appropriate use of ACE inhibitors or angiotensin receptor blockers (ARBs), beta blockers, and aldosterone antagonists was found in 78 %, 86 %, and 34 % of patients, respectively (Fonarow et al. 2010). The quality improvement program showed a significant increase in prescribing of guideline-recommended medical therapy over 2 years, suggesting that at least some of the variation in prescription practices was related to provider- or system-level barriers to appropriate medical therapy (Fig. 3).
Fig. 3 Use of guideline-recommended therapies at baseline, 12 months, and 24 months in a longitudinal cohort of heart failure patients. CRT-P indicates CRT with pacemaker; CRT-D, CRT with defibrillator. * P < 0.001, 12 and 24 months vs. baseline. † P < 0.001, 12 vs. 24 months. ‡ P = 0.007, 12 vs. 24
months. § P = 0.009, 12 vs. 24 months (Fonarow et al. 2010)
Most research on variation in the delivery of heart failure medications has focused on these mortality- improving medications. However, there is a small but important literature regarding variation (or lack thereof) for the other medications used routinely to manage heart failure symptoms. Studies of loop diuretics are uncommon outside of clinical trials, but the Italian Network on Congestive Heart Failure provides a useful report suggesting almost universal use in heart failure patients with a wide range of doses. For the years 1995–2000, 92 % of patients in this registry were prescribed a loop diuretic, with
 
 
 
 
 
 
rate with inotropes between hospitals, from 1 % to 45 % of cases by hospital even after adjusting for age, sex, and comorbidities (IQR 4.3–9.2 %, median 6.3 %) (Partovian et al. 2012). Hospitals also
demonstrated predominant use of a particular inotrope (dobutamine in 29 %, dopamine in 25 %, milrinone in 1 %, and mixed in 45 %), suggesting that hospital-level practice patterns determine the selection of a particular inotrope. Hospitals also vary in their use of aldosterone-antagonizing medicines following heart failure exacerbations. Among post-MI patients with LV EF <40 %, prescription by hospital varied from 0 % to 40 % (median, 7.0 %; interquartile range, 1.9–13.4 %) (Rassi et al. 2013). Variation between countries has been demonstrated for the use of warfarin among heart failure patients with atrial fibrillation between 2005 and 2009, ranging from a risk-adjusted rate of 25 % in Taiwan to 65 % in Australia (Suarez et al. 2012). Medical therapy for heart failure has changed significantly as new studies have demonstrated agents that provide substantial benefit for patients, and their results have been disseminated into society guidelines and clinical practice. A study by Juurlink et al. using data from the Ontario Drug Benefit system reveals the varying degrees of time lag in the adoption of new therapies. Among patients prescribed an ACE inhibitor and hospitalized for heart failure between the years 1994 and 2001, beta blocker use rose steadily over these years and loop diuretic use, already high, declined only slightly (Juurlink et al. 2004). Following the publication of positive results in the randomized aldactone evaluation study (RALES) trial (showing a mortality benefit for aldosterone blockade with spironolactone), spironolactone use quickly rose fivefold from 30 per 1000 patients in 1999–149 per 1000 patients in 2001. Unlike the RALES trial, this real-world study of spironolactone also showed a significant increase in serious hyperkalemia and hyperkalemia-related deaths. Overall, the changing use of medical therapy for heart failure over time and place provides a practical example of the diffusion of innovation occurring in medical care (Rogers 2003).
Variation in Counseling/Patient Education
   
 
 
 
 
 
Fig. 4 Smoking cessation across heart failure clinics, with median percentage for sites ( solid blue line) (Reprinted from The American Journal of Cardiology (AJC), 105/2, Clyde W. Yancy, Gregg C. Fonarow et al., Adherence to Guideline-Recommended Adjunctive Heart Failure Therapies Among Outpatient Cardiology Practices (Findings from IMPROVE HF), 255–260, 2010, with permission from Elsevier)
Variation in Diagnostic Approaches
 
 
 
 
 
 
no association between the presence of viable myocardium detected by SPECT thallium perfusion imaging, dobutamine stress echocardiography, and survival benefit from coronary artery bypass grafting among patients with coronary artery disease and left ventricular dysfunction (Bonow et al. 2011). This finding that the benefit of bypass surgery was not associated with the presence of living heart tissue raises numerous questions about the benefits of revascularization in patients with heart failure. There is considerable regional variation found in the use of echocardiography, which ranges from 17.5 % of Medicare beneficiaries receiving the test in Portland, OR, to 48 % in Miami, FL (Welch 2012). In order to better understand the relationship between practice patterns and the use of cardiac imaging, Lucas et al. posed a clinical vignette describing angina to a national sample of cardiologists. They found substantial variation in when a physician would recommend a resting echocardiogram (29 % said “always/almost always” or “most of the time” for a patient with new angina). Furthermore, there was a significant association between the proportion of cardiologists recommending testing and an index of end-of-life expenditure in their own HRR (~38 % in the highest quintile vs ~18 % in the lowest quintile) (Lucas et al. 2010). This finding links the use of echocardiography to the broader practice patterns within an HRR.
Variation in the Use of Implantable Cardioverter-Defibrillators
implantable cardioverter-defibrillators lower mortality among some individuals with moderate to severe LV systolic dysfunction and congestive heart failure symptoms, even if they have never experienced a life-threatening arrhythmia (Katritsis et al. 2012). Following the 2005 decision by CMS to reimburse physicians for implanting “primary prevention” ICDs (ICDs for patients with heart
   
 
   
 
Fig. 5 Rate ratios of primary prevention. ICD implantation by HRR (mean US rate, 1.0) (Matlock et al. 2011b)
 
 
 
 
 
 
 
 
 
 
 
Appropriate medical management, particularly with beta blockers, may actually improve heart failure to the point where an ICD is no longer indicated. There also appears to be significant variation in this kind of medical management before ICD implantation. Hauptman et al. examined prescriptions filled by patients who received a primary prevention ICD and found 33 % did not receive a beta blocker in the 90 days prior compared with 16 % following implant (Hauptman et al. 2010). Similarly, Miller et al. analyzed the NCDR to show that 26 % of patients receiving primary prevention ICD were eligible for heart failure medical therapy but did not receive it (Miller et al. 2012). Furthermore, the rate of prescribing optimal medical therapy by site ranged from 0 % to 100 % (median 74 %, IQR 64–82 %). These studies point to the fact that cardiac procedures are not isolated events but simply the most easily measured component of many related up- and downstream health-care decisions.
Variation in the Delivery of Advanced Heart Failure Therapies
Heart Transplant People with severe heart failure may be referred for heart transplant. Since the early 1980s, more than 2000 heart transplants have been performed annually in the United States (Stehlik et al. 2010). Transplant techniques have evolved considerably over that period of time with steady improvement in median survival, which is now approximately 10 years. Detailed clinical data on all transplants is available in the United States from the United Network for Organ Sharing and has allowed several investigators to examine practice variation in the transplant system. There is substantial variation between transplant centers in the probability of receiving a transplant or dying within 90 days, even after adjusting for baseline clinical characteristics (Whellan et al. 2000). Russo et al. demonstrated a direct relationship between increasing transplant procedural volume and graft survival at one year (OR 0.995, p = 0.01) (Russo et al. 2010). This weak effect was reexamined by Kilic et al. who found that center volume only accounted for 17 % of variation in mortality with wide ranges of 1-year mortality in low-, medium-, and high-volume centers (67–97 %, 81–97 %, and 84–94 %, respectively)
(Kilic et al. 2012). They suggest that unknown factors may play a more important role than procedural volume in explaining the variation in mortality rates among US heart transplant programs.
 
 
   
 
 
 
 
LVADs for those awaiting cardiac transplant, survival for patients awaiting transplant has improved from 57 % to 59 % in 2002–2004 to 77–81 % in 2008–2010 (Shao et al. 2012).
LVADs are being rapidly adopted for destination therapy (DT), i.e., implantation among patients with severe heart failure who are not seeking cardiac transplantation (59 DT implants in 2009 increased to 546 DT implants in 2010) (INTERMACS Interagency Registry for Mechanically Assisted Circulatory Support: Quarterly Statistical Report 2012). This shift has led to the strategy of LVAD surgeries being performed outside of transplant centers. As of 2010, 79 centers had been certified by CMS to implant destination therapy LVADs (Fig. 7) (Slaughter 2010). An analysis of 73 patients who received their device at an open-heart surgery center where transplants are not performed showed longer length of stay (24 vs 20 days at heart transplant centers) but similar complication and survival rates. Notably, age was greater and transplant rates were lower at 1 year in this group, reflecting the fact that more than half were receiving an LVAD for destination therapy (Katz et al. 2012). As mechanical support devices become smaller and safer, it is possible that more heart failure patients will receive these devices for a broader range of indications. Even now some patients are electing to receive an LVAD instead of pursuing a heart transplant. This new mechanical treatment paradigm for advanced heart failure is likely to have major implications for the care for heart failure patients at the end of life.
Fig. 7 Incidence of underlying deaths coded to heart failure by county. Blue dots are the locations of the 79 destination-therapy ventricular assist device implantation centers currently certified by CMS (Reproduced by permission of Mark Slaughter)
Variation in Heart Failure Care at the End of Life
 
 
 
 
 
 
 
 
 
highly variable in severity, by restricting a study to those patients that died within 2 years, all patients have a similar prognosis. Moreover, end-of-life patients account for about a third of total Medicare spending, an amount that is increasing (Wennberg et al. 2008). Unroe et al. investigated the use of resources among Medicare beneficiaries who died with heart failure between 2000 and 2007 (Unroe et al. 2011). Over that time period, cost of care in the last 6 months of life increased by 11 %, with highest costs associated with lower age, renal and chronic obstructive pulmonary disease, and black race. The Northeast and West regions of the United States had significantly higher costs (unadjusted 5 and 17 % higher and adjusted 14 and 16 % higher, respectively) compared with the South, while the Midwest was significantly lower (unadjusted 8 % and adjusted 4 % lower). At the same time, hospice use in the last 6 months of life increased from 19 % to 40 % and the cost of hospice care doubled (from mean $964 to $2594 per patient). Overall, hospice care in the heart failure population has been shown to increase costs (cost ratio 1.04, 95 % CI 1.01–1.07) but, at the same time, is associated with decreases in hospitalization, cardiac catheterization, implanted defibrillator implant, and mechanical ventilation (Blecker et al. 2011).
Causes of Practice Variation in Heart Failure Care The sources of practice variation in heart failure care are multiple. It may be best to think of a causal network for practice variation rather than any single etiology. The patient serves as the centroid for this network, but it extends outward to include a broad range of interconnected root causes. These include physicians, nurses, allied health-care providers, clinics, hospitals, the local and national health system, as well as the patient’s family, neighborhood, community, and employer. It may also be useful
to consider a “life-course” perspective in which some causes exist only in the patient’s past, while
others are current events affecting their care. From a methodological perspective, it is necessary that most studies of the causes of practice variation in heart failure focus on a single or few related causes rather than a more comprehensive model. Reflecting this available literature, the causes of medical practice variation will be discussed at three levels: the patient, the health-care provider, and the health system. However, it is useful to remember that each isolated cause of variation is likely to effect, and itself be affected by, many other causes.
Patient Factors as a Cause of Variation
In general, heart failure care should be patient-centered in the sense that multiple patient-specific factors should be taken into account. Determining that a patient characteristic inappropriately impacted a care decision proves to be particularly challenging, especially with larger administrative data sets that lack clinical detail, and has only been demonstrated in limited cases. For example, Antonelli et al. showed lower rates of ACE inhibitors used at discharge among older heart failure patients with physical impairments (Incalzi et al. 2002). Yet this finding may reflect entirely appropriate care decisions considering that ACE inhibitors lower blood pressure and may increase fall risk in frail patients. Race and ethnicity is one patient factor that is particularly relevant to heart failure care and has received significant attention. There is an ongoing tension between inappropriate practice variation related to racial-ethnic inequalities and high-quality medical practice that is racially aware and culturally competent and accounts for pathophysiology that may be unique to a particular racial-ethnic group. The best example of this issue is the observation that African-Americans demonstrate a unique
heart failure phenotype and therapeutic response (Ishizawar and Yancy 2010). This hypothesis led to the African-American Heart Failure Trial. The positive results of this study led to the first FDA approval of a medication for a particular racial-ethnic group based on the finding of a survival benefit for the combination of isosorbide dinitrate and hydralazine among patients who self-identified as African-American and of African descent (Taylor et al. 2004). Multiple studies have focused on African-American heart failure patients. African-American heart failure patients have been found to have lower health-related literacy, have worse adherence to prescribed medications, and are less likely to receive guideline-based heart failure medications (Chaudhry et al. 2011; Calvin et al. 2012). Despite these concerning findings, results have not shown systematically worse survival for heart failure among African-American patients. In 1996, Gordon et al. found risk-adjusted in-hospital mortality was actually 13 % lower among African-American’s with
six common conditions, including heart failure, compared with white patients (Gordon et al. 1996). In 2001, Jha et al. used Veterans Health Administration data and showed 30-day mortality was also lower among black men compared with white men for each of six conditions, including heart failure (Jha 2001). Similar results were found in a large heart failure registry (Thomas et al. 2011). More recently, however, McHugh et al. showed that 30-day readmission rates among Medicare beneficiaries in 2008 was 9 % higher for black than white patients, even after controlling for comorbidities and hospital characteristics (McHugh et al. 2010). Joynt et al. also showed a slightly higher 30-day readmission rate for black compared with white patients (27.9 % vs 27.1 %, respectively). These findings, taken together, suggest that African-American race may correlate with factors leading to early readmission but not with factors that determine overall mortality. Heart failure with preserved systolic function (diastolic heart failure) is an example of one factor that may be associated with race and readmission but not overall mortality. Of note, Joynt et al. also found higher readmission rates for white patients admitted at hospitals that predominantly served African-American communities (27.8 % vs 25.2 %). One intriguing explanation is the possibility that higher readmission rates for African-Americans with heart failure reflect the quality of hospitals in predominantly African-American communities rather than the kind of medical care provided to individual African-American patients. This hypothesis may help to explain the significant regional variation in race-specific heart failure hospitalization rates seen across the United States. For example, the highest heart failure admission rates for African-Americans are found in the lower Mississippi River Valley, mid-Appalachia, and northern Illinois, while the highest rates for Hispanics are in southern Texas, the shores of Lake Erie from southern Michigan to New York, and along the urban corridor between Philadelphia and Boston (Casper et al. 2010).
Provider Factors as a Cause of Variation
Several studies have attempted to explain the observed variation in medical care for heart failure by examining the decision-making of individual health-care providers, with mixed results. These studies invoke the possibility of systematic differences in physician practice independent of the severity of heart failure cases. Komaromy et al. surveyed over 1000 physicians from across California with a clinical vignette that asked them to make a decision about hospitalizing an outpatient with increasingly severe portrayals of congestive heart failure (Komaromy et al. 1996). Using these vignettes, they estimated a clinical admission score that represented a particular physician’s threshold
for hospitalizing a patient (termed “practice style”). While practice style correlated with a physician’s
 
 
In addition, several small qualitative studies have examined physician-reported determinants of implementing appropriate heart failure pharmacotherapy. Focus groups involving 30 general practitioners in England in 2002 revealed that, in regard to starting an ACE inhibitor in heart failure patients, physicians had concerns about inducing hypotension and polypharmacy. They were unaware of or questioned the results of clinical trials and complained that they did not understand how to interpret the results of echocardiograms (Fuat 2003). Peters-Klimm et al. surveyed primary care physicians in Germany in 2005 and found that their self-perceived competency and confidence with the use of ACE inhibitors/ARBS in heart failure had a positive relationship with attainment of target doses. A study of general practitioners in the Netherlands found that physician gender and years of work experience did not predict actual prescribing of ACE inhibitors for heart failure (Kasje et al. 2005). More recently, Steinman et al. performed focus groups with academically affiliated physicians in the United States in 2008 to better understand why a physician might not prescribe guideline- recommended heart failure therapies (Steinman et al. 2010). They describe five categories of reasons: (1) adverse effects of drug therapy, (2) nonadherence to therapeutic and monitoring plan, (3) patients’ preferences and beliefs, (4) comanagement and transitions of care, and (5) prioritization and patient benefit. Among academic primary care physicians in New York City, teaching responsibilities and confidence level with heart failure care were associated with greater self-reported prescribing of beta blockers but, interestingly, not with actual prescribing of beta blockers (Sinha et al. 2009). Overall, there is considerable concern but only weak evidence that individual physician characteristics are a primary determinant of inappropriate variation in the use of heart failure pharmacotherapy. In marked contrast to the limited number of studies examining practice style at the level of a single physician, at least 18 studies and one systematic review have inquired as to whether a physician’s
specialty, presumably as an indicator of professional practice style, is associated with variation in heart failure care (Go et al. 2000). This is, at least in part, due to the inclusion of physician specialty within large administrative databases and the American Medical Association Physician Masterfile. Early studies addressed the concern that non-cardiologists were underprescribing ACE inhibitors. In 1997, Stafford et al. analyzed ambulatory visits for heart failure from 1989 through 1994 using data from the National Ambulatory Medical Care Survey. They found that ACE inhibitor use had increased from 24 % to 31 % of visits over that period of time. In a multivariate model, independent predictors of receiving an ACE inhibitor included living in the Midwestern United States, white race, male sex, and care from a cardiologist (Stafford 1997). In the same year, Chin et al. surveyed 500 each of cardiologists, general internists, and family practitioners with clinical vignettes of heart failure. They found that cardiologists were more likely to prescribe an ACE inhibitor (86 % vs 76 % vs 72 % for symptomatic and 94 % vs 70 % vs 58 % for asymptomatic patients, respectively). They were also more likely to increase to a target dose and more likely to accept a systolic blood pressure below 90 mmHg (Chin et al. 1997). From these early studies and the many that have followed, several general conclusions may be drawn. First, increasing physician specialization leads to an intensification of diagnostic and therapeutic care. This has been shown for hospitalists vs nonhospitalists, cardiologists vs general practitioners, and heart failure specialists vs general cardiologists (Baker et al. 1999; Bello et al. 1999; Edep et al. 1997; Roytman et al. 2008; Asghar and Rahko 2010). Second, care by a cardiologist has been associated with lower 30-day readmission rates. Reis et al. examined the effect of inpatient care for heart failure exacerbation by generalists vs inpatients at a tertiary academic medical center (Reis et al. 1997). While cardiologists’ patients were more symptomatic on presentation, received more inotrope therapy, and had a longer length of stay, 30-day readmission rates adjusted for patient characteristics were higher for patients cared for by generalists (relative risk of readmission 1.69, 95 % CI 1.11–2.56). A study by Philbin et al. also found lower 30-day readmission rates for patients cared for by
 
 
 
 
cardiologists (Philbin et al. 1999). Finally, there is some evidence that mortality rates may also improve with specialty care. A single study over 7000 patients in Ontario, Canada, has shown that cardiologist care was associated with improvements in risk-adjusted mortality at 30 days and 1 year, possibly mediated by higher rates of beta blocker use by cardiologists (Boom et al. 2012). This more recent finding of improved outpatient survival contrasts with an older study of 44,926 heart failure patients in New York State for whom care by a cardiologist, internal medicine physician, or family practitioner made no difference on risk-adjusted rates of in-hospital death (Philbin and Jenkins 2000). Results of studies of the effect of physician specialty on heart failure care may reflect the degree of diffusion of knowledge of newer, more effective heart failure pharmacotherapy during the years each study was performed. Perhaps more relevant today is the role of communication among multiple providers caring for heart failure patients rather than the relative benefit of care from a single type of provider. Supporting this view are two studies which have demonstrated that collaborative care by both a cardiologist and primary care physician leads to improved treatment rates compared with care by either group alone (Ahmed et al. 2003; Lee et al. 2010). Provider-level variation in heart failure care has also been measured at the broader level of hospitals and hospital referral regions (HRR). An analysis of Medicare beneficiaries admitted for heart failure found more than a threefold variation in days spent hospitalized among patients cared for in 77 hospitals (median 15.1 days, range 8.9–32.3 days) (Wennberg et al. 2004). These rates were closely
 
 
 
 
 
Causes of Variation in the Use of ICDs
The cause of variation in the use of ICDs deserves special attention for several reasons. First, the observed variation is large (almost fourfold between HRR). In addition, this variation has led to a significant number of studies that attempt to explain the variation. Finally, implanted defibrillators are only the most recent technological advance in cardiac care and provide a paradigm for understanding practice variation that will likely be seen with future medical devices, including LVADs and transcatheter valve replacements. There is evidence that African-American race and female sex are associated with a lower likelihood of receiving an ICD. In 2007, El-Chami et al. examined over 26,000 patients in the ADVANCENT registry of LV dysfunction <40 % and found that nonwhite race and female sex were negative predictors of ICD implantation (OR 0.88, 95 % CI 0.81–0.96, and 0.7, 95 % CI 0.55–0.64) (El-Chami et al. 2007). This association persisted even after adjusting for age, sex, ejection fraction, NYHA class, comorbidities, QRS duration, referring physician type, and insurance type. The same relationship was found for the receipt of any device, including single and biventricular pacemakers. Only 18.5 % of nonwhite women received an ICD compared with 32.1 % of white men. An analysis of the IMPROVE-HF registry found similar heterogeneity by race and sex (Mehra et al. 2009; Thomas et al. 2007). ICD use was also more frequent in the Northeastern United States, at multispecialty practices, and at practices with dedicated heart failure clinics or electrophysiologists on staff. A more recent longitudinal analysis of ICD implantation in the American College of Cardiology Get With The Guidelines-Heart Failure registry found that from 2005 to 2009 ICD implantation increased for both black and nonblack men and women (Fig. 8) (Al-Khatib et al. 2012). By the end of this time period, the racial disparity in implant rates had resolved though the sex difference persisted. Remarkably, black women had experienced a greater than fourfold increase in the rate of ICD implantation over this time period.
   
 
 
Fig. 8 Temporal changes in ICD use by sex and race (Al-Khatib et al. 2012)
A possible explanation for this observed variation by race and sex is that it reflects heterogeneity in physicians’ understanding of who is likely to benefit from an ICD. Sherazi et al. surveyed 332
   
 
 
 
 
 
 
 
 
Fig. 9 Proportion of physicians responding that they would recommend or refer the following patients for implantable cardioverter-defibrillator (ICD) therapy by quintile of ICD use in respondents’ HRR (Matlock et al. 2011a)
Reducing Practice Variation in Heart Failure Care Many of the studies on patient- and provider-level practice variation in heart failure evaluate quality improvement programs that reduce variation in care rather than search for its root cause. These studies generally adopt a clinic or hospital level of analysis, provide a time-series analysis, and provide insight into the degree which unintended practice variation can be reduced through system-level interventions.
Quality Improvement Programs as a Response to Unintended Variation in Medical Practice
 
 
 
 
 
 
appropriate use (Ansari et al. 2003). The IMPROVE-HF quality improvement program increased the number of patients who achieved a maximal target dose of beta blocker from 21 % to 30 % (Gheorghiade et al. 2012). Subsequent studies show increased adherence with guideline- recommended ICD therapy and an association between receiving guideline-recommended care and improved 2-year survival (Mehra et al. 2012; Fonarow et al. 2011; Kfoury et al. 2008). There appears to be significant variation in the way hospitals adopt systems to promote high-quality heart failure care. A survey of 537 hospitals involved in a heart failure discharge improvement program found that, of ten recommended practices, on average only five were in place and only a third of hospitals had implemented all of the practices (Bradley et al. 2012). An analysis of the OPTIMIZE-HF/Get With The Guidelines-Heart Failure registry of hospitalized heart failure patients found that hospitals’ median rate of follow-up within 7 days after heart failure discharge ranged from
0 % to 63.7 % (median 38.3 %, IQR 32.4–44.5 %) (Hernandez et al. 2010). In addition, patients discharged from hospitals with higher rates of early follow-up had lower risk of 30-day readmission. The ADHERE registry for acutely decompensated heart failure hospitalizations also shows wide variation in the adoption of core heart failure quality measures across hospitals. For example, across hospitals the rate of documenting appropriate discharge instructions ranged from 0 % to 99 % (median 24 %) (Fonarow 2005). This is despite the fact that the registry is composed of hospitals that have significantly more cardiac services, including cardiac intensive care, cardiac surgery, and transplant services than hospitals uninvolved in the ADHERE registry (Kociol et al. 2011). A systematic review of multidisciplinary interventions incorporated into heart failure care suggests that they both reduce readmission and mortality (Holland et al. 2005). While centralized multicenter quality programs appear to have improved outcomes in the outpatient care of heart failure, it has been much more difficult to prove that the same process measures, when implemented more broadly, can improve outcomes. An analysis of national discharge quality data found almost no relationship between receiving discharge instructions and 30-day readmission rates (Jha et al. 2009). A study of the effect of computer-order entry found that, in one hospital, reported ACE inhibitor use at discharge increased from 58 % to 100 % but this was entirely due to better documentation of ACE inhibitor contraindications. The actual rate of prescribing did not change significantly (56 % vs 61 %) (Butler et al. 2006). Perhaps the most concerning is that current, widely adopted performance measures for patients hospitalized with heart failure, including receipt of discharge instructions, evaluation of LV systolic function, ACE inhibitor or ARB, smoking cessation counseling, or warfarin for atrial fibrillation, appear to be unassociated with 3- or 12-month mortality and, except for ACE inhibitor or ARB use, with readmission rates as well (Patterson et al. 2010; Fonarow et al. 2007a). The planned use of beta blocker use as a new core discharge measure reflects the fact that this was the only process measure associated with both decreased readmission and mortality at 3 months. Some investigators, noting global variation in hospital length of stay for heart failure, have suggested that incentives to decrease length of stay in the United States may have inadvertently increased readmission rates (Bueno 2010; Howlett et al. 2013).
 
 
 
 
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
some variation in heart failure practice should be reduced. Several approaches to reducing unnecessary practice variation are found in the studies above. Appropriateness criteria for diagnostic imaging and procedural interventions have been widely promoted. Palliative care services and hospital to home transition programs are being expanded. Shared decision-making tools are being trialed. Quality metrics are being adopted and improved. Payment innovations are being tested, including accountable care organizations, bundling of services, and pay for performance systems focused on readmission rates. State and regional quality organizations are organizing around heart failure care. Technology solutions are being developed, including home monitoring, telehealth, and electronic health records that provide summary health data and risk prediction at the point of care. Heart failure remains an important condition for the study of medical practice variation because it is a paradigm for many of the ongoing challenges to this kind of research. Future investigations will require the collection of higher-quality data than what has previously been available. Patient-reported outcomes, more detailed clinical data, and better-quality cost estimates will need to be linked to the large administrative databases upon which this field was founded and built. New provider- and system-level interventions will need to be developed, implemented, and tested if early gains made in the reduction of unwanted practice variation in the care of heart failure are to be sustained.
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Abstract
Introduction
Background
Heart Failure Epidemiology
The Role of Hospitalization in the Care of Heart Failure
Medical Practice Variation in Heart Failure
Regional Variation in HF-Related Hospitalization and Mortality in the United States
A Note on Methodology in the Assessment of Geographic Variation in Heart Failure
Geographic Variation in Heart Failure-Related Hospitalization
Geographic Variation in Heart Failure-Related Mortality
Variation in the Use of Optimal Medical Therapy for HF
Variation in Counseling/Patient Education
Variation in Diagnostic Approaches
Variation in the Delivery of Advanced Heart Failure Therapies
Heart Transplant
Variation in Heart Failure Care at the End of Life
Causes of Practice Variation in Heart Failure Care
Patient Factors as a Cause of Variation
Provider Factors as a Cause of Variation
Causes of Variation in the Use of ICDs
Reducing Practice Variation in Heart Failure Care
Quality Improvement Programs as a Response to Unintended Variation in Medical Practice
Conclusion
References