Prateeti Khazanie

Trends in the Use and Outcomes of Ventricular Assist Devices Among Medicare Beneficiaries, 2006 Through 2011

OBJECTIVES This study sought to examine trends in mortality, readmission, and costs among Medicare beneficiaries receiving ventricular assist devices (VADs) and associations between hospital-level procedure volume and outcomes. BACKGROUND VADs are an option for patients with advanced heart failure, but temporal changes in outcomes and associations between facility-level volume and outcomes are poorly understood. METHODS This is a population-based, retrospective cohort study of all fee-for-service Medicare beneficiaries with heart failure who received an implantable VAD between 2006 and 2011. We used Cox proportional hazards models to examine temporal changes in mortality, readmission, and hospital-level procedure volume. RESULTS Among 2,507 patients who received a VAD at 103 centers during the study period, the in-hospital mortality decreased from 30% to 10% (p < 0.001), the 1-year mortality decreased from 42% to 26% (p < 0.001), and the all-cause readmission was frequent (82% and 81%; p = 0.70). After covariate adjustment, in-hospital and 1-year mortality decreased (p < 0.001 for both), but the all-cause readmission did not change (p = 0.82). Hospitals with a low procedure volume had higher risks of in-hospital mortality (risk ratio: 1.72; 95% confidence interval [CI]: 1.28 to 2.33) and 1-year mortality (risk ratio: 1.55; 95% CI: 1.24 to 1.93) than high-volume hospitals. Procedure volume was not associated with risk of readmission. The greatest cost was from the index hospitalization and remained unchanged (

Outcomes of medicare beneficiaries with heart failure and atrial fibrillation.

204,020 in 2006 and

Patient Selection for Left Ventricular Assist Devices

201,026 in 2011; p = 0.21). CONCLUSIONS Short- and long-term mortality after VAD implantation among Medicare beneficiaries improved, but readmission remained similar over time. A higher volume of VAD implants was associated with lower risk of mortality but not readmission. Costs to Medicare have not changed in recent years.

Clinical and Functional Correlates of Early Microvascular Dysfunction After Heart Transplantation

OBJECTIVES This study sought to examine the long-term outcomes of patients hospitalized with heart failure and atrial fibrillation. BACKGROUND Atrial fibrillation is common among patients hospitalized with heart failure. Associations of pre-existing and new-onset atrial fibrillation with long-term outcomes are unclear. METHODS We analyzed 27,829 heart failure admissions between 2006 and 2008 at 281 hospitals in the American Heart Associations Get With The Guidelines-Heart Failure program linked with Medicare claims. Patients were classified as having pre-existing, new-onset, or no atrial fibrillation. Cox proportional hazards models were used to identify factors that were independently associated with all-cause mortality, all-cause readmission, and readmission for heart failure, stroke, and other cardiovascular disease at 1 and 3 years. RESULTS After multivariable adjustment, pre-existing atrial fibrillation was associated with greater 3-year risks of all-cause mortality (hazard ratio [HR]: 1.14 [99% confidence interval (CI): 1.08 to 1.20]), all-cause readmission (HR: 1.09 [99% CI: 1.05 to 1.14]), heart failure readmission (HR: 1.15 [99% CI: 1.08 to 1.21]), and stroke readmission (HR: 1.20 [99% CI: 1.01 to 1.41]), compared with no atrial fibrillation. There was also a greater hazard of mortality at 1 year among patients with new-onset atrial fibrillation (HR: 1.12 [99% CI: 1.01 to 1.24]). Compared with no atrial fibrillation, new-onset atrial fibrillation was not associated with a greater risk of the readmission outcomes. Stroke readmission rates at 1 year were just as high for patients with preserved ejection fraction as for patients with reduced ejection fraction. CONCLUSIONS Both pre-existing and new-onset atrial fibrillation were associated with greater long-term mortality among older patients with heart failure. Pre-existing atrial fibrillation was associated with greater risk of readmission.

Changing trends in infectious disease in heart transplantation.

Mechanical circulatory support has become an increasingly common method of supporting patients with advanced heart failure. Paramount to the recent progress observed with this therapy has been a greater understanding of patient selection criteria as a primary determinant of early and late patient outcomes. Prior to device implant, patients should undergo a multidisciplinary evaluation of cardiovascular, noncardiovascular, and psychosocial factors that influence postoperative outcomes. The use of multivariable risk scores may also be useful to guide discussions with patients and families regarding the relative risks of different therapeutic alternatives. Despite an evidence base that provides guiding principles in patient selection for mechanically assisted circulation, several aspects of the evaluation require further refinement, including development of tools to objectively assess psychosocial parameters, and definition and validation of measures of right ventricular dysfunction that preclude successful isolated left ventricular support.

Predictors of clinical outcomes in acute decompensated heart failure : Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure outcome models

Background—Microvascular dysfunction is emerging as a strong predictor of outcome in heart transplant recipients. At this time, the determinants and consequences of early microvascular dysfunction are not well established. The objective of the study was to determine the risk factors and functional correlates associated with early microvascular dysfunction in heart transplant recipients. Methods and Results—Sixty-three heart transplant recipients who had coronary physiology assessment, right heart catheterization, and echocardiography performed at the time of their first annual evaluation were included in the study. Microvascular dysfunction was assessed using the recently described index of microcirculatory resistance. The presence of microvascular dysfunction, predefined by an index of microcirculatory resistance >20, was observed in 46% of patients at 1 year. A history of acute rejection and undersized donor hearts were associated with microvascular dysfunction at 1 year, with odds ratio of 4.0 (1.3–12.8) and 3.6 (1.2–11.1), respectively. Patients with microvascular dysfunction had lower cardiac index (3.1±0.7 versus 3.5±0.7 L/min per m2; P=0.02) and mild graft dysfunction measured by echocardiography-derived left and right myocardial performance indices ([0.54±0.09 versus 0.43±0.09; P<0.01] and [0.47±0.14 versus 0.32±0.05; P<0.01], respectively). Microvascular dysfunction was also associated with a higher likelihood of death, graft failure, or allograft vasculopathy at 5 years after transplant (hazard ratio, 2.52 [95% CI, 1.04–5.91]). Conclusions—A history of acute rejection during the first year and smaller donor hearts were identified as risk factors for early microvascular dysfunction. Microvascular dysfunction assessed using index of microcirculatory resistances at 1 year was also associated with worse graft function and possibly worse clinical outcomes.

Heart Failure Patient Adherence: Epidemiology, Cause, and Treatment

BACKGROUND During the past 25 years, advances in immunosuppression and the use of selective anti-microbial prophylaxis have progressively reduced the risk of infection after heart transplantation. This study presents a historical perspective of the changing trends of infectious disease after heart transplantation. METHODS Infectious complications in 4 representative eras of immunosuppression and anti-microbial prophylaxis were analyzed: (1) 38 in the pre-cyclosporine era (1978-1980), (2) 72 in the early cyclosporine era (1982-1984), where maintenance immunosuppression included high-dose cyclosporine and corticosteroid therapy; (3) 395 in the cyclosporine era (1988-1997), where maintenance immunosuppression included cyclosporine, azathioprine, and lower corticosteroid doses; and (4) 167 in the more recent era (2002-2005), where maintenance immunosuppression included cyclosporine and mycophenolate mofetil. RESULTS The overall incidence of infections decreased in the 4 cohorts from 3.35 episodes/patient to 2.03, 1.35, and 0.60 in the more recent cohorts (p < 0.001). Gram-positive bacteria are emerging as the predominant cause of bacterial infections (28.6%, 31.4%, 51.0%, 67.6%, p = 0.001). Cytomegalovirus infections have significantly decreased in incidence and occur later after transplantation (88 +/- 77 days, pre-cyclosporine era; 304 +/- 238 days, recent cohort; p < 0.001). Fungal infections also decreased, from an incidence of 0.29/patient in the pre-cyclosporine era to 0.08 in the most recent era. A major decrease in Pneumocystis jiroveci and Nocardia infections has also occurred. CONCLUSIONS The overall incidence and mortality associated with infections continues to decrease in heart transplantation and coincides with advances in immunosuppression, the use of selective anti-microbial prophylaxis, and more effective treatment regimens.

Nitrate’s Effect on Activity Tolerance in Heart Failure With Preserved Ejection Fraction Trial Rationale and Design

BACKGROUND Patients hospitalized for acute decompensated heart failure (ADHF) are at high risk for early mortality and rehospitalization. Risk stratification of ADHF using clinically available data on admission is increasingly important to integrate with clinical pathways. Our goal was to create a simple method of screening patients upon admission to identify those with increased risk of future adverse events. METHODS Using ASCEND-HF, a pragmatic clinical trial conducted in 398 sites globally, we developed and validated logistic regression risk models for (a) 30-day mortality/HF rehospitalization, (b) 30-day mortality/all-cause rehospitalization, (c) 30-day all-cause mortality, and (d) 180-day all-cause mortality. Fifty-one candidate variables were evaluated based on prior publications and clinical review. Final models were selected based on stepwise selection with entry and a staying criterion of P < .01. The 30-day mortality model was externally validated, and coefficients were converted to an additive risk score. RESULTS Among 7,141 patients, the median age was 67 years, 34% were female, and 80% had a left ventricular ejection fraction <40%. The models had between 5 and 12 risk factors with c-indices ranging from 0.68 to 0.75. A simplified score, including age, systolic blood pressure, sodium, blood urea nitrogen, and dyspnea at rest, discriminated 30-day mortality risk from 0.5% (score 0) to 53% (score 10). CONCLUSIONS Commonly available clinical variables provide simple risk stratification for clinical outcomes among patients with ADHF, and these models may be considered for integration into routine clinical care.

Ventricular Conduction and Long-Term Heart Failure Outcomes and Mortality in African Americans: Insights From the Jackson Heart Study

Poor adherence to therapeutic regimens is a significant impediment to improving clinical outcomes in the HF population. Typical rates of adherence to prescribed medications, low-sodium diets, and aerobic exercise programs remain lower than that needed to decrease morbidity and mortality associated with HF. Factors contributing to poor adherence include multiple comorbidities, clinical depression, and decreased cognitive functioning. HF education and programs to enhance self-management skills have improved patient quality of life but have yet to decrease mortality or rehospitalization rates significantly. Telemonitoring to improve adherence behaviors and self-management interventions within broader HF management programs have demonstrated significant clinical improvements in this population.

Clinical Effectiveness of Hydralazine–Isosorbide Dinitrate Therapy in Patients With Heart Failure and Reduced Ejection Fraction: Findings From the Get With The Guidelines-Heart Failure Registry

The prevalence of heart failure (HF) with preserved ejection fraction (HFpEF) is increasing.1 In patients with HFpEF, the burden of symptoms, functional decline, and mortality is high,2 and health-related quality of life is poor.3 Physicians caring for these patients currently have limited therapeutic options beyond diuresis and management of comorbid conditions. Hence there remains an immediate and critical need for therapies to alleviate symptoms and meaningfully improve quality of life for patients with HFpEF. Long-acting nitrates are used as the cornerstone of antianginal therapy and have demonstrated beneficial effects for treatment of patients with HF and reduced EF (HFrEF). In randomized studies, sustained increases in treadmill exercise time4,5 and peak oxygen consumption6 have been observed at 3 months after initiation of nitrate therapy in patients with HFrEF, including those already treated with angiotensin converting enzyme inhibitors.5 Attenuation of pathological left ventricular (LV) remodeling and improved LV systolic function have also been reported.5 Although no study has directly examined the effects of nitrate monotherapy on survival in HF, symptom relief is a key management goal in patients with HFpEF, whose primary chronic symptom is often exercise limitation.7 Practice guidelines for the management of chronic HF from the American College of Cardiology/American Heart Association8 and Heart Failure Society of America9 advocate a potential role for nitrates in diminishing symptoms in HFpEF but acknowledge the lack of supportive data and the risk of excessive nitrate–induced hypotension in elderly patients with HFpEF. Therefore, it is desirable that a randomized, controlled evaluation of the efficacy and tolerance of nitrate therapy in HFpEF is performed to support its therapeutic applications. To address this lack of data and current clinical equipoise for nitrate therapy in HFpEF, the Nitrate’s Effect on Activity Tolerance in Heart Failure …