Browsing by Author "Curtis, Lesley H"
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Item Open Access Association Between Comorbidities and Outcomes in Heart Failure Patients With and Without an Implantable Cardioverter-Defibrillator for Primary Prevention.(J Am Heart Assoc, 2015-08-06) Khazanie, Prateeti; Hellkamp, Anne S; Fonarow, Gregg C; Bhatt, Deepak L; Masoudi, Frederick A; Anstrom, Kevin J; Heidenreich, Paul A; Yancy, Clyde W; Curtis, Lesley H; Hernandez, Adrian F; Peterson, Eric D; Al-Khatib, Sana MBACKGROUND: Implantable cardioverter-defibrillator (ICD) therapy is associated with improved outcomes in patients with heart failure (HF), but whether this association holds among older patients with multiple comorbid illnesses and worse HF burden remains unclear. METHODS AND RESULTS: Using the National Cardiovascular Data Registry's ICD Registry and the Get With The Guidelines-Heart Failure (GWTG-HF) registry linked with Medicare claims, we examined outcomes associated with primary-prevention ICD versus no ICD among HF patients aged ≥65 years in clinical practice. We included patients with an ejection fraction ≤35% who received (ICD Registry) and who did not receive (GWTG-HF) an ICD. Compared with patients with an ICD, patients in the non-ICD group were older and more likely to be female and white. In matched cohorts, the 3-year adjusted mortality rate was lower in the ICD group versus the non-ICD group (46.7% versus 55.8%; adjusted hazard ratio [HR] 0.76; 95% CI 0.69 to 0.83). There was no associated difference in all-cause readmission (HR 0.99; 95% CI 0.92 to 1.08) but a lower risk of HF readmission (HR 0.88; 95% CI 0.80 to 0.97). When compared with no ICD, ICDs were also associated with better survival in patients with ≤3 comorbidities (HR 0.77; 95% CI 0.69 to 0.87) and >3 comorbidities (HR 0.77; 95% CI 0.64 to 0.93) and in patients with no hospitalization for HF (HR 0.75; 95% CI 0.65 to 0.86) and at least 1 prior HF hospitalization (HR 0.69; 95% CI 0.58 to 0.82). In subgroup analyses, there were no interactions between ICD and mortality risk for comorbidity burden (P=0.95) and for prior HF hospitalization (P=0.46). CONCLUSION: Among older HF patients, ICDs for primary prevention were associated with lower risk of mortality even among those with high comorbid illness burden and prior HF hospitalization.Item Open Access Benefit of adjuvant chemotherapy after resection of stage II (T1-2N1M0) non-small cell lung cancer in elderly patients.(Ann Surg Oncol, 2015-02) Berry, Mark F; Coleman, Brooke K; Curtis, Lesley H; Worni, Mathias; D'Amico, Thomas A; Akushevich, IgorBACKGROUND: We evaluated the use and efficacy of adjuvant chemotherapy after resection of T1-2N1M0 non-small cell lung cancer (NSCLC) in elderly patients. METHODS: Factors associated with the use of adjuvant chemotherapy in patients older than 65 years of age who underwent surgical resection of T1-2N1M0 NSCLC without induction chemotherapy or radiation in the Surveillance, Epidemiology, and End Results-Medicare database from 1992 to 2006 were assessed using a multivariable logistic regression model that included treatment, patient, tumor, and census tract characteristics. Overall survival (OS) was analyzed using the Kaplan-Meier approach and inverse probability weight-adjusted Cox proportional hazard models. RESULTS: Overall, 2,781 patients who underwent surgical resection as the initial treatment for T1-2N1M0 NSCLC and survived at least 31 days after surgery were identified, with adjuvant chemotherapy given to 784 patients (28.2 %). Factors that predicted adjuvant chemotherapy use were younger age and higher T status. The 5-year OS was significantly better for patients who received adjuvant chemotherapy compared with patients not given adjuvant chemotherapy: 35.8 % (95 % confidence interval [CI] 31.9-39.6) vs. 28.0 % (95 % CI 25.9-30.0) (p = 0.008). In the inverse probability weight-adjusted Cox proportional hazard regression model, adjuvant chemotherapy use predicted significantly improved survival (hazard ratio 0.84; 95 % CI 0.76-0.92; p = 0.0002). CONCLUSIONS: Adjuvant chemotherapy after resection of T1-2N1M0 NSCLC is associated with significantly improved survival in patients older than 65 years. These data can be used to provide elderly patients with realistic expectations of the potential benefits when considering adjuvant chemotherapy in this setting.Item Open Access Follow-up of patients with new cardiovascular implantable electronic devices: are experts' recommendations implemented in routine clinical practice?(Circulation. Arrhythmia and electrophysiology, 2013-02) Al-Khatib, Sana M; Mi, Xiaojuan; Wilkoff, Bruce L; Qualls, Laura G; Frazier-Mills, Camille; Setoguchi, Soko; Hess, Paul L; Curtis, Lesley HBackground
A 2008 expert consensus statement outlined the minimum frequency of follow-up of patients with cardiovascular implantable electronic devices (CIEDs).Methods and results
We studied 38 055 Medicare beneficiaries who received a new CIED between January 1, 2005, and June 30, 2009. The main outcome measure was variation of follow-up by patient factors and year of device implantation. We determined the number of patients who were eligible for and attended an in-person CIED follow-up visit within 2 to 12 weeks, 0 to 16 weeks, and 1 year after implantation. Among eligible patients, 42.4% had an initial in-person visit within 2 to 12 weeks. This visit was significantly more common among white patients than black patients and patients of other races (43.0% versus 36.8% versus 40.5%; P<0.001). Follow-up within 2 to 12 weeks improved from 40.3% in 2005 to 55.1% in 2009 (P<0.001 for trend). The rate of follow-up within 0 to 16 weeks was 65.1% and improved considerably from 2005 to 2009 (62.3%-79.6%; P<0.001 for trend). Within 1 year, 78.0% of the overall population had at least 1 in-person CIED follow-up visit.Conclusions
Although most Medicare beneficiaries who received a new CIED between 2005 and 2009 did not have an initial in-person CIED follow-up visit within 2 to 12 weeks after device implantation, the rate of initial follow-up improved appreciably over time. This CIED follow-up visit was significantly more common in white patients than in patients of other races.Item Open Access Generating evidence for therapeutic effects: the need for well-conducted randomized trials.(The Journal of clinical investigation, 2020-12-03) Califf, Robert M; Curtis, Lesley H; Harrington, Robert A; Hernandez, Adrian F; Peterson, Eric DIn this viewpoint, Robert Califf, former commissioner of the U.S. Food and Drug Administration, and colleagues reflect on how to approach questions about which patient treatments and strategies work, particularly in light of the tremendous pressure on the government and biomedical research enterprise to quickly develop safe, effective therapies during the SARS-CoV-2 pandemic.Item Open Access Prescriber continuity and medication availability in older adults with cardiometabolic conditions.(SAGE Open Med, 2018) Maciejewski, Matthew L; Hammill, Bradley G; Voils, Corrine I; Ding, Laura; Bayliss, Elizabeth A; Curtis, Lesley H; Wang, VirginiaBackground: Many older adults have multiple conditions and see multiple providers, which may impact their use of essential medications. Objective: We examined whether the number of prescribers of these medications was associated with the availability of medications, a surrogate for adherence, to manage diabetes, hypertension or dyslipidemia. Methods: A retrospective cohort of 383,145 older adults with diabetes, hypertension or dyslipidemia in the US Medicare program living in 10 states. The association between the number of prescribers of cardiometabolic medications in 2010 and medication availability (proportion of days with medication on hand) in 2011 was estimated via logistic regression, controlling for patient demographic characteristics and chronic conditions. Results: Medicare beneficiaries with diabetes, hypertension and/or dyslipidemia had an average of five chronic conditions overall, obtained 10-12 medications for all conditions and most often had one prescriber of cardiometabolic medications. In adjusted analyses, the number of prescribers was not significantly associated with availability of oral diabetes agents but having more prescribers is associated with increased medication availability in older Medicare beneficiaries with dyslipidemia or hypertension. Conclusion: The incremental addition of new prescribers may be clinically reasonable for complex patients but creates the potential for coordination problems and informational discontinuity over time. Health systems may want to identify complex patients with multiple prescribers to minimize care fragmentation.Item Open Access Ventricular conduction and long-term heart failure outcomes and mortality in African Americans: insights from the Jackson Heart Study.(Circ Heart Fail, 2015-03) Mentz, Robert J; Greiner, Melissa A; DeVore, Adam D; Dunlay, Shannon M; Choudhary, Gaurav; Ahmad, Tariq; Khazanie, Prateeti; Randolph, Tiffany C; Griswold, Michael E; Eapen, Zubin J; O'Brien, Emily C; Thomas, Kevin L; Curtis, Lesley H; Hernandez, Adrian FBACKGROUND: QRS prolongation is associated with adverse outcomes in mostly white populations, but its clinical significance is not well established for other groups. We investigated the association between QRS duration and mortality in African Americans. METHODS AND RESULTS: We analyzed data from 5146 African Americans in the Jackson Heart Study stratified by QRS duration on baseline 12-lead ECG. We defined QRS prolongation as QRS≥100 ms. We assessed the association between QRS duration and all-cause mortality using Cox proportional hazards models and reported the cumulative incidence of heart failure hospitalization. We identified factors associated with the development of QRS prolongation in patients with normal baseline QRS. At baseline, 30% (n=1528) of participants had QRS prolongation. The cumulative incidences of mortality and heart failure hospitalization were greater with versus without baseline QRS prolongation: 12.6% (95% confidence interval [CI], 11.0-14.4) versus 7.1% (95% CI, 6.3-8.0) and 8.2% (95% CI, 6.9-9.7) versus 4.4% (95% CI, 3.7-5.1), respectively. After risk adjustment, QRS prolongation was associated with increased mortality (hazard ratio, 1.27; 95% CI, 1.03-1.56; P=0.02). There was a linear relationship between QRS duration and mortality (hazard ratio per 10 ms increase, 1.06; 95% CI, 1.01-1.12). Older age, male sex, prior myocardial infarction, lower ejection fraction, left ventricular hypertrophy, and left ventricular dilatation were associated with the development of QRS prolongation. CONCLUSIONS: QRS prolongation in African Americans was associated with increased mortality and heart failure hospitalization. Factors associated with developing QRS prolongation included age, male sex, prior myocardial infarction, and left ventricular structural abnormalities.Item Open Access Who enrolls in the Medicare Part D prescription drug benefit program? Medication use among patients with heart failure.(J Am Heart Assoc, 2013-09-11) Eapen, Zubin J; Hammill, Bradley G; Setoguchi, Soko; Schulman, Kevin A; Peterson, Eric D; Hernandez, Adrian F; Curtis, Lesley HBACKGROUND: Dispensing data from Medicare Part D standalone prescription drug plans are now available, but characteristics of enrollees with heart failure have not been well described. METHODS AND RESULTS: We identified 81 874 patients with prevalent heart failure as of January 1, 2010, in a nationally representative 5% sample of Medicare beneficiaries. We classified patients according to enrollment in a Medicare Part D plan as of January 1, 2010. Demographic characteristics, comorbid conditions, and prescriptions were compared by enrollment status. A total of 49 252 (60.2%) were enrolled in a Medicare Part D plan as of January 1. Enrollees were more often women, black, and of lower socioeconomic status. Enrollees with heart failure more often filled prescriptions for loop diuretics than angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, β-blockers, or aldosterone antagonists. During the first 4 months of 2010, 5444 (12.3%) reached the coverage gap, and 566 (1.3%) required catastrophic coverage beyond the gap. CONCLUSIONS: Medicare beneficiaries with heart failure differ significantly according to enrollment in Part D prescription drug plans and represent a population underrepresented in clinical efficacy trials. Many face the coverage gap, and few select Medicare Part D plans that provide coverage during the gap. Linking Medicare Part D event data with clinical registries could help to determine whether eligible enrollees are undertreated for heart failure.