Abstract 74: A Population-Based Study to Evaluate the Effectiveness of Multi-Disciplinary Heart Failure Clinics and Identify Important Service Components

2012 ◽  
Vol 5 (suppl_1) ◽  
Author(s):  
Harindra C Wijeysundera ◽  
Gina Trubiani ◽  
Xuesong Wang ◽  
Nicholas Mitsakakis ◽  
Peter Austin ◽  
...  
Keyword(s):  
Heart Failure ◽  
Real World ◽  
Standard Care ◽  
Randomized Clinical Trials ◽  
Medication Management ◽  
Management Program ◽  
P Value ◽  
Low Intensity ◽  
Improved Outcomes ◽  
Service Components

Background Multi-disciplinary heart failure (HF) clinics improve outcomes for HF patients in randomized clinical trials. It is unclear if this efficacy translates to real world effectiveness. Accordingly, our objectives were to 1) compare real world outcomes of HF patient treated in HF clinics vs that in standard care and 2) identify HF clinic features associated with improved outcomes. Methods The service components at all 34 HF clinics in Ontario, Canada were evaluated and scored using a validated instrument. Based these scores, the clinics were categorized by an expert panel into high/medium or low intensity strata. Our cohort consisted of all patients discharged alive after a HF hospitalization in 2006-07. Patients were classified as either HF clinic or standard care patients and followed until March 31st, 2010, to evaluate mortality, all-cause hospitalization, and HF hospitalization. Propensity score matching was used to compare outcomes between comparable groups of patients in the two groups, using Kaplan-Meier survival curves. We explored the clinic level characteristics associated with improved outcomes by developing marginal Cox-proportional hazard models, restricted to the overall sample of HF clinic patients, so as to account for clustering by HF clinic. Results We identified 14,468 HF patients, of whom 1,288 were seen in HF clinics. In a matched sample of 1,288 pairs, systematic differences between groups were substantially reduced. Over 3 years of follow-up, 52.1% of HF clinic patients died, compared to 54.7% of standard care patients (p-value 0.02). HF clinic patients had a significant increase in hospitalization (87.4% vs 86.6% for all-cause [p-value 0.009]; 58.7% vs 47.3% for HF-related [p-value <0.001]). Clinics in the high intensity strata were associated with lower mortality (hazard ratio [HR] 0.68 (95% confidence interval [CI] 0.48-0.98; p-value 0.04) but higher rates of all-cause hospitalization (HR 1.48; 95% CI 1.01-2.18; p-value 0.04) and HF hospitalization (HR 1.98; 95% CI 1.42-2.77; p-value <0.001), compared to low intensity clinics. HF clinics that targeted both the patient and caregiver were associated with improved survival compared to those that only focused on the patient, as were clinics with an emphasis on peer support. Clinics with frequent contacts between providers and patients had a significant reduction in mortality (HR 0.15; 95% CI 0.09-0.25; p-value <0.0001). A more intensive medication management program was associated with reduced all cause and HF hospitalization (HR 0.35 and HR 0.27 respectively). Conclusions Multi-disciplinary HF clinics are associated with a decrease in mortality but increase in re-hospitalizations compared to standard care. A gradient was observed between clinic intensity and outcomes whereby greater intensity of clinic services was associated with mortality reductions but increased hospitalization.

Abstract P298: The Impact of JNC VII Recommendations for Controlling Blood Pressure in a Heart Failure Disease Management Program

2011 ◽  
Vol 4 (suppl_1) ◽  
Author(s):  
George R Marzouka ◽  
Elyse Julian ◽  
Andre Dias ◽  
Leonardo Tamariz ◽  
Pat Trahan ◽  
...  
Keyword(s):  
Heart Failure ◽  
Blood Pressure ◽  
Disease Management ◽  
Pressure Control ◽  
Management Program ◽  
P Value ◽  
Baseline Visit ◽  
Heart Failure Disease Management ◽  
One Year ◽  
The Impact

Background: A significant correlation between hypertension (HTN) and long-term risk for heart failure (HF) exists. The aim of this study was (i) to assess what percent of patients enrolled in a heart failure disease management program (HFDMP) reach the JNC VII target goals for blood pressure control; (ii) to assess if there is a disparity in HTN control by race or ethnicity; (iii) and to assess the impact of reaching JNC VII targets for blood pressure control on survival. Methods: Patients with an ejection fraction ≤40% were enrolled into HFDMPs and screened for HTN, defined as blood pressure (BP) ≥ 130/80. Patients were titrated to beta blocker therapy and ace inhibitor therapy following the ACC/AHA HF guidelines. Final BP was measured after one year. Results: Mean baseline systolic BP (SBP) (N = 648) was 149.9 mmHg and mean baseline diastolic BP (DBP) was 90.5 mmHg. At one year, mean SBP decreased to 138.0 mmHg, DBP to 81.8 mmHg. There was no significant increase in survival for patients with BP ≤130 and ≤80 versus patients with HTN. There was a significant disparity in BP control in Blacks and Hispanics compared to whites (p<0.001) Conclusion: Disease management programs are an effective way to reduce BP in hypertensive patients, as well as keeping normotensive patients within JNC VII guidelines however health disparities persisted by race and ethnicity. Mean SBP and DBP of cohort at baseline Vs. 12 Month Follow up Blood pressure ≤ 130/80 mmHg Baseline Visit Last Visit P-Value SBP,m sd 110.9 (12.6%) 120.9 (22.2%) <0.001 DBP , m sd 67.1 (8.6%) 72.4 (13.7%) <0.001 Blood pressure > 130/80 mmHg Baseline Visit Last Visit P-Value SBP , m sd 149.9 (21.4%) 138.0 (24.6%) <0.001 DBP , m sd 90.5 (16.3%) 81.8 (16.8%) <0.001

Effect of Visit Frequency of Pharmacist-Led Diabetes Medication Management Program

2020 ◽  
pp. 089719002094868
Author(s):  
Amy Frederick ◽  
Joyce Juan ◽  
Delaney Ivy ◽  
Yolanda Munoz Maldonado
Keyword(s):  
Blood Pressure ◽  
Hemoglobin A1c ◽  
Medication Management ◽  
Retrospective Chart Review ◽  
Management Program ◽  
P Value ◽  
State Management ◽  
Disease State Management ◽  
Visit Frequency ◽  
Patients With Diabetes

Background: Pharmacists have a positive effect on clinical outcomes in chronic disease state management, however, few studies have evaluated the effect that frequency of visits may have on diabetes biomarkers such as hemoglobin A1c and blood pressure readings. Methods: Under the medication management program (MMP), patients with diabetes were seen monthly by pharmacists until early 2015, when time between visits was increased to every 3 months. A retrospective chart review was conducted to evaluate the primary outcome of the percent change in hemoglobin A1c and blood pressure after the change in visit frequency. Results: In the 303 patients enrolled, no statistical difference existed between the pre and post average A1c (p-value = 0.10). The intermediate average A1c was statistically lower from the preintervention mean A1c (p-value = 0.001) but not from the postintervention mean A1c (p-value = 0.30). No statistical differences were seen between systolic blood pressure and diastolic blood pressure. Conclusion: Patients who have been seen by a clinical pharmacist more frequently (every month or every other month) for several years may be able to maintain their reduction in A1c with less-frequent visits (every 3 to 6 months).

scholarly journals 412 Sacubitril/valsartan promotes cardiac reverse remodeling and preserves renal function in a real-world heart failure and reduced ejection fraction (HFrEF) population

2020 ◽  
Vol 21 (Supplement_1) ◽  
Author(s):  
M V Polito ◽  
A Rispoli ◽  
V Vitulano ◽  
F D"auria ◽  
A Silverio ◽  
...  
Keyword(s):  
Heart Failure ◽  
Renal Function ◽  
Ejection Fraction ◽  
Real World ◽  
Cardiac Death ◽  
Nyha Class ◽  
P Value ◽  
Composite Outcome ◽  
Reduced Ejection Fraction ◽  
Echocardiographic Parameters

Abstract Funding Acknowledgements none Aims. To evaluate the effects of Sacubitril/Valsartan (S/V) on clinical, laboratory and echocardiographic parameters and outcomes in a real-world population with heart failure with reduced ejection fraction (HFrEF). Methods and results. Prospective study enrolling consecutive patients with HFrEF treated with S/V.The primary outcome was HF rehospitalization;secondary outcomes were all-cause death, cardiac death and the composite of cardiac death and HF rehospitalization at 12 months follow up.The clinical outcome was compared with a retrospective cohort of 90 HFrEF patients treated with standard medical therapy by using propensity score weighting. At 6 months follow-up, changes in symptoms, echocardiographic parameters, eGFR and furosemide dose were also evaluated. The study population consisted of 90 patients (66.1 ± 11.7 years). At 6 months FU, a significant improvement in NYHA class, LVEF (from 31.0% to 34.0%; p = 0.001), LVESV (from 115.0 to 101.0 mL; p = 0.033) and sPAP (from 31.0 to 25.0 mmHg; p = 0.024) was observed. Moreover, S/V did not affect negatively eGFR and was associated with a significantly lower dose of furosemide prescribed. The propensity score weighting adjusted regression analysis showed a significantly lower risk for HF rehospitalization (HR, 0.131; 95% CI, 0.034-0.503; p = 0.003) and the composite outcome (HR, 0.162; 95% CI, 0.053-0.492; p = 0.001) among patients treated with S/V as compared to the standard therapy group. Conclusions In this real-world HFrEF population, S/V reduced HF rehospitalization and cardiac death at 1 year. Moreover, S/V improved significantly NYHA class, LVEF, LVESV and sPAP at 6 months, preserving renal function and reducing the need of furosemide. Table Study outcomes Unadjusted model HR 95% CI p-value HF rehospitalization 0.273 0.101-0.740 0.011 Cardiac death 0.443 0.137-1.440 0.176 Composite outcome 0.331 0.155-0.710 0.005 All-cause death 0.666 0.272-1.628 0.372 Adjusted model HR 95% CI p-value HF rehospitalization 0.131 0.034-0.503 0.003 Cardiac death 0.259 0.047-1.415 0.119 Composite outcome 0.162 0.053-0.492 0.001 All-cause death 0.713 0.201-2.529 0.601 Adjusted and unadjusted HR for the study outcomes. Abstract 412 Figure.

scholarly journals The Place of Fluvoxamine in the Treatment of Non-critically ill Patients with COVID-19: A Living Systematic Review and Meta-analysis

2021 ◽  
Author(s):  
Salah Eddine Oussama Kacimi ◽  
Elona Greca ◽  
Mohamed Amine Haireche ◽  
Ahmed Sallam ElHawary ◽  
Mounir Ould Setti ◽  
...  
Keyword(s):  
Systematic Review ◽  
Mechanical Ventilation ◽  
Critically Ill ◽  
Standard Care ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Mortality Rates ◽  
P Value ◽  
Exclusion Criteria ◽  
Significant Difference

Background: Fluvoxamine is a selective serotonin reuptake inhibitor that is known to be used as antidepressant. Repurposing of Fluvoxamine for the treatment of COVID-19 is theorized to help in the prevention of the clinical deterioration of SARS CoV-2 patients. In our systematic review and meta-analysis, we aim to assess the safety and efficacy of the drug under study in terms of its effect on the mortality and the risk of hospitalization and mechanical ventilation in non-critically ill COVID-19 patients. Methods: We performed a systematic search of seven electronic databases. The search results were screened based on the previously determined inclusion and exclusion criteria. We determined the data related to our objectives. The mortality rates, rates of hospitalization, risk of mechanical ventilation and serious side effects were extracted from the studies that successfully met our inclusion and exclusion criteria. Then, the extracted data from the included studies was included in the meta-analysis. Results: Three studies, two randomized clinical trials and one observational cohort study, with 1762 patients, were the final outcome of our search and screening processes. Among all participants, 886 patients received Fluvoxamine while 876 were controls. Follow up periods ranged from 7 days to 28 days. There was no significant difference in the intention-to-treat mortality rates between the two groups (RR = 0.66; 95% CI: 0.36 - 1.21, p-value = 0.18; I2 = 0%). However, Fluvoxamine decreased the per-protocol mortality compared to both placebo alone or placebo/standard care (RR = 0.09; 95% CI: 0.01 - 0.64, p-value = 0.02; I2 = 0% and RR = 0.09; 95% CI: 0.01 - 0.72, respectively). As compared to placebo or standard care, the all-cause hospitalization was significantly reduced in the fluvoxamine group (RR = 0.71; 95% CI: 0.54 - 0.93, p-value = 0.01; I2 = 61%). This risk reduction was not significant when compared to placebo alone (RR = 0.76; 95% CI: 0.57 - 1.00; p-value = 0.051; I2 = 48%). Furthermore, the risk of mechanical ventilation was not improved in the fluvoxamine group as compared to placebo (RR = 0.71; 95% CI: 0.43 - 1.16, p-value = 0.17; I2 = 0%). The serious adverse effects were almost the same in the treatment group and the control (13% and 12% respectively). Conclusion: Fluvoxamine does not significantly reduce the mortality rates or the risk of mechanical ventilation in SARS CoV-2 patients. Nonetheless, it was found to have a good impact on reducing all cause hospitalization among patients with COVID-19 disease. Therefore, further clinical studies are needed to determine the effectiveness of the drug and its mechanisms of action.

scholarly journals Patient Selection Bias Limits the Real World Efficacy of Randomized Clinical Trials in Multiple Myeloma

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 1-2
Author(s):  
Augusta Eduafo ◽  
Leland Metheny ◽  
James Driscoll ◽  
Benjamin K. Tomlinson ◽  
Kirsten M Boughan ◽  
...  
Keyword(s):  
Real World ◽  
Research Funding ◽  
Randomized Clinical Trials ◽  
Advisory Board ◽  
P Value ◽  
Exclusion Criteria ◽  
Eligibility Criteria ◽  
Current Infection ◽  
Index Treatment

Randomized clinical trials (RCT) are imperative for testing novel cancer therapies and advancing the science of cancer care. Exclusion criteria are employed to minimize toxicity and maximize benefit. However, the selection process introduces a deviation between enrolled patients (pts) and the real world population. Estimating how much the selected population deviates from the MM cohort at large may increase inclusiveness and could help define barriers to recruiting to MM studies. There has been significant advancement in treating Multiple Myeloma (MM) during the last decade. Over 16 FDA-approved anti-myeloma regimens are now available. We selected the recent 6 RCTs (ASPIRE, TOURMALNE-MM01, ELOQUENT-2, ENDEAVOR, POLLUX and CASTOR studies) which were pharma-sponsored landmark trials that provided the basis for FDA approval of a new agent or established a new indication for formerly FDA-approved drug. We intended to quantify the gap between the trial population and real world by examining the eligibility criteria of these trials compared against a single institution database. Methods: Pts with relapsed MM initiating second or later line of therapy containing lenalidomide (Len) or bortezomib (Bor) were identified retrospectively. The 3-week period before the index treatment date was used to apply the eligibility criteria of the mentioned 6 trials. Pts who received Len-containing regimens were tested as to be enrolled on trials with Len/Dex control arm (ASPIRE, TOURMALINE-MM1, POLLUX, and ELOQUENT-2) and pts who had Bor-containing regimens were reviewed to be enrolled on Bor/Dex trials (CASTOR and ENDEAVOR). Pts were classified as "Trial eligible" or "Trial ineligible", accordingly. Pts were followed up longitudinally from the index treatment date until death, loss to follow-up, or the end of the study period (Jan, 2018). Ten frequently used eligibility criteria were studied (Fig-1). History of other malignancies, except skin and prostate cancer, was defined as any cancer requiring therapy other than anti-myeloma regimen in the 3 years prior to the index treatment date. Current infection referred to the use of any medication other than acyclovir, ciprofloxacin or Bactrim. Shoelace algorithm was used to calculate area under the curve of the polygon graphs. Results: 516 pts were studied between 2010 and 2018; 153 pts were excluded due to missing values, while 224 and 136 pts were treated with Len-containing and Bor-containing regimens, respectively. Overall, the trial-eligible cohort was more likely to have autologous stem cell transplant and to have had longer treatment-free period before index treatment date (p-value: 0.012). There was a substantial variation in the ineligibility rate for these 6 RCTs among the study population (Fig-1). The most common items that excluded a patient from a RCT were: Other malignancies, current infection and renal dysfunction. Within the Len cohort the trial-specific Glomerular Filtration Rate (GFR) threshold for renal function was highest in ASPIRE trial (Cr clearance&gt; 50 ml/min) causing high rate of exclusion (29% vs. 8% in other trials). Only TOURMOULINE-MM01 and ASPIRE trials had bor-refractory status as the exclusion criteria leading to 36% ineligibility rate. The differences between the trial-eligible and trial-ineligible pts stratified by trial are listed in Table-1 and 2 for trials with Len and Bor as the control arms, respectively. The median follow-up for the Len and Bor cohort was 31 and 30 months, respectively. The trial-ineligible pts had significantly worse OS (2-year survival rate 69% vs. 82%, P-value: 0.001) and 43% higher chance of death (hazard ratio 1.43, 90% confidence interval (CI): 1.08-2.02) compared with trail-eligible cohort. Conclusion: Here we assessed the eligibility criteria of 6 landmark MM studies and showed that ineligibility rates were quite different amongst these trials suggesting significant limitations in cross-trial comparison. Furthermore, trial-eligibility per se was associated with improved survival. We therefore proposed a quantitative deviation score calibrating the generalizability of the results of these trials to a single institution cohort. Such a tool can lead to efforts to broaden eligibility criteria and possibly narrow the gap between reported clinical trial efficacy and the observed effectiveness in real-world MM pts. Disclosures de Lima: Kadmon: Other: Personal Fees, Advisory board; Incyte: Other: Personal Fees, advisory board; BMS: Other: Personal Fees, advisory board; Celgene: Research Funding; Pfizer: Other: Personal fees, advisory board, Research Funding. Malek:Medpacto: Research Funding; Takeda: Other: Advisory board , Speakers Bureau; Bluespark: Research Funding; Cumberland: Research Funding; Sanofi: Other: Advisory board; Janssen: Other: Advisory board, Speakers Bureau; Clegene: Other: Advisory board , Speakers Bureau; Amgen: Honoraria.

scholarly journals The effect of milrinone on mortality in adult patients: A systematic review of randomized clinical trials with meta-analysis and trial sequential analysis

2019 ◽  
Author(s):  
Yu-shan Ren ◽  
Lan-fang Li ◽  
Tao Peng ◽  
Yu-jun Tan ◽  
Ying Sun ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Clinical Trials ◽  
Myocardial Ischemia ◽  
Standard Care ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Care Group ◽  
P Value ◽  
Standard Care Group ◽  
Cabg Surgery

Abstract OBJECTIVE: Milrinone is commonly used for patients performed coronary artery bypass graft surgery (CABG) because of its effectiveness in decreasing cardiac index and mitral regurgitation. This study was to perform a systematic meta-analysis of existing studies in the past 20 years to evaluate the impact of milrinone on mortality in patients undergoing CABG surgery. EASUREMENTS AND MAIN RESULTS: The network meta-analysis included 723 patients from 16 randomized clinical trials. Overall, there was no significantly difference in mortality between the milrinone group and the placebo/standard care group [11/352 (3.13%) vs. 9/346 (2.60%), risk ratio = 1.18 (0.53–2.62), p for effect = 0.69, I 2 = 0 %] when patients underwent CABG surgery. Besides that, 9 trials (with 440 randomized patients), 4 trials (with 212 randomized patients), and 10 trials (with 470 randomized patients) reported that the occurrence of myocardial infarction (MI), myocardial ischemia, and arrhythmias in the milrinone group were decreased in comparsion with the placebo/standard care group, respectively. Between the milrinone treatment and placebo/standard care groups, the occurrence of myocardial infarction was [5/219 (2.28 %) vs. 25/212 (17.79 %), odds ratio(OR) = 0.19 (0.08–0.49), p value = 0.0005, I 2 = 5%], the occurrence of myocardial ischemia was [12/106 (11.32 %) vs. 41/106 (36.68 %), OR = 0.20 (0.10–0.42), p value <0.0001, I 2 = 0 %], and the occurrence of arrhythmias was [16/234 (6.84 %) vs. 31/236 (13.14 %), OR= 0.46 (0.24–0.88), p value = 0.02, I 2 =0 %]. However, the occurrence of stroke and renal failure, duration of inotropic support (h), need for intra-aortic balloon pump (IABP), and mechanical ventilation (h) between these two groups showed no differences. CONCLUSION: Based on the current results, milrinone might be unable to decrease the mortality in adult CABG surgical patients, but can significantly ameliorate the occurrence of MI, myocardial ischemia, and arrhythmias compared with placebo-treated patients. These results provide evidence for further clinical application of milrinone and therapy strategies for CABG surgery. However, along with milrinone application in clinical use, sufficient randomized clinical trials need to be collected, and the potential benefit and adverse effects should be analyzed and reevaluated.

scholarly journals CardioMems® device implantation reduces repeat hospitalizations in heart failure patients: A single center experience

2019 ◽  
Vol 8 ◽  
pp. 204800401983329 ◽  
Author(s):  
Mahmoud Assaad ◽  
Sinan Sarsam ◽  
Amir Naqvi ◽  
Marcel Zughaib
Keyword(s):  
Heart Failure ◽  
Monitoring System ◽  
Real World ◽  
Hospital Admissions ◽  
P Value ◽  
Class Iii ◽  
Pressure Monitoring ◽  
Device Implantation ◽  
Real World Setting ◽  
Post Implantation

Introduction Hospital readmission for congestive heart failure remains one of the most important economic burdens on healthcare cost. The implantation of a wireless pressure monitoring device (CardioMEMS®) had led to nearly 40% reduction in readmission rates in the landmark CHAMPION trial. We aim to study the effectiveness of this wireless device in reducing heart failure admissions in a real-world setting. Methods This is a retrospective chart review of patients with recurrent admissions for heart failure implanted with the wireless pressure monitoring system (CardioMEMS®) at our institution. We studied the total number of all-cause hospital admissions as well as heart failure-related admissions pre- and post-implantation. Results A total of 27 patients were followed for 6–18 months. The total number of all-cause hospital admissions prior to device implantation was 61 admissions for all study patients, while the total number for the post-implantation period was 19, correlating with 2.26 + 1.06 admissions/person-year prior to device implantation versus 0.70 + 0.95 admissions/person-year post-implantation (p-value < 0.001). For heart failure-related admissions, the total number prior to device implantation was 46 compared to 9 admissions post device implantations, correlating with 1.70 + 1.07 admissions/person-years pre-implantation versus 0.33 + 0.62 admissions/person-years post-implantation (p-value < 0.001). This translates to 80.4% and 68.9% reduction in heart failure and all-cause admissions, respectively. Conclusion In a real-world setting, the implantation of a wireless heart failure monitoring system in patients with heart failure and class III symptoms has resulted in 80.4% reduction in heart failure admissions and 69% reduction in all-cause admissions.

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