scholarly journals Cost-impact analysis of baroreflex activation therapy in chronic heart failure patients in the United States

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
John Bisognano ◽  
John E. Schneider ◽  
Shawn Davies ◽  
Robert L. Ohsfeldt ◽  
Elizabeth Galle ◽  
...  

Abstract Background The study evaluated the cost of baroreflex activation therapy plus guideline directed therapy (BAT + GDT) compared to GDT alone for HF patients with reduced ejection fraction and New York Heart Association Class III or II (with a recent history of III). Baroreflex activation therapy (BAT) is delivered by an implantable device that stimulates the baroreceptors through an electrode attached to the outside of the carotid artery, which rebalances the autonomic nervous system to regain cardiovascular (CV) homeostasis. The BeAT-HF trial evaluated the safety and effectiveness of BAT. Methods A cost impact model was developed from a U.S. health care payer or integrated delivery network perspective over a 3-year period for BAT + GDT versus GDT alone. Expected costs were calculated by utilizing 6-month data from the BeAT-HF trial and existing literature. HF hospitalization rates were extrapolated based on improvement in NT-proBNP. Results At baseline the expected cost of BAT + GDT were $29,526 per patient more than GDT alone due to BAT device and implantation costs. After 3 years, the predicted cost per patient was $9521 less expensive for BAT + GDT versus GDT alone due to lower rates of significant HF hospitalizations, CV non-HF hospitalizations, and resource intensive late-stage procedures (LVADs and heart transplants) among the BAT + GDT group. Conclusions BAT + GDT treatment becomes less costly than GDT alone beginning between years 1 and 2 and becomes less costly cumulatively between years 2 and 3, potentially providing significant savings over time. As additional BeAT-HF trial data become available, the model can be updated to show longer term effects.

2019 ◽  
Vol 28 (1) ◽  
pp. 3-13 ◽  
Author(s):  
J. F. Veenis ◽  
J. J. Brugts

AbstractExacerbations of chronic heart failure (HF) with the necessity for hospitalisation impact hospital resources significantly. Despite all of the achievements in medical management and non-pharmacological therapy that improve the outcome in HF, new strategies are needed to prevent HF-related hospitalisations by keeping stable HF patients out of the hospital and focusing resources on unstable HF patients. Remote monitoring of these patients could provide the physicians with an additional tool to intervene adequately and promptly. Results of telemonitoring to date are inconsistent, especially those of telemonitoring with traditional non-haemodynamic parameters. Recently, the CardioMEMS device (Abbott Inc., Atlanta, GA, USA), an implantable haemodynamic remote monitoring sensor, has shown promising results in preventing HF-related hospitalisations in chronic HF patients hospitalised in the previous year and in New York Heart Association functional class III in the United States. This review provides an overview of the available evidence on remote monitoring in chronic HF patients and future perspectives for the efficacy and cost-effectiveness of these strategies.


2015 ◽  
Vol 21 (4) ◽  
pp. 335-343 ◽  
Author(s):  
Rahul Chaudhary ◽  
Jalaj Garg ◽  
Parasuram Krishnamoorthy ◽  
Neeraj Shah ◽  
Gregg Lanier ◽  
...  

Heart failure affects over 5 million people in the United States and carries a high rate of mortality. Ivabradine, a new agent has been added to the current medical options for managing heart failure. It is a selective funny current ( If) inhibitor in sinoatrial node and slows its firing rate, prolonging diastolic depolarization without a negative inotropic effect. Ivabradine was only recently approved by Food and Drug administration after the results of Systolic Heart Failure Treatment with the If Inhibitor Ivabradine (SHIFT) trial, for a reduction in rehospitalizations from chronic heart failure. This trial assessed patients with stable heart failure with reduced ejection fraction and a heart rate of at least 70 beats per minute at rest on maximally tolerated beta-blocker therapy and demonstrated statistically significant reduction in heart failure hospitalization and deaths. Additionally, ivabradine has been associated with reduced cardiac remodeling, reduced heart rate variability, improvement in exercise tolerance, improved heart failure class of New York Heart Association, and better quality of life. It has also been tried in other conditions, such as inappropriate sinus tachycardia and cardiogenic shock, and is currently in phase II trial for patients with newly diagnosed multiple organ dysfunction syndrome.


2019 ◽  
Vol 8 (12) ◽  
pp. 2165 ◽  
Author(s):  
Giuseppe Romano ◽  
Giuseppe Vitale ◽  
Laura Ajello ◽  
Valentina Agnese ◽  
Diego Bellavia ◽  
...  

Background: Sacubitril/valsartan has been shown to be superior to enalapril in reducing the risks of death and hospitalization for heart failure (HF). However, knowledge of the impact on cardiac performance remains limited. We sought to evaluate the effects of sacubitril/valsartan on clinical, biochemical and echocardiographic parameters in patients with heart failure and reduced ejection fraction (HFrEF). Methods: Sacubitril/valsartan was administered to 205 HFrEF patients. Results: Among 230 patients (mean age 59 ± 10 years, 46% with ischemic heart disease) 205 (89%) completed the study. After a follow-up of 10.49 (2.93 ± 18.44) months, the percentage of patients in New York Heart Association (NYHA) class III changed from 40% to 17% (p < 0.001). Median N–Type natriuretic peptide (Nt-proBNP) decreased from 1865 ± 2318 to 1514 ± 2205 pg/mL, (p = 0.01). Furosemide dose reduced from 131.3 ± 154.5 to 120 ± 142.5 (p = 0.047). Ejection fraction (from 27± 5.9% to 30 ± 7.7% (p < 0.001) and E/A ratio (from 1.67 ± 1.21 to 1.42 ± 1.12 (p = 0.002)) improved. Moderate to severe mitral regurgitation (from 30.1% to 17.4%; p = 0.002) and tricuspid velocity decreased from 2.8 ± 0.55 m/s to 2.64 ± 0.59 m/s (p < 0.014). Conclusions: Sacubitril/valsartan induce “hemodynamic recovery” and, consistently with reduction in Nt-proBNP concentrations, improve NYHA class despite diuretic dose reduction.


Author(s):  
S. Crnko ◽  
J. J. Brugts ◽  
J. F. Veenis ◽  
N. de Jonge ◽  
J. P. G. Sluijter ◽  
...  

Abstract Aims The CardioMEMS HF system is used to measure pulmonary artery (PA) pressures of patients with heart failure (HF). The goal of this study was to determine the impact of time in the daily PA pressure measurements, considering variance and influence of circadian rhythms on cardiovascular pathophysiology. Methods and results The study included 10 patients with HF with reduced ejection fraction (LVEF < 40%; New York Heart Association class III). Individual daily PA pressures were obtained by CardioMEMS sensors, per protocol, measured up to six times throughout the day, for a period of 5 days. Differences between variation of morning versus evening PA pressures were compared with Wilcoxon signed-rank test. Mean PA pressures (mPAP) increased from a morning value of 19.1 ± 2 mm Hg (8 am; mean ± standard error of the mean [SEM]) to 21.3 ± 2 mm Hg late in the evening (11 pm; mean ± SEM). Over the course of 5 days, evening mPAP exhibited a significantly higher median coefficient of variation than morning mPAP (14.9 (interquartile range [IQR] 7.6–21.0) and 7.0 (IQR 5.0–12.8) respectively; p = 0.01). The same daily pattern of pressure variability was observed in diastolic (p = 0.01) and systolic (p = 0.04) pressures, with diastolic pressures being more variable than systolic at all time points. Conclusions Morning PA pressure measurements yield more stable values for observing PA trends. Patients should thus be advised to consistently perform their daily PA pressure measurements early in the morning. This will improve reliability and interpretation of the CardioMEMS management, indicating true alterations in the patient’s health status, rather than time-of-day-dependent variations.


2019 ◽  
Vol 26 (3) ◽  
pp. 90-100
Author(s):  
Justė Lukoševičiūtė ◽  
Kastytis Šmigelskas

Abstract. Illness perception is a concept that reflects patients' emotional and cognitive representations of disease. This study assessed the illness perception change during 6 months in 195 patients (33% women and 67% men) with acute coronary syndrome, taking into account the biological, psychological, and social factors. At baseline, more threatening illness perception was observed in women, persons aged 65 years or more, with poorer functional capacity (New York Heart Association [NYHA] class III or IV) and comorbidities ( p < .05). Type D personality was the only independent factor related to more threatening illness perception (βs = 0.207, p = .006). At follow-up it was found that only self-reported cardiovascular impairment plays the role in illness perception change (βs = 0.544, p < .001): patients without impairment reported decreasing threats of illness, while the ones with it had a similar perception of threat like at baseline. Other biological, psychological, and social factors were partly associated with illness perception after an acute cardiac event but not with perception change after 6 months.


Heart ◽  
2017 ◽  
Vol 104 (4) ◽  
pp. 306-312 ◽  
Author(s):  
Mauro Chiarito ◽  
Matteo Pagnesi ◽  
Enrico Antonio Martino ◽  
Michele Pighi ◽  
Andrea Scotti ◽  
...  

ObjectivesDifferences in terms of safety and efficacy of percutaneous edge-to-edge mitral repair between patients with functional and degenerative mitral regurgitation (MR) are not well established. We performed a systematic review and meta-analysis to clarify these differences.MethodsPubMed, EMBASE, Google scholar database and international meeting abstracts were searched for all studies about MitraClip. Studies with <25 patients or where 1-year results were not delineated between MR aetiology were excluded. This study is registered with PROSPERO.ResultsA total of nine studies investigating the mid-term outcome of percutaneous edge-to-edge repair in patients with functional versus degenerative MR were included in the meta-analysis (n=2615). At 1 year, there were not significant differences among groups in terms of patients with MR grade≤2 (719/1304 vs 295/504; 58% vs 54%; risk ratio (RR) 1.12; 95% CI: 0.86 to 1.47; p=0.40), while there was a significantly lower rate of mitral valve re-intervention in patients with functional MR compared with those with degenerative MR (77/1770 vs 80/818; 4% vs 10%; RR 0.60; 95% CI: 0.38 to 0.97; p=0.04). One-year mortality rate was 16% (408/2498) and similar among groups (RR 1.26; 95% CI: 0.90 to 1.77; p=0.18). Functional MR group showed significantly higher percentage of patients in New York Heart Association class III/IV (234/1480 vs 49/583; 16% vs 8%; p<0.01) and re-hospitalisation for heart failure (137/605 vs 31/220; 23% vs 14%; p=0.03). No differences were found in terms of single leaflet device attachment (25/969 vs 20/464; 3% vs 4%; p=0.81) and device embolisation (no events reported in both groups) at 1 year.ConclusionsThis meta-analysis suggests that percutaneous edge-to-edge repair is likely to be an efficacious and safe option in patients with both functional and degenerative MR. Large, randomised studies are ongoing and awaited to fully assess the clinical impact of the procedure in these two different MR aetiologies.


Author(s):  
Iranna S. Hirapur ◽  
Ravindran Rajendran ◽  
Jayaranganath . ◽  
Manjunath Nanjappa

Background: Epidemiology and clinical course of dilated cardiomyopathy (DCM) in children and infants are not well established. Thus, this study aims to investigate the clinical course and prognosis of DCM in childrenMethods: This was a single-center, prospective, observational study conducted at a tertiary-care center in India between February 2011 and September 2012. A total of 31 patients admitted to the paediatric department diagnosed with DCM were included in the study. Patients were divided into three groups based on the age at the time of diagnosis: 0-3 years, >3-12 years and >12-16 years. Among the study population, 28 patients were followed up for a mean period of 1.44 years and three patients were lost to follow-up.Results: Of the 31 patients, 11 patients were male with a mean age of 8.9±6 years and 20 patients were female with a mean age of 8.3±6 years. All patients were presented with same characteristics of New York heart association (NYHA) class III-IV dyspnoea and fatigue. Among 28 patients who were followed-up for a mean period of 1.44 years, 20(71.4%) patients died and eight patients were on follow up. Of the eight patients, five patients were with NYHA class III symptoms and three patients were with NYHA class I-II symptoms.Conclusions: Dilated cardiomyopathy in children is a very serious disease with a grave prognosis. Patients with NYHA III-IV symptoms have a very high mortality rate and potential use of other therapies remains to be fully evaluated in paediatric population.


Author(s):  
Luca Testa ◽  
Mauro Agnifili ◽  
Nicolas M. Van Mieghem ◽  
Didier Tchétché ◽  
Anita W. Asgar ◽  
...  

Background: Transcatheter aortic valve replacement (TAVR) has determined a paradigm shift in the treatment of patients with severe aortic stenosis. However, the durability of bioprostheses is still a matter of concern, and little is known about the management of degenerated TAV. We sought to evaluate the outcomes of patients with a degenerated TAV treated by means of a second TAVR. Methods: The TRANSIT is an international registry that included cases of degenerated TAVR from 28 centers. Among around 40 000 patients treated with TAVR in the participating centers, 172 underwent a second TAVR: 57 (33%) for a mainly stenotic degenerated TAV, 97 (56%) for a mainly regurgitant TAV, and 18 (11%) for a combined degeneration. Overall, the rate of New York Heart Association class III/IV at presentation was 73.5%. Results: Valve Academic Research Consortium 2 device success rate was 79%, as a consequence of residual gradient (14%) or regurgitation (7%). At 1 month, the overall mortality rate was 2.9%, while rates of new hospitalization and New York Heart Association class III/IV were 3.6% and 7%, respectively, without significant difference across the groups. At 1 year, the overall mortality rate was 10%, while rates of new hospitalization and New York Heart Association class III/IV were 7.6% and 5.8%, respectively, without significant difference across the groups. No cases of valve thrombosis were recorded. Conclusions: Selected patients with a degenerated TAV may be safely and successfully treated by means of a second TAVR. This finding is of crucial importance for the adoption of the TAVR technology in a lower risk and younger population. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04500964.


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