scholarly journals Lower Rates of Heart Failure and All-Cause Hospitalizations During Pulmonary Artery Pressure-Guided Therapy for Ambulatory Heart Failure

2020 ◽  
Vol 13 (8) ◽  
Author(s):  
David M. Shavelle ◽  
Akshay S. Desai ◽  
William T. Abraham ◽  
Robert C. Bourge ◽  
Nirav Raval ◽  
...  

Background: Ambulatory hemodynamic monitoring with an implantable pulmonary artery (PA) sensor is approved for patients with New York Heart Association Class III heart failure (HF) and a prior HF hospitalization (HFH) within 12 months. The objective of this study was to assess the efficacy and safety of PA pressure-guided therapy in routine clinical practice with special focus on subgroups defined by sex, race, and ejection fraction. Methods: This multi-center, prospective, open-label, observational, single-arm trial of 1200 patients across 104 centers within the United States with New York Heart Association class III HF and a prior HFH within 12 months evaluated patients undergoing PA pressure sensor implantation between September 1, 2014, and October 11, 2017. The primary efficacy outcome was the difference between rates of adjudicated HFH 1 year after compared with the 1 year before sensor implantation. Safety end points were freedom from device- or system-related complications at 2 years and freedom from pressure sensor failure at 2 years. Results: Mean age for the population was 69 years, 37.7% were women, 17.2% were non-White, and 46.8% had preserved ejection fraction. During the year after sensor implantation, the mean rate of daily pressure transmission was 76±24% and PA pressures declined significantly. The rate of HFH was significantly lower at 1 year compared with the year before implantation (0.54 versus 1.25 events/patient-years, hazard ratio 0.43 [95% CI, 0.39–0.47], P <0.0001). The rate of all-cause hospitalization was also lower following sensor implantation (1.67 versus 2.28 events/patient-years, hazard ratio 0.73 [95% CI, 0.68–0.78], P <0.0001). Results were consistent across subgroups defined by ejection fraction, sex, race, cause of cardiomyopathy, presence/absence of implantable cardiac defibrillator or cardiac resynchronization therapy and ejection fraction. Freedom from device- or system-related complications was 99.6%, and freedom from pressure sensor failure was 99.9% at 1 year. Conclusions: In routine clinical practice as in clinical trials, PA pressure-guided therapy for HF was associated with lower PA pressures, lower rates of HFH and all-cause hospitalization, and low rates of adverse events across a broad range of patients with symptomatic HF and prior HFH. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02279888.

2021 ◽  
Vol 7 ◽  
Author(s):  
Aniket S Rali ◽  
Lynne W Stevenson ◽  
Sandip K Zalawadiya

A 57-year-old woman with New York Heart Association Class III heart failure requiring multiple hospitalisations over the previous year presented for CardioMEMS implantation. Because of the patient’s allergy history of anaphylaxis to iodine-based contrast agent she underwent the device implantation with gadolinium-based contrast agent (Magnevist), which was successful.


2013 ◽  
Vol 28 (5) ◽  
pp. 741-746 ◽  
Author(s):  
Oriol Roca ◽  
Purificación Pérez-Terán ◽  
Joan R. Masclans ◽  
Lourdes Pérez ◽  
Enrique Galve ◽  
...  

Author(s):  
Nandini Nair ◽  
Enrique Gongora

<p>Abstract</p><p> </p><p>Background</p><p>The upregulation of inflammation and coagulation in addition to the sympathetic nervous system is known and reported in congestive heart failure. This study was undertaken to assess the correlations of the changes in coagulation parameters with functional class, ejection fraction and brain natriuretic peptide levels.</p><p> </p><p>Methods</p><p>A small prospective study was conducted in dilated cardiomyopathy (DCM) patients.</p><p>The protocol was approved by the Hospital IRB ( Scott and White Memorial, Temple, TX 76508). Statistical analysis was conducted using the online Vassar stats system . Spearman’s rank order correlation was derived for all the correlations mentioned in this paper.</p><p> </p><p>Results</p><p>PT, PTT, INR and d-dimer levels were significantly different in the two groups and correlated positively and significantly with BNP and New York Heart Association class . Statistically significant negative correlation was noted with ejection fraction. fibrinogen levels did not correlate significantly with BNP, New York Heart Association class or ejection fraction.</p><p> </p><p>Conclusions</p><p>Coagulation pathway parameters correlate significantly with BNP, functional class and ejection fraction in this study. The study is limited by its size and the fact that only dilated non- ischemic cardiomyopathy patients were included.   Larger studies are required to further understand the complex interactions of biochemical pathways noted in heart failure.</p><p> </p>


Author(s):  
Shelby D. Reed ◽  
Angelyn O. Fairchild ◽  
F. Reed Johnson ◽  
Juan Marcos Gonzalez ◽  
Robert J. Mentz ◽  
...  

Background: The Food and Drug Administration’s Center for Devices and Radiological Health issued Guidance in 2016 on generating patient preference information to aid evaluation of medical devices. Consistent with this guidance, we aimed to provide quantitative patient preference evidence on benefit-risk tradeoffs relevant to transcatheter mitral valve repair versus medical therapy for patients with heart failure and symptomatic secondary mitral regurgitation. Methods: A discrete-choice experiment survey was designed to quantify patients’ tolerance for 30-day mortality or serious bleeding risks to achieve improvements in physical functioning or reductions in heart failure hospitalizations. Two samples were recruited: an online US panel of individuals reporting a diagnosis of heart failure (n=244) and patients with heart failure treated at Duke University Health System (n=175). Random-effects logit regression was used to model treatment choices as a function of benefit and risk levels. Results: Across both samples, approximately one-quarter (23.5%) consistently chose device profiles offering the higher level of physical functioning despite mortality and bleeding risks as high as 10%. Among respondents who at least once chose a device profile offering a lower level of functioning, improvement in physical functioning equivalent to a change from New York Heart Association class IV to III was ≈6 times more preferred than a change from New York Heart Association class III to II. Estimated discrete-choice experiment utility gains and losses revealed that respondents would accept up to a 9.7 percentage-point (95% CI, 8.2%–13.3%) increase in risk of 30-day mortality with devices that could improve functioning from New York Heart Association class IV to III, or up to 2.0% (95% CI, 1.4%–2.7%) for an improvement from New York Heart Association class III to II. Conclusions: Severity of heart failure symptoms influences patients’ willingness to accept risks associated with mitral valve medical devices. These findings can inform shared decision-making discussions with patients who are being evaluated for transcatheter mitral valve repair.


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