Clinical TrialHeart Failure and Respiratory Hospitalizations Are Reduced in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease With the Use of an Implantable Pulmonary Artery Pressure Monitoring Device
Section snippets
Subjects
The trial enrolled subjects who were male or female ≥18 years of age, diagnosed with New York Heart Association (NYHA) functional class III heart failure for ≥3 months, regardless of left ventricular ejection fraction or cause, and had ≥1 heart failure hospitalization ≤12 months of the baseline visit. Subjects were excluded if they had an active infection, had a history of recurrent (>1) pulmonary embolism or deep vein thrombosis, were unable to tolerate right heart catheterization, experienced
Hospitalizations
From September 2007 to October 2009, 550 subjects were randomly assigned to the treatment (n = 270) and control (n = 280) groups; 187 subjects met the COPD classification criteria for inclusion in the COPD subgroup. The mean follow-up time was 15 ± 7 months. The baseline characteristics of all subjects and subjects with COPD are presented in Table 1, Table 2 respectively. Patients with COPD had a higher prevalence of ischemic cardiomyopathy and other comorbidities compared with patients without
Discussion
Earlier studies have shown that the prevalence of COPD in HF subjects is high and ranges from 11% to 52% in North American patients and from 9% to 41% of European patients, with a higher prevalence in more recent studies.33 Earlier randomized clinical trials in chronic HF have reported a lower prevalence of COPD of 10%–20%. The prevalence of COPD in the CHAMPION trial was high at 34% and is likely due in part to the higher risk study population enrolled in CHAMPION compared with other
Study Limitations
Pulmonary function test data were not available in this study and were not part of the COPD classification criteria. Although our process was thorough and included a detailed evaluation of patient data including both medical histories and medication treatments consistent with other reported evaluations of patients with HF and COPD,12 it is possible that some level of COPD misdiagnosis exists within these data. In addition, although the CEC adjudication process for hospitalizations was rigorous
Conclusion
These data support the notion that physicians need to be more vigilant about optimizing HF treatment in this high-risk population and that targeting filling pressures is an effective strategy for improving clinical outcomes. Further investigation is required to examine the pathophysiologic relationships in greater detail among elevated filling pressures, HF, COPD, and respiratory exacerbations, and the implications in the development of new and effective treatment options.
Disclosures
JSK: None. WTA: National principal investigator, consulting fees, honoraria. PBA: National principal investigator, consulting fees, honoraria. RCB: Steering Committee member. JB: Paid employee of St Jude Medical. GG: Paid employee of St Jude Medical. FJM: None. GJC: None.
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2019, American Heart JournalCitation Excerpt :Additionally, hemodynamic-guided HF management in the subset of HFrEF patients treated with guideline-directed medical therapy (GDMT) was associated with a strong trend toward improved survival compared to traditional clinical management.4,7 Consistent benefit is demonstrated in several retrospective studies from the CHAMPION Trial.10-13 as well as extensive analysis of “real-world” experience.6,14
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