Introduction
Hemodynamic monitoring has been shown to reduce admissions for heart failure in both
the large randomized CHAMPION Trial (CHMP) and a 1200 patient Post Approval Study
registry (PAS). A persistent observation in heart failure (HF) studies is that trial
patient populations differ from patients who are treated in clinical practice. After
identifying patients who could be propensity matched to the CHMP trial patients, we
studied the characteristics and outcomes of the patients who could not be matched.
Methods
PAS was an FDA mandated registry to determine if results of the CHMP trial could be
replicated in clinical practice, as reported previously. Propensity matching was done
between CHMP Control and PAS patients. 387 PAS patients could be propensity matched
and can be considered “Trial-Type” patients (TT) and 813 were not match able (NM).
For each patient group heart failure (HFH) and all-cause (ACH) hospitalization rates
at 1 year were compared to the rate in the year prior to enrollment.
Results
Compared to CHMP Treatment patients, NM patients were older 61.3 vs 71.8, more likely
to be female (18.1% vs 39.6%) and have heart failure with normal ejection fraction
(HFpEF) (23% vs 55.9%), p < 0.001 for all. Wedge pressure was higher (17.5 vs 20.0
mmHg) and GFR was lower (60.4 vs 50.5 mL/min/1.73 m2), p < 0.001 for both. Although ACH and HFH were higher in NM patients before and
during PA pressure guided management, there was a significant decline in both after
implantation of the CardioMEMS™ monitor (Figure 1).
Conclusion
Of the 1200 patients in the PAS, 67% (813/1200) patients were not match able to typical
trial subjects. Nonetheless, these patients with older age, worse renal function,
and more hospitalizations still had significant reduction in rates of HFH and ACH
during ambulatory hemodynamic monitoring.
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Identification
Copyright
© 2020 Published by Elsevier Inc.
