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Pulmonary artery pressure monitor reduces HF hospitalization, costs in real-world cohort
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WASHINGTON — An ambulatory hemodynamic monitoring system with an implantable pulmonary artery pressure sensor was associated with decreased HF hospitalization and comprehensive costs of HF in a real-world population, according to new data presented at the American College of Cardiology Scientific Session.
The system (CardioMEMS HF System, Abbott) showed similar benefits in the real-world cohort as it did in a randomized controlled trial, Akshay Desai, MD, MPH, from the cardiovascular division of Brigham and Women’s Hospital, said during a presentation here.
“Despite guideline-directed medical therapy, patients remain at risk for HF hospitalization and death,” Desai said during the presentation. “Most of these hospitalizations are congestive exacerbations driven by a progressive rise in intracardiac filling pressures. It’s known from previous trials of hemodynamic monitoring that these pressures often rise weeks in advance of overt symptoms. This creates an opportunity for early detection. Ambulatory hemodynamic monitoring may be one strategy ... and may also direct therapy to intervene and prevent HF hospitalizations.”
Desai and colleagues conducted a retrospective cohort study of 1,114 patients (mean age, 71 years; 36% women; 14% black) implanted with the system between June 2014 and December 2015.
They compared HF hospitalization 6 months before implantation vs. 6 months after implantation while accounting for competing risks of death, ventricular assist device implantation or cardiac transplantation.
They also assessed comprehensive HF-related costs 6 months before implantation vs. 6 months after. Cost data were obtained from the Medicare Claims Database.
In the cohort, there were 1,020 HF hospitalizations in the 6 months before the hemodynamic monitoring system was implanted vs. 381 HF hospitalizations, 139 deaths and 17 transplants or VAD implantations in the 6 months after implantation (HR = 0.55; 95% CI, 0.49-0.61), Desai and colleagues found.
The results are consistent with the CHAMPION randomized controlled trial of 550 patients with HF, in which the hemodynamic monitoring system was associated with a 28% reduction in HF hospitalizations over 17.5 months, Desai said.
The reduction in HF hospitalizations was associated with a 6-month reduction in comprehensive HF costs of $7,433 per patient (95% CI, 7,000-7,884) and was consistent when only patients who survived 6 months after implantation were included.
Among 480 patients with complete data for 12 months before and after implantation, a similar reduction in HF hospitalization (HR = 0.66; 95% CI, 0.57-0.76) and costs was observed.
Given the cost of the system as determined by charges to Medicare, the researchers estimate a period “of roughly 2 years to recoup the cost of the initial investment,” Desai said, noting the cost data translate into a savings of $13,190 at 1 year.
Results did not vary by age, sex or inpatient vs. outpatient implantation, he said.
“These data from an unselected population support the real-world effectiveness of this approach to HF management in clinical practice,” Desai said. – by Erik Swain
References:
Desai A, et al. Featured Clinical Research III. Presented at: American College of Cardiology Scientific Session; March 17-19, 2017; Washington, D.C.
Desai A, et al. J Am Coll Cardiol. 2017;doi:10.1016/j.jacc.2017.03.009.
Disclosure: The study was funded by St. Jude Medical, now part of Abbott. Desai reports receiving honoraria for consulting from St. Jude Medical, now part of Abbott.
Perspective
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Gregg C. Fonarow, MD
Implantable hemodynamic monitoring systems have provided evidence of efficacy for substantially reducing HF hospitalizations in the context of randomized clinical trials. However, concerns have been raised that such results would be unlikely to occur in clinical practice, where patients may be less adherent, not be followed as closely and not managed by the same rigorous protocols.
Thus, robust clinical practice-based observational data is vital in evaluating the clinical effectiveness of this new monitoring system.
The analysis of over 1,000 Medicare beneficiaries undergoing pulmonary artery pressure sensor implant demonstrates substantial reductions in HF hospitalizations and associated costs. These findings suggest the benefits of the use of ambulatory hemodynamic monitoring proven in clinical trials extends into real-world clinical practice.
Patients with HF, irrespective of ejection fraction, who are NYHA functional class III despite guideline-directed medical therapy, with a least one prior HF hospitalization, are appropriate candidates for ambulatory hemodynamic monitoring.
These findings suggest there could be substantial benefit to patients with HF, a common, costly and deadly condition, if ambulatory hemodynamic monitoring were more readily available.
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