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Ambulatory hemodynamic sensor reduces risk for HF hospitalization, mortality
ORLANDO, Fla. — Patients who underwent an ambulatory hemodynamic sensor implant had decreased risk for mortality and HF hospitalization compared with a control group, according to data presented at the American College of Cardiology Scientific Session.
“Compared to controls, treated patients had a 30% reduction in all-cause crude mortality and a 24% reduction in HF hospitalization,” Jacob Abraham, MD, medical director at Providence Center for Advanced Heart Disease in Portland, Oregon, said during the presentation.
In the retrospective, propensity-matched study, researchers analyzed CMS administrative claims data from 1,087 patients (mean age, 73 years; 35% women) who underwent an implant of an ambulatory hemodynamic sensor (CardioMEMS, Abbott) from June 2014 to March 2016. An additional 1,087 controls (mean age, 73 years; 35% women) who did not receive the sensor were matched by comorbidities, demographics and timing of HF hospitalization to patients in the treatment cohort.
The primary outcomes were all-cause crude mortality and HF hospitalizations at 12 months.
At baseline, 49.7% of the treatment group and 53.4% of the control group had renal disease.
Before the sensor was implanted, both groups had similar rates of HF hospitalization (HR = 0.99; 95% CI, 0.95-1.05) and total number of days in the hospital. Patients in the treatment cohort had a longer length of stay vs. the control cohort (5.5 days vs. 4.9 days; P < .01).
Compared with the control group, the treatment group had lower risk for mortality after the sensor was implanted (HR = 0.7; 95% CI, 0.59-0.83), Abraham and colleagues found. Death occurred in 325 patients in the control group (mortality rate = 0.3 per patient-year) and 241 patients in the treatment group (mortality rate = 0.22 per patient-year).
Patients in the control group had more HF hospitalizations compared with the treatment group after the sensor was implanted (784 vs. 616; HR = 0.76; 95% CI, 0.65-0.89). The event rate in the control group was 0.88 HF hospitalizations per patient-year vs. 0.65 HF hospitalizations per patient-year in the treatment group.
“When analyzed over time, the reduction in heart failure hospitalization becomes apparent early after sensor implant, but continued separation occurs at 12 months,” Abraham said.
Subgroup analyses found no differences in outcome based on age, comorbid conditions and sex.
“The findings of this study stimulate the need for a randomized prospective trial to define the effect of ambulatory hemodynamic-guided [management] on mortality and chronic HF,” Abraham said. “The upcoming GUIDE-HF study is specifically designed to address this important question.” – by Darlene Dobkowski
Reference:
Abraham J, et al. Featured Clinical Research III. Presented at: American College of Cardiology Scientific Session; March 10-12, 2018; Orlando, Fla.
Disclosure: The study was sponsored by Abbott. Abraham reports no relevant financial disclosures.
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These findings expand the knowledge base by going into a much broader population. It looks at a different population from a clinical trial population. This was done from an administrative database, and that is probably more generalizable to what we see in day-to-day practice. These data also suggest that use of the device to adjust medications is associated with improved survival in patients with HF.
The results should be reassuring to clinicians who are considering this kind of therapy because it looks like there are some real benefits.
In the future, we should further define the algorithms for preventing hospitalizations, observe this population a little closer and gather more information about which patients specifically are going to benefit so that we can avoid putting the device into patients who don’t benefit. Other than that, the database is pretty robust at this point.