Physician-directed patient self-management of left atrial pressure reduced decompensation events after the first 3 months compared to the blinded phase (HR 0.16; 95% CI 0.04 to 0.68; P=0.012).
Observational (n=40)
Double-blind (initial 3 months)
Does physician-directed patient self-management of left atrial pressure improve event-free survival and hemodynamics in patients with advanced chronic heart failure?
Physician-directed patient self-management guided by left atrial pressure monitoring significantly reduced heart failure decompensation events and improved hemodynamics in advanced heart failure.
Effect estimate: HR 0.16 (95% CI 0.04 to 0.68)
p-value: p=0.012
BACKGROUND: Previous studies suggest that management of ambulatory hemodynamics may improve outcomes in chronic heart failure. We conducted a prospective, observational, first-in-human study of a physician-directed patient self-management system targeting left atrial pressure. METHODS AND RESULTS: Forty patients with reduced or preserved left ventricular ejection fraction and a history of New York Heart Association class III or IV heart failure and acute decompensation were implanted with an investigational left atrial pressure monitor, and readings were acquired twice daily. For the first 3 months, patients and clinicians were blinded as to these readings, and treatment continued per usual clinical assessment. Thereafter, left atrial pressure and individualized therapy instructions guided by these pressures were disclosed to the patient. Event-free survival was determined over a median follow-up of 25 months (range 3 to 38 months). Survival without decompensation was 61% at 3 years, and events tended to be less frequent after the first 3 months (hazard ratio 0.16 95% confidence interval 0.04 to 0.68, P=0.012). Mean daily left atrial pressure fell from 17.6 mm Hg (95% confidence interval 15.8 to 19.4 mm Hg) in the first 3 months to 14.8 mm Hg (95% confidence interval 13.0 to 16.6 mm Hg; P=0.003) during pressure-guided therapy. The frequency of elevated readings (>25 mm Hg) was reduced by 67% (P<0.001). There were improvements in New York Heart Association class (-0.7+/-0.8, P<0.001) and left ventricular ejection fraction (7+/-10%, P<0.001). Doses of angiotensin-converting enzyme/angiotensin-receptor blockers and beta-blockers were uptitrated by 37% (P<0.001) and 40% (P<0.001), respectively, whereas doses of loop diuretics fell by 27% (P=0.15). CONCLUSIONS: Physician-directed patient self-management of left atrial pressure has the potential to improve hemodynamics, symptoms, and outcomes in advanced heart failure. Clinical Trial Registration Information- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00547729.
Ritzema et al. (Tue,) conducted a observational in Advanced chronic heart failure (n=40). Physician-directed patient self-management of left atrial pressure vs. Usual clinical assessment (blinded phase) was evaluated on Survival without decompensation (HR 0.16, 95% CI 0.04 to 0.68, p=0.012). Physician-directed patient self-management of left atrial pressure reduced decompensation events after the first 3 months compared to the blinded phase (HR 0.16; 95% CI 0.04 to 0.68; P=0.012).