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Title: Continuous Aortic Flow Augmentation With Medical Therapy Improves Cardiac and Myocardial Function in Acute Decompensated Heart Failure: Presented at HF2008

"Continuous Aortic Flow Augmentation With Medical Therapy Improves Cardiac and Myocardial Function in Acute Decompensated Heart Failure: Presented at HF2008"

By Chris Berrie MILAN, Italy -- June 18, 2008 -- Continuous aortic flow augmentation (CAFA) added to standard optimised medical therapy results in significant improvements in cardiac function and myocardial performance in patients hospitalised with acute decompensated heart failure (ADHF) who have inadequate response to medical treatment, according to a multicentre, randomised, controlled trial. The study findings were presented here on June 16 at the Heart Failure 2008 (HF2008) Congress by Michael R. Zile, MD, Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston, South Carolina. "There are a group of patients who are refractory to medical therapy and come into the hospital with acute decompensated heart failure, which even with the treatment of high-dose diuretics and high-dose inotropes, are still in active heart failure," Dr. Zile said. However, there are indications that combining low-level continuous flow with pulsatile aortic flow can promote downstream vasodilation, cardiac unloading, and improved cardiac performance. The Multicentre Trial of the Orqis Medical CRS for the Enhanced Treatment of Heart Failure Unresponsive to Medical Therapy (MOMENTUM) was designed to compare haemodynamic and clinical effects of medical therapy alone or with CAFA, supplied by a percutaneous system that superimposes continuous flow on pulsatile flow within the descending aorta. The study enrolled patients with ADHF that was not adequately responding to intravenous (IV) inotrope and/or vasodilator and diuretic therapy, according to pulmonary capillary wedge pressure (PCWP) >=20 mm Hg, cardiac index <2.4 L/min/m[², and creatinine >1.2 mg/dL or >=120 mg/day IV furosemide.

The primary efficacy endpoint followed 3 qualifying criteria: on pump for >24 hours; decrease in mean PCWP >5 mm Hg (as average of 8-hour intervals from 72-96 hours postbaseline); and survival for more than 10 days, out of hospital, off mechanical support >35 days, plus absence of death or re-admission for HF during this time.

A total of 59 patients were randomised to optimised medical therapy (mean age, 56 years; male, 83%) and 109 to CAFA plus optimised medical therapy (mean age, 55 years; male, 74%). Baseline characteristics were matched closely across the treatment groups, as was their medication at baseline.

Although the full analysis was neutral for the endpoints, haemodynamic endpoints over the first 4 days of CAFA treatment showed significant benefit over medical therapy alone. Systemic vascular resistance (SVR) decreases with and without CAFA were 1,128 and 1,019 dyne.s/cm5, respectively (P = .0002). Increases in cardiac index were 2.1 and 2.4 L/min/m2 (P < .0001), heart rate increases were 88.8 and 94.4 min-1 (P = .031), and stroke work increases were 2.74 and 3.29 g/cm (P < .001). A beneficial trend was seen with CAFA in a decrease in PCWP (26.7 vs 24.5 mm Hg; P = .074).

Dr. Zile noted that the relationships between cardiac index and PCWP, and stroke work and PCWP (Starling function curves) both showed benefits in favour of CAFA over the full 30-day treatment. Furthermore, there are further indications of this effect in an ongoing analysis, he said.

"When we examine the relationships in the changes in the haemodynamics over the short term, from baseline to 3 days of CAFA therapy, it is predictive of which patients will have a clinical response."

Orqis Medical Corporation manufactures the CAFA device.

[Presentation title: Haemodynamic Effects of Continuous Aortic Flow Augmentation in Patients Hospitalised With Acute Decompensated Heart Failure: Results From the MOMENTUM Trial. Abstract P678]

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