Continuous aortic flow augmentation - A pilot study of hemodynamic and renal responses to a novel percutaneous intervention in decompensated heart failure

Background - Diminished aortic flow may induce adverse downstream vascular and renal signals. Investigations in a heart failure animal model have shown that continuous aortic flow augmentation ( CAFA) achieves hemodynamic improvement and ventricular unloading, which suggests a novel therapeutic approach to patients with heart failure exacerbation that is inadequately responsive to medical therapy. Methods and Results - We studied 24 patients ( 12 in Europe and 12 in the United States) with heart failure exacerbation and persistent hemodynamic derangement despite intravenous diuretic and inotropic and/or vasodilator treatment. CAFA ( mean +/- SD 1.34 +/- 0.12 L/min) was achieved through percutaneous ( n = 19) or surgical ( n = 5) insertion of the Cancion system, which consists of inflow and outflow cannulas and a magnetically levitated and driven centrifugal pump. Hemodynamic improvement was observed within 1 hour. Systemic vascular resistance decreased from 1413 +/- 453 to 1136 +/- 381 dyne (.) s (.) cm(-5) at 72 hours ( P = 0.0008). Pulmonary capillary wedge pressure decreased from 28.5 +/- 4.9 to 19.8 +/- 7.0 mm Hg ( P < 0.0001), and cardiac index ( excluding augmented aortic flow) increased from 1.97 +/- 0.44 to 2.27 +/- 0.43 L (.) min(-1) (.) m(-2) ( P = 0.0013). Serum creatinine trended downward during treatment ( overall P = 0.095). There were 8 complications during treatment, 7 of which were self-limited. Hemodynamics remained improved 24 hours after CAFA discontinuation. Conclusions - In patients with heart failure and persistent hemodynamic derangement despite intravenous inotropic and/or vasodilator therapy, CAFA improved hemodynamics, with a reduction in serum creatinine. CAFA represents a promising, novel mode of treatment for patients who are inadequately responsive to medical therapy. The clinical impact of the observed hemodynamic improvement is currently being explored in a prospective, randomized, controlled trial