Multicenter Trial of the Orqis Medical Cancion System for the Enhanced Treatment of Heart Failure Unresponsive to Medical Therapy - MOMENTUM

Sep 21, 2008
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Orqis Medical Corp., Lake Forest, CA
Date Presented:
01/01/2008
Date Published:
01/01/2008
Date Updated:
09/21/2008
Original Posted Date:
09/21/2008
References

Description:

The goal of this trial was to evaluate treatment with the Orqis® Medical Cancion® System compared with medical management in patients with heart failure (HF) refractory to medical therapy.

Hypothesis:

Continuous aortic flow augmentation will be more effective in reducing pulmonary capillary wedge pressure and days alive out of the hospital.

Study Design

  • Randomized

Patients Enrolled: 168
Mean Follow Up: 65 days
Mean Patient Age: 55 years
Female: 22

Patient Populations:

  • Chronic HF with acute decompensation not responding to intravenous inotrope and/or vasodilator treatment
  • Elevated pulmonary capillary wedge pressure (≥20 mm Hg)
  • Reduced cardiac index (<2.4 L/min/m2)
  • Impaired renal function (creatinine >1.2 mg/dl) or substantial diuretic requirement (>120 mg intravenous per day)

Exclusions:

  • Q-wave myocardial infarction
  • Severe lung disease or liver disease
  • Creatinine >4.0 mg/dl
  • Resynchronization device implanted within 14 days
  • Systolic blood pressure <80 mm Hg or need for cardiac mechanical support
  • Thrombocytopenia
  • Coagulopathy
  • Systemic infection
  • Stroke or transient ischemic attack within 3 months
  • Active status on a cardiac transplantation list
  • Peripheral vascular disease resulting in limb ischemia
  • Severe valvular disease

Primary Endpoints:

  • Composite of pulmonary capillary wedge pressure reduction at 72-96 hours and days alive out of the hospital off mechanical support at 35 days
  • Percentage of patients who experience one or more of the following serious adverse events: death, bleeding, limb ischemia, worsening renal function, pulmonary embolus, or stroke

Secondary Endpoints:

  • Change in cardiac index
  • Change in NT-proBNP
  • Change in serum creatinine
  • Change in body weight
  • Health-related quality of life at 14 and 35 days
  • Morbidity and mortality at 35 and 65 days

Drug/Procedures Used:

Patients with persistent HF symptoms refractory to medical therapy were randomized to the continuous aortic flow augmentation device (superimposing low-level continuous flow on pulsatile aortic flow) (n = 109) or continued medical management (n = 59). Patients were initially randomized 1:1, although it increased to 2:1 after 49 patients enrolled.

Concomitant Medications:

At baseline, the use of medications in the device arm was: angiotension-converting enzyme inhibitors/angiotensin-receptor blockers 42%, beta-blockers 57%, intravenous furosemide 80%, dobutamine 39%, and milrinone 66%.

Principal Findings:

For device vs. control patients, the mean baseline pulmonary capillary wedge pressure was 29 mm Hg vs. 29 mm Hg, cardiac index was 2.0 L/min vs. 2.1 L/min, and N-terminal portion of probrain natriuretic peptide (NT-proBNP) was 7684 pg/ml vs. 7898 pg/ml. Technical success, defined as at least 24 hours of pump flow, was achieved in 93% of the patients. The median treatment time was 95 hours.

Pulmonary capillary wedge pressure was nonsignificantly reduced in the device arm to 24.5 mm Hg vs. 26.7 mm Hg for the control arm (p = 0.074), whereas cardiac index was increased to 2.4 L/min/m2 vs. 2.1 L/min/m2, respectively (p < 0.0001). Death or HF hospitalization was similar between the two groups (53% vs. 58%, respectively; p = 0.51). Limb ischemia occurred in 1.8% vs. 0% (p = 0.54), stroke in 0.9% vs. 3.4% (p = 0.28), renal failure in 12.8% vs. 6.8% (p = 0.30), pulmonary embolus in 0.9% vs. 3.4% (p = 0.28), and major bleeding in 16.5% vs. 5.1% (p = 0.05) for the device vs. control groups, respectively.

Interpretation:

In a sick cohort of HF patients, continuous aortic flow augmentation for 4 days increased cardiac index and may decrease pulmonary capillary wedge pressure. Adverse cardiac outcomes were similar between the two groups, although major bleeding was increased. The investigators commented that this device may be able to reduce clinical events in less-sick patients; however, bleeding complications need to be minimized.

References:

Greenberg G, Czerska B, Delgado RM, et al. Effects of Continuous Aortic Flow Augmentation in Patients With Exacerbation of Heart Failure Inadequately Responsive to Medical Therapy: Results of the Multicenter Trial of the Orqis Medical Cancion System for the Enhanced Treatment of Heart Failure Unresponsive to Medical Therapy (MOMENTUM). Circulation 2008;118:1241-9.

Efficacy and Safety of Continuous Aortic Flow Augmentation in Patients Hospitalized With Acute Decompensated Heart Failure: Results of the MOMENTUM Trial. Presented by Dr. Barry Greenberg at the SCAI-ACC i2 Summit/American College of Cardiology Annual Scientific Session, Chicago, IL, March/April 2008.

Keywords: Stroke, Renal Insufficiency, Pulmonary Wedge Pressure, Diuretics, Heart Failure, Embolism, Creatinine, Vasodilator Agents, Natriuretic Peptide, Brain


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