A prospective comparison of alginate-hydrogel with standard medical therapy to determine impact on functional capacity and clinical outcomes in patients with advanced heart failure (AUGMENT-HF trial).

Abstract

AIMS:

AUGMENT-HF was an international, multi-centre, prospective, randomized, controlled trial to evaluate the benefits and safety of a novel method of left ventricular (LV) modification with alginate-hydrogel.

METHODS:

Alginate-hydrogel is an inert permanent implant that is directly injected into LV heart muscle and serves as a prosthetic scaffold to modify the shape and size of the dilated LV. Patients with advanced chronic heart failure (HF) were randomized (1 : 1) to alginate-hydrogel (n = 40) in combination with standard medical therapy or standard medical therapy alone (Control, n = 38). The primary endpoint of AUGMENT-HF was the change in peak VO2 from baseline to 6 months. Secondary endpoints included changes in 6-min walk test (6MWT) distance and New York Heart Association (NYHA) functional class, as well as assessments of procedural safety.

RESULTS:

Enrolled patients were 63 ± 10 years old, 74% in NYHA functional class III, had a LV ejection fraction of 26 ± 5% and a mean peak VO2 of 12.2 ± 1.8 mL/kg/min. Thirty-five patients were successfully treated with alginate-hydrogel injections through a limited left thoracotomy approach without device-related complications; the 30-day surgical mortality was 8.6% (3 deaths). Alginate-hydrogel treatment was associated with improved peak VO2 at 6 months-treatment effect vs.

CONTROL:

+1.24 mL/kg/min (95% confidence interval 0.26-2.23, P = 0.014). Also 6MWT distance and NYHA functional class improved in alginate-hydrogel-treated patients vs. Control (both P < 0.001).

CONCLUSION:

Alginate-hydrogel in addition to standard medical therapy for patients with advanced chronic HF was more effective than standard medical therapy alone for improving exercise capacity and symptoms. The results of AUGMENT-HF provide proof of concept for a pivotal trial.

TRIAL REGISTRATION NUMBER:

NCT01311791.

• Authors: Stefan D Anker, Andrew J S Coats, Gabriel Cristian, Dinu Dragomir, Enrico Pusineri, Massimo Piredda, Luca Bettari, Robert Dowling, Maurizio Volterrani, Bridget-Anne Kirwan, Gerasimos Filippatos, Jean-Louis Mas, Nicolas Danchin, Scott D Solomon, Randall J Lee, Frank Ahmann, Andy Hinson, Hani N Sabbah, Douglas L Mann
• Journal: European heart journal (Eur Heart J) Vol. 36 Issue 34 Pg. 2297-309 (Sep 07 2015) ISSN: 1522-9645 [Electronic] England
• PMID: 26082085 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

Chemical References

• Alginates
• Hexuronic Acids
• Hydrogel, Polyethylene Glycol Dimethacrylate
• Glucuronic Acid

Topics

• Alginates (administration & dosage)
• Echocardiography
• Exercise Test
• Exercise Tolerance (physiology)
• Female
• Glucuronic Acid (administration & dosage)
• Heart Failure (physiopathology, therapy)
• Hexuronic Acids (administration & dosage)
• Humans
• Hydrogel, Polyethylene Glycol Dimethacrylate (administration & dosage)
• Length of Stay
• Male
• Middle Aged
• Oxygen Consumption (physiology)
• Patient Safety
• Prospective Studies
• Prostheses and Implants
• Quality of Life
• Treatment Outcome
• Walking (physiology)