title: The feasibility and safety of Algisyl-LVR™ as a method of left ventricular augmentation in patients with dilated cardiomyopathy: initial first in man clinical results.
abstract: BACKGROUND
  A tissue engineering approach to augment the left ventricular wall has been suggested as a means to treat patients with advanced heart failure. This study evaluated the safety and feasibility of Algisyl-LVR™ as a method of left ventricular augmentation in patients with dilated cardiomyopathy undergoing open-heart surgery.
  
  
  RESULTS
  Eleven male patients (aged 44 to 74years) with advanced heart failure (NYHA class 3 or 4), a left ventricular ejection fraction (LVEF) of <40% and requiring conventional heart surgery received Algisyl-LVR delivered into the LV myocardial free wall. Serial echocardiography, assessment of NYHA class, Kansas City Cardiomyopathy Questionnaire (KCCQ) and 24-hour Holter monitoring were obtained at baseline, days 3 and 8 (for echocardiography and Holter monitoring), and at 3, 6, 12, 18 and 24months. A total of 9 (81.8%) patients completed 24months of follow-up. Two patients withdrew consent after day 8 and at the 3month visit. Operative mortality was 0% (n=10 with 30day follow-up). There were no adverse events attributed to Algisyl-LVR. Mean LVEF improved from 27.1 (±7.3) % at screening to a mean LVEF of 34.8 (±18.6) % 24months post-discharge. Improvements of NYHA class were corroborated with improvements in KCCQ summary scores. Holter monitor data showed a significant decrease in the episodes of nonsustained ventricular tachycardia following administration of Algisyl-LVR.
  
  
  CONCLUSIONS
  Administration of Algisyl-LVR to patients with advanced HF at the time of cardiac surgery is feasible and safe; warranting continued development of Algisyl-LVR as a potential therapy in patients with advanced HF.
authors.affiliation: Cardiovascular Research Institute, University of California-San Francisco, San Francisco, CA, USA; Department of Medicine, University of California-San Francisco, San Francisco, CA, USA; Institute for Regeneration Medicine, University of California-San Francisco, San Francisco, CA, USA. Electronic address: lee@medicine.ucsf.edu.
authors.forename: Randall J
authors.initials: RJ
authors.lastname: Lee
authors.affiliation: LoneStar Heart, Inc., Laguna Hills, CA, USA.
authors.forename: Andy
authors.initials: A
authors.lastname: Hinson
authors.affiliation: Department for Thoracic and Cardiovascular Surgery, University of Ulm, Ulm, Germany.
authors.forename: Robert
authors.initials: R
authors.lastname: Bauernschmitt
authors.affiliation: Cardiovascular Surgery, University Hospital Dresden, Dresden, Germany.
authors.forename: Klaus
authors.initials: K
authors.lastname: Matschke
authors.affiliation: Cardiovascular Research Institute, University of California-San Francisco, San Francisco, CA, USA; Department of Medicine, University of California-San Francisco, San Francisco, CA, USA.
authors.forename: Qi
authors.initials: Q
authors.lastname: Fang
authors.affiliation: Cardiovascular Division, Washington University School of Medicine, St Louis, MO, USA.
authors.forename: Douglas L
authors.initials: DL
authors.lastname: Mann
authors.affiliation: Dowling Consulting, Louisville, KY, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Dowling
authors.affiliation: Cardiovascular Research Institute, University of California-San Francisco, San Francisco, CA, USA; Department of Medicine, University of California-San Francisco, San Francisco, CA, USA.
authors.forename: Nelson
authors.initials: N
authors.lastname: Schiller
authors.affiliation: Department of Medicine, Division of Cardiovascular Medicine, Henry Ford Hospital, Detroit, MI, USA.
authors.forename: Hani N
authors.initials: HN
authors.lastname: Sabbah
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000464:Alginates / Q000008:administration & dosage*; D006348:Cardiac Surgical Procedures / Q000379:methods*; D002311:Cardiomyopathy, Dilated / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D004452:Echocardiography; D015716:Electrocardiography, Ambulatory; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006352:Heart Ventricles; D006801:Humans; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate / Q000008:administration & dosage*; D007267:Injections; D008297:Male; D008875:Middle Aged; D013318:Stroke Volume; D013997:Time Factors; D023822:Tissue Engineering / Q000379:methods; D016896:Treatment Outcome; D016277:Ventricular Function, Left / Q000502:physiology*; D055815:Young Adult
chemical_list: D000464:Alginates; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate
keywords: Alginate hydrogel; Heart failure; Tissue engineering