First-in-man Safety and Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar.
BACKGROUND
The present study evaluates the safety and efficacy of the Adipose Graft Transposition Procedure (AGTP) as a biological regenerative innovation for patients with a chronic myocardial scar.


METHODS
This prospective, randomized single-center controlled study included 10 patients with established chronic transmural myocardial scars. Candidates for myocardial revascularization were randomly allocated into two treatment groups. In the control arm (n=5), the revascularizable area was treated with CABG and the non-revascularizable area was left untouched. Patients in the AGTP-treated arm (n=5) were treated with CABG and the non-revascularizable area was covered by a biological adipose graft. The primary endpoint was the appearance of adverse effects derived from the procedure including hospital admissions and death, and 24-hour Holter monitoring arrhythmias at baseline, 1week, and 3 and 12months. Secondary endpoints of efficacy were assessed by cardiac MRI.


RESULTS
No differences in safety were observed between groups in terms of clinical or arrhythmic events. On follow-up MRI testing, participants in the AGTP-treated arm showed a borderline smaller left ventricular end systolic volume (LVESV; p=0.09) and necrosis ratio (p=0.06) at 3months but not at 12months. The AGTP-treated patient with the largest necrotic area and most dilated chambers experienced a noted improvement in necrotic mass size (-10.8%), and ventricular volumes (LVEDV: -55.2mL and LVESV: -37.8mL at one year follow-up) after inferior AGTP.


CONCLUSIONS
Our results indicate that AGTP is safe and may be efficacious in selected patients. Further studies are needed to assess its clinical value. (ClinicalTrials.org NCT01473433, AdiFlap Trial).
Cardiology Service, Germans Trias i Pujol University Hospital, Badalona, Spain; Department of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain; ICREC Research Program, Health Science Research Institute Germans Trias i Pujol, Badalona, Spain. Electronic address: abayes.germanstrias@gencat.cat.
Antoni
A
Bayes-Genis
ICREC Research Program, Health Science Research Institute Germans Trias i Pujol, Badalona, Spain.
Paloma
P
Gastelurrutia
Cardiac Surgery Service, Germans Trias i Pujol University Hospital, Badalona, Spain.
Maria-Luisa
ML
Cámara
Cardiology Service, Germans Trias i Pujol University Hospital, Badalona, Spain; Clínica Creu Blanca, Barcelona, Spain.
Albert
A
Teis
Cardiology Service, Germans Trias i Pujol University Hospital, Badalona, Spain; Department of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain.
Josep
J
Lupón
Cardiology Service, Germans Trias i Pujol University Hospital, Badalona, Spain.
Cinta
C
Llibre
Cardiology Service, Germans Trias i Pujol University Hospital, Badalona, Spain.
Elisabet
E
Zamora
Clínica Creu Blanca, Barcelona, Spain.
Xavier
X
Alomar
Cardiac Surgery Service, Germans Trias i Pujol University Hospital, Badalona, Spain.
Xavier
X
Ruyra
ICREC Research Program, Health Science Research Institute Germans Trias i Pujol, Badalona, Spain; Center of Regenerative Medicine in Barcelona, Barcelona, Spain.
Santiago
S
Roura
ICICORELAB, Clinic University Hospital, Valladolid, Spain.
Ana
A
Revilla
ICICORELAB, Clinic University Hospital, Valladolid, Spain.
José Alberto
JA
San Román
ICREC Research Program, Health Science Research Institute Germans Trias i Pujol, Badalona, Spain.
Carolina
C
Gálvez-Montón
D000273:Adipose Tissue / Q000637:transplantation*; D000368:Aged; D002306:Cardiac Volume; D002921:Cicatrix / Q000628:therapy*; D001026:Coronary Artery Bypass / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000601:surgery*; D011446:Prospective Studies; D012038:Regeneration; D014182:Transplantation, Autologous; D016896:Treatment Outcome
Adipose tissue; Cardiac surgery; Cardiac tissue engineering; Myocardial infarction; Regenerative medicine; Stem cell therapy