One-year follow-up of transcoronary sinus administration of autologous bone marrow in patients with chronic refractory angina.
OBJECTIVE
Based on our preclinic studies with autologous unfractionated bone marrow (AUBM) via coronary sinus with transitory occlusion, a clinic study in patients with chronic refractory angina was designed. The objectives were to evaluate tolerance of the procedure, safety, and feasibility with 1 year follow-up.


METHODS
Clinical study with inclusion and exclusion criteria defined by an Independent Clinical Committee was carried out. Fifteen patients underwent transcoronary sinus administration with a 15-min occlusion of freshly aspirated and filtered AUBM (60-120 ml). Feasibility was evaluated with Seattle Angina Questionnaire (SAQ), Canadian Cardiovascular Society (CCS) angina classification, perfusion dipyridamole, and coronary angiography.


RESULTS
There were no changes in the tolerance parameters. There were no deaths or myocardial infarction during the follow-up. Three patients were readmitted into the hospital. During the follow-up, one patient was diagnosed with cancer of the lung. Improvement of 30% in the quality of life was evaluated by SAQ. The CCS angina classification showed that the mean angina class was 3.0+/-0.53 at baseline, which improved to 1.6+/-0.63 at 1 year (P<.001). Perfusion imaging (core lab) showed improvement in 12 of 15 patients, with a mean improvement of 40.9% at rest (22 vs. 13) (P<.01) and 45.3% at stress (26.5 vs. 14.5) (P<.05). Coronary angiography showed more collateral vessels in 10 of 15 patients.


CONCLUSIONS
We can conclude that AUBM via coronary sinus is feasible in patients with chronic refractory angina after 1 year follow-up, and it appears to be safe.
Vicario
Jose
J
J.B. Iturraspe Hospital, Santa Fe, Argentina. josevicario@hotmail.com
Campo
Cesar
C
Piva
Julio
J
Faccio
Fernando
F
Gerardo
Luis
L
Becker
Carlos
C
Ortega
Hugo
H
Pierini
Angel
A
Lofeudo
Carlos
C
Novero
Rafael
R
Baliño
Nestor Perez
NP
Monti
Adrian
A
Benech
Rodolfo
R
Dallo
Matias
M
Pfeiffer
Hernan
H
D000368:Aged; D000787:Angina Pectoris / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D016026:Bone Marrow Transplantation; D017023:Coronary Angiography; D003326:Coronary Circulation; D023921:Coronary Stenosis / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D015425:Myocardial Reperfusion; D010359:Patient Readmission; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life; D018434:Sickness Impact Profile; D013997:Time Factors; D015899:Tomography, Emission-Computed, Single-Photon; D014182:Transplantation, Autologous; D016896:Treatment Outcome