Guillermo Reyes1, keith Allen2, Adrian Alegre1, Beatriz Aguado1, Anas Sarraj1, Jose-Manuel Nuche1, Juan Duarte1.
1La Princesa University Hospital, Madrid, Spain, 2Mid America Heart Institute, St. Luke's Hospital, Kansas City, MO, USA.
BACKGROUND: Transmyocardial laser revascularization is an option for patients with medically refractory angina not amenable to conventional revascularization. Angiogenic up regulation of injured myocytes by the laser is hypothesized to provide a ‘fertile’ area for an enhanced stem cell paracrine effect.
METHODS: Nine patients (7 male and 2 female) with diffuse coronary artery disease and medically refractory class III/IV angina were prospectively evaluated. Sole therapy TMR was combined with intramyocardial injection of autologous concentrated stem cells using a single delivery device. Autologous bone marrow (120cc) was aspirated from the posterior iliac crest and concentrated over 15min into 20cc of concentrated mononuclear cells using a point of care centrifugal system (HARVEST, Boston, MA). Cell counts and flow cytometry were utilized to measure total mononuclear, CD34+, and CD133+ cell numbers. Cardiac exposure was obtained through a fifth interspace limited anterior lateral thorocotomy. A single device performed holmium:YAG TMR (CardioGenesis, Irvine, CA) with injection of 1cc of concentrated stem cells through three needles into the border zone around each laser channel. 
RESULTS: The stem cell separator provided sterilely concentrated stem cells while the TMR/stem cell combination delivery device worked uneventfully. There were no perioperative adverse events including no arrhythmias. With an average follow-up of 6 months, all patients experienced a two class reduction in angina with 7 patients angina free, 1 patient in class I, and 1 patient in class II. Pre operative sublingual nitrate use was 37 per patient per month compared to 4 at follow-up (p=0.03). Mean number of laser channels was 18 and the mean number of injected cells per patient were: total mononuclear cells (1660 x 106), CD34+ (9.8 x 106), and CD133+ (4.6 x 106). Median length of stay was 6 days.
CONCLUSION: TMR has demonstrated superior efficacy over medical therapy in patients with medically refractory angina. Efficient delivery of stem cells combined with TMR in a single device is safe. Larger trials will be required to determine the degree of synergistic effect.
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