A first-in-man study of percutaneous myocardial cryotreatment in nonrevascularizable patients with refractory angina.

摘要: Objectives: To evaluate the safety and feasibility of myocardial cryotreatment for patients with coronary artery disease (CAD) severe angina refractory to standard treatment. Background: Innovative revascularization strategies are needed CAD uncontrolled by conventional methods. Preclinical data have demonstrated that cryotherapy can induce neovascularization through arteriogenesis. Methods: This was a two center, nonrandomized, study enrolled 20 patients. All had (CCS Angina Class III or IV). Safety primary endpoint. Treatment involved 8–10 intramyocardial cryoapplications (at ≤−50°C), 2 min specially designed percutaneous catheter at an identified ischemic area myocardium. Primary endpoint safety, secondary endpoints severity, exercise tolerance, quality life, perfusion assessed radionuclide scintigraphy. Results: The procedure successful in 19 There were three device-related events, pericardial tamponade requiring pericardiocenetesis, clinically nonsignificant effusion, episode ventricular tachycardia cardioversion one patient. Complete 12-month follow-up obtained 16 Significant reduction CCS scores significant improvements both tolerance life (P < 0.05) seen 6 follow-up. Although no differences observed overall group, marked improvement detected 8 (42%) Conclusion: Cryotreatment is feasible safe management. Early efficacy results encouraging further clinical warranted. © 2009 Wiley-Liss, Inc.