Clinical Outcomes of Autologous Stem Cell–Patch Implantation for Patients With Heart Failure With Nonischemic Dilated Cardiomyopathy

概要

〔目的(Purpose)〕
Clinical effectiveness of autologous skeletal cell-patch implantation for non-ischemic dilated cardiomyopathy (NIDCM) has not been clearly elucidated in clinical settings. This clinical study aimed to determine the feasibility, safety, therapeutic efficacy and the predictor of responder of this, treatment in NIDCM patients.

〔方法ならびに成績(Methods/Results)〕
Twenty-four NIDCM patients with LVEF less than 35% on optimal medical therapy were enrol led. Autologous cell-patches were implanted over the surface of left ventricle through left mini-thoracotomy without procedure-related complications and lethal arrhythmia. We identified thirteen responders and eleven non-responders using the combined indicator of major cardiac adverse event and incidence of heart failure event. In the responders, symptoms, exercise capacity and cardiac performance were improved postoperatively (ΝΥΗΛ class II 7 (54%) and III 6 (46%) to ΝΥΗΛ class II 12(92%) and I 1(8%), p<0.05, six-minute walk test； 471(370-541) to 525(425-555)m, p<0. 05, Left ventricular stroke work index； 31.1(22.7-35.5) to 32.8(28-38. 5)g/m2/beat, p=0. 21), However, such improvement was not observed in the non-responders. In responders, actuarial survival rate was 90. 9士8. 7% at 5 years, which was superior to estimated survival rate using Seattle heart failure model SHFM of 70. 9±5. 4%. However they were similar in non-responders (47. 7±21.6% and 56. 3±8.1%). Multivariate regression model with BNP, PCWP and expression of histone H3 lysine 4 trimethylation (H3K4me3) strongly predicted the responder of this treatment (BNP: OR 0. 96, PCWP: OR, 0. 58, H3K4me3： OR, 1.35, R0C~AUC=0.96, p<0.001).

〔総括(Conclusion)〕
The results of our clinical trial demonstrated that skeletal stem cell-patch implantation can provide functional recovery and good clinical outcome in selected patients with NIDCM with preoperatively preserved diastolic function and the ability of protein synthesis in myocytes, as well as safety and feasibility of the procedure.