Introduction: Giving added value to conventional surgical treatment may play an important role in the treatment of heart failure because of serious donor shortage in heart transplantation and poor durability in LVAD. We have developed combination of mitral valve replacement (MVR) and autologous skeletal myoblast cell sheet (SMBc) implantation having anti fibrotic potential for DCM patients with severe MR, aiming at controlling pulmonary pressure and ameliorating fibrotic myocardium. This Phase I clinical trial tested whether this combined treatment is feasible, safe, and effective for treating severe congestive heart failure.
Methods: Six patients who had suffered from heart failure underwent MVR using a biological valve and SMBc implantation from 2010 to 2016 without LVAD support. They were all male and the average age was 60 ± 8 years. Mean MR grade was 3.5 ± 0.5. Observation period was 1305 ± 834 days. The postoperative characteristics and clinical results were compared with the preoperative data, respectively.
Results: All cases were discharged from hospital 106 ± 70 days after MVR. And then SMBc implantation was performed 206 ± 105 days after the first surgery. Although echocardiography showed a trend of EF decline from 26.2 ± 4.7 to 14.7 ± 5.6% (P = 0.08), LV volume in diastole and systole were not significantly changed after this combination therapy (LVEDV: 261 ± 30 vs 253 ± 118 ml, P = 0.88; 198 ± 29 vs 214 ± 125 ml, P = 0.76). NYHA classification was significantly ameliorated from 3.2 ± 0.4 to 2.0 ± 0.9 (P = 0.01) with tended reduction of mPAP (26.8 ± 9.3 vs 22.5 ± 5.5 mmHg, P = 0.35), and PVR (232 ± 103 vs 143 ± 99 dyne*sec*cm-5, P = 0.16) after the combination therapy. In addition, BNP level decreased in all the cases from 595 ± 438 to 398 ± 390 pg/ml (P = 0.43). The rate of admission for heart failure was decreased from 1.12 ± 0.79 to 0.06 ± 0.16 times/year (P = 0.01), and no mid-term mortality was observed.
Conclusions: Although promising results in the safety and functional recovery warrant larger studies and appropriate patients selection to confirm this treatment’s efficacy, this combination therapy might propose new armamentarium for treat DCM patients with severe MR to support existing treatment using LVAD or heart transplant.