Rodrigo Sander F, Mann Imke, van Ramshorst Jan, Beeres Saskia L, Zwaginga Jaap Jan, Fibbe Willem E, Bax Jeroen J, Schalij Martin J, Atsma Douwe E
Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
Department of Immunohematology and Blood Transfusion, Leiden University Medical Center, Leiden, The Netherlands.
J Interv Cardiol. 2017 Oct;30(5):440-447. doi: 10.1111/joic.12408. Epub 2017 Jul 28.
Intramyocardial injection of bone marrow cells (BMC) in refractory angina patients with chronic myocardial ischemia has shown to be safe and improve clinical status during short-term follow-up. However, scarce data are available on long-term (>12 months) safety and efficacy. Therefore, the occurrence of clinical events and the long-term clinical effects of intramyocardial BMC injection were evaluated in patients with chronic myocardial ischemia up to 10 years after treatment.
Patients (n = 100, age 64 ± 9 years, male 88%) with chronic myocardial ischemia who underwent intramyocardial BMC injection between 2004 and 2010 were evaluated. During yearly outpatient clinic visits, the occurrence of clinical events was documented. In addition, clinical status was assessed according to the Canadian Cardiovascular Society (CCS) score and quality of life was measured using the Seattle Angina Questionnaire. These parameters were evaluated at baseline and during the first year, followed by cross-sectional long-term follow-up which was performed in 2011 and 2014. No adverse events considered related to the procedure occurred during 10 years of follow-up. Observed annual mortality rate and annual myocardial infarction rate were 3.8% and 1.9% per year, respectively. When compared to baseline, CCS class and quality of life remained significantly better during 5-year follow-up after BMC treatment (both P < 0.05).
The present long-term follow-up study shows that intramyocardial BMC injection in patients with chronic myocardial ischemia is safe and improves both angina complaints and quality of life up to 5 years after BMC treatment.
在患有慢性心肌缺血的难治性心绞痛患者中，心肌内注射骨髓细胞（BMC）已被证明在短期随访期间是安全的，并能改善临床状况。然而，关于长期（>12个月）安全性和疗效的数据却很少。因此，我们评估了慢性心肌缺血患者在接受治疗后长达10年内心肌内注射BMC的临床事件发生情况和长期临床效果。
对2004年至2010年间接受心肌内BMC注射的慢性心肌缺血患者（n = 100，年龄64±9岁，男性占88%）进行了评估。在每年的门诊就诊时，记录临床事件的发生情况。此外，根据加拿大心血管学会（CCS）评分评估临床状况，并使用西雅图心绞痛问卷测量生活质量。这些参数在基线时和第一年进行评估，随后在2011年和2014年进行横断面长期随访。在10年的随访期间，未发生与该操作相关的不良事件。观察到的年死亡率和年心肌梗死率分别为每年3.8%和1.9%。与基线相比，BMC治疗后5年随访期间，CCS分级和生活质量仍显著更好（均P < 0.05）。
本长期随访研究表明，慢性心肌缺血患者心肌内注射BMC是安全的，并且在BMC治疗后长达5年的时间里可改善心绞痛症状和生活质量。
