Clinical Investigations
Interventional Cardiology
Direct intramyocardial percutaneous delivery of autologous bone marrow in patients with refractory myocardial angina

https://doi.org/10.1016/j.ahj.2005.04.033Get rights and content

Background

Intramyocardial injection of autologous bone marrow (ABM) may induce angiogenesis. We tested the safety and feasibility of catheter-based direct percutaneous intramyocardial delivery of ABM in patients with refractory angina pectoris.

Methods

Ten patients (9 men, 67 ± 8 years) with refractory angina (Canadian Cardiovascular Society class III-IV) and documented myocardial ischemia were enrolled. After left ventricular electromechanical mapping, freshly aspirated and filtered ABM was percutaneously injected into target myocardial ischemic areas. Clinical symptoms (as assessed according to the Canadian Cardiovascular Society class), quality of life, and myocardial perfusion were evaluated before the procedure and through the follow-up.

Results

In all patients, ABM was successfully injected into the target regions. No periprocedural complications occurred. At 12 months, no major cardiac events (death, acute myocardial infarction, stroke, and malignant ventricular arrhythmias) occurred. Severity of angina improved of ≥2 classes in 3 patients. Quality of life showed a significant improvement in all patients. Myocardial perfusion in the target regions improved in 4 of 8 patients.

Conclusions

Direct percutaneous intramyocardial delivery of ABM appears feasible and safe. Further evaluation is warranted to test its clinical efficacy.

Section snippets

Study design

Patients enrolled in this registry fulfilled the following criteria: (1) severe angina (Canadian Cardiovascular Society [CCS] functional class III or IV) despite conventional maximal drug treatment, (2) noncandidate to the conventional revascularization strategies, and (3) clear evidence of reversible myocardial ischemia. All patients signed an informed consent form. The local ethics committee approved the study protocol and gave permission to treat a maximum of 10 patients in this pilot study

Clinical characteristics of the patients

Ten patients were treated from October 2001 to March 2002 (Table I). All patients had refractory severe angina caused by a severe coronary artery disease nonsuitable to conventional treatment. Two patients had spinal cord stimulators. All patients were taking nitrate and antiplatelet agents; all but one patient were also taking β-blockers and calcium antagonists.

Autologous bone marrow aspiration

Autologous bone marrow (36 ± 16 mL) was aspirated from the iliac crest 1 hour before the procedure. The principal characteristics of

Discussion

This pilot study demonstrated in a preliminary format that direct percutaneous myocardial injection of ABM in patients with refractory angina pectoris is feasible and safe. The absence of any acute adverse event with this catheter system confirms previous observations5, 19, 20, 21 and provides encouraging data supporting that direct intramyocardial percutaneous delivery appears to be a safe and feasible vehicle for myocardial angiogenesis. Tse et al19 treated 8 patients with stable refractory

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