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Catheter-based autologous bone marrow myocardial injection in no-option patients with advanced coronary artery disease. A feasibility study
Catheter-Based Autologous Bone Marrow Myocardial Injection in No-Option Patients With Advanced Coronary Artery Disease. A Feasibility Study
ischemic myocardium may be limited (or may require higher doses). KA
Silent and Apparent Cerebral Embolism After Retrograde Catheterization of the Aortic Valve in Valvular Stenosis: A Prospective, Randomized Study
Fuchs S, Satler LS, Kornowski R, et al. J Am Coll Cardiol 2003; 41:1721– 4.
Omran H, Schmidt H, Hackenbroch M, et al. Lancet 2003;361: 1241– 6.
Study Question: Is transendocardial delivery of autologous bone marrow (ABM) a feasible treatment strategy for patients with severe symptomatic chronic myocardial ischemia not amenable to conventional revascularization? Methods and Results: Ten patients underwent transendocardial injection of freshly aspirated and filtered unfractionated ABM using left ventricular electromechanical guidance. Twelve injections of 0.2 mL each were successfully delivered into ischemic noninfarcted myocardium preidentified by single-photon emission computed tomography perfusion imaging. Autologous bone marrow injection was successful in all patients and was associated with no serious adverse effects. In particular, there was no arrhythmia, evidence of infection, myocardial inflammation or increased scar formation. Two patients were readmitted for recurrent chest pain without elevation of cardiac enzymes or ECG changes. At 3 months, Canadian Cardiovascular Society angina score significantly improved (3.1⫾0.3 vs. 2.0⫾0.94, p⬍0.001), as well as stress-induced ischemia occurring within the injected territories (2.1⫾0.8 vs. 1.6⫾0.8, p⬍0.001). Treadmill exercise duration, available in nine patients, increased, but the change was not significant (391⫾155 vs. 485⫾198, p⫽0.11). Conclusions: This study provides preliminary clinical data indicating feasibility of catheter-based transendocardial delivery of ABM to ischemic myocardium. Perspective: This initial report of transendocardial delivery of ABM is consistent with the findings in the authors’ porcine model. The relative simplicity of this approach is certainly appealing. Since the study was blinded neither to the investigators nor to the patients, proof of angina relief, improvement in stress-induced perfusion abnormalities and safety require confirmation in larger, blinded, randomized controlled trials. Note that only two of 21 injected segments with baseline wall motion abnormalities on resting echocardiography showed improvement at 3 months, so the utility of this procedure to improve contractility of
Study Question: What is the frequency of clinically apparent and silent cerebral embolism after retrograde catheterization of the aortic valve for assessing the severity of valvular aortic stenosis? Methods: Consecutive patients with valvular aortic stenosis at a university hospital (n⫽152) were prospectively randomized to receive either cardiac catheterization with (n⫽101) or without (n⫽51) passage through the aortic valve. Cerebral embolism was assessed by cranial MRI and neurological assessment within 48 h before and after the procedure. Patients without valvular aortic stenosis who underwent coronary angiography and left ventriculography (n⫽32) were used as controls. Results: 22 of 101 patients (22%) who underwent retrograde catheterization of the aortic valve demonstrated diffusion-imaging abnormalities in a pattern consistent with acute cerebral embolic events after the procedure clinically apparent neurological deficits were seen in 3% of these patients. In contrast, there was no evidence of cerebral embolism as assessed by MRI either in patients in whom aortic valve was not crossed or in controls. Conclusions: Patients with valvular aortic stenosis who undergo retrograde catheterization of the aortic valve may be at substantial risk of silent cerebral embolism and a smaller but demonstrable risk of clinically important events. Perspective: This well-designed study suggests that cardiac catheterization in patients with aortic stenosis should be limited to only coronary angiography in appropriate patients. Retrograde crossing of aortic valve is associated with significant risk of cerebral embolism and cannot be justified in the current era where noninvasive techniques can provide adequate information about the hemodynamic significance of aortic valve stenosis in the vast majority of patients. RM
ACC CURRENT JOURNAL REVIEW Jul/Aug 2003
68
ischemic myocardium may be limited (or may require higher doses). KA
Silent and Apparent Cerebral Embolism After Retrograde Catheterization of the Aortic Valve in Valvular Stenosis: A Prospective, Randomized Study
Fuchs S, Satler LS, Kornowski R, et al. J Am Coll Cardiol 2003; 41:1721– 4.
Omran H, Schmidt H, Hackenbroch M, et al. Lancet 2003;361: 1241– 6.
Study Question: Is transendocardial delivery of autologous bone marrow (ABM) a feasible treatment strategy for patients with severe symptomatic chronic myocardial ischemia not amenable to conventional revascularization? Methods and Results: Ten patients underwent transendocardial injection of freshly aspirated and filtered unfractionated ABM using left ventricular electromechanical guidance. Twelve injections of 0.2 mL each were successfully delivered into ischemic noninfarcted myocardium preidentified by single-photon emission computed tomography perfusion imaging. Autologous bone marrow injection was successful in all patients and was associated with no serious adverse effects. In particular, there was no arrhythmia, evidence of infection, myocardial inflammation or increased scar formation. Two patients were readmitted for recurrent chest pain without elevation of cardiac enzymes or ECG changes. At 3 months, Canadian Cardiovascular Society angina score significantly improved (3.1⫾0.3 vs. 2.0⫾0.94, p⬍0.001), as well as stress-induced ischemia occurring within the injected territories (2.1⫾0.8 vs. 1.6⫾0.8, p⬍0.001). Treadmill exercise duration, available in nine patients, increased, but the change was not significant (391⫾155 vs. 485⫾198, p⫽0.11). Conclusions: This study provides preliminary clinical data indicating feasibility of catheter-based transendocardial delivery of ABM to ischemic myocardium. Perspective: This initial report of transendocardial delivery of ABM is consistent with the findings in the authors’ porcine model. The relative simplicity of this approach is certainly appealing. Since the study was blinded neither to the investigators nor to the patients, proof of angina relief, improvement in stress-induced perfusion abnormalities and safety require confirmation in larger, blinded, randomized controlled trials. Note that only two of 21 injected segments with baseline wall motion abnormalities on resting echocardiography showed improvement at 3 months, so the utility of this procedure to improve contractility of
Study Question: What is the frequency of clinically apparent and silent cerebral embolism after retrograde catheterization of the aortic valve for assessing the severity of valvular aortic stenosis? Methods: Consecutive patients with valvular aortic stenosis at a university hospital (n⫽152) were prospectively randomized to receive either cardiac catheterization with (n⫽101) or without (n⫽51) passage through the aortic valve. Cerebral embolism was assessed by cranial MRI and neurological assessment within 48 h before and after the procedure. Patients without valvular aortic stenosis who underwent coronary angiography and left ventriculography (n⫽32) were used as controls. Results: 22 of 101 patients (22%) who underwent retrograde catheterization of the aortic valve demonstrated diffusion-imaging abnormalities in a pattern consistent with acute cerebral embolic events after the procedure clinically apparent neurological deficits were seen in 3% of these patients. In contrast, there was no evidence of cerebral embolism as assessed by MRI either in patients in whom aortic valve was not crossed or in controls. Conclusions: Patients with valvular aortic stenosis who undergo retrograde catheterization of the aortic valve may be at substantial risk of silent cerebral embolism and a smaller but demonstrable risk of clinically important events. Perspective: This well-designed study suggests that cardiac catheterization in patients with aortic stenosis should be limited to only coronary angiography in appropriate patients. Retrograde crossing of aortic valve is associated with significant risk of cerebral embolism and cannot be justified in the current era where noninvasive techniques can provide adequate information about the hemodynamic significance of aortic valve stenosis in the vast majority of patients. RM
ACC CURRENT JOURNAL REVIEW Jul/Aug 2003
68