Effects of Transendocardial Delivery of Bone Marrow-Derived CD133+ Cells on Left Ventricle Perfusion and Function in Patients With Refractory Angina: Final Results of Randomized, Double-Blinded, Placebo-Controlled REGENT-VSEL Trial.

RATIONALE: New therapies for refractory angina are needed. OBJECTIVE: Assessment of transendocardial delivery of bone marrow CD133+ cells in patients with refractory angina. METHODS AND RESULTS: Randomized, double-blinded, placebo-controlled trial enrolled 31 patients with recurrent Canadian Cardiovascular Society II-IV angina, despite optimal medical therapy, ≥1 myocardial segment with inducible ischemia in Tc-99m SPECT who underwent bone marrow biopsy and were allocated to cells (n=16) or placebo (n=15). Primary end point was absolute change in myocardial ischemia by SPECT. Secondary end points were left ventricular function and volumes by magnetic resonance imaging and angina severity. After 4 months, there were no significant differences in extent of inducible ischemia between groups (summed difference score mean [±SD]: 2.60 [2.6] versus 3.63 [3.6], P=0.52; total perfusion deficit: 3.60 [3.6] versus 5.01 [4.3], P=0.32; absolute changes of summed difference score: -1.38 [5.2] versus -0.73 [1.9], P=0.65; and total perfusion deficit: -1.33 [3.3] versus -2.19 [6.6], P=0.65). There was a significant reduction of left ventricular volumes (end-systolic volume: -4.3 [11.3] versus 7.4 [11.8], P=0.02; end-diastolic volume: -9.1 [14.9] versus 7.4 [15.8], P=0.02) and no significant change of left ventricular ejection fraction in the cell group. There was no difference in number of patients showing improvement of ≥1 Canadian Cardiovascular Society class after 1 (41.7% versus 58.3%; P=0.68), 4 (50% versus 33.3%; P=0.63), 6 (70% versus 50.0%; P=0.42), and 12 months (55.6% versus 81.8%; P=0.33) and use of nitrates after 12 months. CONCLUSION: Transendocardial CD133+ cell therapy was safe. Study was underpowered to conclusively validate the efficacy, but it did not show a significant reduction of myocardial ischemia and angina versus placebo. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01660581.

Effect of a significant asymptomatic unilateral carotid artery stenosis on outcomes in patients undergoing coronary artery bypass grafting.

BACKGROUND: Occurrence of a stroke is a major concern in patients undergoing coronary artery bypass grafting (CABG). It remains uncertain whether significant asymptomatic carotid artery stenosis (CAS) is associated with stroke incidence in such patients. AIM: To investigate the incidence of cerebrovascular events, myocardial infarction (MI), and death in patients with a significant asymptomatic CAS undergoing CABG. METHODS: We prospectively evaluated 123 consecutive patients with documented carotid artery duplex Doppler ultrasound examination who underwent isolated CABG. Patients with a significant (≥ 60%) asymptomatic unilateral CAS (n = 35) were compared with those without a significant CAS (n = 88) to assess the rates of stroke, MI and mortality after CABG. RESULTS: No significant differences between patients with a significant asymptomatic unilateral CAS and those without a significant CAS in regard to age (p = 0.5955), presence of hypertension (p = 0.2343), diabetes (p = 0.5495), smoking (p = 0.7891), serum creatinine (p = 0.47) and left ventricular systolic function as evaluated by ejection fraction (p = 0.3789). No cerebrovascular events, MI and deaths occurred during the first 30 days postoperatively. At 12 months, no differences were seen between the groups in the incidence of MI (p = 0.1005) and mortality (p = 0.3959). However, a trend towards higher stroke incidence was noted among patients with a significant asymptomatic unilateral CAS (p = 0.0692). The primary combined endpoint (stroke, MI, and mortality) occurred in 40% of patients with a significant asymptomatic unilateral CAS and 17.05% of patients without a significant CAS (p = 0.0097). Linear regression analysis showed an association between significant asymptomatic unilateral CAS and stroke (p = 0.0041), and between significant asymptomatic unilateral CAS and the primary end point (p = 0.0475). CONCLUSIONS: The presence of a significant asymptomatic unilateral CAS does not increase the risk of stroke, MI and mortality within 30 days after CABG but is was associated with an increased risk of cardiovascular events during the first 12 months postoperatively.

Preliminary cardiological examinations in deaf children.

There is some evidence that deaf children are more threatened than the general population by dangerous heart arrhythmias. An example is Jervell-Lange-Nielsen syndrome (one of the forms of long QT syndrome) which is characterised primarily by congenital deafness and prolongation of the QT interval. The aim of this study was to perform preliminary cardiological examinations on 162 deaf children (76 girls and 86 boys, 3-15 years old, mean age 10.5 +/- 2.8 years) who attend the Regional School Centre for Deaf Children in Katowice. The data in our analysis was obtained from case histories (school records and special questionnaires sent to parents), physical examinations with special regard to the cardiovascular system, double blood pressure measurement and 12 lead surface electrocardiogram. In the studied group, 90 children (55.5%) were congenitally deaf. Within this group, 24 children manifested tachycardia while 4 children manifested-bradycardia. A-V block of I degree was found in 3 children. Incomplete right bundle branch block (RBBB) was observed in 44 children while a complete RBBB was noticed in 1 child. QTc interval was prolonged (> 0.44s) in 12 children suffering from congenital form of deafness and in 16 children suffering from all causes of deafness. On the basis of case history, physical examination, and standard 12-lead electrocardiogram, we established the occurrence of risk factors according to the new diagnostic criteria of Schwartz et al. with relative points assigned to the electrocardiographical, clinical and familial findings. These points when summed up represent the risk of sudden death caused by ventricular arrhythmia due to long QT syndrome. In the studied group (according to the Schwartz criteria), 2 (1.2%) children had high probability (> or = 4 points) of long QT syndrome (LQTS), 25 (15.4%) children had intermediate probability of LQTS (2-3 points) and 135 children had low probability of LQTS (< or = 1 point).