Key result
Transendocardial CD34+ cell therapy fails to reduce ventricular arrhythmia burden at 1 year.
Why the study?
Ventricular arrhythmias are a major concern in cell therapy that potentially limit its safety and efficacy, leading investigators to examine the effects of CD34+ cell therapy on ventricular arrhythmia burden in chronic heart failure.
Does transendocardial CD34+ cell therapy increase ventricular arrhythmias in patients with chronic heart failure?
Cohort (n=48)
Open-label, blinded outcome adjudication
No
Does transendocardial CD34+ cell therapy increase ventricular arrhythmias in patients with chronic heart failure?
Transendocardial CD34+ cell therapy appears safe from an electrophysiological standpoint, as it does not increase the burden of ventricular arrhythmias in patients with chronic heart failure.
Answers are grounded in this paper and cite their sources.
No arrhythmia increase seen post-therapy in this cohort; hypothesis-generating for safety and requires randomized confirmation.
Ventricular arrhythmias (VA) are of major concern in the field of cell therapy, potentially limiting its safety and efficacy. We sought to investigate the effects of CD34 + cell therapy on VA burden in patients with chronic heart failure (CHF). We performed registry data analysis of patients with CHF and implanted ICD/CRT devices treated with transendocardial CD 34 + cell therapy. Demographic, echocardiographic, and biochemical parameters were analyzed. Device records were reviewed and the number and type of VA 1 year prior to and 1 year after cell therapy were analyzed. All patients underwent electroanatomical mapping, and myocardial scar was defined as unipolar voltage (UV) <8.3 mV and linear local shortening (LLS) <6%. Of 209 patients screened, 48 met inclusion criteria. The mean age of the patients was 52 years and 88% were male. Nonischemic and ischemic cardiomyopathy were present in 55% and 45% of patients. The average serum creatinine was 91±26 µmol/L, serum bilirubin 18±9 µmol/L, NT-proBNP 1767 (468, 2446) pg/mL, LVEF 27±9% and 6’ walk test 442±123 m. The average scar burden in patients with nonischemic and ischemic DCM was 58±15% and 51±25% (P=0.48). No significant difference in VA burden was observed before and after cell therapy (48% vs. 44%; P=0.68). ICD activation occurred in 19% and 27% of patients before and after cell therapy (P=0.33). According to our results, transendocardial CD34 + cell therapy does not appear to increase the risk of VA in chronic heart failure patients.
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Poglajen et al. (2019) conducted a cohort in Chronic heart failure with reduced LVEF and implanted ICD/CRT (n=48). Transendocardial CD34+ cell therapy vs. 1 year prior to cell therapy (baseline) was evaluated on Change in the number of episodes of ventricular arrhythmias 1 year before and 1 year after stem cell transplantation (p=0.68). Transendocardial CD34+ cell therapy did not significantly change the burden of ventricular arrhythmias compared to the 1-year period prior to therapy (44% vs 48%, p=0.68).
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