The use of adult myogenic stem cells as a cell therapy for skeletal muscle regeneration has been attempted for decades, with only moderate success. Myogenic progenitors (MP) made from induced pluripotent stem cells (iPSCs) are promising candidates for stem cell therapy to regenerate skeletal muscle since they allow allogenic transplantation, can be produced in large quantities, and, as compared to adult myoblasts, present more embryonic-like features and more proliferative capacity in vitro, which indicates a potential for more self-renewal and regenerative capacity in vivo. Different approaches have been described to make myogenic progenitors either by gene overexpression or by directed differentiation through culture conditions, and several myopathies have already been modeled using iPSC-MP. However, even though results in animal models have shown improvement from previous work with isolated adult myoblasts, major challenges regarding host response have to be addressed and clinically relevant transplantation protocols are lacking. Despite these challenges we are closer than we think to bringing iPSC-MP towards clinical use for treating human muscle disease and sporting injuries.
Background
We quantified and characterized the outcomes of ablation in persistent atrial fibrillation (PersAF) subjects, and the utility of electroanatomical mapping with a market-released high-density (HD) mapping catheter.
Methods
PersAF subjects received electroanatomical mapping with the Advisor™ HD Grid mapping catheter, Sensor Enabled™ (HD Grid) and radiofrequency (RF) ablation to gather data regarding ablation strategies, mapping efficiency, quality, and outcomes. Subjects were enrolled from January 2019 to April 2020 across 25 international sites and followed for 12 months after the procedure.
Results
Three hundred thirty-four PersAF subjects (average age 64.2 years; 76% male; 25.4% previous AF ablation) were enrolled. Multiple map types were generated in a variety of rhythms using HD Grid. Significant differences in low voltage areas were identified in maps generated with the HD Wave Solution™ electrode configuration when compared to the standard configuration, which in some cases, influenced physicians’ ablation strategies. PV-only ablation strategy was used in 59.0% of subjects and 34.1% of subjects received PV ablation and additional lesions. Of the subjects, 82.0% were free from recurrent atrial arrhythmias at 12 months and new or increased dose of class I/III antiarrhythmic drugs. About 6.0% of subjects experienced a serious adverse event or serious adverse device effect through 12 months including 1 event deemed related to HD Grid and the index procedure by the investigator and 1 death unrelated to study devices.
Conclusions
The results of this study (NCT03733392) support the safety and utility of electroanatomical mapping with HD Grid in subjects with complex arrhythmias, such as PersAF in the real-world setting.
Supplementary Information
The online version contains supplementary material available at 10.1007/s10840-022-01442-3.
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