Rinaldi Salvatore, Fontani Vania
Department of Regenerative Medicine, Rinaldi Fontani Institute, Florence, ITA.
Department of Adaptive Neuro Psycho Physio Pathology and Neuro Psycho Physical Optimization, Rinaldi Fontani Institute, Florence, ITA.
Cureus. 2024 Dec 20;16(12):e76057. doi: 10.7759/cureus.76057. eCollection 2024 Dec.
This post-market clinical follow-up (PMCF) study evaluates the clinical effectiveness and safety of the external radio electric reprogramming for atrial fibrillation (EX-RER AF) protocol, a non-invasive regenerative medicine approach utilizing radio electric asymmetric conveyer (REAC) technology for managing paroxysmal atrial fibrillation (PAF). Administered with the REAC BENE mod 110 device (ASMED, Scandicci, Italy), the treatment involves a standardized procedure, with the asymmetric conveyor probe (ACP) positioned in the precordial area and fixed, unmodifiable parameters ensuring consistency and reproducibility. During a 36-month post-market clinical follow-up (PMCF), 20 patients with prior diagnoses of PAF underwent the protocol. Significant reductions in symptom severity were observed, with the European Heart Rhythm Association (EHRA) score improving from 3.1 ± 0.4 to 1.8 ± 0.3 (p < 0.01). The quality of life (QoL), as assessed using the Short Form 36-item health survey (SF-36), demonstrated a mean score increase from 58 ± 7 to 78 ± 6 (p < 0.01) across all domains. The safety profile of the protocol was reinforced, with no adverse events reported during the follow-up period. The observed improvements align with the established mechanism of action of REAC technology, which optimizes endogenous bioelectrical activity and promotes the functional reorganization of cardiac conduction pathways. While these findings underscore the protocol's safety, effectiveness, and clinical utility as a non-invasive therapeutic option for PAF, further studies in larger, diverse populations and comparative trials with conventional treatments are warranted to validate long-term outcomes and broader applicability.
这项上市后临床随访（PMCF）研究评估了用于房颤的体外无线电电重编程（EX-RER AF）方案的临床有效性和安全性，这是一种利用无线电电不对称输送器（REAC）技术治疗阵发性房颤（PAF）的非侵入性再生医学方法。使用REAC BENE mod 110设备（意大利斯坎迪奇的ASMED公司）进行治疗，该治疗涉及一个标准化程序，将不对称输送器探头（ACP）置于心前区并固定，不可修改的参数确保了一致性和可重复性。在为期36个月的上市后临床随访（PMCF）期间，20例先前诊断为PAF的患者接受了该方案治疗。观察到症状严重程度显著降低，欧洲心律协会（EHRA）评分从3.1±0.4提高到1.8±0.3（p<0.01）。使用简短36项健康调查（SF-36）评估的生活质量（QoL）在所有领域的平均得分从58±7提高到78±6（p<0.01）。该方案的安全性得到了加强，随访期间未报告不良事件。观察到的改善与REAC技术既定的作用机制一致，该机制可优化内源性生物电活动并促进心脏传导通路的功能重组。虽然这些发现强调了该方案作为PAF的非侵入性治疗选择的安全性、有效性和临床实用性，但仍需要在更大、更多样化的人群中进行进一步研究以及与传统治疗方法进行对比试验，以验证长期疗效和更广泛的适用性。
