Huiyi Wang, Jing Li, David H Hsi, Wenxia Li, Shengjun Ta, Yiyu Jiao, Bo Shan, Lingxiao Chang, Xumei Ou, Lu Yao, Bo Wang, Jing Wang, Changhui Lei, Liwen Liu
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Outcomes included changes in septal thickness, quality of life (Kansas City Cardiomyopathy Questionnaire-12, KCCQ-12) and myocardial function.</p><p><strong>Results: </strong>No major adverse clinical events occurred within 30 days after the procedure. The maximum interventricular septal thickness decreased significantly from 31.3 mm to 17.4 mm (mean difference: -13.9 mm; 95% CI -15.92 to -11.88). Left atrial volume index and left ventricular mass index also decreased significantly. Improvements in global longitudinal strain and global radial strain were observed, indicating possibly enhanced myocardial performance. KCCQ-12 scores improved from 65.6 to 84.4 (mean difference: 18.78; 95% CI 11.62 to 25.93). Patients after PIMSRA were not found to have an increased risk of arrhythmias such as atrial fibrillation, high-grade conduction block or non-sustained ventricular tachycardia during the follow-up.</p><p><strong>Conclusions: </strong>PIMSRA was associated with a reduction of myocardial septal thickness and improvement in functional status in patients with NOHCM. The absence of major adverse events is also encouraging, but larger studies with a control arm are needed to confirm long-term safety.</p><p><strong>Trial registration number: </strong>ChiCTR1900020530.</p>","PeriodicalId":12835,"journal":{"name":"Heart","volume":" ","pages":""},"PeriodicalIF":5.1000,"publicationDate":"2025-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Percutaneous intramyocardial septal radiofrequency ablation: a novel treatment for drug-refractory non-obstructive hypertrophic cardiomyopathy with severe septal hypertrophy.\",\"authors\":\"Huiyi Wang, Jing Li, David H Hsi, Wenxia Li, Shengjun Ta, Yiyu Jiao, Bo Shan, Lingxiao Chang, Xumei Ou, Lu Yao, Bo Wang, Jing Wang, Changhui Lei, Liwen Liu\",\"doi\":\"10.1136/heartjnl-2024-325334\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Patients with drug-refractory non-obstructive hypertrophic cardiomyopathy (NOHCM) lack effective invasive treatment options. This study aimed to evaluate the safety and effectiveness of percutaneous intramyocardial septal radiofrequency ablation (PIMSRA, Liwen procedure) in patients with NOHCM and severe septal hypertrophy (≥28 mm).</p><p><strong>Method: </strong>This single-arm, open-label, prospective study enrolled 20 adult patients with drug-refractory NOHCM between June 2017 and June 2023. Patients underwent PIMSRA and were followed for a median of 15 months. Outcomes included changes in septal thickness, quality of life (Kansas City Cardiomyopathy Questionnaire-12, KCCQ-12) and myocardial function.</p><p><strong>Results: </strong>No major adverse clinical events occurred within 30 days after the procedure. The maximum interventricular septal thickness decreased significantly from 31.3 mm to 17.4 mm (mean difference: -13.9 mm; 95% CI -15.92 to -11.88). Left atrial volume index and left ventricular mass index also decreased significantly. 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引用次数: 0
摘要
背景:药物难治性非阻塞性肥厚性心肌病(NOHCM)患者缺乏有效的侵入性治疗方案。本研究旨在评价经皮心内间隔射频消融(PIMSRA, Liwen手术)治疗NOHCM合并重度间隔肥厚(≥28 mm)患者的安全性和有效性。方法:这项单臂、开放标签、前瞻性研究在2017年6月至2023年6月期间招募了20名成年难治性NOHCM患者。患者接受了PIMSRA,随访时间中位数为15个月。结果包括室间隔厚度、生活质量(堪萨斯城心肌病问卷-12,KCCQ-12)和心肌功能的变化。结果:术后30天内无重大临床不良事件发生。室间隔最大厚度由31.3 mm降至17.4 mm(平均差-13.9 mm;95% CI -15.92至-11.88)。左房容积指数和左室质量指数也明显下降。观察到整体纵向应变和整体径向应变的改善,表明心肌性能可能增强。KCCQ-12评分从65.6分提高到84.4分(平均差:18.78分;95% CI 11.62 ~ 25.93)。在随访期间,未发现PIMSRA后患者发生房颤、高级别传导阻滞或非持续性室性心动过速等心律失常的风险增加。结论:PIMSRA与NOHCM患者心肌间隔厚度减少和功能状态改善有关。没有重大不良事件也令人鼓舞,但需要更大规模的对照研究来确认长期安全性。试验注册号:ChiCTR1900020530。
Percutaneous intramyocardial septal radiofrequency ablation: a novel treatment for drug-refractory non-obstructive hypertrophic cardiomyopathy with severe septal hypertrophy.
Background: Patients with drug-refractory non-obstructive hypertrophic cardiomyopathy (NOHCM) lack effective invasive treatment options. This study aimed to evaluate the safety and effectiveness of percutaneous intramyocardial septal radiofrequency ablation (PIMSRA, Liwen procedure) in patients with NOHCM and severe septal hypertrophy (≥28 mm).
Method: This single-arm, open-label, prospective study enrolled 20 adult patients with drug-refractory NOHCM between June 2017 and June 2023. Patients underwent PIMSRA and were followed for a median of 15 months. Outcomes included changes in septal thickness, quality of life (Kansas City Cardiomyopathy Questionnaire-12, KCCQ-12) and myocardial function.
Results: No major adverse clinical events occurred within 30 days after the procedure. The maximum interventricular septal thickness decreased significantly from 31.3 mm to 17.4 mm (mean difference: -13.9 mm; 95% CI -15.92 to -11.88). Left atrial volume index and left ventricular mass index also decreased significantly. Improvements in global longitudinal strain and global radial strain were observed, indicating possibly enhanced myocardial performance. KCCQ-12 scores improved from 65.6 to 84.4 (mean difference: 18.78; 95% CI 11.62 to 25.93). Patients after PIMSRA were not found to have an increased risk of arrhythmias such as atrial fibrillation, high-grade conduction block or non-sustained ventricular tachycardia during the follow-up.
Conclusions: PIMSRA was associated with a reduction of myocardial septal thickness and improvement in functional status in patients with NOHCM. The absence of major adverse events is also encouraging, but larger studies with a control arm are needed to confirm long-term safety.
期刊介绍:
Heart is an international peer reviewed journal that keeps cardiologists up to date with important research advances in cardiovascular disease. New scientific developments are highlighted in editorials and put in context with concise review articles. There is one free Editor’s Choice article in each issue, with open access options available to authors for all articles. Education in Heart articles provide a comprehensive, continuously updated, cardiology curriculum.