Bo Wang, Shuo Wang, Chao Gao, D Scott Lim, Rutao Wang, Xin Meng, Ying Liu, Cun-Jun Zhu, Yoshinobu Onuma, Yunbing Wang, Patrick W J C Serruys, Runlin Gao, Randall J Lee, Ling Tao
{"title":"经皮心内膜海藻酸-水凝胶注射治疗心力衰竭：首次人体研究。","authors":"Bo Wang, Shuo Wang, Chao Gao, D Scott Lim, Rutao Wang, Xin Meng, Ying Liu, Cun-Jun Zhu, Yoshinobu Onuma, Yunbing Wang, Patrick W J C Serruys, Runlin Gao, Randall J Lee, Ling Tao","doi":"10.1002/ehf2.15417","DOIUrl":null,"url":null,"abstract":"<p><strong>Aims: </strong>Despite the potential of alginate hydrogel intramyocardial injections in the treatment of heart failure (HF), minimally invasive implantation techniques remain scarce. This study evaluated the safety and feasibility of percutaneous transcatheter endocardial alginate hydrogel injection (TEAi), facilitated by novel implants and a dedicated catheter-based device, in patients with HF with reduced ejection fraction (HFrEF).</p><p><strong>Methods and results: </strong>This first-in-human study enrolled HFrEF patients [New York Heart Association (NYHA) Class III-IV and left ventricular ejection fraction (LVEF) ≤35%]. The primary endpoint was the incidence of procedure- or device-related serious adverse events (SADEs) at 30 days. Secondary endpoints included the device success rate, HF hospitalization at 6 months, and change from baseline to 6 months post-procedure in the following parameters: LVEF as assessed by MRI; NYHA functional class; 6 min walk test distance (6MWT); the quality of life assessed by the Kansas City Cardiomyopathy Heart Failure Questionnaire (KCCQ); and serum N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) level. Pre- and post-procedural biomechanical analysis was also evaluated. Ten patients successfully underwent TEAi with no SADEs at 30 days. There was one death and two HF hospitalizations at 6 months. At 6 months, LVEF improved from 17.7% ± 3.8% to 24.9% ± 11.2% (P = 0.021), end-systolic volume decreased from 297.5 ± 67.9 mL to 264.8 ± 101.4 mL (P = 0.029), and KCCQ scores increased from 49.7 ± 3.9 to 79.0 ± 8.07 (P = 0.008). No statistically significant changes were observed in end-diastolic volume, NT-proBNP and 6MWT at six months compared with the baseline. Biomechanical analysis revealed a reduction in peak left ventricular end-diastolic wall stress (6.5 ± 1.1 kPa vs. 5.9 ± 1.3 kPa, P = 0.043).</p><p><strong>Conclusions: </strong>TEAi is feasible and safe for the treatment of HFrEF, warranting further randomized, efficacy clinical trials.</p>","PeriodicalId":11864,"journal":{"name":"ESC Heart Failure","volume":" ","pages":""},"PeriodicalIF":3.7000,"publicationDate":"2025-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Percutaneous endocardial alginate-hydrogel injection in the treatment of heart failure: First-in-human study.\",\"authors\":\"Bo Wang, Shuo Wang, Chao Gao, D Scott Lim, Rutao Wang, Xin Meng, Ying Liu, Cun-Jun Zhu, Yoshinobu Onuma, Yunbing Wang, Patrick W J C Serruys, Runlin Gao, Randall J Lee, Ling Tao\",\"doi\":\"10.1002/ehf2.15417\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Aims: </strong>Despite the potential of alginate hydrogel intramyocardial injections in the treatment of heart failure (HF), minimally invasive implantation techniques remain scarce. This study evaluated the safety and feasibility of percutaneous transcatheter endocardial alginate hydrogel injection (TEAi), facilitated by novel implants and a dedicated catheter-based device, in patients with HF with reduced ejection fraction (HFrEF).</p><p><strong>Methods and results: </strong>This first-in-human study enrolled HFrEF patients [New York Heart Association (NYHA) Class III-IV and left ventricular ejection fraction (LVEF) ≤35%]. The primary endpoint was the incidence of procedure- or device-related serious adverse events (SADEs) at 30 days. Secondary endpoints included the device success rate, HF hospitalization at 6 months, and change from baseline to 6 months post-procedure in the following parameters: LVEF as assessed by MRI; NYHA functional class; 6 min walk test distance (6MWT); the quality of life assessed by the Kansas City Cardiomyopathy Heart Failure Questionnaire (KCCQ); and serum N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) level. Pre- and post-procedural biomechanical analysis was also evaluated. Ten patients successfully underwent TEAi with no SADEs at 30 days. There was one death and two HF hospitalizations at 6 months. At 6 months, LVEF improved from 17.7% ± 3.8% to 24.9% ± 11.2% (P = 0.021), end-systolic volume decreased from 297.5 ± 67.9 mL to 264.8 ± 101.4 mL (P = 0.029), and KCCQ scores increased from 49.7 ± 3.9 to 79.0 ± 8.07 (P = 0.008). No statistically significant changes were observed in end-diastolic volume, NT-proBNP and 6MWT at six months compared with the baseline. 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引用次数: 0
摘要
目的：尽管海藻酸盐水凝胶在心肌内注射治疗心力衰竭（HF）方面具有潜力，但微创植入技术仍然很少。本研究评估了经皮经导管心内膜内海藻酸盐水凝胶注射（TEAi）的安全性和可行性，通过新型植入物和专用导管装置，促进了心力衰竭伴射血分数降低（HFrEF）患者的治疗。方法和结果：这项首次人体研究纳入了HFrEF患者[纽约心脏协会（NYHA） III-IV级，左室射血分数(LVEF)≤35%]。主要终点是30天内手术或器械相关严重不良事件（SADEs）的发生率。次要终点包括器械成功率、6个月HF住院率，以及以下参数从基线到术后6个月的变化：MRI评估的LVEF；NYHA功能类；6分钟步行测试距离（6MWT）；通过堪萨斯城心肌病心力衰竭问卷（KCCQ）评估的生活质量；血清b型利钠肽n端激素原（NT-proBNP）水平。术前和术后生物力学分析也进行了评估。10例患者成功接受TEAi治疗，30天无不良反应。6个月时有1例死亡和2例心衰住院。6个月时LVEF由17.7%±3.8%改善至24.9%±11.2% (P = 0.021)，收缩期末期容积由297.5±67.9 mL降至264.8±101.4 mL (P = 0.029)， KCCQ评分由49.7±3.9升至79.0±8.07 （P = 0.008）。与基线相比，6个月时舒张末期容积、NT-proBNP和6MWT无统计学意义变化。生物力学分析显示左室舒张末期壁应力峰值降低（6.5±1.1 kPa比5.9±1.3 kPa, P = 0.043）。结论：TEAi治疗HFrEF是可行且安全的，值得进一步进行随机、有效的临床试验。
Percutaneous endocardial alginate-hydrogel injection in the treatment of heart failure: First-in-human study.
Aims: Despite the potential of alginate hydrogel intramyocardial injections in the treatment of heart failure (HF), minimally invasive implantation techniques remain scarce. This study evaluated the safety and feasibility of percutaneous transcatheter endocardial alginate hydrogel injection (TEAi), facilitated by novel implants and a dedicated catheter-based device, in patients with HF with reduced ejection fraction (HFrEF).
Methods and results: This first-in-human study enrolled HFrEF patients [New York Heart Association (NYHA) Class III-IV and left ventricular ejection fraction (LVEF) ≤35%]. The primary endpoint was the incidence of procedure- or device-related serious adverse events (SADEs) at 30 days. Secondary endpoints included the device success rate, HF hospitalization at 6 months, and change from baseline to 6 months post-procedure in the following parameters: LVEF as assessed by MRI; NYHA functional class; 6 min walk test distance (6MWT); the quality of life assessed by the Kansas City Cardiomyopathy Heart Failure Questionnaire (KCCQ); and serum N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) level. Pre- and post-procedural biomechanical analysis was also evaluated. Ten patients successfully underwent TEAi with no SADEs at 30 days. There was one death and two HF hospitalizations at 6 months. At 6 months, LVEF improved from 17.7% ± 3.8% to 24.9% ± 11.2% (P = 0.021), end-systolic volume decreased from 297.5 ± 67.9 mL to 264.8 ± 101.4 mL (P = 0.029), and KCCQ scores increased from 49.7 ± 3.9 to 79.0 ± 8.07 (P = 0.008). No statistically significant changes were observed in end-diastolic volume, NT-proBNP and 6MWT at six months compared with the baseline. Biomechanical analysis revealed a reduction in peak left ventricular end-diastolic wall stress (6.5 ± 1.1 kPa vs. 5.9 ± 1.3 kPa, P = 0.043).
Conclusions: TEAi is feasible and safe for the treatment of HFrEF, warranting further randomized, efficacy clinical trials.
期刊介绍：
ESC Heart Failure is the open access journal of the Heart Failure Association of the European Society of Cardiology dedicated to the advancement of knowledge in the field of heart failure. The journal aims to improve the understanding, prevention, investigation and treatment of heart failure. Molecular and cellular biology, pathology, physiology, electrophysiology, pharmacology, as well as the clinical, social and population sciences all form part of the discipline that is heart failure. Accordingly, submission of manuscripts on basic, translational, clinical and population sciences is invited. Original contributions on nursing, care of the elderly, primary care, health economics and other specialist fields related to heart failure are also welcome, as are case reports that highlight interesting aspects of heart failure care and treatment.
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