Calcific aortic stenosis is commonly treated using surgical or transcatheter aortic valve replacement; however, many patients are not considered suitable candidates for these interventions due to severe comorbidities and limited life expectancy. As such, non-invasive therapies might offer alternative therapeutic possibilities in these patients. This study aimed to assess the safety of non-invasive ultrasound therapy and its ability to improve valvular function by softening calcified valve tissue. This prospective, multicentre, single-arm series enrolled 40 adult patients with severe symptomatic aortic valve stenosis at three hospitals in France, the Netherlands, and Serbia between March 13, 2019, and May 8, 2022. Patients were treated with transthoracically delivered non-invasive ultrasound therapy. Follow-ups were scheduled at 1, 3, 6, 12, and 24 months. The primary endpoints were procedure-related deaths within 30 days and improved valve function. We report the 6-month data. This study is registered at , and . 40 high-risk patients with a mean Society of Thoracic Surgeons score of 5·6% (SD 4·4) and multiple severe comorbidities were included. The primary endpoint, procedure-related mortality, did not occur; furthermore, no life-threatening or cerebrovascular events were reported. Improved valve function was confirmed up to 6 months, reflected by a 10% increase in mean aortic valve area from 0·58 cm (SD 0·19) at baseline to 0·64 cm (0·21) at follow-up (p=0·0088), and a 7% decrease in mean pressure gradient from 41·9 mm Hg (20·1) to 38·8 mm Hg (17·8; p=0·024). At 6 months, the New York Heart Association score had improved or stabilised in 24 (96%) of 25 patients, and the mean Kansas City Cardiomyopathy Questionnaire score had improved by 33%, from 48·5 (SD 22·6) to 64·5 (21·0). One serious procedure-related adverse event occurred in a patient who presented with a transient decrease in peripheral oxygen saturation. Non-serious adverse events included pain, discomfort during treatment, and transient arrhythmias. This novel, non-invasive ultrasound therapy for calcified aortic stenosis proved to be safe and feasible. Cardiawave.

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使用无创超声治疗治疗严重症状性主动脉瓣狭窄：一项队列研究

钙化性主动脉瓣狭窄通常采用手术或经导管主动脉瓣置换术来治疗；然而，由于严重的合并症和有限的预期寿命，许多患者不被认为是这些干预措施的合适人选。因此，非侵入性治疗可能为这些患者提供替代治疗的可能性。本研究旨在评估非侵入性超声治疗的安全性及其通过软化钙化瓣膜组织来改善瓣膜功能的能力。这项前瞻性、多中心、单臂系列研究于 2019 年 3 月 13 日至 2022 年 5 月 8 日期间，在法国、荷兰和塞尔维亚的三家医院入组了 40 名有严重症状的主动脉瓣狭窄成年患者。侵入性超声治疗。随访时间安排在 1、3、6、12 和 24 个月。主要终点是 30 天内与手术相关的死亡和瓣膜功能的改善。我们报告 6 个月的数据。这项研究已在 、 和 注册。纳入了 40 名平均胸外科医生协会评分为 5·6% (SD 4·4) 且患有多种严重合并症的高危患者。主要终点，即手术相关死亡率，没有发生；此外，没有报告出现危及生命或脑血管事件。瓣膜功能得到改善长达 6 个月，反映在平均主动脉瓣面积从基线时的 0·58 cm (SD 0·19) 增加到随访时的 0·64 cm (0·21) 10% (p =0·0088)，平均压力梯度从 41·9 mm Hg (20·1) 下降到 38·8 mm Hg (17·8；p=0·024) 7%。6 个月时，25 名患者中有 24 名 (96%) 的纽约心脏协会评分有所改善或稳定，堪萨斯城心肌病问卷评分平均提高了 33%，从 48·5 (SD 22·6) 提高到 64 ·5 (21·0)。一名患者发生了一项与手术相关的严重不良事件，该患者出现外周血氧饱和度短暂下降。非严重不良事件包括治疗期间的疼痛、不适和短暂性心律失常。这种新颖的、非侵入性超声治疗钙化主动脉瓣狭窄的方法被证明是安全可行的。心电波。