Cardiovascular Department, Hôpital Européen Georges-Pompidou, Université Paris-Cité, Paris, France; Paris Cardiovascular Research Center, Inserm UMR_U970, Université Paris-Cité, Paris, France; STOP-AS Research Consortium, Recherche Hospitalo-Universitaire, Rouen, France.
Cardiology Department, Amphia Hospital, Breda, Netherlands.
Lancet. 2023 Dec 16;402(10419):2317-2325. doi: 10.1016/S0140-6736(23)01518-0. Epub 2023 Nov 14.
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 ClinicalTrials.gov, NCT03779620 and NCT04665596.
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.
钙化性主动脉瓣狭窄通常采用外科或经导管主动脉瓣置换术治疗；然而，由于严重的合并症和有限的预期寿命，许多患者不适合这些介入治疗。因此，非侵入性治疗可能为这些患者提供替代的治疗可能性。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组织来改善瓣叶功能的能力。
这项前瞻性、多中心、单臂研究在法国、荷兰和塞尔维亚的三家医院招募了 40 名患有严重症状性主动脉瓣狭窄的成年患者，纳入时间为 2019 年 3 月 13 日至 2022 年 5 月 8 日。患者接受经胸非侵入性超声治疗。随访时间安排在 1、3、6、12 和 24 个月。主要终点是 30 天内与操作相关的死亡和改善的瓣膜功能。我们报告了 6 个月的数据。本研究在 ClinicalTrials.gov 注册，NCT03779620 和 NCT04665596。
40 名高危患者的平均胸外科医生协会评分（SD）为 5.6%（4.4），合并多种严重合并症。主要终点，与操作相关的死亡率没有发生；此外，没有报告危及生命或脑血管事件。直至 6 个月时，瓣膜功能得到了证实，平均主动脉瓣面积从基线时的 0.58 cm（0.19）增加到随访时的 0.64 cm（0.21）（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），均有统计学意义。在 25 名患者中，有 24 名（96%）的纽约心脏协会评分改善或稳定，堪萨斯城心肌病问卷评分平均改善 33%，从 48.5（22.6）改善至 64.5（21.0）。1 例严重与操作相关的不良事件发生于 1 名出现外周血氧饱和度短暂下降的患者。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。
这种新型的、非侵入性的超声治疗钙化性主动脉瓣狭窄被证明是安全和可行的。
Cardiawave。
