球扩式瓣膜Prizvalve^(®)经导管主动脉瓣膜系统治疗重度主动脉瓣狭窄的初步研究

Preliminary clinical experience of the novel transcatheter aortic valve system Prizvalve^(®)for the treatment of severe aortic stenosis

目的初步评价Prizvalve^(®)经导管主动脉瓣膜系统治疗重度主动脉瓣狭窄的安全性及可行性。方法本研究为单中心前瞻性的单组观察性研究,入选2021年3至5月于四川大学华西医院住院的外科手术高风险或不适合常规外科手术的11例重度主动脉瓣狭窄患者,经评估后使用Prizvalve^(®)经导管主动脉瓣膜系统行经导管主动脉瓣植入术。人工瓣膜植入后立即通过经胸超声心动图测量主动脉瓣平均跨瓣压差和峰值流速,计算即刻器械成功率。即刻器械成功定义为:(1)器械成功进入血管入路、被输送、释放和植入,输送系统成功撤出体外;(2)植入瓣膜达到预期的疗效,即手术结束时超声心动图测量主动脉瓣平均跨瓣压差<20 mmHg(1 mmHg=0.133 kPa)或主动脉瓣最大流速<3 m/s,且无严重的人工主动脉瓣反流或瓣周漏。术后30 d复查经胸超声心动图,随访术后30 d内全因死亡及严重心脑血管不良事件(包括急性心肌梗死、致残性出血性或缺血性卒中)的发生情况。结果本研究共纳入11例重度主动脉瓣狭窄患者,年龄(78.1±6.3)岁,其中男性8例,纽约心脏病协会(NYHA)心功能Ⅲ、Ⅳ级患者10例。11例患者均成功完成器械的输送、释放和植入,输送系统成功撤出体外。术后即刻主动脉瓣平均跨瓣压差为(7.55±4.08)mmHg,峰值流速为(1.78±0.44)m/s,与术前相比平均跨瓣压差以及峰值流速均下降(P均<0.05)。无严重的人工主动脉瓣反流或瓣周漏,11例(11/11)患者均达到即刻器械成功。术后30 d,11例患者中无死亡及严重心脑血管不良事件发生。主动脉瓣平均压差为(9.45±5.07)mmHg,峰值流速为(2.05±0.42)m/s,均维持在较为理想的水平,与术后即刻相比差异均无统计学意义(P均>0.05)。结论本研究初步表明,对于中国人群中传统手术高风险或不适合常规外科手术,且为传统内科治疗无法逆转的重度主动脉瓣狭窄患者,使用Prizvalve^(®)经导管主动脉瓣膜系统行经导管主动脉瓣植入术是一种可行的、相对安全的方法,可进一步开展第2阶段的临床研究。

Objective To evaluate the safety and efficacy of transcatheter aortic valve implantation(TAVI)with the novel Prizvalve^(®)system in treating severe aortic stenosis.Methods This is a single-center,prospective,single-arm,observational study.A total of 11 patients with severe aortic stenosis with high risk or inappropriate for conventional surgical aortic valve replacement(SAVR)were included,and TAVI was achieved with the Prizvalve^(®)system between March 2021 and May 2021 in West China Hospital.Transthoracic echocardiography(TTE)was performed immediately after prosthesis implantation to evaluate mean transaortic gradient and maximal transaortic velocity.The device success rate was calculated,which was defined as(1)the device being delivered via the access,deployed,implanted and withdrawn,(2)mean transaortic gradient<20 mmHg(1 mmHg=0.133 kPa)or a maximal transaortic velocity<3 m/s post TAVI,and without severe aortic regurgitation or paravalvular leak post TAVI.TTE was performed at 30 days after the surgery,and all-cause mortality as well as the major cardiovascular adverse events(including acute myocardial infarction,disabling hemorrhagic or ischemic stroke)up to 30 days post TAVI were analyzed.Results The age of 11 included patients were(78.1±6.3)years,with 8 males.A total of 10 patients were with NYHA functional classⅢorⅣ.Devices were delivered via the access,deployed,implanted and withdrawn successfully in all patients.Post-implant mean transaortic gradient was(7.55±4.08)mmHg and maximal transaortic velocity was(1.78±0.44)m/s,and both decreased significantly as compared to baseline levels(both P<0.05).No severe aortic regurgitation or paravalvular leak was observed post TAVI.Device success was achieved in all the 11 patients.No patient died or experienced major cardiovascular adverse events up to 30 days post TAVI.Mean transaortic gradient was(9.45±5.07)mmHg and maximal transaortic velocity was(2.05±0.42)m/s at 30 days post TAVI,which were similar as the values measured immediately post TAVI(both P>0.05).Conclusions TAVI with the Prizvalve^(®)system is a feasible and relatively safe procedure for patients with severe aortic stenosis and at high risk or inappropriate for SAVR.Further clinical studies could be launched to obtain more clinical experience with Prizvalve^(®)system.