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新一代自膨式经导管 Porticoтм 瓣膜植入术治疗退行性主动脉瓣狭窄患者的结果。

Results of new-generation self-expanding transcatheter Porticoтм valve implantation in patients with degenerative aortic stenosis.

机构信息

Chazov National Medical Research Centre of Cardiology.

出版信息

Kardiologiia. 2022 Aug 30;62(8):45-51. doi: 10.18087/cardio.2022.8.n1923.

Abstract

Aim    To evaluate 30-day results of the transcatheter correction of degenerative aortic stenosis using a novel self-expandable valve, PorticoTM.Material and methods    Transcatheter aortic valve implantation (TAVI) was performed in 42 patients with an intermediate surgical risk (mean age, 74.3±6.5 years, 8 men, 34 women, EuroSCORE II risk, 2.5 (1.5;4.1)) with severe degenerative aortic stenosis (AS). 20 (48 %) patients had ischemic heart disease; 8 (19%) of patients had atrial fibrillation, and 16 (38%) of patients had type 2 diabetes mellitus. Most of the patients (88 %) had preserved systolic function, and 5 patients had a pronounced decrease in left ventricular ejection fraction. Early efficacy and safety of the intervention were evaluated with VARC-2 criteria.Results    In-hospital and 30-day mortality following TAVI was absent. Also, there were no adverse events, including cerebrovascular disorders, perioperative myocardial infarction, and conversion to open surgery. One patient had prosthesis migration to the aorta, which required implantation of the second self-expandable valve. Mean duration of the procedure was 90 min (80;110), fluoroscopy time was 21 min (19;24), and contrast volume 154 ml (200;240). Following TAVI, the mean aortic valve (AV) pressure gradient significantly decreased from 56.1±21.2 to 11.2±4.0 mm Hg, the maximal gradient decreased from 88.9±27.8 to 20.0±7.0 mm Hg, and the AV effective orifice area increased from 0.67±0.2 to 1.9±0.3 cm2 (p<0.001). By the time of discharge from the hospital, all patients showed regression of AS clinical manifestations. The percentage of patients with NYHA functional class III chronic heart failure reduced from 62 % to 7 % (p<0.001) after TAVI. In one case after the implantation, grade 3 aortic regurgitation was observed, which required endovascular occlusion to close the paraprosthetic fistula. Moderate paraprosthetic regurgitation (grade <2) was observed in 3 (7 %) patients. Only 2 (4.8%) patients required permanent pacemaker implantation.Conclusion    Results of the single-center prospective TAVI study using a novel self-expandable valve Porticoтм showed satisfactory hemodynamic parameters, efficacy and safety of the procedure for the 30-day follow-up period. A relatively low radial force of the carcass can be beneficial for reducing the incidence of permanent pacemaker implantation after TAVI.

摘要

目的 评估使用新型自膨式瓣膜 PorticoTM 经导管治疗退行性主动脉瓣狭窄的 30 天结果。

材料和方法 在 42 例具有中等手术风险(平均年龄 74.3±6.5 岁,8 名男性,34 名女性,EuroSCORE II 风险 2.5(1.5;4.1))的严重退行性主动脉瓣狭窄(AS)患者中进行了经导管主动脉瓣植入术(TAVI)。20 例(48%)患者有缺血性心脏病;8 例(19%)患者有房颤,16 例(38%)患者有 2 型糖尿病。大多数患者(88%)有保留的收缩功能,5 例患者左心室射血分数明显降低。采用 VARC-2 标准评估介入治疗的早期疗效和安全性。

结果 TAVI 术后住院期间和 30 天内无死亡。也没有发生包括脑血管疾病、围手术期心肌梗死和转为开放性手术在内的不良事件。1 例患者出现假体向主动脉迁移,需要植入第二个自膨式瓣膜。手术平均时间为 90 分钟(80;110),透视时间为 21 分钟(19;24),造影剂用量为 154ml(200;240)。TAVI 后,主动脉瓣(AV)压力梯度从 56.1±21.2mmHg 显著降低至 11.2±4.0mmHg,最大梯度从 88.9±27.8mmHg 降低至 20.0±7.0mmHg,AV 有效开口面积从 0.67±0.2cm2 增加至 1.9±0.3cm2(p<0.001)。出院时,所有患者的 AS 临床表现均有改善。TAVI 后 NYHA 心功能 III 级慢性心力衰竭患者的比例从 62%降至 7%(p<0.001)。植入后 1 例发生 3 级主动脉瓣反流,需要血管内闭塞关闭瓣周漏。3 例(7%)患者存在中度瓣周反流(<2 级)。仅 2 例(4.8%)患者需要植入永久性起搏器。

结论 使用新型自膨式瓣膜 PorticoTM 的单中心前瞻性 TAVI 研究结果显示,该方法在 30 天随访期间具有满意的血流动力学参数、疗效和安全性。假体相对较低的径向力可能有助于降低 TAVI 后永久性起搏器植入的发生率。

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