Ronan Canitrot, Vincent Bataille, Anthony Matta, Bertrand Marcheix, Etienne Grunenwald, Didier Carrie, Jérôme Roncalli, Frédéric Bouisset, Clément Servoz, Francisco Campelo-Parada, Thibault Lhermusier
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引用次数: 0
Abstract
Introduction: Currently, there are 2 types of third generation bioprostheses that can be used in patients with aortic stenosis with a large aortic annulus (LAA): the 29-mm Sapien 3 (S3; Edwards Lifesciences LLC, Irvine, CA) and the 34-mm Evolut-R (ER; Medtronic, Inc, Dublin, Ireland). The objective of this trial was to compare long-term hemodynamic and clinical outcomes of these two valves in patients with LAA and to determine the effect of aortic annulus size on these two outcomes.
Method: We conducted a retrospective, monocentric study (CHU Rangueil–Toulouse) in patients who underwent transcatheter aortic valve implantation (TAVI) for aortic stenosis between 04/01/2018 and 31/12/2020. We included all patients with severe aortic stenosis (SAS) who were diagnosed based on clinical and echocardiographic criteria. All clinical, anatomical, and procedural characteristics were recorded.
Results: We included 172 patients: 110 received a 29-mm S3 prosthesis and 62 patients a 34-mm ER prosthesis. The average area of the aortic annulus was 595 ± 67 mm2. The average aortic perimeter was 87.5 ± 5.1 cm for the S3 and 584 ± 72 mm2 and 86.4 ± 6.3 cm for the ER. The aortic regurgitation (AR) rate was higher with the ER than with the S3 (18.3% vs. 3.9%; p = 0.002) but the mean transvalvular gradient was lower with the ER (7.1 ± 2.8 mmHg vs. 9.9 ± 3.8 mmHg; p < 0.001). At Day 30, there were 4 deaths in the S3 group and 1 death in the ER group. The mean duration of follow-up was 22.7 months. No differences in cardiovascular mortality were observed between the two devices, with a rate of 2.7 deaths per 100 person-years for the ER vs. 3.9 deaths per person-years for the S3 group (p = 0.208). Subgroup analysis according to the LAA size showed a higher rate of AR in patients with the largest annulus dimensions.
Conclusion: In patients with a LAA who require a TAVI, the 34-mm ER and 29-mm S3 prostheses demonstrate significant differences in hemodynamics with no impact on cardiovascular mortality.
目前，第三代生物假体可用于主动脉瓣狭窄伴大主动脉环（LAA）患者有2种：29毫米Sapien 3 (S3)；爱德华兹生命科学有限责任公司，欧文，CA)和34毫米Evolut-R (ER；美敦力公司，都柏林，爱尔兰)。本试验的目的是比较这两个瓣膜在LAA患者中的长期血流动力学和临床结果，并确定主动脉环大小对这两个结果的影响。方法：对2018年4月1日至2020年12月31日因主动脉瓣狭窄接受经导管主动脉瓣植入术（TAVI）的患者进行回顾性、单中心研究（CHU Rangueil-Toulouse）。我们纳入了所有根据临床和超声心动图标准诊断为严重主动脉瓣狭窄（SAS）的患者。记录所有临床、解剖和手术特征。结果：我们纳入172例患者，其中110例采用29 mm S3假体，62例采用34 mm ER假体。主动脉环平均面积为595±67 mm2。S3和ER的平均主动脉周长分别为87.5±5.1 cm和584±72 mm2和86.4±6.3 cm。ER组主动脉瓣反流（AR）率高于S3组(18.3% vs 3.9%；p = 0.002)，但平均经瓣梯度较ER低(7.1±2.8 mmHg vs. 9.9±3.8 mmHg；p & lt;0.001)。第30天，S3组死亡4例，ER组死亡1例。平均随访时间22.7个月。两种装置之间的心血管死亡率无差异，ER组每100人年死亡2.7例，S3组每100人年死亡3.9例（p = 0.208）。根据LAA大小的亚组分析显示，环尺寸最大的患者发生AR的几率更高。结论：在需要TAVI的LAA患者中，34 mm ER和29 mm S3假体在血流动力学方面表现出显著差异，对心血管死亡率没有影响。
期刊介绍：
Journal of Interventional Cardiology is a peer-reviewed, Open Access journal that provides a forum for cardiologists determined to stay current in the diagnosis, investigation, and management of patients with cardiovascular disease and its associated complications. The journal publishes original research articles, review articles, and clinical studies focusing on new procedures and techniques in all major subject areas in the field, including:
Acute coronary syndrome
Coronary disease
Congenital heart diseases
Myocardial infarction
Peripheral arterial disease
Valvular heart disease
Cardiac hemodynamics and physiology
Haemostasis and thrombosis
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