4年随访中自膨式Acurate Neo-2与球囊扩张式Myval经导管心脏瓣膜的比较
Comparison of Self-Expandable Acurate Neo-2 and Balloon-Expandable Myval Transcatheter Heart Valves at 4-Year Follow-Up.
作者信息
Jain Akash, Jose John, Montorfano Matteo, Nissen Henrik, Martin Pedro, Seth Ashok, Stambuk Kresimir, Gunasekaran Sengottuvelu, Mussayev Abdurashid, García-Gómez Mario, Fernandez-Cordón Clara, Campo Alberto, Rodriguez Marcelo, Jorgensen Mathias D, Campillo Sofía, Carrasco-Moraleja Manuel, Román Alberto San, Amat-Santos Ignacio J
机构信息
Cardiology Department, University Clinic Hospital of Valladolid, Valladolid, Spain.
Christian Medical College, Vellore, India.
出版信息
Catheter Cardiovasc Interv. 2025 Sep;106(3):2005-2017. doi: 10.1002/ccd.70034. Epub 2025 Jul 23.
BACKGROUND
Recently, Acurate neo2 (ACN2; Boston Scientific, US) and Sapien-3 series (Edwards Lifesciences, US) were compared in the IDE trial failing to demonstrate non-inferiority of ACN2. The Myval series (MyV), an alternative balloon-expandable device, demonstrated non-inferiority compared to Sapien-3 and Evolut (Medtronic, US) in the LANDMARK trial. However, no direct comparison exists between ACN2 and MyV.
AIMS
We aimed to compare mid-term clinical and hemodynamic outcomes of the ACN2 and MyV transcatheter heart valves.
METHODS
This multicenter retrospective analysis included patients implanted with ACN2 and MyV series devices. The primary objective was to assess 1-year mortality and stroke rates. Secondary outcomes included technical success, mortality, stroke, residual aortic regurgitation (AR), mean aortic gradients, and new permanent pacemaker implantation (PPI) rates up to 4 years. A matched comparison adjusting for clinical and anatomical characteristics was performed and echocardiograms were centrally analyzed.
RESULTS
A total of 545 patients (ACN2: 144; MyV: 401) from nine institutions were included. Matched technical success rates were 87.6% and 94.4%, p = 0.180 (90.3% for ACN2 and 97% for MyV; p < 0.001 in unmatched). In-hospital matched PPI rates were 10.1% for ACN2 and 9% for MyV. At 4 years, matched residual ≥ moderate AR rates were similar (ACN2: 15.8% vs. MyV: 21.1%, p = 0.706), though ACN2 showed better mean aortic gradients (9.2 ± 4.2 vs. 13.1 ± 5.4, p = 0.001) and effective orifice area. Unmatched mortality + stroke rates were comparable but lower for ACN2 after matching (3.4% vs. 15.7%, p = 0.005). Importantly, cardiovascular mortality (3.4% for ACN2 and 5.6% for MyV, p = 0.720) and valve-related deaths were comparable.
CONCLUSION
ACN2 showed superior long-term hemodynamics and lower matched 4-year mortality and stroke rates, though cardiovascular mortality and valve-related deaths were comparable.
背景
最近，在一项器械临床试验（IDE）中对Acurate neo2（ACN2；美国波士顿科学公司）和Sapien-3系列（美国爱德华生命科学公司）进行了比较，结果未能证明ACN2的非劣效性。Myval系列（MyV）是另一种球囊扩张式装置，在LANDMARK试验中显示与Sapien-3和Evolut（美国美敦力公司）相比具有非劣效性。然而，ACN2和MyV之间尚无直接比较。
目的
我们旨在比较ACN2和MyV经导管心脏瓣膜的中期临床和血流动力学结果。
方法
这项多中心回顾性分析纳入了植入ACN2和MyV系列装置的患者。主要目标是评估1年死亡率和卒中发生率。次要结局包括技术成功率、死亡率、卒中、残余主动脉瓣反流（AR）、平均主动脉跨瓣压差以及长达4年的新的永久性起搏器植入（PPI）率。进行了一项针对临床和解剖特征进行调整的匹配比较，并对超声心动图进行了集中分析。
结果
共纳入了来自9家机构的545例患者（ACN2组144例；MyV组401例）。匹配后的技术成功率分别为87.6%和94.4%，p = 0.180（ACN2组为90.3%，MyV组为97%；未匹配时p < 0.001）。ACN2组和MyV组住院期间匹配的PPI率分别为10.1%和9%。在4年时，匹配后的残余≥中度AR发生率相似（ACN2组为15.8%，MyV组为21.1%，p = 0.706），不过ACN2组的平均主动脉跨瓣压差更好（9.2±4.2与13.1±5.4，p = 0.001）且有效瓣口面积更大。未匹配时的死亡率+卒中发生率相当，但匹配后ACN2组较低（3.4%对15.7%，p = 0.005）。重要的是，心血管死亡率（ACN2组为3.4%，MyV组为5.6%，p = 0.720）和瓣膜相关死亡相当。
结论
ACN2显示出更好的长期血流动力学，匹配后的4年死亡率和卒中发生率更低，尽管心血管死亡率和瓣膜相关死亡相当。
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