Chahine Johnny, Jedeon Zeina, Fiocchi Jacob, Shaffer Andrew, Knoper Ryan, John Ranjit, Yannopoulos Demetris, Raveendran Ganesh, Gurevich Sergey
Department of Cardiovascular Disease University of Minnesota Medical School Minneapolis Minnesota USA.
Department of Internal Medicine University of Minnesota Medical School Minneapolis Minnesota USA.
Health Sci Rep. 2022 May 22;5(3):e660. doi: 10.1002/hsr2.660. eCollection 2022 May.
Transcatheter aortic valve replacement (TAVR) is the mainstay of treatment of inoperable and severe high-risk aortic stenosis and is noninferior to surgical aortic valve replacement (SAVR) for low-risk and intermediate-risk patients as well. We aim to compare the valve size, area, and transaortic mean gradients in SAVR patients before and after the implementation of TAVR since being approved by the Food and Drug Administration in 2011.
Patients who underwent a bioprosthetic SAVR placement were divided into two groups based on the date of procedure: the early pre-TAVR implementation group (years 2011-2012) and the contemporary post-TAVR group (years 2019-2020). The primary endpoint was the mean gradient across the aortic valve within 16 months of surgery. The secondary endpoints included the difference in valve size and various aortic valve echocardiographic variables.
One hundred and thirty patients had their valves replaced in the years 2011-2012 and 134 in the years 2019-2020. The early group had a significantly higher mean gradient (median of 13 mmHg [interquartile range, IQR: 9.3-18] vs. 10 mmHg [IQR: 7.5-13.1], = 0.001) and a smaller median effective orifice area index (0.8 cm/m [IQR: 0.6-1] vs. 1.1 cm/m [IQR: 0.8-1.3], < 0.001). The median valve size was significantly smaller in the early group (median of 21 mm [IQR: 21-23] vs. 23 mm [IQR: 22.5-25], < 0.001).
In the contemporary era, surgical patients receive larger valves which translates into lower mean gradients, larger valve area, and lower rates of patient-prosthesis mismatch than in previous years before the routine introduction of TAVR.
经导管主动脉瓣置换术（TAVR）是无法手术的重度高危主动脉瓣狭窄的主要治疗方法，对于低风险和中度风险患者，其疗效也不劣于外科主动脉瓣置换术（SAVR）。我们旨在比较自2011年获得美国食品药品监督管理局批准以来，TAVR实施前后SAVR患者的瓣膜尺寸、面积和经主动脉平均压力阶差。
接受生物人工心脏瓣膜SAVR置换术的患者根据手术日期分为两组：TAVR实施前早期组（2011 - 2012年）和TAVR当代组（2019 - 2020年）。主要终点是术后16个月内主动脉瓣的平均压力阶差。次要终点包括瓣膜尺寸差异和各种主动脉瓣超声心动图变量。
2011 - 2012年有130例患者接受瓣膜置换，2019 - 2020年有134例。早期组的平均压力阶差显著更高（中位数为13 mmHg[四分位间距，IQR：9.3 - 18] vs. 10 mmHg[IQR：7.5 - 13.1]，P = 0.001），有效瓣口面积指数中位数更小（0.8 cm/m²[IQR：0.6 - 1] vs. 1.1 cm/m²[IQR：0.8 - 1.3]，P < 0.001）。早期组的瓣膜尺寸中位数显著更小（中位数为21 mm[IQR：21 - 23] vs. 23 mm[IQR：22.5 - 25]，P < 0.001）。
在当代，与TAVR常规应用前的前几年相比，接受外科手术的患者植入的瓣膜更大，这意味着平均压力阶差更低、瓣膜面积更大以及患者 - 人工瓣膜不匹配率更低。
