The Heart Center, Rigshospitalet, Copenhagen, Denmark.
Heart Center Lucerne, Lucerner Kantonsspital, Lucerne, Switzerland.
Catheter Cardiovasc Interv. 2024 Jul;104(1):115-124. doi: 10.1002/ccd.31089. Epub 2024 May 19.
Transcatheter aortic valve replacement (TAVR) is increasingly being used to treat severe aortic stenosis in younger patients. Accordingly, lifetime management regarding future reintervention and coronary access is a concern.
To assess the impact of commissural alignment on ACURATE neo2 transcatheter aortic valve (TAV) performance.
COMALIGN-neo2 was an observational, retrospective study enrolling consecutive TAVR patients treated with the ACURATE neo2 (October 2021 to October 2022). The degree of commissural (mis)-alignment (CMA) with the native aortic valve commissures was determined and transvalvular gradient, effective orifice area, patient-prosthesis mismatch (PPM), and aortic regurgitation (AR) were assessed.
Among 825 patients, the mean age was 80.7 years and 42% were female. Commissural alignment was achieved in 60% of cases; mild (26%), moderate (9%), and severe misalignment (5%) were found less often. Severe PPM occurred more frequently in patients with severe CMA (14.7%) compared to aligned valves (p = 0.034). By multivariate analysis, severe CMA (odds ratio [OR]: 3.12, 95% confidence interval [CI] [1.09-8.90]; p = 0.033) and lack of postdilatation (OR: 3.85, [1.33-11.1]; p = 0.012) were associated with severe PPM. Higher rates of ≥mild AR (51.4%) were found in TAVs implanted with severe CMA compared to aligned (34.3%), mildly (38.1%) or moderately (36.0%) misaligned TAVs (p = 0.030). Multivariate analysis identified severe CMA (OR: 2.05, [1.05-4.02]; p = 0.037) to be an independent predictor of ≥mild AR.
COMALIGN-neo2 is the largest study to date assessing the impact of commissural alignment on acute TAV performance. Severe CMA with the ACURATE neo2 platform was associated with worse valve hemodynamics and increased risk for mild AR.
经导管主动脉瓣置换术（TAVR）越来越多地用于治疗年轻患者的严重主动脉瓣狭窄。因此，未来再介入和冠状动脉入路的终身管理是一个关注点。
评估瓣环对位对 ACURATE neo2 经导管主动脉瓣（TAV）性能的影响。
COMALIGN-neo2 是一项观察性、回顾性研究，纳入了 2021 年 10 月至 2022 年 10 月期间接受 ACURATE neo2 治疗的连续 TAVR 患者。确定了与原生主动脉瓣交界的交界对位（CMA）程度，并评估了跨瓣梯度、有效瓣口面积、患者-瓣膜不匹配（PPM）和主动脉瓣反流（AR）。
在 825 例患者中，平均年龄为 80.7 岁，42%为女性。60%的病例实现了交界对位；轻度（26%）、中度（9%）和重度对位不良（5%）较少见。严重 CMA 患者（14.7%）比对位良好的瓣膜（p=0.034）更容易发生严重 PPM。多变量分析显示，严重 CMA（比值比 [OR]：3.12，95%置信区间 [CI] [1.09-8.90]；p=0.033）和缺乏后扩张（OR：3.85，[1.33-11.1]；p=0.012）与严重 PPM 相关。与对位良好（34.3%）、轻度（38.1%）或中度（36.0%）对位不良 TAV 相比，严重 CMA 组（51.4%）TAV 植入后≥轻度 AR 发生率更高（p=0.030）。多变量分析确定严重 CMA（OR：2.05，[1.05-4.02]；p=0.037）是≥轻度 AR 的独立预测因素。
COMALIGN-neo2 是迄今为止评估交界对位对急性 TAV 性能影响的最大研究。ACURATE neo2 平台上严重的 CMA 与瓣膜血流动力学恶化和轻度 AR 风险增加相关。
