Labrousse Louis, Moront Michael G, Dagenais Francois, Reardon Michael J, Deeb G Michael, Günzinger Ralf, Ruel Marc, Wu Tianhua, Klautz Robert J M, Sabik Joseph F
Medico-Surgical Department of Valvulopathies, Bordeaux Heart University Hospital, Bordeaux-Pessac, France.
Cardiothoracic Surgery, ProMedica Toledo Hospital, Toledo, OH, USA.
Port J Card Thorac Vasc Surg. 2025 Apr 29;32(1):25-33. doi: 10.48729/pjctvs.531.
Bicuspid aortic valve affects 0.5-2% of the population in developed countries. Given uncertainties about the best aortic valve replacement (AVR) option in this often younger, low-risk, population, it is important to understand how newer bioprostheses perform in these patients. The primary objective of this analysis was to compare 7-year outcomes of surgical AVR (SAVR) with the Avalus bioprosthesis between patients with a congenital bicuspid or tricuspid valve.
This prospective, non-randomized study included 1132 patients with aortic valve stenosis or chronic severe aortic regurgitation who underwent successful SAVR with the Avalus bioprosthesis. Patients were categorized into bicuspid (n=339) and tricuspid (n=775) groups; 18 patients had unknown etiology. Kaplan-Meier analyses estimated valve-related adverse events over 7 years. Multivariable Cox proportional hazard models with propensity score adjustments evaluated the association of valve etiology with clinical outcomes, and a multivariable analysis identified risk factors for all-cause mortality.
Patients with a tricuspid valve were older with more advanced heart failure symptoms and a higher mean Society of Thoracic Surgeons risk score (P<0.01). At 7 years postimplant, mortality was lower [8.9% (95% CI: 5.9%-13.4%) versus 21.3% (95% CI: 18.1%-24.9%), P<0.01] and non-structural valve dysfunction was higher in the bicuspid cohort [2.9% (95% CI: 1.5%-5.5%) versus 0.6% (95% CI: 0.2%-1.6%), P<0.01]. Other safety parameters were not significantly different. In the bicuspid and tricuspid cohorts, the respective mean effective orifice area was 2.0±0.5 and 2.0±0.5 at 7 years, and the respective mean aortic gradient was 13.6±6.4 and 14.1±5.7. Reintervention rates were low [6.8% (95% CI: 4.1%-10.9%) versus 5.4% (95% CI: 3.7%-7.8%), P=0.54] in both cohorts.
SAVR with the Avalus bioprosthesis yielded excellent 7-year outcomes for patients with either a congenital bicuspid or tricuspid valve. Hemodynamic performance and reintervention rates were similar between cohorts with low rates of other valve-related adverse events.
在发达国家，二叶式主动脉瓣影响着0.5%-2%的人口。鉴于在这个通常较为年轻、低风险的人群中，关于最佳主动脉瓣置换（AVR）方案存在不确定性，了解新型生物瓣膜在这些患者中的表现非常重要。本分析的主要目的是比较先天性二叶式或三叶式瓣膜患者接受使用Avalus生物瓣膜的外科主动脉瓣置换术（SAVR）后的7年结局。
这项前瞻性、非随机研究纳入了1132例患有主动脉瓣狭窄或慢性重度主动脉瓣反流且成功接受使用Avalus生物瓣膜的SAVR的患者。患者被分为二叶式（n=339）和三叶式（n=775）两组；18例患者病因不明。采用Kaplan-Meier分析评估7年内与瓣膜相关的不良事件。带有倾向评分调整的多变量Cox比例风险模型评估瓣膜病因与临床结局的关联，多变量分析确定全因死亡率的危险因素。
三叶式瓣膜患者年龄更大，心力衰竭症状更严重，胸外科医师协会平均风险评分更高（P<0.01）。植入后7年，二叶式队列的死亡率更低[8.9%（95%CI：5.9%-13.4%）对21.3%（95%CI：18.1%-24.9%），P<0.01]，非结构性瓣膜功能障碍更高[2.9%（95%CI：1.5%-5.5%）对0.6%（95%CI：0.2%-1.6%），P<0.01]。其他安全性参数无显著差异。在二叶式和三叶式队列中，7年时各自的平均有效瓣口面积分别为2.0±0.5和2.0±0.5，各自的平均主动脉跨瓣压差分别为13.6±6.4和14.1±5.7。两个队列的再次干预率都很低[6.8%（95%CI：4.1%-10.9%）对5.4%（95%CI：3.7%-7.8%），P=0.54]。
对于先天性二叶式或三叶式瓣膜患者，使用Avalus生物瓣膜的SAVR产生了出色的7年结局。两个队列的血流动力学表现和再次干预率相似，其他与瓣膜相关的不良事件发生率较低。
