Interventional Cardiology Department, Nantes Université, CHU Nantes, L'institut du thorax, Nantes, France.
Nantes Université, CHU Nantes, CNRS, INSERM, L'institut du thorax, Nantes, France.
EuroIntervention. 2024 Sep 2;20(17):e1076-e1085. doi: 10.4244/EIJ-D-24-00339.
Large datasets of transcatheter aortic valve implantation (TAVI) for pure aortic valve regurgitation (PAVR) are scarce.
We aimed to report procedural safety and long-term clinical events (CE) in a contemporary cohort of PAVR patients treated with new-generation devices (NGD).
Patients with grade III/IV PAVR enrolled in the FRANCE-TAVI Registry were selected. The primary safety endpoint was technical success (TS) according to Valve Academic Research Consortium 3 criteria. The co-primary endpoint was defined as a composite of mortality, heart failure hospitalisation and valve reintervention at last follow-up.
From 2015 to 2021, 227 individuals (64.3% males, median age 81.0 [interquartile range {IQR} 73.5-85.0] years, with EuroSCORE II 6.0% [IQR 4.0-10.9]) from 41 centres underwent TAVI with NGD, using either self-expanding (55.1%) or balloon-expandable valves (44.9%; p=0.50). TS was 85.5%, with a non-significant trend towards increased TS in high-volume activity centres. A second valve implantation (SVI) was needed in 8.8% of patients, independent of valve type (p=0.82). Device size was ≥29 mm in 73.0% of patients, post-procedure grade ≥III residual aortic regurgitation was rare (1.2%), and the permanent pacemaker implantation (PPI) rate was 36.0%. At 30 days, the incidences of mortality and reintervention were 8.4% and 3.5%, respectively. The co-primary endpoint reached 41.6% (IQR 34.4-49.6) at 1 year, increased up to 61.8% (IQR 52.4-71.2) at 4 years, and was independently predicted by TS, with a hazard ratio of 0.45 (95% confidence interval: 0.27-0.76); p=0.003.
TAVI with NGD in PAVR patients is efficient and reasonably safe. Preventing the need for an SVI embodies the major technical challenge. Larger implanted valves may have limited this complication, outweighing the increased risk of PPI. Despite successful TAVI, PAVR patients experience frequent CE at long-term follow-up.
用于单纯主动脉瓣反流（PAVR）的经导管主动脉瓣植入术（TAVI）的大型数据集很少。
我们旨在报告使用新一代器械（NGD）治疗 PAVR 患者的当代队列中的手术安全性和长期临床事件（CE）。
从 2015 年至 2021 年，从 FRANCE-TAVI 注册中心选择了患有 III/IV 级 PAVR 的患者。主要安全性终点是根据 Valve Academic Research Consortium 3 标准定义的技术成功（TS）。共同主要终点定义为最后一次随访时死亡率、心力衰竭住院和瓣膜再介入的复合终点。
共有 41 个中心的 227 名患者（64.3%为男性，中位年龄 81.0[四分位距 {IQR} 73.5-85.0]岁，EuroSCORE II 6.0%[IQR 4.0-10.9]）接受了 NGD 的 TAVI，其中使用自膨式瓣膜（55.1%）或球囊扩张瓣膜（44.9%；p=0.50）。TS 为 85.5%，高容量活动中心的 TS 呈上升趋势，但无统计学意义。8.8%的患者需要进行第二次瓣膜植入（SVI），与瓣膜类型无关（p=0.82）。73.0%的患者采用了≥29 毫米的器械尺寸，术后残余主动脉瓣反流程度为 III 级的情况很少（1.2%），永久起搏器植入（PPI）率为 36.0%。30 天时，死亡率和再介入率分别为 8.4%和 3.5%。主要终点在 1 年时达到 41.6%（IQR 34.4-49.6），4 年时增加到 61.8%（IQR 52.4-71.2），并与 TS 独立相关，风险比为 0.45（95%置信区间：0.27-0.76）；p=0.003。
用于 PAVR 患者的 NGD 的 TAVI 既有效又安全。防止需要 SVI 是主要的技术挑战。更大的植入瓣膜可能会限制这种并发症，同时增加 PPI 的风险。尽管 TAVI 成功，但 PAVR 患者在长期随访中经常出现 CE。
