Robin Le Ruz, Lionel Leroux, Thibault Lhermusier, Thomas Cuisset, Eric Van Belle, Alain Dibie, Vincenzo Palermo, Didier Champagnac, Jean-François Obadia, Emmanuel Teiger, Patrick Ohlman, Didier Tchétché, Hervé Le Breton, Christophe Saint-Etienne, Pierre-Guillaume Piriou, Julien Plessis, Sylvain Beurtheret, Florence Du Chayla, Manon Leclère, Thierry Lefèvre, Jean-Philippe Collet, Hélène Eltchaninoff, Martine Gilard, Bernard Iung, Thibaut Manigold, Vincent Letocart, On Behalf Of Stop-As And France-Tavi Investigators
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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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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. 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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.</p><p><strong>Conclusions: </strong>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. 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引用次数: 0
摘要
背景：经导管主动脉瓣植入术（TAVI）治疗单纯主动脉瓣反流（PAVR）的大型数据集非常稀缺：方法：选取法国-TAVI登记处登记的III/IV级PAVR患者。根据瓣膜学术研究联盟 3 标准，主要安全性终点是技术成功率（TS）。共同主要终点定义为最后一次随访时的死亡率、心衰住院率和瓣膜再介入率的综合：从2015年到2021年，来自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% [IQR4.0-10.9]）接受了NGD TAVI，使用自膨胀瓣膜（55.1%）或球囊扩张瓣膜（44.9%；P=0.50）。TS为85.5%，高流量活动中心的TS增加趋势不明显。8.8%的患者需要二次瓣膜植入（SVI），与瓣膜类型无关（P=0.82）。73.0%的患者瓣膜尺寸≥29毫米，术后≥III级残余主动脉瓣反流很少见（1.2%），永久起搏器植入（PPI）率为36.0%。30 天内，死亡率和再介入发生率分别为 8.4% 和 3.5%。共同主要终点在1年时达到41.6%（IQR为34.4-49.6），在4年时增加到61.8%（IQR为52.4-71.2），并且是由TS独立预测的，危险比为0.45（95%置信区间：0.27-0.76）；P=0.003：在PAVR患者中使用NGD进行TAVI是有效且相当安全的。防止需要进行 SVI 是主要的技术挑战。较大的植入瓣膜可能限制了这一并发症的发生，从而抵消了 PPI 风险的增加。尽管 TAVI 取得了成功，但 PAVR 患者在长期随访中仍经常出现 CE。
Outcomes of transcatheter aortic valve implantation for native aortic valve regurgitation.
Background: Large datasets of transcatheter aortic valve implantation (TAVI) for pure aortic valve regurgitation (PAVR) are scarce.
Aims: 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).
Methods: 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.
Results: 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.
Conclusions: 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.
期刊介绍：
EuroIntervention Journal is an international, English language, peer-reviewed journal whose aim is to create a community of high quality research and education in the field of percutaneous and surgical cardiovascular interventions.
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