Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis
Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis
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DOI：
10.1093/eurheartj/ehw112
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发表时间：
2016-07-21
影响因子：
39.3
通讯作者：
Leon, Martin B.
中科院分区：
文献类型：
--
作者：
Kodali, Susheel;Thourani, Vinod H.;Leon, Martin B.
目的基于使用第一代器械的随机试验，经导管主动脉瓣置换术（TAVR）已被广泛用于治疗重度主动脉瓣狭窄（AS）高危（HR）患者。迄今为止，评价新一代器械和低风险患者结局的裁定前瞻性数据较少。我们报告了一项大型多中心登记研究的早期结果，该登记研究包括接受下一代SAPIEN 3经导管心脏瓣膜（THV）治疗的无法手术、HR和中等风险（IR）患者。方法和结果患有严重症状性AS的患者（583例高手术风险或无法手术，1078例IR）被纳入美国和加拿大57个研究中心的多中心非随机登记研究。所有患者均通过经股动脉（n = 1443，86.9%）和经心尖或经主动脉（n = 218，13.1%）入路接受SAPIEN 3系统的TAVR。HR/不可手术患者的30天全因死亡率为2.2%[平均胸外科医师协会（STS）评分为8.7%]，IR患者为1.1%（平均STS评分为5.3%）;心血管死亡率分别为1.4%和0.9%。在HR/不可手术患者中，30天严重/致残性卒中发生率为0.9%，大出血为14.0%，严重血管并发症为5.1%，需要永久性起搏器的为13.3%。在IR患者中，30天严重/致残性卒中发生率为1.0%，大出血为10.6%，严重血管并发症为6.1%，需要永久性起搏器为10.1%。平均总体堪萨斯城心肌病问卷评分从47.8增加到67.8（HR/不可手术，P < 0.0001）和54.7增加到74.0（IR，P < 0.0001）。总体而言，30天时55.9%的患者无/微量瓣周返流，40.7%为轻度，3.4%为中度，0.0%为重度。具有配对基线和30天或出院超声心动图的患者的平均压差从基线时的45.8 mmHg降至30天时的11.4 mmHg，而主动脉瓣面积从0.69 cm增加到1.67 cm（2）。结论SAPIEN 3 THV系统的30天死亡率和重大/重大事件发生率较低。致残性卒中以及中度或重度瓣周返流的发生率较低。
Aims Based on randomized trials using first-generation devices, transcatheter aortic valve replacement (TAVR) is well established in the treatment of high-risk (HR) patients with severe aortic stenosis (AS). To date, there is a paucity of adjudicated, prospective data evaluating outcomes with newer generation devices and in lower risk patients. We report early outcomes of a large, multicentre registry of inoperable, HR, and intermediate-risk (IR) patients undergoing treatment with the next-generation SAPIEN 3 transcatheter heart valve (THV).Methods and results Patients with severe, symptomatic AS (583 high surgical risk or inoperable and 1078 IR) were enrolled in a multicentre, non-randomized registry at 57 sites in the USA and Canada. All patients received TAVR with the SAPIEN 3 system via transfemoral (n = 1443, 86.9%) and transapical or transaortic (n = 218, 13.1%) access routes. The rate of 30-day allcause mortality was 2.2% in HR/inoperable patients [mean Society of Thoracic Surgeons (STS) score 8.7%] and 1.1% in IR patients (mean STS score 5.3%); cardiovascular mortality was 1.4 and 0.9%, respectively. In HR/inoperable patients, the 30-day rate of major/disabling stroke was 0.9%, major bleeding 14.0%, major vascular complications 5.1%, and requirement for permanent pacemaker 13.3%. In IR patients, the 30-day rate of major/disabling stroke was 1.0%, major bleeding 10.6%, major vascular complications 6.1%, and requirement for permanent pacemaker 10.1%. Mean overall Kansas City Cardiomyopathy Questionnaire score increased from 47.8 to 67.8 (HR/inoperable, P < 0.0001) and 54.7 to 74.0 (IR, P < 0.0001). Overall, paravalvular regurgitation at 30 days was none/trace in 55.9% of patients, mild in 40.7%, moderate in 3.4%, and severe in 0.0%. Mean gradients among patients with paired baseline and 30-day or discharge echocardiograms decreased from 45.8 mmHg at baseline to 11.4 mmHg at 30 days, while aortic valve area increased from 0.69 to 1.67 cm(2).Conclusions The SAPIEN 3 THV system was associated with low rates of 30-day mortality and major/disabling stroke as well as low rates of moderate or severe paravalvular regurgitation.