Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart and Lung Institute, Department of Medicine, Laval University, Québec, Canada.
Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
JAMA Cardiol. 2017 Nov 1;2(11):1208-1216. doi: 10.1001/jamacardio.2017.3425.
Moderate/severe and even mild paravalvular regurgitation (PVR) are associated with increased mortality following transcatheter aortic valve replacement (TAVR) with first and second generations of transcatheter valves.
To examine the incidence, evolution, and effect on 1-year outcomes of PVR following TAVR with a third-generation balloon-expandable transcatheter heart valve.
DESIGN, SETTING, AND PARTICIPANTS: Prespecified analysis of PVR in the Placement of Aortic Transcatheter Valves (PARTNER) II SAPIEN 3 trial, conducted between October 1, 2013, and September 3, 2014. Multicenter, nonrandomized registry of 1661 patients at intermediate or high surgical risk undergoing TAVR with the SAPIEN 3. Patients with severe, symptomatic aortic stenosis and high/intermediate surgical risk were enrolled in the registry at 51 sites in the United States and Canada.
Transcatheter aortic valve replacement with the SAPIEN 3 valve.
Paravalvular regurgitation was assessed in a core laboratory at 30 days and 1 year according to a 5-class scheme: 0, none or trace; 1, mild; 2, mild to moderate; 3, moderate; 4, moderate to severe; and 5, severe. We assessed the effect of PVR on 1-year mortality and heart failure rehospitalization.
Among the 1661 included in the registry, 1592 received a SAPIEN 3 valve and had assessment of PVR. Of these patients, 55.7% had none-trace PVR, 32.6% had mild, 8.2% had mild to moderate, and 3.5% had at least moderate PVR at 30 days. At 1 year, 9.3% of patients had died and 14.2% had been rehospitalized. Only patients with at least moderate PVR had higher 1-year mortality (hazard ratio [HR], 2.40; 95% CI, 1.30-4.43; P = .005) and composite of mortality/rehospitalization (HR, 2.35; 95% CI, 1.52-3.62; P < .001). In a paired comparison including 1213 patients, 73% of the patients with at least moderate PVR at 30 days showed a reduction in PVR severity of at least 1 PVR class at 1 year.
In this series of patients undergoing TAVR with the SAPIEN 3 valve, at least moderate PVR was rare but associated with increased risk of death and heart failure rehospitalization at 1 year. Even the upper range of the mild class in the 3-class grading scheme (ie, mild to moderate in the 5-class scheme) had no significant effect on short-term mortality or rehospitalization. Most patients with at least moderate PVR at 30 days showed a decrease of PVR severity grade at 1 year.
clinicaltrials.gov Identifier: NCT01314313.
经导管主动脉瓣置换术（TAVR）后，第一代和第二代经导管瓣膜的中度/重度甚至轻度瓣周漏（PVR）与死亡率增加相关。
研究第三代球囊扩张式经导管心脏瓣膜 TAVR 后 PVR 的发生率、演变及其对 1 年结局的影响。
设计、地点和参与者：在 2013 年 10 月 1 日至 2014 年 9 月 3 日进行的经导管放置主动脉瓣膜（PARTNER）II SAPIEN 3 试验的 PVR 预设分析。这是一项在美国和加拿大 51 个地点进行的、中间或高危外科手术风险患者接受 SAPIEN 3 经导管主动脉瓣置换术的多中心、非随机登记研究。在该登记处，患有严重、有症状的主动脉瓣狭窄和高/中危外科手术风险的患者入组。
经导管主动脉瓣置换术，使用 SAPIEN 3 瓣膜。
根据 5 级方案，在 30 天和 1 年时在核心实验室评估瓣周漏：0，无或微量；1，轻度；2，轻度至中度；3，中度；4，中度至重度；和 5，重度。我们评估了 PVR 对 1 年死亡率和心力衰竭再入院的影响。
在登记处的 1661 例患者中，1592 例接受了 SAPIEN 3 瓣膜，并对 PVR 进行了评估。这些患者中，55.7%无/微量 PVR，32.6%轻度，8.2%轻度至中度，3.5%至少中度 PVR 在 30 天。在 1 年时，9.3%的患者死亡，14.2%的患者再次住院。只有至少中度 PVR 的患者有更高的 1 年死亡率（风险比[HR]，2.40；95%CI，1.30-4.43；P=0.005）和死亡率/再入院复合终点（HR，2.35；95%CI，1.52-3.62；P<0.001）。在包括 1213 例患者的配对比较中，30 天时至少中度 PVR 的患者中，有 73%在 1 年时 PVR 严重程度至少降低了 1 个 PVR 级别。
在接受 SAPIEN 3 瓣膜治疗的这一系列患者中，至少中度 PVR 罕见，但与 1 年时的死亡风险和心力衰竭再入院风险增加相关。即使在 3 级分级方案的轻度级别上限（即 5 级分级方案中的轻度至中度）也没有对短期死亡率或再入院产生显著影响。大多数在 30 天时至少有中度 PVR 的患者在 1 年时 PVR 严重程度的等级有所下降。
clinicaltrials.gov 标识符：NCT01314313。
