Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, Quebec, Canada.
Escola Paulista de Medicina - UNIFESP, São Paulo, Brazil.
JACC Cardiovasc Interv. 2018 Jan 22;11(2):133-141. doi: 10.1016/j.jcin.2017.08.039.
The aim of this study was to determine whether the association of small label size of the surgical valve with increased mortality after transcatheter valve-in-valve (ViV) implantation is, at least in part, related to pre-existing prosthesis-patient mismatch (PPM) (i.e., a bioprosthesis that is too small in relation to body size).
Transcatheter ViV implantation is an alternative for the treatment of patients with degenerated bioprostheses. Small label size of the surgical valve has been associated with increased mortality after ViV implantation.
Data from 1,168 patients included in the VIVID (Valve-in-Valve International Data) registry were analyzed. Pre-existing PPM of the surgical valve was determined using a reference value of effective orifice area for each given model and size of implanted prosthetic valve indexed for body surface area. Severe PPM was defined according to the criteria proposed by the Valve Academic Research Consortium 2: indexed effective orifice area <0.65 cm/m if body mass index is <30 kg/m and <0.6 cm/m if BMI is ≥30 kg/m. The primary study endpoint was 1-year mortality.
Among the 1,168 patients included in the registry, 89 (7.6%) had pre-existing severe PPM. Patients with severe PPM had higher 30-day (10.3%, p = 0.01) and 1-year (unadjusted: 28.6%, p < 0.001; adjusted: 19.3%, p = 0.03) mortality rates compared with patients with no severe PPM (4.3%, 11.9%, and 10.9%, respectively). After adjusting for surgical valve label size, Society of Thoracic Surgeons score, renal failure, diabetes, and stentless surgical valves, presence of pre-existing severe PPM was associated with increased risk for 1-year mortality (odds ratio: 1.88; 95% confidence interval: 1.07 to 3.28; p = 0.03). Patients with severe PPM also more frequently harbored high post-procedural gradients (mean gradient ≥20 mm Hg).
Pre-existing PPM of the failed surgical valve is strongly and independently associated with increased risk for mortality following ViV implantation.
本研究旨在确定经导管瓣中瓣（ViV）植入术后，外科瓣标签尺寸较小与死亡率增加之间的关联是否至少部分与预先存在的瓣-患者不匹配（PPM）（即生物瓣相对于体型过小）有关。
经导管 ViV 植入术是治疗退行性生物瓣患者的一种替代方法。外科瓣标签尺寸较小与 ViV 植入术后死亡率增加相关。
对 VIVID（瓣中瓣国际数据）注册研究中的 1168 例患者的数据进行了分析。使用每个植入的假体瓣膜型号和尺寸的有效瓣口面积参考值，通过经体表指数来确定外科瓣的预先存在的 PPM。根据 Valve Academic Research Consortium 2 提出的标准，严重 PPM 定义为：体重指数（BMI）<30 kg/m 时，经指数有效瓣口面积<0.65 cm/m；BMI≥30 kg/m 时，经指数有效瓣口面积<0.6 cm/m。主要研究终点为 1 年死亡率。
在该注册研究中的 1168 例患者中，89 例（7.6%）存在预先存在的严重 PPM。与无严重 PPM 的患者相比，严重 PPM 患者的 30 天（10.3%，p=0.01）和 1 年（未校正：28.6%，p<0.001；校正：19.3%，p=0.03）死亡率更高（分别为 4.3%、11.9%和 10.9%）。在校正外科瓣标签尺寸、胸外科医生协会评分、肾功能衰竭、糖尿病和无支架外科瓣后，存在预先存在的严重 PPM 与 1 年死亡率增加相关（比值比：1.88；95%置信区间：1.07 至 3.28；p=0.03）。严重 PPM 患者也更频繁地存在较高的术后梯度（平均梯度≥20 mmHg）。
失败的外科瓣预先存在的 PPM 与 ViV 植入术后死亡率增加密切相关，且独立相关。
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