Abstract：
BACKGROUND: Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) stenosis is technically challenging and is burdened by an increased risk of paravalvular regurgitation (PVR).
OBJECTIVE: To identify the incidence, predictors, and clinical outcomes of PVR following TAVR in Sievers type 1 BAV stenosis.
METHODS: Consecutive patients with severe Sievers type 1 BAV stenosis undergoing TAVR with current generation transcatheter heart valves (THVs) in 24 international centres were enrolled. PVR was graded as none/trace, mild, moderate, and severe according to echocardiographic criteria. The endpoint of major adverse events (MAE), defined as a composite of all-cause death, stroke, or hospitalization for heart failure, was assessed at the last available follow-up.
RESULTS: A total of 946 patients were enrolled. PVR occurred in 423 patients (44.7%): mild, moderate, and severe in 387 (40.9%), 32 (3.4%), and 4 (0.4%) patients, respectively. Independent predictors of moderate or severe PVR were larger virtual raphe ring (VRR) perimeter (ORadj 1.07, 95% CI 1.02-1.13), severe annular or left ventricular outflow tract (LVOT) calcification (ORadj 5.21, 95% CI 1.45-18.77), self-expanding valve (ORadj 9.01, 95% CI 2.09-38.86), and intentional supra-annular THV positioning (ORadj 3.31, 95% CI 1.04-10.54). At a median follow-up of 1.3 [IQR 0.5-2.4] years, moderate or severe PVR was associated with an increased risk of MAE (HRadj 2.52, 95% CI 1.24-5.09).
CONCLUSIONS: After TAVR with current-generation THVs in Sievers type 1 BAV stenosis, moderate or severe PVR occurred in about 4% of cases and was associated with an increased risk of MAE during follow-up.
OBJECTIVE: To identify the incidence, predictors, and clinical outcomes of PVR following TAVR in Sievers type 1 BAV stenosis.
METHODS: Consecutive patients with severe Sievers type 1 BAV stenosis undergoing TAVR with current generation transcatheter heart valves (THVs) in 24 international centres were enrolled. PVR was graded as none/trace, mild, moderate, and severe according to echocardiographic criteria. The endpoint of major adverse events (MAE), defined as a composite of all-cause death, stroke, or hospitalization for heart failure, was assessed at the last available follow-up.
RESULTS: A total of 946 patients were enrolled. PVR occurred in 423 patients (44.7%): mild, moderate, and severe in 387 (40.9%), 32 (3.4%), and 4 (0.4%) patients, respectively. Independent predictors of moderate or severe PVR were larger virtual raphe ring (VRR) perimeter (ORadj 1.07, 95% CI 1.02-1.13), severe annular or left ventricular outflow tract (LVOT) calcification (ORadj 5.21, 95% CI 1.45-18.77), self-expanding valve (ORadj 9.01, 95% CI 2.09-38.86), and intentional supra-annular THV positioning (ORadj 3.31, 95% CI 1.04-10.54). At a median follow-up of 1.3 [IQR 0.5-2.4] years, moderate or severe PVR was associated with an increased risk of MAE (HRadj 2.52, 95% CI 1.24-5.09).
CONCLUSIONS: After TAVR with current-generation THVs in Sievers type 1 BAV stenosis, moderate or severe PVR occurred in about 4% of cases and was associated with an increased risk of MAE during follow-up.
摘要：
背景：二叶主动脉瓣（BAV）狭窄患者的经导管主动脉瓣置换术（TAVR）在技术上具有挑战性，并且增加了瓣膜旁反流（PVR）的风险。
目的：为了确定发病率，预测因子,Sievers1型BAV狭窄患者TAVR后PVR的临床结果。
方法：纳入24个国际中心接受TAVR的重度Sievers1型BAV狭窄患者，并采用电流代经导管心脏瓣膜（THV）。PVR被分级为无/痕迹，温和,中度,根据超声心动图标准严重。主要不良事件（MAE）的终点，定义为全因死亡的复合物，中风,或者因心力衰竭住院，在最后一次可用的随访中进行了评估。
结果：共纳入946例患者。423例患者发生PVR（44.7%）：轻度，中度,387例严重（40.9%），32（3.4%），和4名(0.4%)患者，分别。中度或重度PVR的独立预测因素是较大的虚拟中环（VRR）周长（ORadj1.07，95％CI1.02-1.13），严重的环形或左心室流出道（LVOT）钙化（ORadj5.21，95％CI1.45-18.77），自膨胀阀（ORadj9.01，95%CI2.09-38.86），和有意的超环形THV定位(ORadj3.31，95%CI1.04-10.54)。在中位随访1.3[IQR0.5-2.4]年时，中度或重度PVR与MAE风险增加相关(HRadj2.52,95%CI1.24-5.09).
结论：在Sievers1型BAV狭窄的TAVR和电流生成THV后，约4%的病例发生中度或重度PVR,并与随访期间MAE风险增加相关.
目的：为了确定发病率，预测因子,Sievers1型BAV狭窄患者TAVR后PVR的临床结果。
方法：纳入24个国际中心接受TAVR的重度Sievers1型BAV狭窄患者，并采用电流代经导管心脏瓣膜（THV）。PVR被分级为无/痕迹，温和,中度,根据超声心动图标准严重。主要不良事件（MAE）的终点，定义为全因死亡的复合物，中风,或者因心力衰竭住院，在最后一次可用的随访中进行了评估。
结果：共纳入946例患者。423例患者发生PVR（44.7%）：轻度，中度,387例严重（40.9%），32（3.4%），和4名(0.4%)患者，分别。中度或重度PVR的独立预测因素是较大的虚拟中环（VRR）周长（ORadj1.07，95％CI1.02-1.13），严重的环形或左心室流出道（LVOT）钙化（ORadj5.21，95％CI1.45-18.77），自膨胀阀（ORadj9.01，95%CI2.09-38.86），和有意的超环形THV定位(ORadj3.31，95%CI1.04-10.54)。在中位随访1.3[IQR0.5-2.4]年时，中度或重度PVR与MAE风险增加相关(HRadj2.52,95%CI1.24-5.09).
结论：在Sievers1型BAV狭窄的TAVR和电流生成THV后，约4%的病例发生中度或重度PVR,并与随访期间MAE风险增加相关.
