Division of Cardiology, Department of Medicine, University of Colorado Denver, Aurora, Colorado.
Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina.
J Am Coll Cardiol. 2017 Jul 4;70(1):29-41. doi: 10.1016/j.jacc.2017.04.056.
Transcatheter aortic valve replacement (TAVR) has been introduced into U.S. clinical practice with efforts to optimize outcomes and minimize the learning curve.
The goal of this study was to assess the degree to which increasing experience during the introduction of this procedure, separated from other outcome determinants including patient and procedural characteristics, is associated with outcomes.
The authors evaluated the association of hospital TAVR volume and patient outcomes for TAVR by using data from 42,988 commercial procedures conducted at 395 hospitals submitting to the Transcatheter Valve Therapy Registry from 2011 through 2015. Outcomes assessed included adjusted and unadjusted in-hospital major adverse events.
Increasing site volume was associated with lower in-hospital risk-adjusted outcomes, including mortality (p < 0.02), vascular complications (p < 0.003), and bleeding (p < 0.001) but was not associated with stroke (p = 0.14). From the first case to the 400th case in the volume-outcome model, risk-adjusted adverse outcomes declined, including mortality (3.57% to 2.15%), bleeding (9.56% to 5.08%), vascular complications (6.11% to 4.20%), and stroke (2.03% to 1.66%). Vascular and bleeding volume-outcome associations were nonlinear with a higher risk of adverse outcomes in the first 100 cases. An association of procedure volume with risk-adjusted outcomes was also seen in the subgroup having transfemoral access.
The initial adoption of TAVR into practice in the United States showed that increasing experience was associated with better outcomes. This association, whether deemed a prolonged learning curve or a manifestation of a volume-outcome relationship, suggested that concentrating experience in higher volume heart valve centers might be a means of improving outcomes. (STS/ACC Transcatheter Valve Therapy Registry [TVT Registry]; NCT01737528).
经导管主动脉瓣置换术（TAVR）已引入美国临床实践，旨在优化结果并尽量减少学习曲线。
本研究旨在评估在引入该手术期间经验的增加程度，与包括患者和手术特征在内的其他结果决定因素分开，与结果的关联程度。
作者使用了 2011 年至 2015 年期间，395 家参与经导管瓣膜治疗注册（Transcatheter Valve Therapy Registry）的医院向该注册提交的 42988 例商业手术的数据，评估了医院 TAVR 量与 TAVR 患者结局之间的关联。评估的结局包括调整后和未调整后的住院主要不良事件。
随着部位量的增加，住院风险调整后的结局（包括死亡率、血管并发症和出血）降低（p<0.02），但与中风无关（p=0.14）。在体积-结局模型中，从第一例到第 400 例，风险调整后的不良结局下降，包括死亡率（从 3.57%降至 2.15%）、出血（从 9.56%降至 5.08%）、血管并发症（从 6.11%降至 4.20%）和中风（从 2.03%降至 1.66%）。血管和出血的体积-结局关联是非线性的，在前 100 例中不良结局的风险更高。经股动脉入路的亚组也观察到手术量与风险调整结局之间的关联。
TAVR 在 美国的最初应用表明，经验的增加与更好的结果相关。这种关联，无论是被认为是一个延长的学习曲线还是表现出一个体积-结果关系，都表明在更高容量的心脏瓣膜中心集中经验可能是改善结果的一种手段。（STS/ACC 经导管瓣膜治疗注册[TVT 注册]；NCT01737528）。
