WATCHMAN 左心耳封堵术的操作量和结果。
Procedure Volume and Outcomes With WATCHMAN Left Atrial Appendage Occlusion.
机构信息
Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (D.J.F., S.V., A.S.K., J.P.P.).
Center for Outcomes Research and Evaluation, Yale New Haven Health, CT (C.D., S.Z., Z.T., Z.L., L.P., K.E.M., K.F.F., J.P.C., J.V.F.).
出版信息
Circ Cardiovasc Interv. 2024 Jun;17(6):e013466. doi: 10.1161/CIRCINTERVENTIONS.123.013466. Epub 2024 Jun 18.
BACKGROUND
Procedure volumes are associated with outcomes for many cardiovascular procedures, leading to guidelines on minimum volume thresholds for certain procedures; however, the volume-outcome relationship with left atrial appendage occlusion is poorly understood. As such, we sought to determine the relationship between hospital and physician volume and WATCHMAN left atrial appendage occlusion procedural success overall and with the new generation WATCHMAN FLX device.
METHODS
We performed an analysis of WATCHMAN procedures (January 2019 to October 2021) from the National Cardiovascular Data Registry LAAO Registry. Three-level hierarchical generalized linear models were used to assess the adjusted relationship between procedure volume and procedural success (device released with peridevice leak <5 mm, no in-hospital major adverse events).
RESULTS
Among 87 480 patients (76.2±8.0 years; 58.8% men; mean CHADS-VASc score, 4.8±1.5) from 693 hospitals, the procedural success rate was 94.2%. With hospital volume Q4 (greatest volume) as the reference, the likelihood of procedural success was significantly less among Q1 (odds ratio [OR], 0.66 [CI, 0.57-0.77]) and Q2 (OR, 0.78 [CI, 0.69-0.90]) but not Q3 (OR, 0.95 [CI, 0.84-1.07]). With physician volume Q4 (greatest volume) as the reference, the likelihood of procedural success was significantly less among Q1 (OR, 0.72 [CI, 0.63-0.82]), Q2 (OR, 0.79 [CI, 0.71-0.89]), and Q3 (OR, 0.88 [CI, 0.79-0.97]). Among WATCHMAN FLX procedures, there was attenuation of the volume-outcome relationships, with statistically significant but modest absolute differences of only ≈1% across volume quartiles.
CONCLUSIONS
In this contemporary national analysis, greater hospital and physician WATCHMAN volumes were associated with increased procedure success. The WATCHMAN FLX transition was associated with increased procedural success and less heterogeneity in outcomes across volume quartiles. These findings indicate the importance of understanding the volume-outcome relationship for individual left atrial appendage occlusion devices.
背景
对于许多心血管手术来说，手术量与结果相关，这导致了某些手术最低量的指南；然而，左心耳封堵术的量效关系却知之甚少。因此，我们试图确定医院和医生的手术量与 Watchman 左心耳封堵术的总体成功率以及与新一代 Watchman FLX 装置的关系。
方法
我们对全国心血管数据登记处左心耳封堵术登记处（2019 年 1 月至 2021 年 10 月）的 Watchman 手术进行了分析。使用三级层次广义线性模型评估手术量与手术成功率（装置释放后器械周围漏<5mm，院内无重大不良事件）之间的调整关系。
结果
在来自 693 家医院的 87480 名患者（76.2±8.0 岁；58.8%为男性；平均 CHADS-VASc 评分 4.8±1.5）中，手术成功率为 94.2%。以医院量 Q4（最大量）为参照，Q1（优势比 [OR]，0.66 [CI，0.57-0.77]）和 Q2（OR，0.78 [CI，0.69-0.90]）的手术成功率明显较低，但 Q3（OR，0.95 [CI，0.84-1.07]）则不然。以医生量 Q4（最大量）为参照，Q1（OR，0.72 [CI，0.63-0.82]）、Q2（OR，0.79 [CI，0.71-0.89]）和 Q3（OR，0.88 [CI，0.79-0.97]）的手术成功率明显较低。在 Watchman FLX 手术中，体积与结果的关系减弱，仅在体积四分位组之间存在统计学显著但适度的绝对差异约 1%。
结论
在这项当代的全国性分析中，更大的医院和医生 Watchman 量与手术成功率的提高有关。Watchman FLX 过渡与手术成功率的提高以及在体积四分位数之间结果的异质性降低有关。这些发现表明，了解个体左心耳封堵装置的量效关系非常重要。
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