The Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology (J.B.S., Y.Z., K.F.F., H.T., L.R.V., C.S., R.W.Y.).
Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center (J.B.S., Y.Z., K.F.F., H.T., L.R.V., C.S., J.J.P., R.W.Y.).
Circ Cardiovasc Interv. 2019 Nov;12(11):e008231. doi: 10.1161/CIRCINTERVENTIONS.119.008231. Epub 2019 Nov 7.
Cerebrovascular events (CVEs) are devastating complications after aortic valve replacement. We assessed whether billing claims accurately identify CVEs in place of clinical event adjudication in structural heart disease trials.
Adult participants in the US CoreValve High Risk and SURTAVI trials (Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients) were linked to Medicare inpatient claims from January 1, 2006 to December 31, 2016. Claims consistent with CVEs within 14 days of a similar trial-adjudicated CVE were considered a match. The sensitivity, specificity, and positive and negative predictive values of billing codes for cerebrovascular disease were determined against trial-defined CVEs as the criterion standard. Kaplan-Meier estimates of claims-defined versus trial-defined CVEs were compared.
Among 4230 linked trial participants (linkage rate 79.8%), 550 (13.0%) sustained 630 adjudicated CVEs over a 5-year follow-up period. Linked and nonlinked individuals were similar. An algorithm using 4 codes (434.91, 434.11, 433.11, and 997.02) had a sensitivity of 60.9%, specificity of 99.0%, positive predictive value of 86.5%, and negative predictive value of 95.8% for identifying a trial-adjudicated ischemic stroke. An algorithm using 3 codes (I63.9, I63.40, I63.49) had a sensitivity of 66.7%, specificity of 99.4%, positive predictive value of 88.9%, and negative predictive value of 97.6%.
In linked clinical trial and Medicare claims data, 4 and 3 billing codes identified half of trial-adjudicated CVEs during follow-up with high specificity and predictive value, but imperfect sensitivity. Although low sensitivity may limit the use of claims to substitute for traditional trial outcomes to identify CVEs, high specificity suggests claims could be used to trigger evaluation of neurological events, potentially improving the efficiency of the evaluation of techniques and devices designed to reduce such events.
脑血管事件（CVE）是主动脉瓣置换术后的毁灭性并发症。我们评估了在结构性心脏病试验中，计费是否能准确识别 CVE，而不是通过临床事件裁决。
在美国 CoreValve High Risk 和 SURTAVI 试验（中危患者的外科或经导管主动脉瓣置换术）中，成年参与者与 2006 年 1 月 1 日至 2016 年 12 月 31 日的 Medicare 住院记录相关联。在类似的试验裁决 CVE 后 14 天内，与 CVE 一致的索赔被认为是匹配的。使用试验定义的 CVE 作为金标准，确定了脑血管疾病计费代码的敏感性、特异性、阳性和阴性预测值。比较了索赔定义与试验定义的 CVE 的 Kaplan-Meier 估计值。
在 4230 名相关联的试验参与者中（关联率为 79.8%），550 名（13.0%）在 5 年的随访期间发生了 630 例经裁决的 CVE。关联和非关联个体相似。一种使用 4 个代码（434.91、434.11、433.11 和 997.02）的算法，其识别试验裁决的缺血性中风的敏感性为 60.9%，特异性为 99.0%，阳性预测值为 86.5%，阴性预测值为 95.8%。一种使用 3 个代码（I63.9、I63.40、I63.49）的算法，其敏感性为 66.7%，特异性为 99.4%，阳性预测值为 88.9%，阴性预测值为 97.6%。
在关联的临床试验和医疗保险索赔数据中，4 个和 3 个计费代码在随访期间识别了一半的试验裁决的 CVE，特异性和预测值较高，但敏感性较低。虽然低敏感性可能限制了使用索赔来替代传统试验结果来识别 CVE，但高特异性表明，索赔可用于触发对神经事件的评估，这可能提高评估旨在减少此类事件的技术和设备的效率。
