Abstract：
BACKGROUND: The ThermoCool STSF catheter is used for ablation of ischemic ventricular tachycardia (VT) in routine clinical practice, although outcomes have not been studied and the catheter does not have Food and Drug Administration (FDA) approval for this indication. We used real-world health system data to evaluate its safety and effectiveness for this indication.
METHODS: Among patients undergoing ischemic VT ablation with the ThermoCool STSF catheter pooled across two health systems (Mercy Health and Mayo Clinic), the primary safety composite outcome of death, thromboembolic events, and procedural complications within 7 days was compared to a performance goal of 15%, which is twice the expected proportion of the primary composite safety outcome based on prior studies. The exploratory effectiveness outcome of rehospitalization for VT or heart failure or repeat VT ablation at up to 1 year was averaged across health systems among patients treated with the ThermoCool STSF vs. ST catheters.
RESULTS: Seventy total patients received ablation for ischemic VT using the ThermoCool STSF catheter. The primary safety composite outcome occurred in 3/70 (4.3%; 90% CI, 1.2-10.7%) patients, meeting the pre-specified performance goal, p = 0.0045. At 1 year, the effectiveness outcome risk difference (STSF-ST) at Mercy was - 0.4% (90% CI: - 25.2%, 24.3%) and at Mayo Clinic was 12.6% (90% CI: - 13.0%, 38.4%); the average risk difference across both institutions was 5.8% (90% CI: - 12.0, 23.7).
CONCLUSIONS: The ThermoCool STSF catheter was safe and appeared effective for ischemic VT ablation, supporting continued use of the catheter and informing possible FDA label expansion. Health system data hold promise for real-world safety and effectiveness evaluation of cardiovascular devices.
METHODS: Among patients undergoing ischemic VT ablation with the ThermoCool STSF catheter pooled across two health systems (Mercy Health and Mayo Clinic), the primary safety composite outcome of death, thromboembolic events, and procedural complications within 7 days was compared to a performance goal of 15%, which is twice the expected proportion of the primary composite safety outcome based on prior studies. The exploratory effectiveness outcome of rehospitalization for VT or heart failure or repeat VT ablation at up to 1 year was averaged across health systems among patients treated with the ThermoCool STSF vs. ST catheters.
RESULTS: Seventy total patients received ablation for ischemic VT using the ThermoCool STSF catheter. The primary safety composite outcome occurred in 3/70 (4.3%; 90% CI, 1.2-10.7%) patients, meeting the pre-specified performance goal, p = 0.0045. At 1 year, the effectiveness outcome risk difference (STSF-ST) at Mercy was - 0.4% (90% CI: - 25.2%, 24.3%) and at Mayo Clinic was 12.6% (90% CI: - 13.0%, 38.4%); the average risk difference across both institutions was 5.8% (90% CI: - 12.0, 23.7).
CONCLUSIONS: The ThermoCool STSF catheter was safe and appeared effective for ischemic VT ablation, supporting continued use of the catheter and informing possible FDA label expansion. Health system data hold promise for real-world safety and effectiveness evaluation of cardiovascular devices.
摘要：
背景：在常规临床实践中，ThermoCoolSTSF导管用于消融缺血性室性心动过速（VT），尽管尚未对结局进行研究，并且该导管也未获得食品和药物管理局（FDA）的批准。我们使用真实世界的卫生系统数据来评估该适应症的安全性和有效性。
方法：在两个健康系统（MercyHealth和MayoClinic）中使用ThermoCoolSTSF导管进行缺血性VT消融术的患者中，死亡的主要安全综合结局，血栓栓塞事件,7天内的手术并发症与15%的性能目标相比，这是基于先前研究的主要复合安全性结果的预期比例的两倍。在接受ThermoCoolSTSF治疗的患者中，在长达1年的时间内，因室性心动过速或心力衰竭再住院或重复室性心动过速消融术的探索性有效性结果在整个卫生系统中平均。ST导管。
结果：共有70例患者使用ThermoCoolSTSF导管接受了缺血性室性心动过速消融术。主要安全性复合结局发生在3/70（4.3％;90％CI，1.2-10.7％）患者中，达到预先指定的绩效目标，p=0.0045。在1年,Mercy的有效性结局风险差异（STSF-ST）为-0.4％（90％CI：-25.2％，24.3%)，梅奥诊所为12.6%(90%CI：-13.0%，38.4%）；两家机构的平均风险差为5.8%（90%CI：-12.0，23.7）。
结论：ThermoCoolSTSF导管对于缺血性室性心动过速消融术是安全且有效的，支持继续使用导管并告知可能的FDA标签扩展。卫生系统数据为心血管设备的实际安全性和有效性评估提供了希望。
方法：在两个健康系统（MercyHealth和MayoClinic）中使用ThermoCoolSTSF导管进行缺血性VT消融术的患者中，死亡的主要安全综合结局，血栓栓塞事件,7天内的手术并发症与15%的性能目标相比，这是基于先前研究的主要复合安全性结果的预期比例的两倍。在接受ThermoCoolSTSF治疗的患者中，在长达1年的时间内，因室性心动过速或心力衰竭再住院或重复室性心动过速消融术的探索性有效性结果在整个卫生系统中平均。ST导管。
结果：共有70例患者使用ThermoCoolSTSF导管接受了缺血性室性心动过速消融术。主要安全性复合结局发生在3/70（4.3％;90％CI，1.2-10.7％）患者中，达到预先指定的绩效目标，p=0.0045。在1年,Mercy的有效性结局风险差异（STSF-ST）为-0.4％（90％CI：-25.2％，24.3%)，梅奥诊所为12.6%(90%CI：-13.0%，38.4%）；两家机构的平均风险差为5.8%（90%CI：-12.0，23.7）。
结论：ThermoCoolSTSF导管对于缺血性室性心动过速消融术是安全且有效的，支持继续使用导管并告知可能的FDA标签扩展。卫生系统数据为心血管设备的实际安全性和有效性评估提供了希望。
