Kaufman Center for Heart Failure, Heart and Vascular Institute Cleveland Clinic Cleveland OH.
Independent Biostatistician Athens Greece.
J Am Heart Assoc. 2020 Jul 21;9(14):e015897. doi: 10.1161/JAHA.119.015897. Epub 2020 Jul 10.
Background Left ventricular assist device (LVAD) thrombosis is clinically devastating and impacts the cost effectiveness of LVAD therapy for advanced heart failure. Anticoagulation and antiplatelet therapies represent the standard of care to mitigate LVAD thrombosis. Phosphodiesterase type 5 inhibitors (PDE-5is) exhibit hemodynamic, antiplatelet, and antithrombotic effects. Using a national registry, we examined the relationship of PDE-5i use on thrombotic events in patients with continuous-flow LVADs. Methods and Results We obtained data from 13 772 patients with continuous flow LVADs participating in a national registry. Patients implanted with primary LVADs from 2012 to 2017 were included in the analysis. The primary end point was a composite of LVAD thrombosis and ischemic stroke. Patients were analyzed according to any use of PDE-5i after LVAD implantation (PDE-5i group) versus no use after LVAD implantation (no PDE-5i group). The primary end point was significantly lower in the PDE-5i group compared with the no PDE-5i group (hazard ratio [HR], 0.84; 95% CI, 0.77-0.91; <0.001) at 48 months. The components of the primary end point (LVAD thrombosis: HR, 0.82; 95% CI, 0.74-0.90; <0.001; and ischemic stroke: HR, 0.85; 95% CI, 0.75-0.97; =0.019), as well as the secondary end point all-cause mortality (HR, 0.86; 95% CI, 0.79-0.93; <0.001) were lower in the PDE-5i group versus the no PDE-5i at 48 months post LVAD. The favorable results observed with postimplant PDE-5i use were consistent with both axial and centrifugal flow devices. Conclusions The postimplant use of PDE-5i was associated with fewer thrombotic events and improved survival in LVAD patients. A randomized clinical trial is warranted to confirm these findings.
左心室辅助装置(LVAD)血栓形成具有临床破坏性,会影响 LVAD 治疗晚期心力衰竭的成本效益。抗凝和抗血小板治疗是减轻 LVAD 血栓形成的标准治疗方法。磷酸二酯酶 5 抑制剂(PDE-5i)具有血流动力学、抗血小板和抗血栓作用。利用国家登记处,我们研究了 PDE-5i 在连续流 LVAD 患者血栓形成事件中的应用关系。
我们从参与国家登记处的 13772 例连续流 LVAD 患者中获得了数据。分析纳入了 2012 年至 2017 年植入原发性 LVAD 的患者。主要终点是 LVAD 血栓形成和缺血性卒中的复合终点。根据 LVAD 植入后是否使用 PDE-5i(PDE-5i 组)与 LVAD 植入后未使用(无 PDE-5i 组)对患者进行分析。在 48 个月时,PDE-5i 组的主要终点显著低于无 PDE-5i 组(风险比[HR],0.84;95%CI,0.77-0.91;<0.001)。主要终点的组成部分(LVAD 血栓形成:HR,0.82;95%CI,0.74-0.90;<0.001;和缺血性卒中:HR,0.85;95%CI,0.75-0.97;=0.019)以及次要终点全因死亡率(HR,0.86;95%CI,0.79-0.93;<0.001)在 LVAD 后 48 个月时,PDE-5i 组均低于无 PDE-5i 组。LVAD 植入后使用 PDE-5i 的有利结果与轴流和离心流装置一致。
LVAD 患者植入后使用 PDE-5i 可减少血栓形成事件并改善生存。需要进行随机临床试验来证实这些发现。