Background

The use of polytetrafluoroethylene (PTFE) material as a protective cover for left ventricular assist device (LVAD) outflow grafts (OG) is a common practice. However, it has descriptively been linked to the development of blood flow obstruction (BFO).

Methods

Patient data from 194 consecutive HVAD (Medtronic Inc; Medtronic, Minneapolis, MN) recipients implanted between March 2006 and January 2021 were retrospectively analyzed. PTFE covers were used in 102 patients. Study outcomes included the incidence of BFO and survival on LVAD support.

Results

Thirty-seven patients (19.1%) developed BFO during the study period. On a multivariable Cox regression analysis, PTFE use was an independent predictor for the development of BFO (HR 2.15, 95% CI 1.03-4.48, p = .04). BFO comprised of 2 types of device malfunction: eleven patients (5.7%) developed outflow graft stenosis (OGS), and 31 patients (16.0%) developed pump thrombosis (PT). There was a significantly higher cumulative incidence of OGS in patients with PTFE cover than in those without (Gray's test, p =.03). However, the observed higher cumulative incidence of PT in PTFE patients was non-significant (Gray's test, p =.06). In a multivariable Cox regression model, the effect of PTFE use on survival was non-significant (HR 0.95, 95% CI 0.60-1.48, p =.81), while the development of BFO was independently associated with increased mortality (HR 3.43, 95% CI 1.94-6.06, p < .0001).

Conclusions

The use of PTFE OG cover in LVAD patients is associated with an increased cumulative probability of development of BFO, the latter adversely impacting survival and is therefore, harmful.

中文翻译：

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闭塞性聚四氟乙烯流出移植物保护器对左心室辅助装置接受者的影响

背景

使用聚四氟乙烯(PTFE) 材料作为左心室辅助装置 (LVAD) 流出移植物 (OG) 的保护盖是一种常见的做法。然而，它已被描述为与血流阻塞 (BFO) 的发展有关。

方法

对 2006 年 3 月至 2021 年 1 月期间植入的 194 位连续 HVAD（美敦力公司；美敦力，明尼阿波利斯，明尼苏达州）接受者的患者数据进行了回顾性分析。102 名患者使用了 PTFE 盖。研究结果包括 BFO 的发生率和 LVAD 支持的生存率。

结果

研究期间有 37 名患者 (19.1%) 出现 BFO。在多变量 Cox 回归分析中，PTFE 的使用是 BFO 发展的独立预测因素（HR 2.15，95% CI 1.03-4.48，p  = .04）。BFO 包括 2 种类型的设备故障：11 名患者 (5.7%) 出现移植物流出道狭窄 (OGS)，31 名患者 (16.0%) 出现泵血栓形成 (PT)。有 PTFE 覆盖物的患者 OGS 的累积发生率明显高于没有覆盖物的患者（Gray 检验，p =.03）。然而，在 PTFE 患者中观察到的较高的 PT 累积发生率并不显着（格雷检验，p =.06）。在多变量 Cox 回归模型中，使用 PTFE 对生存的影响不显着（HR 0.95，95% CI 0.60-1.48，p =.81)，而 BFO 的发展与死亡率增加独立相关 (HR 3.43, 95% CI 1.94-6.06, p < .0001)。

结论

在 LVAD 患者中使用 PTFE OG 盖与 BFO 发展的累积概率增加有关，后者对生存产生不利影响，因此是有害的。