Transcatheter Pulmonary Artery Banding in High-Risk Neonates: In-Vitro Study Provoked by Initial Clinical Experience,Cardiovascular Engineering and Technology

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Transcatheter Pulmonary Artery Banding in High-Risk Neonates: In-Vitro Study Provoked by Initial Clinical Experience
Cardiovascular Engineering and Technology ( IF 1.6 ) Pub Date : 2023-08-14 , DOI: 10.1007/s13239-023-00674-2
Shannen B Kizilski ₁ , Dominic P Recco ₁ , Francesca Sperotto ₂ , Nora Lang _{2,

3} , Peter E Hammer ₁ , Christopher W Baird ₁ , Nicola Maschietto ₂ , David M Hoganson ₁

Affiliation

Purpose

Very high-risk, ductal-dependent or complex two-ventricle patients with associated comorbidities often require pulmonary blood flow restriction as bridge to a more definitive procedure, but current surgical options may not be well-tolerated. An evolving alternative utilizes a fenestrated Micro Vascular Plug (MVP) as a transcatheter, internal pulmonary artery band. In this study, we report a case series and an in-vitro evaluation of the MVP to elicit understanding of the challenges faced with device implantation.

Methods

Following single-center, retrospective review of eight patients who underwent device placement, an in-vitro flow study was conducted on MVP devices to assess impact of device and fenestration sizing on pulmonary blood flow. A mathematical model was developed to relate migration risk to vessel size. Results of the engineering analysis were compared to the clinical series for validation.

Results

At median follow-up of 8 months (range 1–15), survival was 63% (5/8), and 6 (75%) patients underwent subsequent target surgical intervention with relatively low mortality (1/6). Occluder-related challenges included migration (63%) and peri-device flow, which were evaluated in-vitro. The device demonstrated durability over normal and supraphysiologic conditions with minimal change in fenestration size. Smaller vessel size significantly increased pressure gradient due to reduced peri-device flow and smaller effective fenestration size.

Conclusion

Device oversizing, with appropriate adjustment to fenestration size, may reduce migration risk and provide a clinically appropriate balance between resulting pressure gradient and Qp:Qs. Our results can guide the interventionalist in appropriately selecting the device and fenestrations based on patient-specific anatomy and desired post-implantation flow characteristics.

中文翻译：

高危新生儿的经导管肺动脉束带术：由初步临床经验引发的体外研究

目的

具有相关合并症的极高风险、导管依赖性或复杂的两心室患者通常需要限制肺血流作为更明确手术的桥梁，但目前的手术选择可能无法很好地耐受。一种不断发展的替代方案利用有孔微血管塞（MVP）作为经导管肺内动脉带。在这项研究中，我们报告了一个病例系列和 MVP 的体外评估，以加深对设备植入所面临的挑战的了解。

方法

对接受装置放置的 8 名患者进行单中心回顾性审查后，对 MVP 装置进行了体外血流研究，以评估装置和开窗尺寸对肺血流的影响。开发了一个数学模型来将迁移风险与容器尺寸联系起来。将工程分析的结果与临床系列进行比较以进行验证。

结果

中位随访 8 个月（范围 1-15）时，生存率为 63% (5/8)，6 名 (75%) 患者接受了后续目标手术干预，死亡率相对较低 (1/6)。与封堵器相关的挑战包括迁移（63%）和设备周围流动，这些都在体外进行了评估。该装置在正常和超生理条件下表现出耐用性，开窗尺寸变化最小。由于设备周围流量减少和有效开窗尺寸较小，较小的容器尺寸显着增加了压力梯度。