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Transcatheter Pulmonary Artery Banding in High-Risk Neonates: In-Vitro Study Provoked by Initial Clinical Experience

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Abstract

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.

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Abbreviations

CO:

Cardiac output

HLHS:

Hypoplastic left heart syndrome

LPA:

Left pulmonary artery

LV:

Left ventricle

MPA:

Main pulmonary artery

MVP:

Micro Vascular PlugTM

PA:

Pulmonary artery

PAB:

Pulmonary artery banding

PBF:

Pulmonary blood flow

PDA:

Patent ductus arteriosus

PFR:

Pulmonary flow restrictor

PTFE:

Polytetrafluoroethylene

Qp:Qs:

Pulmonary-systemic flow ratio

SV:

Single ventricle

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Acknowledgements

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Funding

This work was supported by internal funds.

Author information

Author notes

  1. Shannen B. Kizilski and Dominic P. Recco—co-first authors.

  2. Nicola Maschietto and David M. Hoganson—co-senior authors.

Authors and Affiliations

  1. Department of Cardiac Surgery, Harvard Medical School, Boston Children’s Hospital, 300 Longwood Avenue, Bader, 2nd Floor, Boston, MA, 02215, USA

    Shannen B. Kizilski, Dominic P. Recco, Peter E. Hammer, Christopher W. Baird & David M. Hoganson

  2. Department of Cardiology, Harvard Medical School, Boston Children’s Hospital, Boston, MA, USA

    Francesca Sperotto, Nora Lang & Nicola Maschietto

  3. Department of Pediatric Cardiology, University Heart & Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

    Nora Lang

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Correspondence to David M. Hoganson.

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Conflict of interest

S.B. Kizilski, D.P. Recco, F. Sperotto, N. Lang, P.E. Hammer, C.W. Baird, N. Maschietto, D.M. Hoganson declare that they have no conflicts of interest.

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This study was approved by the Boston Children’s Hospital Institutional Review Board (IRB-P000044617) with waiver of consent.

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Kizilski, S.B., Recco, D.P., Sperotto, F. et al. Transcatheter Pulmonary Artery Banding in High-Risk Neonates: In-Vitro Study Provoked by Initial Clinical Experience. Cardiovasc Eng Tech 14, 640–654 (2023). https://doi.org/10.1007/s13239-023-00674-2

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