Utility of the Medtronic microvascular plug™ as a transcatheter implantable and explantable pulmonary artery flow restrictor in a swine model

Catheter Cardiovasc Interv. 2019 Jun 1;93(7):1320-1328. doi: 10.1002/ccd.28162. Epub 2019 Mar 3.

Abstract

Background: A surgical pulmonary artery band (PAB) is used to control excessive pulmonary blood flow for certain congenital heart diseases. Previous attempts have been made to develop a transcatheter, implantable pulmonary flow restrictor (PFR) without great success. We modified a microvascular plug (MVP) to be used as a PFR. The objectives of this study were to demonstrate feasibility of transcatheter implantation and retrieval of the modified MVP as a PFR, and compare PA growth while using the PFR versus PAB.

Methods and results: The PFR was implanted in eight newborn piglets in bilateral branch pulmonary arteries (PAs). Immediately post-PFR implantation, the right ventricular systolic pressure increased from a median of 20-51 mmHg. Transcatheter retrieval of PFR was 100% successful at 3, 6, and 9 weeks and 50% at 12-weeks post-implant. A left PAB was placed via thoracotomy in four other newborn piglets. Debanding was performed 6-weeks later via balloon angioplasty. On follow-up, the proximal left PA diameters in the PFR and the PAB groups were similar (median 8 vs. 7.1 mm; p = 0.11); albeit the surgical band sites required repeat balloon angioplasty secondary to recurrent stenosis. By histopathology, there was grade II vessel injury in two pigs immediately post-retrieval of PFR that healed by 12 weeks.

Conclusions: Transcatheter implantation and retrieval of the MVP as a PFR is feasible. PA growth is comparable to surgical PAB, which is likely to require reinterventions. The use of the MVP as a PFR in humans has to be trialed before recommending its routine use.

Keywords: animal models; coil/device/transcatheter; congenital heart disease; embolization; foreign body retrieval; interventional devices/innovation; pediatric intervention; pediatrics.

Publication types

  • Comparative Study

MeSH terms

  • Angioplasty, Balloon
  • Animals
  • Animals, Newborn
  • Blood Flow Velocity
  • Device Removal
  • Endovascular Procedures / adverse effects
  • Endovascular Procedures / instrumentation*
  • Feasibility Studies
  • Ligation
  • Models, Animal
  • Pulmonary Artery / growth & development
  • Pulmonary Artery / surgery*
  • Pulmonary Circulation*
  • Recurrence
  • Risk Factors
  • Stenosis, Pulmonary Artery / etiology
  • Stenosis, Pulmonary Artery / physiopathology
  • Stenosis, Pulmonary Artery / therapy
  • Sus scrofa
  • Time Factors
  • Vascular Access Devices*
  • Vascular Surgical Procedures* / adverse effects