Biocompatibility of an apical ring plug for left ventricular assist device explantation: Results of a feasibility pre‐clinical study

Abstract

Background: Patients receiving left ventricle assist devices (LVADs) as bridge to recovery remain a minority with 1%-5% of LVADs explanted after improvement of myocardial function. Nevertheless, considering the growing population of patients supported with LVADs, an increasing demand of new explantation strategies is expected in the near future. A novel plug for LVAD explantation has been developed and its biocompatibility profile needs to be proved. This study tested the biocompatibility of this novel plug in an in vivo ovine model. Methods:Six adult Blackhead Persian female sheep received plug implantation on the cardiac apex via minimally invasive approach and were clinically observed up to 90 days. Echocardiography was performed to detect thrombus formation or further plug-related complications. After the observation period, euthanasia was performed and samples including the plug and the surrounding tissues were obtained to be analyzed with correlative light and electron microscopy. Organ necrosis, ischemia and peripheral embolism were investigated.Results: Three animals survived surgery and completed the follow-up time without experiencing clinical complications. Echocardiographic controls excluded the presence of an intracavitary thrombus in the left ventricle (LV). Autopsy confirmed no signs of local infection, LV thrombus or peripheral embolism. Light and electron microscopy revealed an intact epithelium covering a layer of connective tissue on the plug surface facing the heart lumen.Conclusions: This novel apical plug for LVAD explantation allows for endothelial and connective tissue growth on its ventricular side within 90 days from surgery. Further studies are required to fully demonstrate the biocompatibility of this apical plug and investigate the optimal anticoagulation regimen to be applied after implantation.

Novel Plug Device for HeartMate 3 Explantation: First Multicenter Experience

“…If proven, anticoagulation would be only necessary for the early postoperative period, reducing the long-term bleeding risks. Ongoing in-vivo animal studies are currently testing this hypothesis 12 . Studies with longer follow-up can monitor the evolution of the outflow graft status and risk of infection related the graft material and thrombus formation inside the graft.…”

Outcome of percutaneous HeartMate3 decommissioning: A single‐centre experience

“…Moreover, the use of the recovery plug is still off-label, and further studies are needed to evaluate its biocompatibility and the possibility of causing infection. 17 Furthermore, other studies are required to compare the long-term results of both methods, especially regarding the possibility of infection due to retained parts. 18 There has been considerable debate regarding whether anticoagulation should be continued after decommissioning.…”

“…Compared with percutaneous decommissioning, the latter appears to be easier and less demanding. Moreover, the use of the recovery plug is still off‐label, and further studies are needed to evaluate its biocompatibility and the possibility of causing infection 17 . Furthermore, other studies are required to compare the long‐term results of both methods, especially regarding the possibility of infection due to retained parts 18 …”

Impella 5.5 implantation in a patient with left ventricular assist device thrombosis as a bridge to recovery strategy

“…The usage of Impella 5.5 implantation is a feasible and safe concept to bridge LVAD patients to cardiac recovery and offers the possibility of LVAD re‐implantation as a bailout option. Alternative concepts for decommissioning the device are the placement of a plug or full LVAD, interventional decommissioning, surgical explantation, and left ventricular reconstruction 3–5 . We refrained from both due to the limited availability of the HVAD plug and to reduce surgical trauma and operating time as well as to avoid the use of the heart‐lung machine.…”