A new tool for an explantation strategy of HeartMate 3™ left ventricular assist device

Abstract

Although rare, recovery of cardiac function after mechanical support of the left ventricle is the most desirable therapeutic goal in the treatment of end-stage heart failure.Herein, we present a novel implantable device for explantation of the HeartMate 3™ left ventricular assist device (LVAD) in patients, following cardiac recovery, avoiding (re-) sternotomy.This article demonstrates the feasibility of applying this novel device, which fits into the sewing ring of the LVAD.This custom-made mechanical plug offers a promising alternative to standard device-explantation procedures.

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

“…Several approaches to LVAD explantation have been described, including ventriculoplasty with removal of the sewing ring or apical sewing ring preservation and occlusion with the use of a plug 4,8,22 . Different custom manufactured plugs have been designed for this purpose but none of them is currently FDA (Food and Drug Administration) or CE‐mark (Communauté européenne mark) approved for routine clinical use 8,11,13,23 . This lack of clear and approved strategies generates some degrees of uncertainty in case of LVAD explant.…”

“…The plug has been designed to resist a pressure greater than 750 mm Hg and completely seal the apical sewing ring based on a silicone gasket. 13…”

Is this the right MOMENTUM?—evidence from a HeartMate 3 randomized trial

“…In our experience, we prefer to explant the pump and ligate the outflow graft, while leaving the inflow sewing ring in place. As with this technique a strategy to occlude the ventriculotomy is required, we designed a novel custommade apical ring plug which facilitates a minimally invasive implantation approach (19).…”

The evolution of mechanical circulatory support (MCS): a new wave of developments in MCS and heart failure treatment

“…Ricklefs et al presented data on the outcome of the worldwide first successful HeartMate 3 implantation as a treatment for right HF (14). The same group also described a novel surgical tool for myocardial recovery after LVAD implantation (15). Pump thrombosis is a particularly severe post-operative complication and is often treated by lysis therapy.…”

“…Therefore currently, considerable research is focused on the detection of pump thrombosis, as demonstrated by Feldmann et al who presented data from a study on an acoustic detection method for testing artificial thrombus models (18). In cases where pump exchange is an inevitable treatment option, less invasive surgical strategies and innovative devices that facilitate less invasiveness will help reduce further post-operative complications in patients (15). Another critical postoperative complication associated with LVAD-related re-hospitalization and mortality is the occurrence of LVAD-driveline infections.…”