Novel Plug Device for HeartMate 3 Explantation: First Clinical Results

Purpose Recovery after left ventricular assist device (LVAD) implantation occurs in 1-5% of patients, allowing for LVAD explantation. Considering the growth in LVAD numbers, we can expect an increase of potential candidates to LVAD explantation in the near future. Therefore, there is an important need for novel less invasive explantation strategies. Herein, we report the first series of patients who underwent HeartMate 3 (HM3) explantation with the use of a custom-made apical ring plug. Methods We retrospectively reviewed data of patients who underwent HeartMate3 (HM3) explantation with a new apical ring plug between September 2018 and September 2019. All patients underwent standardized weaning protocol including echocardiography (at rest and under exercise) and right heart catheterization. Apical ring plug positioning was performed through left lateral thoracotomy under cardiopulmonary bypass support. This study analysed perioperative survival, Intensive Care Unit (ICU) stay, postoperative bleeding, perioperative transfusions, infections, thrombosis and strokes. Results Four patients were included. Median age was 44.5 years (M:F= 3:1) and time on LVAD support was 21 months (Table 1). All surgical procedures were uneventful and without technical difficulties. Transfusions and blood loss were minimal. No hemorrhagic, embolic or infective events were recorded. Anticoagulation with heparin was started 6 hours after surgery as bridge to oral anticoagulation (INR: 2-2.5). All patients were discharged from ICU. Three of them were discharged within 48 hours from surgery, one patient required re-intubation for pneumonia and was successfully discharged from ICU after 10 days. Conclusion This novel plug device for HM3 explantation was successfully and safely implanted in this first patient series. Even if no plug-related complications were recorded, the plug use should still be considered off-label and wider studies are required before allowing its application on larger populations.