Results from a multicentre evaluation of plug use for left ventricular assist device explantation

Abstract

OBJECTIVES Myocardial recovery allows for left ventricular assist device (LVAD) explantations after long-term support. Several surgical approaches, including interventional decommissioning, off-pump explantation using a custom-made plug and complete LVAD removal through redo sternotomy, have been described. We present the results from an evaluation of the long-term follow-up of patients who received a titanium sintered plug after LVAD explantation. METHODS We performed a retrospective, European, multicentre analysis of patients who received a titanium sintered plug to seal the apical fixation ring after LVAD explantation. Data were collected from a questionnaire that included demographics, procedural details and follow-up information. RESULTS Out of 54 contacted centres in 12 countries (n = 179 patients), a total of 68 patients were successfully included in the study. The median follow-up was 34 months (interquartile range: 17–58.5 months); 57 (84%) patients had >1-year follow-up. At the time of the last follow-up, 55 (81%) patients were alive, with a Kaplan–Meier 1-year survival of 90.1% (95% confidence interval: 84.0–98.1%) and a 5-year survival of 80.0% (95% confidence interval: 68.4–92.9%). One patient (1.5%) developed a plug infection originating from an infected part of the incorporated driveline and, after complete removal, is currently in good condition. No postoperative stroke has been reported after plug implantation. CONCLUSIONS In this European multicentre study, the use of a custom-made titanium plug to close the apical fixation ring after LVAD explantation resulted in a low incidence of plug-related complications. With the volume of patients undergoing LVAD explantations after myocardial recovery increasing, the plug has evolved as a simple alternative to more invasive device explantation procedures or decommissioning with a high risk for infection of the remaining system or stroke.

Patient-tailored silicone plug for HeartMate 3™ left ventricular assist device explantation

“…Explantation of LVAD devices is becoming increasingly prevalent as the number of patients receiving LVAD implantation increases and medical treatment advances [ 2 , 3 ]. Restoring cardiac function is the ultimate objective of congestive heart failure treatment.…”

Left ventricular assist device explantation using a new double-patch technique

“…In addition, a titanium plug system for simplified removal of the pump with closure of the apex via the suture ring has been described in a large cohort of patients, with good results. This procedure can usually be performed without the use of the heart‒lung machine [ 10 ]. To date, however, no CE-certified plug system on the market has been approved, so individual approval must be obtained from local health authorities.…”

“…A retrospective multicentre study analysed the use of a titanium plug to close the apical fixation ring after LVAD explantation and showed a low incidence of plug-related complications [ 10 ]. The use of different plug systems with total explantation of the LVAD and driveline was described previously [ 11 ].…”

Recovery of a dilated left ventricle after cessation of cocaine and HVAD™ explantation using a titanium plug

“…LVAD device explantation is becoming more common as the number of patients getting LVAD implantation grows along with the improvement of medical therapy. [2][3][4] F I G U R E 1 Custom-made mechanical plug (manufactured by INNOVO Solutions GmbH, Germany; contact: info@innovosolutions. de) for the explantation of a HeartWare™ (HVAD) ventricular assist device Restoring cardiac function is the ultimate goal in treating congestive heart failure.…”

“…LVAD device explantation is becoming more common as the number of patients getting LVAD implantation grows along with the improvement of medical therapy 2–4 …”