Ventricular Assist Device Explantation Research Articles

Intraoperative cytokine adsorption in cardiothoracic transplant patients: An Australian propensity-score matched pilot study.

It is unclear if immunomodulation via cytokine adsorption (CA) to reduce perioperative inflammatory cascade in cardiothoracic transplants is associated with better outcomes. This pilot study aims to assess the clinical outcomes of intraoperative CA in heart/lung transplantation. From July to October 2020, intraoperative CA was instituted in 11 patients who underwent heart/lung transplantation. One-to-one propensity score matching without replacement was conducted with historical patients who did not receive CA at the time of surgery. Primary end-points evaluated were vasopressor/ inotropic demands, blood loss and mortality. Secondary end-points measured were operative morbidities. After matching, there were 2 (18.2%) ventricular assist device explant with heart transplantation, 2 (18.2%) heart transplantation and 7 (63.6%) lung transplantation in each group. Mean age in both groups were 53.3 years and 54.9 years respectively. The duration of noradrenaline requirement in the CA group was shorter (median, 1627 versus 3144 min, P = 0.5) and postoperative dopamine demand was significantly higher (median peak dose, 5.0 versus 0 μg/kg/min, P = 1.0; median duration of use, 7729 versus 0 min, P = 0.01). Non-red blood cell transfusion rate was two times higher in CA patients (90.9% versus 45.4%, P = 0.06). Early mortality was higher in the control group (18.2% versus 9.1%, P = 1.0). No differences were observed in the incidences of operative morbidities. Intraoperative CA in heart and lung transplantation in our institution was not associated with significant improvement in clinical outcomes, including vasopressor/inotropic demand. Larger studies are required to evaluate the transfusion requirements and mortality risks with CA use in this patient population.

Durable left ventricular assist device explantation following recovery in paediatric patients: Determinants and outcome after explantation.

Myocardial recovery in children supported by a durable left ventricular assist device is a rare, but highly desirable outcome because it could potentially eliminate the need for a cardiac transplant and the lifelong need for immunosuppressant therapy and the risk of complications. However, experience with this specific outcome is extremely limited. All patients < 19 years old supported by a durable left ventricular assist device from the European Registry for Patients with Mechanical Circulatory Support database were included. Participating centres were approached for additional follow-up data after explantation. Associated factors for explantation due to myocardial recovery were explored using Cox proportional hazard models. The incidence of recovery in children supported by a durable left ventricular assist device was 11.7% (52/445; median duration of support, 122.0 days). Multivariable analyses showed body surface area (hazard ratio 0.229; confidence interval 0.093-0.565; P = 0.001) and a primary diagnosis of myocarditis (hazard ratio 4.597; confidence interval 2.545-8.303; P < 0.001) to be associated with recovery. Left ventricular end-diastolic diameter in children with myocarditis was not associated with recovery. Follow-up after recovery was obtained for 46 patients (88.5%). Sustained myocardial recovery was reported in 33/46 (71.7%) at the end of the follow-up period (28/33; >2 year). Transplants were performed in 6/46 (11.4%) (in 5 after a ventricular assist device was reimplanted). Death occurred in 7/46 (15.2%). Myocardial recovery occurs in a substantial portion of paediatric patients supported with durable left ventricular assist devices, and sustainable recovery is seen in around three-quarters of them. Even children with severely dilated ventricles due to myocarditis can show recovery. Clinicians should be attentive to (developing) myocardial recovery. These results can be used to develop internationally approved paediatric weaning guidelines.

(152) - Explantation of Durable Ventricular Assist Device for Myocardial Functional Recovery in Children: A Report from The Action Registry

(152) - Explantation of Durable Ventricular Assist Device for Myocardial Functional Recovery in Children: A Report from The Action Registry

Maine Medical Center Experience with Explantation of Left Ventricular Assist Devices

Maine Medical Center Experience with Explantation of Left Ventricular Assist Devices

Abstract 17254: Myocardial Functional Recovery Following Durable Ventricular Assist Device in Children

Introduction: Ventricular Assist Device (VAD) explantation following myocardial functional recovery (MFR) for heart failure (HF) is uncommon and associated with a risk of recurrence of HF. Research Question: What are the patient characteristics and outcomes for VAD explantation in children following MFR? Methods: Retrospective, single centre study of patients who were supported with durable VADs, both intracorporeal continuous flow devices (CFD) and paracorporeal pulsatile flow devices (PFD) between 2004 to 2022. Results: A total of 75 children, of which 43 were female, underwent VAD implantation (PFD = 61 and CFD = 14) at a median (IQR) age of 5.6 (0.8, 13.5) years and with a weight of 16.2 (7.5, 40.7) kg. From this cohort, we identified 8/75 (11%) children who underwent VAD explantation for MFR after a median duration of 56 (22, 115) days. All were supported with durable PFD. Five were listed for transplantation as a part of their HF management strategy following VAD implantation and four patients had dilated cardiomyopathy (DCM). Of those, 7/8 (88%) children with MFR were under 2 years of age and 5/8 (63%) were supported for &gt; 90 days. The pathological findings on the LV core samples were variable in severity and no patient had any evidence of active inflammation (see Table). After explant, 7/8 patients remained in HF remission with no symptoms and stable LV function. One patient had a recurrence of HF following explantation after demonstrating MFR while on VAD support. This patient was 5 years old at implant and was in HF remission for ~9 months following explant before HF recurrence, requiring VAD re-implantation and eventual heart transplantation. Conclusions: MFR resulting in VAD explantation is feasible in children with chronic HF especially for those &lt; 2 years of age. Further work is needed to help better identify the features that promote MFR and maintain it after explant.

Left Ventricular Assist Device explantation using a new double patch technique.

There are several surgical approaches for explantation of an LVAD after recovery of cardiac function. Thus, remaining ventricular assist device components may bear significant risks of infection or thrombosis. We hereby report our technique and two-center experience with explantation of LVADs using a new double patch technique. From March 2019-April 2021, 5 patients underwent LVAD explantation after myocardial recovery (HVAD, n = 2; HeartMate 3, n = 3). Mean patient age was 50.3 years (100% male) and mean time on LVAD was 23.1 ± 20.8 months. Primary heart failure aetiology was dilated cardiomyopathy (n = 4) and myocarditis (n = 1).LVAD explantation was performed using a median sternotomy and cardiopulmonary bypass. The LVAD was stopped, and the outflow graft clamped. The outflow graft was ligated and sutured close to the aortic anastomosis. The driveline was clipped and removed. Under induced fibrillation, the attachment of the LVAD was released from the apical cuff and the LVAD was removed. A round pericardial patch was fixed from the inner of the ventricle. This already seals the apex of the heart. An additional Goretex patch is continuously sutured epicardially over the suture ring. The 5 cases showed technically uncomplicated explantation of the LVADs. During the follow-up of mean 16.4 ± 16.9 months, survival of 100% was observed. There were no bleeding complications or thromboembolic events during follow-up. LVAD explantation with the double patch technique is feasible and safe. This technique allows discontinuation of anticoagulation. There was a 30-day survival of 100%. Further studies are needed to provide better evidence for LVAD explantation and long-term follow-up.

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

Patient-tailored silicone plug for HeartMate 3™ left ventricular assist device explantation in two successive males proceeded successfully. Given medical therapeutic advancements, FDA-approved plug systems designed by LVAD manufacturers themselves will be necessary for the near future to provide a safe and simple device explantation alternative that fulfills all regulatory standards.

Epidemiology, management, and clinical outcomes of extrapulmonary Mycobacterium abscessus complex infections in heart transplant and ventricular assist device recipients

Nontuberculous mycobacteria are emerging pathogens, yet data on the epidemiology and management of extrapulmonary nontuberculous mycobacteria infections in orthotopic heart transplantation (OHT) and ventricular assist device (VAD) recipients are scarce. We retrospectively reviewed records of OHT and VAD recipients who underwent cardiac surgery at our hospital and developed Mycobacterium abscessus complex (MABC) infection from 2013 to 2016 during a hospital outbreak of MABC linked to heater-cooler units. We analyzed patient characteristics, medical and surgical management, and long-term outcomes. Ten OHT patients and 7 patients with VAD developed extrapulmonary M. abscessus subspecies abscessus infection. The median time from presumed inoculation during cardiac surgery to the first positive culture was 106 days in OHT and 29 days in VAD recipients. The most common sites of positive cultures were blood (n = 12), sternum/mediastinum (n = 8), and the VAD driveline exit site (n = 7). The 14 patients diagnosed when alive received combination antimicrobial therapy for a median of 21 weeks, developed 28 antibiotic-related adverse events, and underwent 27 surgeries. Only 8 (47%) patients survived longer than 12 weeks after diagnosis, including 2 patients with VAD who experienced long-term survival after an explantation of infected VADs and OHT. Despite aggressive medical and surgical management, OHT and VAD patients with MABC infection experienced substantial morbidity and mortality.

(1075) The Crossroads in VAD - To Wean or Not to Wean: A Meta-Analysis on Predictors of Feasibility of Ventricular Assist Device Explantation with Stable Myocardial Recovery in Chronic Non-Ischemic Dilative Cardiomyopathy

(1075) The Crossroads in VAD - To Wean or Not to Wean: A Meta-Analysis on Predictors of Feasibility of Ventricular Assist Device Explantation with Stable Myocardial Recovery in Chronic Non-Ischemic Dilative Cardiomyopathy

(1025) Myocardial Recovery Profile in Patients Following Left Ventricular Assist Device Explantation

(1025) Myocardial Recovery Profile in Patients Following Left Ventricular Assist Device Explantation

P58: Late Infectious Complications Following Ventricular Assist Device Explant: A Case Series

P58: Late Infectious Complications Following Ventricular Assist Device Explant: A Case Series

Left Ventricular Assist Device as a Bridge to Recovery: Single Center Experience of Successful Device Explantation.

Continuous-flow left ventricular assist devices (CF-LVAD) have been shown to enhance reverse remodeling and myocardial recovery in certain patients allowing for device removal. We sought to analyze the characteristics and describe outcomes of patients who underwent CF-LVAD explantation at a large academic center. We retrospectively identified all patients who underwent CF-LVAD explants due to recovery from 2006 to 2019. Patient baseline characteristics and data on pre- and postexplant evaluation were collected and analyzed. Of 421 patients who underwent CF-LVAD implantation, 13 underwent explantation (3.1%). Twelve HeartMate II and one HeartWare LVAD were explanted. All patients had nonischemic cardiomyopathy. Median time from heart failure diagnosis to LVAD implant was 12 months (interquartile range [IQR], 2-44) and the median time supported on LVAD was 22 months (IQR, 11-28). Two patients died within 30 days of explant. Three additional patients died during the follow-up period and all were noted to be nonadherent to medical therapy. After a mean follow-up duration of 5 years, overall survival was 52%. Mean pre-explant ejection fraction was 49%, which decreased at most recent follow-up to 32%. Mean pre-explant left ventricular internal diameter in diastole (LVIDD) was 4.37 cm and increased to 5.52 cm at most recent follow-up. Continuous-flow left ventricular assist device explantation is feasible and safe in select patients.

Ventricular assist device support for children with chemotherapy-induced cardiomyopathy and advanced heart failure: Perspectives gained from a single-center experience.

Guidance and data on ventricular assist device (VAD) support for children with chemotherapy-induced cardiomyopathy, particularly within the first 2years after chemotherapy, are limited. We performed a single-center retrospective case series, reviewing medical records of children <18years of age with chemotherapy-induced cardiomyopathy and advanced heart failure (HF) who received durable VAD support. Six patients met inclusion criteria-5 HeartWare™ HVAD, 1 Berlin Heart EXCOR® . Median age at cancer diagnosis was 6years (IQR 4.5-10years). Median dose of anthracycline received was 540mg/m2 (IQR 450-630mg/m2 ). All patients developed HF within 1year after initiation of cancer treatment (median 8months, IQR 6-11.5months) and were initiated on durable VAD support at a median of 8months after completion of cancer treatment (IQR 3.3-43.5months). Four patients had significant right ventricular dysfunction needing oral pulmonary vasodilator therapy, one patient had a major bleeding complication, and two patients had thromboembolic strokes while on VAD support. Median duration of VAD support was 7.5months (IQR 3-11.3months). Two patients underwent VAD explant due to recovery of LV function, one died due to cancer progression, and three underwent heart transplantation. Durable VAD support should be considered as a therapeutic option for children who have advanced HF due to chemotherapy-induced cardiomyopathy, even within 2years of completing cancer treatment. A multi-disciplinary approach is essential for appropriate patient selection prior to implant and to ensure comprehensive care throughout the duration of VAD support.

Successful Explantation of Berlin Heart Excor in Two Young Children.

Berlin Heart EXCOR ventricular assist device (VAD) implantation in children is widely used as bridge-to-heart transplantation. Berlin left ventricular assist device (LVAD) support as a bridge to recovery is rare. There is a scarcity of literature describing systematic evaluation in pediatric VAD explantation. Patient 1. A 3 month old boy presented with acute heart failure secondary to myocarditis. An echocardiogram demonstrated severely depressed left ventricular function. He required ECMO cannulation and was decannulated 11 days later. He continued to be hemodynamically unstable and required Berlin LVAD implantation with the intent to bridge to transplantation. Patient 2. A 3 month old boy presented initially with a heart rate of 250 beats/min and an electrocardiogram showed multifocal atrial tachycardia. An echocardiogram showed severely decreased left ventricular function. He was placed on ECMO due to unstable hemodynamics. He did not tolerate ECMO decannulation due to persistent chaotic atrial rhythm and underwent Berlin LVAD implantation with the intent to bridge to transplantation. After both patients showed evidence of myocardial recovery, they underwent a weaning protocol that includes: screening, trial-off with echocardiography, and trial-off in the catheterization suite. Our patients met the criteria and underwent successful explantation. Explantation of VAD can be successfully performed even in young children with appropriate candidate selection and a multidisciplinary and systematic approach.

Bacteriophage Therapy for Treatment of a Multi-Drug Resistant VAD-Specific Infection in a Pediatric Patient

<h3>Introduction</h3> Ventricular assist device (VAD) driveline infections are a source of significant morbidity and recurrence can result in multi-drug resistant infections (MDRIs). Bacteriophage (BP) therapy has been successfully used for MDRIs, but it has not been described in a pediatric VAD-specific MDRI. We present the case of BP therapy used for the control of a <i>Klebsiella pneumoniae</i> VAD-specific MDRI in a pediatric patient. <h3>Case Report</h3> A 10 y/o highly sensitized male with a HeartWare HVAD™ (Medtronic, Fridley, MN) in place for heart failure secondary to congenital heart disease developed a MDR <i>K. pneumoniae</i> VAD pump pocket and deep driveline infection. He underwent debridement, creation of fistulous tract for additional drainage, and prolonged IV antibiotic therapy (including extended infusions of meropenem). He continued to have purulent drainage from his fistulous tract, intermittent fevers, and evidence of worsening infection on serial imaging. Fifteen months after the infection was identified, he developed worsening heart failure and concern for pump thrombosis prompting plans for device exchange. Given the high risk of infection of the new VAD, BP therapy was developed (TAILOR, Baylor College of Medicine, Houston, TX) and administered under an emergency Investigational New Drug application with the US Food and Drug Administration. After 4 days of systemic BP therapy he underwent VAD explant to extracorporeal membrane oxygenation (ECMO) support followed by serial mediastinal washouts with antibiotic and local BP application prior to placement of the new VAD. He completed a 6 week course of systemic BP with ongoing meropenem therapy. No adverse reactions associated with BP were observed. He subsequently underwent heart transplant on day 37 of 42 of BP therapy when a donor organ became available. No evidence of mediastinitis was observed intra-operatively at time of transplant; cultures and PCRs from the mediastinal tissue were negative. He is now 6 months post-transplant without any evidence of infection recurrence. <h3>Summary</h3> Bacteriophage played a significant role in the eradication of a VAD-specific MDRI in a pediatric patient. This may represent a safe and effective therapy for device-related MDRIs refractory to antibiotic and surgical therapy in pediatric patients.

Vasoplegia Scoring System: Classifying a Poorly Defined Syndrome Following Heart Transplantation

<h3>Purpose</h3> Vasoplegia post heart transplantation is a well-recognised phenomenon, yet it is poorly defined within the literature, with contention regarding criteria for diagnosis. We therefore created a scoring system to retrospectively identity vasoplegic patients by rating their vasopressor requirements, cardiac function, and markers of vasodilation. <h3>Methods</h3> A total of 45 patients (71% male) who underwent heart transplantation were chosen and grouped into 3 cohorts to isolate key risk factors for vasoplegia. 15 patients underwent ventricular assist device explant (VE), 15 patients had undergone previous sternotomies (PS), and 15 had no previous sternotomies (NPS). The scoring tool was used to allocate points based on high vasopressor requirement, preserved cardiac index, low systemic vascular resistance and low SvO2. Demographic, operative, and post-operative data was obtained from the medical records, operation reports and ICU charts. <h3>Results</h3> Using the Vasoplegia Scoring System, a total of 13 patients were identified as having developed vasoplegia within the first 48 hours following transplant (p=1.0). This was most apparent at 24 hours with 4 VE, 2 PS and 5 NPS patients developing vasoplegia (p=0.57). However, using the Vasoplegia Scoring System, we could not detect a difference in the rates of vasoplegia between the three cohorts which may be on account of a small sample size. With similar rates of vasoplegia, there did not appear to be any difference in 30-day mortality, ICU length of stay and overall hospital length of stay amongst the three groups. <h3>Conclusion</h3> Using the Vasoplegia Scoring System, we identified that 29% of the patients developed vasoplegia in the immediate post-operative period. Using this scoring system, there was no statistically significant difference between the three groups in terms of which patients experienced vasoplegia at higher rates. As such, there did not appear to be any difference in their post operative outcomes.

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

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. Six adult Blackhead Persian female sheep received plug implantation on the cardiac apex via minimally invasive approach and were clinically observed up to 90days. 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. 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. This novel apical plug for LVAD explantation allows for endothelial and connective tissue growth on its ventricular side within 90days 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.

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

OBJECTIVESMyocardial 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. METHODSWe 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.RESULTSOut 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.CONCLUSIONSIn 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.

Cardiac MRI Detection of Left Ventricular Aneurysm in Children After Ventricular Assist Device Explantation.

Consensus is lacking regarding screening for complications such as ventricular aneurysms after ventricular assist device explant. We report two pediatric patients, status-post explantation, who developed true left ventricular apical aneurysms diagnosed by cardiac magnetic resonance imaging. Imaging also suggested laminated thrombus versus postoperative changes which were treated with antiplatelet therapy.

Antiplatelet and Anticoagulant Strategies Following Left Ventricular Assist Device (LVAD) Explantation or Decommissioning: A Scoping Review of the Literature

Mechanical circulatory support using left ventricular assist devices (LVADs) has transformed management of patients with end-stage heart failure with more patients on LVAD therapy surviving long enough to necessitate either device explantation or decommissioning. Usually, there is foreign material retained following these procedures that requires maintaining antiplatelet and/or anticoagulant therapy. However, there is no consensus on optimal management of antiplatelet and anticoagulant therapy following LVAD explantation or decommissioning. We conducted a scoping review of antiplatelet and anticoagulation strategies, searching EMBASE, PubMed and CENTRAL. A total of 15 case reports and series encompassing 38 patient cases were found that met inclusion criteria. There was a heterogeneity of LVAD types and techniques used for explantation and decommissioning. Most reports identified in our review maintained patients on a vitamin K antagonist for at least 3 months post-explantation or decommissioning with or without concomitant antiplatelet therapy with low-dose aspirin. However, there was no single agreed-upon optimal strategy for antiplatelet and anticoagulant use post-procedure. Factors such as the degree of foreign material retained following device explantation or decommissioning and whether there is another indication for anticoagulation or antiplatelet use must be considered. A lack of overall consensus indicates that more studies are needed in this area to establish definitive guidelines around antiplatelet and anticoagulant therapy following LVAD explantation or decommissioning.