Underwent Ventricular Assist Devices Implantation Research Articles

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 > 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 < 2 years of age. Further work is needed to help better identify the features that promote MFR and maintain it after explant.

CoronaVac, BNT162b2 and heterologous COVID-19 vaccine outcomes in patients with ventricular assist device.

A consensus has not yet been reached regarding which COVID-19 vaccine program should be applied in patients with ventricular assist device (VAD). Our aim was to assess the clinical outcome of inactivated, mRNA and heterologous vaccine program in patient with VAD. In this retrospective and cross-sectional study; adult patients who underwent VAD implantation between January 2012 and September 2021 and received any vaccine that were used in Republic of Türkiye for COVID-19, were included. The patients were divided into three groups according to the type of vaccine; "inactivated," "mRNA" and "heterologous." Clinical outcomes were analyzed. Eighteen patients were in each group in the "inactivated," "mRNA" and "heterologous" groups. Mean age was 51.6 ± 12 years in "inactivated" group, 42.5 ± 15.5 years in "mRNA" group and 41.1 ± 15.4 years in "heterologous" group. There was no significant difference between the groups in age, gender, body surface area, body mass index and etiology (p > 0.05). After last dose of vaccines, the number of patients had COVID-19 positive test were three (16.7%), one (5.6%), and two (11.1%) in "inactivated," "mRNA" and "heterologous" groups, respectively. Pump thrombosis was seen in two patients in "mRNA" group and one patient in "heterologous" group. No pump thrombosis was seen in "inactivated" group. COVID-19-related death or intubation was not observed. All vaccine that used for COVID-19 are safe and effective in patients with VAD. In countries that give priority to inactivated vaccines, mRNA vaccines may then be made as boosters.

Ventricular Assist Device Outcomes in Infants and Children With Stage 1 Single Ventricle Palliation.

Data on ventricular assist device (VAD) outcomes in infants with stage 1 single ventricle (SV) palliation are limited. We examined the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry for outcomes of pre/poststage 1 SV patients undergoing VAD implantation between March 2018 and October 2020. Data are collected from 32 centers and major adverse events undergo central adjudication. During the study period, 30 stage 1 SV patients underwent VAD implant with median age of 0.9 months (range 0.1-25) and weight 3.7 kg (2.4-17). Preimplant illness severity was high: ventilator support (90%), ECMO (30%), prior cerebral vascular accident (CVA, 23%), and dialysis (13%). Devices used included paracorporeal pulsatile (50%), paracorporeal continuous-flow (37%), and multiple devices (13%). Median support duration was 56 days (range 3-246). A positive clinical outcome (transplanted or weaned) was attained in 63% (63% transplanted, 37% mortality, 0% weaned). VAD adverse events included: major infection (43%), neurologic dysfunction (any = 30%; CVA = 20%), major bleeding (17%), renal dysfunction (13%), and device malfunction (3%). In conclusion, stage 1 SV patients undergoing VAD support have high preimplant illness severity and complexity, as well as significant morbidity and mortality postimplant. A variety of devices and strategies are employed by centers to support this challenging population.

Neonatal ventricular assist device implantation for high-risk hypoplastic left heart syndrome: How we do it.

Neonatal ventricular assist device implantation for high-risk hypoplastic left heart syndrome: How we do it.

Outcomes Of Intermittent Hemodialysis During Support With Ventricular Assist Devices: A Potential Bridge To Heart/kidney Transplantation?

Introduction Severe renal dysfunction is a contraindication for receiving ventricular assist devices (VADs). Hence, patients with end-stage heart failure (ESHF) and severe renal dysfunction who are not candidates for heart/kidney transplantation (HT/KT) may only be considered for either intermittent hemodialysis (IHD) or hospice. However, there is little evidence about the outcomes of patients with ESHF who are initiated on IHD after VAD implantation. Methods We reviewed the medical charts of all patients in our center who received IHD after VAD implantation. We considered IHD <6-hour sessions 3-4 times weekly, excluding continuous renal replacement therapy (CRRT). Continuous variables were expressed in means and standard deviations, or medians and p25-p75, according to their distribution. Categorical variables were represented in absolute numbers and percentages. Results Eleven patients (54.1 [±9.9] years of age, 6 [54.6%] women, and 6 [54.6%] African American) underwent VAD implantation as destination therapy (40%) or bridge to transplant (60%) and received IHD. Seven (63.6%) of them received HeartMate II, whereas the other patients were supported with HVAD HeartWare, and HeartMate 3 systems. By the time of VAD implantation, nine (81.8%) patients had history of chronic kidney disease with a median GFR was 60 (45-60) mL/min/1.73 m2 and a mean creatinine was 1.2 (±0.4) mg/dL. The mean outpatient furosemide-dose equivalent prior VAD implantation was 106 (±59.7) mg/day. Ten patients started IHD prior to discharge after VAD placement with a median time from VAD implantation to initiation of IHD was 26 (17-50) days. Another patient was initiated on IHD as outpatient within a year after receiving a VAD. Eight (72.7%) patients died during a follow-up of 886.7 (±762.1) days after initiation of IHD with a median survival time of 838 days. Three patients were bridged to transplantation: 2 HT/KT, and 1 HT (recovered renal function). Details about the timeline of events can be found in Fig 1. Conclusions Intermittent hemodialysis helped to bridge 2 VAD patients to HT/KT, and another to HT and recovery of renal function. Larger studies could provide valuable insight into this potential strategy to widen the options of advanced heart failure therapies for patients with ESHF. Severe renal dysfunction is a contraindication for receiving ventricular assist devices (VADs). Hence, patients with end-stage heart failure (ESHF) and severe renal dysfunction who are not candidates for heart/kidney transplantation (HT/KT) may only be considered for either intermittent hemodialysis (IHD) or hospice. However, there is little evidence about the outcomes of patients with ESHF who are initiated on IHD after VAD implantation. We reviewed the medical charts of all patients in our center who received IHD after VAD implantation. We considered IHD <6-hour sessions 3-4 times weekly, excluding continuous renal replacement therapy (CRRT). Continuous variables were expressed in means and standard deviations, or medians and p25-p75, according to their distribution. Categorical variables were represented in absolute numbers and percentages. Eleven patients (54.1 [±9.9] years of age, 6 [54.6%] women, and 6 [54.6%] African American) underwent VAD implantation as destination therapy (40%) or bridge to transplant (60%) and received IHD. Seven (63.6%) of them received HeartMate II, whereas the other patients were supported with HVAD HeartWare, and HeartMate 3 systems. By the time of VAD implantation, nine (81.8%) patients had history of chronic kidney disease with a median GFR was 60 (45-60) mL/min/1.73 m2 and a mean creatinine was 1.2 (±0.4) mg/dL. The mean outpatient furosemide-dose equivalent prior VAD implantation was 106 (±59.7) mg/day. Ten patients started IHD prior to discharge after VAD placement with a median time from VAD implantation to initiation of IHD was 26 (17-50) days. Another patient was initiated on IHD as outpatient within a year after receiving a VAD. Eight (72.7%) patients died during a follow-up of 886.7 (±762.1) days after initiation of IHD with a median survival time of 838 days. Three patients were bridged to transplantation: 2 HT/KT, and 1 HT (recovered renal function). Details about the timeline of events can be found in Fig 1. Intermittent hemodialysis helped to bridge 2 VAD patients to HT/KT, and another to HT and recovery of renal function. Larger studies could provide valuable insight into this potential strategy to widen the options of advanced heart failure therapies for patients with ESHF.

Short-term Outcomes Of Intermittent Hemodialysis In Patients With Ventricular Assist Devices

<h3>Introduction</h3> There is little evidence about the short-term outcomes of patients undergoing implantation of ventricular assist devices (VADs) who require initiation of chronic intermittent hemodialysis (IHD). Filling this knowledge gap may help anticipate potential complications and improve outcomes. <h3>Methods</h3> This is a chart review, retrospective study that included all patients who underwent VAD implantation followed by initiation of IHD at our center. Intermittent hemodialysis was defined as ≤6-hour sessions, 3-4 times weekly. Continuous renal replacement therapy (CRRT) did not meet this inclusion criteria. Continuous and categorical variables were expressed in means (standard deviation) and numbers (%), respectively. <h3>Results</h3> Among the 11 patients that met inclusion criteria, 6 (54.6%) were female, 6 (54.6%) were African American, 6 (54.6%) had non-ischemic cardiomyopathy, 6 were being bridged to HT, and 9 (81.8%) had chronic kidney disease. Home regimen was available for 10 patients, all of whom were taking loop diuretics, but only 7 (70%) and 3 (30%) of them had medical regimens with ACEIs or ARBs, and spironolactone, respectively. All patients received tunneled catheters, and in 2 of them AV fistulas were performed afterwards. At least 3 patients experienced asymptomatic hypotension (<60 mm Hg) during the first 10 IHD sessions, leading to finishing the session early in one of the cases. Another patient had catheter thrombosis leading to catheter exchange. No other major event was documented during the 10 initial IHD sessions. One patient started IHD outpatient without complications. Among the 10 (90.9%) patients who started IHD during index hospitalization, the length of hospital stay was 81.5 (±40.7) days, and their most relevant complications were death (1), stroke (1), infections (5), gastrointestinal bleeding (4), right ventricular failure (2), and tracheostomy (1). For those who started IHD during index hospitalization, time to first readmission was 44.6 (±36.3) days, with 4 (44.4%) patients being readmitted within 30 days, and 1 of them dying during the first readmission. Additional information is found in Table 1. <h3>Conclusions</h3> This study confirms feasibility of IHD initiation after VAD implantation, even as outpatient, but also proves a high burden of morbidity during index hospitalization and short-term follow up. Larger studies prospective studies with the newest VADs could provide valuable insight into this strategy for left ventricular and renal replacement therapies.

Ventricular Assist Device Use in Pediatric Restrictive and Hypertrophic Cardiomyopathy: An Advanced Cardiac Therapies Improving Outcomes Network (ACTION) Analysis

<h3>Purpose</h3> Use of ventricular assist devices (VAD) in patients with restrictive (RCM) and hypertrophic cardiomyopathy (HCM) remains low compared to use in dilated cardiomyopathy. We describe the outcomes of patients with RCM and HCM supported by VAD and characteristics associated with successful VAD support. <h3>Methods</h3> We examined the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry for outcomes of patients with RCM, HCM and mixed HCM/RCM who underwent VAD implantation from March 2012 - July 2021, including major adverse events, and survival. <h3>Results</h3> Fourteen patients were identified and represent 2.2% of the ACTION registry at data collection. There were 9 initial LVAD (with 2 subsequent RVAD) and 5 initial BIVAD (1 total artificial heart). Of 12 LVAD patients with data, 4 had LA and 8 had LV cannulation. Median age was 3.4 years (range 0.3-16.9), weight 15 kg (5.2-57.2), and BSA 0.64 m2 (0.29-1.67). Diagnoses included RCM (50%), HCM (35.7%), and mixed RCM/HCM (14.3%). Illness severity at implant was high with 29% Intermacs profile 1, 50% on ECMO, 57.1% on ventilator support, 85.7% on 1 or more inotrope, and 64.3% on TPN. Twenty devices were used in 14 patients: 10 (50%) paracorporeal pulsatile, 6 (30%) paracorporeal continuous, 3 (15%) implantable continuous, and 1 (5%) intracorporeal pulsatile. Median duration of support was 80 days (8-412). Four patients died on device, 9 transplanted and 1 alive on device. Though not statistically significant, patients who died had higher incidence of pre-VAD: ECMO, TPN, Intermacs profile 1, HCM, initial BIVAD and major VAD-related adverse events. Cause of death was inadequate support (1, HCM with Rotaflow BiVAD), infection (2), and multi-organ failure (1). <h3>Conclusion</h3> Patients with restrictive and hypertrophic cardiomyopathy have high pre-implant illness severity, however, most patients had successful VAD outcomes. VAD support is a reasonable strategy for select RCM and HCM patients.

Outcomes of Pediatric Patients Supported with Ventricular Assist Devices

<h3>Purpose</h3> There has been a remarkable increase in the number of pediatric ventricular assist devices (VAD) implanted over the past decade. Asian pediatric heart centers had not participated in the multicenter registries of the Western countries. This article aimed to report the outcomes of pediatric VAD in our institution from the Asia-Pacific region. <h3>Methods</h3> Prospectively registered VAD database was reviewed. Data of patients younger than 18 years at the time of VAD implantation were retrieved. The study group enrolled all pediatric patients who underwent VAD implantation between January 2008 and July 2021. <h3>Results</h3> There were 33 patients with diagnosis of acute fulminant myocarditis (N = 9), congenital heart disease (N = 5), dilated cardiomyopathy (N = 16), restrictive cardiomyopathy (N = 2) and chronic rejection with graft failure (N = 1). Paracorporeal continuous-flow pump was the most frequently implanted (N = 27). Most of the devices were implanted in patients with INTERMACS profile 1 (N = 24). The median duration on VAD was 22 days (range 2-254 days). The proportion of patients attaining positive outcomes (alive on device, bridge to transplantation or recovery) was 72.7% at 1 month, 67.7% at 3 months, and 67.7% at 6 months. Most of the deaths on device occurred within the first month post-implant (N = 9), with neurological complications being the most frequent cause of death. All recovered cases were successfully weaned off the device within the first month of implantation. <h3>Conclusion</h3> We demonstrated a favorable outcome in pediatric patients supported with VAD, predominantly the paracorporeal continuous-flow pump, at our institution from the Asia-Pacific region.

Ventricular Assist Device Implantation for Infant End-Stage Heart Failure - A Single-Center Experience

<h3>Purpose</h3> Ventricular assist device (VAD) application in children is increasing these days. But, there are many challenges to successful clinical outcomes as a bridge to pediatric heart transplantation in young infants. We present our VAD implantation experience in a single center for pediatric end-stage heart failure in the infant. <h3>Methods</h3> We retrospectively reviewed clinical records of pediatric patients (n=10) under one year old who underwent VAD implantation between January 2018 and August 2021. Primary endpoints were heart transplantation, ongoing VAD support, or death. <h3>Results</h3> The median patient age was 11 month-old (239days old) (range: 3-12 month-old). The median BSA was 0.35m² (range: 0.26-0.45). The leading cause of heart failure requiring VAD support was dilated cardiomyopathy (<i>n</i> = 5), restrictive cardiomyopathy (n=1), myocarditis (<i>n</i> = 1), congenital heart disease (<i>n</i> = 2). There were two cases of the majority with INTERMACS Level 1 and 2 at the time of implant. Six patients (66.6%) had Berlin Heart EXCOR® LVAD, whereas four patients underwent BVAD implantation. The median length of HVAD support was 116 days (range 6-186 days). Among the nine patients, survival during VAD therapy to date is 77.7% (7/9), with four (57.1%) bridged to heart transplantation, two (28.5%) continuing to receive support, one recovery of ejection fraction and weaning from VAD support (14.2%). Posttransplant survival has been 100%, with a median follow-up of 509 days (range 353-830). <h3>Conclusion</h3> An active application of VAD implantation can provide excellent pediatric heart failure management results for very young and small end-stage heart failure patients. Further large-scale multicenter registration and standardization of management could improve clinical outcomes for infant patients with VAD.

Abstract 11868: A Reduced Anticoagulation Strategy Among Patients Supported With Ventricular Assist Device is Not Associated With Increased Mortality

Introduction: Patients with left ventricular assist device (VAD) are typically treated with aspirin and warfarin. However, some patients are unable to tolerate full anticoagulation (AC). There is limited information available regarding intermediate-term outcomes in patients on reduced or no anticoagulation. Methods: Patients who underwent VAD implantation at California Pacific Medical Center from January 2015 to January 2020 were studied retrospectively. Patients received aspirin 81 mg daily and warfarin with a target INR of 2-3, and anticoagulation was gradually de-intensified or withdrawn in response to recurrent mucosal bleeding. Pre-implantation characteristics, thrombolytic events (hemolysis, pump thrombosis requiring exchange, TIA, or ischemic CVA), and survival post-implant were compared among patients treated with full AC vs. reduced or no AC. We performed nonparametric survival analysis to obtain Kaplan-Meier survival estimates as of 9/15/2020. Cox proportional hazards regression was used to adjust for confounders measured at baseline. Results: 91 patients underwent VAD implant (80 HeartMate 3 and 11 HeartMate II). The median age was 65, and the majority of patients (79%) were treated as destination therapy. Reduced AC was used in 43 patients (47%), including no anticoagulation (12 patients), aspirin monotherapy (2 patients), warfarin monotherapy (16), warfarin monotherapy with a reduced INR target (10), and aspirin plus warfarin with a reduced INR target (3). During a median follow-up of 22 months, 15 thrombotic events were observed (12 in the reduced AC group and 3 in the full AC group, P=0.19). Two patients underwent pump exchange. 67% of thrombotic events and both pump exchanges occurred in HMII recipients. Survival was similar in both groups (Figure). Conclusions: The use of a reduced or no anticoagulation strategy after VAD implant is not uncommon and is associated with acceptable outcomes, particularly among HeartMate 3 recipients.

Atrial Cannulation in Pediatric Mechanical Circulatory Support

Purpose Several centers have considered the potential benefits of atrial inflow cannulation to provide mechanical circulatory support (MCS) among pediatric patients with small or restrictive ventricles particularly in those with potential for myocardial recovery. Limited pediatric data are available on contemporary outcomes of atrial cannulation. We sought to describe the characteristics, complications, and outcomes of children supported with atrial cannulation using the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) ventricular assist device (VAD) database. Methods Data were collected from the ACTION VAD database for all patients who underwent VAD implantation via atrial cannulation from 8/16/2012 to 9/8/2020. Patient characteristics, VAD types, complications, and outcomes were analyzed. Results Forty-one patients met the study criteria with 52 implants. Median age was 3.6 years (range 0.02 - 25.32), weight 13.6 kg (2.7-106), and BSA 0.6 (0.15 - 2.2). Diagnoses included dilated cardiomyopathy (42%), congenital heart disease (37%), transplant graft dysfunction (7%), restrictive and hypertrophic cardiomyopathies (5% each). VAD indications were bridge to decision (42%), bridge to transplant (42%), and bridge to recovery (17%). Eighty-four percent of patients were INTERMACS 1 or 2, 44% were on ECMO, and 63% were mechanically ventilated. Devices utilized included Berlin Heart Excor (40%), paracorporeal continuous flow devices (38%), Heartware (19%) and one Heartmate 3. Median support duration was 43.5 days (range 0-307). Overall mortality was 22%. Twenty patients (49%) were successfully transplanted, 7 (17%) recovered, and 5 (12%) are still alive on the device. Adverse events included major bleeding (24%), stroke (12%), sepsis (10%), right heart failure requiring RVAD (5%), and one instance of pump thrombosis. Conclusion Atrial cannulation in pediatric MCS can be performed across a variety of anatomic substrates and age ranges with outcomes and complication rates that are comparable to left ventricular cannulation strategies. This method may be advantageous in certain circumstances including patients with small or restrictive ventricles, potential for myocardial recovery, or multiple prior sternotomies to minimize surgical dissection. Further studies are needed to delineate the ideal patient population and benefits of varying atrial cannulation techniques.

Chronic Hemolysis May Predict Mortality in Patients with Ventricular Assist Devices

<h3>Purpose</h3> Hemolysis is an important complication of ventricular assist device (VAD) therapy. Several studies have postulated that chronic hemolysis may be a cause of adverse outcomes in patients with VADs, but consistent definitions and clinical outcome data are lacking. <h3>Methods</h3> We conducted a single-center retrospective cohort study examining survival to transplantation in patients who underwent VAD implantation from 2010-2020. Baseline demographics, renal function, echocardiographic, and cardiac catheterization data for the first 12 months of VAD therapy or until transplantation were collected. Additionally, all available lactate dehydrogenase (LDH) values were collected over this time frame and means were calculated for each patient. <h3>Results</h3> VADs were implanted in 166 patients, 19% female and 87% left-sided devices. Patients with mean LDH above the upper limit of normal for our laboratory's LDH assay of 440 units/liter (U/L) were more likely to die prior to transplantation compared to those with mean LDH <440 U/L [Odds Ratio (OR) 3.51, 95% Confidence Interval (CI) 1.28 - 9.63, p = 0.011 (Figure 1)]. This relationship remained significant when controlled for gender, length-of-stay, and peri-VAD-implant acute kidney injury in a binomial logistic regression analysis (OR 1.75, 95% CI 1.23 - 18.47, p = 0.032). Adjudicated episodes of acute hemolysis and the presence of severe right ventricular (RV) dysfunction did not increase mortality. <h3>Conclusion</h3> Mean LDH above the normal range was an independent and significant predictor of mortality in patients with VADs awaiting transplantation at our center over the last decade. While concomitant severe liver or RV dysfunction can raise LDH, chronic hemolysis is an important potential etiology for our observations. Further work is needed to define chronic hemolysis and its impact on outcomes in patients with VADs.

Acute Kidney Injury Predicts Outcomes Following Ventricular Assist Device Insertion

<h3>Purpose</h3> Renal function following ventricular assist device (VAD) implantation is a key determinant of survival. The purpose of our study was to investigate whether the development of acute kidney injury (AKI) prior to, or following, VAD implantation influenced survival to transplant. We also sought to determine if the use of extra-corporeal membrane oxygenation (ECMO) or intra-aortic balloon pump (IABP) influenced AKI pre or post-VAD. <h3>Methods</h3> We undertook a single-centre retrospective cohort study examining outcomes in patients who underwent VAD implantation between 2010 and 2020. AKI was defined as per the KDIGO guidelines. The primary outcome was survival to transplant. <h3>Results</h3> 61% (96/158) of patients experienced pre-VAD AKI which predicted an increased risk of mortality (OR 2.32, p=0.032, CI 1.07 - 5.04). The incidence of post-VAD AKI was 54% (89/165) which was similarly associated with an increased risk of mortality (OR 2.49, p=0.012, CI 1.21 - 5.13). 67% (64/96) of patients who experienced pre-VAD AKI had post-VAD AKI. Patients who had both pre and post-VAD AKI had a significantly increased mortality prior to transplant with an OR of 3.5 (P=0.01, CI 1.3 - 9.41). Patients with pre-VAD AKI were more likely to require ECMO prior to VAD implantation (OR 2.94) however no difference was observed for IABP use. The use of ECMO or IABP prior to VAD implantation did not influence post-VAD AKI. <h3>Conclusion</h3> Acute kidney injury both pre and post-VAD implantation reduced likelihood of survival to transplant. Patients with AKI prior to VAD insertion were more likely to require ECMO, however the use of ECMO or IABP pre-VAD insertion did not appear to influence post-VAD AKI.

Outcomes of Infants and Children with Stage 1 Single Ventricle Implanted with Ventricular Assist Devices: An Analysis of the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) Registry

<h3>Purpose</h3> Ventricular assist device (VAD) use in patients with congenital heart disease is increasing. Data on VAD outcomes in infants/children with stage 1 single ventricle (SV) are limited. Our study aims to characterize the outcomes of this population using multi-center registry data. <h3>Methods</h3> We examined the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry for outcomes of stage 1 SV patients undergoing VAD implantation between March 2018 - June 2020. ACTION data are collected from 30 centers, and major adverse events undergo central adjudication using pre-specified event definitions. Clinical characteristics, major adverse events, and survival are reported. <h3>Results</h3> During the study period, 27 stage 1 SV patients underwent VAD implant with median age of 1 month (range 0.1-44), weight 3.7kg (2.4-17), and BSA 0.24 m² (0.18-0.65). Pre-implant comorbidities were frequent: ventilator support (85%), ECMO (37%), history of cerebral vascular accident (CVA, 30%), and pre-implant dialysis (18.5%). Device strategy included paracorporeal continuous-flow VAD in 11 patients, paracorporeal pulsatile VAD (12), and multiple devices (4). Concomitant surgical procedure was performed in 4 patients. Median support duration was 56 days (2-271). A positive clinical outcome, defined as transplant, weaned, or alive on device was obtained in 59%, with 12 patients transplanted while 11 died on device (Fig 1). Adverse events on VAD support included neurologic dysfunction (18.5%, with n=2 CVA), bleeding (22%), infection (48%), renal dysfunction (15%), and device malfunction (4%). <h3>Conclusion</h3> Stage 1 SV patients undergoing VAD support have frequent and severe pre-implant comorbidities, which likely contributed to the significant morbidity and mortality post-implant. A variety of device types and surgical strategies are employed by centers to support this challenging physiology.

Ventricular Assist Devices in Adults with Failing Systemic Right Ventricle: The Importance of Concomitant Tricuspid Valve Replacement

<h3>Purpose</h3> Ventricular assist device (VAD) for systemic right ventricular failure (SRVF) post atrial switch for transposition of the great arteries (TGA) and congenitally corrected TGA (ccTGA) has proven useful to reduce transpulmonary gradient (TPG) and bridge-to-transplantation. The hemodynamic impact of severe tricuspid regurgitation (TR), potential role of systemic tricuspid valve replacement (TVR) and long-term outcomes are still unknown. The purpose of this study is to describe our experience of VAD in SRVF and our move towards concomitant TVR. <h3>Methods</h3> Single-centre retrospective study of consecutive adult patients receiving HeartWare-VAD for SRVF between 2010 and 2020. From 2017, concomitant TVR was performed routinely. Demographic, clinical variables and echocardiographic and haemodynamic measurements pre and post VAD implantation were recorded. Complications on support, heart transplantation and survival rates were described. <h3>Results</h3> 24 patients underwent VAD implantation. Moderate or severe systemic TR was present in 83% of patients, and subpulmonic left ventricular (LV) impairment in 79%. One and two-year survival rates were 75% and 60% respectively. VAD implantation was technically feasible and successful in all but one. Post VAD, TPG fell from 16 (15-20) to 10 (7-13) mmHg; p=0.002. Patients with TVR (n=12) also demonstrated reduction in pulmonary and atrial pressures (figure). Subpulmonic LV end-diastolic dimension (50 vs 42mm; p=0.05) and systolic function improved in this group. On the other hand a high prevalence of subpulmonic LV failure was noted in the non TVR group (50% vs 8.3%; p=0.03) resulting in higher mortality. After six months on support, 63% of patients were suitable for transplantation. <h3>Conclusion</h3> VAD implantation for patients with SRVF in TGA or ccTGA is feasible, and significantly reduces the TPG to transplantable limits. Concomitant TVR at the time of implant associates better haemodynamic and echocardiographic results.

Pediatric Ventricular Assist Device Implantation: An Anesthesia Perspective.

Ventricular assist devices (VADs) are increasingly being implanted in children, yet there is little literature to guide anesthetic management for these procedures. To describe the pediatric population presenting for VAD implantation and the anesthetic management these patients receive. To compare (a) children under and over 12 months of age and (b) children with and without congenital heart disease. Retrospective review of patients aged 0 to 17 years who underwent VAD implantation at a single center between 2014 and 2019. Seventy-seven VADs were implanted in 68 patients (46 left VADs, 24 biventricular VADs, 6 right VADs, and 1 univentricular VAD). One procedure was abandoned. Preoperatively, 20 (26%) patients were supported with extracorporeal membrane oxygenation and 57 (73%) patients were ventilated. Intraoperative donor blood products were required in 74 (95%) cases. Postimplantation inotropic support was required in 66 (85%) cases overall and 46 (100%) patients receiving a left VAD. Infants under 12 months were more likely to require preoperative extracorporeal membrane oxygenation (42% vs 19%), have femoral venous access (54% vs 28%), receive an intraoperative vasoconstrictor (42% vs 24%), and have delayed sternal closure (63 vs 22%). Mortality was higher in patients under 12 months (25% vs 19%) and in patients with congenital heart disease (25% vs 20%). Children undergoing VAD implantation require high levels of preoperative organ support, high-dose intraoperative inotropic support, and high-volume blood transfusion. Children under 12 months and those with congenital heart disease are particularly challenging for anesthesiologists and have worse overall outcomes.

Thoracoscopic repair of diaphragmatic hernia following ventricular assist device implantation

BackgroundDiaphragmatic hernia is a rare complication of ventricular assist device (VAD), mainly developing after explantation of the device. We herein report a case of diaphragmatic hernia that developed following the implantation of VAD.Case presentationA 4-month-old girl with a diagnosis of dilated cardiomyopathy underwent VAD implantation for a bridge to heart transplantation. Three months later, intermittent vomiting developed, and left-sided diaphragmatic hernia was confirmed on plain X-ray and computed tomography. Without any findings of ischemia, we performed elective thoracoscopic repair of the diaphragmatic hernia. In the right decubitus position, thoracoscopy revealed the small intestine to be herniated into the left thorax. After reduction of the herniated intestine, the defect of the diaphragm (3 × 2 cm in size) was directly closed with interrupted non-absorbable sutures. Her postoperative course was uneventful.ConclusionThoracoscopic repair of diaphragmatic hernia associated with VAD implantation may be a safe approach.

Transition from VA-ECMO to Durable VAD Systems. Do We Need Cardiopulmonary Bypass Machine? On Behalf of ECMO-VAD Study Group

Many surgeons prefer to use cardiopulmonary bypass (CPB) machine when durable ventricular assist devices (VAD) is implanted in patients on veno-arterial membrane oxygenation (VA-ECMO). The aim of this study was to investigate if omitting CPB machine at the time of surgery negatively influence the outcome. Data of eleven high volume VA-ECMO/VAD centers are collected and evaluated to identify patients who underwent VAD implantation after ECMO support between January 2010 and July 2018. Preoperative parameters and postoperative outcome are analyzed. Propensity score analysis was performed to identify two identical groups; one who were operated on without CPB (no CPB group) and the other group were operated on using CPB (CPB group) RESULTS: A total of 531 patients met the inclusion criteria. Nineteen patients were supported with Cardiowest TAH and are excluded from this analysis. The remaining 512 patients included 306 patients in the CPB group and 206 patients in no CPB group. After 1:1 propensity score matching 207 patients remained in each group and were compared. The total surgery time was significantly longer in the CBP group (288 ± 92 vs. 206 ± 64 min, p= <0.001). The postoperative chest tube output on the day of surgery was comparable between the groups (1580 ± 1271 vs. 1321 ± 1047 ml , p= 0.09). However, resternotomy for bleeding was necessary in 41% vs. 30% of patients with or without CPB respectively (p=0.022) and a significantly higher number of PRBC were given to the patients who were operated with CPB (11 ± 8 Units vs. 9 ± 4 Units, p= 0.009); The number of transufused FFP and platelets were comparable. A temporary postoperative right ventricular assist device implantation was necessary in 48% vs. 40% of the patients with or without CPB respectively (p=0.082). Stroke rate of 20% comparable in both groups (p= 0.922). Postoperative renal failure, liver failure and respiratory failure were also comparable (p= 0.223 - 0.708). No significant difference in the postoperative survival between the two groups was observed (p=0.096). This study shows, omitting CPB at the time of durable VAD implantation for patients on VA-ECMO results in shorter surgery time, lower reexploration rate for bleeding and less blood product requirements. A trend toward lower RVAD use was also observed. Survival remains similar between both Groups.

Implanting Durable VAD Systems in Patients on VA-ECMO: Comparing Less Invasive to Sternotomy Approach. On Behalf of ECMO-VAD Study Group

Patients on veno-arterial membrane oxygenation (VA-ECMO) are high-risk candidates for durable ventricular assist device (VAD) surgery. The aim of this study was to compare the outcome of patients who received durable VAD on VA-ECMO using less invasive (LIS) vs. sternotomy approach. Data of eleven high volume VA-ECMO/VAD centers are collected and evaluated to identify patients who underwent VAD implantation after ECMO support between January 2010 and July 2018. Preoperative parameters and postoperative outcome are analyzed. A total of 531 patients met the inclusion criteria. Nineteen patients were supported with Cardiowest TAH and were excluded from this analysis. The remaining 512 patients were 1:3 propensity score matched and resulted in 99 patients remained in LIS group vs. 293 patients in sternotomy group. The total surgery time was significantly longer in the sternotomy group (270±80 vs. 203±61 min; p<0.001). The postoperative chest tube Output was comparable between the groups (p= 0.476). The number of postoperative PRBC, FFP and platelets given were comparable (p=0.296, 0.081 and 0.111 respectively). A temporary postoperative RVAD was necessary in 37% vs. 43% of the patients in LIS vs. sternotomy, respectively (p=0.353). Surgical re-exploration for bleeding was necessary in 39% vs. 34% of patients in LIS vs. sternotomy (p=0.345). Stroke rate was not statistically different in both groups (25% vs 17%, p = 0.097). Renal and liver failure rates were comparable with 31% vs. 30% and 28% vs 22% (LIS vs. sternotomy, p= 0.762 and 0.173). Comparison of the postoperative outcome between the two groups demonstrated superior short and long-term survival for LIS patients (p=0.015) (Figure 1) CONCLUSION: This study shows that LIS approach may be superior to sternotomy approach for patients on VA-ECMO. The postoperative morbidities were comparable. However, a superior short and long term outcome was observed in LIS Group.

Single Ventricular Assist Device Support for the Failing Bidirectional Glenn Patient

Given poor outcomes, strategies to improve ventricular assist devices (VADs) for single-ventricle patients with bidirectional Glenn (BDG) palliation are needed. This retrospective review describes an institutional experience with VAD support for patients with BDG from April 2011 to January 2019. Surgical strategies, complications, and causes of death are described. Survival to heart transplantation for various strategies are compared. A total of 7 patients with BDG (weights, 5.6 to 28.8 kg; ages, 7 months to 11 years) underwent VAD implantation. Three patients underwent implantation of Berlin Heart EXCOR devices (Berlin Heart, Inc, Spring, TX), 2 had HeartWare HVADs (Medtronic, Minneapolis, MN) implanted, and 2 patients underwent implantation of paracorporeal continuous flow devices. Four patients underwent ventricular inflow cannulation, and 3 underwent atrial inflow cannulation. At the time of VAD implantation, the BDG was left intact in 3 patients, taken down in 3 patients, and created de novo in 1 patient. Over a total of 420 VAD support days, 2 patients survived to heart transplantation, 1 patient with HeartWare ventricular cannulation and intact BDG (after 174 days) and another with Berlin Heart atrial cannulation and BDG take-down (after 72 days). There were 3 deaths within 2 weeks of VAD implantation (2 from respiratory failure, 1 from infection) and 2 deaths after 30 days as a result of strokes. The surgical strategy and postoperative management of VAD with BDG are still evolving. Successful support can be achieved with (1) both pulsatile and continuous flow pumps, (2) atrial or ventricular cannulation, and (3) with or without BDG take-down. Surgical strategy should be determined by individual patient anatomy, physiology, and condition.