Levitronix CentriMag Research Articles

P58: Heart Transplantation Outcomes In Patients Bridged With Mechanical Circulatory Support Devices: Kazakhstan Experience

Background: The management of end-stage heart failure (HF) with heart transplantation (HTx) as the gold standard therapy relies on a long-term mechanical circulatory support (MCS) devices for bridging patients. This study aimed to analyze clinical outcomes of HTx in bridge-to-transplant population in Kazakhstan. Methods: In this retrospective, single-center study we included 40 patients with MCS devices who were transplanted in Kazakhstan between 2014 and 2022. Results: Of the 85 transplantations performed, 40 (47%) were bridged with MCS including 31 (77,5%) with durable left ventricular assist devices (LVAD), 3 (7,5%) with total artificial heart (TAH), 2 (5 %) with fully implantable LVAD (FIVAD), 3 patients (7.5%) right ventricular plus LVAD, 1 (2.5%) with biventricular support device (Levitronix CentriMag). 25 (62.5%) HTx performed by using Organ Care System Transmedics due to large territory of Kazakhstan. Average age was 41,3 years (interquartile range, 17–64) and 4 patients (10%) were female. 26 patients (65%) with dilated cardiomyopathy. The most common complications on LVAD support before HTx were driveline infection (57.5%), arrhythmias (20%) and allosensitization (17.5%). Minimum waiting time was 15 days, maximum waiting time – 1999 days, average waiting time - 809±635 days. According to the Kaplan-Meier survival analysis unadjusted survival at 1 and 5 years posttransplant was 80 % and 67.5 %. For comparison, posttransplant survival of HF patients without LVAD was 80% and 57.7% respectively. Maximum life span after HTx was 7.8 years, median – 3.6 years. The most common causes of death in group of transplants bridged with MCS were multiorgan failure (n=6, 46.2%), infection/sepsis (n= 4, 30.7%) and acute graft rejection (n=1, 7.7%). In group of transplants without LVAD the most common causes of death were acute graft rejection (n=5, 22.7%), COVID-19 (n=4, 18.2%), kidney disease (n=4, 18.2%). Conclusion: Long waiting time in consequence of donor organ shortage in Kazakhstan and life-threatening complications on MCS device support are serious issue with particular significance in the bridge-to-transplant population. Despite these limiting factors, HTx in patients bridged with MCS demonstrated favorable survival outcomes similar in other published studies.

Outcome of Paediatric Cardiac Re-Transplantation in the Mechanical Support Era

<h3>Purpose</h3> To review the outcome of paediatric cardiac re-transplantation (reOHTx) in the mechanical cardiac support (MCS) era. <h3>Methods</h3> A retrospective study of patients less than 18 years of age who underwent reOHTx in our Institution. Data were obtained from departmental databases and hospital medical records. <h3>Results</h3> From 1987 to 2021, 21 patients underwent reOHTx. Diagnoses leading to first transplant were dilated cardiomyopathy in 12 (10 idiopathic, 1 post-chemotherapy, 1 related to viral myocarditis), restrictive cardiomyopathy in 1, hypertrophic cardiomyopathy in 1 and congenital heart disease in 7 patients. Mean age at first OHTx was 8 years. Prior to primary transplant, one patient was supported with Levitronix Centrimag LVAD, one with BIVAD, a child with VA-ECMO followed by Berlin Heart EXCOR LVAD and one child with VA-ECMO only. Mean time course between first and second OHTx was 82 months. Eleven patients were mechanically supported as a bridge to reOHTx: 8 with Levitronix Centrimag BIVAD (2 from VA-ECMO), 4 with VA-ECMO, 2 with Berlin Heart EXCOR BIVAD, 2 with Berlin Heart EXCOR LVAD and 1 with Heartware. Mean time on support was 54 days (1-275). There was only one early death after reOHTx. This patient received the second heart 8 days after the first transplant and died from 2 days post reOHTx due to brain hemorrhage. One patient required 2 VA-ECMO runs due to acute graft failure. Two patients required VA-ECMO post reOHTx. Eight patients required renal replacement therapy. Five suffered a cerebrovascular accident. Mean follow up is 112 months. There were 7 late deaths in this period of 34 years, 2 of them related to rejection due to poor compliance with immunosuppressive treatment. <h3>Conclusion</h3> Re-transplantation in children carries a very good outcome. With mechanical cardiac support we can bridge children to reOHTx more effectively. Furthermore, MCS can be also used in acute graft failure or for immunological manipulation in acute rejection.

Analysis of the Intrahospital and Long-Term Survival of Heart Transplant Patients With a Short-Term Mechanical Assistance Device

The purpose of this study was to compare early and late survival among patients who have undergone heart transplantation (HTx) with a short-term mechanical assist device. This was an ambispective, single-center, consecutive study of patients undergoing urgent HTx for 5 years. Pediatric transplants, retransplants, and combined transplants were excluded. Forty-five patients were included. Four groups were analyzed: those with venoarterial extracorporeal membrane oxygenation (ECMO) implanted <10 days before HTx; those with ECMO implanted for >10 days; patients classified as INTERMACS 2 to 3 with Levitronix Centrimag implanted; and those classified as INTERMACS 2 with Levitronix Centrimag implanted. Survival and the influence of orotracheal intubation (OI) at the time of transplantation were compared. There were differences in in-hospital mortality (P=.03) and total mortality (P=.06). The groups with the highest risk for mortality were those who carried ECMO for >10 days before transplantation or those classified as INTERMACS 2 with Levitronix Centrimag implanted. In these groups, the need for posttransplant circulatory support was also greater (P = .04) as was the length of stay in critical care (P = .02). The need for OI during the days of care and until transplantation had a negative effect on survival in all groups (P < .1). There are different risk subgroups among patients who are transplanted with a circulatory/ventricular assist device. The lowest mortality occurs when the days of ECMO implantation are <10 and when the implanted device is a Levitronix Centrimag in INTERMACS 2 to 3 profile, particularly when the patient reaches the HTx without requiring OI.

Complications After Heart Transplantation According to the Type of Pretransplant Circulatory/Ventricular Support

The purpose of the study was to analyze postcardiac transplant complications in patients who received transplants with short-term mechanical ventricular assist devices and to compare complications according to the type of device. Ambispective and consecutive study of urgent heart transplants from 2015 to 2019. Pediatric transplants, retransplants, and combined transplants were excluded. A total of 45 patients were analyzed in 4 groups: (1) venoarterial extracorporeal membrane oxygenation (ECMO) implanted <10 days before heart transplant (HTx) (n=17); (2) ECMO implanted for more than 10 days (n=8); (3) Levitronix Centrimag implanted in INTERMACS 2 to 3 patients (n=13); and (4) Levitronix Centrimag implanted in INTERMACS 2 patients (n=7). ECMO assistance was in INTERMACS 2 and severe right ventricular dysfunction. Levitronix Centrimag was implanted in patients with preserved right ventricular function. Primary graft failure associated with the need for ECMO was more frequent in patients with ECMO than with Levitronix (P < .05). When comparing the 2 groups with ECMO, an implant more than 10 days before HTx was associated, after transplant, with a longer stay in the critical care unit (P=.02), higher mortality (P=.03), and an increase in complications in general. When comparing the 2 groups with Levitronix, all the parameters studied were much better when the Levitronix was implanted in INTERMACS 2-3 (P < .05). On the other hand, all cases of deep vein thrombosis and pulmonary thromboembolism occurred in patients who were assisted with ECMO. HTx with mechanical assist devices is associated with significant complications. ECMO produces more complications than the Levitronix Centrimag, although they are related to the days of implantation. The best group are patients implanted with a Levitronix in INTERMACS 2-3.

Temporary biventricular support as a bridge to recovery: A justifiable strategy for small children with fulminant myocarditis.

Short-term mechanical circulatory support can be life-saving in the pediatric population with acute cardiogenic shock (ACS). However, recovery from MCS is a rare entity. MCS options are limited for low-body-weight children in Turkey. Over the last decade, extracorporeal membrane oxygenation (ECMO) has been the primary bridging modality for children with end-stage heart failure in our country. However, VA-ECMO may cause increased wall stress and oxygen demand, which may alter myocardial recovery. Here, we describe using a Levitronix CentriMag Systems for biventricular support as a bridge to recovery in a 16-month-old boy (weight, 11 kg; BSA, 0.5 m2) with type A influenza related-fulminant myocarditis (FM). Levitronix CentriMag System provides a safe and efficient short-term, biventricular, paracorporeal support for infants, and small children with ACS.

Refractory cardiac arrrest treated with extracorporeal cardiopulmonary resuscitation, 2-year follow-up

Abstract Introduction Extracorporeal cardiopulmonary resuscitation (ECPR) has been introduced as a life-saving procedure in refractory cardiac arrest. Methods Eligible patients for this analysis had to undergo ECPR after unsuccessful cardiopulmonary resuscitation with a minimum of three defibrillation attempts. For extracorporeal life support (ECLS) was used Cardiohelp system or Levitronix CentriMag blood pump. LUCAS II system was used for chest compressions during cardiac arrest. The relations of blood lactate and pH levels, measured before ECPR insertion and after 24 hours as well as comorbities (diabetes, hypertension, BMI) to the clinical outcomes at 2 years were evaluated. Results We analyzed data from 59 patients treated with ECPR for refractory cardiac arrest. The mean age of our patients was 61 years. Out-of-hospital cardiac arrest (OHCA) occurred in 33 patients, 26 patients suffered from in-hospital arrest (IHCA). Baseline value of lactate was 11.57±4.22 mmol/l, initial pH 6.95±0.31. In comparison with survivors, patients who died had significantly higher initial lactate levels (12.05±0.81 vs. 8.01±0.77; P&amp;lt;0.05). Moreover, survivors had significantly lower lactate levels after 24 hours (7.39 vs 2.56) and lower BMI (27.4 vs 31.2; P&amp;lt;0.05). Diabetes or hypertension in our group have no influence on the mortality. The difference of mortality in the group of OHCA or IHCA was also not significant. 32% patients survived one month with good neurological outcome (CPC 1–2), 30% six months, 23% one year and 21% two years. Conclusions ECPR give the last chance to survive refractory cardiac arrest. The levels of blood lactate are significantly associated with clinical outcomes of ECPR. Obesity was associated with significantly higher mortality in our group. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): MH CZ DRO (Nemocnice Na Homolce - NNH, 00023884)

P3440Can pre-operative echocardiography predict RV failure post-LVAD implantation in children?

Abstract Background One of the most frequent complications of left ventricular assist device (LVAD) implantation is the development of right ventricular (RV) failure, which occurs in 10%-40% of patients. It is, therefore, essential to identify which LVAD candidates are at risk for RV failure and will require additional RV mechanical support with a biventricular assist device (BiVAD). However, the echocardiographic assessment of the RV is challenging due to its complex geometry and marked load dependence of its function indices. To our knowledge, there is no published evidence regarding which specific RV echocardiographic parameters should inform this decision in the paediatric population. Aims We sought to determine which pre-operative RV echocardiographic parameters best correlate with the need for a BiVAD, as opposed to LVAD alone, in a paediatric population undergoing VAD insertion at a tertiary care institution. Methods Retrospective review of the pre-operative echocardiograms of children (&lt;18 years) with dilated cardiomyopathy undergoing elective VAD implantation at our institution, from November 2007 to December 2018. Preoperative quantitative and qualitative RV echocardiographic parameters described in the literature to be associated with RV failure after LVAD implantation in adults were collected. Moreover, qualitative RV function was independently assessed by three echocardiographers, blinded to the outcome of the patients. Results 89 patients were included, 39 (43.8%) males, median age = 1.7 years (IQR = 6.9), median weight = 11.6 kg (IQR = 13.8). 49 (55.1%) patients had an LVAD implanted, whereas 40 (44.9%) were deemed to need biventricular support. 45 (50.6%) patients received an EXCOR Berlin Heart, 16 (18%) a HeartWare HVAD and 28 (31.4%) a Levitronix Centrimag device. Requirement of BiVAD support was significantly more common in patients with moderate to severe RV impairment, as per expert assessment (OR = 2.864; 95% CI: 1.188–6.903, p=0.018), and tricuspid regurgitation &gt; grade III (OR = 3.154; 95% CI: 1.124–8.850, p=0.025). All the other parameters collected – tricuspid annular plane systolic excursion (TAPSE), tricuspid regurgitant jet velocity, tricuspid regurgitation duration corrected for heart rate, RV tissue Doppler indices, RV fractional area change, and RV/LV diameter ratio– were not significantly different among groups. Conclusions In our paediatric population, expert assessment of RV function and degree of tricuspid regurgitation were strong predictors of RV failure among patients undergoing LVAD implantation, allowing for pre-emptive RVAD implantation and improving patient outcomes.

The Levitronix CentriMag ventricular assist device as a bridge to decision in patients with end-stage heart failure: Our single-center experience

The Levitronix CentriMag ventricular assist device as a bridge to decision in patients with end-stage heart failure: Our single-center experience

Rescue Levitronix Centrimag as a bridge to decision: is it still worthwhile?

Cardiogenic shock has poor prognosis with medical management alone and/or intra-aortic balloon pump support. Levitronix Centrimag®centrifugal pump has been increasingly used to bridge patients to decision for further advanced mechanical uni- or bi-ventricular support with a view to heart transplantation on the newly implemented super-urgent recipient scheme. We sought to review our experience as a designated centre for mechanical circulatory support to investigate its role despite the emergence of percutaneously implantable miniature devices. Between April 2009 and December 2015, 98 patients in cardiogenic shock [age 41.4 ± 12.7 years; 52 (53%) male and 46 (47%) female] underwent mechanical circulatory support of whom 90 were treated with Levitronix Centrimag as a primary procedure. Diagnosis was dilated cardiomyopathy [37 (38.1%)], ischaemic cardiomyopathy [25 (25.8%)], and other [36 (36.1%)]. Main indications were cardiogenic shock or decompensated heart failure. Other indications were early graft failure following heart transplant or right ventricular failure following left ventricular assist device insertion. Levitronix support was as follows: extra corporeal membrane oxygenation [22 (24.4%) central, 26 (28.9%) peripheral], Left Ventricular Assist Device [12 (13.3%)], Right Ventricular Assist Device [5 (5.6%)], and Bi-Ventricular Assist Device [25 (27.8%)]. The average duration of support on Levitronix was 17.1 days (range 1–111). The 30-day survival was 52% (47 patients), 6-month survival was 40% (36 patients), and 12-month survival was 37.7% (34 patients). Of the surviving patients, five underwent successful orthotopic heart transplantation, one received a HeartMate II which was subsequently explanted because of myocardial recovery, and one received a HeartMate II and is currently on the transplant list. Cause of death while on support was multiorgan failure [12 (13.3%)], cardiovascular system (CVA)/Neurological [10 (11.1%)], further haemodynamic deterioration [9 (10%)], graft failure [5 (5.6%)], bleeding [4 (4.4%)], sepsis [3 (3.3%)], myocardial infarction [3 (3.3%)], right ventricular failure [3 (3.3%)], pulmonary embolism [1 (1.1%)], embolic [1 (1.1%)], respiratory failure [1 (1.1%)], influenza + rejection [1 (1.1%)], and unknown [3 (3.3%)]. Levitronix Centrimag® remains a versatile device with potential in an acute setting. Early aggressive treatment and a younger patient population may well justify its use.

Post-heart transplantation outcome of HeartMate II-bridged recipients requiring unplanned concomitant temporary right ventricular mechanical support.

Second-generation axial-flow left ventricular assist devices (LVADs) have become an established therapy in bridging end-stage heart failure patients to cardiac transplantation. Despite the proven clinical success of these devices, some patients develop right ventricular (RV) failure after LVAD implantation. We sought to determine post-heart transplantation outcomes of HeartMate II (HMII)-bridged patients who developed postimplantation right ventricular failure and received Levitronix CentriMag for RV support in addition to LVAD. This was a single-centre institutional report of 64 patients transplanted during 2007-2013 from a HeartMate II device. Patients were divided into two groups according to whether they received an isolated LVAD (n = 56) or required additional RV mechanical support (n = 8). These two groups were compared for early graft loss (death before discharge or retransplantation), major early post-transplant complications and 3-year graft survival. Early graft loss was 10.7% in isolated HMII and 25% in HMII + RVAD patients (P = 0.26). There were no observed differences in the rates of primary graft dysfunction (7.3 vs 0%, P = NS), renal failure (16.7 vs 12.5%, P = NS) and stroke (11.1 vs 25%, P = 0.273) between the two groups. Pulmonary artery resistance (odds ratio: 3.286, 95% confidence interval: 1.063-10.157, P = 0.039) was identified as a significant predictor for adverse outcome of mechanically-bridged heart transplant recipients. The 3-year graft survival rate was 86 ± 5% in isolated HMII and 75 ± 15% in HMII + RVAD patients, P = 0.326. Our data demonstrate that heart transplant recipients who required unplanned RV mechanical support after LVAD implantation achieved comparable rates of early graft loss, post-transplant renal failure and stroke rate in comparison with patients bridged with an isolated HeartMate II assist device. Three-year graft survival was equivalent between those two groups. Given the small sample size, further studies involving more patients are needed to support or challenge our conclusions.

RotaFlow and CentriMag extracorporeal membrane oxygenation support systems as treatment strategies for refractory cardiogenic shock.

RotaFlow and Levitronix CentriMag veno-arterial extracorporeal membrane oxygenation (ECMO) support systems have been investigated as treatment for refractory cardiogenic shock (CS). Between 2004 and 2012, 119 consecutive adult patients were supported on RotaFlow (n = 104) or CentriMag (n = 15) ECMO at our institution (79 men; age 57.3 ± 12.5 years, range:19-78 years). Indications for support were: failure to wean from cardiopulmonary bypass in the setting of postcardiotomy (n = 47) and primary graft failure (n = 26); post-acute myocardial infarction CS (n = 11); acute myocarditis (n = 3); and CS on chronic heart failure (n = 32). A central ECMO setting was established in 64 (53.7%) patients while peripherally in 55 (46.2%). Overall mean support time was 10.9 ± 8.7 days (range:1-43 days). Forty-two (35.2%) patients died on ECMO. Overall success rate, in terms of survival on ECMO (n = 77), weaning from mechanical support (n = 51; 42.8%) and bridge to heart transplantation (n = 26; 21.8%), was 64.7%. Sixty-eight (57.1%) patients were successfully discharged. Stepwise logistic regression identified blood lactate level and CK-MB relative index at 72 h after ECMO initiation, and number of packed red blood cells (PRBCs) transfused on ECMO as significant predictors of mortality (p = 0.011, odds ratio [OR] = 2.48; 95% confidence interval [CI] = 1.11-3.12; p = 0.012, OR = 2.81, 95% CI = 1.02-2.53; and p = 0.012, OR = 1.94; 95% CI = 1.02-5.21; respectively). Central ECMO population had a higher rate of continuous veno-venous hemofiltration (CVVH) need and bleeding events when compared with the peripheral setting. Patients with a poor hemodynamic status may benefit by rapid insertion of veno-arterial ECMO. The blood lactate level, CK-MB relative index and PRBCs transfused should be strictly monitored during ECMO support.

Extracorporeal membrane oxygenation for the treatment of refractory cardiogenic shock in adults: strategies, results, and predictors of mortality

The RotaFlow (Maquet, Jostra Medizintechnik AG, Hirrlingen, Germany) and Levitronix CentriMag (Levitronix LCC, Waltham, MA, USA) veno-arterial extracorporeal membrane oxygenation (ECMO) support systems have been investigated as treatment for refractory cardiogenic shock. Between 2004 and 2012, 119 consecutive adult patients were supported on RotaFlow (n=104) or CentriMag (n=15) ECMO at our Institution (79 men; mean age 57.3 ± 12.5 years, range 19-78 years). Indications for support were: failure to wean from cardiopulmonary bypass in the setting of postcardiotomy (n=47) and primary graft failure (n=26); post-acute myocardial infarction cardiogenic shock (n=11); acute myocarditis (n=3), and cardiogenic shock on chronic heart failure (n=32). A central ECMO setting was established in 64 (53.7%) patients while peripherally in 55 (46.2%). Overall mean support time was 10.9 ± 8.7 days (range 1-43 days). Forty-two (35.2%) patients died on ECMO. Overall success rate, in terms of survival on ECMO (n=77), weaning from mechanical support (n=51; 42.8%) and bridge to heart transplantation (n=26; 21.8%), was 64.7%. Sixty-eight (57.1%) patients were successfully discharged. Stepwise logistic regression identified blood lactate levels and creatine kinase-MB relative index at 72h after ECMO initiation, and number of packed red blood cells (PRBCs) transfused on ECMO as significant predictors of mortality. Central ECMO population had a higher rate of continuous veno-venous hemofiltration need and bleeding events compared with the peripheral setting. ECMO support provides encouraging results in different subsets of patients in cardiogenic shock. Blood lactate levels, creatine kinase-MB relative index and PRBCs transfused should be strictly monitored during veno-arterial ECMO running. Type of ECMO implantation, if peripheral or central, should be decided according to the specific patient subset.

Extracorporeal membrane oxygenation support in refractory cardiogenic shock: treatment strategies and analysis of risk factors.

Two centrifugal pumps, the RotaFlow (Maquet, Jostra Medizintechnik AG, Hirrlingen, Germany) and Levitronix CentriMag (Levitronix LCC, Waltham, MA, USA), used in central or peripheral veno-arterial extracorporeal membrane oxygenation (ECMO) support systems have been investigated, in terms of double-center experience, as treatment for patients with refractory cardiogenic shock (CS). Between January 2006 and December 2012, 228 consecutive adult patients were supported on RotaFlow (n=213) or CentriMag (n=15) ECMO, at our institutions (155 men; age 58.3±10.5 years, range: 19-84 years). Indications for support were: failure to wean from cardiopulmonary bypass in the setting of postcardiotomy (n=118) and primary donor graft failure (n=37); postacute myocardial infarction CS (n=27); acute myocarditis (n=6); and CS on chronic heart failure (n=40). A peripheral ECMO setting was established in 126 (55.2%) patients while it was established centrally in 102 (44.7%). Overall mean support time was 10.9±9.7 days (range: 1-43 days). Eighty-four (36.8%) patients died on ECMO. Overall success rate, in terms of survival on ECMO (n=144), weaning from mechanical support (n=107; 46.9%), bridge to mid-long-term ventricular assist device (n=6; 2.6%), and bridge to heart transplantation (n=31; 13.5%), was 63.1%. One hundred twenty-two (53.5%) patients were successfully discharged. Stepwise logistic regression identified blood lactate level and MB isoenzyme of creatine kinase (CK-MB) relative index at 72 h after ECMO initiation, and number of packed red blood cells (PRBCs) transfused on ECMO as significant predictors of mortality on ECMO (P=0.010, odds ratio [OR]=2.94; 95% confidence interval [CI]=1.10-3.14; P=0.010, OR=2.82, 95% CI=1.014-3.721; and P=0.011, OR=2.69; 95% CI=1.06-4.16, respectively). Central ECMO population had significantly higher rate of continuous veno-venous hemofiltration need and bleeding requiring surgery events compared with the peripheral ECMO setting population. No significant differences were seen by comparing the RotaFlow and CentriMag populations in terms of device performance. At follow-up, persistent heart failure with left ventricle ejection fraction (LVEF)≤40% was a risk factor after hospital discharge. Patients with a poor hemodynamic status may benefit from rapid central or peripheral insertion of ECMO. The blood lactate level, CK-MB relative index, and PRBCs transfused should be strictly monitored during ECMO support. In addition, early ventricular assist device placement or urgent listing for heart transplant should be considered in patients with persistent impaired LVEF after ECMO.

Ventricular Mechanical Support

In this issue of the Argentine Journal of Cardiology, Bertolotti et al. from the Hospital Universitario Fundacion Favaloro (1) present excellent results with the Levitronix CentriMag® centrifugal flow pump in patients with cardiogenic shock. With this centrifugal flow pump, whose magnetically levitated rotor is the only mobile piece, femoral arteriovenous implantation with extracorporeal membrane oxygenator (ECMO) or left atrioaortic or right atriopulmonary implantation can be performed. Its clinical application has attracted great interest: simple and easily transportable management that represents an excellent alternative to hospitals without cardiac transplantation program, univentricular or biventricular support, high flows reaching up to 10 L / min, low hemolysis, low thromboembolism, albeit requiring anticoagulation, and low cost. (2) In my personal experience, out of 102 assist device implantations during the 1987-2011 period, 32 were with Levitronix CentriMag® pump, becoming the most implanted assist device since 2006. Although authorized as Class I support up to 30 days, we also use it as Class II support, with pump replacement every four weeks. The results reported by Bertolotti et al. (1) show 40% mortality. It is an excellent result and it would be more representative to describe 60% survival since all the patients had refractory cardiogenic shock in INTERMACS 1, despite inotropic support; therefore, survival without support would have been null. Is support justified considering the price and that the healthcare system cannot provide unlimited benefits with limited resources? Lack of survival in this group of patients without support justifies the treatment. Moreover, the reduced price of CentriMag® assist device compared to other Class II and III medical assist devices is validated as bridge to decision in patients requiring longterm support, gaining precious time to assess patient viability. Is the cost-benefit and cost-utility ratio justified, especially as a conclusive therapy? Any new treatment is asked to improve survival and quality of life.

Experience with Magnetically-levitated Centrifugal Flow Pump in Patients with Cardiogenic Shock (interMaCS 1)

Introduction Short term use of magnetically-levitated ventricular assist devices offers hemodynamic stabilization of patients with refractorycardiogenic shock in INTERMACS stage 1, enablinga therapeutic strategy. Objective The aim of this study was to assess in a single centre the results with second generation centrifugal flow pumps inpatients with refractory cardiogenic shock. Methods Fifteen patients with Levitronix CentriMag ventricular assistdevice implantation were retrospectively analyzed from 2006 to 2011. All patients presented refractory cardiogenic shock under two inotropic agents and 13 patients were also assisted with intra aortic balloon pump. The indications were:end stage cardiomyopathy in 8 patients, viral myocarditis in 1 patient, postpartum cardiomyopathy in 1 patient, postcardiotomycardiogenic shock in 3 patients and post heart transplantation graft failure in 2 patients. Results Mean age was 49 ± 13 years, and 66% (10/15) were men. Only 1 patient underwent left ventricular assist device implantation(LVA) and 14 patients underwent biventricular assistance (BVA). Mean support duration was 6 ± 4 days(2-19). Final post-implant therapeutic decision was bridgeto heart transplantation in 12 patients (80%), bridge to recovery in 1 patient (7%) and bridge to decision in 2 patients(13%). One patient was successfully weaned from BVA dueto ventricular function recovery and 8 patients were transplanted,with a survival rate of 60% (9/15). Reoperation dueto bleeding was performed in 6 patients (40%) and 1 patient presented cannulae thrombosis. None of the patients hadstroke or technical system failures. Six patients died whilereceiving circulatory assistance (40%) (5 BVA and 1 LVA),1 patient due to sepsis, 1 patient due to coagulopathy and4 patients due to multiple system organ failure. Out of the 6 deaths, 2 patients were in postcardiotomy cardiogenic shock and 4 were on heart transplantation waiting list. Conclusions In this series, circulatory support with Levitronix CentriMagcentrifugal flow pump was effective in critical patients with asurvival rate of 60%. Reoperation for bleeding was the mostfrequent complication.

Acquired von Willebrand Disease During CentriMag Support Is Associated with High Prevalence of Bleeding During Support and After Transition to Heart Replacement Therapy

The Levitronix CentriMag is a magnetically levitated centrifugal-flow pump that can be implanted rapidly in the operating room for both right and left ventricular support. Recently, continuous-flow pumps have been associated with excessive bleeding, which can be at least partially explained by acquired von Willebrand disease (vWD). We investigated whether acquired vWD occurs during CentriMag support and determined the frequency of bleeding complications during device support as well as after transition to long-term support. We found that acquired vWD is common early post CentriMag implantation and is associated with frequent bleeding events and high requirement of blood products.

Acute pulmonary injury with refractory hypoxaemia after implantation of Levitronix CentriMag ventricular assist device: successful treatment with veno-venous extracorporeal membrane oxygenation

Although acute pulmonary injury after cardiopulmonary bypass has been detailed in the literature, it was seldom mentioned in the context of following implantation of a ventricular assist device. We report on a 65-year-old male with end-stage ischemic cardiomyopathy who underwent implantation of Levitronix CentriMag (Levitronix, Waltham, MA) for cardiac support and was listed for heart transplantation. Acute pulmonary injury with profound hypoxaemia was noted 6h after the implantation. Despite optimal medical treatment and maximal ventilator support, refractory hypoxaemia persisted, and veno-venous extracorporeal membrane oxygenation (oxygenator: Affinity-NT; centrifugal pump: BPX-80 Bio-Pump, Medtronic, Minneapolis, MN, USA) was applied for ventilation support. The patient was weaned from the extracorporeal membrane oxygenation 4days later and from the ventilator on the next 2days. He underwent a successful orthotopic heart transplant after a total of 77days on Levitronix left ventricular device cardiac support.

Postcardiotomy mechanical circulatory support in two infants with williams' syndrome.

Supravalvar aortic stenosis (SVAS) in patients with Williams' syndrome is often accompanied by coronary, pulmonary, and even myocardial lesions and therefore associated with increased perioperative morbidity and mortality. Extracorporeal membrane oxygenation (ECMO) provides reliable short-term mechanical circulatory support to patients, especially young, in acute postoperative cardiac failure when conventional means are ineffective. The incorporation of centrifugal pumps in these systems has made their use more efficient and less traumatic. We describe our experience of using the Levitronix CentriMag pump in two patients with Williams' syndrome who underwent surgical correction of supravalvular aortic stenosis.

Levitronix centrimag ventricular assist device use in post-cardiotomy syndrome

Levitronix centrimag ventricular assist device use in post-cardiotomy syndrome

028 * EXTRACORPOREAL MEMBRANE OXYGENATION SYSTEM AS SALVAGE TREATMENT FOR PATIENTS WITH REFRACTORY CARDIOGENIC SHOCK

Objectives: The RotaFlow (Maquet, Jostra Medizintechnik AG, Hirrlingen, Germany) and the Levitronix CentriMag (Levitronix LCC, Waltham, MA) as central or peripheral veno-arterial extracorporeal membrane oxygenation (ECMO) support systems have been investigated as treatment for patients with refractory cardiogenic shock (CS). Methods: Between January 2007 and December 2012, 228 consecutive adult patients were supported on RotaFlow (n = 213) or CentriMag (n = 15) ECMO, at our institutions (155 men, age 58.3 ± 10.5, range 19-84 years). Indications for support were: failure to wean from cardiopulmonary bypass in the setting of postcardiotomy (n = 118) and primary donor graft failure (n = 37); post-acute myocardial infarction CS (n = 27); acute myocarditis (n = 6); and CS in chronic heart failure (n = 40). Results: A central ECMO setting was established in 102 (44.7%) patients and peripherally in 126 (55.2%). Overall mean support time was 10.9 ± 9.7 (range 1-34) days. Eighty-four (36.8%) patients died on ECMO. Overall success rate, in terms of survival on ECMO (n = 144), weaning from mechanical support (n = 107; 46.9%), bridge to long-term ventricular assist device (n = 6, 2.6%) and bridge to heart transplantation (n = 31, 13.5%), was 63.1%. One-hundred and twenty-two (53.5%) patients were successfully discharged. Stepwise logistic regression identified blood lactate level and CK-MB relative index at 72 h after ECMO initiation, and number of packed red blood cells (PRBCs) transfused on ECMO as significant predictors of mortality on ECMO (P = 0.010, odds ratio [OR] 2.94, 95% confidence interval [CI] 1.10-3.14; P = 0.010, OR 2.82, 95% CI 1.014-3.72; P = 0.011, OR = 2.69, 95% CI 1.06-4.16, respectively). No significant differences were seen by comparing RotaFlow and CentriMag populations in terms of device performance. Conclusions: Patients with a poor haemodynamic status may benefit from rapid central and peripheral insertion of ECMO. The blood lactate level, CK-MB relative index and PRBCs transfused should be strictly monitored during ECMO support.