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Despite the withdrawal of the HeartWare Ventricular Assist Device (HVAD), hundreds of patients are still supported with this continuous-flow pump, and the long-term management of these patients is still under debate. This study aims to analyse 5 years survival and freedom from major adverse events in patients supported by HVAD and HeartMate3 (HM3). From 2010 to 2022, the MIRAMACS Italian Registry enrolled all-comer patients receiving a LVAD support at seven Cardiac Surgery Centres. Out of 447 LVAD implantation, 214 (47.9%) received HM3 and 233 (52.1%) received HVAD. Cox-regression analysis adjusted for major confounders showed an increased risk for mortality (HR 1.5 [1.2-1.9]; p = 0.031), for both ischemic stroke (HR 2.08 [1.06-4.08]; p = 0.033) and haemorrhagic stroke (HR 2.6 [1.3-4.9]; p = 0.005), and for pump thrombosis (HR 25.7 [3.5-188.9]; p < 0.001) in HVAD patients. The propensity-score matching analysis (130 pairs of HVAD vs. HM3) confirmed a significantly lower 5 years survival (81.25% vs. 64.1%; p 0.02), freedom from haemorrhagic stroke (90.5% vs. 70.1%; p < 0.001) and from pump thrombosis (98.5% vs. 74.7%; p < 0.001) in HVAD cohort. Although similar perioperative outcome, patients implanted with HVAD developed a higher risk for mortality, haemorrhagic stroke and thrombosis during 5 years of follow-up compared to HM3 patients., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Francica, Loforte, Attisani, Maiani, Iacovoni, Nisi, Comisso, Terzi, De Bonis, Vendramin, Boffini, Musumeci, Luciani, Rinaldi, Pacini and Onorati.)

Objectives: In patients supported by a durable left ventricular assist device (LVAD), infections are a frequently reported adverse event with increased morbidity and mortality. The purpose of this study was to investigate the possible association between infections and thromboembolic events, most notable cerebrovascular accidents (CVAs), in LVAD patients., Methods: An analysis of the multicentre European Registry for Patients Assisted with Mechanical Circulatory Support was performed. Infections were categorized as VAD-specific infections, VAD-related infections and non-VAD-related infections. An extended Kaplan-Meier analysis for the risk of CVA with infection as a time-dependent covariate and a multivariable Cox proportional hazard model were performed., Results: For this analysis, 3282 patients with an LVAD were included with the majority of patients being male (83.1%). During follow-up, 1262 patients suffered from infection, and 457 patients had a CVA. Cox regression analysis with first infection as time-dependent covariate revealed a hazard ratio (HR) for CVA of 1.90 [95% confidence interval (CI): 1.55-2.33; P &lt; 0.001]. Multivariable analysis confirmed the association for infection and CVAs with an HR of 1.99 (95% CI: 1.62-2.45; P &lt; 0.001). With infections subcategorized, VAD-specific HR was 1.56 (95% CI: 1.18-2.08; P 0.002) and VAD-related infections [HR: 1.99 (95% CI: 1.41-2.82; P &lt; 0.001)] remained associated with CVAs, while non-VAD-related infections (P = 0.102) were not., Conclusions: Infection during LVAD support is associated with an increased risk of developing an ischaemic or haemorrhagic CVA, particularly in the setting of VAD-related or VAD-specific infections. This suggests the need of a stringent anticoagulation management and adequate antibiotic treatment during an infection in LVAD-supported patients., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Left ventricular assist devices (LVADs) are used to provide haemodynamic support to patients with critical cardiac failure. Severe complications can occur because of the modifications of the blood flow in the aortic region. In this work, the effect of a continuous flow LVAD device on the aortic flow is investigated by means of a non-intrusive reduced order model (ROM) built using the proper orthogonal decomposition with interpolation (PODI) method based on radial basis functions (RBF). The full order model (FOM) is represented by the incompressible Navier-Stokes equations discretized by using a Finite Volume (FV) technique, coupled with three-element Windkessel models to enforce outlet boundary conditions in a multi-scale approach. A patient-specific framework is proposed: a personalized geometry reconstructed from Computed Tomography (CT) images is used and the individualization of the coefficients of the three-element Windkessel models is based on experimental data provided by the Right Heart Catheterization (RHC) and Echocardiography (ECHO) tests. At FOM level, we also consider the pre-surgery configuration in order to further validate the predictive capabilities of the model in several contexts. The ROM has been tested by considering a parametric setting with respect to the LVAD flow, which is a crucial parameter of the problem. We consider a parameter range that covers typical clinical values. The accuracy of the ROM is assessed against results obtained with the FOM both for primal, velocity and pressure, and derived quantities, wall shear stress (WSS). Finally, we briefly discuss the efficiency of our ROM approach., (Copyright © 2022 IPEM. Published by Elsevier Ltd. All rights reserved.)

Background: Patients with LVAD require continuous monitoring and care, and since Implanting Centers (ICs) are more experienced in managing LVAD patients than other healthcare facilities, the distance between patient residency and IC could negatively affect the outcomes., Methods: Data of patients discharged after receiving an LVAD implantation between 2010 and 2021 collected from the MIRAMACS database were retrospectively analyzed. The population was divided into two groups: A (n = 175) and B (n = 141), according to the distance between patient residency and IC ≤ or >90 miles. The primary endpoint was freedom from Adverse Events (AEs), a composite outcome composed of death, cerebrovascular accident, hospital admission because of GI bleeding, infection, pump thrombosis, and right ventricular failure. Secondary endpoints were incidences of mortality and complications. All patients were followed-up regularly, according to participating center protocols., Results: Baseline clinical characteristics and indications for LVAD did not differ between the two groups. The mean duration of support was 25.5 ± 21 months for Group A and 25.7 ± 20 months for Group B (p = 0.79). At 3 years, freedom from AEs was similar between Group A and Group B (p = 0.36), and there were no differences in rates of mortality and LVAD-related complications., Conclusions: Distance from the IC does not represent a barrier to successful outcomes as long as regular and continuous follow-up is provided., (© 2022 International Center for Artificial Organ and Transplantation (ICAOT) and Wiley Periodicals LLC.)

Aims: Pulmonary artery pulsatility index (PAPi) is an indicator of right ventricular (RV) function and an independent predictor of right ventricular failure (RVF) following left ventricular assist device (LVAD) implantation. Administration of vasodilator challenge during right heart catheterization (RHC) could reduce RV workload allowing a better assessment of its functional reserve., Methods and Results: Patients undergoing LVAD implantation at our Institution between May 2013 and August 2021 were enrolled. Only patients who had undergone RHC and vasodilator challenge with sodium nitroprusside were analyzed. We collected all available clinical, instrumental, and haemodynamic parameters, at baseline and after nitroprusside infusion and evaluated potential associations with post-LVAD RVF. Of the 54 patients analyzed, 19 (35%) developed RVF after LVAD implantation. Fractional area change (FAC) (OR: 0.647, CI: 0.481-0.871; P = 0.004), pulmonary artery systolic pressure (PASP) (OR: 0.856, CI: 0.761-0.964; P = 0.010), and post-sodium nitroprusside (NTP) PAPi (OR: 0.218, CI: 0.073-0.653; P = 0.006) were independent predictors of post-LVAD RVF. The model combining FAC, PASP, and post-NTP PAPi demonstrated a predictive accuracy of 90.7%. Addition of post-NTP PAPi significantly increased the predictive accuracy of the European Registry for Patients with Mechanical Circulatory Support right-sided heart failure risk score [79.4 vs. 70.4%; area under the curve (AUC): 0.841 vs. 0.724, P = 0.022] and the CRITT score (79.6% vs. 74%; AUC: 0.861 vs. 0.767 P = 0.033)., Conclusion: Post-NTP PAPi has observed to be an independent predictor of RVF following LVAD implantation. Dynamic assessment of PAPi using a vasodilator challenge may represent a method of testing RV functional reserve in candidates for LVAD implantation. Larger and prospective studies are needed to confirm this hypothesis., Competing Interests: Conflict of interest: None declared., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objectives: In the third report of the European Registry for Patients with Mechanical Circulatory Support of the European Association for Cardio-Thoracic Surgery, outcomes of patients receiving mechanical circulatory support are reviewed in relation to implant era., Methods: Procedures in adult patients (January 2011-June 2020) were included. Patients from centres with <60% follow-ups completed were excluded. Outcomes were stratified into 3 eras (2011-2013, 2014-2017 and 2018-2020). Adverse event rates (AERs) were calculated and stratified into early phase (<3 months) and late phase (>3 months). Risk factors for death were explored using univariable Cox regression with a stepwise time-varying hazard ratio (<3 vs >3 months)., Results: In total, 4834 procedures in 4486 individual patients (72 hospitals) were included, with a median follow-up of 1.1 (interquartile range: 0.3-2.6) years. The annual number of implants (range: 346-600) did not significantly change (P = 0.41). Both Interagency Registry for Mechanically Assisted Circulatory Support class (classes 4-7: 23, 25 and 33%; P < 0.001) and in-hospital deaths (18.5, 17.2 and 11.2; P < 0.001) decreased significantly between eras. Overall, mortality, transplants and the probability of weaning were 55, 25 and 2% at 5 years after the implant, respectively. Major infections were mainly noted early after the implant occurred (AER<3 months: 1.44 vs AER>3 months: 0.45). Bilirubin and creatinine levels were significant risk factors in the early phase but not in the late phase after the implant., Conclusions: In its 10 years of existence, EUROMACS has become a point of reference enabling benchmarking and outcome monitoring. Patient characteristics and outcomes changed between implant eras. In addition, both occurrence of outcomes and risk factor weights are time dependent., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Heart failure is a complex clinical syndrome with a severe prognosis, despite therapeutic progress. The management of the advanced stages of the syndrome is particularly complex in patients who are referred to palliative care as well as in those who are candidates for cardiac replacement therapy. For the latter group, a prompt recognition of the transition to the advanced stage as well as an early referral to the centers for cardiac replacement therapy are essential elements to ensure that patients follow the most appropriate diagnostic-therapeutic pathway. The aim of this document is to focus on the main diagnostic and therapeutic aspects related to the advanced stages of heart failure and, in particular, on the management of patients who are candidates for cardiac replacement therapy.

Background: Right ventricular failure (RVF) is a severe event that increases perioperative mortality after left ventricle assist device (LVAD) implantation. Right ventricular (RV) function is particularly affected by the LVAD speed by altering RV preload and afterload as well as the position of the interventricular septum. However, there are no studies focusing on the relationship between pump speed optimization and risk factors for the development of late RVF., Methods: Between 2015 and 2019, 50 patients received LVAD implantation at San Camillo Hospital in Rome. Of these, 38 who underwent pump speed optimization were included. Post-optimization hemodynamic data were collected. We assessed a new Hemodynamic Index (HI), calculated as follows:  HI = MAP × PCWP CVP × RPM set RPM max , to determine the risk of late RVF, which was defined as the requirement for rehospitalization and inotropic support., Results: Ten patients had late RVF after LVAD implantation. Five patients required diuretic therapy and speed optimization. Three patients required inotropic support with adrenaline 0.05 μg/kg/min. Two patients needed prolonged continuous venovenous hemofiltration and high dose inotropic support. Multivariate analysis revealed that a low HI (odds ratio 11.5, 95% confidence interval, 1.85-65.5, p [.003]) was an independent risk factor for late RVF after LVAD implantation., Conclusion: We demonstrated a low HI being a significant risk factor for the development of RVF after LVAD implantation. We suggest implementing HI as a decision support tool for goal-direct optimization of the device aiming to reduce the burden of late-onset RVF during the follow-up., (© 2021 Wiley Periodicals LLC.)

Percutaneous transcatheter intervention for aortic regurgitation secondary to implantation of a continuous-flow left ventricular assist device remains challenging, because of the minimal global experience with these procedures. Two treatment options are available: transcatheter aortic valve replacement, which is not always feasible when a dilated aortic annulus is present, and percutaneous aortic valve occlusion. We report a successful percutaneous closure of the aortic valve using an oversized Amplatzer patent foramen ovale multifenestrated device (St Jude Medical, Saint Paul, MN) to treat aortic regurgitation associated with dilated aortic annulus in a patient with a continuous-flow left ventricular assist device., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Left ventricular assist device (LVAD) management is very challenging since many adverse events can occur in ongoing patients. Inadequate anticoagulation treatment can lead to life-threatening situations like ischemic stroke or pump thrombosis. The main intention of our study was to investigate if early identification of aspirin nonresponders by using aggregometry can improve anticoagulation management, reducing the risk of pump thrombosis., Methods: From December 2010 to May 2018, 24 patients were implanted with a HeartMate II (HMII), 6 received a HeartWare HVAD system--full support VAD (HVAD), and 22 received a HeartMate III (HMIII). All patients were maintained with a target INR of 2.0 to 3.0. When the aggregometry test revealed a normal platelet function, 100 mg of aspirin were initiated. Only aspirin nonresponders were early identified by repeating the aggregometry after 7 days of aspirin administration. In acetylsalicylic acid nonresponder patients, 75 mg of clopidogrel was used, and the patients were tested again. Ticlopidine (250 mg) was used when clopidogrel was unsuccessful., Results: Four patients required modification in antiplatelet therapy. Three patients (5%), 2 HVAD and 1 HMII, suffered from pump thrombosis. One patient died as a consequence of a large intracranial hemorrhagic event following thrombolytic treatment. One patient required a pump exchange; in 1 patient, thrombolytic infusion was conducted successfully., Conclusion: Reported rates of pump thrombosis at 12 months for patients implanted with commonly used LVADs were 6% to 12% for axial-flow pumps and 8% with centrifugal-flow devices. In our series, the reported 5% overall incidence of pump thrombosis encourages the routine use of an aggregometry test for early identification of aspirin nonresponders., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Pump speed optimization in patients implanted with a ventricular assist device represents a major challenge during the follow-up period. We present our findings on whether combined invasive hemodynamic ramp tests and cardiopulmonary exercise testing (CPX) can help optimize patient management., Methods: Eighteen patients implanted with a HeartMate 3 (HM3) device underwent ramp tests with right heart catheterization (including central venous pressure [CVP], pulmonary artery pressure, pulmonary capillary wedge pressure [PCWP], and blood pressure) and echocardiography. Data were recorded at up to 4 speed settings. Speed changes were in steps of 200 revolutions/min (rpm). Evaluation of functional capacity by CPX was conducted according to the modified Bruce protocol., Results: Only 30% of patients had normal PCWPs at their original rpm settings. In going from lowest to highest speeds, cardiac output improved by 0.25 ± 0.35 L/min/step (total change, 1.28 ± 0.3 L/min), and PCWP decreased by 1.9 ± 0.73 mm Hg/step (total change, 6 ± 1.6 mm Hg). CVP and systolic blood pressure did not change significantly with rpm. The rpm assessment was adjusted based on test results to achieve CVPs and PCWPs as close to normal limits as possible, which was feasible in all patients. On CPX, all patients demonstrated good performance (peak VO 2 , 16.8 ± 3.5 mL/kg/min)., Conclusion: Hemodynamic ramp testing provides an objective means of optimizing rpm, and has the potential to provide good exercise tolerance., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Introduction: The measurement of blood pressure (BP) and the management of hypertension in patients with continuous-flow ventricular assist devices (CF-VADs) can present unique challenges. Patients with CF-VADs often do not have a palpable pulse, and therefore traditional blood pressure measurement by auscultation or automated cuff is less reliable. We tested the efficacy of blood pressure estimation using sphygmomanometry combined with finger pulse oximetry only after a hemodynamic optimization was effected to make the values estimated approximately similar to mean arterial pressure., Methods: Fifteen consecutive patients with a mean age of 57.8 ± 11.2 years were implanted with HeartMate 3 between November 2015 and March 2017. All patients underwent pump speed optimization by conducting a ramp test during right heart catheterization. The patients were prospectively studied during the follow-up period and mean arterial pressure was estimated using 3 different methodologies: Doppler ultrasound, pulse oximeter, and automated blood pressure cuff. For each method 3 consecutive evaluations were conducted during 3 follow-up visits., Results: For each patient, 9 different evaluations were obtained (3 for each method). The overall success rate was 100% for blood pressure assessment conducted with Doppler ultrasound and pulse oximeter and 80%-87% for automated monitor evaluations. The first 2 methodologies were 100% successful, while the third was 60% successful. Pearson's correlation analyses for the Doppler ultrasound and pulse oximeter measurements showed a good correlation when evaluations conducted with the same method were compared. A high variability emerged between estimations obtained by using an automated monitor and a poor correlation was found when this method was compared to the Doppler ultrasound and pulse oximeter measurements., Conclusion: According to our results, the pulse oximeter method showed a high success rate and a good correlation level with the standard procedure. Our data encourage the use of oximeters for domiciliary blood pressure assessment in patients implanted with a continuous flow device., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Right ventricular failure after continuous-flow left ventricular assist device (LVAD) implantation is still an unsolved issue and remains a life-threatening event for patients. We undertook this study to determine predictors of the patients who are candidates for isolated LVAD therapy as opposed to biventricular support (BVAD). We reviewed demographic, echocardiographic, hemodynamic, and laboratory variables for 258 patients who underwent both isolated LVAD implantation and unplanned BVAD because of early right ventricular failure after LVAD insertion, between 2006 and 2017 (LVAD = 170 and BVAD = 88). The final study patients were randomly divided into derivation (79.8%, n = 206) and validation (20.1%, n = 52) cohorts. Fifty-seven preoperative risk factors were compared between patients who were successfully managed with an LVAD and those who required a BVAD. Nineteen variables demonstrated statistical significance on univariable analysis. Multivariable logistic regression analysis identified destination therapy (odds ratio [OR] 2.0 [1.7-3.9], p = 0.003), a pulmonary artery pulsatility index <2 (OR 3.3 [1.7-6.1], p = 0.001), a right ventricle/left ventricle end-diastolic diameter ratio >0.75 (OR 2.7 [1.5-5.5], p = 0.001), an right ventricle stroke work index <300 mm Hg/ml/m (OR 4.3 [2.5-7.3], p < 0.001), and a United Network for Organ Sharing modified Model for End-Stage Liver Disease Excluding INR score >17 (OR 3.5 [1.9-6.9], p < 0.001) as the major predictors of the need for BVAD. Using these data, we propose a simple risk calculator to determine the suitability of patients for isolated LVAD support in the era of continuous-flow mechanical circulatory support devices.

Background: Mechanical circulatory support (MCS) is the standard therapy for the management of acute or chronic end-stage heart failure. We report on our two-center experience with MCS therapy., Methods: Between January 2000 and December 2012, 116 adult patients (mean age 56.8 ± 9.9 years, range: 31 to 76 years) were primarily supported on temporary or long-term ventricular assist devices (VADs) or total artificial hearts (TAHs) at our institutions. Temporary extracorporeal radial VAD support was established in 50 patients (43.1%) (Group A) whereas 66 (56.8%) patients received long-term paracorporeal and intracorporeal VAD or TAH (Group B). LVAD support was established in 63 patients (54.3%), with BVAD/TAH support in 29 (25%). A temporary CentriMag was the only device adopted as an isolated RVAD support, being placed in 24 patients (20.6%)., Results: In Group A, the overall mean support time was 10.2 ± 6.6 days (range: 3 to 43 days) and the overall success rate was 55.1% (27 patients). The mean LVAD support time was 357 ± 352.3 days (range: 1 to 902 days) in Group B and 98 ± 82.6 days (range: 8 to 832 days) in BVAD/TAH patients, with success rates of 72.5% (37 patients) and 46.6% (seven patients), respectively. The heart transplantation (Htx) rate for both groups combined was 25.8% (n = 30). The overall one- and five-year survival rates after Htx were 73.3% and 60%, respectively., Conclusions: When a decision to treat with VAD or TAH is made early, either modality can be used as an alternative to Htx, affording comparable early to mid-term outcomes., (© 2014 Wiley Periodicals, Inc.)

Background: Currently, ventricular assist device (VAD) or total artificial heart (TAH) mechanical support provides an effective treatment of unstable patients with advanced heart failure. We report our single-center experience with mechanical circulatory support therapy., Methods: From March 2002 to December 2012, 107 adult patients (mean age, 56.8 ± 9.9 y; range, 31-76 y) were primarly supported on temporary or long-term VAD or TAH support as treatment for refractory heart failure at our institution. Temporary extracorporeal radial VAD support (group A) was established in 49 patients (45.7%), and long-term paracorporeal and intracorporeal VAD or TAH (group B) in 58 patients (54.2%). Left ventricular (LVAD) support was established in 55 patients (51.4%; n = 33, Heartmate II; n = 6, Heartmate I XVE; n = 4, Heartware HVAD; and n = 12, Centrimag) and biventricular (BVAD/TAH) support (group B) in 28 patients (26.1%; n = 10, Thoratec paracorporeal; n = 2, Heartware HVAD, n = 1, Thoratec implantable; n = 1, Syncardia TAH; and n = 14, Centrimag). The temporary Centrimag was the only device adopted as isolated right ventricular (RVAD) support, and it was inserted in 24 patients (22.4%)., Results: In group A, overall mean support time was 10.2 ± 6.6 days (range, 3-43 d). In group B, LVAD mean support time was 357 ± 352.3 days (range, 1-902 d) and BVAD/TAH support time was 98 ± 82.6 days (range, 8-832 d). In group A, the overall success rate was 55.1% (27 patients). In group B, LVAD overall success rate was 74.4% (32 patients) and BVAD/TAH success rate was 50% (7 patients). Overall heart transplantation rate for both groups was 27.1% (n = 2, group A; n = 27, group B). Overall 1-year and 5-year survivals after heart transplantation were 72.4% (n = 21) and 58.6% (n = 17), respectively., Conclusions: Mechanical circulatory support is an effective strategy even in cases of end-stage heart failure according to our experience. Further improvement of VAD and TAH technologies may support their adoption as an encouraging alternative to heart transplantation in the near future., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Early planned institution of temporary right ventricular assist device (RVAD) support with the CentriMag (Levitronix LLC, Waltham, MA, USA) in left ventricular assist device (LVAD) recipients was compared with permanent biventricular assist device (BVAD) or total artificial heart (TAH) support. Between 2007 and 2011, 77 patients (age range: 25-70 years) with preoperative evidence of biventricular dysfunction (University of Pennsylvania score >50; University of Michigan score >5) were included. Forty-six patients (38 men; median age 54.5 years, range: 25-70 years) underwent LVAD placement combined with temporary RVAD support (group A); in 31 patients (25 men; median age 56.7 years, range: 28-68 years), a permanent BVAD or TAH implantation (group B) was performed. Within 30 days, 12 patients from group A (26.08%) and 14 patients from group B (45.1%) died on mechanical support (P = 0.02). Thirty patients (65.2%) in group A were weaned from temporary RVAD support and three (6.5%) underwent permanent RVAD (HeartWare, Inc., Framingham, MA, USA) placement. A total of 26 patients (56.5%) were discharged home in group A versus 17 (54.8%) in group B (P = 0.56). Three patients (8.5%) received heart transplantation in group A and six (19.3%) in group B (P = 0.04). In group A, 90-day and 6-month survival was 54.3% (n = 25) versus 51.6% (n = 16) in group B (P = 0.66). In group A, 1-year survival was 45.6% (n = 21) versus 45.1% (n = 14) in group B (P = 0.81). The strategy of planned temporary RVAD support in LVAD recipients showed encouraging results if compared with those of a similar permanent BVAD/TAH population. Weaning from and removal of the temporary RVAD support may allow patients to be on LVAD support only despite preoperative biventricular dysfunction., (© 2013, Copyright the Authors. Artificial Organs © 2013, International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.)

The diagnosis of a patent foramen ovale (PFO) is a dynamic process and it is based on the detection of blood shunting at the atrial level. Only under abnormal physiologic conditions, such as with a left ventricular assist device (LVAD), when right atrial pressure (RAP) exceeds left atrial pressure (LAP) the PFO may cause hypoxemia due to a right-to-left shunt. We report the closure of a PFO using a transcatheter approach in a patient on LVAD support., (© 2012 Wiley Periodicals, Inc.)

Background: When patients at high risk for failure of isolated left ventricular assist device (LVAD) support are identified, biventricular assist device implantation is suggested as a primary option. Results of a planned temporary right ventricular mechanical support (RVAD) placement in high-risk LVAD recipients have been reported and analyzed., Methods: Between 2009 and 2011, 10 consecutive adult patients (9 men; age range 31-69 years), with preoperative evidence of moderate to severe biventricular failure, were supported simultaneously with an axial flow HeartMate II (Thoratec Corp., Pleasanton, California) LVAD and a temporary CentriMag (Levitronix LCC, Waltham, Massachusetts) RVAD as a primary option at our institution. Indications for support at implantation were ischemic dilated cardiomyopathy in 6 cases and idiopathic dilated cardiomyopathy in 4. Planned temporary RVAD insertion was defined as RVAD support placement at the same time as LVAD placement., Results: Nine patients were successfully weaned from temporary RVAD support after an average time of 18.6 days (range 3-43 days) and discharged from hospital. One patient died due to respiratory failure. RVAD removal was performed through a minimally invasive approach without repeat sternotomy in 6 patients. None of the patients required a permanent RVAD support., Conclusions: When patients at high risk for failure of isolated LVAD support are identified, temporary biventricular assist device implantation is advised to improve the outcome of such a vulnerable patient population.

The Levitronix CentriMag (Levitronix LLC, Waltham, MA) ventricular assist device (VAD) is a magnetically levitated rotary pump designed for temporary extracorporeal support. Between February 2004 and May 2010, 42 consecutive adult patients were supported with Levitronix at our institution (32 men; age 62.3 ± 10.5 years, range: 31-76 years). Indications for support were (group A, n = 37) failure to wean from the cardiopulmonary bypass in the setting of postcardiotomy (n = 23), primary donor graft failure (n = 4), or right ventricular failure after axial left VAD (LVAD) placement (n = 10) and (group B, n = 5) refractory heart failure after acute myocardial infarction. The mean support time was 11.2 ± 6.8 days (range: 3-43 days) in group A and 8.6 ± 4.3 days (range: 5-11 days) in group B. In the postcardiotomy cohort (group A), 11 (47.8%) patients were weaned from support as all were supported graft failure patients. Eight patients of axial LVAD cohort were weaned from right VAD (RVAD). One patient was bridged to heart transplantation (Htx). Thirteen (35.1%) patients died on support in group A. In group B, one patient was bridged to Htx and four died on support. In overall population, bleeding requiring reoperation occurred in 15 (35.7%) cases and cerebral major events in four (9.5%). There were no device failures. Of the 23 (54.7%) patients who recovered and were discharged home, 20 (47.6%) are presently alive, and additionally, two patients of both groups who were bridged to Htx (overall n = 22, 52.3%). The Levitronix proved to be useful in patients previously considered nonsuitable for transplantation or long-term assist device. The device was technically easy to manage, and the results were encouraging.

A long-term mechanical biventricular support by HeartWare HVAS third-generation continuous flow pump (HeartWare, Inc, Miramar, FL, USA) was implanted in a Korean patient with a small chest size for treatment of a refractory end-stage heart failure due to an idiopathic dilative cardiomyopathy. We report our experience with a single patient and the early mid-term follow-up results with such a mechanical ventricular support.

An approach is reported for right ventricle temporary mechanical support in long-term axial left ventricular assist device (LVAD) patients preoperatively judged at high risk of right ventricular (RV) failure. The timing for RV assist device (RVAD) weaning and the technique for its removal through a right mini-thoracotomy are described. This strategy provides a good outcome in LVAD recipients avoiding the risk of immediate postoperative RV failure.

Objectives: The excellent results with left ventricular assist devices (LVADs) have revolutionized the treatment options for end-stage heart failure. The use of pulsatile devices is associated with significant comorbidity and limited durability. The axial-flow HeartMate II LVAD represents the new generation of devices. The clinical use of this pump resulted in superior outcomes. We review the HeartMate II technology, management, clinical usage and our experience., Methods: Between 3/2002 and 12/2008, 18 transplantable adult patients were supported on long-term HeartMate II LVAD at our institution (13 men, age 52 +/- 8.4 years, range: 31-64 years). Primary indications were: ischemic cardiomyopathy (CMP) (n = 13), idiopathic CMP (n = 5). All patients were in New York Heart Association (NYHA) Class IV heart failure. None of patients had prior open-heart surgery. Implantation via cannulation of the left ventricular apex and the ascending aorta was always elective., Results: Mean support time was 217 +/- 212.3 days (range: 1-665 days). Early (30-day) mortality was 27.7% (five patients) with multiple organ failure and sepsis as main causes of death. Bleeding requiring reoperation occurred in six (33.3%) cases. Cerebral hemorrhage occurred in one patient. There were two driveline infections and no device failure. Twelve (66.6%) patients were successfully discharged home. Overall nine patients (50%) were transplanted and two patients are actually waiting for a suitable organ (n = 2 patients discharged home and n = 1 patient in hospital). At latest, follow-up survival rate after heart transplantation is 66.6% (six patients)., Conclusion: Long-term HeartMate II LVAD provides good mid-term, long-term results. This new technology requires delicate management. Functional status and quality of life greatly improve in patients who survive the perioperative period.

Background: The use of left ventricular assist devices (LVAD) is an accepted therapy for patients with refractory heart failure. The HeartMate II is a small (350 g), implantable, axial-flow pump (nonpulsatile flow), which is designed to support the left ventricle for extended periods of time. Here we have reported our initial single-center clinical experience with this device as a bridge to heart transplantation., Materials and Methods: Between March 2002 and December 2008, 18 transplantable adult patients were supported on long-term HeartMate II LVAS at our institution. The cohort included 15 men with an overall mean age of 52 +/- 8.4 years (range, 31-64 years). Primary indications for implantation were ischemic cardiomyopathy (CMP; n = 13) and idiopathic CMP (n = 5). All heart failure patients were New York Heart Association (NYHA) functional class IV. None of them had undergone prior open heart surgery. Implantation was performed via cannulation of the left ventricular apex and ascending aorta, and in each case was an elective procedure., Results: Mean support time was 217 +/- 212.3 days (range, 1-665 days). Early (30-day) mortality was 27.7% (n = 5) due to multiple organ failure and sepsis as main causes of death. Bleeding requiring reoperation occurred in 6 cases (33.3%). Cerebral hemorrhage occurred in 1 case. There were 2 driveline infections and no device failure. Twelve subjects (66.6%) were successfully discharged home. Overall, 9 patients (50%) underwent transplantation and 3 are awaiting a suitable organ (2 were discharged home and 1 is in hospital). At latest follow-up, the survival rate after heart transplantation was 66.6% (n = 6)., Conclusions: Long-term HeartMate II LVAS can successfully bridge patients to heart transplantation. Good mid- and long-term results may support the use of this device even for a permanent solution in nontransplantable subjects.

Objective: The novel axial flow left ventricular assist device HeartMate II was introduced into clinical practice in Europe as part of the pilot study and after CE approval in November 2005. In order to get an overview of the use and performance of the device in Europe a group of investigators was founded to compare the initial results., Methods: In a retrospective analysis of the first 101 consecutive cases in Europe, data were collected with regard to postoperative outcome and severe adverse events and anticoagulation protocols. Results were stratified by intention to treat as a bridge to transplant or as chronic support therapy in heart failure (destination therapy)., Results: In 70% of patients, the HeartMate II was intended as a bridge to transplant therapy, in 30%, it was used as a destination therapy device. The perioperative mortality post implant was 20% in the bridge to transplant patients and 7% in the destination therapy arm. However, after 1 year a comparable survival was observed in both groups (69% destination therapy, 63% bridge to transplant). Main causes of death were multiple organ failure (n=12) and cerebrovascular accidents (n=5). All, but one cerebrovascular accident occurred in the first 9 days after surgery. Only one other death was reported thereafter and there was no mechanical failure of the device., Conclusions: Even in the early experience the HeartMate II was used as a chronic support device in a substantial number of patients in Europe. Although the total experience is still limited, the incidence of cerebrovascular accidents is very low and the survival beyond the perioperative period is excellent.