When all Else Fails, Try This: The HeartMate III Left Ventricle Assist Device.

Heart failure (HF) is a progressive disease. It is estimated that more than 250,000 patients suffer from advanced HF with reduced ejection fraction refractory to medical therapy. With limited donor pool for heart transplant, continue flow left ventricle assist device (LVAD) is a lifesaving treatment option for patients with advanced HF. This review will provide an update on indications, contraindications, and associated adverse events for LVAD support with a summary of the current outcomes data.

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

BACKGROUND: Patients receiving left ventricle assist devices (LVADs) as bridge to recovery remain a minority with 1%-5% of LVADs explanted after improvement of myocardial function. Nevertheless, considering the growing population of patients supported with LVADs, an increasing demand of new explantation strategies is expected in the near future. A novel plug for LVAD explantation has been developed and its biocompatibility profile needs to be proved. This study tested the biocompatibility of this novel plug in an in vivo ovine model. METHODS: Six adult Blackhead Persian female sheep received plug implantation on the cardiac apex via minimally invasive approach and were clinically observed up to 90 days. Echocardiography was performed to detect thrombus formation or further plug-related complications. After the observation period, euthanasia was performed and samples including the plug and the surrounding tissues were obtained to be analyzed with correlative light and electron microscopy. Organ necrosis, ischemia and peripheral embolism were investigated. RESULTS: Three animals survived surgery and completed the follow-up time without experiencing clinical complications. Echocardiographic controls excluded the presence of an intracavitary thrombus in the left ventricle (LV). Autopsy confirmed no signs of local infection, LV thrombus or peripheral embolism. Light and electron microscopy revealed an intact epithelium covering a layer of connective tissue on the plug surface facing the heart lumen. CONCLUSIONS: This novel apical plug for LVAD explantation allows for endothelial and connective tissue growth on its ventricular side within 90 days from surgery. Further studies are required to fully demonstrate the biocompatibility of this apical plug and investigate the optimal anticoagulation regimen to be applied after implantation.

Isolated left ventricular assist device implantation produces variable changes to patient body mass index.

BACKGROUND: Body mass index (BMI) is an important consideration for transplant-eligible left ventricular assist device (LVAD) recipients. LVAD therapy's impact on BMI is unclear. We evaluated BMI changes in patients who underwent LVAD implantation. The association between these patients' BMI and the transplant was studied. METHODS: This was a retrospective cohort study of patients who underwent LVAD implantation between January 1, 2012 and December 31, 2018 at our institution. Patients were stratified by preoperative BMI (kg/m2 ) into four groups: <30, 30-34.9, 34.9-39.9, and ≥40. BMI data were collected at 12 and 6 months prior to implantation, time of implantation, and 3- and 6- months postimplantation. RESULTS: A total of 107 patients underwent LVAD implantation at our institution. Data were available for 80 patients. Baseline characteristics included a mean age of 56.0 years, 69% male, and a mean implant BMI of 29.9 ± 6.8 kg/m2 . The mean BMI (kg/m2 ) for each of the BMI (kg/m2 ) groups <30, 30-34.9, 35-39.9, and ≥40 (n = 60, 25, 12, and 10, respectively) was 25.1, 32.5, 36.8, and 43.8, respectively. There was no consistent pattern with weight change across differing implant BMIs. No patient with a BMI of <30 gained sufficient weight to impact transplant candidacy. Twenty-three percent of patients with a BMI of 30-34.9 kg/m2 , 60% of patients with a BMI of 35-39.9 kg/m2 , and 87.5% of patients with a BMI of ≥40 kg/m2 had a 6-month BMI potentially affecting transplant. CONCLUSIONS: Associated weight changes during LVAD support may significantly impact transplant candidacy. Higher BMI groups may benefit from multimodal and multidisciplinary targeted weight-loss interventions.

A new hemodynamic index to predict late right failure in patients implanted with last generation centrifugal pump.

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.

Ventricular arrhythmias following continuous-flow left ventricular assist device implantation: A systematic review.

Ventricular arrhythmias (VA) are not uncommon after continuous-flow left ventricular assist device (CF-LVAD) implantation. In this systematic review, we sought to identify the patterns of VA that occurred following CF-LVAD implantation and evaluate their outcomes. An electronic search was performed to identify all articles reporting the development of VA following CF-LVAD implantation. VA was defined as any episode of ventricular fibrillation (VF) or sustained (>30 seconds) ventricular tachycardia (VT). Eleven studies were pooled for the analysis that included 393 CF-LVAD patients with VA. The mean patient age was 57 years [95%CI: 54; 61] and 82% [95%CI: 73; 88] were male. Overall, 37% [95%CI: 19; 60] of patients experienced a new onset VA after CF-LVAD implantation, while 60% [95%CI: 51; 69] of patients had a prior history of VA. Overall, 88% of patients [95%CI: 78; 94] were supported on HeartMate II CF-LVAD, 6% [95%CI: 3; 14] on HeartWare HVAD, and 6% [95%CI: 2; 13] on other CF-LVADs. VA was symptomatic in 47% [95%CI: 28; 68] of patients and in 50% [95%CI: 37; 52], early VA (<30 days from CF-LVAD) was observed. The 30-day mortality rate was 7% [95%CI: 5; 11]. Mean follow-up was 22.9 months [95%CI: 4.8; 40.8], during which 27% [95%CI: 17; 39] of patients underwent heart transplantation. In conclusion, approximately a third of patients had new VA following CF-LVAD placement. VA in CF-LVAD patients is often symptomatic, necessitates treatment, and carries a worse prognosis.

The influence of left ventricular assist device inflow cannula position on thrombosis risk.

The use of left ventricular assist devices (LVADs) as a treatment method for heart failure patients has been steadily increasing; however, pathological studies showed presence of thrombi around the HeartWare ventricular assist device inflow cannula (IC) in more than 95% of patients after device explantation. Flow fields around the IC might trigger thrombus formation and require further investigation. In this study flow dynamics parameters were evaluated for different patient geometries using computational fluid dynamics (CFD) simulations. Left ventricular (LV) models of two LVAD patients were obtained from CT scans. The LV volumes of Patient 1 (P1) and Patient 2 (P2) were 264 and 114 cm3 with an IC angle of 20° and 9° from the mitral-IC tip axis at the coronal plane. The IC insertion site at the apex was central for P1, whereas it was lateral for P2. Transient CFD simulations were performed over 9 cardiac cycles. The wedge area was defined from the cannula tip to the wall of the LV apex. Mean velocity magnitude and blood stagnation region (volume with mean velocity <5 mm/s) as well as the wall shear stress (WSS) at the IC surface were calculated. Cardiac support resulted in a flow mainly crossing the ventricle from the mitral valve to the LVAD cannula for P2, while the main inflow jet deviated toward the septal wall in P1. Lower WSS at the IC surface and consequently larger stagnation volumes were observed for P2 (P1: 0.17, P2: 0.77 cm3 ). Flow fields around an LVAD cannula can be influenced by many parameters such as LV size, IC angle, and implantation site. Careful consideration of influencing parameters is essential to get reliable evaluations of the apical flow field and its connection to apical thrombus formation. Higher blood washout and lower stagnation were observed for a central implantation of the IC at the apex.

In vitro evaluation of multi-objective physiological control of the centrifugal blood pump.

Left ventricular assist devices (LVADs) have been used as a bridge to transplantation or as destination therapy to treat patients with heart failure (HF). The inability of control strategy to respond automatically to changes in hemodynamic conditions can impact the patients' quality of life. The developed control system/algorithm consists of a control system that harmoniously adjusts pump speed without additional sensors, considering the patient's clinical condition and his physical activity. The control system consists of three layers: (a) Actuator speed control; (b) LVAD flow control (FwC); and (c) Fuzzy control system (FzC), with the input variables: heart rate (HR), mean arterial pressure (MAP), minimum pump flow, level of physical activity (data from patient), and clinical condition (data from physician, INTERMACS profile). FzC output is the set point for the second LVAD control schemer (FwC) which in turn adjusts the speed. Pump flow, MAP, and HR are estimated from actuator drive parameters (speed and power). Evaluation of control was performed using a centrifugal blood pump in a hybrid cardiovascular simulator, where the left heart function is the mechanical model and right heart function is the computational model. The control system was able to maintain MAP and cardiac output in the physiological level, even under variation of EF. Apart from this, also the rotational pump speed is adjusted following the simulated clinical condition. No backflow from the aorta in the ventricle occurred through LVAD during tests. The control algorithm results were considered satisfactory for simulations, but it still should be confirmed during in vivo tests.

Early versus standard renal replacement therapy after left ventricular assist device implantation.

OBJECTIVES: Renal function may improve after left ventricular assist device (LVAD) implant, however, some patients develop postoperative acute kidney injury (AKI). Randomized trials showed benefit for early renal replacement therapy (RRT) in critically ill patients with AKI, but this practice has not been studied in LVAD patients. METHODS: We performed a single-center, retrospective cohort study of all adults (>18 years) who underwent LVAD placement from 1/2010 to 12/2018. We collected preoperative, hemodynamic, echocardiographic, intraoperative, and postoperative data. AKI was defined according to Kidney Disease: Improving Global Outcomes definition. Early (E) RRT was considered treatment at AKI stage II or below. Standard (S) RRT was considered treatment at AKI stage III. Outcomes and Kaplan-Meier analysis were compared between groups. RESULTS: A total of 184 patients were included (mean age 56.10 years, 81% males, 30.4% African-American race). A total of 71 (38.6%) developed AKI and 17 (9.24%) needed RRT (11 E vs 6 S). A total of 11 remained hemodialysis-dependent at discharge (5 [45.5%] in E vs 6 [100%] in S, P = .043). There was a trend toward shorter intensive care unit stay and ventilation time in E group, and overall hospital stay was significantly less in the E group (48.18 ± 25.95 vs 94.00 ± 53.07 days, P = .028). Thirty-day mortality was similar between groups (E 18% vs S 16%, P = .9), but there was a trend toward improved overall survival in the E group. CONCLUSION: This is the first study to examine early initiation of RRT after LVAD implant. Early RRT was associated with shorter hospital stay, lower need for permanent RRT, and a trend toward improved survival. This practice may provide significant cost savings and should be examined further.

Peripheral Artery Disease and Continuous Flow Left Ventricle Assist Device: An Engaging Complement Analysis May Help to Guide Treatment.

Use of continuous flow left ventricle assist device (CF-LVAD) in advanced heart failure (HF) patients results in clinically relevant improvements in survival, functional capacity, and quality of life. Peripheral artery disease (PAD) can occur in patients with CF-LVAD due to the high rate of concomitance between risk factors for atherosclerosis and HF. Diagnosis of PAD can be difficult in the specific setting of a patient supported by this kind of device because of the marked alteration in waveform morphology and velocity created by the artificial physiology of an LVAD. We report the case of a 53-year-old man with HF secondary to ischemic cardiomyopathy supported by the HeartWare HVAD as bridge to transplant, who after the implant developed symptoms suggestive of PAD. We describe additional computational flow analysis for the study of PAD-related hemodynamic disturbances induced by a CF-LVAD. Flow simulations enhance the information of clinical image data, and may have an application in clinical investigations of the risk of hemodynamic disturbances induced by LVAD implantation.

Left ventricle assist devices and driveline's infection incidence: a single-centre experience.

Different left ventricular assist devices (LVADs) are provided of different driveline exit sites: HeartWare HVAD presents abdominal power-cable-supply, while the Jarvik 2000 LVAD is powered by a retroauricular driveline. We analyzed 93 LVAD-implanted patients from January-2009 to October-2016 (41 HeartWare and 52 Jarvik 2000), hypothesizing a different incidence of infection, according to driveline exit site. The two populations were propensity matched for the demographic data and preoperative variables, and the outcomes were further analyzed. Nine driveline infections (DLIs) were in each LVAD group recorded (22% for HVAD and 17% for Jarvik 2000). The incidence of the complication was similar between groups (p = 0.97), even during time (p = 0.27 within 6 months and p = 0.16 over 6 months of support). Age at implant (p = 0.01), revision for bleeding (p = 0.05), days of postoperative intubation (p = 0.002), and ICU stay (p < 0.001), as well as days on device (p < 0.001) were identified as risk factors for DLIs. The type of device and the driveline exit site were not statistically co-related to infections. Similar infection-freedom survival was identified (p = 0.87). Younger age at implant, revision for bleeding, prolonged mechanical ventilation, delayed rehabilitation, as well as long time LVAD support were identified as risk factors for exit site DLIs. Despite similar incidence of DLIs, the different management and care of the retroauricular exit site makes it more appropriate and comfortable in long-term support.

Initial experience with intracorporeal continuous ow LVAD in pediatric patients in Poland.

THE AIM: The aim of the study is to present the initial experience with continuous flow left ventricle assist device (CF-LVAD) in pediatric patients with BSA below 1.5 m2. MATERIAL AND METHODS: Between 2016 and 2017, CF-LVAD (the Heartware System) have been implanted in three pediatric patients in the Department of Pediatric Cardiac Surgery, Jagiellonian University, Krakow, Poland. The indications for initiating CF-LVAD were end-stage congestive heart failure due to dilated cardiomyopathy in all children. RESULTS: Implanted patients have had BSA of 1.09, 1.42, 1.2 m2, and 37, 34, 34 kg of body weight and the age 12, 11, 12 years, respectively. The time of support was 550 days in two patients and 127 in another one, and is ongoing. The main complication has been driveline infection. CONCLUSION: The outcomes from our single-center experience using the HeartWare CF-LVAD have been excellent with a low incidence of complication and no necessity to reoperation in our patients. Children could be successfully and safely discharged home.

Effects of HeartWare ventricular assist device on the von Willebrand factor: results of an academic Belgian center.

BACKGROUND: Left Ventricular Assist Device (LVAD) is a promising therapy for patients with advanced heart failure (HF), but bleeding complications remain an important issue. Previous series show that acquired von Willebrand syndrome was present in up to 100 % of first generation LVAD recipients. We report the effects of new generation LVADs on vW factor (vWF) metabolism and activity in our center. METHODS: Fifteen LVAD recipients (HeartWare®, Framingham, MA, USA) were compared to 12 HF patients, matched for age and body mass index. vWF antigen and activity, as well as D-dimers, were measured on hemostasis analyzers. A vWF LVAD-induced alteration was evocated when the [vWF activity]/[vWF antigen] ratio was <0.6. ADAMTS13 and high molecular weight multimers of vWF were also assessed. RESULTS: LVAD recipients had similar levels of endothelial vWF production than the HF subjects (137 ± 14.5 vs. 147 ± 11.7 %; respectively, p = 0.611) but a decreased vWF activity (90 ± 11 vs. 132.6 ± 13 %; respectively, p = 0.017). [vWF activity]/[vWF antigen] ratio was 0.65 ± 0.02 in the LVAD recipients and 0.92 ± 0.06 in the subjects with HF (p = 0.001). ADAMTS13 activity was 80.3 ± 4.7 % in LVAD recipients and 96.2 ± 3.5 % in the HF patients (p = 0.016). LVAD patients disclosed markedly elevated D-dimers (3217.7 ± 735 vs. 680.6 ± 223.2 ng/mL FEU in the HF patients, p = 0.006). The LVAD patients experienced one major hemorrhagic event and one systemic thrombotic event during the median follow-up of 345 days. CONCLUSIONS: LVAD recipients achieved a new hemostatic equilibrium characterized by infrequent major hemorrhagic and thrombotic events, despite a mildly impaired vWF function and a markedly enhanced thrombin formation. TRIAL REGISTRATION: ISRCTN39517567.

When all Else Fails, Try This: The HeartMate III Left Ventricle Assist Device.

Heart failure (HF) is a progressive disease. It is estimated that more than 250,000 patients suffer from advanced HF with reduced ejection fraction refractory to medical therapy. With limited donor pool for heart transplant, continue flow left ventricle assist device (LVAD) is a lifesaving treatment option for patients with advanced HF. This review will provide an update on indications, contraindications, and associated adverse events for LVAD support with a summary of the current outcomes data.

Clinical outcomes of continuous flow left ventricular assist device therapy as bridge to transplant strategy in muscular dystrophy: a single-center study.

OBJECTIVE: In muscular dystrophies (MD) patients with end-stage heart failure (HF), continuous flow left ventricular assist device (cf-LVAD) therapy is still controversial due to a progressive nature of MD-associated muscle weakness. METHODS: All the MD patients who had cf- VAD implants between March 2013 and August 2019 in our hospital were retrospectively studied. Study end points were death, major LVAD-associated complications or respiratory dysfunction caused by muscular weakness. RESULTS: A total of 11 MD patients (Becker type: n = 6; Emery-Dreifuss Myodystrophy: n = 2; Fukuyama subtype: n = 1; Limb-girdle 1B: n = 2) were enrolled. DEMOGRAPHICS: median age 41 years (IQR; 29-47); median Japanese Registry for Mechanically Assisted Circulatory Support: level 3 (2-3); a median interval between MD diagnosis and LVAD implantation 9 years (6-18). The pulmonary function test at LVAD implantation showed a median of %VC; 62% (45-82), FEV1%, 82% (81-88). Survival to discharge was 100% without pulmonary complication and early VAD-related complications. During a median follow-up of 38 months (27-53), re-admissions were needed due to device infection (n = 2), cerebrovascular accidents (disabling, n = 2 and non-disabling, n = 2), ventricular tachycardia (n = 4), and right HF (n = 3), respectively. 7 patients received successful heart transplant after a median waiting time of 44 months (34-61); 3 patients are still on the waiting list (waiting time: 21, 38, and 39 months). One patient died of right HF 15 months after VAD implantation. No one had overt pulmonary dysfunction during LVAD support. CONCLUSION: In selected MD patients with end-stage HF, cf-LVAD therapy is a viable therapeutic option as bridge to heart transplant.

Daptomycin Pharmacokinetics in Blood and Wound Fluid in Critical Ill Patients with Left Ventricle Assist Devices.

Daptomycin is a cyclic lipopeptide antibiotic with bactericidal effects against multidrug-resistant Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus faecalis (VRE). For critically ill patients, especially in the presence of implants, daptomycin is an important therapeutic option. Left ventricle assist devices (LVADs) can be utilized for intensive care patients with end-stage heart failure as a bridge to transplant. We conducted a single-center prospective trial with critically ill adults with LVAD who received prophylactic anti-infective therapy with daptomycin. Our study aimed to evaluate the pharmacokinetics of daptomycin in the blood serum and wound fluids after LVAD implantation. Daptomycin concentration were assessed over three days using high-performance liquid chromatography (HPLC). We detected a high correlation between blood serum and wound fluid daptomycin concentration at 12 h (IC95%: 0.64 to 0.95; r = 0.86; p < 0.001) and 24 h (IC95%: -0.38 to 0.92; r = 0.76; p < 0.001) after antibiotic administration. Our pilot clinical study provides new insights into the pharmacokinetics of daptomycin from the blood into wound fluids of critically ill patients with LVADs.

Antiphospholipid antibody syndrome and LVAD: What are the chances? A case report and literature review.

Left-ventricular-assist-device (LVAD) implantation in patients with antiphospholipid-syndrome (APS) is considered a high-risk procedure and its indication still represents an open challenge. Herein, we report a 63-year-old man with APS and end-stage heart failure, for whom a HeartMate3-LVAD and a continuous rheologic profile monitoring with a multiparametric assessment resulted the optimal therapeutic strategy.

Prognostic value of TAPSE/PASP ratio in right ventricular failure after left ventricular assist device implantation: Experience from a tertiary center.

Background: In this study, we aimed to investigate the prognostic value of the tricuspid annular plane systolic excursion (TAPSE)/ pulmonary arterial systolic pressure (PASP) ratio in right ventricular failure patients undergoing left ventricular assist device implantation. Methods: Between February 2013 and February 2020, a total of 75 heart failure patients (65 males, 10 females; median age: 54 years; range, 21 to 66 years) were retrospectively analyzed. The prognostic value of TAPSE/PASP ratio was assessed using the multivariate Cox regression models and confirmed using the Kaplan-Meier analyses. Results: Forty-one (55.4%) patients had an ischemic heart failure etiology. The indication for assist device implantation was bridge to transplant in 64 (85.3%) patients. The overall survival rates at one, three, and five years following left ventricular assist device implantation were 82.7%, 68%, and 49.3%, respectively. Right ventricular failure was observed in 24 (32%) patients during follow-up. In the multivariate analysis, TAPSE/PASP was found to be independently associated with postoperative right ventricular failure (HR: 1.63; 95% CI: 1.49-2.23). A TAPSE/PASP of 0.34 mm/mmHg was found to be the most accurate predictor value, with lower ratios correlating with right ventricular failure. The Kaplan-Meier analysis showed a better overall survival using a TAPSE/PASP ≥ of 0.34 mm/mmHg (p<0.001). Conclusion: A lower TAPSE/PASP ratio, particularly lower values than 0.34 mm/mmHg, strongly predicts right ventricular failure after left ventricular assist device implantation in patients with advanced heart failure.

Effects of the atrium on intraventricular flow patterns during mechanical circulatory support.

Simulations of the ventricular flow patterns during left ventricular assist device (LVAD) support are mainly performed with idealized cylindrical inflow, neglecting the influence of the atrial vortex. In this study, the influence of the left atrium (LA) on the intra-ventricular flow was investigated via Computational Fluid Dynamics (CFD) simulations. Ventricular flow was simulated by a combined Eulerian (carrier flow)/Lagrangian (particles) approach taking into account either the LA or a cylindrical inflow section to mimic a fully support condition. The flow deviation at the mitral valve, the blood low-velocity volume as well as the residence time and shear stress history of the particles were calculated. Inclusion of the LA deflects the flow at the mitral valve by 25°, resulting in an asymmetric flow jet entering the left ventricle. This reduced the ventricular low-velocity volume by 40% (from 6.4 to 3.9 cm3), increased (40%) the shear stress experienced by particles and correspondingly increased (27%) their residence time. Under the studied conditions, the atrial geometry plays a major role in the development of intraventricular flow patterns. A reliable prediction of blood flow dynamics and consequently thrombosis risk analysis within the ventricle requires the consideration of the LA in computational simulations.

Impact of Continuous Flow Left Ventricular Assist Device on Heart Transplant Candidates: A Multi-State Survival Analysis.

(1) Objectives: The aim of this study was to investigate the impact of the prolonged use of continuous-flow left ventricular assist devices (LVADs) on heart transplant (HTx) candidates. (2) Methods: Between January 2012 and December 2019, we included all consecutive patients diagnosed with end-stage heart failure considered for HTx at our institution, who were also eligible for LVAD therapy as a bridge to transplant (BTT). Patients were divided into two groups: those who received an LVAD as BTT (LVAD group) and those who were listed without durable support (No-LVAD group). (3) Results: A total of 250 patients were analyzed. Of these, 70 patients (28%) were directly implanted with an LVAD as BTT, 11 (4.4%) received delayed LVAD implantation, and 169 (67%) were never assisted with an implantable device. The mean follow-up time was 36 ± 29 months. In the multivariate analysis of survival before HTx, LVAD implantation showed a protective effect: LVAD vs. No-LVAD HR 0.01 (p < 0.01) and LVAD vs. LVAD delayed HR 0.13 (p = 0.02). Mortality and adverse events after HTx were similar between LVAD and No-LVAD (p = 0.65 and p = 0.39, respectively). The multi-state survival analysis showed a significantly higher probability of death for No-LVAD vs. LVAD patients with (p = 0.03) or without (p = 0.04) HTx. (4) Conclusions: The use of LVAD as a bridge to transplant was associated with an overall survival benefit, compared to patients listed without LVAD support.

Effects of implanting a long-term left ventricle assist device on post-transplant outcomes.

BACKGROUND: An increasing number of patients are receiving left ventricle assist devices as a bridge to heart transplantation. The aim of this study was to determine the difference between patients who received transplants from a left ventricle assist device and those who underwent heart transplantation without a prior left ventricle assist device implantation. MATERIAL AND METHODS: The study included patients who underwent heart transplantation in our institute between January 2010 and November 2018. The following clinical variables were evaluated: donor characteristics, patient's pre-transplant demographical data, post-transplant data, and patient survival. Cardiac allograft vasculopathy progression was prospectively examined (after 1 month and 12 months after heart transplantation) by coronary optical coherence tomography. We were interested in the difference in 1- and 5-year survival between the left ventricle assist device and non-left ventricle assist device groups. RESULTS: A total of 248 patients were identified; out of them, 48 patients received a left ventricle assist device before heart transplantation, whereas 200 had transplants with no prior left ventricle assist device implantation. There were no significant differences in any donor characteristics. The mean duration of cardiopulmonary bypass time in the non-left ventricle assist device group was 156 versus 175 min in the left ventricle assist device group (p = 0.009), blood loss was 650 versus 1045 mL (p < 0.001), the need to implant an extracorporeal membrane oxygenation was 10% versus 23% (p = 0.02). There was no difference in cardiac allograft vasculopathy progression between the groups 1 year after heart transplantation (p = 0.528). The 1- and 5-year survival, according to Kaplan-Meier, was 80% and 70% in the left ventricle assist device group, compared to 80% and 73%, respectively, in the non-left ventricle assist device group (Log-rank test: p = 0.945). CONCLUSION: Our results indicate that patients undergoing heart transplantation from left ventricle assist devices suffer significantly more from intraoperative and post-operative complications; however, only insignificant cardiac allograft vasculopathy progression and survival differences between the two groups were observed.