Aspirin resistance in patients with ventricular assist devices-A follow-up study.

BACKGROUND: Despite combined anticoagulation therapy consisting of a vitamin K antagonist and an antiplatelet agent, thromboembolic complications often occur in patients with a left ventricular assist device (LVAD). In addition, bleeding events are also common. Resistance to antiplatelet drugs is a well-known phenomenon; however, the utilization of laboratory chemistry testing for the presence of such resistance, and then switching therapy, is controversial. METHODS: We tested 132 patients with LVAD (HeartWare n = 57, HeartMate II n = 22, HeartMate 3 n = 53) on acetylsalicylic acid (ASA) therapy for resistance and followed them for a maximum of 7 years regarding pump thrombosis. Light transmission aggregometry (LTA) and impedance aggregometry (IPA) were performed for testing platelet function. RESULTS: We could show that patients with ASA resistance displayed an increased risk of pump thrombosis, regardless of the test used (LTA: OR = 6.20, CI [1.86-20.64], p = 0.003; IPA: OR = 12.14, CI [3.00-49.07], p < 0.001). In patients with a HeartMate 3, we could not detect any pump thrombosis associated with aspirin resistance. Furthermore, there was no significant difference in bleeding events between patients with ASA resistance and ASA responders. CONCLUSION: Laboratory testing of ASA resistance seems to be a good tool to detect an increased risk of pump thrombosis, at least for patients with a HeartWare or HeartMate II. The extent to which these thromboses can be prevented with a change of medication has to be investigated in further studies. No pump thrombosis was detected in patients with a HeartMate 3, and the question should be asked as to what constellation of underlying and concomitant diseases must be present to justify ASA therapy for these patients.

Pulmonary Vascular Resistance to Predict Right Heart Failure in Patients Undergoing Left Ventricular Assist Device Implantation.

Right heart failure (RHF) is associated with poor outcomes, especially in patients undergoing left ventricular assist device (LVAD) implantation. The aim of this study was to identify predictors of RHF after LVAD implantation. Of 129 consecutive patients (mean age 56 ± 11 years, 89% male) undergoing LVAD implantation, 34 developed RHF. Compared to patients without RHF, those with RHF required longer invasive mechanical ventilation and had longer intensive care unit and hospital stays (p < 0.01). One-year all-cause mortality was significantly higher in patients with versus without RHF after LVAD implantation (29.4% vs. 1.2%; hazard ratio 35.4; 95% confidence interval 4.5-277; p < 0.001). Mortality was highest in patients with delayed RHF after initial LVAD-only implantation (66.7%). Patients who did versus did not develop RHF had significantly higher baseline pulmonary vascular resistance (PVR; 404 ± 375 vs. 234 ± 162 dyn/s/cm5; p = 0.01). PVR > 250 dyn/s/cm5 was a significant predictor of survival in patients with RHF after LVAD implantation. These data confirm the negative impact of RHF on morbidity and mortality after LVAD implantation. Preoperative PVR > 250 dyn/s/cm5 determined using invasive right heart catheterization was an independent predictor of developing RHF after LVAD implantation, and of subsequent mortality, and could be used for risk stratification in the setting for deciding between single or biventricular support strategy.

Driveline infection according to driveline positioning in left ventricular assist device implant recipients.

We conducted a prospective, open-labeled, clinical trial, with a two-by-two factorial design, of argon cold plasma application and two different types of driveline positioning for the prevention of driveline infection (DLI) in 80 patients with a left ventricular assist device (LVAD) implant. Here, we present the results of intracorporeal loop positioning (n = 40) versus no intracorporeal loop positioning (n = 40). Patients were followed up for 1 year. According to the Driveline Expert STagINg and carE grading (DESTINE) system, a DLI was considered in case of a stage 2 or higher graded infection. During follow-up, 29 (36%) patients experienced a DLI, 16 in the group with intracorporeal loop positioning and 13 in the group with no intracorporeal loop positioning. Kaplan-Meier estimates of freedom from DLI showed no statistically significant difference between study groups during follow-up (p = 0.33). In detail, 30-day freedom from DLI was for the groups with and without intracorporeal loop positioning 92 and 92%, respectively, and 1-year freedom from DLI was 51 and 62%, respectively. In conclusion, this controlled clinical trial was unable to show a statistically significant difference in freedom from DLI during one year of follow-up in groups with or without intracorporeal loop positioning. However, larger trials have to confirm these results.

Fully magnetically centrifugal left ventricular assist device and long-term outcomes: the ELEVATE registry.

BACKGROUND AND AIMS: HeartMate 3 (HM3) is a fully magnetically levitated continuous flow left ventricular assist device, which received CE marking in 2015. The ELEVATE Registry was initiated to collect real-world outcomes in patients treated with HM3 post-CE Mark approval. METHODS: A total of 540 subjects implanted at 26 centres between March 2015 and February 2017 were included in this registry. Of these, 463 received the device as a primary implant (primary implant cohort, PIC), 19 as a pump exchange (pump exchange cohort), and in 58 patients, only anonymized survival data were collected (anonymized cohort, AC). Patients in the PIC contributed to the baseline demographics, survival, adverse events, quality of life (QoL) (EuroQoL-5 Dimensions-5 Levels visual analogue scale), and functional capacity (6 min walk distance) assessments, while patients in the AC contributed only to survival. RESULTS: Primary implant cohort patients had a mean age of 56 years and were predominantly male (89%) with 48% ischaemic aetiology. The majority of subjects was designated bridge to transplant (66%) and had INTERMACS Profiles 1-3 (70%). At baseline, the subjects had poor functional capacity (104 ± 140 m) and impaired QoL (35 ± 19 points). The overall survival rate of the PIC was 63.3% and survival free of stroke was 58.1% at 5 years. Significant improvements in functional capacity and QoL were observed and maintained for 5 years (301 ± 131 m and 64 ± 20 points, respectively). CONCLUSIONS: Real-world data from the ELEVATE registry demonstrate an overall survival rate for primary implants of 63.3%. In the PIC, reductions in adverse events for patients in the extended follow-up and improved QoL and functional capacity were observed at 5 years in this patient population with advanced heart failure.

Argon Cold Plasma Use and Driveline Infection in Left Ventricular Assist Device Implant Recipients.

We conducted a prospective open-labeled, clinical trial, with a two-by-two factorial design, of argon cold plasma (ACP) application and two different types of driveline positioning for the prevention of driveline infection (DLI) in patients with a left ventricular assist device (LVAD) implant. Here, we present the results of ACP application versus no ACP application. Eighty patients were allocated to the control group (no preventive ACP use; n = 40) or ACP group (preventive ACP use for 30 days post-LVAD implantation; n = 40). Patients were followed up for 1 year. The secondary endpoint was survival on device. Preventive ACP use improved 30 day freedom from DLI significantly (100% vs. 85%; p = 0.012); results remained significant at 6 months (92% vs. 69%, p = 0.007) and were 55% and 60%, respectively ( p = 0.65) at 1 year follow-up. With respect to survival on device, results in the control and ACP groups did not differ significantly at 30 days (97.5% vs. 100%, respectively; p = 0.32), but tended to be lower in the control group than in the ACP group at 1 year follow-up (74% vs. 90%, respectively; p = 0.09). In conclusion, preventive ACP use was able to significantly reduce DLI both during the application period and up to 6 months after LVAD implantation.

Long-term assist device patients admitted to ICU: Tips and pitfalls.

Left ventricular assist device (LVAD) therapy is well-established in the treatment of end-stage cardiac failure. Indications are bridge to transplant (BTT), bridge to candidacy (BTC), bridge to recovery (BTR), and destination therapy (DT). The durability and adverse event (AE) rate of LVADs have improved over the years. However, due to donor shortage, the duration of support in the BTT population has increased tremendously; similarly, DT patients are on the device for a long time. Consequently, the number of readmissions of long-term LVAD patients has increased. In cases of severe AEs, intensive care unit (ICU) treatment can be necessary. Infectious complications are the most common AE. Furthermore, embolic or hemorrhagic strokes can occur due to foreign surfaces, acquired von Willebrand syndrome, and anticoagulation treatment. Another consequence of the coagulative status, in combination with the continuous flow, are gastrointestinal bleeding events. Moreover, in most patients, an isolated LVAD is implanted, and this involves the risk of late right heart failure. Adjustment of pump speed and optimization of the volume status can help solve this issue. Malignant arrhythmias, pre-existing or de novo after LVAD implantation, can be a life-threatening AE. Antiarrhythmic medical therapy or ablation are potential treatment options. As for specific LVADs, the Medtronic HeartWare™ ventricular assist device (HVAD) is not manufactured and distributed currently; however, 4000 patients are still on the device. Pump thrombosis can occur, wherein thrombolytic therapy is the first-line treatment option. Additionally, the HVAD can fail to restart after controller exchange due to technical issues, and precautions must be taken. The Momentum 3 trial showed superior survival without pump exchange or disabling stroke in patients treated with the HeartMate 3Ⓡ (HM3; Abbott, Abbott Park, IL, USA) device in comparison to the HeartMate II (HMII). However, in a few cases, a twisted graft or bio debris formation between the outflow graft and bend relief could be observed, causing outflow graft obstruction. Patients on LVADs are still heart failure patients, in many cases with comorbidities. Therefore, many situations can occur requiring ICU treatment. Ethical aspects should always be the focus when taking care of these patients.

Vitamin D deficiency and driveline infection in patients with a left ventricular assist device implant.

Driveline infection is a frequent complication in recipients of durable left ventricular assist devices (LVAD), but its cause is largely unclear. Since vitamin D supplementation can reduce the risk of infections, we aimed at investigating the association of vitamin D deficiency with driveline infection. In 154 patients with continuous flow LVAD implants, we assessed 2-year risk of driveline infection according to vitamin D status (circulating 25-hydroxyvitamin D < 25 nmol/L or ⩾25 nmol/L). Of the study cohort, 34% (n = 53) had 25-hydroxyvitamin D concentrations <25 nmol/L. Kaplan-Meir estimates of 2-year freedom from driveline infection were in the vitamin D deficient and vitamin D non-deficient groups 49.7% and 74.2%, respectively (p = 0.017). Covariate-adjusted hazard ratio of driveline infection for the vitamin D deficient versus non-deficient group was 2.51 [95% CI: 1.11-5.69; p = 0.028). Circulating concentrations of endocrine regulators of calcium and phosphorus metabolism such as parathyroid hormone, 1,25-dihydroxyvitamin D, and fibroblast growth factor-23 were not significantly associated with the risk of driveline infection (p-values > 0.15). In total, our data indicate that in LVAD recipients deficient vitamin D status is a predictor of driveline infection, but future studies are needed to investigate whether these associations are causal.

Left Ventricular Unloading in Patients on Venoarterial Extracorporeal Membrane Oxygenation Therapy in Cardiogenic Shock: Prophylactic Versus Bail-Out Strategy.

BACKGROUND: The benefit of prophylactic left ventricular (LV) unloading during venoarterial extracorporeal membrane oxygenation (VA-ECMO) in selected patients at risk of developing LV distension remains unclear. METHODS: We enrolled 136 patients treated with Impella pump decompression during VA-ECMO therapy for refractory cardiogenic shock. Patients were stratified by specific indication for LV unloading in the prophylactic vs. bail-out group. The bail-out unloading strategy was utilized to treat LV distension in VA-ECMO afterload-associated complications. The primary endpoint was all-cause 30-day mortality after VA-ECMO implantation. The secondary endpoint was successful myocardial recovery, transition to durable mechanical circulatory support (MCS), or heart transplantation. RESULTS: After propensity score matching, prophylactic unloading was associated with a significantly lower 30-day mortality risk (risk ratio 0.38, 95% confidence interval 0.23-0.62, and p < 0.001) and a higher probability of myocardial recovery (risk ratio 2.9, 95% confidence interval 1.48-4.54, and p = 0.001) compared with the bail-out strategy. Heart transplantation or durable MCS did not differ significantly between groups. CONCLUSIONS: Prophylactic unloading compared with the bail-out strategy may improve clinical outcomes in selected patients on VA-ECMO. Nevertheless, randomized trials are needed to validate these results.

Identifying patients at risk: multi-centre comparison of HeartMate 3 and HeartWare left ventricular assist devices.

AIMS: Since the withdrawal of HeartWare (HVAD) from the global market, there is an ongoing discussion if and which patients require prophylactically exchange for a HeartMate 3 (HM3). Therefore, it is important to study outcome differences between HVAD and HM3 patients. Because centres differ in patient selection and standard of care, we performed a propensity score (PS)-based study including centres that implanted both devices and aimed to identify which HVAD patients are at highest risk. METHODS AND RESULTS: We performed an international multi-centre study (n = 1021) including centres that implanted HVAD and HM3. PS-matching was performed using clinical variables and the implanting centre. Survival and complications were compared. As a sensitivity analysis, PS-adjusted Cox regression was performed. Landmark analysis with conditional survival >2 years was conducted to evaluate long-term survival differences. To identify which HVAD patients may benefit from a HM3 upgrade, Cox regression using pre-operative variables and their interaction with device type was performed. Survival was significantly better for HM3 patients (P < 0.01) in 458 matched patients, with a median follow-up of 23 months. Within the matched cohort, HM3 patients had a median age of 58 years, and 83% were male, 80% of the HVAD patients were male, with a median age of 59 years. PS-adjusted Cox regression confirmed a significantly better survival for HM3 patients when compared with HVAD, with a HR of 1.46 (95% confidence interval 1.14-1.85, P < 0.01). Pump thrombosis (P < 0.01) and ischaemic stroke (P < 0.01) occurred less in HM3 patients. No difference was found for haemorrhagic stroke, right heart failure, driveline infection, and major bleeding. Landmark-analysis confirmed a significant difference in conditional survival >2 years after implantation (P = 0.03). None of the pre-operative variable interactions in the Cox regression were significant. CONCLUSIONS: HM3 patients have a significantly better survival and a lower incidence of ischaemic strokes and pump thrombosis than HVAD patients. This survival difference persisted after 2 years of implantation. Additional research using post-operative variables is warranted to identify which HVAD patients need an upgrade to HM3 or expedited transplantation.

Stroke Complications in Patients Requiring Durable Mechanical Circulatory Support Systems After Extracorporeal Life Support.

Stroke is one of the leading complications following durable mechanical circulatory support (MCS) implantation. The aim of this multicenter study was to investigate stroke complications in patients requiring durable MCS following extracorporeal life support (ECLS). Data of 11 high volume MCS centers were collected and evaluated to identify patients who underwent durable MCS implantation after ECLS support between January 2010 and August 2018. The primary outcome was stroke following durable MCS implantation. Univariate and multivariate logistic regression analyses were performed to determine predictors of stroke. Overall, 531 patients met the inclusion criteria. Only patients who were supported with continuous flow pumps were included in this study accounting for 495 patients (median age 54 years old [interquartile range 47-60]). A total of 136 patients (27%) developed postoperative stroke on device during the follow-up (48% ischemic and 52% hemorrhagic) after a median durable MCS support of 320 [32-1,000] days, accounting for 0.17 events per patient-year. Of 133 patients with known date of stroke, a total of 47 (10%) developed stroke during the first 30 days (64% ischemic and 36% hemorrhagic), and 86 patients developed stroke after 30 days (38% ischemic and 62% hemorrhagic) of durable MCS support (late stroke). Survival rate was significantly lower in patients with hemorrhagic stroke ( p = 0.00091). Stroke appears to be a common complication in patients transitioned to durable MCS support after ECLS. Hemorrhagic stroke is a more common type of late stroke and is associated with inferior outcomes.

Use of the CytoSorb® filter for elimination of residual therapeutic argatroban concentrations during heparinized cardiopulmonary bypass for heart transplantation.

INTRODUCTION: No antidote or established extracorporeal elimination strategy is available for argatroban. Hemadsorption facilitates elimination of smaller drugs. CASE REPORT: A 34-year-old patient underwent urgent heart transplantation. Because of a history of heparin-induced thrombocytopenia, preoperative anticoagulation was performed with argatroban. Despite ceasing of the continuous infusion of argatroban 2 h before surgery, concentration only declined from 0.60 µg/ml to 0.58 µg/ml before surgery, and the activated clotting time (ACT) value shortly was 223 s. Microvascular bleeding had been observed when starting surgery. A CytoSorb® absorption column was integrated into the system of the heparin-anticoagulated cardiopulmonary bypass (CPB) circuit and a flow of 400 mL/min provided during the 2 h of extracorporeal circulation. The argatroban concentration after weaning from CPB was 0.04 µg/ml and satisfying hemostasis had been achieved after protamine administration. CONCLUSION: Data indicate that the CytoSorb® absorption column might be an effective tool for quick extracorporeal removal of therapeutic concentrations of argatroban.

A multicenter evaluation of external outflow graft obstruction with a fully magnetically levitated left ventricular assist device.

BACKGROUND: The HeartMate 3 (HM 3; Abbott) left ventricular assist device (LVAD) has improved hemocompatibility-related adverse outcomes. In sporadic cases, external compression of the outflow graft causing obstruction (eOGO) can result from substance accumulation between the outflow graft and its bend relief. We sought to evaluate the prevalence, course, and clinical implications of eOGO in an international study. METHODS: A multicenter retrospective analysis of HM 3 LVADs implanted between November 2014 and April 2021 (n = 2108) was conducted across 17 cardiac centers in 8 countries. We defined eOGO as obstruction >25% in the cross-sectional area in imaging (percutaneous angiography, computed tomography, or intravascular ultrasound). The prevalence and annual incidence were calculated. Serious adverse events and outcomes (death, transplantation, or device exchange) were analyzed for eOGO cases. RESULTS: Of 2108 patients, 62 were diagnosed with eOGO at a median LVAD support duration of 953 (interquartile range, 600-1267) days. The prevalence of eOGO was 3.0% and the incidence at 1, 2, 3, 4, and 5 years of support was 0.6%, 2.8%, 4.0%, 5.2%, and 9.1%, respectively. Of 62 patients, 9 were observed, 27 underwent surgical revision, 15 underwent percutaneous stent implantation, 8 received a heart transplant, and 2 died before intervention. One patient underwent surgical revision and later stent implantation. The mortality with therapeutic intervention was 9/53 (17.0%). CONCLUSIONS: Although uncommon, HM 3 LVAD-supported patients might develop eOGO with an increasing incidence after 1 year of support. Although engineering efforts to reduce this complication are under way, clinicians must maintain a focus on early detection and remain vigilant.

Noninvasive evaluation of the hemodynamic status in patients after heart transplantation or left ventricular assist device implantation.

INTRODUCTION: Hemodynamic assessment is crucial after heart transplantation (HTX) or left ventricular assist device (LVAD) implantation. Gold-standard is invasive assessment via thermodilution (TD). Noninvasive pulse contour analysis (NPCA) is a new technology that is supposed to determine hemodynamics completely noninvasive. We aimed to validate this technology in HTX and LVAD patients and conducted a prospective single-center cohort study. METHODS: Patients after HTX or LVAD implantation underwent right heart catheterization including TD. NPCA using the CNAP Monitor (V.5.2.14; CNSystems Medizintechnik AG, Graz, Austria) was performed simultaneously. Three TD measurements were compared with simultaneous NPCA measurements for hemodynamic assessment. To describe the agreement between TD and NPCA, Bland-Altman analysis was done. RESULTS: In total, 28 patients were prospectively enrolled (HTX: n = 10, LVAD: n = 18). Bland-Altman analysis revealed a mean bias of +1.05 l/min (limits of agreement ± 4.09 l/min, percentage error 62.1%) for cardiac output (CO). In LVAD patients, no adequate NPCA signal could be obtained. In 5 patients (27.8%), any NPCA signal could be detected, but was considered as low signal quality. CONCLUSION: In conclusion, according to our limited data in a small cohort of HTX and LVAD patients, NPCA using the CNAP Monitor seems not to be suitable for noninvasive evaluation of the hemodynamic status.

Pre-operative risk factors for driveline infection in left ventricular-assist device patients.

AIMS: Implantation of left ventricular-assist devices (LVAD) to treat end-stage heart failure is of increasing relevance due to donor shortage. Infections of the driveline are common adverse events. LVAD infections can lead to high urgency listings for transplantation. However, transplantation in patients with infection leads to worse post-transplantation outcomes. This study aims to evaluate specific risk factors for driveline infections at the time of implantation. METHODS AND RESULTS: Four hundred forty-one patients receiving either Heartmate II or Heartware system from August 2009 to October 2013 were assessed. An expert committee sorted patients into four different groups concerning the likeliness of infection. Twenty-eight (6%) of discussed infection cases were judged as secured, 33 (7%) as likely, 18 (4%) as possible, and 20 (4%) as unlikely. The remaining 342 (78%) subjects showed either no signs of infection at all times (329 [75%]) or developed signs of infection in a second observation period within 1 year after ending of the first observation period (13 [3%]). For a better discriminatory power, cases of secured and likely infections were tested against the group with no infection at all times in a Cox proportional hazard model. Among all variables tested by univariate analysis (significance level P < 0.15), only age (P = 0.07), LVAD-type (P = 0.12), need for another thoracic operation (P = 0.02), and serum creatinine value (P = 0.02) reached statistical significance. These were subsequently subjected to multivariate analysis to calculate the cumulative risk of developing a drive infection. The multivariate analysis showed that of all the potential risk factors tested, only the necessity of re-thoracotomy or secondary thoracic closure had a significant, protective effect (hazard ratio [95% CI] = 0.45 [0.21-0.95]; P = 0.04). CONCLUSION: This single-centre cohort study shows that driveline infections are common adverse events. The duration of support represents the major risk factor for LVAD driveline infections.

Spatial multi-omic map of human myocardial infarction.

Myocardial infarction is a leading cause of death worldwide1. Although advances have been made in acute treatment, an incomplete understanding of remodelling processes has limited the effectiveness of therapies to reduce late-stage mortality2. Here we generate an integrative high-resolution map of human cardiac remodelling after myocardial infarction using single-cell gene expression, chromatin accessibility and spatial transcriptomic profiling of multiple physiological zones at distinct time points in myocardium from patients with myocardial infarction and controls. Multi-modal data integration enabled us to evaluate cardiac cell-type compositions at increased resolution, yielding insights into changes of the cardiac transcriptome and epigenome through the identification of distinct tissue structures of injury, repair and remodelling. We identified and validated disease-specific cardiac cell states of major cell types and analysed them in their spatial context, evaluating their dependency on other cell types. Our data elucidate the molecular principles of human myocardial tissue organization, recapitulating a gradual cardiomyocyte and myeloid continuum following ischaemic injury. In sum, our study provides an integrative molecular map of human myocardial infarction, represents an essential reference for the field and paves the way for advanced mechanistic and therapeutic studies of cardiac disease.

Bacteriophage-Enriched Galenic for Intrapericardial Ventricular Assist Device Infection.

We report a case of severe outflow graft infection following left ventricular assist device (LVAD) implantation. A 51-year old male LVAD patient was readmitted to our hospital presenting signs of systemic infection. One year previously, LVAD implantation (HeartMate3, Abbott, Chicago, IL, USA) with concomitant patent foramen ovale closure had been performed in the context of end-stage heart failure due to dilative cardiomyopathy (INTERMACS III). The indication for LVAD-therapy was bridge-to-candidacy, since the patient did not instantly fulfill all criteria for cardiac transplantation. At admission, a PET-CT scan unveiled fluid accumulation, encircling the outflow-graft prosthesis (SUVmax 10.5) with contrast-enhancement involving the intrathoracic driveline (SUVmax 11.2). Since cardiac transplantation was not feasible, the patient underwent surgical revision. In the first step, redo sternotomy was performed with local debridement, including jet lavage. Intraoperative swabs confirmed bacterial infection with staphylococcus aureus. Following this, the patient underwent negative pressure wound therapy (NPWT) with instillation using the V.A.C. VERAFLO system (KCI-3M, San Antonio, TX, USA) for a total of 19 days. Due to the severity of infection, local bacteriophage application was performed within the wound closure. In order to concentrate phage therapy at the infection site, phages were applied using a novel semi-fluid galenic. After wound closure, the patient was discharged with an uneventful course. A control PET-CT scan 3 months after discharge showed a significant decrease in infection (outflow graft: SUVmax 7.2, intrathoracic driveline: SUVmax 3.0) correlated with contrast enhancement. Bacterial infection of intrathoracic VAD components represents a severe and potentially life-threatening complication. If cardiac transplantation is not feasible, complex wound management strategies are required. Local bacteriophage therapy might be a promising addition to already established therapeutical options. In order to improve bacteriophage retention at the wound site, application of a viscous galenic might be beneficial.

Global best practices consensus: Long-term management of patients with hybrid centrifugal flow left ventricular assist device support.

OBJECTIVES: Six months after withdrawal of the HeartWare HVAD System (HVAD; Medtronic) from sale, approximately 4000 patients continue ongoing support with this device. In light of the diminishing experience, this global consensus document summarizes key management recommendations. METHODS: International experts with experience in the management of patients with ongoing HVAD support were invited to summarize key aspects of patient and pump management and highlight differences in the current HeartMate 3 (Abbott Laboratories) ventricular assist device. Clinicians from high-implanting HVAD sites reviewed current literature and reported experience to generate a consensus statement. RESULTS: Specific guidelines to assist in the management of ongoing HVAD patients are developed. Key management protocols and helpful techniques developed from experienced clinicians are combined into a short guideline document. As experience with HeartMate 3 increases, key differences in approach to management are highlighted, where appropriate. CONCLUSIONS: With decreasing worldwide experience in the ongoing management of HVAD-supported patients, this consensus guideline provides a summary of best practice techniques from international centers. Differences in HeartMate 3 management are highlighted.

The HeartWare Ventricular Assist Device (HVAD): A Single Institutional 10-Year Experience.

OBJECTIVES: The aim of this study was to analyze our 10-year experience with the HVAD in a real-world scenario in a high-volume German heart center. METHODS: We retrospectively analyzed outcomes of adults (≥18 years) with terminal heart failure (HF), who underwent HVAD implantation for durable LVAD therapy in our center between October 2009 and March 2020. Primary and secondary end points were all-cause death after implantation and LVAD-associated complications, respectively. We focused the distinct analyses on risk profiles at the time of implantation and implant strategies, i.e., bridge-to-transplant (BTT) or destination therapy (DT). RESULTS: A total of 510 patients were included, with 229 and 281 individuals in Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) level 1 (45%) and 2 to 4, respectively. Median follow-up was 26 months (IQR: 5-54 months). Overall survival at 1, 3, and 5 years after HVAD implantation was 66% (95% CI; 61.7-70%), 49.4% (95% CI; 44.9-53.8%), and 37.4% (95% CI; 32.8-42%), not censored for LVAD exchange, LVAD explantation, or heart transplantation. INTERMACS level 1 and peri-operative temporary right heart assistance were independent risk factors for survival. Survival was best in BTT patients undergoing heart transplantation at any time during follow-up. The INTERMACS level at time of HVAD implantation did not affect survival after heart transplantation. Freedom from the combined end point of any device-associated severe complication and death was 44.5% (95% CI; 40-48.8%) at 1-year after implantation. CONCLUSION: The HVAD is a reliable pump for durable mechanical circulatory support even in high-risk patients. Still, heart transplantation outperforms durable MCS therapy for a superior long-term survival.

Evolution of thrombolytic therapy in patients with HeartWare ventricular assist device thrombosis: a single-institutional experience.

OBJECTIVES: Pump thrombosis remains a major challenge in heart failure patients with left ventricular HeartWare assist device. Current International Society for Heart and Lung Transplantation recommendations favour surgical pump exchange over lysis because safety and efficacy of lysis has been controversially reported. This study summarizes our experience on our HeartWare thrombosis prevention strategy as well as thrombolysis through implementation of our institutional standardized HeartWare assist device protocol. METHODS: Outcomes of all HeartWare thrombosis patients admitted between 2010 and 2020 were analysed. Thrombolysis therapy using tissue plasminogen activator was used as the first-line therapy in this study and thrombolysis therapy efficacy was defined as freedom from stroke, bleeding, recurrent HeartWare assist device thrombosis or surgical device exchange within 30 days after lysis application. RESULTS: A total of 507 patients have been included in this study and 66 patients (13%) collectively developed a first HeartWare-thrombosis after a median of 12 months (8-22 months) after HeartWare implantation. Forty patients were treated with unstandardized lysis, of whom 7 patients had thrombolysis associated complications, such as incomplete thrombus resolution requiring surgical pump exchange in 4 patients, but also intracranial haemorrhage occurring in 3 patients. Three patients died in the non-protocol group. Eight device thrombosis patients were treated according to our protocol, showing no lysis-associated complication. CONCLUSIONS: Despite current recommendations, preferring surgical HeartWare pump exchange in thrombosis, thrombolysis therapy for first HeartWare thrombosis can be safe and effective in a standardized protocol setting, including anticoagulation adjustment and intensified blood pressure control management.