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While notable improvements in survival, the incidence of hemocompatibility-related adverse events, hospitalizations, and cost have been demonstrated with the only commercially available durable left ventricular assist device, a category of pump malfunctions characterized by outflow graft obstruction has been noted with broader use and clinical follow-up of recipients of this technology. Of particular concern is the accumulation of acellular biodebris between the outflow graft and bend relief covering the outflow graft at its origin with the pump (which we term extrinsic outflow graft obstruction at the bend relief). This process tends to be insidious, occurs late in the postoperative course, can be challenging to diagnose, and can result in significant morbidity and mortality. Herein, we provide a review of this complication and outline diagnostic, treatment, and preventive strategies. [ABSTRACT FROM AUTHOR]

Background Methods Results Conclusions No clear guidelines exist for perioperative anticoagulation management after durable left ventricular assist device insertion. In this study, we sought to compare outcomes between anti‐factor Xa (FXa) and activated partial thromboplastin time (aPTT) in monitoring unfractionated heparin (UFH) dosing after HeartMate 3 (HM3) insertion.This is a single‐center retrospective review of patients who received UFH after HM3 insertion between 01/2020–12/2022. Post‐operative UFH dose was titrated by aPTT goal 45–60 sec (n = 53) or FXa goal 0.1–0.2 U/mL (n = 59). Baseline differences between cohorts were balanced by inverse probability treatment weighting.At baseline, unadjusted FXa patients were more likely to be white (47.5% vs. 35.8%, p < 0.001), INTERMACS 1–2 (69.5% vs. 47.2%, p = 0.013), have history of coronary artery disease (66.1% vs. 43.4%, p = 0.026), and lower eGFR (54.1 vs. 63.7 mL/min/1.73 m2, p = 0.029) compared to the aPTT group. After adjusting for several bleeding/thrombosis risk factors, 97.5% of FXa and 91.0% of aPTT patients reached therapeutic levels with comparable UFH duration and maximum dose. Moreover, in‐hospital mortality (2.5% vs. 3.1%, p = 0.842), major bleeding events (4.2% vs. 9.2%, p = 0.360), and thromboembolic events (21.8% vs. 10.1%, p = 0.151) remained without significant differences between FXa and aPTT cohorts. There was a high degree of variability in FXa (r2 = 0.20) and aPTT (r2 = 0.22) values for any given UFH dose.No differences in frequency of bleeding or thromboembolic events were observed in this study between FXa versus aPTT cohorts after HM3 implantation. More longitudinal studies are warranted to determine whether or not one assay is superior to the other. [ABSTRACT FROM AUTHOR]

In end-stage heart failure, which is characterized by persistent or progressive ventricular dysfunction despite optimal medical therapy, a left ventricular assist device (LVAD) can be beneficial. Congestive heart failure provokes inflammatory and prothrombotic activation. The aim of this study was to evaluate the serum concentration of citrullinated histone 3 (CH3) representing neutrophil extracellular trap (NET) formation in patients referred for LVAD implantation. There were 10 patients with a median age of 61 (57–65) years enrolled in a prospective single-center analysis who underwent LVAD implantation. The CH3 plasma concentration was measured preoperatively and on the 1st and 7th postoperative days, followed by control measurements on the median (Q1–3) 88th (49–143) day. The preoperative CH3 concentration strongly correlated with brain natriuretic peptide (r = 0.879, p < 0.001). Significant differences in CH3 serum concentration were observed between pre- and postoperative measurements, including an increase on the first postoperative day (p < 0.001), as well as a decrease on the seventh day (p = 0.016) and in follow-up (p < 0.001). CH3 concentration, as a marker of NET formation, decreases after LVAD implantation. [ABSTRACT FROM AUTHOR]

Durable mechanical circulatory support options for patients with biventricular failure are limited. One emerging strategy is the use of 2 fully magnetically levitated durable ventricular assist devices (HeartMate 3s) in a biventricular configuration. The use of a HeartMate 3 as a right ventricular assist device (RVAD) requires several complex technical modifications. Here, we provide step-wise detailed figures and a comprehensive description of bilateral HeartMate 3 insertion, with a particular focus on right atrial inflow cannulation for the RVAD. Potential pitfalls and solutions are also described. [ABSTRACT FROM AUTHOR]

Abstract Aims While echocardiography remains essential within haemodynamic monitoring of durable mechanical circulatory support, previous echocardiographic guidelines are missing scientific evidence for the novel HeartMate 3™ (HM3) system. Accordingly, this review aims to summarize available echocardiographic evidence including HM3. Methods and results This systematic review adhered to the PRISMA 2020 guidelines. Searches were conducted during August 2023 across PubMed, Embase, and Google Scholar using specific echocardiographic terms combined with system identifiers. Study quality was assessed using the Newcastle–Ottawa Scale (NOS) for cohort studies and Critical Appraisal Instrument (PCAI) for cross‐sectional studies. Nine studies met the inclusion criteria, of which eight cohort studies and one cross‐sectional study. Aortic regurgitation (AR) prevalence at approximately 12 months of support exhibited heterogenicity (33.5% (Δ 33%)) in a limited number of studies (n = 3). Several studies (n = 5) demonstrated an increasing prevalence and severity of AR during HM3 support, generating moderate to high level of evidence. One AR study showed a higher cumulative incidence of death and heart failure (HF) readmission compared with those without significant AR, hazard ratio 3.42 (95% CI 1.48–8.76). A second study showed that a worsening AR group had significantly lower survival‐free from HF readmission (59% vs. 89%, P = 0.023) with a hazard ratio of 5.18 (95% CI 1.07–25.0), while a third study did not reveal any differences in cardiac‐related hospitalizations in the 12 months follow‐up or non‐cardiac‐related hospitalization. Mitral regurgitation (MR) prevalence at approximately 12 months of support exhibited good consistency 15.0% (Δ 0.8%) in both included studies, which did not reveal any significant pattern of changing prevalence over time. Tricuspid regurgitation (TR) prevalence at approximately 12 months of support exhibited fair consistency 28.5% (Δ 8.3%) in a limited number of studies (n = 2); both studies showed a statistically un‐confirmed trend of increased TR prevalence over time. The evidence of general prevalence of right ventricular dysfunction (RVD) was insufficient due to lack of studies. Conclusions There are few methodologically consistent studies with focus on long‐term haemodynamic effects. Aortic regurgitation still seems to be a prevalent and potentially significant finding. The available evidence concerning right heart function is limited despite clinical relevance and potential prognostic value. Potential interventricular and haemodynamic interplay are identified as a white field for future research.

Abstract Aims Use of novel anticoagulation in mechanical circulatory support is controversial. We report the rationale and design of the ApixiVad pilot trial, a pilot study testing the safety of apixaban as an anticoagulant in patients bridged to transplant (BTT) or for destination (DT) with Heartmate 3 (HM3) left ventricular assist device (LVAD). Methods and results Apixaban has been used in small non‐randomized cohorts in LVAD patients and shown to be effective in ex vivo studies. The ApixiVAD study examines apixaban use in a multicentre, international, open‐label, randomized, controlled trial aiming to include 50 BTT or DT HM3 patients with a 1:1 randomization ratio. This event‐driven study has a maximum follow‐up period of 24 months with interim analysis at 6 months. The primary outcome is death, thromboembolic events and major bleeding, including operative bleeding and immediate transplant outcomes. The secondary outcome focuses on patients' quality of life related to anticoagulation. This investigator‐driven pilot study is not powered to determine the non‐inferiority of apixaban. An increase in primary outcome in the apixaban group of 20% will be considered a signal of harm. Conclusions A positive outcome in the ApixiVAD study would provide the basis for future, larger, pivotal anticoagulation trials in LVAD patients.

Aims: Use of novel anticoagulation in mechanical circulatory support is controversial. We report the rationale and design of the ApixiVad pilot trial, a pilot study testing the safety of apixaban as an anticoagulant in patients bridged to transplant (BTT) or for destination (DT) with Heartmate 3 (HM3) left ventricular assist device (LVAD). Methods and results: Apixaban has been used in small non‐randomized cohorts in LVAD patients and shown to be effective in ex vivo studies. The ApixiVAD study examines apixaban use in a multicentre, international, open‐label, randomized, controlled trial aiming to include 50 BTT or DT HM3 patients with a 1:1 randomization ratio. This event‐driven study has a maximum follow‐up period of 24 months with interim analysis at 6 months. The primary outcome is death, thromboembolic events and major bleeding, including operative bleeding and immediate transplant outcomes. The secondary outcome focuses on patients' quality of life related to anticoagulation. This investigator‐driven pilot study is not powered to determine the non‐inferiority of apixaban. An increase in primary outcome in the apixaban group of 20% will be considered a signal of harm. Conclusions: A positive outcome in the ApixiVAD study would provide the basis for future, larger, pivotal anticoagulation trials in LVAD patients. [ABSTRACT FROM AUTHOR]

Aims: While echocardiography remains essential within haemodynamic monitoring of durable mechanical circulatory support, previous echocardiographic guidelines are missing scientific evidence for the novel HeartMate 3™ (HM3) system. Accordingly, this review aims to summarize available echocardiographic evidence including HM3. Methods and results: This systematic review adhered to the PRISMA 2020 guidelines. Searches were conducted during August 2023 across PubMed, Embase, and Google Scholar using specific echocardiographic terms combined with system identifiers. Study quality was assessed using the Newcastle–Ottawa Scale (NOS) for cohort studies and Critical Appraisal Instrument (PCAI) for cross‐sectional studies. Nine studies met the inclusion criteria, of which eight cohort studies and one cross‐sectional study. Aortic regurgitation (AR) prevalence at approximately 12 months of support exhibited heterogenicity (33.5% (Δ 33%)) in a limited number of studies (n = 3). Several studies (n = 5) demonstrated an increasing prevalence and severity of AR during HM3 support, generating moderate to high level of evidence. One AR study showed a higher cumulative incidence of death and heart failure (HF) readmission compared with those without significant AR, hazard ratio 3.42 (95% CI 1.48–8.76). A second study showed that a worsening AR group had significantly lower survival‐free from HF readmission (59% vs. 89%, P = 0.023) with a hazard ratio of 5.18 (95% CI 1.07–25.0), while a third study did not reveal any differences in cardiac‐related hospitalizations in the 12 months follow‐up or non‐cardiac‐related hospitalization. Mitral regurgitation (MR) prevalence at approximately 12 months of support exhibited good consistency 15.0% (Δ 0.8%) in both included studies, which did not reveal any significant pattern of changing prevalence over time. Tricuspid regurgitation (TR) prevalence at approximately 12 months of support exhibited fair consistency 28.5% (Δ 8.3%) in a limited number of studies (n = 2); both studies showed a statistically un‐confirmed trend of increased TR prevalence over time. The evidence of general prevalence of right ventricular dysfunction (RVD) was insufficient due to lack of studies. Conclusions: There are few methodologically consistent studies with focus on long‐term haemodynamic effects. Aortic regurgitation still seems to be a prevalent and potentially significant finding. The available evidence concerning right heart function is limited despite clinical relevance and potential prognostic value. Potential interventricular and haemodynamic interplay are identified as a white field for future research. [ABSTRACT FROM AUTHOR]

Purpose: LVAD outflow graft stenosis continues to remain prevalent with a high complication rate. We sought to pool the existing evidence on indications, utilization patterns, and outcomes of transcatheter interventions for outflow graft stenosis in the HeartMate 3 LVAD. Methods: An electronic search was performed to identify all studies in the English literature reporting on HeartMate 3 LVAD outflow graft stenting. Patient‐level data were extracted for analysis. Results: Thirteen published reports and one unpublished case comprising a total of 28 patients were included. Median patient age was 68.5 years [Interquartile range: 58, 71] and 25.9% (7/27) were female. Dyspnea [60.7% (17/28)] was the most common presenting symptom. Low flow alarms were present in 60% (15/25) of patients. Findings included external compression [35.7% (10/28)], graft twist [21.4% (6/28)], graft twist and external compression [14.3% (4.28)], intraluminal thrombus [10.7% (3/28)], graft twist and intraluminal thrombus [3.6% (1/28)], and pseudoaneurysm of outflow graft [3.6% (1/28)]. Median time from LVAD implantation to stenting was 2.1 years [1.4, 3]. Immediate flow normalization after stenting was observed in 85.7% (24/28). The 30‐day mortality was 12% (3/25). Overall mortality was 12% (3/25) at a median follow‐up of 3.9 months [1, 17]. Conclusion: Outflow graft stenting in the HeartMate 3 LVAD appears to be a reasonable treatment option for outflow graft stenosis, with low overall rates of complications and mortality. Further refinement of indications and approaches may improve outcomes. [ABSTRACT FROM AUTHOR]

Aortic root thrombosis(ART) is a complication of continuous-flow left ventricular assist device therapy. However, the incidence and related complications of ART in HeartMate 3 (HM3) patients remain unknown. Patients who underwent HM3 implantation from November 2014 to August 2020 at a quaternary academic medical center were included. Demographics and outcomes were abstracted from the medical record. Echocardiograms and contrast-enhanced computed tomography studies were reviewed to identify patients who developed ART and/or moderate or greater aortic insufficiency (AI) on HM3 support. The study cohort included 197 HM3 patients with a median postimplant follow-up of 17.5 months. Nineteen patients (9.6%) developed ART during HM3 support, and 15 patients (7.6%) developed moderate or greater AI. Baseline age, gender, race, implantation strategy, and INTERMACS classification were similar between the ART and no-ART groups. ART was associated with an increased risk of death, stroke, or aortic valve (AV) intervention (subhazard ratio [SHR] 3.60 [95% confidence interval (CI) 1.71-7.56]; p = 0.001) and moderate or greater AI (SHR 11.1 [CI 3.60-34.1]; p < 0.001) but was not associated with a statistically significantly increased risk of death or stroke on HM3 support (2.12 [0.86-5.22]; p = 0.10). Of the 19 patients with ART, 6 (31.6%) developed moderate or greater AI, necessitating more frequent AV interventions (ART: 5 AV interventions [3 surgical repairs, 1 surgical replacement, 1 transcatheter replacement; 26.3%]; no-ART: 0). Nearly 10% of HM3 patients developed ART during device support. ART was associated with increased risk of a composite end-point of death, stroke, or AV intervention as well as moderate or greater AI. [ABSTRACT FROM AUTHOR]

ObjectivesWe aim to evaluate our initial experience with the HeartMate 3 (HM3) device (Abbott, USA) for palliating pediatric patients with end−stage heart failure (ESHF).MethodsWe conducted a retrospective review of clinical data from pediatric patients (aged 7–18 years) who underwent HM3 implantation for ESHF at our institution between 2022 and 2024. Patient demographics and follow−up data were comprehensively analyzed.ResultsWe identified 11 patients (45% males) with a median age of 14 years (IQR 11–17), a median weight of 47 kg (IQR 28–50), a median height of 159 cm (IQR 135–165), and a median body surface area of 1.36 m2 (IQR 1.07–1.53) at the time of the intervention. All patients were diagnosed with dilated cardiomyopathy and categorized with PEDIMACS profiles ranging from one to three. The median ICU stay was 14 days (IQR 6–32), with 11 patients receiving inotropic support for a median of four postoperative days (IQR 3–8). The median follow−up period was 150 days (IQR 90–210). Early complications included two cases of pleural effusion, 1 case of cardiac tamponade, 3 cases of polyuria, and one instance of positive blood cultures. One patient, who was non−compliant with warfarin therapy, developed a thrombus in the right atrium that was resolved with a revision of anticoagulant therapy, and did not experience pump thrombosis. During follow−up, one patient died after 28 days from sepsis, one underwent heart transplantation after 10 days, and nine patients remained alive on the device. Notably, there were no reported cases of pump thrombosis, ischemia, or stroke post− implantation.ConclusionsThe HM3 device appears to be a safe and effective palliative option for pediatric patients with ESHF.

Gastrointestinal bleeding (GIB) results in frequent hospitalizations and impairs quality of life in durable left ventricular assist device (LVAD) recipients. Anticipation of these events before implantation could have important implications for patient selection and management. The study population included all adult HeartMate 3 (HM3) primary LVAD recipients enrolled in the STS Intermacs registry from January 2017 to December 2020. Using multivariable modeling methodologies, we investigated the relationships between preimplantation characteristics and postimplant bleeding, bleeding and death, and additional bleeding episodes on subsequent bleeding episodes and created a risk score to predict the likelihood of post-LVAD GIB based solely on preimplantation factors. Of 6,425 patients who received an HM3 LVAD, 1,010 (15.7%) patients experienced GIB. Thirteen preimplantation factors were independent predictors of post-LVAD GIB. A risk score was created from these factors and calculated for each patient. By 3 years postimplant, GIB occurred in 11%, 26%, and 43% of low-, medium- and high-risk patients, respectively. Experiencing 1 post-LVAD GIB event was associated with an increased risk for further GIB events, with 33.9% of patients experiencing at least 1 recurrence. While post-LVAD GIB was associated with mortality, there was no relationship between number of GIB events and death. The Michigan Bleeding Risk Model is a simple tool, which facilitates the prediction of post-LVAD GIB in HM3 recipients using 13 preimplant variables. The implementation of this tool may help in the risk stratification process and may have therapeutic and clinical implications in HM3 LVAD recipients. [ABSTRACT FROM AUTHOR]

The Heartmate 3 (HM3) risk score (HM3RS) was derived and validated internally from within the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) trial population and provides 1- and 2-year mortality risk prediction for patients in those before HM3 left ventricular assist device (LVAD) implantation. We aimed to evaluate the HM3RS in nontrial unselected patients, including those not meeting inclusion criteria for MOMENTUM 3 trial enrollment. Patients who underwent HM3 LVAD implant at 1 of 7 US centers between 2017 and 2021, with at least 1-year follow-up, were included in this analysis. Patients were retrospectively assessed for their eligibility for the MOMENTUM 3 trial based on study inclusion and exclusion criteria. HM3RS risk discrimination was evaluated using time-dependent receiver operating characteristic curve analysis for 1-year mortality for all patients and further stratified by MOMENTUM 3 trial eligibility. Kaplan-Meier curves were constructed using the HM3RS-based risk categories. Of 521 patients included in the analysis, 266 (51.1%) would have met enrollment criteria for MOMENTUM 3. The 1- and 2-year survival for the total cohort was 85% and 81%, respectively. There was no statistically significant difference in survival between those who met and did not meet enrollment criteria at 1 (87% vs 83%; p = 0.21) and 2 years postimplant (80% vs 78%; p = 0.39). For the total cohort, HM3RS predicted 1-year survival with an area under the curve (AUC) of 0.63 (95% confidence interval [CI]: 0.57-0.69, p < 0.001). HM3RS performed better in the subset of patients meeting enrollment criteria: AUC 0.69 (95% CI:0.61-0.77, p < 0.001) compared to the subset that did not: AUC 0.58 (95% CI: 0.49-0.66, p = 0.078). In this real-world evidence, multicenter cohort, 1- and 2-year survival after commercial HM3 LVAD implant was excellent, regardless of trial eligibility. The HM3RS provided adequate risk discrimination in "trial-like" patients, but predictive value was reduced in patients who did not meet trial criteria. [ABSTRACT FROM AUTHOR]

The Minnesota Pectoralis Risk Score (MPRS) utilizes computed tomography–quantified thoracic muscle and clinical variables to predict survival after left ventricular assist device (LVAD) implantation. The model has not been prospectively tested in HeartMate 3 recipients. A single-center HeartMate 3 cohort from July 2016 to July 2021 (n = 108) was utilized for this analysis. Cohort subjects with complete covariates for MPRS calculation (pectoralis muscle measures, Black race, creatinine, total bilirubin, body mass index, bridge to transplant status, and presence/absence of contrast) implanted after MPRS development were included. MPRS were calculated on each subject. Receiver operating characteristic curves were generated to test model discrimination at 30-day, 90-day, and 1-year mortality post-LVAD. Next, the performance of the 1-year post-LVAD outcome was compared to the HeartMate 3 survival risk score (HM3RS). The mean age was 58 (15 years), 80% (86/108) were male, and 26% (28/108) were destination therapy. The area under the curve (AUC) for the MPRS model to predict post-LVAD mortality was 0.73 at 30 days, 0.78 at 90 days, and 0.81 at 1 year. The AUC for the HM3RS for the 1-year outcome was 0.693. Each 1-unit point of the MPRS was associated with a significant increase in the hazard rate of death after LVAD (hazard ratio 2.1, 95% confidence interval 1.5-3.0, p < 0.0001). The MPRS had high performance in this prospective validation, particularly with respect to 90-day and 1-year post-LVAD mortality. Such a tool can provide additional information regarding risk stratification to aid informed decision-making. [ABSTRACT FROM AUTHOR]

The use of ventricular assist devices as bridge-to-transplantation therapy has a critical role in the management of end-stage heart failure in pediatric patients without available compatible organ donors. The HeartMate 3 is an intracorporeal centrifugal flow pump with a fully magnetically levitated motor currently approved for the management of advanced refractory left ventricular failure in pediatric patients, with positive early outcomes. We report the case of a 17-year-old adolescent girl with end-stage heart failure secondary to dilated cardiomyopathy of idiopathic etiology, with multiple failed attempts of weaning from inotropic support (PEDIMACS 3 profile), who successfully received a HeartMate 3 left ventricular assist device as bridge-to-transplantation therapy with no significant adverse events during the early follow-up period. This paper presents the first case of pediatric ventricular assist device implantation in Romania. [ABSTRACT FROM AUTHOR]

Background: End-stage heart failure is associated with high mortality. Recent developments such as the left ventricular assist device (LVAD) have improved patient outcomes. The HeartMate 3 LVAD is a novel centrifugal pump that was developed to provide hemodynamic support in heart failure patients, either as a bridge-to-transplant (BTT), myocardial recovery, or destination therapy (DT). Our objective was to evaluate the survival rates and LVAD-related complications of the HeartMate 3 LVAD before and after hospital discharge in our center. Methods: We retrospectively reviewed all patients implanted with the HeartMate 3 LVAD in our institute between September 2015 and June 2024. Patients who received a Heart Ware Ventricular Assist Device (HVAD) and HeartMate 2 LVAD devices were excluded. The primary endpoint was survival before and after hospital discharge. The secondary endpoints included an incidence of serious LVAD adverse events (bleeding, major infection, hemolysis, device thrombosis and malfunction, and neurological dysfunction) and the causes of re-admission along the follow-up period. Results: A total of 48 consecutive HeartMate 3 LVAD patients were enrolled in this study. The mean age was 56.1 ± 10.6 years. A total of 72.9% of patients received LVAD therapy as a BTT, 14.6% as DT, 10.4% as a bridge-to-decision, and 2.1% as a bridge-to-recovery. A total of 85.4% of patients were discharged after implantation. The main cause for in-hospital mortality was right ventricular failure (8.3%), followed by stroke, abdominal bleeding, and multi-organ failure (2.1% each). One patient (2.1%) had successful heart transplantation, 26 patients (63.4%) are still on LVAD support, and 11 (26.8%) patients have died during follow-up. The main cause of mortality after hospital discharge was sepsis, which occurred in 9.8% of patients, followed by right ventricular failure, non-LVAD-related causes, unknown causes with two (4.9%) cases each, and one case of fatal stroke (2.4%). During the follow-up, there was no need for LVAD replacement. Conclusions: HeartMate 3 LVAD is associated with excellent in-hospital survival rates in patients with end-stage heart failure. Right ventricular failure was the main cause of death before hospital discharge, whereas sepsis was the main cause of death after hospital discharge.

In end-stage heart failure, which is characterized by persistent or progressive ventricular dysfunction despite optimal medical therapy, a left ventricular assist device (LVAD) can be beneficial. Congestive heart failure provokes inflammatory and prothrombotic activation. The aim of this study was to evaluate the serum concentration of citrullinated histone 3 (CH3) representing neutrophil extracellular trap (NET) formation in patients referred for LVAD implantation. There were 10 patients with a median age of 61 (57–65) years enrolled in a prospective single-center analysis who underwent LVAD implantation. The CH3 plasma concentration was measured preoperatively and on the 1st and 7th postoperative days, followed by control measurements on the median (Q1–3) 88th (49–143) day. The preoperative CH3 concentration strongly correlated with brain natriuretic peptide (r = 0.879, p < 0.001). Significant differences in CH3 serum concentration were observed between pre- and postoperative measurements, including an increase on the first postoperative day (p < 0.001), as well as a decrease on the seventh day (p = 0.016) and in follow-up (p < 0.001). CH3 concentration, as a marker of NET formation, decreases after LVAD implantation.

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. [ABSTRACT FROM AUTHOR]

The HeartMate 3 (HM3) left ventricular assist device (LVAD) has demonstrated excellent clinical outcomes; however, pump speed optimization is challenging with the available HM3 monitoring. Therefore, this study reports on clinical HM3 parameters collected with a noninvasive HM3 monitoring system (HM3 Snoopy) during echocardiographic speed ramp tests and Valsalva maneuvers. In this prospective, single-center study, the HM3 data communication between the controller and pump was recorded with a novel data acquisition system. Twelve pump parameters sampled every second (1 Hz) and clinical assessments (echocardiography, electrocardiogram (ECG), and blood pressure measurement) during speed ramp tests were analyzed using Pearson's correlation (r , median [IQR]). The cause for the occurrence of pulsatility index (PI)-events during ramp speed tests and valsalva maneuvers was investigated. In 24 patients (age: 58.9 ± 8.8 years, body mass index: 28.1 ± 5.1 kg/m2, female: 20.8%), 35 speed ramp tests were performed with speed changes in the range of ±1000 rpm from a baseline speed of 5443 ± 244 rpm. Eight HM3 pump parameters from estimated flow, motor current, and LVAD speed together with blood pressure showed positive collinearities (r = 0.9 [0.1]). Negative collinearities were observed for pump flow pulsatility, pulsatility index, rotor noise, and left ventricular diameters (r = −0.8 [0.1]), whereas rotor displacement and heartrate showed absence of collinearities (r = −0.1 [0.08]). In this study, the HM3 Snoopy was successfully used to acquire more parameters from the HM3 at a higher sampling rate. Analysis of HM3 per-second data provide additional clinical diagnostic information on heart-pump interactions and cause of PI-events. [Display omitted] [ABSTRACT FROM AUTHOR]

This comprehensive review highlights the significant advancements in Left Ventricular Assist Device (LVAD) therapy, emphasizing its evolution from the early pulsatile flow systems to the cutting-edge continuous-flow devices, particularly the HeartMate 3 (HM3) LVAD. These advancements have notably improved survival rates, reduced complications, and enhanced the quality of life (QoL) for patients with advanced heart failure. The dual role of LVADs, as a bridge-to-transplantation and destination therapy is discussed, highlighting the changing trends and policies in their application. The marked reduction in hemocompatibility-related adverse events (HRAE) with the HM3 LVAD, compared to previous models signifies ongoing progress in the field. Challenges such as managing major infections are discussed, including innovative solutions like energy transfer systems aimed at eliminating external drivelines. It explores various LVAD-associated complications, including HRAE, infections, hemodynamic-related adverse events, and cardiac arrhythmias, and underscores emerging strategies for predicting post-implantation outcomes, fostering a more individualized patient care approach. Tools such as the HM3 risk score are introduced for predicting survival based on pre-implant factors, along with advanced imaging techniques for improved complication prediction. Additionally, the review highlights potential new technologies and therapies in LVAD management, such as hemodynamic ramp tests for optimal speed adjustment and advanced remote monitoring systems. The goal is to automate LVAD speed adjustments based on real-time hemodynamic measurements, indicating a shift towards more effective, patient-centered therapy. The review concludes optimistically that ongoing research and potential future innovations hold the promise of revolutionizing heart failure management, paving the way for more effective and personalized treatment modalities. [ABSTRACT FROM AUTHOR]

Background: To descriptively present data and outcomes of left ventricular assist device (LVAD) implantations at Karolinska University Hospital. Methods: Data were collected from consecutive patients (n = 44) who were implanted with HeartMate 3 (HM3) at Karolinska University Hospital between 2017 and 2022. The study presents baseline characteristics, clinical course during the inpatient hospital care after implantation, adverse events, and clinical outcomes. Results: Median intensive care unit stay and hospital stay after HM3 implantation was 8 (interquartile range [IQR] 6; 15) and 28 days (IQR 22; 36), respectively. In total, 73% underwent ramp test at some point after the implantation. Death from all causes within 30 days postimplantation was 5%. A total of 21 patients (48%) underwent right heart catheterization, at a median of 0.5 years (IQR 0.3; 0.7) after implantation, and all exhibited optimally unloaded left ventricles. During the study period, 34% of the patients were transplanted, 5% were explanted, and 16% died with LVAD. In total, 11% and 5% suffered from early and late right ventricle failures, respectively. Acute renal failure affected 46% and 18% had driveline infection. Spontaneous cerebral hemorrhage and cerebral infarction affected 5% and 7% of the study population, respectively. Gastrointestinal bleeding affected 16%. The median LVAD duration was 10 months (IQR 5; 22). The 1-year survival rate with LVAD was 85%, and the 2-year survival rate was 80%. Conclusions: The results of this low-volume single-center retrospective study on LVAD implantations align with the results of other studies and international registries.

This article discusses the first-in-human implantation of the CorLog device, a pressure sensor used for postoperative intravascular pressure sensing in patients with left ventricular assist devices (LVADs). The CorLog device is implanted through the jugular vein and enables permanent, wireless pressure monitoring of the right atrium or ventricle. The device was successfully implanted in a 61-year-old male patient who underwent LVAD implantation due to terminal heart failure. The device collected a full dataset of right ventricular pressures without any complications, demonstrating its feasibility and safety. The CorLog device offers a viable option for wireless, continuous right heart monitoring in heart failure patients for the first 30 days after LVAD implantation. [Extracted from the article]

This article discusses a rare case of a lightning strike causing damage to a left ventricular assist device (LVAD), a device used to manage end-stage heart failure. The patient's LVAD was connected to a house power source when lightning struck, resulting in dysfunction of the device. The article highlights the vulnerability of electrical devices to external factors such as lightning strikes and emphasizes the importance of proper electrical isolation in the patient's home. The case also suggests the use of percutaneous venoarterial ECMO implantation and LVAD exchange in cases of severe electrical damage to the LVAD. The article concludes by emphasizing the need for physicians to remain vigilant and prepared for unexpected challenges in managing LVAD patients. [Extracted from the article]

Abstract While technological advances in the field of continuous‐flow left ventricular assist device (CF‐LVAD) are constantly being made, CF‐LVAD recipients are still subjected to a relatively high rate of LVAD‐related adverse events, with post‐LVAD gastrointestinal bleeding (GIB) being the most common one. GIB is associated with a significant impairment in quality of life, multiple hospital admissions, blood transfusion requirements and possibly death. Furthermore, of those patients who bled once, many will experience recurrent GIB events, which further aggravates their discomfort. While some medical and endoscopic treatment options are available, evidence regarding their benefit remains largely equivocal, with all related studies based on data from registries rather than clinical trials. Although having a major impact on LVAD recipients, an effective and validated pre‐implant screening options to predict GIB events post‐implant are scarce. This review focuses on the aetiology, incidence, risk factors, treatment options and the effect of new generation devices on post‐LVAD GIB.

Background: Patient selection for real-world use of HeartMate 3 left ventricular assist device (HM3 LVAD) differs from that of clinical trials. We assessed adverse-event rates between “nontrial like” (NTL) and “trial like” (TL) patients who underwent commercial HM3 implantation. Methods: We conducted a multicenter, retrospective cohort study of 231 consecutive patients who underwent primary HM3 implant from October 2017 to December 2021. Patients were identified as NTL if they met ≥1 exclusion criteria from the Mulitcenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) trial and TL if they had no exclusion criteria. The primary outcome was freedom from death, heart failure hospitalization, LVAD-related infection, and hemocompatibility-related adverse events including major gastrointestinal bleed, all-cause stroke, and pump thrombosis. Results: Of the 231 patients (median age 59 years, 24% female), 105 (45%) were categorized as NTL, most commonly due to low albumin and/or prealbumin levels alone (n = 48) followed by the use of temporary mechanical circulatory support alone (n = 10) and having ≥2 exclusion criteria (n = 26). Compared to the TL group, the NTL group had a lower 1-year event-free survival (34% vs 48%, adjusted hazard ratio (HR) [95% confidence interval (CI)]: 1.5[1.01-2.0], p = 0.043). One-year overall survival was 82% in NTL group vs 95% in TL group (adjusted HR [95%CI]: 3.3[1.1-8.7], p = 0.013). Post-HM3 adverse events were associated with the presence of ≥2 exclusion criteria (adjusted HR [95%CI]: 1.8[1.06-3.1], p = 0.028); and veno-arterial extracorporeal membrane oxygenation support prior to HM3 (adjusted HR [95%CI]: 1.9[1.08-3.4], p = 0.026). Conclusions: In this multicenter cohort of HM3 patients, those outside of traditional clinical trial eligibility had a significantly lower 1-year event-free survival.

Despite improving outcomes with modern pump technology, left ventricular assist device (LVAD) utilization for patients with end-stage heart failure (HF) has declined significantly in the preceding half-decade. Here, we examine this trend, noting an inherent contradiction in the declining utilization of an improving therapeutic option. We propose a series of provocative questions as a "call to action" for the field of advanced HF to consider both scientifically and clinically, focusing on our evaluation parameters for LVAD candidacy, our approach to dichotomous LVAD vs transplant decisions, and our current management paradigms. We conclude that modernization in these areas to match the advantages of modern pump technology is required to best serve patients with advanced HF. [ABSTRACT FROM AUTHOR]

Median sternotomy is a standard surgical technique used for left ventricular assist device (LVAD) implantation. However, if sternotomy has a prohibitive surgical risk, LVAD implantation can be performed through only left thoracotomy. We managed a patient with endstage heart failure who had recently undergone coronary artery bypass grafting (CABG) elsewhere. The patient also had a deep sternal wound infection and bacteremia. Because of refractory cardiogenic shock, we performed extracorporeal membrane oxygenation (ECMO). After multiple mediastinal washouts and omental flap placement, ECMO was converted to extracorporeal LVAD (from the left ventricular apex to the descending aorta) through a left thoracotomy. The extracorporeal LVAD was maintained for 18 days and replaced by the HeartMate 3 LVAD. The patient was discharged in good condition 115 days after CABG.

While technological advances in the field of continuous‐flow left ventricular assist device (CF‐LVAD) are constantly being made, CF‐LVAD recipients are still subjected to a relatively high rate of LVAD‐related adverse events, with post‐LVAD gastrointestinal bleeding (GIB) being the most common one. GIB is associated with a significant impairment in quality of life, multiple hospital admissions, blood transfusion requirements and possibly death. Furthermore, of those patients who bled once, many will experience recurrent GIB events, which further aggravates their discomfort. While some medical and endoscopic treatment options are available, evidence regarding their benefit remains largely equivocal, with all related studies based on data from registries rather than clinical trials. Although having a major impact on LVAD recipients, an effective and validated pre‐implant screening options to predict GIB events post‐implant are scarce. This review focuses on the aetiology, incidence, risk factors, treatment options and the effect of new generation devices on post‐LVAD GIB. [ABSTRACT FROM AUTHOR]

Since the recall of the HeartWare HVAD device in 2021, the management of the remaining implants range from medical management, transplant, to exchange. This article describes 2 feasible approaches to exchange the HVAD to the HeartMate3 device through a combination of a left lateral thoracotomy with a superior hemi-sternotomy. These approaches minimize dissection and complications of a redo-sternotomy and minimizes bypass time. Pitfalls and solutions are also herein described. [ABSTRACT FROM AUTHOR]

Aims: We assessed the incidence, predictors and clinical correlates of de‐novo aortic regurgitation (AR), which physiologically reduces left ventricular assist device (LVAD) effectiveness due to recirculation syndrome, in the MOMENTUM 3 trial portfolio of the fully magnetically levitated HeartMate 3 (HM3) pump using the randomized pivotal trial (PT) and post‐trial continued access protocol (CAP). Methods and results: De‐novo aortic regurgitation incidence at 2 years was analysed in the randomized PT and validated in the first 1000 implanted patients of the CAP. Patients with concomitant/prior aortic valve surgery or without baseline or post‐implant echocardiograms were excluded from this analysis. AR severity was assessed qualitatively by site‐adjudicated echocardiograms (significant AR was defined as moderate or severe grade on echocardiogram). Of 1028 patients enrolled in the PT, 918 were eligible for inclusion in this analysis (HM3, n = 465; HMII, n = 453). At 2 years of LVAD support, freedom from significant AR was greater in the HM3 (92%) than HMII (82%) (hazard ratio 0.45, 95% confidence interval 0.27–0.75, p < 0.01). Of 907 HM3 patients analysed from the first 1000 implanted CAP patients, the rate of freedom from significant AR was 90%, consistent with the PT (p = 0.3). In the combined HM3 group (n = 1372), multivariable Cox modelling identified increasing age and female sex as significant predictors. Survival free of urgent transplant or AR corrective procedure was similar between HM3 patients with and without significant de‐novo AR. Conclusions: The development of moderate or severe grade de‐novo AR is reduced with the fully magnetically levitated HM3 LVAD compared to the axial‐flow HMII pump. The occurrence of significant de‐novo AR with the HM3 pump is not associated with a worse outcome at 2 years of follow‐up. [ABSTRACT FROM AUTHOR]

Background: We evaluated the impact of a standardized driveline care strategy, including a subfascial‐tunneling method and dressing protocol, on the incidence of driveline infection (DLI). Methods: DLI data from all HeartMate II (HMII) and HeartMate 3 (HM3) patients (including exchange devices) were retrospectively collected between 2013 and 2021. The driveline subfascial‐tunneling method was altered in three steps (A: right direct; B: left triple, C: right triple), and the shower protocol was changed in two steps (A: with/without cover, B: with cover). Disinfection was individually tailored after changing the shower protocol. Complications associated with morbidity and mortality were evaluated for each modification. Results: During the study period, 80 devices were implanted (HMII, n = 54; HM3, n = 26). The 8‐year incidence of DLI was 15% (n = 8) in HMII patients and 0% in HM3 patients (p = 0.039). DLI was not associated with hospital mortality. The modified dressing protocol and tunneling method was associated with a significantly better DLI incidence rate in comparison to the previous one: Protocol‐A (n = 17), Protocol‐B (n = 63), 35% vs 3% (p = 0.0009), Method‐A (n = 13), Method‐B (n = 42), Method‐C (n = 25), 46% vs 5% vs 0% (p = 0.0001). The rete of freedom form DLI at 1, 2, and 3 years had also significant difference between groups: Protocol‐A and Protocol‐B, 80%, 54%, 54% vs 96%, 96%, 96%, respectively (p < 0.0001), Method‐A, Method‐B and Method‐C, 76%, 44%, 44%, vs 94%, 94%, 94% vs 100%, 100%, respectively (p < 0.0001). Conclusions: A standardized triple driveline tunneling strategy and waterproof dressing protocol reduced driveline infection in HM3 patients to 0%. [ABSTRACT FROM AUTHOR]

Background: In patients with left ventricular assist devices (LVADs), ischemic and hemorrhagic stroke are dreaded complications. Predictive markers for these events are lacking. This study aimed to investigate the prevalence and predictive value of microembolic signals (MES) for stroke, detected by Transcranial Doppler sonography (TCD) in patients with HeartMate 3 (HM 3) or HeartWare (HW). Methods: A thirty‐minute bilateral TCD monitoring of the middle cerebral artery (MCA) was performed in 62 outpatients with LVAD (HM 3 N = 31, HW N = 31) and 31 healthy controls. Prevalence and quantity of MES were investigated regarding clinical and laboratory parameters. Cerebrovascular events (CVE) were recorded on follow‐up at 90 and 180 days. Results: MES were detected in six patients with HM 3, three patients with HW, and three controls. Within the LVAD groups, patients on monotherapy with vitamin‐K‐antagonist (VKA) without antiplatelet therapy were at risk for a higher count of MES (negative binomial regression: VKA: 1; VKA + ASA: Exp(B) = 0.005, 95%CI 0.001–0.044; VKA + clopidogrel: Exp(B) = 0.012, 95%CI 0.002–0.056). There was no association between the presence of MES and CVE or death on follow‐up (p > 0.05). Conclusion: For the first time, the prevalence of MES was prospectively investigated in a notable outpatient cohort of patients with HM 3 and HW. Despite optimized properties of the latest LVAD, MES remain detectable depending on antithrombotic therapy. No association between MES and CVE could be detected. [ABSTRACT FROM AUTHOR]

Background: Driveline (DL) damages are a common difficulty among ventricular assist devices (VAD). Repairing the electrical fibers inside the DL on a running pump is hazardous and requires technical expertise, which is not easily available on site. A new feature of the HeartMate3 (Abbott, U.S.A.) LVAD is a modular driveline that allows an easy exchange of the DL cord. In this report we analyze our experiences with this feature. Methods: We performed a retrospective analysis of 302 patients who underwent either HeartMate II or HeartMate 3 implantation between February 2004 and September 2021. Patients were screened for driveline faults and need for exchange or repair of driveline or VAD exchange. Documented were baseline characteristics, reasons for DL or VAD exchange, and complications. Follow‐up was three months after the procedure. Results: We present a cohort of 302 patients who underwent either HMII (n = 107;35.4%) or HM 3 (n = 195; 64.5%) implantation. Out of those, 40 patients (40/302; 13.2%) required driveline repair (DLRe) or exchange (DLEx). Out of 107 HMII patients, 9 showed severe DL damages (9/107; 8.4%). Six patients (6/9; 66.6%) underwent DLRe, two patients (2/6; 33.3%) required VAD exchange after DLRe, one patient (1/2;50%) experienced emergency VAD exchange after pump stop. The DLRe procedure in the other four patients (4/6; 66.6%) was successful. Due to damage to the internal driveline two patients (2/9; 22.2%) underwent emergency device exchange and one patient (1/9;11.1%) was listed for transplantation. 31 out 195 HM3 patients underwent exchange of the modular DL. In none of the cases, damages of the internal fibers were the reasons for the exchange. In 100% of the cases, damages of the external coating were the reason for DL exchange. In none of the cases, complications occurred after the exchange procedure. Conclusions: Driveline damages are a habitual, recurrent complication in VAD patients. The exchange of the modular driveline cable of the HM3 is feasible and safe compared to the conventional DL repair in HMII patients. Risky repair attempts and surgical LVAD exchange due to major damages of the electrical fibers can be avoided successfully by the new feature of HM3 driveline. [ABSTRACT FROM AUTHOR]

Systemic right ventricular failure after physiologic repair for dextro‐transposition of the great arteries can be managed with durable mechanical circulatory support; however, the right ventricular morphology, such as intervening papillary muscles, presents challenges to inflow cannula positioning. Papillary muscle repositioning is an innovative technique to circumvent obstructive anatomy. [ABSTRACT FROM AUTHOR]

Left-ventricular assist devices (LVADs) improve outcomes in end-stage heart failure patients. Two centrifugal-flow LVAD systems are currently approved, HeartMate 3 (HM3) and Medtronic/Heartware HVAD (HVAD). Clinical findings suggest differences in thrombogenicity between both systems. We compared markers of platelet activation and aggregation between HM3 and HVAD. We prospectively included 59 LVAD patients (40 HM3, 19 HVAD). Platelet P-selectin expression, activated glycoprotein (GP) IIb/IIIa and monocyte-platelet aggregates (MPA) were assessed by flow-cytometry. Platelet aggregation was measured by light-transmission aggregometry (LTA) and multiple-electrode aggregometry (MEA). Von-Willebrand factor (VWF) antigen (VWF:Ag), VWF activity (VWF:Ac), and VWF multimer pattern analysis were determined. Soluble P-selectin (sP-selectin) was measured with an enzyme-linked immunoassay. P-selectin, GPIIb/IIIa and MPA levels in vivo and in response to arachidonic acid, adenosine diphosphate, and thrombin receptor activating peptide were similar between HM3 and HVAD (all p > .05). Likewise, agonist-inducible platelet aggregation by LTA and MEA did not differ between HM3 and HVAD (all p > .05). VWF:Ag levels and FVIII:C were similar between both systems (both p > .05), but patients with HVAD had significantly lower VWF:Ac (p = .011) and reduced large VWF multimers (p = .013). Finally, sP-selectin levels were similar in patients with HVAD and HM3 (p = .845). In conclusion, on-treatment platelet activation and aggregation are similar in HM3 and HVAD patients. Potential clinical implications of observed differences in VWF profiles between both LVAD systems need to be addressed in future clinical trials.

Introduction: Although anticoagulation therapy is mandated after implantation of a left ventricular assist device (LVAD), postoperative bleedings and reoperations occur relatively frequently and are associated with worse outcomes. We evaluated the use of a conservative postoperative anticoagulation protocol in patients implanted with a HeartMate 3 (HM3) LVAD. Methods: In a single-centre retrospective analysis of postoperative outcomes after HM3 LVAD implantation, a standard (old) anticoagulation protocol (i.e. early, full-dose anticoagulation with low-molecular weight heparin and overlapping vitamin K antagonist) was compared with a new conservative anticoagulation protocol (i.e. slow initiation of vitamin K antagonists without overlapping heparin). Main outcomes were changes in international normalised ratio (INR), lactate dehydrogenase (LDH), bleeding and/or tamponade events requiring reoperation, length of stay and adverse events. Results: In total, 73 patients (48 in old vs 25 in new protocol group) were evaluated. Mean age was 56 years (standard deviation 13) and most patients (78%) were males. Changes in INR and LDH in the first 14 days were similar in both groups (p = 0.50 and p = 0.997 for interaction, respectively). Number of bleeding/tamponade events requiring reoperation was lower in the new than in the old protocol group (4% vs 33%, p = 0.005). Postoperative 30-day mortality was similar, and we observed no thromboembolic events. Median (25th–75th percentiles) total length of postoperative hospital stay (27 (25–41) vs 21 (19–27) days, p < 0.001) and length of intensive care unit stay (5 (2–9) vs 2 (2–5) days, p = 0.022) were significantly shorter in the new protocol group. Conclusion: These retrospective data suggest that conservative slow initiation of anticoagulation therapy after HM3 LVAD implantation is associated with less bleeding/tamponade events requiring reoperation, a similar safety profile and a shorter duration of stay than the currently advised standard anticoagulation protocol. [ABSTRACT FROM AUTHOR]

Objectives: The HeartMate 3 (Abbott) left ventricular assist device provides substantial improvement in long-term morbidity and mortality in patients with advanced heart failure. The Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study compares thoracotomy-based implantation clinical outcomes with standard median sternotomy., Methods: We conducted a prospective, multicenter, single-arm study in patients eligible for HeartMate 3 implantation with thoracotomy-based surgical technique (bilateral thoracotomy or partial upper sternotomy with left thoracotomy). The composite primary end point was survival free of disabling stroke (modified Rankin score >3), or reoperation to remove or replace a malfunctioning device, or conversion to median sternotomy at 6-months postimplant (elective transplants were treated as a success). The primary end point (noninferiority, -15% margin) was assessed with >90% power compared with a propensity score-matched cohort (ratio 1:2) derived from the Multi-Center Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 continued access protocol., Results: The study enrolled 102 patients between December 2020 and July 2022 in the thoracotomy-based arm at 23 North American centers. Follow-up concluded in December 2022. In the Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study group, noninferiority criteria was met (absolute between-group difference, -1.2%; Farrington Manning lower 1-sided 95% CI, -9.3%; P < .0025) and event-free survival was not different (85.0% vs 86.2%; hazard ratio, 1.01; 95% CI, 0.58-2.10). Length of stay with thoracotomy-based implant was longer (median, 20 vs 17 days; P = .03). No differences were observed for blood product utilization, adverse events (including right heart failure), functional status, and quality of life between cohorts., Conclusions: Thoracotomy-based implantation of the HeartMate 3 left ventricular assist device is noninferior to implantation via standard full sternotomy. This study supports thoracotomy-based implantation as an additional standard for surgical implantation of the HeartMate 3 left ventricular assist device., Competing Interests: Conflict of Interest Statement Dr Gosev reports consulting for Abbott. Dr Pham reports consulting for Abbott, Abiomed, and Medtronic. Dr Itoh reports speaker honoraria from Abbott and Abiomed. Dr Kotkar is a speaker (nonfinancial) for Abiomed and 3M. Dr Naka reports consulting for Abbott, Biomet-Zimmer, Cryolife, and receiving speaker’s fees for Nipro Co. Dr Peltz reports research support from Bridge to Life Ltd and Paragonix Inc. Dr Silvestry reports consulting for Abbott, Abiomed, Medtronic, and data and safety monitoring board participation for Carmat. Dr Leacche reports consulting for Abbott and advisory board participation for Abiomed. Dr Rao reports consulting for Abbott, Medtronic, and Gore. Dr Sun reports consulting for Abbott. Dr Tedford reports consulting for Abbott, Medtronic, Aria CV Inc, Alleviant, Acorai, Acceleron, Cytokinetics, Itamar, Edwards LifeSciences, Eidos Therapeutics, Lexicon Pharmaceuticals, Gradient, and United Therapeutics. He is the national co-principal investigator for the RIGHT-FLOW clinical trial (Edwards), serves on steering committees for Merck, and a research advisory board for Abiomed. He also does hemodynamic core lab work for Merck. Dr Mokadam reports consulting for Abbott, Medtronic, SynCardia, Carmat, and Xylocor. Drs McNutt and Crandall are employees of Abbott. Dr Mehra reports payment made to institution from Abbott for consulting; consulting fees from Mesoblast, Janssen, Moderna, and Paragonix, and Baim Institute for clinical research; he is an advisory board member for Transmedics, NuPulseCV, Leviticus, and FineHeart. Dr Salerno reports consulting for Abbott. All other authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling manuscripts for which they may have a conflict of interest. The editors and reviewers of this article reported no conflicts of interest., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Significant variability in post-left ventricular assist device (LVAD) implantation outcomes emphasize the importance of accurately assessing patients' risk prior to surgery. This study assesses the MARKER-HF mortality risk model, a machine learning-based tool utilizing 8 clinical variables, to predict post-LVAD implantation mortality and its prognostic enhancement over the INTERMACS profile., Methods: Analyzing 25,365 INTERMACS database patients (mean age 56.8 years, 78% male), 5,663 (22.3%) and 19,702 (77.7%) received HeartMate 3 and other types of LVAD. They were categorized into low, moderate, high, and very high-risk groups based on MARKER-HF score. The outcomes of interest were in-hospital and 1-year post-discharge mortality., Results: In patients receiving HM3 devices, 6.2% died during index hospitalization. In-hospital mortality progressively increased from 4.4% in low to 15.2% in very high -risk groups with MARKER-HF score. MARKER-HF provided additional risk discrimination within each INTERMACS profile. Combining MARKER-HF score and INTERMACS profile identified patients with the lowest (3.5%) and highest in-hospital mortality (19.8%) rates. Post-discharge mortality rate at one year was 5.8% in this population. In a Cox-proportional hazard regression analysis adjusting for both MARKER-HF and INTERMACS profile, only MARKER-HF score (hazard ratio: 1.27, 95% CI: 1.11-1.46, P<0.001) was associated with post-discharge mortality. Similar findings were observed for patients receiving other types of LVAD., Conclusions: The MARKER-HF score is a valuable tool for assessing mortality risk in HF patients undergoing HM3 and other LVAD implantation. It offers prognostic information beyond that of the INTERMACS profile alone and it's use should help in the shared decision-making process for LVAD implantation., Competing Interests: Declaration of competing interest None, (Copyright © 2024. Published by Elsevier Inc.)

Objectives: We aim to evaluate our initial experience with the HeartMate 3 (HM3) device (Abbott, USA) for palliating pediatric patients with end-stage heart failure (ESHF)., Methods: We conducted a retrospective review of clinical data from pediatric patients (aged 7-18 years) who underwent HM3 implantation for ESHF at our institution between 2022 and 2024. Patient demographics and follow-up data were comprehensively analyzed., Results: We identified 11 patients (45% males) with a median age of 14 years (IQR 11-17), a median weight of 47 kg (IQR 28-50), a median height of 159 cm (IQR 135-165), and a median body surface area of 1.36 m 2 (IQR 1.07-1.53) at the time of the intervention. All patients were diagnosed with dilated cardiomyopathy and categorized with PEDIMACS profiles ranging from one to three. The median ICU stay was 14 days (IQR 6-32), with 11 patients receiving inotropic support for a median of four postoperative days (IQR 3-8). The median follow-up period was 150 days (IQR 90-210). Early complications included two cases of pleural effusion, 1 case of cardiac tamponade, 3 cases of polyuria, and one instance of positive blood cultures. One patient, who was non-compliant with warfarin therapy, developed a thrombus in the right atrium that was resolved with a revision of anticoagulant therapy, and did not experience pump thrombosis. During follow-up, one patient died after 28 days from sepsis, one underwent heart transplantation after 10 days, and nine patients remained alive on the device. Notably, there were no reported cases of pump thrombosis, ischemia, or stroke post- implantation., Conclusions: The HM3 device appears to be a safe and effective palliative option for pediatric patients with ESHF., 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., (© 2024 Doğan, Ulger Tutar, Tuncer, Levent, Engin, Yağdı, Atay and Özbaran.)

Background: End-stage heart failure is associated with high mortality. Recent developments such as the left ventricular assist device (LVAD) have improved patient outcomes. The HeartMate 3 LVAD is a novel centrifugal pump that was developed to provide hemodynamic support in heart failure patients, either as a bridge-to-transplant (BTT), myocardial recovery, or destination therapy (DT). Our objective was to evaluate the survival rates and LVAD-related complications of the HeartMate 3 LVAD before and after hospital discharge in our center., Methods: We retrospectively reviewed all patients implanted with the HeartMate 3 LVAD in our institute between September 2015 and June 2024. Patients who received a Heart Ware Ventricular Assist Device (HVAD) and HeartMate 2 LVAD devices were excluded. The primary endpoint was survival before and after hospital discharge. The secondary endpoints included an incidence of serious LVAD adverse events (bleeding, major infection, hemolysis, device thrombosis and malfunction, and neurological dysfunction) and the causes of re-admission along the follow-up period., Results: A total of 48 consecutive HeartMate 3 LVAD patients were enrolled in this study. The mean age was 56.1 ± 10.6 years. A total of 72.9% of patients received LVAD therapy as a BTT, 14.6% as DT, 10.4% as a bridge-to-decision, and 2.1% as a bridge-to-recovery. A total of 85.4% of patients were discharged after implantation. The main cause for in-hospital mortality was right ventricular failure (8.3%), followed by stroke, abdominal bleeding, and multi-organ failure (2.1% each). One patient (2.1%) had successful heart transplantation, 26 patients (63.4%) are still on LVAD support, and 11 (26.8%) patients have died during follow-up. The main cause of mortality after hospital discharge was sepsis, which occurred in 9.8% of patients, followed by right ventricular failure, non-LVAD-related causes, unknown causes with two (4.9%) cases each, and one case of fatal stroke (2.4%). During the follow-up, there was no need for LVAD replacement., Conclusions: HeartMate 3 LVAD is associated with excellent in-hospital survival rates in patients with end-stage heart failure. Right ventricular failure was the main cause of death before hospital discharge, whereas sepsis was the main cause of death after hospital discharge.

Heart transplant remains the gold standard treatment for patients with end-stage heart failure. However, given the limited availability of donor hearts, alternative approaches and strategies are required. The development of a variety of mechanical circulation support options, including left ventricular assist devices and total artificial heart, have allowed improved quality of life and eventually have facilitated a bridge to heart transplantation strategies for certain patients. However, the presence of an intracorporeal left ventricular assist device poses a technical challenge at the time of heart transplantation. In this video tutorial, we describe the surgical strategy and removal technique for a patient who had received a HeartMate 3 (Abbott, North Chicago, IL, USA) using a classic implantation technique via sternotomy, who underwent concomitant orthotopic heart transplant., (© The Author 2024. Published by MMCTS on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Competing Interests: Conflicts of Interest The following authors reported no actual or potential conflicts of interest in relation to this document: A.N., S.M.C., S.P.C., M.A.D., N.K.K., G.B.M., V.M., RF.S., B.X. The following authors reported relationships with one or more commercial interests: JD.E has participated as consultant to Abbott and Getinge and medical advisor to Medtronic; J.C. has received consulting fees from Boston Scientific and Abbott Vascular and has been a speaker for Medtronic, Circle Cardiovascular Imaging, and Siemens Healthineers; J.C. has participated as speaker and consultant to Abbott and Medtronic; B.D.H. has participated as speaker for Philips Medical; E.K. has participated as clinical consultant for Lantheus Medical Imaging.

Ejection Fraction (EF), a measure of the ability of the heart to pump blood, is an important parameter for the diagnosis for heart failure as well as in the monitoring of the therapy provided. The standard method of calculating EF uses the left ventricular volume (LVV) by identifying the end-diastolic and end-systolic volumes. For patients implanted with a continuous flow (CF) left ventricular assist devices (LVADs), there are two pathways for blood ejection, Trans-Aortic Valve Flow (TAVF) which is intermittent and Trans-VAD Flow (TVF) that flows continuously throughout the cardiac cycle. Using the standard method to calculate EF in LVAD patients provides the fraction of the total blood ejected from the ventricle over a cardiac cycle. When monitoring the patient for recovery, it is vital to quantify the precise contribution of the Trans-Aortic Valve path independently from the Trans-VAD contribution. In this paper we demonstrate how this can be accomplished with a mathematical lumped parameter model of the interaction of the cardiovascular system and the LVAD. We introduce the Trans-Aortic Valve Ejection Fraction (TAVEF), which is the measure of the Trans-Aortic Valve contribution to the overall circulation. The dilated failing heart is represented by an unimodal End-Sytolic Pressure Volume Relationship (ESPVR). Our results indicate that TAVEF describes the contribution of the TAVF better as compared to standard EF over the entire range of LVAD speeds, and captures the point of aortic valve closure by becoming 0, whereas the standard EF is non-zero. TAVEF can be a useful, reliable, non-invasive mechanism for monitoring ventricular recovery.

Purpose: The withdrawal of HVAD in 2021 created a concern for the pediatric population. The alternative implantable centrifugal blood pump HeartMate 3 has since been used more frequently in children. This paper analyses the outcome of children on LVAD support provided with an HVAD or HM3. Methods: A retrospective analysis of the EUROMACS database on children supported with VAD < 19 years of age from 1 January 2009 to 1 December 2021 was conducted. All patients with an LVAD and either an HVAD or HM3 were included. Patients with missing data on VAD status and/or missing baseline and/or follow up information were excluded. Kaplan–Meier survival analysis was performed to evaluate survival differences. Analyses were performed using Fisher’s exact test. Results: The study included 150 implantations in 142 patients with 128 implants using an HVAD compared to 28 implants using an HM3. Nine patients (6%) needed temporary right ventricular mechanical support, which was significantly higher in the HM3 group, with 25% (p: 0.01). Patients in the HVAD group were significantly younger (12.7 vs. 14.5 years, p: 0.01), weighed less (45.7 vs. 60 kg, p: 2, p: p: ns). A total of 123 children (86%) survived to transplantation, recovery or are ongoing, without differences between groups. In the HVAD group, 10 patients (8%) died while on support, whereas in 12% of HM3 patients died (p: 0.7). Conclusions: Survival in children implanted with an HM3 was excellent. Almost 90% were discharged and sent home on the device.