Left Ventricular Assist System Research Articles

P101: Feasibility Study of the Percutaneous Access Device for Long-Term LVAS Application

Background: Driveline infection (DLI) is a major chronic adverse event requiring re-hospitalization after durable left ventricular assist system (LVAS) implantation. The risk of DLI continues to rise over time and is associated with long-term mortality. Percutaneous access device (PAD) may be a potential technology to prevent DLI by the mechanical barrier interfaced with epidermal tissue. Methods: A prototype PAD was fabricated for the LVAS driveline and evaluated with two mini pigs for up to 69 days at the GLP facility. Test articles were implanted at the subcutaneous position on the left and right abdominal walls. After implant surgery, antibiotics were administered intravenously for three days for prophylactic purposes and discontinued unless there was any sign of infection. Skin and implanted PAD are showered weekly with warm water without any other disinfectant agent. Animals received humane care without restraints in the cage and were checked for general physical condition daily. The blood sample was collected at baseline, POD 7, 14, 28, and 69. Test Animals were euthanized, and articles and surrounding tissue samples were explanted en bloc for histopathology assessment. Results: Postoperative recovery was uneventful, and no remarkable organ dysfunction and no sign of infection were identified. A normal inflammatory response was observed on the skin a few days post-op but normalized within a week. Good tissue integrity was confirmed (no visible gap) around the interface between the test article and the skin without evidence of epidermal down growth and infection. Rich fibromatous tissue with keratin formation was confirmed. Conclusion: Initial feasibility of PAD for LVAS driveline was verified. Further design optimization will be required to finalize the clinical prototype before the pre-clinical GLP study.Figure 1. Upper left: Percutaneous access device tested (implanted to the test animal) Upper right: Close-up view of the skin interface Lower center: Histopathology of test article at subcutaneous tissue

The Effect of Artificial Pulsatility on the Peripheral Vasculature in Patients With Continuous-Flow Ventricular Assist Devices

BackgroundImplantation of left-ventricular assist systems (LVASs) has become the standard of care for advanced heart failure (HF). The absence of pulsatility in previous devices contributes to vascular and endothelial dysfunction related to atherosclerotic or vascular complications. We hypothesized that the artificial pulsatility provided by the HeartMate 3 (HM3) (Abbott, Chicago, IL) LVAS would exert a favourable effect on the vasculature. MethodsIn 32 patients implanted with HM3 (5 female patients, mean age 55 ± 13.6 years), the reactive hyperemia index (RHI) and peripheral augmentation index (AI), markers of endothelial function and arterial stiffness, were measured with an EndoPAT2000 before and in the third and sixth month after implantation. RHI and AI data from 30 HeartMate II (HM II) (Abbott) recipients in the third and sixth month after implantation, from 15 patients with advanced HF without LVASs and from 13 healthy volunteers were also analyzed. ResultsIn HM3 recipients, the mean RHI significantly decreased at 3 and 6 months after implantation. The RHI was substantially lower at baseline than that of healthy or the HF reference group. Increasing AI values, indicating worsening arterial stiffness, were also observed. Similar trends were observed in HM II recipients between the third and sixth months but with higher absolute values of RHI and AI. ConclusionsWe detected impaired vascular function in HM3 patients and provided additional evidence on the negative effect of low pulsatility on vascular function after LVAS implantation. The results suggest that the artificial pulsatility of the HM3 does not avert the progression of endothelial dysfunction.

A Comparative Analysis of Long-Term Outcomes in the MOMENTUM 3 Pivotal Trial and Continued Access Protocol Post-Approval Study Phase: A Study of over 1500 HeartMate 3 Implants

Purpose The MOMENTUM 3 pivotal trial conducted from 2014 to 2018 evaluated safety and effectiveness of the HeartMate 3 (HM3) left ventricular assist system (LVAS) compared to the HeartMate II pump. The trial demonstrated superiority of the HM3 LVAS for the primary endpoint of survival free of disabling stroke or reoperation to replace a malfunctioning pump at 2-years. HM3 LVAS superiority was due to improved hemocompatibility with near-elimination of device thrombosis, halving of stroke rates, and a decrease in gastrointestinal bleeding rates compared to the control device. Once enrollment for the pivotal trial was completed, and prior to FDA approval of the HM3 LVAS, the MOMENTUM 3 Continued Access Protocol (CAP) was initiated in 2016 as a single arm study to evaluate the HM3 LVAS in the post-approval phase using similar entry criteria as the pivotal trial. We plan to compare 2-year outcomes from the first 1000 CAP patients to the 515 patients implanted with HM3 in the pivotal trial. We hypothesize that clinical outcomes from the CAP cohort (post-approval phase) will be comparable or better to early results observed in the pivotal trial. Methods The MOMENTUM 3 CAP is a single arm, prospective study conducted at 68 centers that participated in the pivotal trial and designed as the post-approval study phase of the trial. Entry criteria for MOMENTUM 3 CAP matched those of the pivotal trial until FDA approval for short-term HM3 use was granted in August 2017. BTT patients were subsequently excluded from the CAP cohort starting in October 2017 and only transplant ineligible patients were enrolled afterwards. Baseline demographics and 2-year outcomes will be compared between the pivotal trial and CAP cohorts. The data lock will be performed in December 2020 with results available by March 2021. Endpoints These trial findings will include the first presentation of the largest comprehensive comparative analysis of long-term outcomes in over 1500 HM3 patients from the MOMENTUM 3 pivotal trial and CAP cohorts with respect to survival, adverse events, quality of life and functional status at 2 years. The findings will inform the field on whether “within trial” findings are preserved in the “post-approval” phase and account for temporal changes in medical and surgical management with the HM3 LVAS. (MOMENTUM 3 and CAP funded by Abbott)

Decreased RPM reduces von Willebrand factor degradation with the EVAHEART LVAS: implications for device-specific LVAD management.

Continuous-flow left ventricular assist devices (LVADs) produces supraphysiologic shear stress that causes von Willebrand factor (VWF) degradation and a bleeding diathesis. Reduction of revolutions per minute (RPM) with axial-flow LVADs does not decrease shear stress enough to reduce VWF degradation and bleeding. However, it is unknown if RPM reduction with centrifugal flow LVADs may minimize VWF degradation. We tested the hypothesis that RPM reduction preserves VWF multimers in the centrifugal-flow EVAHEART left ventricular assist system (LVAS), which is designed to minimize shear stress and blood trauma. Whole blood samples were collected from humans (n = 28). Blood was circulated in ex vivo mock circulatory loops for 6 hours with an EVAHEART LVAS at 2300 (n = 12), 2100 (n = 8), or 1800 RPM (n = 8). Immunoblotting was used to resolve and quantify VWF multimers and degradation fragments. RPM reduction from 2300 to 2100 to 1800 RPM significantly decreased EVAHEART blood flow from 5.8 ± 0.4 to 4.3 ± 0.6 to 4.1 ± 0.5 L/min (analysis of variance [ANOVA], P = .03). RPM reduction protected VWF from pathologic degradation. At lower RPMs, significantly greater levels of VWF multimers were observed (ANOVA, P = .001). Similarly, at lower RPMs, significantly fewer VWF fragments, a product of VWF degradation, were observed (ANOVA, P = .007). RPM reduction significantly reduced VWF degradation with the centrifugal-flow EVAHEART LVAS, an LVAD specifically designed with low shear stress. Different LVADs have unique hematologic footprints and should be managed with device-specific protocols. Adjustment of RPM to minimize blood trauma while still maintaining physiologic hemodynamics has the potential to decrease complications related to LVAD-associated von Willebrand's disease, such as gastrointestinal bleeding and hemorrhagic stroke.

The Unique Impact of Blood Type O on Gastrointestinal Bleeding with Left Ventricular Assist Systems

Acquired von Willebrand syndrome is implicated in the pathology of gastrointestinal bleeding (GIB) after implantation of continuous-flow left ventricular assist systems (CF-LVAS). Adults with blood type (BT) O have lower circulating levels of von Willebrand factor. In this analysis, we sought to explore the association between BT O and GIB following CF-LVAS implantation. We performed a single center, retrospective, observational cohort study in 200 consecutive adults implanted with a durable CF-LVAS over a 10-year period (2008-2018). Patients were grouped according to BT O (N = 97) vs Non-O (N = 103), and further stratified by the HAS-BLED score. Cumulative Kaplan-Meier event curves were constructed. Patients with at least 1 GIB event were generally older (60.8±10.1 vs 53.0±13.9 years, P <;0.001) and more likely to have chronic kidney disease (47.2 vs 23.8%, P = 0.001). Baseline characteristics were similar between BT groups. After a median follow-up of 10.4 months (IQR 2.7-18.4), univariate analysis showed no significant difference in rates of GIB by BT (HR, 1.23; 95% CI, 0.72-2.12) when unadjusted for bleeding propensity. However, among patients with a HAS-BLED score >;=3 (N = 87) the rates of GIB were significantly higher for BT O (HR, 2.36; 95% CI, 1.06-5.27; P = 0.036) (Figure). Our study suggests an important association of BT O with higher rates of GIB in CF-LVAS patients at high baseline risk for bleeding complications (HAS-BLED >;=3). These findings suggest that in this specific population characterized by BT O, a greater vigilance and targeted anticoagulation strategies may need to be investigated.

Infection-Related Morbidity with Continuous-Flow Left Ventricular Assist Systems: A Comprehensive Analysis of the Randomized MOMENTUM 3 Trial

The MOMENTUM 3 trial established superiority of a fully magnetically-levitated HeartMate 3 (HM3) centrifugal pump over the axial flow HeartMate II (HMII) pump on hemocompatibility-related outcomes. Infection-related outcomes were no different between the two devices. We sought to understand the types of infection, temporal trends, clinical correlates and risk markers over 2-years of support. MOMENTUM 3 randomized 1020 patients to either the HM 3 (515) or HM II (505) groups. Morbidity and mortality related outcomes were analyzed between patients with or without major infection complications. Cox regression analyses were utilized to identify characteristics associated with major infectious complications. The cumulative number of infections was 1213 (634 HM3 and 579 HMII), and major infection occurred in 58% HM3 and 56% HMII patients (p=0.57). Localized infections unrelated to pump components were most common (n=681/1213; 56%), followed by driveline infection (n=329/1213; 27%), sepsis (n=194/1213; 16%), and other events (n=9/1213; 0.7%). Bacterial pathogens were implicated in 806/1213 events (66%) and significant predictors of infection included gender (men vs. women; HR:0.73, p=0.003), BUN (HR:1.12, p=0.01), preimplant history of cardiac surgery (HR:1.28, p=0.01), and BMI≥30 (HR:1.43, p<0.0001). Most deaths in those with infection ultimately occurred due to non-infectious causes (Figure). Infection is the commonest adverse effect in patients implanted with contemporary continuous-flow pumps with most such events presenting as events unrelated to the pump components. Whether mechanical circulatory devices confer an immunosuppressive effect leading to propensity for infection warrants closer scrutiny to understand and ameliorate this morbidity. (Funded by Abbott; MOMENTUM 3 NCT02224755).

Long-Term Survival of Patients With Advanced Heart Failure Receiving an Left Ventricular Assist Device Intended as a Bridge to Transplantation: The Registry to Evaluate the HeartWare Left Ventricular Assist System.

The paucity of available hearts for transplantation means that more patients remain on durable left ventricular support for longer periods of time. The Registry to Evaluate the HeartWare Left Ventricular Assist System was an investigator-initiated multicenter, prospective, single-arm database established to collect post-Conformité Européene mark clinical information on patients receiving the HeartWare ventricular assist device system as a bridge to transplantation. This registry represents the longest multicenter follow-up of primary left ventricular assist device outcomes. Data were collected on 254 commercial implants performed between February 2009 and March 2012 from 9 centers in Europe (7) and Australia (2). Patients were followed to device explant, heart transplantation, or death. The outcomes of patients through July/August 2018 were analyzed. Summary statistics were used to describe patient demographics, adverse events, length of support, and outcomes for this extended-term cohort. A total of 122 patients were on support for >2 years, and 34 patients were on support for >5 years. Twenty nine patients are still alive on support (support ranging from 1213 to 3396 days), and 23 of those are on their original HeartWare ventricular assist device system. Kaplan-Meier survival through 7 years was 51%. Through 6 years, freedom from any stroke was 82%, while freedom from severely disabling stroke was 89%. Low rates of heart transplant now require longer periods of left ventricular assist device support in patients. This analysis demonstrates that long-term support using a HeartWare ventricular assist device system offers survival of 51% through 7 years.

Subcutaneous implantable cardioverter defibrillators in patients with left ventricular assist devices: case report and comprehensive review.

BackgroundLeft ventricular assist devices (LVAD) are increasingly used in patients with advanced heart failure, many of whom have been or will be implanted with an implantable cardioverter defibrillator (ICD). Interaction between both devices is a matter of concern. Subcutaneous ICD (S-ICD) obtains its signals through subcutaneous vectors, which poses special challenges with regards to adequate performance following LVAD implantation.Case summaryWe describe the case of a 24-year-old man implanted with an S-ICD because of idiopathic dilated cardiomyopathy, severe biventricular dysfunction, and self-limiting sustained ventricular tachycardias. After the implantation of a HeartMate 3™ (Left Ventricular Assist System, Abbott) several months later, the S-ICD became useless because of inappropriate sensing due to electromagnetic interference and attenuation of QRS voltage.DiscussionWe reviewed the reported cases in PubMed about the concomitant use of S-ICD and LVAD. Seven case reports about the performance of S-ICD in patients with an LVAD were identified, with discordant results. From these articles, we analyse the potential causes for these differing results. Pump location and operating rates in LVAD, as well as changes in the subcutaneous-electrocardiogram detected by the S-ICD after LVAD implantation are related to sensing disturbances when used in the same patient.

A Trial of Complete Withdrawal of Anticoagulation Therapy in the Heartmate 3 Pump

Summary of Objectives The HeartMate 3 Left Ventricular Assist System has demonstrated absence of confirmed de-novo pump thrombosis and reduction in stroke. However, bleeding related adverse events persist under standard anticoagulation targeting a INR range of 2.0-3.0. In an initial experience we demonstrated safety of transition to low intensity anticoagulation (INR target 1.5-1.9, n=15, follow up of at least 6 months). Whether complete cessation of anticoagulation maintains “thromboresistance” in the HeartMate 3 pump remains unknown. Methods We previously reported on a strategy of low-intensity warfarin anticoagulation in patients implanted with HeartMate 3 (J Heart Lung Transplant. 2018;37(5):579-586). Following completion of this study phase, a staged trial was approved by the single site's ethics committee and registered as NCT03704220. All patients enrolled in the low intensity warfarin study (target INR of 1.5-1.9) were considered eligible for enrollment in the “anticoagulation withdrawal” study, if they were continuing on long-term support. All patients had to meet safe eligibility criteria including pump speed reduction to facilitate aortic valve opening (to avoid root thrombus), absence of thrombus in the pre-pump cardiac system, and absence of signs of poor unloading at reduced device speed. Careful surveillance for pump thrombosis was algorithmically mandated with biomarker and serial pump log file analyses. If enrolled, they were withdrawn from warfarin therapy and followed for survival free of pump thrombosis, disabling stroke or major bleeding for at least 3 months as the primary safety end point. Endpoints Enrollment and follow up in the low intensity anticoagulation study has been reported (n=15); 13 men, mean age 57 years (18-72), with intended goal of therapy of either BTT or DT, INTERMACS Profile mean 3 (2-5), Cardiac Index mean 1.62 l/min/m2. Of 10 patients followed beyond 1 year on reduced anticoagulation, 5 patients have qualified for complete withdrawal of anticoagulation and the safety endpoint analysis will be completed prior to the ISHLT meeting in March 2019. This pivotal study is the first indication-independent anticoagulation withdrawal study in the HeartMate 3 designed to establish thrombo-resistance for the device and form the rationale for a large scale multicenter trial.

HeartMate 3 Surgical Implant Technique and Outcomes in the MOMENTUM 3 Trial

Purpose The HeartMate 3 (HM3) Left Ventricular Assist System is a fully magnetically levitated, centrifugal, continuous-flow pump. In the MOMENTUM 3 trial, the HM3 apical cuff could be attached with two different Methods Cut then Sew or Sew then Cut. This analysis describes the surgical techniques used in the trial and evaluates their impact on outcomes. Methods 189 patients in the Long Term (LT) cohort were implanted with the HM3 pump. Patients were divided into groups based on the technique used to attach the apical cuff at implant. Survival and adverse events at 2 years of follow-up were compared between the groups. The burden of hemocompatibility related adverse events (HRAE) was evaluated with a previously defined hemocompatibility score (Mehra. Eur Heart J. 2017). Continuous and categorical data were compared with the Wilcoxon rank sum and chi-square tests. The log-rank test was used to compare survival. This analysis will be updated to the 515 patients implanted with HM3 in the Full Cohort, which will be available in March 2019. Results 189 patients were implanted with HM3 by 68 surgeons at 52 centers. The median implant and bypass times were 261 and 83 minutes respectively. The majority of implants used the Cut then Sew apical attachment method (64%), true apical inflow cannula insertion (79%), silicone to skin driveline interface (90%), and right-sided driveline exit (54%). Cut then Sew was associated with longer median bypass times when compared to Sew then Cut (86 vs 77.5 minutes, p = 0.033). In the LT Cohort, there were no significant differences in 2-year survival between the groups (log-rank P=0.16). However, there was a trend for Cut then Sew to have a higher risk of stroke compared to Sew then Cut (Figure). Patients implanted with Cut then Sew vs Sew then Cut were also more likely to have a hemocompatibility score>1 (27% vs 15%, p=0.048). Conclusion We demonstrate that the Cut then Sew method used additional bypass time and may confer a higher stroke risk and HRAE net burden compared to Sew then Cut pump implantation technique.

Development of Multidisciplinary Anticoagulation Management Guidelines for Patients Receiving Durable Mechanical Circulatory Support.

Patients receiving durable mechanical circulatory support (MCS) require life-long anticoagulation with a vitamin K antagonist (VKA). Due to alternations in hemostasis, concomitant therapy with antiplatelet agents and critical illness, they are at increased risk of thromboembolic and bleeding complications compared with the general population managed on VKAs. To prevent thrombotic events, current guidelines recommend that patients with MCS receive long-term anticoagulation with a VKA to maintain a target international normalized ratio (INR) as specified by device manufacturers, but limited data exist regarding specific routine management of anticoagulation therapy and its potential complications. To optimize anticoagulation management and minimize risk in these patients, we have centralized anticoagulation management in a collaborative approach between the inpatient hemostatic and antithrombotic (HAT) stewardship service and between ambulatory anticoagulation management service (AMS) and the advanced heart disease team. Patients are followed by these three services beginning when the device is implanted and extending the duration that patients have the device. The teams include multiple clinicians from cardiac surgery, cardiology, hematology, pharmacy, nursing, case management, nutrition, and psychiatry, therefore, in order to standardize practice among clinicians without compromising patient centered decision making, we assembled an interdisciplinary team to create multiple treatment guidelines. In addition to a centralized and collaborative approach, our guidelines ensure seamless transitions of care between the inpatient and outpatient settings. We believe our approach has demontrated a positive improvement in the care of these challenging patients. In this article, we present our comprehensive centralized anticoagulation management approach for patients with left ventricular assist systems (LVAS).

Long-term evaluation of a fully magnetically levitated circulatory support device for advanced heart failure-two-year results from the HeartMate 3 CE Mark Study.

This study aimed to assess safety and outcomes of patients, 2 years after implantation with the HeartMate 3 Left Ventricular Assist System. This study included 50 adults with New York Heart Association (NYHA) class IIIB or IV symptoms or American College of Cardiology/American Heart Association stage D heart failure with an ejection fraction ≤25% and a cardiac index ≤2.2 L/min/m2 without inotropes, or inotrope-dependent with optimal medical management, or listed for heart transplant. The median duration of left ventricular assist device support was 694 days (range: 19-833 days). At baseline, cardiac index was 1.8 ±0.5 L/min/m2 , 58% of patients were receiving inotropes, and 92% were INTERMACS profiles 2-4. At 2 years, Kaplan-Meier survival was 74 ±6%, 5 (10%) patients were transplanted, and 32 patients (64%) remain with support. Adverse event rates include bleeding requiring surgery (16%), gastrointestinal bleeding (20%), driveline infection (24%), ischaemic stroke (16%), haemorrhagic stroke (8%), right heart failure (14%), and outflow graft thrombosis (2%). Notably, no haemolysis, pump thrombosis, or pump malfunction events occurred. At 2 years, 47% of patients remained in NYHA class I and 41% in NYHA class II (P <0.0001). From baseline to 2 years, the mean six-minute walk distance increased from 239 m to 347 m (P <0.0001), and the mean EQ-5D quality of life score improved from 48.2 to 70.6 (P < 0.0001). Two years post-HeartMate 3 implantation, results show expected and acceptable survival, enhanced haemocompatibility, improved patient functional status and quality of life. This corroborates the success of HeartMate 3 since its first-in-man implantation case in Germany. ClinicalTrials.gov: NCT02170363.

Stroke Patterns and Implications for Ventricular Functional Remodeling in Left Ventricular Assist Systems

Ischemic stroke-related complications (particularly in the right hemisphere) are frequently encountered with Left Ventricular Assist Systems (LVAS). The neuro-cardiac axis may influence ventricular remodeling. However it remains unknown if stroke patterns are related to ventricular remodeling after facilitated hemodynamic support with LVAS. We hypothesized that strokes occurring in the right hemisphere, within the insula region, may enhance left ventricular remodeling through unopposed activation of the left insular region.

Minimal AnticoaGulation EvaluatioN To aUgment heMocompatibility - The MAGENTUM 1 Study

The HeartMate 3 Left Ventricular Assist system (LVAS) has demonstrated enhanced hemocompatibility, with absence of de-novo pump thrombosis. However, clinically observed bleeding-related adverse events continue to remain significantly burdensome. We hypothesized that the enhanced hemocompatibility of the HeartMate 3 LVAS allows the safe use of decreased anticoagulation intensity, potentially decreasing bleeding-related adverse events.

Long-Term Durability Test for the Left Ventricular Assist System EVAHEART under the Physiologic Pulsatile Load.

The EVAHEART Left Ventricular Assist System (LVAS) was designed for the long-term support of a patient with severe heart failure. It has an original water lubrication system for seal and bearing and wear on these parts was considered one of its critical failure modes. A durability test focusing on wear was designed herein. We developed a mock loop, which generates a physiologic pulsatile flow and is sufficiently durable for a long-term test. The pulsatile load and the low fluid viscosity enable the creation of a severe condition for the mechanical seal. A total of 18 EVAHEART blood pumps completed 2 years of operation under the pulsatile condition without any failure. It indicated the EVAHEART blood pump had a greater than 90% reliability with a 88% confidence level. The test was continued with six blood pumps and achieved an average of 8.6 years, which was longer than the longest clinical use in Japan. The test result showed that no catastrophic, critical, marginal, or minor failures of the blood pump or their symptoms were observed. The seal performance was maintained after the test. Moreover, the surface roughness did not change, which showed any burn or abnormal wear occurred. The original water lubrication system equipped in EVAHEART LVAS prevent severe wear on the seal and the bearing, and it can be used in the bridge to transplant and destination therapy.

HeartMate 3 fully magnetically levitated left ventricular assist device for advanced heart failure: Initial Serbian experience

Introduction. As the waiting time for heart transplantation continues to increase due to shortage in organ donation, supporting patients with advanced heart failure with left ventricular assist device (LVAD) increases as well. The latest generation of LVAD, left ventricular assist system (LVAS) started to expand worldwide due to more promising outcomes. The aim of this article was to present the case of treating advanced heart failure in a patient who underwent implantation of HeartMate 3 LVAS as the bridge to transplantation. Case otline. The patient was a 59-year-old man with advanced heart failure requiring inotropic drug support, with ischemic cardiomyopathy as the underlying cause of heart failure. Therefore, in the absence of an adequate donor, it was decided to incorporate the LVAS as a bridge to transplantation. Functional capacity, cardiac, renal, and liver functions improved in the patient. Conclusion. The use of the HeartMate 3 in an advanced heart failure patient results in improvements in functional capacity, cardiac, renal and liver function. Further studies should be performed in order to identify whether improved outcomes are sustained with a longer follow-up period.

Four Factor Prothrombin Complex Concentrate for Anticoagulation Reversal in an LVAS Patient Undergoing Robotic Prostatectomy: A Case Report

Recipients of left ventricular assist system (LVAS) require long-term anticoagulation with warfarin to prevent thromboembolic complications. We discuss a successful case of the use of four factor prothrombin complex concentrate (4F-PCC) for temporary warfarin reversal in a patient with a HeartMate 3 LVAS requiring robotic assisted laparoscopic prostatectomy.

Quality of life and functional capacity outcomes in the MOMENTUM 3 trial at 6 months: A call for new metrics for left ventricular assist device patients

The Multicenter Study of MAGLEV Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) clinical trial demonstrated improved 6-month event-free survival, but a detailed analysis of health-related quality of life (HR-QOL) and functional capacity (FC) was not presented. Further, the effect of early serious adverse events (SAEs) on these metrics and on the general ability to live well while supported with a left ventricular assist system (LVAS) warrants evaluation. FC (New York Heart Association [NYHA] and 6-minute walk test [6MWT]) and HR-QOL (European Quality of Life [EQ-5D-5L] and the Kansas City Cardiomyopathy [KCCQ]) assessments were obtained at baseline and 6 months after HeartMate 3 (HM3, n = 151; Abbott, Abbott Park, IL) or HeartMate II (HMII, n = 138; Abbott) implant as part of the MOMENTUM 3 clinical trial. Metrics were compared between devices and in those with and without events. The proportion of patients "living well on an LVAS" at 6 months, defined as alive with satisfactory FC (NYHA I/II or 6MWT > 300 meters) and HR-QOL (overall KCCQ > 50), was evaluated. Although the median (25th-75th percentile) patient KCCQ (change for HM3: +28 [10-46]; HMII: +29 [9-48]) and EQ-5D-5L (change for HM3: -1 [-5 to 0]; HMII: -2 [-6 to 0]) scores improved from baseline to 6 months (p < 0.05), there were no differences between devices (p > 0.05). Likewise, there was an equivalent improvement in 6MWT distance at 6 months in HM3 (+94 [1-274] meters] and HMII (+188[43-340 meters]) from baseline. In patients with SAEs (n = 188), 6MWTs increased from baseline (p < 0.001), but gains for both devices were less than those without SAE (HM3: +74 [-9 to 183] meters with SAE vs +140 [35-329] meters without SAE; HMII: +177 [47-356] meters with SAE vs +192 [23-337] meters without SAE, both p < 0.003). SAEs did not affect the 6-month HR-QOL scores. The "living well" end point was achieved in 145 HM3 (63%) and 120 HMII (68%) patients (p = 0.44). Gains in HR-QOL and FC were similar early after HM3 and HMII implant. 6MWT improvements were attenuated in patients experiencing SAEs, but HR-QOL metrics did not change. The development of left ventricular assist device-specific HR-QOL tools is needed to better characterize the effect of SAEs on a patient's well-being. MOMENTUM 3 clinical trial #NCT02224755.

Screening for heart transplantation and left ventricular assist system: results from the ScrEEning for advanced Heart Failure treatment (SEE‐HF) study

Heart transplantation (HTx) and implantable left ventricular assist systems (LVAS) improve outcomes in advanced heart failure but may be underutilized. We hypothesized that screening can identify appropriate candidates. The ScrEEning for advanced Heart Failure treatment (SEE-HF) study was a multicentre prospective study screening patients with existing cardiac resynchronization therapy (CRT) and/or implantable cardioverter-defibrillator (ICD) for ejection fraction ≤40% and New York Heart Association (NYHA) class III-IV, and subsequently for guideline-based HTx and LVAS indication. Of 1722 (mean age 64 ± 14 years, 26% women) patients screened at eight centres in seven European countries, 121 (7.0%) were eligible and 99 (5.7%; mean age 61 ± 10 years, 19% women) patients were enrolled for detailed assessment. Twenty-six of the 99 enrolled patients (26%) were eligible for either HTx or LVAD (18 eligible for HTx; 7 eligible for LVAD; and 1 eligible for both). Eleven patients were listed for HTx and three received an LVAS. Eligible patients were 61 ± 8 years and 19% women, whereas those actually receiving intervention were 56 ± 8 years and 8% women. Among patients with CRT and/or ICD, a minority have NYHA class III-IV heart failure and ejection fraction ≤40%. Among these, however, more than one-quarter have an unrecognized need for HTx or LVAS. When patients are offered intervention based on screening, many decline. Discrepancies exist between clinical and patient equipoise. Clinical Trial Registration ClinicalTrials.gov Unique Identifier: NCT00894387.

O49-4 - Beneficial Effects of Early Cardiac Rehabilitation under Left Ventricular Assist System in a Patient with Peripartum Cardiomyopathy: Case Report

O49-4 - Beneficial Effects of Early Cardiac Rehabilitation under Left Ventricular Assist System in a Patient with Peripartum Cardiomyopathy: Case Report