HeartMate Left Ventricular Assist Device Research Articles

Unplanned hospital readmissions following HeartMate 3 implantation: Readmission rates, causes, and impact on survival.

Hospital readmissions following left ventricular assist device (LVAD) remain a frequent comorbidity, associated with decreased quality of life and increased resources utilization. This study sought to determine causes, predictors, and impact on survival of hospitalizations during HeartMate 3 (HM3) support. All patients implanted with HM3 between November 2014 to December 2019 at Columbia University Irving Medical Center were consecutively enrolled in the study. Demographics and clinical characteristics from the index admission and the first outpatient visit were collected and used to estimate 1-year and 900-day readmission-free survival and overall survival. Multivariable analysis was performed for subsequent readmissions. Of 182 patients who received a HM3 LVAD, 167 (92%) were discharged after index admission and experienced 407 unplanned readmissions over the median follow up of 727 (interquartile range (IQR): 410.5, 1124.5) days. One-year and 900-day mean cumulative number of all-cause unplanned readmissions was 0.43 (95%CI, 0.36, 0.51) and 1.13 (95%CI, 0.99, 1.29). The most frequent causes of rehospitalizations included major infections (29.3%), bleeding (13.2%), device-related (12.5%), volume overload (7.1%), and other (28%). One-year and 900-day survival free from all-cause readmission was 38% (95%CI, 31-46%) and 16.6% (95%CI, 10.3-24.4%). One-year and 900-day freedom from 2, 3, and ≥4 readmissions were 60.7%, 74%, 74.5% and 26.2%, 33.3%, 41.3%. One-year and 900-day survival were unaffected by the number of readmissions and remained >90%. Male sex, ischemic etiology, diabetes, lower serum creatinine, longer duration of index hospitalization, and a history of readmission between discharge and the first outpatient visit were associated with subsequent readmissions. Unplanned hospital readmissions after HM3 are common, with infections and bleeding accounting for the majority of readmissions. Irrespective of the number of readmissions, one-year survival remained unaffected.

Value of nutritional indices in predicting survival free from pump replacement and driveline infections in centrifugal left ventricular assist devices

ObjectiveThere is a paucity of data assessing the impact of nutritional status on outcomes in patients supported with the HeartMate 3 (HM3) left ventricular assist device (LVAD). MethodsPatients ≥18 years of age who underwent HM3 LVAD implantation between 2015 and 2020 were identified from a single tertiary care center. The primary outcome assessed was death or device replacement. A secondary outcome of driveline infection was also evaluated. Kaplan-Meier survival analysis and a multivariate Cox-proportional hazards model were used to identify predictors of outcome. ResultsOf the 289 patients identified, 94 (33%) experienced a primary outcome and 96 (33%) a secondary outcome during a median follow-up time of 2.3 years. Independent predictors of the primary outcome included peripheral vascular disease (hazard ratio [HR], 3.40; 95% confidence interval [CI], 1.66-6.97, P < .01), diabetes mellitus (HR, 0.46; 95% CI, 0.27-0.80, P < .01), body mass index ≥40 kg/m2 (HR, 2.63 per 1 kg/m2 increase; 95% CI, 1.22-5.70, P < .05), preoperative creatinine level (HR, 1.86 per 1 mg/dL increase; 95% CI, 1.31-2.65, P < .01), and preoperative prognostic nutritional index (PNI) score (HR, 0.88 per 1-point increase; 95% CI, 0.81-0.96, P < .01). Independent predictors of driveline infection included age at the time of implantation (HR, 0.97; 95% CI, 0.96-0.99, P < .01) and diabetes mellitus (HR, 1.79; 95% CI, 1.17-2.73, P < .01). ConclusionsPreoperative PNI scores may independently predict mortality and the need for device replacement in patients with HM3 LVAD. Routine use of the PNI score during preoperative evaluation and, when possible, supplementation to PNI >33, may be of value in this population.

HeartMate 3 implantation with an emphasis on the biventricular configuration.

Right ventricular failure following implantation of a durable left ventricular assist device (LVAD) is a major driver of mortality. Reported survival following biventricular (BiVAD) or total artificial heart (TAH) implantation remains substantially inferior to LVAD alone. We report our outcomes with LVAD and BiVAD HeartMate 3 (HM3). Consecutive patients undergoing implantation of an HM3 LVAD between November 2014 and December 2021, at The Alfred, Australia were included in the study. Comparison was made between the BiVAD and LVAD alone groups. A total of 86 patients, 65 patients with LVAD alone and 21 in a BiVAD configuration underwent implantation. The median age of the LVAD and BiVAD groups was 56 years (Interquartile range 46-62) and 49 years (Interquartile range 37-55), respectively. By 4 years after implantation, 54% of LVAD patients and 43% of BiVAD patients had undergone cardiac transplantation. The incidence of stroke in the entire experience was 3.5% and pump thrombosis 5% (all in the RVAD). There were 14 deaths in the LVAD group and 1 in the BiVAD group. The actuarial survival for LVAD patients at 1 year was 85% and BiVAD patients at 1 year was 95%. The application of HM 3 BiVAD support in selected patients appears to offer a satisfactory solution to patients requiring biventricular support.

Gender and Race Differences in HeartMate3 Left Ventricular Assist Device as a Bridge to Transplantation

Gender and Race Differences in HeartMate3 Left Ventricular Assist Device as a Bridge to Transplantation

Gastrointestinal bleeding following Heartmate 3 left ventricular assist device implantation: The Michigan Bleeding Risk Model

BackgroundGastrointestinal 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. MethodsThe study population included all adult HeartMate 3 (HM3) primary LVAD recipients enrolled in the STS-Intermacs registry from January 2017-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 pre-implantation factors. ResultsOf 6425 patients who received a HM3 LVAD, 1010 (15.7%) patients experienced GIB. Thirteen pre-implantation 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. Experiencing one post-LVAD GIB event was associated with an increased risk for further GIB events, with 33.9% of patients experiencing at least one recurrence. While post-LVAD GIB was associated with mortality, there was no relationship between number of GIB events and death. ConclusionThe Michigan Bleeding Risk Model is a simple tool which facilitates the prediction of post-LVAD GIB in HM3 recipients, by using 13 pre-implant variables. The implementation of this tool may help in the risk stratification process and may have therapeutic and clinical implications in HM3 LVAD recipients.

A multicenter evaluation of the HeartMate 3 risk score

BackgroundThe Heartmate 3 (HM3) risk score (HM3RS) was derived and validated internally from within the MOMENTUM 3 trial population and provides 1- and 2-year mortality risk prediction for patients in those prior to HM3 left ventricular assist device (LVAD) implantation. We aimed to evaluate the HM3RS in non-trial unselected patients, including those not meeting inclusion criteria for MOMENTUM 3 trial enrollment. MethodsPatients who underwent HM3 LVAD implant at one of 7 US centers between 2017-2021, 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 (ROC) 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. ResultsOf 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 post-implant (80% vs 78%; P=0.39). For the total cohort, HM3RS predicted 1-year survival with an AUC of 0.63 (95% 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). ConclusionIn this real-world evidence, multi-center 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.

Comparing 3-year survival and readmissions between HeartMate 3 and heart transplant as primary treatment for advanced heart failure

ObjectiveTo compare 3-year survival and readmissions of patients who received the HeartMate 3 (HM3) left ventricular assist device (LVAD) or underwent orthotopic heart transplantation (OHT) as primary treatment for advanced heart failure. MethodsWe retrospectively analyzed 381 adult patients who received an HM3 LVAD or were listed for OHT between January 2014 and March 2021 at our center. To minimize crossover bias, OHT recipients with a prior LVAD were excluded, and HM3 patients were censored at the time of transplant. Cohorts were propensity score–matched to reduce confounding variables. The primary outcome was 3-year survival, and the secondary outcome was mean cumulative all-cause unplanned readmission. ResultsThe study population comprised 185 HM3 patients (49%) and 196 OHT patients (51%), with 104 propensity score–matched patients in each group. After propensity score matching, there was no statistical difference in 3-year survival (83.7% for HM3 vs 87.0% for OHT; P = .91; relative risk [RR], 1.00; 95% confidence interval [CI], 0.45-2.20). In the unmatched cohorts, patients age 18 to 49 years had comparable survival with HM3 and OHT (96.9% vs 95.9%; N = 91; P = 1.00; RR, 0.92; 95% CI, 0.09-9.78). Patients age 50+ years had slightly inferior survival with HM3 (75.0% vs 83.9%; N = 290; P = .60; RR, 1.51; 95% CI, 0.85-2.68). The mean number of readmissions at 3 years was higher in the HM3 group (3.89 vs 2.05; P < .001). ConclusionsThis exploratory analysis suggests that for similar patients, HM3 may provide comparable 3-year survival to OHT as a primary treatment for heart failure but may result in more readmissions.

The Hemodynamic Effects of Aortic Regurgitation in Patients Supported by a HeartMate 3 Left Ventricular Assist Device

Aortic regurgitation (AR) is a common complication following left ventricular assist device (LVAD) implantation. We evaluated the hemodynamic implications of AR in patients with HeartMate 3 (HM3) LVAD at baseline and in response to speed changes. Clinically stable outpatients supported by HM3 who underwent a routine hemodynamic ramp test were retrospectively enrolled in this analysis. Patients were stratified based on the presence of at least mild AR at baseline speed. Hemodynamic and echocardiographic parameters were compared between the AR and non-AR groups. Sixty-two patients were identified. At the baseline LVAD speed, 29 patients (47%) had AR, while 33 patients (53%) did not. Patients with AR were older and supported on HM3 for a longer duration. At baseline speed, all hemodynamic parameters were similar between the groups including central venous pressure, pulmonary capillary wedge pressure, pulmonary arterial pressures, cardiac output and index, and pulmonary artery pulsatility index (p > 0.05 for all). During the subacute assessment, AR worsened in some, but not all, patients, with increases in LVAD speed. There were no significant differences in 1-year mortality or hospitalization rates between the groups, however, at 1-year, ≥ moderate AR and right ventricular failure (RVF) were detected in higher rates among the AR group compared to the non-AR group (45% vs. 0%; p < 0.01, and 75% vs. 36.8%; p = 0.02, respectively). In a cohort of stable outpatients supported with HM3 who underwent a routine hemodynamic ramp test, the presence of mild or greater AR did not impact the ability of HM3 LVADs to effectively unload the left ventricle during early subacute assessment. Although the presence of AR did not affect mortality and hospitalization rates, it resulted in higher rates of late hemodynamic-related events in the form of progressive AR and RVF.

First In-Man Experience With TricValve Transcatheter Bicaval Valve System in Left Ventricular Assist Device Heartmate II Patient for High-Risk Tricuspid Regurgitation.

HomeCirculation: Heart FailureAhead of PrintFirst In-Man Experience With TricValve Transcatheter Bicaval Valve System in Left Ventricular Assist Device Heartmate II Patient for High-Risk Tricuspid Regurgitation No AccessCase ReportRequest AccessAboutView PDFSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplemental MaterialNo AccessCase ReportRequest AccessFirst In-Man Experience With TricValve Transcatheter Bicaval Valve System in Left Ventricular Assist Device Heartmate II Patient for High-Risk Tricuspid Regurgitation Karthic Chandran, Ashleigh Long, Jennifer Bishop, Peter Berman, Fadi Matar, Guilherme H. Oliveira and Hiram G. Bezerra Karthic ChandranKarthic Chandran https://orcid.org/0000-0002-5476-2452 Department of Cardiovascular Sciences, University of South Florida Morsani College of Medicine, Tampa (K.C., A.L., J.B., F.M., G.H.O., H.G.B.). Search for more papers by this author , Ashleigh LongAshleigh Long Department of Cardiovascular Sciences, University of South Florida Morsani College of Medicine, Tampa (K.C., A.L., J.B., F.M., G.H.O., H.G.B.). Search for more papers by this author , Jennifer BishopJennifer Bishop https://orcid.org/0000-0003-3676-8743 Department of Cardiovascular Sciences, University of South Florida Morsani College of Medicine, Tampa (K.C., A.L., J.B., F.M., G.H.O., H.G.B.). Minimally Invasive Valve Program, Tampa General Hospital Heart and Vascular Institute, FL (J.B., P.B.). Search for more papers by this author , Peter BermanPeter Berman Minimally Invasive Valve Program, Tampa General Hospital Heart and Vascular Institute, FL (J.B., P.B.). Search for more papers by this author , Fadi MatarFadi Matar https://orcid.org/0000-0002-5064-0052 Department of Cardiovascular Sciences, University of South Florida Morsani College of Medicine, Tampa (K.C., A.L., J.B., F.M., G.H.O., H.G.B.). Search for more papers by this author , Guilherme H. OliveiraGuilherme H. Oliveira Department of Cardiovascular Sciences, University of South Florida Morsani College of Medicine, Tampa (K.C., A.L., J.B., F.M., G.H.O., H.G.B.). University of South Florida/Tampa General Hospital Heart and Vascular Institute (G.H.O.). Search for more papers by this author and Hiram G. BezerraHiram G. Bezerra Correspondence to: Hiram G. Bezerra, MD, PhD, Department of Cardiology, University of South Florida, 2 Tampa General Cir, Tampa, FL 33603. Email E-mail Address: [email protected] https://orcid.org/0000-0001-8973-2440 Department of Cardiovascular Sciences, University of South Florida Morsani College of Medicine, Tampa (K.C., A.L., J.B., F.M., G.H.O., H.G.B.). Tampa General Hospital Interventional Cardiology Center of Excellence, FL (H.G.B.). Search for more papers by this author Originally published6 Jun 2023https://doi.org/10.1161/CIRCHEARTFAILURE.122.010027Circulation: Heart Failure. 2023;0:e010027FootnotesFor Sources of Funding and Disclosures, see page XXX.Supplemental Material is available at https://www.ahajournals.org/doi/suppl/10.1161/CIRCHEARTFAILURE.122.010027.Correspondence to: Hiram G. Bezerra, MD, PhD, Department of Cardiology, University of South Florida, 2 Tampa General Cir, Tampa, FL 33603. Email [email protected]edu Previous Back to top Next FiguresReferencesRelatedDetails Advertisement Article InformationMetrics © 2023 American Heart Association, Inc.https://doi.org/10.1161/CIRCHEARTFAILURE.122.010027PMID: 37278243 Originally publishedJune 6, 2023 PDF download Advertisement SubjectsCardiomyopathyHeart FailureValvular Heart Disease

CARC13: Evaluation of Response to Aspirin Platelet Therapy and Hemocompatibility-Related Adverse Events with the HeartMate 3 Left Ventricular Assist Device

Background: Left ventricular assist device (LVAD) patients usually are prescribed a combination of anticoagulation and aspirin (ASA) therapy. HeartMate 3 (HM3) demonstrates reduced hemocompatibility-related adverse events (HRAEs) including stroke, thrombosis and bleeding. However, it’s not known whether ASA responders vs. non-responders are non-inferior in the incidence of HRAEs, and whether there are temporal changes in ASA sensitivity during HM3 support. Methods: This prospective, observational, single-center cohort study included 21 HM3 LVAD patients (Age: 59.0±11.1 years, female: 4.8%, BMI: 29.6±6.1kg/m2) implanted between 2019 and 2021, with serial ASA platelet sensitivity assays (VerifyNow Assay). ASA platelet therapy resistance was defined by ASA reactivity units (ARU) > 550. Primary endpoint was the incidence of HRAEs (ASA responders vs. non-responders) 6 months before initial assessment and until the next outpatient follow-up visit (3 months ± 30 days). Secondary endpoint was the temporal change in ASA resistance. Results: Eight (38.1%) patients were ASA resistant at the first ARU assessment (426 days after HM3 implantation) and 21.1% (p=0.38) during follow-up, without ARU changes over time (512±64 vs. 491±53, p=0.22). ASA responders and non-responders received a comparable ASA daily dose per-protocol (108±28mg vs. 100±28mg, p=0.43), without significant differences in baseline demographics (age: 62±9 vs. 55±14 years, p=0.17; female: 0% vs. 12.5%, p=0.38; BMI: 29±7 vs. 32±3, p=0.55; ischemic heart failure: 46.2% vs. 25.0%, p=0.45) or risk factors (Atrial fibrillation: 30.8% vs. 25.0%, diabetes: 30.8% vs. 37.5% and stroke history: 15.4% vs. 12.5%, p>0.99). The incidence of HRAEs was comparable between ASA responders and non-responders 6 months before the first measurement (15.4% vs. 0.0%, p=0.26) and between the two ARU measurements (0.0% vs. 12.5%, p=0.22). Conclusion: Although the ASA resistance varies considerably between LVAD outpatients, without significant changes over time, the HM3 demonstrated excellent hemocompatibility. Further large-scale multicenter studies are needed to confirm the findings of this study that ASA plays only a minor role in antithrombotic treatment with HM3 and can be safely removed.

SHOCK5: Utilization of an RP Flex Impella to support Right Ventricular Dysfunction post Left Ventricular Assist Device Placement

Background: Right ventricular dysfunction (RVD) during Left Ventricular Assist Device (LVAD) placement is associated with increased morbidity and mortality. Right Ventricular Assist Device (RVAD) implantation has been shown to reduce the severity of RVD and can improve overall outcomes. We describe the first use of the RP Flex Impella (Abiomed, Danvers MA) RVAD to support RVD during durable LVAD HeartMate 3 implantation(Abbott, Chicago, IL). Case: A 68 year old female with a history of postpartum cardiomyopathy on home inotropic support for 4 years presented with acute exacerbation of heart failure in the setting of sustained ventricular tachycardia. She was evaluated for LVAD however preoperatively there were concerns for risk of RVD due to pulmonary artery pressure index (PAPI) 1.5 and echocardiogram with moderate right ventricular (RV) dilation and significantly reduced function which had progressed as compared to prior assessments. It was decided during the pre implant meeting to support the RV given borderline parameters despite high dose inotropic support. The RP flex impella was placed via the right internal jugular vein and provided 2.8L support. A sodium bicarbonate purge was utilized instead of heparin due to bleeding concerns. By postoperative day (POD) 1 epinephrine and inhaled nitric oxide were successfully titrated down to facilitate early extubation and systemic heparin was started with a goal PTT 50-60 along with aspirin 81mg. Central venous pressure (CVP) remained 8-12mmHg with PAPI 1.2-1.9 over the next few days. RV function on echo remained mildly reduced and LVAD parameters and hemodynamics were stable. Based on the ability to wean inotropes with stable hemodynamics, formal wean occurred on POD4 with reduction to 1.5L flow. Hemodynamics remained unchanged with CVP 10, PA 30/15, PAPI 1.5. Low dose milrinone remained for RV support and the Impella was removed POD 5 at bedside without complication. Post removal RV dilation and drop in PIs resulted in iNO therapy, which was quickly transitioned to sildenafil. Inotropes were fully weaned off POD 12 and the patient was discharged to acute rehab on POD 16 off inotropes and on sildenafil. Throughout this course, renal function remained within the patient’s normal range and the patient was ambulatory from POD 6. Conclusion: This experience describes the first use of RP flex impella to support RVD during durable LVAD placement. The RP flex impella offers a small, percutaneous option for RV support with ease of use and easy bedside removal due to small sheath size. Early use of the RP flex, preventing further sequelae of RVD allowed for adequate support, bypassing the need for surgical RVAD and thus a shorter recovery than traditionally required. Additionally this case adds to the growing literature of RVAD utilization to improve outcomes in patients with marginal RV function for a successful durable LVAD.

Incidence and clinical correlates of de-novo aortic regurgitation with a fully magnetically levitated left ventricular assist device: a MOMENTUM 3 trial portfolio analysis.

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). 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. 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 occurrenceof significant de-novo AR with the HM3 pump is not associated with a worse outcome at 2 years of follow-up.

Abstract 15267: LV Aneurysm Rupture - Dreaded Complication in an LVAD Patient

Introduction: Left ventricular (LV) aneurysm rupture is a highly fatal mechanical complication, usually seen following a myocardial infarction. We describe a unique case of a patient with a left ventricular assist device (LVAD) who presented with cardiac arrest due to an LV aneurysm rupture. Case: A 57-year-old male with history of ischemic cardiomyopathy status post HeartMate3 (HM3) LVAD presented as an out of hospital cardiac arrest. Following resuscitation, Computed Tomography Angiography (CTA) of the chest showed a large long-standing aneurysm along the inferior wall of the LV measuring 2.9 x 3.3 x 3.5 cm with rupture dissecting the pericardium and extending to cause hemo-peritoneum (Figure1), not amenable to intervention. He had presented earlier in the month with anemia that stabilized with transfusion. Abdominal imaging at the time showed a contained bleed with unknown source. He had likely suffered a progressive bleed from the rupture leading to his cardiac arrest. Decision Making: Pseudoaneurysm has been reported as a rare complication with earlier generation LVADs, but to our knowledge, this is the first reported case of an aneurysm formation with rupture with an HM3 LVAD. Conclusions: With the advent of advanced mechanical support devices, there is a heightened need for awareness and cognizance of diagnosing such mechanical complications in this patient population. An early diagnosis requires a high clinical index of suspicion and a multi-disciplinary approach. Multimodality imaging including CT scan can assist with this diagnosis.

Prediction of Survival After Implantation of a Fully Magnetically Levitated Left Ventricular Assist Device

BackgroundClinical trials inform on average efficacy, but individualized risk assessments for outcome prediction are important in guiding treatment implementation. ObjectivesThe authors developed and validated a patient-specific risk score to predict survival at 1 and 2 years after HeartMate 3 (HM3) left ventricular assist device (LVAD) implantation. MethodsThe MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3) trial includes 2,200 HM3 LVAD patients in the pivotal trial and Continued Access Protocol study (2014-2018). The authors randomly assigned all patients to a derivation cohort (n = 1,540) or validation cohort (n = 660). Univariate mortality predictors were screened for potential model inclusion, stepwise selection was used to build the multivariable Cox proportional hazards regression model, and performance (discrimination and calibration) was evaluated. ResultsAge, prior cardiac surgery (coronary artery bypass grafting [CABG] or valve procedure), lower serum sodium, higher blood urea nitrogen (BUN), small left ventricular size, and right atrial pressure-to-pulmonary capillary wedge pressure (RAP/PCWP) ratio >0.6 were significant risk factors for mortality. Receiver-operating characteristic (ROC) analysis in the validation cohort demonstrated an area under the curve (AUC) of 0.76 (95% CI: 0.70-0.81) at 1 year and 0.71 (95% CI: 0.66-0.77) at 2 years. Calibration between predicted and observed survival of the risk quintiles was high, with Pearson correlation coefficients of 0.986 and 0.994 at 1 and 2 years, respectively. Patients were successfully stratified into tertiles with higher-than-average, average, and lower-than-average survival, and observed mortality risk increased by 2-fold from one tertile to the next. ConclusionsA practical, easy-to-use HM3 Survival Risk Score with 6 components was developed to accurately predict 1- and 2-year survival after HM3 LVAD implantation. The survival risk score can be used to provide individual survival estimates to facilitate shared decision making when considering HM3 LVAD therapy. (MOMENTUM 3 Trial Portfolio; NCT02224755, NCT02892955)

Outcomes in Patients With HeartMate3 Versus HeartWare Ventricular Assist Device Implanted as Destination Therapy

Donor organ shortage caused a growing interest in mechanical circulatory support not only as a bridge to transplant but also as a destination therapy. Improved results and increased applicability and durability of left ventricular assist devices (LVADs) have established this treatment option as an alternative for patients with end-stage heart failure. The aim of the study was to compare the early results, major complications, and the follow up of all patients undergoing HeartMate3 (HM3) LVAD and HeartWare Ventricular Assist Device (HVAD) system implantation in one of the most experienced Clinic in Poland between 2015 and 2020. There were 78 individuals (72 male, 92%; 6 female, 8%), with median age 57 years (range, 50-62 years). Until 2020 we implanted 47 (60%) HVADs and 31 (40%) HM3 LVADs. Patient characteristics were comparable between both groups apart from median left ventricle diameter (8.2 cm [range, 7.4-8.4 cm] in HM3 group vs 7.2 cm [range, 6.7-7.9 cm] in HVAD group; P < .01) The overall survival was 53.2% in the HVAD group and 77.4% in the HM3 group (P =.03). Mean survival time was higher in HM3 group (2.97 years [range, 2.43-3.5 years] vs 2.51 years [range, 1.94-3.08 years]; P < .05). Mean complication-free survival time was also higher in the HM3 group (2.16 years [range, 1.55-2.76] vs 1.61 [range, 1.16-2.06 years]; P < .05), with overall complication-free rate of 54.8% for HM3 vs 29.8% for HVAD (P=.27). Median hospitalization time was comparable (31 days [range, 25-39 days] in the HM3 group vs 32 days [range, 24-38 days] in the HVAD group; P=.49). Patients supported with the HM3 had significantly fewer major complications than HVAD. Moreover, the HVAD was associated with higher mortality.

Conservative initial postoperative anticoagulation strategy after HeartMate3left ventricular assist device implantation.

IntroductionAlthough 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.MethodsIn 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.ResultsIn 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.ConclusionThese 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.Supplementary InformationThe online version of this article (10.1007/s12471-022-01671-1) contains supplementary material, which is available to authorized users.

Warfarin Discontinuation in Patients with HeartMate3 Left Ventricular Assist Device

<h3>Purpose</h3> The standard of care for management in patients with Heartmate 3 (HM3) left ventricular assist devices (LVAD) involves anticoagulation with warfarin for thromboprophylaxis. To date, there have been no major prospective studies that evaluate outcomes of patients with HM3 LVAD off anticoagulation. We aimed to review cases of patients with HM3 LVAD in which warfarin was discontinued for various reasons. <h3>Methods</h3> A multicenter retrospective review was done of patients implanted with a HM3 LVAD. Patients who were initially on anticoagulation after implantation but later discontinued were identified. The primary outcome evaluated was the presence of a pump related thrombotic adverse event defined as pump thrombosis, stroke, or systemic embolism. Additional characteristics including echocardiographic parameters, hematologic lab values, and LVAD parameters were assessed. <h3>Results</h3> A total of eight patients were identified at three advanced heart failure centers. LVAD therapy was implemented for a median of 556 days (67-1113 days, range). Warfarin was discontinued in five patients due to substantial bleeding (recurrent GI bleeds, intracranial bleeds/subdural hematoma) and discontinued in the other three patients due to self-discontinuation/non-adherence. Warfarin was discontinued for a median of 180 days (43-567 days, range). Of the identified patients, 50% of the patients were not on aspirin. None of the patients reviewed had pump related thromboembolic or thrombotic events after discontinuing warfarin. One patient died due to cirrhosis and right ventricular failure. There was no observed change in echocardiographic parameters, lab values, or LVAD parameters after cessation of warfarin. <h3>Conclusion</h3> In this multicenter case review, warfarin discontinuation in patients with HM3 LVAD did not result in an increase of pump related thrombotic events. In select cases, it is reasonable to discontinue anticoagulation however close monitoring is required. Further investigation is required to understand the long term safety and hemocompatibility of discontinuing anticoagulation in patients with HM3 LVAD.

A Multi-Center Evaluation of Outflow Graft Obstruction with a Fully Magnetically Levitated Left Ventricular Assist Device

<h3>Purpose</h3> The HeartMate3 (HM3) left ventricular assist device (LVAD) has markedly improved hemocompatibility related adverse outcomes. In sporadic cases, external compression of the outflow graft causing obstruction (eOGO) can result from gelatinous substance accumulation between outflow graft and its bend relief covering. We sought to evaluate the prevalence, temporal course and clinical implications of eOGO with the HM3 LVAD in a global cohort study. <h3>Methods</h3> A Multi-center retrospective analysis was conducted among 2014 HM3 LVAD patients across 16 cardiac centers in 8 countries (between 11/2014 and 4/2021). Presence of eOGO was defined as >25% of cross-sectional area identified by established imaging (percutaneous angiography, computed tomography or intravascular ultrasound). The prevalence and annual incidence were calculated. Serious adverse events and outcome (death, transplant or device exchange) at the end of the study were analyzed for those eOGO cases that required therapy versus those who were observed. <h3>Endpoints</h3> Among 2014 patients, 61 patients were diagnosed with eOGO at a median LVAD support duration of 1024 [IQR: 636-1409] days. The overall prevalence of eOGO was at 3.0 %. The incidence at 1, 2, 3, 4, and 5 years on support was 0.6, 2.8, 4.1, 4.6 and 9.8 %. Of 52 patients, who required a therapeutic intervention, 26 underwent surgical revision, 16 patients were treated by percutaneous stent implantation, 8 underwent urgent heart transplantation and 2 died before intervention. In 9 patients a watchful waiting strategy without treatment was chosen. The mortality among those requiring therapeutic intervention was 9 of 52 (17.3%). This global multicenter cohort study suggests that while rare, HM3 LVAD supported patients may develop eOGO with an increasing incidence after 1 year on support. While targeted engineering efforts to alleviate this complication are underway by addressing early detection as well as outflow graft and bend relief design, clinicians must remain vigilant to this complication, especially in long-term survivors supported with the HM3 LVAD.

Successful Thrombolytic Therapy in a Suspected Case of HeartMate 3 LVAD Thrombosis

IntroductionAlthough less common with the HeartMate 3 (HM3), pump thrombosis remains a life-threatening complication of durable left ventricular assist devices (LVAD). We present what we believe is the first case of suspected pump thrombosis in a patient with a HM3 LVAD that was successfully managed with tissue plasminogen activator (tPA).Case ReportA 22-year-old man who underwent HM3 implantation for end stage heart failure due to left ventricular non-compaction presented after experiencing two low flow alarms. His physical examination was notable for tachycardia at 125 beats per minute and an elevated Doppler mean blood pressure of 92 mm Hg. LVAD interrogation revealed low flows without power spikes (Figure 1A). Within 24 hours, he developed persistent hypotension requiring vasopressor support and multiple low flow alarms. Serial laboratory results were notable for rising LDH, peaking at 4,741 U/L and acute liver injury with AST 2,712 U/L, ALT 798 U/L and INR 5.2. Transthoracic echocardiography and computed tomography (CT) angiography did not reveal any obvious thrombus. Given this constellation of findings, pump thrombosis was suspected. Following multidisciplinary discussion, unfractionated heparin bolus and infusion were started. After an unremarkable head CT, heparin was stopped and systemic tPA was given at a dose of 5 mg over one minute followed by 10 mg over 10 minutes due to ongoing liver dysfunction. Heparin was resumed after PTT returned to therapeutic range. Immediately post tPA infusion, his LVAD flows improved from 2.3 L/min to 4.1 L/min (Figure 1B). Vasopressor support was quickly weaned. LDH, creatinine, and liver enzymes improved over the following days. Warfarin was resumed on day 14 of admission. He was discharged on aspirin, clopidogrel and warfarin.SummaryThrombolytics may be a potential therapeutic option in select cases of HM 3 pump thrombosis. Further research is warranted to delineate LVAD parameters that facilitate early recognition of pump thrombosis and successful medical management. Although less common with the HeartMate 3 (HM3), pump thrombosis remains a life-threatening complication of durable left ventricular assist devices (LVAD). We present what we believe is the first case of suspected pump thrombosis in a patient with a HM3 LVAD that was successfully managed with tissue plasminogen activator (tPA). A 22-year-old man who underwent HM3 implantation for end stage heart failure due to left ventricular non-compaction presented after experiencing two low flow alarms. His physical examination was notable for tachycardia at 125 beats per minute and an elevated Doppler mean blood pressure of 92 mm Hg. LVAD interrogation revealed low flows without power spikes (Figure 1A). Within 24 hours, he developed persistent hypotension requiring vasopressor support and multiple low flow alarms. Serial laboratory results were notable for rising LDH, peaking at 4,741 U/L and acute liver injury with AST 2,712 U/L, ALT 798 U/L and INR 5.2. Transthoracic echocardiography and computed tomography (CT) angiography did not reveal any obvious thrombus. Given this constellation of findings, pump thrombosis was suspected. Following multidisciplinary discussion, unfractionated heparin bolus and infusion were started. After an unremarkable head CT, heparin was stopped and systemic tPA was given at a dose of 5 mg over one minute followed by 10 mg over 10 minutes due to ongoing liver dysfunction. Heparin was resumed after PTT returned to therapeutic range. Immediately post tPA infusion, his LVAD flows improved from 2.3 L/min to 4.1 L/min (Figure 1B). Vasopressor support was quickly weaned. LDH, creatinine, and liver enzymes improved over the following days. Warfarin was resumed on day 14 of admission. He was discharged on aspirin, clopidogrel and warfarin. Thrombolytics may be a potential therapeutic option in select cases of HM 3 pump thrombosis. Further research is warranted to delineate LVAD parameters that facilitate early recognition of pump thrombosis and successful medical management.

Sex-Based Differences in Survival and Readmissions After Insertion of HeartMate3 (HM3) Left Ventricular Assist Device

<h3>Purpose</h3> Left ventricular assist device (LVAD) technology remains underutilized among women with advanced heart failure, likely biased by concerns for increased risk in this population. We investigated survival and cumulative incidence of readmission in LVAD patients separated by sex. <h3>Methods</h3> We retrospectively reviewed all patients who underwent HM3 LVAD implantation from 11/26/14 to 12/4/19 at a single large-volume center. All unplanned readmissions up to 900-days of follow up were analyzed. Readmissions were categorized based on INTERMACS criteria into: major bleeding, infection, arrhythmia, volume overload, device-related complications and other causes. Survival was evaluated by KM method. Incidence of all-cause readmission was evaluated using mean cumulative function method. <h3>Results</h3> Of 182 HM3 pts, 30 were women and 152 were men. Relative to women, men were more commonly white (65.1% vs 30.0%, p=0.0003), had ischemic cardiomyopathy (42.8% vs 16.7%, p=0.007) and higher baseline serum creatinine (1.45(1.2-1.8) vs 1.12(0.81-1.4)mg/dL, p<0.0001). Overall survival during index admission and at 900-days was similar (women vs men: 93.3% vs 94.1%, p=0.9; 83.3% vs 83.0%, p=0.9, respectively (<b>Figure 1A</b>). Cumulative incidence of all-cause readmissions was similar (p=0.55). Readmissions separated by etiology were also similar, except women had a greater incidence of device-related readmissions (19.7% vs 11.3%, p=0.05) (<b>Figure 1B</b>). The most common reason among device-related readmissions was low flow alarm. Median time to first readmission (p=0.56) and length of stay during index admission (p=0.66) was similar. <h3>Conclusion</h3> Women have similar survival during index admission and at 900-days of follow up. Cumulative incidence of all-cause readmission did not differ by sex, however women were more commonly admitted with device-related complications. Future investigations into the sex related LVAD outcomes is critical to avoid this treatment disparity.