Durable LVAD Research Articles

A Comparison of Novel Developed Centrifugal-Flow and Conventional Pulsatile-Flow Extracorporeal Left Ventricular Assist Devices as Bridging Strategy in Patients with Refractory Heart Failure; Sub-Analysis of NCVC-BTD_01 Trial

Purpose An extracorporeal centrifugal-flow left ventricular assist device (CF-E-LVAD) system (BR16010) was newly developed. Since implantation of the durable implantable LVAD (I-LVAD) is still controversial in patients with cardiogenic shock or refractory heart failure because of its significant inferiority of outcomes as compared with higher INTERMACS profile patients, short-term E-LVADs have been still clinically important for bridging strategy for the next definitive treatment. Our aim of this study was to evaluate the influence of the novel developed CF-E-LVAD on the clinical prognosis in patients with bridging strategy, as compared with conventional extracorporeal pulsatile flow LVAD (PF-E-LVAD). Methods We retrospectively reviewed the medical records of 62 patients who were implanted E-LVAD as bridging strategy from April 2011 to January 2019. Six patients (9.7%) were implanted CF-E-LVAD. The clinical prognosis until 30 days after E-LVAD implantation, and the change of cardiac function and laboratory data at the early follow up were evaluated. Results Improvement of left ventricular ejection fraction was significantly greater in the CF-E-LVAD group than in the PF-E-LVAD group (217.9 [147.8 to 335.3] vs 38.3 [-21.7 to 128.8] %, P=0.010). Serum total bilirubin level significantly improved in CF-E-LVAD group than in the PF-E-LVAD group (-7.9 [-33.3 to 82.4] vs 68.8 [10.0 to 202.1] %, P=0.041). Although clinical courses, including death, cerebrovascular accidents and re-thoracotomy due to removal of mediastinal hematoma, were no significant difference between two groups, almost half (54.5%) in the PF-E-LVAD group was still ongoing the E-LVAD support at the 30 days post-E-LVAD implantation while only one patient (16.7%) was supported with E-LVAD in the CF-E-LVAD group. Conclusion The novel developed CF-E-LVAD system might influence on the earlier recovery of cardiac function and the multiple organ failure, and lead to the earlier decision for next definitive strategy.

Improvement in Right Ventricular Stroke Work Index in Cardiogenic Shock Associated with Excellent Durable Left Ventricular Assist Implantation Results

Purpose Cardiogenic shock results from inadequate cardiac output to satisfy organ perfusion with potential need for pharmacologic and mechanical circulatory support for survival. Impella 5.0 insertion is used as a rescue device and bridge to durable mechanical circulatory support. We sought to evaluate changes in right ventricular parameters in patients bridged with Impella 5.0 undergoing durable left ventricular device implantation (LVAD). Methods A single center retrospective review of patients presenting in cardiogenic shock requiring micro-axial circulatory support with Abiomed Impella 5.0 between 2016-2020 was performed. Patient demographics, pre- and post-implant laboratory values and right heart catheterization pressures were reviewed. Patient demographics were evaluated using chi square test, clinical value means compared with unpaired t-test, p Results A total of 24 patients presenting in cardiogenic shock receiving durable LVAD after Impella 5.0 were included for analysis. The majority of patients were male, 59.3 ± 11.1 years old, with history of ischemic heart disease. All patients received an Impella 5.0 via axillary approach. Significant improvement in serum creatinine (1.83 vs 1.42, p 0.05). No patients received right ventricular assist device support, 30-day mortality was 8.3% Conclusion Impella 5.0 insertion for cardiogenic shock significantly decreased central venous and mean pulmonary artery pressure with concomitant improvement in RV function as measured by increased right ventricular stroke work index. Total bilirubin increased, likely as a result of pump hemolysis. Excellent results can be obtained with LVAD implantation in cardiogenic shock patients utilizing Impella 5.0 as a bridge.

Increased Bleeding Risk with Phosphodiesterase-5 Inhibitors after Left Ventricular Assist-Device Implantation

Purpose Phosphodiesterase-5 inhibitors (PDE5I) are frequently implemented after left ventricular assist device implantation (LVAD) to improve right heart hemodynamics. No prospective study has yet evaluated the net benefit of off-label long-term PDE5I on clinical outcomes and their potential risks. We aimed to evaluate the impact of PDE5I on bleeding risk as well as severity and type of bleeding according to The Bleeding Academic Research Consortium (BARC) classification after LVAD implantation. Methods We retrospectively reviewed the database of our heart failure unit to identify adult patients who received a durable LVAD at our institution from December 2010 through May 2019. Patients were included in the analysis if they were discharged on oral PDE5I after LVAD implantation. Patients were excluded if they had received biventricular assist-devices, in case of postoperative death during the index hospitalization, follow-up interruption or follow-up in an affiliated hospital. Major bleeding was defined as fatal bleeding, and/or symptomatic bleeding in a critical area or organ, and/or bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells. All non-major bleedings were considered minor bleedings. Results The analytic cohort included 109 patients. Seventy-five patients (69%) received long-term PDE5I therapy and thirty-four (31%) did not receive PDE5I. At 12 months 19 (17%) patients experienced cumulatively 28 bleeding events (26 events in patients on PDE5I, 2 not on PDEI5) leading to 27 red blood cell transfusions (all in the PDE5I group). Patients on PDE5I had higher bleeding rates (23% vs. 6%, p = 0.03) and more bleeding events per patient (0.32 vs. 0.06, p = 0.03). Most events concerned major bleeding (24 events, 85.7%) and 50% non-gastrointestinal bleeding. BARC Type 2 had the highest incidence and was more frequent in the PDE5I group (19 vs 3%, p = 0.03). Hospitalizations for bleeding and their duration were numerically higher for PDE5I (0.28 vs 0.03 hospitalizations, p = 0.07 and 2.4 vs. 0.2 days, p = 0.07, respectively). Conclusion Long-term PDE5I treatment after LVAD increases the risk of bleeding at 12 months after LVAD implantation. The role of off-label PDE5I in LVAD patients remains unclear and should be further clarified in contemporary patient and device cohorts.

Decreased Utilization of Durable Left Ventricular Assist Device Therapy in Blacks Relative to Whites with Advanced Heart Failure

Purpose Heart failure affects 6 million people in the US, and is most prevalent in Blacks who suffer the highest mortality risk[1, 2]. Yet prior studies have suggested that black patients are less likely to receive advanced heart failure therapy[3-6]. We hypothesized that black patients would have decreased rates of durable LVAD implantation within our expansive heart failure program. Methods A retrospective single center cohort study was conducted using electronic medical record data at our high-volume academic medical center. Patients between 18 and 85 years admitted with a diagnosis of cardiogenic shock or congestive heart failure between 1/2013 and 12/2017 with an LVEF Results A total of 702 patients were included, of which 60.8% were white and 34.2% were Black; 72% of the patients in the study were men. Comorbidities were similar among the racial groups with the exception of coronary artery disease (CAD), which had an increased prevalence in whites (N=248; 58%). White patients were older (65 vs 59; p Conclusion Black patients in our study had a decreased rate of durable LVAD implantation compared with white patients after adjustments were made for age, gender and clinical covariates. While this finding was likely mediated by socioeconomic factors, larger prospective studies are needed to validate these findings.

1,2,3: Use of Ang II in a HM3

<h3>Introduction</h3> Vasodilatory shock is characterized by peripheral vasodilation, hypotension and preserved cardiac output. Management involves identifying and treating the underlying cause and reestablishing adequate blood pressure. Contemporary vasopressors include catecholamines and vasopressin, and their use is limited by adverse effects. Adjunctive use of Angiotensin II (Ang II) has been shown to increase mean arterial pressure (MAP) in patients with vasodilatory shock. We describe the first successful use of Ang II in a patient with a HM3 left ventricular assist device (VAD). <h3>Case Report</h3> 58-year-old gentleman with long-standing NICM, LV EF 20-25%, atrial fibrillation (AF), CKD stage III, recent COVID-19, presented with an ST elevation myocardial infarction and progressed to refractory cardiogenic shock. He was supported with inotropes and an intra-aortic balloon pump and implanted with a HM3. VAD course was complicated by right ventricular dysfunction, respiratory failure, and renal failure, necessitating initiation of continuous dialysis. Patient developed sepsis due to clostridium dificile colitis and pneumonia that progressed to refractory vasodilatory shock on post-op day 20. He was supported on HM3 at 5600 rpm, inotropes and escalating doses of pressors. He developed AF with rapid ventricular response, limiting further uptitration, thus, Ang II was initiated. Initial dose was 20 ng/kg/min, with a robust response in MAPs from 60s to 80s mmHg in 2 minutes. Within 24 hours he was weaned off of Ang II and within 72 hours, he was weaned off of all pressors (Table). He was subsequently transitioned to HD and weaned off of inotropic and ventilatory support. <h3>Summary</h3> Treatment options for patients with catecholamine-resistant vasodilatory shock are limited. In patients with refractory vasodilatory shock supported with durable LVAD therapies, information on the use of Ang II is limited. In our patient with multi-system organ failure and impending death, we were able to utilize Ang II to provide hemodynamic stability and rescue him from septic shock.

To VAD or Not to VAD: A Case of Durable Left Ventricular Assist Device Implantation in a COVID-19 Patient

IntroductionThe management of patients with heart failure who contract COVID-19 and those who develop heart failure as a consequence of the disease is challenging. The use of advanced therapies in the form of durable left ventricular assist device or heart transplant in this patient population remains a data free zone. We present, to our knowledge, the first case of durable LVAD implantation in a recovered COVID-19 patient.Case ReportA 63-year old, previously healthy, male was admitted to OSH with COVID-19 pneumonia and acute respiratory distress syndrome requiring prolonged mechanical ventilation. This hospitalization was complicated by anterior STEMI, cardiomyopathy with severe LV dysfunction and cardiogenic shock. Due to widespread COVID-19 pandemic, invasive evaluation was deferred and the patient was medically managed. He was then transferred to our institution after re-admission for recurrent cardiogenic shock. Echocardiogram revealed dilated LV cavity (6.3 cm), LVEF 10% and large apical aneurysm. Chest CT showed sequelae of prior COVID-19 with changes suggestive of fibrosis. CMR which showed LV dilatation, severe LV systolic dysfunction, LVEF 7% and large apical aneurysm with evidence of thrombus. A large transmural infarct in the LAD territory without viability was confirmed. Cardiogenic shock was managed with Dobutamine and attempts to wean inotrope resulted in worsening hemodynamic and clinical profile. Axillary IABP was placed to facilitate physical and respiratory rehabilitation. The patient underwent placement of HeartMate™ 3 device as DT and LV aneurysm repair. Post-operative course was uneventful and he was ultimately discharged to acute rehabilitation in stable condition.SummaryAs the global case rate continues to climb and the threat of an exponential surge of long-term cardiac complications looms in the not so distant future, the use of durable MCS in recovered COVID-19 patients may evolve. This case highlights LVAD as a feasible option in end-stage HF and emphasizes the importance of a multidisciplinary approach in assessing candidacy for advanced HF therapies in post-COVID-19 patients. Continued international collaboration and further study regarding use of MCS will be paramount in optimizing care and outcomes in this growing patient population.

Inhaled Selective Pulmonary Vasodilators for Advanced Heart Failure Therapies

<h3>Purpose</h3> Inhaled pulmonary vasodilators (iPVD) are commonly used to lower PVR to modify the risk of acute RV failure in durable LVAD implantation or orthotopic heart transplantation (OHT). While inhaled nitric oxide (iNO) is the iPVD gold standard, inhaled epoprostenol (Veletri®) has been introduced as a cost-conscious alternative without high-grade evidence. Thus, we conducted an investigation to primarily determine if inhaled epoprostenol is equivalent to iNO in the ability to modify acute RVF after advanced heart failure therapies. <h3>Methods</h3> Our group has enrolled 232 patients (LVAD, N=100; OHT, N=132) in a triple-blinded (clinician, subject, statistician) randomized controlled trial conducted between May 2017-October 2020 (NCT03081052). Participants were grouped into strata according to key clinical prognostic features. Within each stratum, subjects were assigned either iNO or inhaled epoprostenol via 1:1 randomization. To assess equivalency between the two treatment arms for our primary outcome analysis, we will calculate absolute and relative risk estimates and corresponding confidence intervals (CI). If the CI do not contain the margin of difference (15%), then we will conclude there is sufficient evidence that the risk of the primary outcome in each treatment arm is similar. For each secondary outcome, we will construct univariable effect estimates and corresponding CI, which will allow for assessment of difference between treatment arms. In the case that patients have switched to the other treatment arm, we will perform an intent-to-treat (ITT) analysis without reclassifying treatment assignment. To verify ITT results, we will perform a per-protocol analysis. <h3>Endpoints</h3> <b>Primary.</b>LVAD: Moderate or Severe RVF (defined by INTERMACS, up to 21-days after surgery); OHT: PGD-RV treated with RVAD <i>or</i> VA-ECMO, up to 30-days after surgery. <b>Secondary.</b> Duration of postoperative mechanical ventilation, iPVD duration/cost, ICU and hospital lengths-of-stay, postoperative acute kidney injury, and 30-day mortality.

The Impact of Obesity and LVAD-Bridging on Heart Transplant Candidate Outcomes: A Linked STS INTERMACS - UNOS Data Analysis

<h3>Purpose</h3> Limited data integrating waitlist and post-heart transplant (HT) mortality have evaluated outcomes of LVAD-bridged strategy vs no LVAD based on patient characteristics. We aimed to evaluate waitlist and post-HT mortality in bridged in comparison to non-bridged patients based on body mass index (BMI). <h3>Methods</h3> We included adults listed for HT in UNOS and patients receiving durable LVAD as bridge to HT or candidacy in STS/INTERMACS databases (2010-2019). Using patient identifiers, we linked both databases. We categorized patients as underweight (BMI <18.5 kg/m²), normal weight (BMI 18.5-24.99 kg/m²), overweight (BMI 25-29.99 kg/m²) and obese (BMI ≥30 kg/m²). We assessed the effect of bridged and non-bridged strategy by BMI on waitlist mortality, HT probability and post-HT mortality. We used Kaplan-Meier analysis and log-rank test to compare risk across BMI classes, and competing risk and multivariable Cox PH models to assess the effect for each BMI class. <h3>Endpoints</h3> We included 12,761 LVAD-bridged and 17,518 non-bridged candidates. Bridged vs non-bridged patients were more frequently obese (37.2 vs 28.7%) or underweight (3.6 vs 2.6%) (p<0.001). In competing risk analysis, bridged compared to non-bridged patients had a lower rate of HT and higher waitlist mortality (Fig 1A,B). Multivariable analysis stratified by BMI showed increased waitlist mortality in bridged vs non-bridged overweight (HR 1.29 95%CI 1.09, 1.52) and obese patients (HR1.39 95%CI 1.18, 1.65) (Fig 1C) and similar risk in normal and underweight patients. LVAD-bridged patients had higher waitlist mortality and lower HT probability in comparison to non-bridged in overweight and obese patients. We will next integrate these results with post-HT survival in the linked STS-INTERMACS/UNOS cohort to provide further insights into the strategy most likely to lead to survival benefit based on BMI and determine whether the current guideline recommendation of using LVAD as a bridge to weight loss should be re-examined.

Impact of Beta-blockers Use on Ventricular Arrhythmias and ICD Shocks in Patients on Long-Term Inotropic Therapy

Purpose Continuous infusion of inotropes is increasingly used in patients with end-stage heart failure who are being discharged from the hospital. However, Dobutamine and Milrinone are both known to be arrhythmogenic agents. Because Milrinone does not act through the beta-adrenergic system, it may allow for the cautious addition of beta-blockers (BB). We therefore sought to compare the impact of BB use is these patients on ventricular arrhythmias. Methods We retrospectively reviewed all patients who were discharged from our Institution on inotropes (used as a bridge to durable LVAD or transplant, as a bridge to recovery, or as a palliative measure). The cohort was stratified into 2 groups based on whether BB were added to the medical regimen. We compared the incidence of ventricular arrhythmias and ICD device therapy (defined as shock or anti-tachycardia pacing) between the 2 groups. Results Between 2010 and 2017, 349 patients were discharged on inotropes. Mean age was 61+14 years, 74% were men and 64% were African American. Most patients (330) were treated with Milrinone. BB were used in 195 (56%) of patients, whereas 154 (44%) did not receive these meds. There were no significant differences between the 2 groups in baseline socio-demographics, etiology of cardiomyopathy, CV comorbidities, or invasive hemodynamics. Patients on BB were more likely to receive an LVAD/transplant (49% vs. 41%) or be weaned off inotropes (12% vs. 4%), and less likely to transition to hospice care/death (37% vs 53%). Patients on BB were more likely to receive ACEI/ARB than those who were not on BB (67% vs. 47%, p Conclusion In heart failure patients who are discharged on inotropes, the use of BB appears to be associated with a lower incidence of sustained ventricular arrhythmias, ICD shocks or anti-tachycardia pacing. Prospective studies are warranted to confirm these findings.

Recovery of RV Function Determines Outcomes of Extracorporeal Biventricular Support for Acute Biventricular Failure

<h3>Purpose</h3> Mechanical circulatory support for acute biventricular failure is challenging. Given that durable VAD is available only for LV support as bridge-to-transplantation in Japan, the treatment options for this pathology are limited to extracorporeal biventricular assist device (BiVAD) support first, which can be subsequently upgraded to durable LVAD in cases having recovery of RV function and transplant candidacy. The purpose of this study was to review the outcomes of extracorporeal BiVAD and to explore factors associated with the outcomes. <h3>Methods</h3> This study enrolled an institutional consecutive series of 39 cases who underwent extracorporeal BiVADs implantation for acute biventricular failure between April 2014 and October 2020. The etiological diagnosis was myocarditis in 27 cases, acute MI in 6 cases, and dilated cardiomyopathy (DCM) in 6 cases. The cases were assigned into the two groups according to the BiVAD support less than 7 days (n=18, Short group) or 7 days or more (n=21, Long group). The Long group consisted of 6 cases of acute MI (100%), 13 cases (48%) of myocarditis, two cases of DCM (33%). <h3>Results</h3> There was no case who deceased within 7 days after BiVAD implantation. In the Short group, extracorporeal LVAD was weaned-off in 11 cases (61%) or upgraded to durable LVAD in 6 cases after withdrawal of RV support within 7 days. The remaining one case deceased under extracorporeal LVAD. In the Long group, RV support was discontinued in 10 cases in the median support of 60 days (IQR; 24.2-76.8), while two cases were on BiVAD support at October 2020. The remaining nine cases (43%) deceased under BiVAD support in-hospital. Survival and VAD-free survival at 1 year were 79% and 56% in the Short group versus 48% and 20% in the Long group, respectively. <h3>Conclusion</h3> Outcomes of extracorporeal BiVAD support for acute biventricular failure were dependent on recovery of RV function. Targeting approach for RV function would be warranted for poor biventricular function.

Peak troponin predicts successful weaning from VA ECMO in patients with acute myocardial infarction complicated by cardiogenic shock.

In patients treated for refractory cardiogenic shock (RCS) following acute myocardial infarction (AMI), predicting successful weaning from veno-arterial extracorporeal membrane oxygenation (VA ECMO) has important implications for decision-making and prognosis. We performed a retrospective review of adult VA ECMO patients with RCS complicating AMI at our institution from 2010 to 2019. We evaluated use of peak troponin I as a predictor of successful decannulation. Sixty-two patients were analyzed; mean age 61.1 ± 9.8 years, 73% males, 62% presented with STEMI. Forty-five patients were successfully weaned (group I). Seventeen patients did not wean (group II); seven patients received a durable LVAD, 10 died. Patients from group I had significantly lower peak troponin I (89 vs 434 ng/mL, p = 0.0001). Receiver operating characteristic curves showed a peak troponin I cutoff of 400 ng/mL correctly classified patients by weaning status 90% of the time, with associated sensitivity of 71% and specificity of 98%. With each 50 ng/mL increase in troponin I, the likelihood of weaning decreased by 33%. Peak troponin I above 400 ng/mL may be helpful in predicting unsuccessful weaning from VA ECMO support for refractory cardiogenic shock following myocardial infarction and facilitate triage decisions regarding need for advanced therapies.

Surgical Implantation Techniques of Modern Continuous Flow Ventricular Assist Devices

Implantable left ventricular assist devices (durable LVADs) have dramatically improved mortality and morbidity in patients with advanced heart failure. Originally designed as a bridge or candidacy to heart transplantation, the indications extend toward permanent support and palliation. Modern durable continuous flow LVADs are small, commercially available, and allow for different surgical approaches to a wide range of patients with various cardiac pathologies. We will review different surgical implantation techniques of modern continuous flow LVADs, as well as specific aspects of preoperative patient evaluation and planning.

Temporary surgical ventricular assist device for treatment of acute myocardial infarction and refractory cardiogenic shock in the percutaneous device era.

Acute myocardial infarction with refractory cardiogenic shock (AMI-RCS) is associated with poor outcomes. Several percutaneous mechanical circulatory support devices exist; however, limitations exist regarding long-term use. Herein, we describe our experience with the temporary surgical CentriMag VAD. We reviewed 74 patients with AMI-RCS who underwent CentriMag VAD insertion as bridge-to-decision device from 2007 to 2020. Patients were divided into groups based on introduction of the "shock team" model: Era 1 (2007-2014, n = 51) and Era 2 (2015-2020, n = 23). Era 2 had higher proportion of patients with INTERMACS Profile I. The use of percutaneous MCS as bridge to VAD and the use of minimally invasive VAD were higher in Era 2. There were fewer postoperative bleeding events in Era 2 (80% vs 61%, p = .07). Thirty-day mortality was 23% and 1-year survival was 55%, which were no differences between eras. Destinations after CentriMag VAD included myocardial recovery (39%), durable LVAD (27%), and transplantation (5%). CentriMag VAD device represents a viable bridge-to-decision device with acceptable short- and long-term outcomes for patients with AMI-RCS. Stable outcomes in a progressively sicker population may be related to changes in practice patterns as well as introduction of the "shock team" concept.

Mechanical circulatory support-Challenges, strategies, and preparations.

BackgroundCoronavirus disease 2019 (COVID‐19) is usually mild, but patients can present with pneumonia, acute respiratory distress syndrome (ARDS), and circulatory shock. Although the symptoms of the disease are predominantly respiratory, the involvement of the cardiovascular system is common. Patients with heart failure (HF) are particularly vulnerable when suffering from COVID‐19.Aim of the ReviewTo examine the challenges faced by healthcare organizations, and mechanical circulatory support management strategies available to patients with heart failure, during the COVID‐19 pandemic.ResultsExtracorporeal membrane oxygenation (ECMO) can be lifesaving in patients with severe forms of ARDS, or refractory cardio‐circulatory compromise. The Impella RP can provide right ventricular circulatory support for patients who develop right side ventricular failure or decompensation caused by COVID‐19 complications, including pulmonary embolus. HT are reserved for only those patients with a high short‐term mortality. LVAD as a bridge to transplant may be a viable strategy to get at‐risk patients home quickly. Elective LVAD implantations have been reduced and only patients classified as INTERMACS profile 1 and 2 are being considered for LVAD implantation. Delayed recognition of LVAD‐related complications, misdiagnosis of COVID‐19, and impaired social and psychological well‐being for patients and families may ensue. Remote patient care with virtual or telephone contacts is becoming the norm.ConclusionsHF incidence, prevalence, and undertreatment will grow as a result of new COVID‐19‐related heart disease. ECMO should be reserved for highly selected cases of COVID‐19 with a reasonable probability of recovery. Special considerations are needed for patients with advanced HF, including those supported by durable LVADs.

Use of durable left ventricular assist devices for high-risk patients: Korean experience before insurance coverage.

BackgroundLeft ventricular assist devices (LVADs) were not covered by the Korean national insurance until September 2018, and they were implanted at the patient’s own or a third party’s expense. However, there have been no reports on using an LVAD without insurance coverage or manufacturer support.MethodsWe reviewed 23 patients who underwent durable LVAD implantation at our institution from August 2012 to September 2018. Patients with temporary LVADs using extracorporeal or paracorporeal circulation were excluded. The available devices were the HeartMate IITM (HMII) and HeartWareTM Ventricular Assist Device (HVAD). The primary outcome was 30-day mortality. The secondary outcomes were postoperative complications and late mortality.ResultsThe mean age of the patients was 68.7±9.9 years. The study sample comprised six female (26.1%) and 17 male (73.9%) patients. All patients had modifiable (bridge to candidacy) or unmodifiable absolute (destination therapy) contraindications for heart transplantation (HT). Among the patients in this study, 12 (52.2%) had ischemic cardiomyopathy and 11 (47.8%) had non-ischemic cardiomyopathy. Nine patients (39.1%) had temporary mechanical circulatory support such as extracorporeal membrane oxygenation or a temporary LVAD in place preoperatively. The average duration of LVAD support was 618.6±563.2 days (range, 59–2,285 days). There was no 30-day mortality. Four patients (17.4%) underwent HT. Six patients (26.1%) underwent re-exploration for postoperative bleeding, and one patient (4.3%) had a disabling stroke after discharge. The estimated survival rates at 12 and 24 months were 89.2% and 68.8%, respectively.ConclusionsAll patients who received LVADs before insurance coverage had contraindications for HT. The overall outcomes were comparable with those reported in the international registry.

Abstract 13425: Comparison Between Impella 5.0 and External Corporeal Left Ventricular Assist Device as a Bridge to Decision in Patients With Cardiogenic Shock

Background: In cardiogenic shock refractory to medical treatment, choosing and changing mechanical circulatory support to stabilize hemodynamics until cardiac recovery or next treatment is a strategic cornerstone for improving the outcome. We aimed to clarify the differences in treatment course and outcome between Impella 5.0 and extracorporeal left ventricular assist device (eLVAD) in patients with cardiogenic shock refractory to medical therapy or other mechanical circulatory support. Methods: We performed a retrospective medical record review of consecutive patients who were treated with Impella 5.0 or eLVAD as a bridge to decision (BTD) at our medical center from December 2011 to January 2020. Results: A total of 26 patients (median age 40 years, 16 males) were analyzed. Of seven patients managed with Impella 5.0, one patients used Impella CP and four patients used peripheral veno-arterial extracorporeal membrane oxygenation (VA-ECMO) before Impella 5.0 implantation. On the other hand, of 19 patients managed with eLVAD, 11 patients used VA-ECMO before eLVAD implantation. In patients managed with Impella 5.0, Impella 5.0 was removed successfully in two patients (29%) and four patients (71%) underwent the operation for durable LVAD. In patients managed with eLVAD, eLVAD was successfully removed in three patients (16%), nine patients (47%) required durable LVAD, and seven patients (37%) died during eLVAD management. The period between implantation of Impella 5.0 or eLVAD to durable LVAD surgery was significantly shorter with Impella 5.0 (58 [38 - 95] vs. 235 [126 - 318] days, p=0.001). During durable LVAD implantation, cardiopulmonary bypass time was significantly shorter and a significantly smaller amount of red blood cells transfusion was required with Impella 5.0 (149 [125 - 182] vs. 192 [170 - 250] minutes, p=0.042; 7.0 [5.0 - 9.5] vs. 15.0 [10.0- 2.0] units, p=0.019, respectively). There were 4 massive stroke events in eLVAD, but no massive stroke events in Impella 5.0. In Impella 5.0. Conclusions: Impella 5.0 facilitates smoother management as a BTD and reduces surgical invasiveness during durable LVAD implantation. Impella 5.0 would be a more effective option for success to cardiac recovery or next therapy than eLVAD.

Abstract 14529: Management of Acute Myocardial Infarction in a Patient With a Left Ventricular Assist Device

Introduction: We present a case of an LVAD patient presenting with nonspecific symptoms found to have type I MI due to critical LAD stenosis. Case Presentation: A 65-year-old male patient with a HeartMate II LVAD as destination therapy for ischemic cardiomyopathy presented with chest pain and generalized malaise. Examination demonstrated euvolemia and no stigmata of infection or thromboembolism. Labs were notable for an INR of 1.4 and high-sensitivity troponin values of 792 and 886 ng/L (ULN, 53 ng/L). ECG showed old anterior and inferior infarct; echocardiography revealed an LVEF of 20% with mild RV dysfunction and an immobile aortic valve. Non-atherosclerosis-related causes of MI were initially explored: CT of the chest and abdomen did not show infection or PE, and LVAD interrogation did not show any abnormal power trends or flows. Coronary angiography showed a 99% ostial LAD lesion, clearly progressed compared to 3 years earlier (Figures 1A and 1B). PCI with a drug-eluting stent restored normal flow (Figure 1C) with prompt resolution of symptoms. The patient is doing well over 1 year after PCI. Discussion: Acute MI is uncommon in LVAD patients and may present differently from a traditional CAD population due to the impact of the device on myocardial wall stress and oxygen demand through direct and continuous LV unloading. Case series of PCI in durable LVAD patients generally identify right heart failure, VT, or embolized thrombus from an immobile aortic valve, rather than a type I MI, as the primary indication. There is a paucity of data regarding the best approach for anticoagulation and antiplatelet management in LVAD patients after PCI. Conclusion: Type I MI should be considered in the right clinical context in LVAD patients presenting with elevated cardiac biomarkers, recognizing the potential for reduced specificity of clinical and ECG data. Future study of the long-term outcomes and appropriate secondary management of LVAD patients undergoing PCI is needed.

Abstract 16583: Beta Blocker Administration Within 30 Days Post-Left Ventricular Assist Device Significantly Decreases 1-Year Mortality in a Multi-institutional Retrospective Cohort Study

Introduction: The utilization of beta blockers (BB) post LVAD implantation is controversial, especially in the setting of right ventricular failure. There is limited evidence-based data regarding the survival benefits of BB post LVAD implantation Hypothesis: We hypothesized that BB use would not be associated with increased mortality Methods: We performed a dual-center retrospective study of 487 patients from Ohio State University &amp; Montefiore Medical Center who received a continuous-flow durable LVAD bet. Jan 2006 through Dec 2016. A survival analysis was done to determine if patients had increased 1 year mortality depending on whether they received BB within 30 days post LVAD, after 30 days &amp; up to 1 year post LVAD, or did not receive BB. Multivariate analysis of predictors of post LVAD mortality was conducted. Results: Overall the baseline characteristics bet. the 3 groups were similar (Table 1). BB utilization within 30 days post LVAD was associated with a drastic decrease in 1 year mortality (p &lt;0.001; Fig.1). Multivariate analysis shows that no BB use (HR 3.36, p &lt;0.001), age ≥70 (HR 2.73, p = 0.005) &amp; pre LVAD creatinine ≥1.5 mg/dl (HR 1.86, p = 0.022) were significant independent predictors of mortality (Table 2). Conclusions: The early use of BB significantly improves 1 year survival post LVAD. Notably these results are from Midwest and East Coast Medical Centers to improve generalizability.

Device thrombosis in the Heartware LVAD treatment decision and role of log files

Abstract Background Device thrombosis is a significant problem during durable LVAD support, and device-specific diagnosis and treatment algorithms are necessary to optimize outcomes. The HVAD LVAD has a unique and well-developed logfile capability, yet clinical data on it's use are lacking. Methods and results We reviewed overall outcomes of 322 consecutive patients implanted at our University Medical Center with the HVAD LVAS with a particular emphasis on device thrombosis events. Thirty days, one year, and two years survival was 85.4%,65.0%, and 53.1%, respectively. One hundred eighty-one device thrombosis events occurred in 76 patients. Based on logfile patterns, events were categorized as gradual build-up or sudden build-up or acute occlusion/ingestion (Jorde U JACC-HF 2015). The first thrombosis event was a gradual build-up in 32, sudden build up in 5, and acute occlusion in 11 pts. An additional 46 gradual build-up, two sudden build-up, nine acute occlusion events occurred as recurrent events. 2-year survival without CVA was 72.8% in patients with gradual onset device thrombosis 72 pts received TPA. TPA was given, after discontinuing anticoagulation, and taking the INR level is under 2.0 and keeping invasively measured mean arterial blood pressure between 65–80 mmHg low dose tenecteplase (1000 units) was then given, and if clinical and logfile improvement did not occur repeated every six hours up to a total fo 4 doses (4000 units) over 24 hours. Successful therapy was defined as clinical resolution of pump thrombosis without recurrence in 30 days, LDH improvement and power consumption returned to normal, and occurred in 74.4% gradual onset, 71.4% sudden onset, and 56.3% acute occlusion. TPA was complicated by severe hemorrhage or death in 6.4% of patienst with a gradual build-up pattern, 14.3% with sudden build-up, and in 33.3% with acute occlusion. Conclusion Device thrombosis frequently occurs in HVAD patients, and response to therapy can be predicted by logfile analysis. TPA is an excellent option for gradual onset device thrombosis but should be avoided in the setting of acute occlusions, where early device exchange may be a better first-line strategy. Refinement of logfile analysis including earlier thrombus detection and incorporation of these techniques into clinical practice may significantly improve outcomes with the HVAD LVAD. Funding Acknowledgement Type of funding source: None

Escalating Temporary Mechanical Circulatory Support In Worsening Cardiogenic Shock: Feasibility In Advanced Heart Failure Therapy Candidates

Background Temporary mechanical circulatory support (tMCS) can be used in cardiogenic shock (CS) as a bridge to advanced heart failure therapies (AHFT) (durable LVAD, cardiac transplantation). tMCS escalation in worsening CS has never been studied and prognostication in this cohort is needed, particularly in candidates for AHFT. We evaluated potential predictors of survival and outcomes of those that received AHFT. Methods From 07/2016-07/2018 we identified patients with worsening CS shock requiring tMCS escalation. Worsening CS was defined as persistent hypotension; increasing doses of vasopressors/inotropes; worsening end-organ perfusion parameters; and/or worsening invasive hemodynamics. tMCS escalation was defined as adding/exchanging tMCS device to existing tMCS. Potential prognostic variables were evaluated in ROC curves. All statistical tests were performed with a two-sided p value=05. Results 81 consecutive patients (61±14y, 73%m) had worsening CS shock requiring tMCS escalation. Devices used were IABP, Impella (2 5, CP, 5 0), ECMO and Tandem (TandemHeart, TandemLife, ProtekDuo). Survival to discharge was 32%. Etiology of shock was heterogeneous (33% AMI; 62% decompensated heart failure). 62% were transfers from outside hospitals. Utilization of a PA catheter pre-escalation was associated with improved survival compared to absence of a PA catheter (40% vs 18%, p=0.05). ROC curves demonstrated prognostic thresholds associated with survival: age 0.92 Watts (87% specificity). While prognostic thresholds associated with mortality were: age >69 y (81% specificity), BMI >35 kg/m2 (81% specificity), pre-escalation cardiac power output (CPO) 3 mmol/L (81% specificity). AUC was greatest in post-escalation blood pressure indicating persistence of hypotension post-escalation (SBP Conclusions tMCS escalation in worsening CS incurs poor survival overall (32%). tMCS escalation is feasible in stabilizing patients with worsening CS that are candidates for AHFT.