Microaxial Left Ventricular Assist Device Research Articles

Intravascular Microaxial Left Ventricular Assist Device Manufacturer Payments to Cardiologists and Use of Devices

This study examines whether payments from a left ventricular assist device manufacturer to cardiologists performing percutaneous coronary intervention were associated with any use of the devices.

Comparative Effectiveness of Percutaneous Microaxial Left Ventricular Assist Device vs Intra-Aortic Balloon Pump or No Mechanical Circulatory Support in Patients With Cardiogenic Shock

Recent studies have produced inconsistent findings regarding the outcomes of the percutaneous microaxial left ventricular assist device (LVAD) during acute myocardial infarction with cardiogenic shock (AMICS). To compare the percutaneous microaxial LVAD vs alternative treatments among patients presenting with AMICS using observational analyses of administrative data. This comparative effectiveness research study used Medicare fee-for-service claims of patients admitted with AMICS undergoing percutaneous coronary intervention from October 1, 2015, through December 31, 2019. Treatment strategies were compared using (1) inverse probability of treatment weighting to estimate the effect of different baseline treatments in the overall population; (2) instrumental variable analysis to determine the effectiveness of the percutaneous microaxial LVAD among patients whose treatment was influenced by cross-sectional institutional practice patterns; (3) an instrumented difference-in-differences analysis to determine the effectiveness of treatment among patients whose treatment was influenced by longitudinal changes in institutional practice patterns; and (4) a grace period approach to determine the effectiveness of initiating the percutaneous microaxial LVAD within 2 days of percutaneous coronary intervention. Analysis took place between March 2021 and December 2022. Percutaneous microaxial LVAD vs alternative treatments (including medical therapy and intra-aortic balloon pump). Thirty-day all-cause mortality and readmissions. Of 23 478 patients, 14 264 (60.8%) were male and the mean (SD) age was 73.9 (9.8) years. In the inverse probability of treatment weighting analysis and grace period approaches, treatment with percutaneous microaxial LVAD was associated with a higher risk-adjusted 30-day mortality (risk difference, 14.9%; 95% CI, 12.9%-17.0%). However, patients receiving the percutaneous microaxial LVAD had a higher frequency of factors associated with severe illness, suggesting possible confounding by measures of illness severity not available in the data. In the instrumental variable analysis, 30-day mortality was also higher with percutaneous microaxial LVAD, but patient and hospital characteristics differed across levels of the instrumental variable, suggesting possible confounding by unmeasured variables (risk difference, 13.5%; 95% CI, 3.9%-23.2%). In the instrumented difference-in-differences analysis, the association between the percutaneous microaxial LVAD and mortality was imprecise, and differences in trends in characteristics between hospitals with different percutaneous microaxial LVAD use suggested potential assumption violations. In observational analyses comparing the percutaneous microaxial LVAD to alternative treatments among patients with AMICS, the percutaneous microaxial LVAD was associated with worse outcomes in some analyses, while in other analyses, the association was too imprecise to draw meaningful conclusions. However, the distribution of patient and institutional characteristics between treatment groups or groups defined by institutional differences in treatment use, including changes in use over time, combined with clinical knowledge of illness severity factors not captured in the data, suggested violations of key assumptions that are needed for valid causal inference with different observational analyses. Randomized clinical trials of mechanical support devices will allow valid comparisons across candidate treatment strategies and help resolve ongoing controversies.

P5: Red Blood Cell Distribution Width in Patients with Cardiogenic Shock Supported with Impella 5.5 Temporary Percutaneous Microaxial Left Ventricular Assist Device

Background: Severe cardiogenic shock with metabolic derangement can preclude candidacy to durable left ventricular assist device (LVAD) or cardiac transplant, but may be reversed with temporary mechanical circulatory support. Our primary aim was to determine if red cell distribution width- coefficient of variation (RDW-CV) differed among survivors and non-survivors during their admission with temporary circulatory support. Methods: A series of 27 consecutive patients supported with Impella 5.5 percutaneous microaxial LVAD were reviewed retrospectively. All implants were performed via a tunneled vascular graft anastomosed to the right subclavian artery to allow ambulation. RDW-CV was recorded at admission and at the end of circulatory support. The series was divided into survivors and non-survivors. Groups were compared using Student’s t-test. Results: Surviving patients had a lower percentage of males (79% vs 88%), their cardiomyopathy was more likely to be non-ischemic (58% vs 25%), and were slightly younger (62 vs 69.5 years old) than non-survivors. RDW-CV at the end of Impella support was significantly different between those that survived [median RDW-CV 16.8], and those that did not [median RDW-CV 19.98] (p=0.04). Conclusion: In patients supported with temporary circulatory support with Impella 5.5, RDW-CV is significantly lower among patients that survive to discharge when compared to non-survivors.

Microaxial Left Ventricular Assist Device in Cardiogenic Shock: A Systematic Review and Meta-Analysis.

Microaxial left ventricular assist devices (LVAD) are increasingly used to support patients with cardiogenic shock; however, outcome results are limited to single-center studies, registry data and select reviews. We conducted a systematic review and meta-analysis, searching three databases for relevant studies reporting on microaxial LVAD use in adults with cardiogenic shock. We conducted a random-effects meta-analysis (DerSimonian and Laird) based on short-term mortality (primary outcome), long-term mortality and device complications (secondary outcomes). We assessed the risk of bias and certainty of evidence using the Joanna Briggs Institute and the GRADE approaches, respectively. A total of 63 observational studies (3896 patients), 6 propensity-score matched (PSM) studies and 2 randomized controlled trials (RCTs) were included (384 patients). The pooled short-term mortality from observational studies was 46.5% (95%-CI: 42.7–50.3%); this was 48.9% (95%-CI: 43.8–54.1%) amongst PSM studies and RCTs. The pooled mortality at 90 days, 6 months and 1 year was 41.8%, 51.1% and 54.3%, respectively. Hemolysis and access-site bleeding were the most common complications, each with a pooled incidence of around 20%. The reported mortality rate of microaxial LVADs was not significantly lower than extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pumps (IABP). Current evidence does not suggest any mortality benefit when compared to ECMO or IABP.

Clinical Outcomes and Cost Associated With an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump in Patients Presenting With Acute Myocardial Infarction Complicated by Cardiogenic Shock

Intravascular microaxial left ventricular assist device (LVAD) compared with intra-aortic balloon pump (IABP) has been associated with increased risk of mortality and bleeding among patients with acute myocardial infarction (AMI) and cardiogenic shock (CS) undergoing percutaneous coronary intervention (PCI). However, evidence on the association of device therapy with a broader array of clinical outcomes, including data on long-term outcomes and cost, is limited. To examine the association between intravascular LVAD or IABP use and clinical outcomes and cost in patients with AMI complicated by CS. This retrospective propensity-matched cohort study used administrative claims data for commercially insured patients from 14 states across the US. Patients included in the analysis underwent PCI for AMI complicated by CS from January 1, 2015, to April 30, 2020. Data analysis was performed from April to November 2021. Use of either an intravascular LVAD or IABP. The primary outcomes were mortality, stroke, severe bleeding, repeat revascularization, kidney replacement therapy (KRT), and total health care costs during the index admission. Clinical outcomes and cost were also assessed at 30 days and 1 year. Among 3077 patients undergoing PCI for AMI complicated by CS, the mean (SD) age was 65.2 (12.5) years, and 986 (32.0%) had cardiac arrest. Among 817 propensity-matched pairs, intravascular LVAD use was associated with significantly higher in-hospital (36.2% vs 25.8%; odds ratio [OR], 1.63; 95% CI, 1.32-2.02), 30-day (40.1% vs 28.3%; OR, 1.71; 95% CI, 1.37-2.13), and 1-year mortality (58.9% vs 45.0%; hazard ratio [HR], 1.44; 95% CI, 1.21-1.71) compared with IABP. At 30 days, intravascular LVAD use was associated with significantly higher bleeding (19.1% vs 14.5%; OR, 1.35; 95% CI, 1.04-1.76), KRT (12.2% vs 7.0%; OR, 1.88; 95% CI, 1.30-2.73), and mean cost (+$51 680; 95% CI, $31 488-$75 178). At 1 year, the association of intravascular LVAD use with bleeding (29.7% vs 24.3%; HR, 1.36; 95% CI, 1.05-1.75), KRT (18.1% vs 10.9%; HR, 1.95; 95% CI, 1.35-2.83), and mean cost (+$46 609; 95% CI, $22 126-$75 461) persisted. In this propensity-matched analysis of patients undergoing PCI for AMI complicated by CS, intravascular LVAD use was associated with increased short-term and 1-year risk of mortality, bleeding, KRT, and cost compared with IABP. There is an urgent need for additional evidence surrounding the optimal management of patients with AMI complicated by CS.

Intravascular Microaxial Left Ventricular Assist Device for Acute Myocardial Infarction With Cardiogenic Shock—A Call for Evidence of Benefit

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Combining Repeated VT Ablations with Axillary Transaortic Microaxial Left Ventricular Assist Device Support to Successfully Bridge to Heart Transplantation in a Patient with Recurrent Electrical Storm - A Case Report

<h3>Introduction</h3> End-stage heart failure is associated with high morbidity and mortality rates and can be complicated by sustained ventricular tachycardia (VT) with increased risk of ventricular fibrillation and sudden cardiac death. Transaortic microaxial left ventricular assist devices can be surgically implanted using an axillary approach and provide temporary mechanical circulatory support (tMCS). We report a case of combining repeated VT ablations with tMCS to successfully bridge to heart transplantation (OHT) in a patient with recurrent electrical storm. <h3>Case Report</h3> We report a case of a 66-year-old male with dilated cardiomyopathy due to myocarditis, who suffered a non-ST-elevation myocardial infarction due to three-vessel coronary artery disease. Despite urgent coronary bypass surgery, he showed no improvement of heart function and presented episodes of sustained VT. Due to poor RV function a durable left ventricular assist device was deemed not a suitable therapeutic strategy and he was evaluated for OHT. He underwent VT/premature ventricular contraction ablation in three areas of the right ventricular outflow tract (RVOT; free wall, posterolateral and HIS area). However, he suffered an intrahospital cardiac arrest with refractory cardiogenic shock and a resuscitation time of 75 minutes with subsequent veno-arterial extracorporeal membrane oxygenation (VA-ECMO) implantation. Following the surgical implantation of a transaortic microaxial pump, the VA-ECMO was successfully weaned. He showed good neurological outcome and underwent physiotherapy with full mobilization and ambulation on the ward. Under hemodynamic support he underwent another high-risk VT ablation and concomitant stellate ganglion blockade and postprocedural stable sinus rhythm was achieved. After 34 days of tMCS the patient underwent OHT. Postoperative course was uneventful. 13 days after OHT he was discharged to a rehabilitation facility, after which he was discharged home after three weeks. <h3>Summary</h3> In patients with end-stage heart failure and recurrent electrical storm a surgically implanted transaortic microaxial pump can allow hemodynamic stabilization during high-risk procedures such as VT ablation and neuromodulation as a feasible bridge to OHT strategy.

Temporary Extracorporeal Femoro-Femoral Crossover Bypass to Treat Acute Limb Ischemia due to Occlusive Femoral Transaortic Microaxial Left Ventricular Assist Device – A Novel Technique and Case Series

The Impella transaortic microaxial left ventricular assist device (MLVAD) bears the risk of severe ipsilateral limb ischemia due to its percutaneous insertion through the common femoral artery (CFA). As long as the MLVAD is required for cardio - circulatory support, treatment options are limited. Therefore, we developed a temporary extracorporeal femoral - femoral crossover bypass to restore and maintain perfusion of the affected leg. From October 2018, we treated all patients with severe limb ischemia due to the MLAVD with a femoral - femoral crossover bypass. For comparison, a consecutive cohort of patients undergoing placement of the MLAVD between January 2011 and October 2018 was identified. The primary outcome is the feasibility and safety of our percutaneously established extracorporeal femoral - femoral crossover bypass. Between January 2011 and July 2019, 25 of 245 (10.3%) patients developed a severe ipsilateral limb ischemia following the MLVAD placement. Until October 2018, 20 patients were treated conventionally (C - cohort) and since October 2018, five (consecutive) patients have been treated by an extracorporeal femoral - femoral cross over bypass (BP - Cohort). Following the BP - procedure, an immediate improvement of the perfusion was seen in all patients. Limb salvage was documented in 100% of our patients and 30 - day mortality was 60% in both groups. This is the first case series reporting on this novel technique. We demonstrated that the percutaneous creation of an extracorporeal crossover bypass is feasible, safe and effective and should therefore be promoted.

What’s Old Is New Again

Microaxial Left Ventricular Assist Device Versus Intraaortic Balloon Pump as a Bridge to TransplantThe Annals of Thoracic SurgeryPreviewHeart transplantation (HTx) candidates supported by Impella (Abiomed, Danvers, MA) or intraaortic balloon pump (IABP), who demonstrate evidence of cardiogenic shock, may qualify for waitlist status 2 without exception under the new donor heart allocation system. However limited data comparing Impella versus IABP as a bridge to HTx exist. Full-Text PDF

Microaxial Left Ventricular Assist Device Versus Intraaortic Balloon Pump as a Bridge to Transplant

BackgroundHeart transplantation (HTx) candidates supported by Impella (Abiomed, Danvers, MA) or intraaortic balloon pump (IABP), who demonstrate evidence of cardiogenic shock, may qualify for waitlist status 2 without exception under the new donor heart allocation system. However limited data comparing Impella versus IABP as a bridge to HTx exist. MethodsThe United Network for Organ Sharing database was queried for adults listed and/or transplanted between January 2014 and February 2020. Temporal trends regarding Impella and IABP use were analyzed using the Royston trend test and χ2 test. Waitlist mortality was examined using Fine-Gray competing risks analysis. Post-HTx 180-day survival was analyzed using the Kaplan-Meier method and Cox proportional hazards models. ResultsImpella use increased from 0.2% in 2014 to 2.6% in 2020 (P < .01) and from 0.4% to 2.2% (P < .01) under the new allocation system. IABP use increased from 4.9% in 2014 to 27.6% in 2020 (P < .01) and from 6.7% to 26.6% (P < .01) under the new allocation system. Post-HTx survival was similar between groups (adjusted hazard ratio, 0.82; 95% CI, 0.38-1.78) despite more preoperative ventilation (3.6% vs 1.1%, P = .01) and higher model for end-stage liver disease excluding international normalized ratio scores (12.4 vs 9.5, P < .01) among Impella-supported recipients. Under the new system Impella-supported candidates were at higher risk of waitlist delisting compared with IABP-supported candidates (subhazard ratio, 2.42; 95% CI, 1.19-4.92). ConclusionsPost-HTx survival is comparable between Impella-supported and IABP-supported recipients despite worse preoperative profiles among Impella-supported recipients. Higher risk of waitlist delisting among Impella-supported candidates under the new allocation system requires close attention.

Temporary extracorporeal femoro-femoral crossover bypass to treat critical limb ischemia due to occlusive femoral transaortic microaxial left ventricular assist device – a novel technique and case series

Abstract Objective The Impella transaortic microaxial left ventricular assist device (MLVAD) bears the risk of severe ipsilateral limb ischemia due to it´s percutaneous insertion through the common femoral artery (CFA). As long as the MLVAD is required for cardio-circulatory support, treatment options are limited. Therefore, we developed a temporary extracorporeal femoro-femoral crossover bypass to restore and maintain perfusion of the affected leg. Methods From October 2018, we treated all patients with severe limb ischemia due to the MLAVD with a femoro-femoral crossover bypass. For comparison, a consecutive cohort of patients undergoing placement of the MLAVD between January 2011 and July 2019 was identified. For those patients who experienced limb ischemia after Impella placement, data on age, gender, BMI and diabetes, underlying cardiac condition, duration of Impella pump in place, limb complications, limb salvage procedure, need for additional surgical procedure on the affected limb (e.g. fasciotomy) were recorded. The primary outcome is the feasibility and safety of our percutaneously established extracorporeal femoro-femoral crossover bypass. As secondary outcomes, we report overall 30 day mortality and limb salvage rates. Results Between January 2011 and July 2019, 25 of 245 (10.3%) patients developed a severe ipsilateral limb ischemia following the MLVAD placement. Until October 2018, 20 patients were treated conventionally (C-cohort) and since October 2018, five (consecutive) patients have been treated by an extracorporeal femoro-femoral cross over bypass (BP-Cohort). Following the BP-procedure, an immediate improvement of the perfusion was seen in all patients. The bypass remained in place during a median of 5 days. Limb salvage was documented in 100% of our patients and 30 days mortality was 60% in both groups. Conclusion This is the first case series reporting on this novel technique. We demonstrated that the percutaneous creation of an extracorporeal femoro-femoral crossover bypass is feasible, safe and effective and should therefore be promoted in the future.

Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock

Acute myocardial infarction (AMI) complicated by cardiogenic shock is associated with substantial morbidity and mortality. Although intravascular microaxial left ventricular assist devices (LVADs) provide greater hemodynamic support as compared with intra-aortic balloon pumps (IABPs), little is known about clinical outcomes associated with intravascular microaxial LVAD use in clinical practice. To examine outcomes among patients undergoing percutaneous coronary intervention (PCI) for AMI complicated by cardiogenic shock treated with mechanical circulatory support (MCS) devices. A propensity-matched registry-based retrospective cohort study of patients with AMI complicated by cardiogenic shock undergoing PCI between October 1, 2015, and December 31, 2017, who were included in data from hospitals participating in the CathPCI and the Chest Pain-MI registries, both part of the American College of Cardiology's National Cardiovascular Data Registry. Patients receiving an intravascular microaxial LVAD were matched with those receiving IABP on demographics, clinical history, presentation, infarct location, coronary anatomy, and clinical laboratory data, with final follow-up through December 31, 2017. Hemodynamic support, categorized as intravascular microaxial LVAD use only, IABP only, other (such as use of a percutaneous extracorporeal ventricular assist system, extracorporeal membrane oxygenation, or a combination of MCS device use), or medical therapy only. The primary outcomes were in-hospital mortality and in-hospital major bleeding. Among 28 304 patients undergoing PCI for AMI complicated by cardiogenic shock, the mean (SD) age was 65.0 (12.6) years, 67.0% were men, 81.3% had an ST-elevation myocardial infarction, and 43.3% had cardiac arrest. Over the study period among patients with AMI, an intravascular microaxial LVAD was used in 6.2% of patients, and IABP was used in 29.9%. Among 1680 propensity-matched pairs, there was a significantly higher risk of in-hospital death associated with use of an intravascular microaxial LVAD (45.0%) vs with an IABP (34.1% [absolute risk difference, 10.9 percentage points {95% CI, 7.6-14.2}; P < .001) and also higher risk of in-hospital major bleeding (intravascular microaxial LVAD [31.3%] vs IABP [16.0%]; absolute risk difference, 15.4 percentage points [95% CI, 12.5-18.2]; P < .001). These associations were consistent regardless of whether patients received a device before or after initiation of PCI. Among patients undergoing PCI for AMI complicated by cardiogenic shock from 2015 to 2017, use of an intravascular microaxial LVAD compared with IABP was associated with higher adjusted risk of in-hospital death and major bleeding complications, although study interpretation is limited by the observational design. Further research may be needed to understand optimal device choice for these patients.

Management of Severe Cardiogenic Shock With the Impella Microaxial Left Ventricular Assist Device: Early Experience in a Single Center

Despite recent advances in therapeutic interventions and improvements in medical care, cardiogenic shock is still associated with high mortality. The Impella left ventricular assist device is a microaxial pump designed to unload the left ventricle and provide temporary support in the setting of severe left ventricular dysfunction. The purpose of this study is to report our initial experience with the Impella device in patients with severe cardiogenic shock.

The Impella(R) LP 5.0 as a bridge to long-term circulatory support

Multi-organ failure (MOF) secondary to bi-ventricular cardiac dysfunction is a major therapeutic challenge. In addition to aggressive medical therapy, it frequently requires circulatory support with uni- or bi-ventricular assist devices. The Impella LP 5.0 is a new microaxial left ventricular assist device (LVAD). Microaxial LVADs have been used for short-term circulatory support in patients with cardiogenic shock due to myocarditis, post coronary artery bypass grafting (CABG), or during high-risk percutaneous coronary interventions (PCI). We present a case of a patient in bi-ventricular failure successfully bridged to permanent circulatory support. Relative merits of this therapeutic approach are outlined and discussed.