Impella Device Research Articles

Clinical indications and outcomes of Impella devices for severe cardiogenic shock in COVID-19 patients: a systematic review

Background: Coronavirus disease 2019 (COVID-19) can present with significant cardiac dysfunction, including cardiogenic shock. Mechanical circulatory support with an Impella device may be utilized in these patients to support and offload native right ventricle (RV) and left ventricle (LV) functions. This systematic review aims to describe clinical indications, management, laboratory data, and outcomes in patients with severe cardiogenic shock from COVID-19 treated with an Impella device. Methods: A PRISMA-directed systematic review was performed and prospectively registered in PROSPERO. The databases accessed included PubMed/MEDLINE, Scopus, and ScienceDirect. Quality and risk of bias assessments were completed using the Joanna Briggs Institute (JBI) checklist for case reports. Results: A total of 16 records were included in the qualitative synthesis; 8/16 (50%) of the patients were men. The average age was 39 years (SD: 14.7). The biventricular Impella (BiPella) approach was recorded in 3/16 (18.75%) patients. A total of 4/16 (25%) individuals required renal replacement therapy (RRT). Single-device usage was observed in three cases: 2/16 Impella CP (12.5%) and 1/16 Impella RP (6.25%). Treatment of COVID-19 myocarditis included a wide range of antivirals and immunomodulators; 8/16 (50%) cases needed ECMO (extracorporeal membrane oxygenation) support. Overall, only 2/16 (11.7%) individuals died. Conclusions: Sixteen reported individuals have received an Impella implanted with a mortality rate of 11.7%. Concurrent use of RRT and ECMO implantation was often observed. Overall, the Impella device is an effective and safe strategy in the management of COVID-19-related cardiogenic shock. Future studies should include long-term results.

Carboxyhemoglobin and methemoglobin levels to diagnose hemolysis in patients supported with mechanical circulatory support devices

Decreased systemic oxygen delivery derived from gas exchange abnormalities in severe hemolysis may complicate critically ill patients supported with mechanical circulatory support devices such as the Impella device and others. Severe hemolysis releases free hemoglobin in plasma causing elevation of carboxyhemoglobin and methemoglobin levels in blood. Hemolysis induced decline in hemoglobin and oxyhemoglobin saturation may drastically reduce the arterial oxygen content in blood, therefore decreasing systemic oxygen delivery, causing or worsening lactic acidosis. These patients develop significant hypoxemia with misleadingly normal oxygen saturation measured by standard pulse oximetry. The objective of this study is to report two cases that illustrate these physiologic phenomena, emphasizing the value of monitoring carboxyhemoglobin and methemoglobin levels to readily identify and modify the management of ongoing hemolysis secondary to invasive supportive devices.

Comprehensive simulation training for E-CPR improves the 1-year mortality of patients with refractory cardiac arrest

Abstract Background Extracorporeal cardiopulmonary resuscitation (E-CPR) has been utilized as a rescue strategy for patients with refractory cardiac arrest (CA). The collapse to ECMO initiation time (CTET) has a strong correlation with survival, but decisions of initiating E-CPR are sometimes difficult to make and the opportunities for developing teamwork skills are limited. Therefore, to improve the outcome of E-CPR, we developed a comprehensive simulation-based E-CPR training program. Purpose In the present study we assessed whether the E-CPR training improved the mortality and the neurological outcome. Methods E-CPR simulation training program was carried out twice a year to the medical team using a mock vascular model since October 2017. We enrolled 177 consecutive patients who underwent E-CPR from January 2012 to January 2022. The patients were divided into two groups: the pre-simulation and the post-simulation. The outcome was CTET, 1-year mortality and favorable neurological outcomes defined as cerebral performance categories (CPC) of 1 or 2 at hospital discharge. Results There were 86 patients in the Pre-simulation group and 91 patients in the Post-simulation group. No differences were found in age, rates of witnessed CA and bystander-CPR, shockable rhythms, or acute coronary syndrome (ACS). The frequency of use of the intra-aortic balloon pump was significantly higher in the Pre-simulation group compared to the Post-simulation group (74% vs. 23%; p <0.001), while the Impella device was only used in the Post-simulation group (46%), due to its availability in our institution since October 2017. Compared to Pre-simulation group, the CTET was significantly shorter (44 minutes vs. 33 minutes; p = 0.001), and the Kaplan-Meier analysis for 1-year survival was significantly higher with the Post-simulation group (12% vs. 23%; p = 0.02 by log-rank test). The rate of favorable neurological outcome was not significantly different between the two groups. However, when patients were analyzed separately by in-hospital CA (IHCA) and out-of-hospital CA (OHCA), no significant difference was observed in IHCA, whereas OHCA demonstrated a significant reduction in both door to ECMO initiation time and CTET, leading to a significant improvement in neurological outcome (3% vs. 20%; p = 0.04). Multivariate cox proportional hazard analysis revealed that age (hazard ratio [HR], 1.22 [10 years increase]; 95% confidence interval [CI], 1.07-1.41, p = 0.004), initial shockable rhythm (HR, 0.61; 95%CI 0.41-0.91, p = 0.01), combined use of Impella (HR, 0.59; 95% CI, 0.37–0.98, p = 0.02), and CTET (HR, 1.02, 95%CI, 1.01-1.03, p <0.0001) were significantly associated with the 1-year mortality. Conclusions The E-CPR training significantly improved the collapse to ECMO time. The faster deployment of ECMO increased the 1-year survival rate in patients with refractory CA. Additionally, the use of Impella (ECPELLA) may have improved the survival rate.The effect of simulation trainingKaplan-Meier analysis

Safety and Effectiveness of an Anti-Xa-based Unfractionated Heparin Protocol for Impella Percutaneous Ventricular Assist Devices.

Background: Impella devices are used for mechanical circulatory support in patients with cardiogenic shock or those undergoing high-risk percutaneous coronary intervention (PCI). Anticoagulation protocols in this population are not well established and are complicated by concomitant use of purge solutions containing unfractionated heparin (UFH) and intravenous UFH continuous infusion (CI) for systemic anticoagulation. Objectives: To evaluate thrombotic and bleeding complications when using a novel UFH protocol with a reduced initial UFH CI dose of 6 units/kg/hour targeting an anti-Xa goal of 0.3 to 0.5 units/mL in patients receiving Impella support. Methods: This single-center, retrospective study included 41 patients on Impella support who received an UFH purge solution and/or an IV UFH infusion. The primary outcome was overall composite bleeding. Secondary outcomes included thrombotic events and systemic UFH exposure. An exploratory analysis was performed to identify risk factors for bleeding. Results: Anti-Xa values were in therapeutic range 46% of the time while on support (interquartile range 16.6%-75%), with a median IV UFH dose of 6 units/kg/hour. The overall bleeding rate was 29.2%, with 6 minor bleeds and 2 major bleeds with no fatal bleeding or intracranial hemorrhage. Rate of overall thrombosis was 4.9%, including 1 ischemic stroke and 1 occurrence of limb ischemia. Conclusion: Use of a modified UFH protocol to target an anti-Xa goal of 0.3 to 0.5 units/mL resulted in bleeding and thrombotic event rates similar to previous literature. This protocol utilizing an initial rate of 6 units/kg/hour may be a useful approach to achieve therapeutic anticoagulation while accounting for UFH exposure from the purge solution and minimizing need for frequent calculations.

Abstract 14751: A Rare Presentation of 5-Fluorouracil-Induced Cardiotoxicity

Background: 5-fluorouracil (5-FU) is associated with numerous cardiotoxic effects, most commonly chest pain and acute coronary syndrome. Less common effects include arrhythmias, myocarditis, pericarditis, and heart failure. We present a rare case of 5-FU causing cardiogenic shock. Case: A 54-year-old man with metastatic esophageal adenocarcinoma presented at 3:50 with chest pain that began the day before at 16:00, shortly after starting a 5-FU pump. Electrocardiogram (EKG) showed normal sinus rhythm with no ST or T wave changes. High sensitivity troponin T was 18 ng/L, followed by 24 ng/L at 1 hour and 81 ng/L at 6 hours. Computed tomography angiography (CTA) ruled out pulmonary embolism. Transthoracic echocardiogram (TTE) showed a globally reduced left ventricular ejection fraction (LVEF) of 35-40%. The patient received metoprolol and was scheduled for coronary CTA to investigate for coronary disease. Over the next few hours, he continued to report chest pain. Repeat troponin at 18:12 was 235 ng/L. Repeat EKG showed new anterior ST depressions. Posterior EKG did not show ST elevations. Repeat TTE revealed LVEF of 15%. The patient underwent left and right heart catheterization at 21:14, which showed normal coronary arteries, pulmonary artery pressure 50/31 mmHg (mean 38 mmHg), pulmonary capillary wedge pressure 36 mmHg, and cardiac index 1.1 L/min/m 2 . An Impella device was placed for circulatory support. He was treated with vasopressors and milrinone. Given concern for 5-FU toxicity, he received the antidote uridine triacetate 10 g IV every 6 hours for 5 days. LVEF improved to 70%. He was treated with nifedipine for possible coronary vasospasm. He was discharged 8 days later with heart failure medications. Conclusion: The incidence of cardiotoxicity from 5-FU ranges from 1.2-18%. Mechanistic theories include coronary vasospasm and direct cellular injury. Symptoms usually present within 12 hours of initiation but may present up to 2 days later. Management includes stopping the offending agent and starting anti-anginal drugs and uridine triacetate. Uridine triacetate is deacetylated to uridine, which prevents cell damage and death via competitive inhibition of 5-FU.

Abstract 15838: To Tear Again: Recurrent and Complicated Spontaneous Coronary Artery Dissection

Background: SCAD is as an infrequent cause of ACS with a predominance affecting a mean age of 42.6 years and 82% of patients being female. SCAD can be classified as primary or secondary, where primary dissections occur spontaneously, and secondary causes involve the aortic root and are a direct consequence of coronary interventions, surgery, or trauma. Case: 26-year-old female with no previous cardiac or significant family history presented with severe mid-sternal chest pain, radiating to both arms and back, and associated with nausea and cold sweats. Cardiovascular exam was unremarkable. Troponins were elevated at 0.18 and 0.59. Echo showed anteroseptal wall hypokinesis, consistent with Takotsubo cardiomyopathy. ECG showed anterolateral ST elevations. The patient went for cardiac catheterization and had spontaneous dissection of the left main into the LAD/diagonal with 100% occlusion of the LAD and 99% occlusion of the ramus/circumflex. Impella device was implanted due to persistent shock, V. fib., and cardiac arrest. Stents were placed in the proximal, mid, and distal LAD, ramus/circumflex, and LCA. The patient had an LVEF of 25%. Follow-up echo showed an LVEF of 30%, with subsequent Impella removal. Following week, LVEF increased to 45-50%. The patient began aspirin 81 mg, atorvastatin 10 mg, bisoprolol 5 mg, prasugrel 10 mg, and rivaroxaban 10 mg. Over the next few years, she had recurrent chest pain, syncope, palpitations, and a non-viable pregnancy at 12 weeks of gestation due to premature bleeding complications. 3 years after the initial SCAD, the patient presented with spiral dissection of the RCA, requiring three stents. LVEF was 30%. She is being managed with aspirin 81 mg, atorvastatin 20 mg, bisoprolol 10 mg, and prasugrel 10 mg. Discussion: The initial age of presentation of this patient makes this case unique. Risk of recurrent SCAD was present in 17% of patients at a median age of 2.8 years after the initial episode. Triggers for recurrent SCAD include extreme emotional/physical stress and pregnancy. Pregnancy it is not recommended in this patient population. Beta-blockade and adequate BP control are mainstay in medical management and reduce the reoccurrence of SCAD.

Abstract 16318: Using Arterial Recoil for Large Bore Access Closure After Impella Assist Device Removal

Background: The use of Impella assist device for high-risk percutaneous coronary interventions (HR-PCI) and cardiogenic shock (CS) has increased in the last decade and requires a large bore arterial access (LBA). However, LBA closure following Impella removal is associated with significant complications. Objective: To describe the safety and efficacy of a novel method of LBA closure using arterial recoil following Impella removal. Methods: A descriptive, retrospective review of electronic medical records in all patients that underwent LBA closure using this novel method from July 1, 2018, to June 30, 2022, was performed at the University of Mississippi Medical Center. The procedure involves controlled downsizing of the arterial sheath from 12 French (Fr) to 6 Fr with intermittent compression to allow patent hemostasis facilitated by arterial recoil. Baseline characteristics and outcomes including closure success, immediate or delayed (>6 hours) bleeding, and access site hematoma/pseudoaneurysm were included. Results: Of 103 patients with Impella placement, 20 (19%) underwent LBA closure with the arterial recoil method. Patients were predominantly male (80%) and White (55%) with a mean age of 65 + 16 years. The most common indication for Impella placement was HR-PCI (40%), followed by non-acute myocardial infarction (AMI) CS (35%), and AMI-CS (25%). After downsizing of the femoral sheath to 6 Fr, 14 patients (70%) underwent manual compression, 3 patients had a 6 Fr sheath left in place to maintain access, 2 patients underwent placement of a Perclose device, and 1 patient underwent placement of a Vascade device. Successful LBA closure was performed in all patients with no immediate or delayed bleeding complications. A total of 5 patients (25%) died inpatient, including one patient who had palliative removal of the Impella device; the deaths were unrelated to complications of Impella removal. Conclusions: LBA closure post-Impella removal with this novel method is safe and effective. Further prospective studies are needed to ascertain its comparative efficacy.

Abstract 11621: Impact of Data Reporting on Outcome Analyses of Intra-Aortic Balloon Pump versus Impella Devices in Bridging Adult Heart Transplant Patients

Introduction: There is a paucity of evidence to guide temporary mechanic circulatory support (tMCS) as bridge to heart transplant (HTx). Question: Can matching techniques reveal device-related effects on peri-HTx outcomes between IABP (Intra-Aortic Balloon Pump) and Impella? Methods: Using the UNOS registry, this retrospective study selected adult patients listed as status 2 on IABP or Impella (V5.0 or V5.5) from 10/2018 to 1/2023. We assessed demographic, medical, hemodynamic, and biochemical data. Primary outcome was failure of status 2 listing strategy (composite of waitlist mortality, escalation of tMCS, and deactivation or delisting due to medical instability). Propensity scores were calculated using logistic regression and matching with a k-nearest neighbors classifier. Results: 3505 IABP and 648 impella patients were identified based on missingness: (1) No missing data (n = 991, 23%), (2) missing hemodynamic data (n = 1606, 39%), (3) missing both hemodynamic and biochemical data(n = 1664, 40%), and (4) the completedataset (n = 4153). Prior to matching,, failure on status 2 occurred in 12.1% of all patients, 11% of IABP patients, and 17.7% of impella patients in group 4 (p < 0.01). After matching, only in group 4 did impella patients have a significantly higher rate of failure on status 2 (12.6 vs 18%, p < 0.01). Average treatment effect for impella on failure of status 2 was nonsignificant for group 1(ATE 0.06, 95%CI -0.016-0.166) and significant for group 2(ATE 0.06; 95% 0.001-0.125), group 3 (ATE 0.05, 95%CI 0.012-0.094), and group 4 (ATE 0.067, 95%CI 0.037-0.102) cohorts, favoring IABP. There was an increase in request for status 2 by exception in group 4 for impella patients (9.8% vs 8.6%, p=0.04). Conclusion: IABP versus Impella had minimal to no impact on failure on status 2 for matched cohorts. Differences appeared when either biochemical or hemodynamic data were omitted. Complete data availability is crucial for developing trustworthy and actionable models.

Use of the Impella device in cardiogenic shock

Use of the Impella device in cardiogenic shock

Growing Evidence for LV Unloading in VA ECMO.

Impressively increasing availability of mechanical circulatory/cardiac support systems (MCSs) worldwide, together with the deepening of the knowledge of critical care medical practitioners, has inevitably led to the discussion about further improvements of intensive care associated to MCS. An appealing topic of the left ventricle (LV) overload related to VA ECMO support endangering myocardial recovery is being widely discussed within the scientific community. Unloading of LV leads to the reduction in LV end-diastolic pressure, reduction in pressure in the left atrium, and decrease in the LV thrombus formation risk. Consequently, better conditions for myocardial recovery, with comfortable filling pressures and a better oxygen delivery/demand ratio, are achieved. The combination of VA ECMO and Impella device, also called ECPELLA, seems to be a promising strategy that may bring the improvement of CS mortality rates. The series of presented trials and meta-analyses clearly showed the potential benefits of this strategy. However, the ongoing research has brought a series of new questions, such as whether Impella itself is the only appropriate unloading modality, or any other approach to unload LV would be beneficial in the same way. Benefits and potential risks of LV unloading and its timing are being discussed in this current review.

Abstract P368: A Case Of Cardiac Arrest In A Healthy 21-year-old Man Due To Ischemic Cardiomyopathy

Background: Sudden cardiac arrest due to coronary artery disease (CAD) is an important matter of research, particularly among young adults with no overt heart disease. Despite the rare incidence of myocardial infarction (MI) in patients aged < 45 years, it is necessary to identify the etiologies and the angiographic profile of the disease at a young age. Case report: A 21-year-old male with no past medical history presented with cardiac arrest. The patient was playing basketball, and he went for a water break. Then, he was found unconscious with no pulse. At the emergency department, the patient was hypoxemic (oxygen saturation: 88% on room air) with T wave inversions on electrocardiogram. Laboratory testing showed elevations of lactate, creatine kinase, creatinine, liver function parameters, lactic acid, and white blood cells. An echocardiogram showed an ejection fraction (EF) of 25% and acute non-ST elevation MI. Coronary angiography revealed a ruptured plaque and total occlusion of the proximal left anterior descending (LAD) coronary artery. The patient was intubated and he underwent a successful percutaneous coronary intervention (PCI) and stenting of the occluded LAD. An Impella blood pump (Impella 3.5) was implanted, which led to an improvement of the EF (42%). On the next day, the Impella device was removed; the patient passed the spontaneous breathing trial and was extubated. Patient started on carvedilol 3.125 mg twice daily, spironolactone 25 mg daily, aspirin, ticagrelor and sacubitril/ valsartan. Follow-up was advised at the outpatient clinic for the possible placement of an automated implantable cardioverter defibrillator. Conclusion and clinical implications: Among young patients with MI due to ischemic cardiomyopathy, echocardiogram and coronary angiography are diagnostic, and emergency PCI results in a significant improvement.

Complications and Outcomes of Impella Treatment in Cardiogenic Shock Patients With and Without Acute Myocardial Infarction.

Background In patients with cardiogenic shock (CS), acute myocardial infarction (AMI) is the most common cause, and a percutaneous microaxial ventricular assist device (Impella, Abiomed, Danvers, MA) is a choice for temporary mechanical circulatory support. However, data are limited on complications and outcomes of Impella treatment in patients with CS with and without AMI. Methods and Results Using nationwide prospective registry data in Japan, we included a total of 2047 patients with CS in whom the Impella devices were successfully placed between February 2020 and December 2021. Patients were divided into 2 groups according to the primary indication for the Impella use: AMI versus non-AMI. The primary end point was a composite of in-hospital all-cause death and major complications. Of the 2047 patients, the Impella was indicated for AMI in 1337 (65.3%). In the group without AMI, myocarditis was the leading cause of CS. Patients with AMI-CS were older and more likely to have cardiovascular risk factors than those with non-AMI-CS. The rates of in-hospital mortality (46.0% versus 43.9%, P=0.38) and major complications (35.2% versus 34.7%, P=0.85) were similar between the 2 groups. Overall, multivariable analysis identified older age, higher body mass index, previous transient ischemic attack or stroke, out-of-hospital cardiac arrest, and the Impella 5.0 as factors significantly associated with the primary end point. Conclusions The use of Impella in patients with and without AMI was related to similar clinical outcomes with high mortality and complication rates. Further studies are needed to identify patients who may benefit from the Impella devices in CS. Registration URL: https://www.umin.ac.jp/english. Identifier: UMIN000033603.

Implanting Impella 5.5 under Local Anesthesia.

Surgically implanted Impella 5.5. delivers full cardiac support and left ventricular unloading for patients with heart failure. So far, the Impella device is implanted under general anesthesia (GA). A total of n = 3 critically ill patients presented with acute heart failure in need of cardiac support. All patients suffered cardiogenic shock of varying etiology. Due to hemodynamically unstable conditions, GA was avoided. All implantations were performed solely under local anesthesia (LAS) without any regional anesthesia. All implantations were performed successfully under LAS with 60 mL of mepivacaine of 2% solution and ropivacaine of 1% solution (50:50 ratio). All devices were placed from the right axillary artery. One patient needed hematoma evacuation several days after surgery. No other Impella-related complication was observed. A surgical implantation of the Impella 5.5 device under LAS is feasible and safe. Despite the small number of cases, no disadvantage can be described at the present moment. Our series should encourage physicians to perform the procedure under LAS.

Sex Differences in pLVAD-Assisted High-Risk Percutaneous Coronary Intervention: Insights From the PROTECT III Study

BackgroundPrior studies have found that female patients have worse outcomes following high-risk percutaneous coronary intervention (HRPCI). ObjectivesThe authors sought to evaluate sex-based differences in patient and procedural characteristics, clinical outcomes, and safety of Impella-supported HRPCI in the PROTECT III study. MethodsWe evaluated sex-based differences in the PROTECT III study; a prospective, multicenter, observational study of patients undergoing Impella-supported HRPCI. The primary outcome was 90-day major adverse cardiac and cerebrovascular events (MACCE)—the composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization. ResultsFrom March 2017 to March 2020, 1,237 patients (27% female) were enrolled. Female patients were older, more often Black, more often anemic, and had more prior strokes and worse renal function, but higher ejection fractions compared to male patients. Preprocedural SYNTAX score was similar between sexes (28.0 ± 12.3). Female patients were more likely to present with acute myocardial infarction (40.7% vs 33.2%; P = 0.02) and more often had femoral access used for PCI and nonfemoral access used for Impella device implantation. Female patients had higher rates of immediate PCI-related coronary complications (4.2% vs 2.1%; P = 0.004) and a greater drop in SYNTAX score post-procedure (−22.6 vs −21.0; P = 0.04). There were no sex differences in 90-day MACCE, vascular complications requiring surgery, major bleeding, or acute limb ischemia. After adjustment using propensity matching and multivariable regression, immediate PCI-related complications was the only safety or clinical outcome that was significantly different by sex. ConclusionsIn this study, rates of 90-day MACCE compared favorably to prior cohorts of HRPCI patients and there was no significant sex differences. (The PROTECT III Study is a substudy of The Global cVAD Study [cVAD]; NCT04136392)

Clinical outcomes and predictors of success with Impella weaning in cardiogenic shock: a single-center experience.

Cardiogenic shock (CS) is a severe syndrome with poor prognosis. Short-term mechanical circulatory support with Impella devices has emerged as an increasingly therapeutic option, unloading the failing left ventricle (LV) and improving hemodynamic status of affected patients. Impella devices should be used for the shortest time necessary to allow LV recovery because of time-dependent device-related adverse events. The weaning from Impella, however, is mostly performed in the absence of established guidelines, mainly based on the experience of the individual centres. The aim of this single center study was to retrospectively evaluate whether a multiparametrical assessment before and during Impella weaning could predict successful weaning. The primary study outcome was death occurring during Impella weaning and secondary endpoints included assessment of in-hospital outcomes. Of a total of 45 patients (median age, 60 [51-66] years, 73% male) treated with an Impella device, 37 patients underwent impella weaning/removal and 9 patients (20%) died after the weaning. Non-survivors patients after impella weaning more commonly had a previous history of known heart failure (p = 0.054) and an implanted ICD-CRT (p = 0.01), and were more frequently treated with continuous renal replacement therapy (p = 0.02). In univariable logistic regression analysis, lactates variation (%) during the first 12-24 h of weaning, lactate value after 24 h of weaning, left ventricular ejection fraction (LVEF) at the beginning of weaning, and inotropic score after 24 h from weaning beginning were associated with death. Stepwise multivariable logistic regression identified LVEF at the beginning of weaning and lactates variation (%) in the first 12-24 h from weaning beginning as the most accurate predictors of death after weaning. The ROC analysis indicated 80% accuracy (95% confidence interval = 64%-96%) using the two variables in combination to predict death after weaning from Impella. This single-center experience on Impella weaning in CS showed that two easily accessible parameters as LVEF at the beginning of weaning and lactates variation (%) in the first 12-24 h from weaning begin were the most accurate predictors of death after weaning.

Roadmap towards an institutional Impella programme for high-risk coronary interventions.

Coronary artery disease (CAD) and its complications remain the main cause of morbidity and mortality worldwide. Patients with extensive CAD and multiple comorbidities who require complex, high-risk percutaneous coronary intervention (HR-PCI) are at risk of haemodynamic instability and may require short-term mechanical circulatory support (MCS) during the procedure to maintain sufficient perfusion and prevent ischaemia. Impella is a microaxial continuous blood flow pump used for percutaneous support of the left ventricle in patients undergoing HR-PCI. Data from randomized controlled trials and registries suggested an advantage for Impella devices in patients undergoing HR-PCI, compared with other types of MCS. As a thorough understanding of the benefits and drawbacks of the Impella technology is crucial for patient outcomes, we provide a technological overview of Impella and share our experiences gathered during the implementation of institutional Impella programmes in Poland as a roadmap of selection and periprocedural care for patients treated with Impella in the setting of HR-PCI. We propose 10 steps for implementation of an institutional Impella programme for HR-PCI, including (i) dedicated staff training; (ii) standard operating procedure and troubleshooting algorithms prior to the first intervention; (iii) patient selection by the multidisciplinary Heart Team; (iv) patient preparation using multimodality imaging; (v) procedure planning in terms of large-bore access, equipment, and complete revascularization; (vi) starting with HR-PCI support; (vii) starting with femoral artery access in a patient without extensive peripheral artery disease; (viii) multidisciplinary care after the procedure; (ix) haemodynamic and laboratory monitoring to ensure immediate diagnosis of access-site complications, bleeding, haemolysis, acute kidney injury, and infections; and (x) careful revision of every HR-PCI case with the team.

CARC21: Outcomes in Transplant Recipients Bridged with Impella Support: A GUARDIAN-Heart Subgroup Analysis

Background: The 2018 UNOS allocation changes prioritized recipients bridged with temporary MCS, which has recently increased in use. Also in 2018, the SherpaPak Cardiac Transport System (CTS) was introduced, which maintains donor heart temperatures continuously between 4°C - 8°C, potentially minimizing freezing-related myocardial injury. A subgroup analysis of the GUARDIAN Heart Registry examined outcomes in transplant recipients bridged using Impella. Methods: The GUARDIAN registry is an international, multicenter registry assessing outcomes after heart transplant comparing CTS preservation and traditional ice-cold (ICE) donor heart storage. Retrospective review of clinical outcomes in recipients bridged with an Impella were examined using summary statistics. Further analysis with ongoing enrollment will be available for presentation. Results: A total of 47 recipients with an Impella device received donor hearts preserved using either CTS (n=33) vs ICE (n=14). The two groups had similar baseline characteristics except the CTS cohort had significantly longer average ischemic time (175.3 vs and 223.9 minutes, p value = 0.02, ICE vs CTS,) and greater procurement distance travelled (170.2 vs 447.5 miles, p value < 0.001, ICE vs CTS). Post-transplant rates of severe PGD were low (14.3% vs 3.0%, p value = 0.15, ICE vs CTS, respectively). Survival was excellent with 100% 30-day survival in both cohorts. Conclusions: Despite significantly longer ischemic times by 48.6 minutes and over 2.5x farther organ procurement distance travelled, the use of the CTS was associated with excellent post-transplant outcomes in patients bridged using an Impella device. Considering ischemic time is a known risk factor for post-transplant PGD, these data support continued study of CTS use to optimize outcomes, in particular in an era of increasing distance travelled for organ procurement and complex bridging strategies.

Transaxillary implantation of a temporary microaxial left ventricular assist device in a patient with a rectangular kinked subclavian artery.

Transaxillary implantation of a temporary microaxial left ventricular assist device in patients suffering from cardiogenic shock is an established technique. We present a 77-year-old female patient with severe mitral regurgitation. She underwent minimally invasive surgical mitral valve replacement. After an uneventful postoperative course, the patient developed acute heart failure on the 11th postoperative day. Transthoracic echocardiography revealed new onset of takotsubo cardiomyopathy with a severely decreased left ventricular ejection fraction. Implantation of a microaxial flow pump for left ventricular decompression was scheduled. Preoperative computed tomography revealed a rectangular course of the right subclavian artery. To advance the Impella we employed an introducer fitted over the guidewire behind the Impella device as a 'cue stick' to move the rigid part of the pump forward to overcome the kinking using a 'shuffleboard technique'. The haemodynamic situation stabilized immediately after implantation. The Impella 5.5 was successfully weaned after six days of support. In the event of (rectangular) kinking of the subclavian artery, the 'shuffleboard technique' can be used for successful positioning of the pump.

P71: Use of Veno-Arterial Extracorporeal Membrane Oxygenation and Impella for Cardiogenic Shock due to Cocaine Abuse

Background: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) and Impella left ventricular assist device individually offer cardiovascular support for cardiogenic shock patients. Each modality has its own benefits and downfalls. We present a case in which a patient developed cocaine-induced coronary vasoconstriction resulting in cardiogenic shock with rapid systemic decompensation. We employed VA-ECMO and subsequent Impella to recover the patient. Methods: A 26-year-old male with a history of Graves’ Disease and chronic cocaine abuse presented to the ED with chest pain following cocaine ingestion. EKG showed sinus tachycardia and ST-elevations throughout, suspicious of coronary vasospasm. Labs showed an acute kidney injury as well as shock liver. Bedside echocardiogram (ECHO) revealed a severely depressed left ventricular ejection fraction (LVEF) of <10%. He was hemodynamically unstable for coronary catheterization and was emergently cannulated for VA-ECMO via the right femoral artery and left femoral vein. After we gained stability and slowly weaned the inotropic support. A follow-up ECHO revealed a dilated left ventricle and biventricular failure. With better hemodynamics, we did a catheterization showing coronary vasoconstriction, “clamping down” of distal vessels. (Figure 1) Due to the left ventricular dilation and its poor contractility, we decided to place an Impella. Results: The patient was supported on VA ECMO for 4 days, at which his LVEF recovered to 30-35%. The Impella device remained for an additional 3 days as his labs and hemodynamics improved. His LVEF at Impella removal was 40%. The patient was discharged in 14 days with a normal LVEF. Conclusion: One of the major downfalls of VA-ECMO is the lack of left ventricular unloading resulting in increased afterload and hindering recovery. An Impella can be used to help vent the left ventricle. This combination has been shown in several studies to improve outcomes in patients with acute coronary syndrome. The technique was employed with successful cardiac recovery in a patient who developed cardiogenic shock from coronary vasospasm from cocaine use.Figure 1. Coronary angiography showing coronary vasoconstriction due to cocaine use

Bridging with surgical implanted Impella devices.

Bridging with surgical implanted Impella devices.