Impella Removal Research Articles

Successful implantation and removal of Impella 5.5 device via a 4-mm subclavian artery in an adult patient

AbstractRecently, the utilization of Impella 5.5, especially in the axillary position, has increased exponentially. The device provides excellent hemodynamic support for patients in cardiogenic shock, as a bridge to recover, transplant, or durable left ventricular device. However, small size arteries remain its main limitation. With a maximum diameter of 19 Fr (6.33 mm), the recommended artery size needed for implantation is 7 mm. In this case, we discuss the successful implantation and removal of the Impella 5.5 device into a patient, with a subclavian artery diameter of 4 mm, whose other short- and mid-term options for mechanical circulatory support were limited.

Abstract 4129273: Severe Mitral Regurgitation from Impella-associated Mitral Chordae Rupture with Successful Transcatheter Edge-to-edge Repair

Background: Limited data exists describing Impella-related mechanical mitral valve complications. Diagnosis and management can be challenging due to potential underestimation of mitral regurgitation severity from Impella and acute clinical deterioration upon removal. We present a case of successful mitral transcatheter edge-to-edge repair (TEER) for acute severe MR secondary to Impella-related mitral chordae rupture resulting in acute pulmonary edema post-Impella removal. Case Summary: A 37-year-old male smoker presented with chest pain complicated by cardiac arrest due to ventricular fibrillation. Spontaneous circulation could not be restored, requiring veno-arterial extracorporeal membrane oxygenation (VA-ECMO). Coronary angiography revealed total occlusion of the proximal left anterior descending artery, which was successfully stented. Transfemoral Impella CP was placed for left ventricular venting under fluoroscopy (Panel A) with TTE showing no complications. In the intensive care unit, the Impella was advanced under TTE guidance; its tip was found to be positioned deep at the base of the posteromedial pupillary muscle without suction alarms or ventricular arrhythmias on the following day (Panel B). Several days later, TTE revealed new eccentric MR with hyperdynamic left ventricular motion (Panel C). The patient remained hemodynamically stable after VA-ECMO decannulation with Impella at P4. Following Impella removal, he developed repeated flash pulmonary edema despite aggressive fluid removal attributed to acute severe MR secondary to a flail P3 leaflet with ruptured chordae tendineae confirmed by transesophageal echocardiography (Panel D). Given the patient's poor surgical candidacy with a STS score of 13.2%, the team proceeded with mitral TEER, successfully reducing MR severity from severe to mild with a single NT Mitraclip ® across the medial commissure (Panel E). His post-operative cardiac course was uneventful without recurrence of pulmonary edema. Discussion: Irreversible mechanical damage to the mitral valve apparatus caused by Impella placement and repositioning is a rare, potentially fatal complication requiring emergent intervention. Mitral TEER can be a viable salvage option for poor surgical candidates.

Transcaval Impella-Assisted CHIP-PCI and Transcaval TAVR With Impella Removal in Freshly Implanted TAVR

Transcaval Impella-Assisted CHIP-PCI and Transcaval TAVR With Impella Removal in Freshly Implanted TAVR

Clinical outcomes of the post-closure technique for arteriotomy closure with the Impella cardiac power percutaneous left ventricular assist device.

With the increasing utilization of endovascular mechanical circulatory support devices, such as the Impella CP (Abiomed), there is a need for standardized guidelines for its safe removal. Development of the Perclose post-closure technique was facilitated by the introduction of a new Impella repositioning sheath in 2019, which enabled re-access to the sidearm and stylet, rewiring of the access artery, and Impella sheath removal. Our retrospective single-center study included all patients undergoing Perclose post-closure technique for vascular access closure after Impella removal between 2018 and 2024. Forty-six patients, with a mean age of 63.8 years, predominantly male (82.6%), were included in the analysis. Indications for Impella placement included complex percutaneous coronary intervention (34.8%) and cardiogenic shock (CS) (heart failure-CS: 32.6%, myocardial infarction-CS: 21.7%). Clinically relevant complications were encountered in less than 5% of cases. No instances of covered stent placement, fasciotomy, amputation, or access site infections were reported. Our study underscores the safety of the Perclose post-closure technique following Impella removal in a diverse cohort of patients, with an overall clinically significant complication rate of less than 5%. The Perclose post-closure technique is a reliable and well-tolerated method for vascular access closure in patients undergoing Impella support.

A case of successful surgical treatment of left ventricular thrombus associated with acute myocardial infarction by Impella combined with extracorporeal membrane oxygenation approach.

The mortality rate in patients with heart failure complicated by cardiogenic shock following acute myocardial infarction (AMI) remains high, prompting research on mechanical circulatory support. Improved mortality rates have been reported with the early introduction of EcMELLA (Impella combined with extracorporeal membrane oxygenation, ECMO). However, clear indications for this treatment have not been established, given the associated risks and limitations related to access routes. Left ventricular thrombosis is traditionally considered a contraindication for Impella use. A 74-year-old man without specific medical history or coronary risk factors was diagnosed with Forrester IV heart failure due to cardiogenic shock complicated by AMI and left ventricular thrombosis. The patient underwent emergency coronary artery bypass surgery, intracardiac thrombus removal, and Dor surgery. Following cardiopulmonary bypass, ongoing heart failure was observed, necessitating the implementation of EcMELLA for circulatory support. Preoperative computed tomography showed that the bilateral subclavian arteries were too narrow (< 7mm) and anatomically unsuitable for traditional access methods. Thus, we introduced a single-access EcMELLA 5.5, through which the Impella was introduced and veno-arterial-ECMO blood was delivered from a single artificial vessel anastomosed to the brachiocephalic artery. The patient was weaned off veno-arterial-ECMO and extubated on postoperative day 3. By postoperative day 14, improved cardiac function allowed for Impella removal. The patient was discharged on postoperative day 31 with improved ambulation; thereafter, the patient returned to work. Thus, the single-access EcMELLA5.5 treatment strategy combined with Dor procedure was effective in left ventricular thrombosis in patients with heart failure with cardiogenic shock complicated by AMI.

Using Arterial Recoil for Large Bore Access Closure After Impella Assist Device Removal.

The use of Impella assist device for high-risk percutaneous coronary interventions and cardiogenic shock 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. Herein, we describe the safety and efficacy of a novel method of LBA closure using arterial recoil following Impella removal. We performed a retrospective review of electronic medical records of patients who underwent LBA closure using this method from July 1, 2018 to June 30, 2022. The procedure involves controlled downsizing of the arterial sheath from 12 French (Fr) to 6 Fr catheters with intermittent compression to allow patent hemostasis facilitated by arterial recoil. Baseline characteristics and outcomes including closure success, immediate/delayed bleeding, and access site complications were included. Of 103 patients with Impella placement, 20 (19%) underwent LBA closure with this method. Patients were predominantly male (80%) and White (55%) with a mean age of 65 ± 16 years. After downsizing of the femoral sheath to 6 Fr, 14 patients underwent manual compression, 3 patients had a 6 Fr catheter left in place to maintain access, and 3 patients underwent placement of a Perclose or Vascade device. Successful LBA closure was performed in all patients with no immediate or delayed bleeding complications. Five patients (25%) died inpatient; the deaths were unrelated to complications of Impella removal. In conclusion, LBA closure post-Impella removal with this novel method was safe and effective. Further prospective studies are needed to ascertain its comparative efficacy.

MCS current practice and weaning: CCCTN survey of CICU directors at academic medical centers

Abstract Background/Introduction As the treatment of cardiogenic shock evolves, temporary mechanical circulatory support (MCS) use is increasing. Few studies have examined Cardiac Intensive Care Unit (CICU) practices for management and weaning of MCS. Purpose We aimed to describe current management and weaning practices for patients supported with an intra-aortic balloon pump (IABP) or Impella in CICUs. Methods During December 2022, a 45-question survey was electronically distributed by the Critical Care Cardiology Trials Network (CCCTN) to the CICU directors of 44 academic medical centers in North America. Descriptive statistics were used to summarize the results. Results A response rate of 84% was achieved. Among respondents, CICU bed capacity ranged from 8-32 (Mean of 17). Staffing was primarily by cardiologists without board certification in heart failure or critical care (38%). One-in-four centers reported staffing by a multi-disciplinary team consisting of cardiologists and intensivists. Most centers use heparin anticoagulation for both IABP (32, 87%) and Impella (32, 91%) and primarily used PTT to monitor anticoagulation (23, 62%) with a target of 50-70 seconds (27, 73%). While using Impella support, daily TTE (29%), plasma free hemoglobin measurements (34%) and prophylactic antibiotics (3%) were uncommon. Most institutions did not have a formal weaning protocol for IABP (78%) or Impella (66%). The majority of centers reported IABP weaning to be a subjective decision led by the CICU attending (65%), while Impella weaning was commonly a decision made by a multi-disciplinary team including the CICU attending (57%). PACs are used routinely when weaning Impella (83%) but not IABP (46%). IABP removal is most commonly done at bedside by CICU team (70%), whereas Impella removal is most commonly done in the catheterization laboratory (43%). Conclusions In this survey of academic CICUs, IABP and Impella management showed substantial variability across centers. Use of invasive hemodynamic monitoring was common but its use during weaning was not uniform. Multidisciplinary involvement was more common with Impella support and weaning when compared to IABP. These heterogeneous results highlight the need for further investigation to guide best practices in MCS management.

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 (&gt;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 13671: A Case of Diffuse Alveolar Hemorrhage While on Systemic Anticoagulation for Impella

A 57 year old male with PMH of non-ischemic cardiomyopathy (EF 30%), atrial fibrillation, and VT s/p ICD was admitted to the cardiac intensive care unit for cardiogenic shock. His condition deteriorated necessitating Impella 5.5 implantation as bridge to cardiac transplant. Systemic heparin was started per Impella protocol with a lower anti-Xa goal of 0.2 - 0.3 given post-op bleeding at the R axillary Impella site. Five days post Impella placement he developed bloody secretions from the endotracheal tube requiring multiple blood transfusions and discontinuation of systemic heparin, while maintaining heparin purge. Labs were notable for anti-Xa 0.22, hemoglobin 9.7, and platelets 221. CT Chest demonstrated parenchymal opacities concerning for diffuse alveolar hemorrhage (DAH) which was confirmed via bronchoalveolar lavage; he had no known history of lung disease. High-dose corticosteroids were administered as a high ANA titer (1:128) and low C3 suggested capillaritis. However, decreasing ANA (1: 320) and a negative autoimmune workup decreased the likelihood of a rheumatologic cause for DAH and steroids were discontinued. DAH secondary to acquired von Willebrand syndrome (aVWS) was considered, but factor VIII and vWF activity levels were normal. The bloody secretions improved with inhaled thromboxane and systemic heparin was restarted. Orthotopic heart and kidney transplant was performed with subsequent Impella removal 104 days after Impella placement. Discussion: We present the first documented case of DAH with isolated Impella 5.5 support. Previously reported cases of DAH post-Impella were observed in patients with concurrent ECMO or RVAD. As autoimmune and coagulopathic causes of DAH were excluded, bland DAH secondary to systemic anticoagulation is most likely in this case. This raises a question about how to balance the risk of bleeding with the risk of device thrombosis, stroke and embolic events and when to switch from heparin to sodium bicarbonate purge.

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.

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

E-46 | Bedside Removal of Impella Devices in Cardiogenic Shock Patients Is Feasible and Safe

Patients with cardiogenic shock (CS) requiring mechanical circulatory support (MCS) are complex. The Impella CP (Abiomed, Danvers, MA) is a percutaneously placed left ventricular assist device and there is no established best-practice for device removal. Vascular complications from MCS devices are common and many patients undergo operative removal of these devices. To our knowledge there is no published data concerning the safety of bedside removal of femorally-placed Impella devices in the cardiovascular intensive care unit (CICU) for patients with CS. We conducted a retrospective chart review of all CS patients requiring MCS at our institution in 2020, approved by our institutional review board. In 2020 we cared for 84 patients requiring MCS in our CICU, excluding patients with intra-aortic balloon pumps. Of these, 55 patients had a femorally-placed Impella CP, either alone or with veno-arterial extracorporeal membrane oxygenation. 18 patients died with devices in place and three were transferred to another facility on MCS. 14 patients had their Impella removed in the operating room and five in the cardiac catheterization lab. 15 total patients (27%) underwent Impella removal at bedside in the CICU. Of the patients with bedside removal, a vascular closure device was used in the vast majority (87%). Only one patient had post-removal leg ischemia requiring surgical or endovascular intervention; this patient had preexisting peripheral vascular disease and the Impella was removed via manual pressure for clinical ischemia. Bedside removal of femorally-placed Impella CP devices is feasible and safe in select CS patients. More research is needed to establish best-practices for MCS device removal.

A Post-closure Technique Using a Single Perclose Device in the Removal of a Transfemoral Impella Catheter

Objective: A transfemoral Impella can substantially support patients with cardiogenic shock, and surgical closure has conventionally been used for the removal of large-bore catheters. However, while percutaneous closure is a prompt and minimally invasive technique, single Perclose post-closure outcomes remain to be evaluated. The present study evaluated the safety and efficacy of single Perclose post-closure in the removal of transfemoral Impella catheters.Methods: Of 37 patients supported by an Impella device, 25 patients (68%) were excluded due to a transsubclavian approach, an inability to wean, or primary surgical closure. We reviewed 12 patients (32%) receiving the single Perclose post-closure method. For percutaneous closure, we inserted a 0.035-inch guidewire through the side port of the Impella device and extracted the device while retaining the guidewire. Single Perclose was deployed with an additional maneuver as backup, such as second Perclose or surgical closure. The outcomes were defined according to the Valve Academic Research Consortium-2 criteria.Results: All patients had received the Impella CP due to cardiogenic shock. All patients received single/dual antiplatelets without oral anticoagulants. Percutaneous closure was successful in 11 patients (92%); the remaining patient was converted to surgical closure. The mean (range) procedural time was 8.0 (5.8–9.0) minutes. Major bleeding and vascular complications were observed only in the patient with surgical conversion (8.3%). No closure-site infection or closure-related limb ischemia was observed. All patients were discharged alive after the removal of the Impella device.Conclusion: Single Perclose post-closure is a promising closure method for removing a transfemoral Impella, but further investigations are needed.

Optimal bail-out and complication management strategies in protected high-risk percutaneous coronary intervention with the Impella.

Despite the routine use of percutaneous mechanical circulatory support (pMCS) with the Impella heart pump, vascular and bleeding complications may occur during removal with or without pre-closure. To safely close the large-bore access (LBA), post-hoc selection of the appropriate treatment of vascular complications is critical to patient recovery and survival. Femoral artery access is typically utilized for LBA, and percutaneous axillary artery access is a common alternative, especially in the instance of severe peripheral artery disease. Optimization of patient outcomes and efficiency of pMCS can be achieved with adequate arterial access using state-of-the-art techniques. Impella removal techniques with or without pre-closure will be addressed as well as the management of large-bore femoral access complications. In addition, treatment strategies to manage patient deterioration during a protected high-risk percutaneous coronary intervention will be provided.

Manual compression versus MANTA device for access management after impella removal on the ICU

To compare the safety and efficacy of manual compression versus use of the MANTA closure device for access management after Impella removal on the intensive care unit (ICU). The number of patients treated with percutaneous left ventricular assist devices (pLVAD), namely Impella and ECMO, for complex cardiac procedures or shock, is growing. However, removal of pLVAD and large bore arteriotomy closure among such patients on the ICU remains challenging, since it is associated with a high risk for bleeding and vascular complications. Patients included in a prospective registry between 2017 and 2020 were analyzed. Bleeding and vascular access site complications were assessed and adjudicated according to VARC-2 criteria. We analyzed a cohort of 87 consecutive patients, who underwent access closure after Impella removal on ICU by using either the MANTA device or manual compression. The cohort´s mean age was 66.1 ± 10.7 years and 76 patients (87%) were recovering from CS. Mean support time was 40 h (interquartile range 24–69 h). MANTA was used in 31 patients (35.6%) and manual compression was applied in 56 patients (64.4%). Overall access related bleedings were significantly lower in the MANTA group (6.5% versus 39.3% (odds ratio (OR) 0.10, 95% CI 0.01–0.50; p = 0.001), and there was no significant difference in vascular complications between the two groups (p = 0.55). Our data suggests that the application of the MANTA device directly on the ICU is safe. In addition, it seems to reduce access related bleeding without increasing the risk of vascular complications.

Association between lowering heart rate during IMPELLA support and favorable short-term outcome in patients with cardiogenic shock

Abstract Background Impella has been increasingly used in patients with cardiogenic shock (CGS). Target values for clinical indices for appropriate management of Impella have not yet been established. Purpose We aimed to elucidate the association between heat rate (HR) during Impella treatment in patients with CGS and clinical outcomes. Methods and results We retrospectively evaluated 62 patients (68±14 years; male 77%) with CGS receiving temporary circulatory support with the Impella between February 1, 2019, and February 31, 2021. The primary end point was 30-day mortality. Clinical characteristics, laboratory and hemodynamic markers at implantation of Impella (baseline), 12, 24 hr after implantation, and removal of Impella were assessed. There were 28 patients with concomitant use of extracorporeal membrane oxygenation (ECMO). Treatment periods using Impella were 8±6 days. After excluding 11 patients who died during Impella support, the relationship between clinical indicators at each time points and 30-day mortality was evaluated. There were 22 patients (43%) with 30-day mortality. Factors associated with 30-day mortality were: female, ECMO, higher 24-hr lactate level, lower 24-hr cardiac power output, and higher HR at removal. Lower HR of ≤81 bpm at removal was found to most accurately predict lower 30-day mortality (Figure 1). Higher increases in dose of beta-blockers during Impella support and lower absolute doses of norepinephrine at removal were correlated with decreases in HR during Impella support. Conclusions In patients with CGS treated with Impella, lower HR at removal was associated with lower incidence of 30-day mortality. Lowering HR during Impella treatment was recognized as a simple indicator for favorable clinical outcomes in patients with CGS. It was suggested that chronotropic interventions during Impella treatment may be novel therapeutic options in patients with CGS. Funding Acknowledgement Type of funding sources: None. Figure 1

Utility and safety of the MANTA device for access site closure after removal of the mechanical hemodynamic support device Impella on the intensive care unit

Abstract Background The percutaneously implanted hemodynamic mechanical support devices Impella are commonly used in patients at risk for or with cardiogenic shock (CS). Impella removal after hemodynamic stabilization on the intensive care unit (ICU) remains a major challenge and is prone to high rates of bleeding and vascular complications. Purpose It is unknown if the use of the novel large-bore access closure device MANTA® is safe and facilitates access management compared to manual compression. Methods Between January 2017 and December 2020, 172 CS patients were treated with an Impella® device at our centre. Of those, in 89 patients the Impella® was removed on the ICU and access site management occurred with either MANTA® device or manual compression. The criteria for MANTA® 14 french device deployment included: (i) femoral artery Diameter &amp;gt;6mm and (ii) absence of significant peripheral arterial disease (PAD). Bleeding and vascular access site complications were assessed and adjudicated according to the Valve Academic Research Consortium-2 (VARC-2) criteria. Results Among the 89 included patients, Impella® removal was performed using the MANTA® device in 31 cases and manual compression in 58 cases. Mean age was 66±11 years, and 50 (56.2%) patients had a CS classified as Society for Cardiovascular Angiography and Interventions (SCAI) D or higher due to myocardial infarction. Median support time was 40 (IQR 24; 69) hours. Baseline characteristics are displayed in Table 1. Immediate haemostasis was more frequently achieved by MANTA® device compared to manual compression (p=0.034). Moreover, we observed significantly less overall (2 (6.5%) vs. 22 (37.9%), p=0.001) and minor bleedings (1 (3.2%) vs. 15 (25.9%), p=0.006) with the MANTA® device when compared to manual compression. Of note, there were no significant differences in vascular complications between the two groups (Table 2). Conclusions In patients requiring Impella® support and residing on ICU, the MANTA® device, compared to standard of care manual compression, seems to be a safe and effective option for access site management, especially with regards to the reduction of bleeding events. However, physicians should carefully assess the vascular anatomy and degree of calcification prior to deployment of the MANTA® device. Nevertheless, more prospective data is necessary for evaluating the optimal access closure among CS patients treated with a percutaneously implanted Impella® device. Funding Acknowledgement Type of funding sources: None. Table 1. Baseline demographicsTable 2. Outcomes

Thrombosis of the innominate artery during prolonged cardiac support by right transaxillary Impella 5.0 device

We describe an unexpected complication in a 46-years-old man affected by ischemic cardiomyopathy who received a prolonged mechanical cardiac support by means of right transaxillary Impella 5.0. The postoperative course was complicated by recurrent septicemia from multi-durg resistant Acinetobacter baumanii. He underwent implantation of venoarterial extracorporeal membrane oxygenation because of refractory cardiac arrest, followed by Impella removal that has been complicated by embolic stroke. The likely source of the embolus was a large thrombus inside the innominate artery. After a long-standing right transaxillary device implantation, particularly in patients with intercurrent septic episodes, a CT angiographic scan should be planned to exclude arterial thrombosis before removal of the transarterial device.

Removal of Impella in the Setting of Left Ventricular Thrombus: A Potential Indication for Cerebral Embolic Protection Devices

Successful percutaneous mechanical circulatory support (MCS) has been used for acute stabilization of cardiogenic shock (CS). Improved survival outcomes have been observed in patients with CS from an acute myocardial infarction (AMI) who undergo implantation of left ventricular (LV) to ascending aorta rotodynamic pumps, such as the Impella® device (Abiomed). However, thrombotic events are a known complication of such devices in poor flow states such as CS. There is limited evidence regarding the management of patients who develop an LV thrombus after Impella insertion. Currently, the Sentinel cerebral protection system (SCPS, Boston Scientific) is the only FDA-approved device for cerebral embolic protection during transcatheter aortic valve replacement procedures. While the use of a cerebral embolic protection device (CEPD) has a theoretical benefit, no current CEPD is approved for use in conjunction with Impella device removal or other MCS devices. We present a case describing the use of the SCPS during the removal of the Impella CP device in a patient who developed an LV thrombus after CS from AMI. Our case highlights a potential role for the expanded use of CEPDs in similar clinical scenarios.

Trans-Caval Impella 5.0: A Bridge to Recovery in Peripartum Cardiomyopathy

Introduction The incidence of peripartum cardiomyopathy (PPCMP) varies worldwide, the etiology is thought to be related to both environmental and genetic factors. The mortality rates are reported up to 16.7% and transplant rates up to 11%. The Interagency Registry for Mechanically Assisted Circulatory Support demonstrated improved myocardial recovery in PPCMP patients compared to non-PPCMP patients (6% vs. 1%) who required durable mechanical circulatory support devices (MCS). Our case demonstrates the use of trans-caval Impella 5.0 as a bridge to recovery in a PPCMP patient with cardiogenic shock post delivery. Clinical Presentation 37-year-old woman with a history of PPCMP presented with progressive shortness of breath during the third trimester of pregnancy. She was found to have a decrease in left ventricular ejection fraction (LVEF) to 30-35% at 30 weeks gestation. Right heart catheterization showed RA 12 mmHg, PA 75/38 (50) mmHg, PCWP 30 mmHg, and CI 1.99 L/min/m2. She was transferred to Cardiac Intensive Care Unit (CICU) for invasive hemodynamic monitoring and tailored therapy. Nitroprusside was started with up titration of oral afterload reduction medications and continued intravenous diuresis. Due to preeclampsia, labor induction was initiated during week 34 of gestation. Secondary to multiple decelerations on fetal monitoring, an emergent primary C-section with bilateral tubal ligation was performed. Immediately after delivery, patient suffered hemodynamic collapse requiring emergent placement of a right femoral 2.5L Impella; noting small ilio-femoral arteries on angiography. There was no significant hemodynamic improvement (low cardiac index, elevated PA pressure, and progressive hypotension); patient was emergently upgraded to an Impella 5.0 via trans-caval approach under transesophageal echocardiogram guidance. Patient experienced cardiac arrest during procedure, with immediate ROSC. The Impella 5.0 placement was successful without complications and with improvement in hemodynamics (Improved CI from 1.3 to 1.6 L/min/m2, MAP from 55 to 88 mmHg, cardiac power output from 0.29 to 0.42 W), pH from 7.02 to 7.30. The 2.5L Impella removal was complicated by a right iliac artery rupture requiring a covered stent placement. CICU course was complicated by retroperitoneal hematoma, and acute renal failure requiring hemodialysis. Impella 5.0 was removed four days later; a 12/10 mm amplatz ductal occluder was used to close the trans-caval arteriotomy site. Hemodialysis was discontinued 12 days post-delivery and her LVEF improved to 40-45%. She was discharged to rehab and had significant improvement in her functional capacity on her 6-week follow up. Conclusion Close monitoring and prompt action to escalate hemodynamic support, with temporary MCS to achieve better outcomes in cardiogenic shock is imperative. Trans-caval Impella 5.0 is a feasible alternative to extracorporeal membrane oxygenation and provides a high level of hemodynamic support which could bridge to myocardial recovery in PPCMP patients suffering from cardiogenic shock.