Impella 2.5® Device Support Prior to Unprotected Left Main PCI is Associated with Improved Survival Among AMICS Patients
- In the setting of acute myocardial infarction (AMI) cardiogenic shock (CS), Impella® device prior to percutaneous coronary intervention (PCI) has been associated with a survival benefit.
- Researchers assessed outcomes of patients supported with Impella 2.5® prior to and after PCI on an unprotected left main coronary artery (ULMCA) culprit lesion in the setting of AMICS.
- The Pre-PCI support group had better survival to discharge (55.0% vs 18.8%).
- Impella 2.5® device support before PCI on an ULMCA culprit lesion correlates with survival benefit in patients supported for AMICS.
The incidence of acute myocardial infarction (AMI) complicating cardiogenic shock (CS) due to an unprotected left main coronary artery (ULMCA) lesion is low; however, since many patients die before treatment, the incidence of AMICS due to an ULMCA lesion may in fact be higher than currently reported.1
The occurrence of AMICS due to an ULMCA lesion is associated with significant morbidity and mortality.2,3 Compared with AMI patients without an ULMCA occlusion, patients with AMICS and an ULMCA lesion have an approximately 10-fold higher in-hospital mortality rate.4
A study by Meraj et al in the Journal of Interventional Cardiology examined the associated outcomes of patients receiving the Impella 2.5® heart pump prior to and after the start of percutaneous coronary intervention (PCI) on an unprotected left main coronary artery (≥70% stenosis) culprit lesion in the setting of AMICS (n=36).5 Patient data were obtained from the cVAD Registry™, an ongoing, multicenter registry. The cVAD Registry™, a retrospective database which currently includes 58 sites worldwide (44 active U.S. centers), was designed for post-market and real-world use reporting of the Impella® device in routine care. High and low volume centers and private and academic institutions are included in the cVAD Registry™.
Patients in the cVAD Registry receiving the Impella 2.5® device for AMICS and who also underwent PCI on an ULMCA culprit lesion (n = 36) were selected for analysis.
Patients had a baseline left ventricular ejection fraction (LVEF) of 24.6%±12.1%. The patient population used in this analysis represents individuals at considerably high risk in the setting of AMICS.
Since the safety of the Impella® device has been supported in previous research,6,7,8 the authors of this study wished to focus their endpoints on survival. The endpoints used in this study were as follows:
- Primary Endpoint
- The difference in survival to discharge between patients receiving the Impella® heart pump before (Pre-PCI) and after (Post-PCI) the start of PCI.
- Secondary Endpoints
- Hemodynamics of patients receiving Impella 2.5® device support and in-hospital incidence of bleeding, hemolysis, infection, limb ischemia, myocardial re-infarction, renal insufficiency, repeat revascularization, stroke, and vascular complications requiring surgical repair.
Patients receiving the Impella 2.5® device after PCI necessitated higher inotrope administration during support compared with the Pre-PCI group (2.50±1.15 vs 1.54±0.66, p=0.013). Only 65% of patients in the Pre-PCI group required inotropes/pressors during Impella® device support vs 100% of the patients in the Post-PCI group.
72.7% of the patients presented with CS on admission, and 30.6% had anoxic brain damage (ABI) when the Impella® device was initiated. None of the ABI patients survived to discharge.
Approximately half of the study cohort received the Impella® device prior to the start of PCI (55.6%) vs after the start of PCI (44.4%). The group receiving the Impella® device before PCI had a greater number of diseased lesions at ≥50% stenosis (2.40±0.88 vs 1.81±0.83, p=0.050). There was no significant difference between the duration of PCI between the two groups.
In regard to in-hospital outcomes, there was a significant survival-to-discharge difference between the Pre- and Post-PCI groups (55% vs 18.75%, respectively). Only one-quarter of the Post-PCI patients without anoxic brain injury before Impella® device support survived to discharge vs 84.62% in the Pre-PCI group. A majority of patients in the Pre-PCI group with shock on hospital admission survived to discharge (75%) vs those in the Post-PCI group (8.33%).
Bleeding which required transfusion (2.3%), hemolysis (5.6%), and vascular complications requiring surgery (2.3%) were low in both groups.
This study supports previous safety and efficacy reports of Impella 2.5® device in AMICS,9 and suggests the importance of early (Pre-PCI) support for improved outcomes,6 particularly in the setting of a LMCA culprit lesion.
- Fabre A, Sheppard MN. Sudden adult death syndrome and other non-ischaemic causes of sudden cardiac death. Heart. 2006;92(3):316-320.
- de Feyter PJ, Serruys PW. Thrombolysis of acute total occlusion of the left main coronary artery in evolving myocardial infarction. Am J Cardiol. 1984;53(11):1727-1728.
- Quigley RL, Milano CA, Smith LR, White WD, Rankin JS, Glower DD. Prognosis and management of anterolateral myocardial infarction in patients with severe left main disease and cardiogenic shock. The left main shock syndrome. Circulation. 1993;88(5 Pt 2):II65-70.
- Patel N, De Maria GL, Kassimis G, Rahimi K, Bennett D, Ludman P, Banning AP. Outcomes after emergency percutaneous coronary intervention in patients with unprotected left main stem occlusion: the BCIS national audit of percutaneous coronary intervention 6-year experience. JACC Cardiovasc Interv. 2014;7(9):969-980.
- Meraj PM, Doshi R, Schreiber T, Maini B, O'Neill WW. Impella 2.5 initiated prior to unprotected left main PCI in acute myocardial infarction complicated by cardiogenic shock improves early survival. J Interv Cardiol. 2017.
- O'Neill WW1, Schreiber T, Wohns DH, Rihal C, Naidu SS, Civitello AB, Dixon SR, Massaro JM, Maini B, Ohman EM. The current use of Impella 2.5 in acute myocardial infarction complicated by cardiogenic shock: results from the USpella Registry. J Interv Cardiol. 2014;27(1):1-11.
- Griffith BP, Anderson MB, Samuels LE, Pae WE Jr, Naka Y, Frazier OH. The RECOVER I: a multicenter prospective study of Impella 5.0/LD for postcardiotomy circulatory support. J Thorac Cardiovasc Surg. 2013;145(2):548-554.
- Dixon SR, Henriques JP, Mauri L, Sjauw K, Civitello A, Kar B, Loyalka P, Resnic FS, Teirstein P, Makkar R, Palacios IF, Collins M, Moses J, Benali K, O'Neill WW. A prospective feasibility trial investigating the use of the Impella 2.5 system in patients undergoing high-risk percutaneous coronary intervention (The PROTECT I Trial): initial U.S. experience. JACC Cardiovasc Interv. 2009.
- Joseph SM, Brisco MA, Colvin M, Grady KL, Walsh MN, Cook JL; genVAD Working Group. Women With Cardiogenic Shock Derive Greater Benefit From Early Mechanical Circulatory Support: An Update From the cVAD Registry. J Interv Cardiol. 2016;29(3):248-256.
Impella® Device — Indication & Safety Information
INDICATIONS FOR USE
IMPELLA® LEFT-SIDE DEVICES INDICATION & SAFETY INFORMATION
The Impella 2.5®, Impella CP® and Impella CP® with SmartAssist® Systems are temporary (≤ 6 hours) ventricular support devices indicated for use during high-risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5, Impella CP, and Impella CP with SmartAssist Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.
The Impella 2.5®, Impella CP®, Impella CP® with SmartAssist®, Impella 5.0® and Impella LD® Catheters, in conjunction with the Automated Impella® Controller (collectively, "Impella® System Therapy"), are temporary ventricular support devices intended for short term use (≤ 4 days for the Impella 2.5, Impella CP, and the Impella CP with SmartAssist, and ≤ 14 days for the Impella 5.0, and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP). The intent of Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.
Important Risk Information for Impella devices
The Impella 2.5, Impella CP, Impella 5.0 and Impella LD are contraindicated for use with patients experiencing any of the following conditions: Mural thrombus in the left ventricle; Presence of a mechanical aortic valve or heart constrictive device; Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less); Moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); Severe peripheral arterial disease precluding placement of the Impella System; Significant right heart failure*; Combined cardiorespiratory failure*; Presence of an Atrial or Ventricular Septal Defect (including post-infarct VSD)*; Left ventricular rupture*; Cardiac tamponade*
* This condition is a contraindication for the cardiogenic shock indication only.
POTENTIAL ADVERSE EVENTS
Acute renal dysfunction, Aortic valve injury, Bleeding, Cardiogenic shock, Cerebral vascular accident/Stroke, Death, Hemolysis, Limb ischemia, Myocardial infarction, Renal failure, Thrombocytopenia and Vascular injury
In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices. Visit http://www.abiomed.com/important-safety-information to learn more.
The Impella Connect® transfers the video image of the screen on the Automated Impella® Controller to an authorized remote user. The transmitted image can be viewed by authorized remote users. The users can include the hospital’s clinicians, Abiomed local support staff, and Customer Support Center (CSC) team members.
Impella Connect Precautions
- Impella Connect is not intended to provide real-time information for monitoring patient status on the Automated Impella® Controller.
- During use of the Impella Connect, there will be a delay between when an image appears on the controller screen and when it is displayed at a remote viewing location.
- The Impella Connect is not a source of patient alarms, nor is its use intended as a replacement for monitoring the controller’s alarms.
- During use of the Impella Connect, receipt of the displayed controller information is not confirmed by the Automated Impella® Controller, nor is the delivery of the displayed controller information to the authorized remote users guaranteed.
- The Impella Connect is not designed for use during transport.
- Radiated and conducted electromagnetic interference can affect the performance of the Impella Connect, causing a temporary loss of connectivity. To clear interference, either increase the distance between system components and the EMI source or turn off the EMI source. Any electromagnetic interference related to the Impella Connect will have no impact on any of the controller functional specifications.
- Portable and mobile RF communications equipment can affect medical electrical equipment.
Right-Side Support – Indication & Safety Info.
INDICATIONS FOR USE
The Impella RP® System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.
Important Risk Information for Impella RP
The Impella RP System is contraindicated for patients with the following conditions: Disorders of the pulmonary artery wall that would preclude placement or correct positioning of the Impella RP device. Mechanical valves, severe valvular stenosis or valvular regurgitation of the tricuspid or pulmonary valve. Mural thrombus of the right atrium or vena cava. Anatomic conditions precluding insertion of the pump. Presence of a vena cava filter or caval interruption device, unless there is clear access from the femoral vein to the right atrium that is large enough to accommodate a 22 Fr catheter.
POTENTIAL ADVERSE EVENTS
The potential adverse effects (eg, complications) associated with the use of the Impella RP System: Arrhythmia, Atrial fibrillation, Bleeding, Cardiac tamponade, Cardiogenic shock, Death, Device malfunction, Hemolysis, Hepatic failure, Insertion site infection, Perforation, Phlegmasia cerulea dolens (a severe form of deep venous thrombosis), Pulmonary valve insufficiency, Respiratory dysfunction, Sepsis, Thrombocytopenia, Thrombotic vascular (non-central nervous system) complication, Tricuspid valve injury, Vascular injury, Venous thrombosis, Ventricular fibrillation and/or tachycardia.
In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella RP®. Visit http://www.abiomed.com/impella/impella-rp to learn more.
General Indication and Safety Information
To learn more about the Impella platform of heart pumps, including important risk and safety information associated with the use of the devices, please visit: www.protectedpci.com/indications-use-safety-information/