Use of the Impella 2.5 Device With Multi-Vessel Stenting in Severe Peripheral Artery and Left Main Disease

Abstract: Percutaneous transcatheter coronary angioplasty (PTCA) and stenting to the left main coronary artery or to multiple vessels are options in patients who are poor candidates for coronary artery bypass graft surgery (CABG). However, it is associated with high mortality and morbidity, and is considered to be high-risk percutaneous coronary intervention (PCI). These patients can develop fatal arrhythmias, hemodynamic instability or cardiogenic shock due to ischemia to the viable myocardium by balloon dilatation and catheter manipulations. High-risk PCI assisted with left ventricular assist devices has shown better outcomes with less hemodynamic instability intra and post operatively by increasing the cardiac output and coronary perfusion. The Impella 2.5 catheter is a ventricular assist device with a catheter-mounted micro axial rotary blood pump and a pigtail catheter that is inserted percutaneously to the left ventricular outflow tract. It has very low adverse events. We present herein our successful experience with PTCA and multi-vessel stenting with the assistance of the Impella 2.5 device in a patient with three-vessel disease with significant left main coronary artery occlusion without any complications.

Introduction

CABG is the class IA recommended treatment option for patients with three-vessel coronary artery disease or severe involvement of the left main coronary artery. Percutaneous trans-catheter coronary angioplasty (PTCA) and stenting to the left main coronary artery or to multiple vessels are options in patients who are poor candidates for CABG. However, these conditions are associated with high mortality and morbidity, especially during the procedure, which is considered high-risk PCI. These patients can develop fatal arrhythmias, hemodynamic instability or cardiogenic shock due to ischemia in viable myocardium, caused by balloon dilatation and catheter manipulations. Reducing left ventricular workload and minimizing myocardial oxygen demand are some of the strategies identified to minimize these complications. High-risk PCI assisted with left ventricular assist devices has shown better outcome with less hemodynamic instability both during and after the procedure by increasing cardiac output and coronary perfusion. The intra-aortic balloon pump is the most commonly used support device, but its use is limited in patients with low ejection fraction and aortic valvular abnormality, and is associated with many complications. A multitude of such devices have been used in recent years in high-risk coronary angioplasty without great success.¹ The Impella 2.5 catheter, a left ventricular assist device, is a percutaneous micro heart pump with an integrated motor and sensors.² Experience with Impella 2.5 catheter use for high-risk PCI with multi-vessel disease in the United States is limited and still in the early stages. Herein we present our successful experience with PTCA and multi-vessel stenting with the assistance of the Impella 2.5 device in a patient with three-vessel disease with significant left main coronary artery occlusion (Figure 1).

Case report

The patient is a 56-year-old African-American gentleman who presented to the emergency department with retro-sternal chest pain. His past medical history is significant for coronary artery disease, hyperlipidemia, hypertension, peripheral vascular disease, liver cirrhosis secondary to hepatitis C, and peptic ulcer disease. Past surgical history is significant for a fem-pop bypass graft in the right and fem-fem bypass graft, right above-knee amputation due to ischemic leg disease. His home medications are furosemide, lactulose, propranolol, ranitidine, rifaximin, and spironolactone. He denied any allergies and admitted tobacco smoking for 40 years, with a history of cocaine and heroin use. On physical exam, his vitals were stable and no abnormalities were found except for the healed right above-knee amputation. Since the patient presented with chest pain, an electrocardiogram (EKG) and troponin-I test were ordered to rule out acute coronary syndrome. Initial EKG was normal sinus rhythm without any ST changes and troponin-I was negative. The patient did not have any abnormality in the electrolyte panel or the chest x-ray. His subsequent troponin-I came elevated at 2.29 and 14.66 ng/ml (normal The patient’s left ventricular ejection fraction was 35%. He was given aspirin, clopidogrel, and metoprolol, and was immediately taken to the cath lab. Coronary angiography showed multi-vessel disease with a >70% stenosis in left main, and involving the proximal left anterior descending (LAD), diagonal 1, left circumflex and right coronary arteries (RCA). The patient was continued on aspirin, clopidogrel, metoprolol, rosuvastatin, and isosorbide mononitrate. Cardiothoracic surgery was consulted for possible CABG. After evaluation by the surgeons, it was decided that the patient is a high-risk surgical candidate because of his multiple medical problems, especially considering his baseline clinical status due to cirrhosis and hepatitis C. After a long discussion with the patient regarding available options, the patient agreed to undergo high-risk PTCA and multiple stenting with the use of the Impella device for hemodynamic support. Procedure: The Impella device was inserted through the femoral arterial access and placement in the left ventricle was confirmed under fluoroscopy. Successful PTCA and stenting to the mid and distal RCA with a 2.5 x 12 mm Microdriver stent, a 2.25 x 8 mm Microdriver stent, and a 2.5 x 18 mm Driver stent was performed. PTCA and stenting to the LAD with a 3.5 x 9 mm Endeavor stent was also successfully performed, as was distal left main to ostial left circumflex with a 3.0 x 18 mm Endeavor stent. Successful TIMI-3 flow in all arteries was achieved. At this point, the Impella was removed. Total time spent on the procedure was approximately one hour and the patient had the Impella device throughout the procedure, as well as for one hour intraoperatively. We did not observe any hemodynamic compromise during and post procedure, and his mean arterial pressure was maintained above 70 mmHg, with heart rate of 65-70 beats/min. The patient had good oxygen saturation. There were no significant cardiac arrhythmias during the immediate post-procedure period. Post PCI, the patient was initially observed in the coronary care unit, then stepped down to the telemetry unit and was discharged home three days later in stable condition. The patient continued on aspirin 325 mg, clopidogrel 75 mg q 12 hours, metoprolol, lisinopril, rosuvastatin, and isisorbide mononitrate. He was followed up one week later in the office and found to be in a clinically stable condition.

Discussion

Interruption of blood flow due to balloon dilatation and stent implantation during PTCA and stenting to left main or multiple vessels could be detrimental to a significant area of the myocardium. At the same time, ischemia resulting from interventional maneuvers may not be short and/or uneventful. Therefore, it is the operators’ responsibility to prevent the consequences of longer ischemic times that could result in electromechanical dissociation or ventricular fibrillation that may not reverse after restoring circulation in the vessel.² Maintaining coronary blood flow, as well as systemic perfusion, with a ventricular assist device is very important to prevent the additional risk of distal embolization, and prolonged ischemia and necrosis, due to low flow or no reflow. The Impella 2.5 catheter is a ventricular assist device with a catheter-mounted micro axial rotary blood pump and a pigtail catheter. It has very low adverse events.^1,5,7 The catheter is inserted percutaneously to the left ventricular outflow tract. It sucks in blood from the left ventricle and pumps out blood to the aortic root. It can maintain a cardiac output of 2.5 liters per minute, sufficient enough to maintain good coronary and peripheral perfusion. The Impella 2.5 device was cleared by the U.S Food and Drug Administration (FDA) in June 2008 for partial circulatory support for up to six hours in the United States.² Some European countries have greater experience with this device and have shown good outcomes when it is used in high-risk PCI procedures. Short- and long-term safety has been reported by studies performed in Europe.^3,4 According to some European studies, the Impella can be left safely in place for up to 5 days.⁵ The Impella 2.5 device can be used both for prophylactic support in patients undergoing high-risk PCI, as a rescue device for acute irreversible left ventricular failure, and in cardiogenic shock. Our own clinical experience of 149 cases supported with the Impella (15 of which have been for patients requiring emergent support) has yielded very positive outcomes for our patients. The major adverse cardiac and cerebrovascular event (MACCE) rates at 30 days for the first 59 patients was an incredibly low 3.3%, and the in-hospital complication rate was only 3%. We have submitted these data for publication; results will be soon forthcoming. The Impella 2.5 has replaced an IABP for these patients at Detroit Medical Center due to its ease of use, low risk profile, consistent circulatory support throughout the PCI, including maintaining diastolic pressure during left main inflations and enabling minimally invasive revascularization in the cath lab for patients with complex coronary artery disease and at high surgical risk. The PROTECT II data will provide important new data about treating high-risk patients. The Impella appears to yield great promise for changing current guidelines for hemodynamic support in these types of patients. The patient described was symptomatic with significant vascular disease and was a high-risk surgical candidate due to multiple medical problems, as well as high risk for PTCA due to multiple vessel involvement. However, revascularization was successfully completed without any complications with the help of the Impella 2.5 device. We believe that this initial experience may be helpful for challenging cases of end-stage patients needing myocardial revascularization. The authors can be contacted via Dr. Tamam Mohamad at tmohamad@dmc.org This article received double-blind peer review from members of the Cath Lab Digest editorial board. Disclosure: Dr. Mohamad, Dr. Alani and Dr. Munir report no conflict of interest regarding the content herein. Dr. Schreiber reports that he is a member of Abiomed's Impella Advisory Board.

References

1. Marella PC, Lassetter JE, Heuser RR. The Impella ventricular assist device: use in patients at high risk for coronary interventions: successful multivessel percutaneous coronary intervention in a 62-year-old high-risk patient. Cardiovasc Revasc Med 2011;12(1):69.e9-e12.
2. Arieti M, Pesarini G, Ribichini F. Percutaneous Impella Recover circulatory support in high-risk coronary angioplasty. Cardiovasc Revasc Med 2008;9(4):269–274.
3. Henriques JP, Remmelink M, Baan J Jr, et al. Safety and feasibility of elective high-risk percutaneous coronary intervention procedures with left ventricular support of the Impella Recover LP 2.5. Am J Cardiol 2006;97(7):990-992.
4. Burzotta F, Paloscia L, Trani C, et al. Feasibility and long-term safety of elective Impella-assisted high-risk percutaneous coronary intervention: a pilot two-centre study. J Cardiovasc Med (Hagerstown) 2008;9(10):1004-1010.
5. Sjauw KD, Konorza T, Erbel R, et al. Supported high-risk percutaneous coronary intervention with the Impella 2.5 device the Europella registry. J Am Coll Cardiol 2009;54(25):2430-2434.
6. Catena E, Milazzo F, Merli M, et al. Echocardiographic evaluation of patients receiving a new left ventricular assist device: the Impella recover 100. Eur J Echocardiogr 2004;5(6):430-437.
7. Maini B. Experiences with Impella in STEMI: The USPELLA study. Paper presented at: TCT Session III: Optimizing Primary PCI for STEMI in the Cath Lab. Transcatheter Cardiovascular Therapeutics; October 21-25, 2010; Washington, D.C.