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High-Risk Left Main Coronary Stenting Supported by
Percutaneous Impella Recover LP 2.5 Assist Device
Percutaneous coronary interventions (PCI) are increasingly performed in patients with severely depressed left ventricular (LV) function and complex coronary lesions, including left main (LM) disease. During these high-risk procedures, prolonged ischemia from balloon inflations, no-reflow or dissection may have major hemodynamic consequences.1 Various percutaneous supportive techniques have been described for high-risk angioplasty, but no single approach has achieved wide acceptance.1–99 Furthermore, device-related complications have hampered a more widespread use of these devices.6,7 The Impella Recover LP 2.5 assist device (Abiomed®, Aachen, Germany) may constitute a promising option for circulatory support during high-risk PCI.10,11 We report on a patient with severe LV impairment who underwent unprotected left main coronary stenting supported by the Impella Recover LP 2.5 assist device.
Device description. The Impella Recover LP 2.5 assist device is a microaxial rotary blood pump (4 mm diameter, 12 Fr) which is placed through the aortic valve, aspirates blood from the left ventricular cavity and expels it into the ascending aorta. At its maximal rotation speed of 50,000 rpm, the pump can deliver an output of up to 2.5 L/minute. The device can be inserted percutaneously through a 13 Fr femoral sheath, is mounted on a 9 Fr pigtail catheter and can be safely left in place for up to 5 days. The distal part of the device is connected to a driving console, which allows the management of pump speed and displays the pressure difference between inflow and outflow.
Case Report. An 86-year-old male was transferred to our hospital because of unstable angina and congestive heart failure. He had a history of ischemic cardiomyopathy with a posterior myocardial infarction and coronary angioplasty of the mid-portion of the left anterior descending (LAD) artery in 1999. The electrocardiogram (ECG) performed on admission showed sinus rhythm with left bundle-branch block. Blood tests revealed an elevation of biological markers of myocardial necrosis, and the hemoglobin level, creatine and routine parameters of coagulation were within normal limits.
Transthoracic echocardiography showed a severely diminished left ventricular ejection fraction (LVEF) of 30% without intracavitary thrombus. Coronary angiography revealed a significant and calcified distal left main (LM) stenosis, with a very tight ostial lesion of the dominant left circumflex artery (LCX). The proximal part of the LAD showed a significant stenosis, and the mid-portion was free of restenosis. The right coronary artery (RCA) had a chronic total occlusion in the middle segment. A duplex ultrasound examination showed distinct elongations of both iliac arteries and the abdominal aorta, and 60% stenosis of both internal carotid arteries.
The preoperative logistic EuroSCORE12 predicted a 21.37% mortality rate for this patient. Facing this clinical situation and the highly elevated operative risk, the patient appeared very reluctant to undergo coronary artery bypass grafting (CABG) as the mode of revascularization. Therefore, we decided to perform percutaneous revascularization of the distal bifurcation LM supported by the Impella Recover LP 2.5 assist device.
The procedure was begun by inserting a 13 Fr sheath into the left femoral artery and a 7 Fr sheath into the right femoral artery. After administration of 5,000 units of heparin, an angiographic Judkins right catheter was used to deliver a dedicated 0.14 inch guidewire into the left ventricle; the diagnostic catheter was then removed, and the Impella device was advanced over the wire across the aortic valve under angiographic guidance. The Impella output was 2.3 L/minute at maximal speed. PCI began with balloon angioplasty of the LM and ostia of the LCX and LAD utilizing the double-wire technique. A 4.5 x 20 mm Taxus stent (Boston Scientific Corp., Natick, Massachusetts) was deployed at 20 atm in the LM and the ostial LCX after predilatation. Next, postdilatation of the stent was performed with a Quantum 5 x 20 mm balloon (Boston Scientific) at 14 atm. The ostium and proximal segments of the LAD were stented with a 3.5 x 20 mm Taxus (Boston Scientific) using the T-stenting technique. PCI was finished by kissing-balloon inflation, with a good final angiographic result (Figure). The intervention was uneventful, and the patient’s hemodynamic status remained stable during the procedure as well. The Impella device was left in place overnight and surgically removed without incident the following morning. Seven days after the procedure, thepatient was discharged in stable condition and follow up remained uneventful.
Discussion. Significant LM coronary artery stenosis usually identifies an anatomic subset requiring CABG for revascularization.13 However, patients with LM coronary artery disease and severe LV dysfunction are often poor surgical candidates, especially in those with severe comorbidities. Consequently, PCI has emerged as an alternative to CABG in patients presenting with an unacceptably high mortality risk for cardiac surgery, even if these patients are still considered to be at very high risk for PCI-related mortality.13–16
Our 86-year-old patient was estimated to have a very high operative mortality risk associated with surgery (logistic EuroSCORE of 21.37%), but PCI was clearly a high-risk option as well, not only because of the patient’s coronaryanatomy, which showed unprotected LM disease and total occlusion of the RCA, but also given his severely depressed LV function.
To avoid hemodynamic deterioration during these highrisk PCI procedures, various devices with diverse mechanisms of action have been proposed, aiming to unload the LV and augment systemic circulation.1–9 Currently, the most commonly used LV support device is the intra-aortic balloon pump (IABP), despite the modest increase in cardiac output (0.5 L/minute) and coronary blood flow it offers. Percutaneous LV assist devices have been developed to provide better circulatory support during these high-risk PCIs, and may be more effective in terms of hemodynamic parameters than IABP.17 However, no single approach has achieved wide acceptance, especially because of the device-related complications which have hampered their more widespread use.6,7
The safety and feasibility of the Impella Recover LP 2.5 assist device have been recently suggested in a series of 19 patients.10 The Impella pump provides flow of up to 2.5 L/minute at maximal rotation speed in clinical conditions, which is comparable to the performance of the Hemopump support system (Medtronic Inc., Minneapolis, Minnesota), with less procedure-related morbidity.7 The Impella device can be easily and rapidly inserted percutaneously by a retrograde approach, in contrast with the TandemHeart device (Cardiac Assist Technologies Inc., Ithaca, New York), which requires transseptal puncture and both arterial and venous femoral approaches.1,6 There is no need for surgical assistance during the implantation procedure. Hemolysis and thromboembolism were very rarely reported in previous series with the Impella Recover LP 2.5 device.10,11 Prior to implantation, iliofemoral duplex ultrasound is strongly recommended, and a long sheath should be used in the event of peripheral arterial tortuous trajectories. Another important point is the need for preprocedural echocardiography to exclude LV thrombus or a severely calcified aortic valve, which are both considered contraindications.
To achieve femoral closure in our patient, we used a surgical approach. This limitation could be removed by the double Perclose device technique (Abbott Laboratories, Abbott Park, Illinois) used by Henriques et al,10 with practically no device-related complications concerning the femoral entry site in their series.
In conclusion, this case demonstrated that very high-risk PCI supported by the Impella Recover LP 2.5 assist device is feasible and safe, and should be attempted in unstable patients with severe coronary lesions and high-risk mortality with cardiac surgery. Large, randomized trials assessing the hemodynamic and clinical effects of this device are highly warranted.
References
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