Totally Percutaneous Insertion and Removal of Impella Device Using Axillary Artery in the Setting of Advanced Peripheral Artery Disease

Abstract: Traditionally, brachial and common femoral arteries have served as access sites of choice, with many operators recently converting to radial artery access for coronary angiography and percutaneous intervention due to literature suggesting reduced bleeding risk, better patient outcomes, and lower hospital-associated costs. However, radial access has limitations when percutaneous procedures requiring larger sheath sizes are performed. Six Fr sheaths are considered the limit for safe use with the radial artery given that the typical luminal diameter of the vessel is approximately 2 mm, while peripheral artery disease (PAD) may often limit use of the common femoral artery, particularly in patients with multiple co-morbid risk factors. Similarly, the brachial artery has fallen out of favor due to both thrombotic and bleeding risks, while also not safely and reliably accommodating sheaths larger than 7 Fr. Here we describe 3 cases of a new entirely percutaneous technique utilizing the axillary artery for delivery of Impella 2.5 (13.5 Fr) and CP (14 Fr) cardiac-assist devices for protected percutaneous coronary intervention in the setting of prohibitive PAD. 

J INVASIVE CARDIOL 2016;28(9):374-380. 2016 July 15 (Epub ahead of print)

Key words: axillary artery, percutaneous access, high-risk PCI

Interventional cardiology is a rapidly evolving field with a wide array of new and more complex percutaneous coronary intervention (PCI) and peripheral intervention, including structural heart and endovascular procedures, being performed today. Accordingly, the interventional cardiologist must be adept, now more so than ever, at totally percutaneous arterial access and exit from multiple sites. Arterial access via the common femoral artery (CFA) remains the default vascular access site of choice in the United States,^{1, 2} particularly for advanced interventional procedures and successful delivery of equipment utilized for complex coronary intervention, chronic total occlusions, intraaortic balloon pump or Impella (Abiomed, Inc) insertion, endovascular aortic or thoracic aneurysm repair, and transcatheter aortic valve replacement (TAVR). However, advanced peripheral artery disease (PAD) may preclude the CFA as a suitable access site.³ Use of the subclavian and/or axillary arteries has previously been described for vascular access with surgical cut-down^4-8 and a percutaneous approach^9,10 for Impella insertion and TAVR. As peripheral endovascular specialists, we have developed a level of comfort utilizing alternate access sites such as high brachial artery or axillary artery (AA) for treatment of lower-extremity arterial disease most typically in the setting of hostile aorto-iliofemoral segments due to extensive calcification and atherosclerotic disease. From this experience, we noted the AA to be typically accommodative of larger sheaths and infrequently diseased. Thus, we sought to explore the feasibility of the AA as a percutaneous access site for complex interventions requiring the delivery of large artery sheaths (10-18 Fr). Our previous work has demonstrated that the AA can accommodate sheaths with an outer diameter of up to 18 Fr with a mean vessel diameter of 6.38 mm (right) and 6.52 mm (left).¹¹ 

Moreover, we found that the AA is less frequently affected by the atherosclerotic disease that often complicates the use of the CFA even in the setting of advanced PAD, with 2.1% of AAs displaying computed tomographic evidence of atherosclerotic disease vs 19.8% in common femoral arteries.¹¹ We utilized this factual information to develop a technique that is reproducible, safe, and effective for the percutaneous insertion and removal of the Impella 2.5 or Impella CP device for high-risk protected PCI in settings that preclude access via the CFA. Percutaneous insertion of large delivery systems, such as used during TAVR, was previously described by Schäfer et al,¹⁰ and uses brachial and common femoral arteries to establish an arterial-arterial monorail access loop. However, we did not use the brachial artery and utilized only the same CFA that was being used for high-risk PCI. Based on our experience, we felt the additional arteriotomy site being used for the PCI was large enough to reliably accommodate a 7 Fr sheath in the event bail-out placement of a covered stent was required. Furthermore, our simplified approach reduces procedural time, complexity, and potential vascular complications related to obtaining a second ipsilateral brachial or radial access without compromising efficacy or safety in achieving complete hemostasis at the end of Impella-supported high-risk PCI. 

Technique

1.     The patient is prepped in a supine position with the arm abducted at 120°, after which the AA is readily palpable in the deltopectoral groove, usually in close proximity to the inferior portion of the humeral head. 

2.     A hemostat is placed medial to the inferior border of the glenoid cavity as identified under fluoroscopy in the anterior posterior view. Anatomically, the AA is divided into three parts depending on their relation to the pectoralis minor muscle. The posterior, lateral, and medial cords of brachial plexus embrace the second part of the AA, as per their names (Figure 1). Contrary to conventional teaching, we suggest accessing the AA in its second portion because the chance of brachial plexus injury may be smaller since none of the three cords travel on the anterior surface of the AA. Moreover, at the discretion of the operator, nerve structures are readily identifiable on ultrasound prior to access (Figure 2). 

3.    Access and placement of a 7 Fr sheath is then achieved in standard fashion from an alternate access point (usually the CFA), and a catheter of choice is then advanced from the CFA to selectively engage the subclavian artery. We suggest access from the CFA in this instance as secure cannulation and adequate support of the contralateral subclavian artery from the radial artery can be difficult. This also facilitates “dry closure” of the AA at the end of the procedure and allows bidirectional control of the AA during percutaneous closure. We also prefer use of the left AA in the older age subset because of the higher prevalence of type III aortic arch in this population, as it is felt to provide a more favorable trajectory to the heart.¹² 

4.     Baseline angiography or a fluoroscopic subtraction image (roadmapping) of the subclavian, axillary, and high brachial arteries is performed after the artery has been localized by direct palpation (Figure 3). A micropuncture needle may be placed in the subcutaneous tissue after administration of local anesthetic as a marker. Ultrasound may be used to readily identify the artery and the surrounding nerve structures of the brachial plexus depending on operator preference; however, we have found familiarity with bony landmarks sufficient to routinely obtain safe access without incident. 

5.     The micropuncture needle is then used to access the second portion of the AA through a combination of direct palpation, fluoroscopic guidance, and/or ultrasound imaging, in a fashion applicable to the CFA. A 4 Fr micropuncture sheath is then placed, followed by access-site angiography to confirm sheath placement at an appropriate position within the AA (Figure 4).

6.     A standard 0.035˝ J-tip wire is then advanced into the subclavian artery and the micropuncture sheath is exchanged for a 6 Fr sheath. 

7.     Utilizing the well-described pre-close technique, two Proglide suture-mediated closure devices (Abbott Vascular) are deployed at the standard 10 o’clock and 2 o’clock positions and left uncinched. 

8.     The arteriotomy is then sequentially dilated, typically with a 9 Fr dilator, prior to introduction of the 13.5 Fr or 14 Fr Impella sheath over a stiff 0.035˝ wire of choice.

9.     Using standard valve crossing techniques, a pigtail catheter is positioned securely in the left ventricle and left ventricular pressures are recorded. A 0.018˝ Impella wire (with a generous curve at the tip) is then advanced through the catheter and the Impella 2.5 or Impella CP device is then inserted through the sheath and advanced under fluoroscopic guidance into the left ventricle; employing standard protocol, hemodynamic support is initiated for use (Figure 5). PCI is then performed from the initial CFA access site (Figure 6).

11.     Following PCI, the Impella device is removed and a 0.035˝ wire is passed from the large-bore arteriotomy sheath into the descending aorta (Figure 7). Then, the left subclavian artery is reengaged with a 3DRC guide catheter (or the operator’s catheter of choice) from the 7 Fr CFA sheath and an exchange-length 0.035˝ wire (we prefer either a Glidewire Advantage [Terumo] or Rosen wire [Boston Scientific]) is advanced well beyond the AA sheath into the brachial artery (Figure 8).

12.     The large-bore arteriotomy sheath is now slowly withdrawn close to the AA large-bore arteriotomy site under fluoroscopic guidance. A 0.035˝-compatible, appropriately-sized 6 x 20 mm or larger balloon is then advanced over the 0.035˝ wire from the CFA and inflated in the distal subclavian artery to totally occlude flow proximal to the now partially withdrawn large-bore axillary artery sheath (Figure 9).

13.     The Impella sheath is now completely removed over the 0.035˝ wire already in place and the pre-close technique is completed by sequentially cinching and locking the previously deployed Perclose ProGlide sutures (Abbott Vascular) (Figure 10). This “dry closure” limits blood loss and allows the operator time to adequately complete the arteriotomy closure in a controlled manner. 

14.     The balloon in the subclavian artery is deflated and digital subtraction angiography is performed through the balloon wire-lumen to confirm there is no leak at the large-bore arteriotomy site (Figure 11). The 3DRC guide catheter and 0.035˝ wire are now removed and light manual pressure is applied for 5 minutes to ensure complete hemostasis (Figure 12). 

15.     If significant extravasation is noted from the arteriotomy site following closure, continued application of external manual pressure is suggested; however, if difficulty is encountered in effectively securing hemostasis, we recommend having a covered stent (Viabahn [Gore] or iCast [Atrium]) available as a bail-out strategy. We would suggest the Viabahn in this location due to the increased flexibility of the device.

Case Presentations

Patient #1. A 65-year-old female deemed high risk for coronary artery bypass graft (CABG) surgery with history of hypertension, diabetes mellitus type 2 on insulin, tobacco use, chronic kidney disease, percutaneous intervention in the past with known chronic total occlusion of the right coronary artery, ostial disease of a dominant left circumflex artery, obstructive sequential stenosis of the proximal and mid-left anterior descending (LAD) artery with severe left ventricular systolic dysfunction (ejection fraction, 15%-20%), severe PAD including right above-the-knee amputation (AKA), left subclavian artery stent placement, and recent left superficial femoral artery and popliteal artery stenting for threatened amputation of left leg presented with angina. She also had history of subclavian steal syndrome requiring stent placement. 

Additionally, on previous coronary angiography she was noted to have diminutively sized and diffusely diseased iliofemoral vessels that were not feasible to accommodate either a 7.5 Fr intraaortic balloon pump or Impella support device. Accordingly, she had been told medical therapy was her only option because she was felt to be high risk for unsupported percutaneous intervention. She underwent successful percutaneous insertion and removal of an Impella 2.5 support device via the left AA. Multivessel PCI via the right CFA was performed with drug-eluting stent  implantation in the ostial left circumflex and proximal LAD. The arteriotomy site in the AA was closed using the steps shown in Figures 7 to 12. She was discharged home the next day. 

Patient #2. An 83-year-old male with past medical history significant for multivessel coronary artery disease with severely reduced left ventricular systolic function (ejection fraction, 20%) and notable dyskinesis of the anterior, anteroapical, and inferoapical walls presented to the hospital with dyspnea on exertion. Prior angiograms revealed an 80% ostial stenosis of a dominant left circumflex artery in addition to a chronic total occlusion beyond the LAD at the origin of the first diagonal, and a functionally occluded co-dominant right coronary artery. After previous evaluations at our center as well as two other tertiary-care facilities, he had been treated medically due to his concomitant history of severe PAD and known infrarenal abdominal aortic aneurysm measuring 7.7 cm. These conditions precluded the use of hemodynamic support during PCI and were also felt to significantly elevate his risk of operative mortality with CABG. 

Subsequently, the patient was readmitted to our institution due to the development of recurrent unstable Canadian Cardiovascular Society class IV symptomatology and thus was brought to the catheterization laboratory to undergo high-risk multivessel PCI with Impella 2.5 support after previous angiography revealed widely patent AA and left subclavian artery. The Impella device was placed and removed entirely percutaneously as per our described technique. The left coronary system was selectively engaged utilizing an XB 3.5 6 Fr guide catheter and PCI was completed with a drug-eluting stent deployed successfully in the ostial circumflex artery using standard techniques. The AA arteriotomy site was closed using the steps shown in Figures 7 to 12. The patient tolerated the procedure well without any neurovascular compromise. He successfully underwent endovascular repair of his infrarenal aortic aneurysm 6 weeks later.

Patient #3. A 41-year-old male patient had multiple co-morbidities, such as long-standing cigarette smoking, hypertension, dyslipidemia, type 1 diabetes mellitus, severe PAD with above-the-knee amputation of the right-lower extremity, moderate to severe pulmonary hypertension, multivessel coronary artery disease, and severe systolic dysfunction (ejection fraction, 15%). He presented with angina and non-ST segment myocardial infarction after several recurrent admissions due to acute on chronic decompensated systolic heart failure. Coronary angiography revealed a 20% stenosis in the mid-left main coronary artery, an 80% stenosis of the mid-LAD followed by a long tubular 50%-70% stenosis of the mid-distal vessel, 40% proximal and 99% mid stenosis of the left circumflex coronary artery, as well as 90% ostial stenosis of a moderate-sized posterolateral branch. Selective angiography of the left subclavian and AAs revealed them to be widely patent and free of significant disease despite the presence of severe iliofemoral disease.

Due to lack of adequate distal targets and his multiple co-morbidities, the patient was deemed unsuitable for revascularization via CABG. Thus, he was referred to undergo high-risk multivessel PCI after percutaneous Impella 2.5 insertion. Once again, the Impella device was placed and removed entirely percutaneously as per our previously described technique. The left coronary system was selectively engaged utilizing an XB 3.0 6 Fr guide catheter, and drug-eluting stents were sequentially deployed in the left circumflex artery, mid-LAD, and posterolateral branch of the right coronary artery. The arteriotomy site in the AA was closed using the steps shown in Figures 7 to 12.

The patient was discharged after successful revascularization without neurovascular compromise. To date, he has not had a recurrent hospitalization secondary to a cardiac cause, has undergone fitting of prosthesis to his right lower extremity, and lives at home. 

Discussion

The use of the AA or subclavian artery as alternate access sites has previously been described, although most often by surgical cut-down with or without conduit graft placement. Small case series have emerged from Europe also describing percutaneous access and closure of the AA for TAVR. However, this approach has not gained favor in the United States, as many operators cite the potential for nerve damage and difficulties affecting hemostasis due to the lack of compressibility against a bony structure as potential drawbacks to utilizing the AA as an alternate access point. Risks of nerve damage and bleeding have also been described during the surgical approach. We feel confident that our approach’s reproducibility minimizes these risks both with or without the use of ultrasound identification of surrounding nerve structures prior to achieving arterial access as well as providing a method for always maintaining internal control of the vessel.  

Conclusion

Utilizing our totally percutaneous technique, we have safely introduced large sheaths and removed them from the AA without the need for a surgical cut-down. Our previously published study has demonstrated the average diameter of the AA to range between 6.38-6.52 mm.¹¹ This has allowed us to safely and efficiently perform protected high-risk PCI with Impella support on a number of individuals who otherwise may be deemed too high risk for this device using the customary CFA approach due to the presence of prohibitive aortoiliac disease. With rapid advances in transcatheter technologies, including commercial availability of TAVR delivery systems requiring vessel diameters of approximately 6 mm, we propose that the AA approach could serve as a viable alternate percutaneous access site with fewer associated costs or complications when compared with transcaval, transapical, or transaortic approaches. 

References

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9.    Schäfer U, Ho Y, Frerker C, et al. Direct percutaneous access technique for transaxillary transcatheter aortic valve implantation: “the Hamburg Sankt Georg approach.” JACC Cardiovasc Interv. 2012;5:477-486. 

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From the ¹Department of Cardiology, Newark Beth Israel Medical Center, Newark, New Jersey; and ²Mary Washington Hospital, Fredericksburg, Virginia. 

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.

Manuscript submitted March 10, 2016, provisional acceptance given April 13, 2016, final version accepted May 16, 2016.

Address for correspondence: Najam Wasty, MD, Department of Cardiology C2, Newark Beth Israel Medical Center, 201 Lyons Avenue at Osborne Terrace, Newark, NJ 07112. Email: nwasty@barnabashealth.org