axillary approach for treatment of PAD

Percutaneous Insertion and Removal of Impella® Using the Axillary Artery for Treatment of Advanced Peripheral Artery Disease

October 20, 2016

Peripheral arterial disease (PAD), also referred to as hardening of the arteries, is a vascular disease that occurs in the arteries in the circulatory system. In PAD, the disease occurs in the arteries that carry oxygen and nutrient-rich blood from the heart to the arms and legs. For interventions that are aimed toward treating PAD or providing mechanical support, common femoral and brachial arteries are typical access sites for devices such as Impella® or intraaortic balloon pumps. Radial access does present its fair share of limitations, despite it becoming an increasingly popular access method among interventionalists. This synopsis of a recent article from the Journal of Invasive Cardiology provides a brief overview of the percutaneous insertion and removal of the Impella device using the axillary artery.

The technique for insertion and removal of the Impella device using the axillary artery (AA) is as follows:

  • The patient is placed in a supine position and the arm raised from the midline of the body at a 120-degree angle. Abducting the arm makes the AA available in the deltopectoral groove.
  • Fluoroscopy identifies the inferior border of the glenoid cavity. Following identification, a hemostat is placed in the medial of the glenoid cavity.
  • A 7 Fr sheath is then used for access and placement from a designated access point, typically the common femoral artery, and a catheter is advanced from the CFA to engage the subclavian artery.
  • Following localization of the artery by direct palpation, fluoroscopic subtraction imaging or baseline angiography is performed on the axillary, subclavian, and high brachial arteries. The usage of bony landmarks or ultrasound can also help identify the artery and neighboring nerve structures of the brachial plexus.
  • With the use of palpation, ultrasound, and fluoroscopic imaging, a micropuncture needle is used to access the second portion of the AA. This is usually accomplished following administration of a local anesthetic.
  • The placement of a 4 Fr micropuncture sheath is the next step. Access-site angiography follows to verify placement of the sheath at the best position within the AA.
  • Then, the interventionalist advances a 0.035” J-tip wire into the subclavian artery and exchanges the micropuncture sheath for a 6 Fr sheath.
  • Following advancement and exchange, the interventionalist deploys two ProGlide suture-mediated closure devices at the 10 o’clock and 2 o’clock positions.
  • Arteriotomy is dilated with a 9 Fr dilator before introducing the 13.5 Fr or 14 Fr Impella sheath over a stiff 0.035” wire.
  • A pigtail catheter is placed securely in the left ventricle using valve crossing techniques. The 0.018” Impella wire with a curve at the tip is advanced through the catheter. Then, the Impella device (2.5 or CP) is inserted through the sheath, and fluoroscopic imaging is used to advance the device into the left ventricle. Hemodynamic support is then used under standard protocol, and percutaneous coronary intervention (PCI) is performed from the CFA site.
  • After PCI has been performed, the Impella is removed. The passing of a 0.035” wire from the large-bore arteriotomy sheath and into the descending aorta follows.
  • A 3DRC guide catheter reengages the left subclavian artery from the 7 Fr CFA sheath. Then, the advancement of an exchange length 0.035” wire into the brachial artery and past the AA sheath is performed.
  • Using fluoroscopic guidance, the large-bore arteriotomy sheath is carefully withdrawn close to the AA large-bore arteriotomy access site. A 6 x 20 mm (or larger), 0.035”-compatible balloon is advanced over the 0.035” wire from the CFA. Inflation in the distal subclavian artery follows.
  • Complete removal of the Impella sheath can now occur, and the action of cinching and locking the deployed Perclose ProGlide sutures rounds out the pre-close technique.
  • The interventionalist can then deflate the balloon, using digital subtraction angiography through the wire-lumen of the balloon to verify zero leakage at the large-bore arteriotomy site.
  • The 0.035” wire and 3DRC guide catheter are then removed, and light pressure is applied to ensure hemostasis.

Impella® Device — Indication & Safety Information

INDICATIONS FOR USE

Protected PCI

The Impella 2.5® and Impella CP® 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 and Impella CP 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.

Cardiogenic Shock

The Impella 2.5®, Impella CP®, 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 and Impella CP, and ≤ 6 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

CONTRAINDICATIONS

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.

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

CONTRAINDICATIONS

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/

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