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Use of EndoAnchors in Endovascular Treatment of Aneurysms with Short Neck
Endovascular aneurysm repair (EVAR) with standard devices can be challenging in cases with “hostile” aortic necks. Several studies have confirmed a close relationship between proximal neck morphology and complications such as type I endoleak. Most authors define a “hostile neck” as one with marked angulation, short length, complex shape, or the presence of calcification or thrombus. A challenging aortic neck represents one of the most significant limitations for the endovascular treatment of abdominal aortic aneurysm (AAA).
The use of EndoAnchors may be an alternative approach to establish a secure sealing of the endograft during initial EVAR procedures and to treat intraoperative or late type Ia endoleak ( Fig. 3.1 ).
Abdominal aortic aneurysm with hostile proximal aortic neck: A, preoperative CT scan; B, insertion of endograft; C, deployment of the endograft; D, detection of type I endoleak; E, no endoleak after implantation of Endoanchors.
Endoanchor Deployment
The Heli-FX EndoAnchor System (Medtronic Endovascular, Santa Rosa, California, USA) consists of the helical anchors, the EndoAnchor implant (supplied in a cassette containing 10 EndoAnchors), the Heli-FX Applier (a catheter-based device for placement of the EndoAnchor), and the Heli-FX Guide (a deflectable sheath to position the Applier). The system is designed to attach an endograft to the aortic wall by endovascularly placed screws. The EndoAnchors are manufactured from medical-grade nickel-cobalt wire in a helical shape. The leading end is sharpened to a conical point to act as an integral needle, facilitating atraumatic but adequate deployment through the endograft into the vessel wall up to the media, without penetrating the adventitia.
The Heli-FX Applier implants one EndoAnchor at a time using a motorized, two-stage deployment mechanism with reposition ability. It can be used to implant multiple EndoAnchors in a single patient. The Heli-FX Applier is a 12-French (l2F) (outer diameter [OD]) catheter with an integrated control handle.
The Heli-FX Guide is a sterile, single-use, disposable device designed to direct the Heli-FX Applier to the desired location for EndoAnchor implantation. The guide has a high degree of fluoroscopic visibility. The device is compatible with a 0.035-inch guidewire. The Heli-FX Guide consists of a 12F-compatible (inner diameter [ID]) guide sheath with integrated control handle and a matching obturator. Deflection of the distal tip of the catheter is accomplished by rotating the control knob located on the control handle. The Heli-FX Guide is available in both 62-cm (low-profile l6F OD) and 90-cm (l8F OD) working lengths. Multiple deflectable tip lengths are available to accommodate a range of aortic diameters.
Indications
According to the instructions for use, the Heli-FX EndoAnchor system is intended for use where augmented radial fixation or endograft sealing is required to maintain (prophylactic) or regain (therapeutic) adequate aneurysm exclusion. Furthermore, this system is intended to treat type Ia endoleaks at the initial implantation or in late-onset cases where sealing has been lost because of proximal neck expansion, device deficiencies (e.g., fracture of suprarenal stent supporting structures), or other problems that result in loss of adequate sealing. When loss of seal is accompanied by endograft migration, EndoAnchors must be used in conjunction with aortic extension cuffs to restore sealing to the renal artery level.
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