Percutaneous Vascular Interventions

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CHAPTER 86 Percutaneous Vascular Interventions

The first known use of angiography was performed on a cadaver hand in 1896, a year after Roentgen developed the first x-ray. The progress of angiography was initially slow because of the lack of a suitable in vivo contrast medium. Eventually, a contrast agent was developed based on linking iodine to carbon, a formula fundamental to all current iodinated agents. Vascular access remained a problem until 1954, when Seldinger described the technique for percutaneous vascular access.1 This allowed safe vascular cannulation and resulted in the rapid development of techniques for diagnostic percutaneous angiography.

Percutaneous vascular therapeutic interventions evolved from the successes of diagnostic angiography. The first case of percutaneous revascularization was performed by Dotter and Judkins,2 who successfully dilated a superficial femoral artery stenosis in 1964 using serial dilation over a percutaneously inserted guide wire. Since then, many technologic innovations in hardware materials, such as balloons, metallic stents and guide wires, have led to the rapid progression of percutaneous vascular interventions. Advances in contrast media and imaging technology, such as digital subtraction angiography, CT, and MRI, have also ushered in new approaches and methods to identify and treat a wide array of vascular diseases through the percutaneous approach. One such example of great clinical usefulness is the use of carbon dioxide (CO2) as a contrast material for arteriography in digital subtraction angiography system.3 The knowledge gained through such arterial interventions has been applied for cancer therapy to achieve temporary tumor devascularization in preparation for surgery or to treat the tumor through a combination of chemotherapy and vascular occlusion materials.

In this chapter, we will briefly discuss the tools, principles, and methods of diagnostic arteriography and percutaneous arterial interventions. We have broadly divided arterial interventions into revascularization procedures and vascular exclusion procedures. Our intention is not to provide detailed descriptions of procedures but to provide an overview of the indications, principles, complications, and results. For detailed descriptions of these procedures, refer to the subsequent specialized chapters in this book.

EQUIPMENT AND TOOLS

The essential tools for diagnostic arteriography are catheters, vascular sheaths, and guide wires. In addition to these, revascularization procedures use various types of balloons, metallic stents, and aspiration and infusion catheters. Vascular occlusion and exclusion procedures use particulate materials, metallic coils, detachable balloons, liquid embolic agents, and stent grafts.

Catheters

A catheter commonly serves as a delivery conduit for contrast materials, drugs and embolic devices. Catheters are long hollow tubes made of various materials, usually polyethylene or polyurethane. The size (diameter) refers to the outer diameter of a catheter, with typical sizes varying from 4F to 9F. The inner lumen of a diagnostic catheter is constant, and allows a 0.038-inch diameter guide wire. Within the shaft of a catheter, there is a layer of fine braided wire, resulting in a flexible, kink resistant, torqueable structure. The luminal surface is coated with Teflon or other low-friction substances to provide a low-friction surface for passage of the guide wire and other devices used for peripheral arterial interventions. The tip of the catheter is soft and often tapered. Some catheters have a preformed shape. This may help manipulate the catheter across a vessel or allow selective cannulation of a vessel. Various tip configurations are currently available. Catheter selection depends on the angle at which the target vessel arises from the parent vessel. Several catheters have a reverse curve (e.g., Simmons, SOS omni), which require reformation in a larger vessel to return to the original curve of the catheter.4 Other catheters have multiple side holes at the tip and allow injection of a large volume of contrast material at a high flow rate.

Microcatheters are generally 3F or smaller in diameter and can be passed through a diagnostic catheter. A microcatheter allows superselective cannulation of a small or tortuous vessel.

Vascular Sheaths and Dilators

Vascular sheaths are generally larger catheters of varying lengths, with a hemostatic valve on the proximal end of the sheath. A side arm is connected to the hemostatic valve. These catheters are inserted over a wire following needle cannulation of the vessel. An inner dilator is present and removed following cannulation of the vessel with the sheath. After removing the dilator, the vascular sheath provides hemostatic access to the vascular system, greatly reducing trauma to the vessel associated with repetitive catheter insertion and manipulation. Most procedures require the use and manipulation of multiple catheters that can be introduced atraumatically to the vessel lumen via the sheath. In addition, sheaths provide support for catheter manipulation and interventions. Sheaths are available in varying sizes, shapes, and lengths. The size (diameter) of sheaths is described in a similar fashion as catheters but, in the case of sheaths, the inner diameter of a vascular sheath is used as the metric, which therefore corresponds to the largest catheter diameter that the sheath will accommodate.

Dilators are short, stiff catheters with a smoothly tapered end. They are passed over a guide wire into the vessel and are used to create a smooth, minimally traumatic tract from the skin surface to the vessel lumen. These are particularly useful for scarred tissue and serial dilations can be performed to enlarge a soft tissue tract to accommodate larger catheters and sheaths. The dilator shape and size are closely matched to the sheath to facilitate nontraumatic introduction of the sheath to the vessel.

Balloons

Although the first percutaneous angioplasty was described by Dotter and Judkins2 in 1964, Gruentzig devised the first successful balloon angioplasty in 1976, and this method became widely accepted.5 The primary mechanism of balloon angioplasty is controlled tear and shearing of the atheromatous plaque, the intima, and the media beneath the plaque.

The characteristics of a balloon depend on the material and its construction. There are essentially two types of balloons, compliant and noncompliant. All balloons have a nominal diameter at a given pressure as well as a predetermined burst pressure.

Compliant and Noncompliant Angioplasty Balloons

Compliant balloons are made of latex, silicone, or polyurethane. These balloons elongate and conform to the vessel rather than dilate as pressure is applied. They are particularly useful for temporary vascular occlusion, embolectomy, or the molding of a stent graft.

Noncompliant balloons are made of noncompliant polymers with high tensile strength. The balloon reaches a nominal predetermined diameter during inflation. These balloons are useful for angioplasty.

Atherectomy Devices

Atherectomy devices (e.g., SilverHawk Plaque Excision System; U.S. Peripheral Products, Plymouth, MN) use a small rotating blade to cut and remove vessel wall atheroma. Theoretically, atherectomy offers the following advantages over conventional percutaneous transluminal angioplasty. It reduces focally and selectively the degree of stenosis by debulking the atheromatous mass, which increases immediate technical success, given the absence of subintimal dissection and local trauma. Although short-term results show a favorable trend toward decreased restenosis rates, long-term efficacy data of this technique is not yet available.7

Stents

The first endovascular stent (endovascular splint) was used by Dotter in 1969.8 Since then, stent technology has grown significantly and revolutionized the percutaneous management of vascular disease. Currently, there are two basic devices, balloon-mounted and self-expanding stents.

PERCUTANEOUS ARTERIOGRAPHY

High spatial resolution catheter-based angiography is crucial for diagnostic and interventional procedures. It is necessary to provide fine anatomic detail of the target lumen. It is important to optimize the technique to obtain temporal and spatial resolution.

Percutaneous Vascular Access

Vascular access techniques have evolved little since Seldinger described the technique of percutaneous access using a removable core or hollow needle, which allows the insertion of a guide wire.1 The choice of the vascular access site is based on the procedure being performed, the location of the target vessel, and the degree of focal atherosclerotic disease in the affected vascular region. The access vessel should be readily free of disease. Access may be performed using a single-wall or double-wall technique. Regardless of the technique, once the vessel is accessed, a nontraumatic wire is passed through the lumen of the needle into the vessel. The entrance site to the vessel should be located over a bone whenever possible. This provides a stable object against which to compress the vessel following completion of the procedure and removal of the catheters and sheaths.

Specific Regions of Interest

Renal Angiography

Renal angiography is indicated for the diagnosis and management of suspected renovascular hypertension (Fig. 86-3), hematuria of unknown origin, trauma, preoperative assessment of a donor kidney, and postoperative evaluation of a transplanted kidney. It may also be performed for the devascularization of renal tumors prior to surgery or as a palliative therapy.

Outcomes and Complications

Complications of angiography are generally related to the arterial puncture site and nephrotoxic effects of the contrast material.11,12 The most common puncture site complication is local hemorrhage, which occurs in fewer than 3% of patients. Large hematomas may require transfusion or vascular surgical repair. The risk of hemorrhage is increased with large-caliber catheters, multiple sheath or catheter changes, and patients with bleeding diathesis, local aneurysmal or atherosclerotic arterial disease, or inadequate compression of the puncture artery. In addition to hematoma, false aneurysms (less than 0.5%) and, rarely, arteriovenous fistula formation (less than 0.1%) may occur.

Arterial thrombosis at the puncture site is a rare complication. Arterial spasm, the use of large-caliber sheaths, multiple punctures, polycythemia, hypercoagulable states, and excessive compression of the puncture site also increase the risk of thrombosis.

Subintimal dissection may occur secondary to wire, dilator, or catheter malpositioning. This complication occurs more commonly in the femoral or iliac artery during initial puncture. Frank perforation of the arterial wall is rare.

Embolization into the distal arterial tree occurs most frequently in the lower limbs, given the overwhelming predominance of femoral arterial access. Embolization is caused by thrombus stripping off the guide wire or catheter or by dislodgment of an atheroma (cholesterol emboli) during catheter manipulation. The administration of systemic anticoagulation during the procedure helps reduce the incidence of distal embolization. The use of embolic protection devices during lower extremity interventions also may reduce the incidence of clinically significant distal embolization.13

Complications with the use of iodinated contrast material include allergic reactions, renal failure and, rarely, cardiac failure. Premedication with prednisone or diphenhydramine is recommended for patients with a history of minor allergic reactions to contrast materials. As noted, the nephrotoxic effects of contrast can be minimized by preprocedural hydration and possibly the use of N-acetylcysteine. Cardiotoxicity is related to the high osmolarity of the contrast material, largely a historical complication given the widespread current use of low iso-osmolar, nonionic iodinated contrast agents.

Imaging Findings

ANGIOPLASTY

Angioplasty was initially described by Dotter and Judkins,2 who successfully carried out angioplasty of a superficial femoral arterial stenosis using serial dilation. Later, balloon technology was developed by Gruentzig in 1976. Since then, balloon angioplasty has become the standard for revascularization procedures. Successful angioplasty requires careful attention to patient work-up, high-quality angiography, selection of proper hardware, and careful postprocedure management. In general, short-segment stenoses and occlusions respond well to angioplasty.

In addition to routine laboratory work-up and noninvasive vascular studies prior to a planned revascularization procedure, patients should ideally be treated with antiplatelet drugs (e.g., clopidogrel and/or aspirin). Depending on the location of the stenosis or occlusion, an antegrade or retrograde approach is undertaken. In general, a guide catheter or large sheath is placed at the arterial access site to allow angiography of the segment being treated and a balloon catheter to be used. Heparin (70 to 100 U/kg) is administered intravenously prior to crossing the stenosis. The stenosis or occlusion is crossed first with a hydrophilic wire and then with a catheter. The intravascular location of the catheter distal to the stenotic segment is confirmed by contrast material administration and then a stiff working wire (e.g., Rosen or Amplatz wire) is positioned across the stenosis. The catheter is exchanged for a properly sized balloon. The diameter of the balloon is determined by the vascular segment being treated and the size of the normal adjacent vessel. The balloon is inflated, deflated, and removed. Inflation devices are helpful to treat the lesion adequately. A postangioplasty diagnostic arteriogram is obtained (Fig. 86-4) to confirm the therapeutic result. A successful angioplasty is revealed by the absence of any significant residual stenosis (i.e., residual stenosis less than 30%), normalization of intravascular pressures across the stenosis (pressure gradient less than 10 mm Hg), and disappearance of collaterals. Postprocedure, heparin may be infused intravenously for 24 hours.

Special Considerations

Outcomes and Complications

The optimal clinical outcome is a durable improvement of the patient’s symptoms. Many early failures of angioplasty were caused by technical problems encountered at the time of the procedure, such as an occlusive dissection adjacent to the intervention site, elastic recoil of a fibrotic lesion, or perhaps an unrecognized lesion that continued to impair flow. Delayed failure occurs when there is restenosis of the treated segment. This is typically seen from 3 months onward and is predominantly caused by neointimal hyperplasia. Late failure occurs as the disease progresses in the inflow and outflow tracts. Vessel patency rates following angioplasty vary significantly, depending on the vascular territory, length of the stenotic lesion, complications during the procedure, and preexisting or unaltered patient factors such as smoking, lifestyle, and the use of antiplatelet medications.

As noted, access site complications include hematoma, pseudoaneurysm, arteriovenous (AV) fistula, and thrombosis. Atheroemboli causing blue toe syndrome occur in less than 1% of patients; dissection and occlusion of the branch vessels occur at a rate of 0.5%. Another rare complication is rupture of the vessel during angioplasty. Predisposing factors for arterial rupture include long-term therapy with corticosteroids and underlying vascular abnormalities such as Marfan syndrome and Ehler-Danlos syndrome. Immediate reinflation of the balloon across the rupture or proximal to the lesion can be a lifesaving maneuver. Urgent surgical repair or endovascular therapy with a stent graft is usually required to stop bleeding. Systemic complications are relatively uncommon and include sepsis (0.2%) and transient acute tubular necrosis (0.3% to 1%).

Imaging Findings

Postprocedural Surveillance

Antiplatelet therapy with aspirin and/or clopidogrel is generally recommended following angioplasty.14 The duration of antiplatelet therapy is debatable and many interventional interpreting physicians prefer to treat the patient for at least 6 months following angioplasty. It is essential to carry out a postprocedure assessment such as a Doppler ultrasound examination or ABI testing at 24 to 48 hours postangioplasty. Long-term follow-up (e.g., at 1, 3, 6, and 12 months) is also important to monitor patient outcome. Imaging studies such as Doppler or CTA may be performed if there is suspicion of residual or recurrent disease. Secondary interventions with repeat angioplasty or stent placement may be performed to increase the assisted patency following angioplasty.

REVASCULARIZATION WITH STENTS AND STENT GRAFTS

When angioplasty alone is ineffective for treating a stenosis or occlusion, stents and stent grafts provide an alternative solution. It is necessary to have a normal vessel both proximally and distally to allow internal fixation of the device and prevent disease recurrence. Today, many designs are approved by the U.S. Food and Drug Administration (FDA) and numerous devices are being used commercially or in clinical investigations. Stent grafts can also be used to treat aneurysmal disease.

In general, self-expanding stents are preferable for revascularization. However, the design and nature of the delivery system do not allow a precise deployment of the stent in complex locations. As such, balloon-expandable stents are used when location of the stent deployment is complex, as in the treatment of osteal stenosis of the subclavian and renal arteries and intracranial arterial disease.

Primary stenting—direct placement of a stent without prior angioplasty—is often practiced for the treatment of iliac, renal, and subclavian artery disease when the stenosis affects the ostium or is a result of an eccentric ulcerated plaque (Fig. 86-6). Secondary stenting following failed angioplasty or a complication of angioplasty is more commonly done.

The procedure involves the same steps as angioplasty. The stenosis or occlusion is crossed with a wire. The extent, location, and size of the diseased artery are measured and an optimal stent is chosen. The stent is deployed across the disease segment as per the manufacturer’s guidelines. Angioplasty of the stent is often performed to bring the stent to the optimal size. If multiple stents are required, deployment of the distal stent should be performed first and adequate overlap of the stents achieved. The deployment of a stent graft for steno-occlusive disease is similar to that used for regular stents. However, when stent grafts are chosen to treat an aneurysmal disease, proper planning with regard to the size of the proximal and distal arteries is essential to prevent residual perfusion of the aneurysm.

THROMBOLYSIS

Thromboses in the peripheral vascular system are a major cause of morbidity and mortality. An arterial or venous thrombosis can lead to ischemia and tissue infarction. The aim of thrombolysis is to restore blood flow to the ischemic limb or organ and to identify the underlying lesion for treatment via an endovascular approach or surgery.

Several pharmacologic agents are available for thrombolysis, including streptokinase, urokinase and recombinant tissue plasminogen activator (rt-PA). Each has a slightly different mechanism of action but they generally exert their effects by converting plasminogen to plasmin. Plasmin is an enzyme that degrades multiple blood plasma proteins, most notably fibrin (fibrinolysis), the predominant component of fibrin clots. At present, rt-PA has emerged as the most commonly used agent.

During vascular access, care is taken to ensure a single wall puncture to the artery. A diagnostic arteriogram is obtained to assess whether the event is secondary to in situ thrombosis or embolization. Angiography may also provide information about the chronicity of the problem. The arterial inflow, extent of thrombosis, and patency of distal arterial bed are assessed. The thrombus is crossed using a wire and an infusion catheter with multiple side holes is placed within the thrombus. The tip of the infusion catheter should be advanced beyond the thrombus, if possible, and the side holes within the thrombus.

There are multiple regimens for thrombolytic infusion. The most common is a bolus infusion of the thrombolytic agent followed by a continuous infusion for 24 to 48 hours. The catheter may be repositioned during thrombolysis to provide a more even distribution of the thrombolytic agent. Repeat angiograms are obtained at regular intervals to evaluate the progression of thrombolysis. Concomitant low-dose heparin therapy is administered through the arterial sheath or an intravenous route. The patient’s activated partial thromboplastin time (aPTT) and hematocrit should be followed during thrombolysis. In addition, serum fibrinogen levels are determined to assess the degree of fibrinolysis, which may correlate with the risk of hemorrhagic complications.

During thrombolysis, there may be a distal embolization as the thrombus fragments. Continued upstream thrombolytic infusion is usually sufficient to lyse any distal thromboemboli. If no improvement occurs within several hours, the infusion catheter can be repositioned within the distal emboli.

Thrombolytic therapy is terminated once antegrade blood flow is established and no significant thrombus remains. In general, thrombolytic therapy is stopped after 48 hours if there is no significant clinical improvement. Thrombolysis is terminated sooner if hemorrhagic complications arise.

After a successful thrombolysis, the patient should be evaluated for any underlying vascular lesion or clotting disorder. If identified, these lesions should be treated to prevent further recurrence.

Special Considerations

Mechanical Thrombolysis

Mechanical thrombectomy devices are used as an adjunct to pharmacologic thrombolysis. These devices excel in the treatment of acute limb ischemia caused by thrombotic occlusion. In addition, there is increasing interest in the use of these devices for the treatment of acute deep venous thrombosis (DVT). Also, these devices allow thrombectomy when pharmacologic thrombolysis is contraindicated or has failed. Several mechanical thrombectomy devices are available.

AngioJet (Possis Medical, Minneapolis) uses retrograde fluid jets to create a negative pressure gradient directed toward the catheter lumen (Bernoulli principle). The thrombus is drawn into the catheter, where it is fragmented by the jets and evacuated from the body. The device consists of a catheter, disposable pump bag and nondisposable motorized drive unit. The catheters have two lumens. The larger lumen allows debris evacuation and guide wire passage while a small profile inner lumen allows the pressurized perfusate to be removed. The pump set pressurizes the saline that energizes the catheter and creates the vacuum. The drive unit activates the pump, monitors safety, and ensures balanced flow and volume of the saline solution. This monitoring and control allow the system to theoretically remain iso-volumetric.

The Arrow Trerotola device (Arrow International, Reading, Pa) is a direct contact mechanical fragmentation device that uses a spinning wire to macerate the thrombus. The device consists of a motor-driven fragmentation cage attached to a drive cable. The cage and drive cable are housed in a 5F catheter containing a self-expanding cage, with a soft rubber distal tip. Once the cage is unsheathed, the cage expands to a predetermined diameter (9 mm). The open cage is rotated within the graft at a fixed speed (3000 rpm) using a separate handheld rotator unit. This device has FDA approval for declotting dialysis access in patients with arteriovenous fistulas and synthetic grafts.

As its name suggests, the ultrasound thrombolytic infusion catheter (EKOS, Bothell, Wash) combines the use of catheter-directed pharmacologic thrombolysis with ultrasound. Ultrasound functions to alter the structure of the thrombus by temporarily increasing its permeability while providing an acoustic pressure gradient that helps move the drug into the thrombus to speed its dissolution (Fig. 86-7).

ATHERECTOMY

The concept of removing an obstructive plaque by a catheter-based excision technique was first introduced by Höfling and colleagues.17 There are several different types of atherectomy devices available, including directional atherectomy devices (e.g., SilverHawk), orbital atherectomy devices (e.g., Diamondback 360, Cardiovascular Systems, Minneapolis), rotational atherectomy devices (e.g., Pathway Jetstream, Pathway Medical Technologies, Kirkland, Wash; Rotablator, Boston Scientific), and laser atherectomy devices (e.g., Excimer laser wire).18 At present, no specific recommendations have been established for the treatment of lower limb disease with atherectomy devices and there are no long-term results of peripheral application of atherectomy. The procedure involves crossing of a stenotic lesion with a wire and repeatedly passing the atherectomy catheter over the wire to remove the plaque. The size of the atherectomy device depends on the target vessel diameter.

Outcomes and Complications

Few large studies exist evaluating the efficacy of atherectomy compared with balloon angioplasty.19,20 However, there are several theoretic advantages. Physical debulking of the atheromatous plaque compared with fracturing of the media would seem to provide better long-term patency. However, studies have demonstrated that the long-term patency obtained with atherectomy catheters is no better than that achieved with traditional balloon angioplasty.20,21

Complications associated with atherectomy are similar to those seen when procedures necessitate the use of large sheaths, including hematoma, dissection, pseudoaneurysm, and complications related to emboli. Additionally, complications from the atherectomy device itself may be encountered, including dissection, tissue emboli or atheroemboli, thrombosis, and vessel damage or perforation.

EMBOLIZATION

Embolization refers to the percutaneous therapeutic blockage of blood vessels to stop or prevent hemorrhage, devitalize an organ or tumor, reduce blood flow through a vascular malformation, or redistribute blood flow.

Embolic Agents and Devices

A variety of embolic agents are available, including the following:

Particulate Agents

Mechanical Occlusion Devices

Liquid Embolic Agents

These agents include sclerosants, glue, and thrombin. Common sclerosant agents are absolute ethanol and sodium tetradecyl (STD). Common glue agents are cyanoacrylate and an ethylene–vinyl alcohol copolymer (Onyx Liquid Embolic System, Micro Therapeutics, Irvine, Calif).

Principles of Embolization

A detailed description of various embolization procedures is beyond the scope of this chapter. Here we will briefly discuss the principles of embolization.22 When distal arteriolar or capillary embolization (as in tumor embolization) is desired, particulate or liquid embolizing agents are used. It is important to occlude all collateral supply to the tissue to achieve complete devascularization. When a distal arterial bed needs to be reperfused through collaterals (as in splenic artery embolization for splenic trauma), proximal embolization with mechanical devices is carried out. During therapy of aneurysms and pseudoaneurysms, the arterial inflow and outflow should be occluded to prevent persistent perfusion of the aneurysm. Another option is to completely pack the aneurysm sac with mechanical coils. In the treatment of arteriovenous malformations, all the branch vessels supplying the nidus or the entire nidus should be completely embolized. Arteriovenous fistulas can be treated with coil embolization of the communication or by excluding the communication with a stent graft.

Imaging Findings

REFERENCES

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21 Chung SW, Sharafuddin MJ, Chigurupati R, Hoballah JJ. Midterm patency following atherectomy for infrainguinal occlusive disease: a word of caution. Ann Vasc Surg. 2008;22:358-365.

22 Osuga K, Mikami K, Higashihara H, et al. Principles and techniques of transcatheter embolotherapy for peripheral vascular lesions. Radiat Med. 2006;24:309-314.