Sahil A. Parikh, Joseph J. Ingrassia, and Matthew T. Finn Division of Cardiovascular Diseases, Columbia University Irving Medical Center, New York, NY, USA Endovascular intervention has become the preferred initial therapy for the invasive treatment of femoropopliteal disease, with bypass surgery commonly reserved for complex or refractory lesions [1]. Patients with peripheral arterial disease are now 4× more likely to receive endovascular approach rather than an open surgical treatment of their disease [2]. This clinical demand has driven device development creating numerous treatment options available for the proceduralist [3]. Despite significant technologic improvements, the femoropopliteal vascular segment presents unique biomechanical challenges for lasting definitive treatment given the complex forces on the vessel from the adjacent joint movements [4, 5]. In this chapter, we describe in detail the indications, approaches, imaging technologies, and devices which may be used to approach pathology in the femoropopliteal vessel. Furthermore, we entail the available evidence surrounding their use. The patient evaluation centers on the standard history and physical evaluation. Classical historical symptoms of femoropopliteal obstructive disease involve exertional symptoms in the calf and foot. Claudication may be described as a burning or cramping discomfort brought on by exertion and improved with rest. In more severe cases, symptoms may be aggravated by elevation and improved with dependent positioning. Symptomatology may be atypical in a significant percentage of patients, particularly those with comorbidities affecting pain receptor function (i.e. spinal stenosis and diabetic neuropathy). The patient exam will demonstrate diminished pulses below the affected area typically in the popliteal and pedal segments. Temperature in the affected limb may be reduced and the limb may develop distal pallor when elevated. The skin may also lose dermal appendages appearing hairless and dry with brittle discolored nails on the affected feet. An ankle brachial index may be performed bedside or in the vascular laboratory by taking the ratio of the higher upper extremity Dopplered systolic pressure over the higher of the Dopplered systolic pressures between the dorsalis pedis and the posterior tibial artery. Finally, the neurologic assessment of sensory and motor function is an essential component of a comprehensive vascular exam. Classical vascular imaging involves vascular ultrasound with Doppler assessment. Computed tomography with lower extremity runoff can also be helpful for precise imaging of the lower extremities and is particularly useful for the aortoiliac and femoropopliteal segments. The 2016 American Heart Association/American College of Cardiology guidelines for the treatment of peripheral arterial disease provide a IIa recommendation for revascularization of claudication for patients with an inadequate response to goal‐directed medical treatment defined as supervised exercise program, aspirin, cilostazol (in those without a contraindication), and intensive comorbidity management (diabetes, hyperlipidemia, blood pressure management, as well as smoking cessation) [6]. The recently released multi‐societal appropriate use criteria for peripheral intervention [1] grant an “M” designation for “May Be Appropriate” to the superficial femoral artery (SFA) and popliteal arterial chronic total occluded segments for endovascular or surgical treatment of symptoms despite goal‐directed medical therapy. In nonoccluded femoropopliteal segment lesions, endovascular treatment is escalated to “A” for “Appropriate” for symptoms despite goal‐directed medical treatment. Fluoroscopic angiography with use of contrast remains the first‐line tool for the endovascular operator. Digital subtraction imaging (DSA) is utilized and enhances vascular visualization by subtracting the bony or dense structures from the image [7]. DSA can also reduce the amount of dye required for image acquisition. Even with less contrast delivered, full‐strength contrast injections into the extremity tend to be painful. A 50/50 mix of contrast and saline with DSA can allow for diagnostic images while reducing patient discomfort. Peripheral arterial disease is prevalent in the chronic kidney disease populations [8, 9]. CO2 angiography presents an attractive alternative to enable successful peripheral arterial disease intervention without the need for contrast dye exposure. Furthermore, CO2 can be useful in patients with severe contrast allergies [10]. CO2 angiography has important limitations. First, it may require specialized software to visualize the CO2. Second, medical grade CO2 cannot be delivered via mechanical power injection; and therefore, manual injection must be performed to achieve imaging. Third, in order to prevent erroneous air injection into the arterial system, one must create a separate system of tubing and syringes to allow for purging of atmospheric air and the creation of a closed CO2‐filled circuit. Importantly, caution should be observed if a patient complains of abdominal pain after a CO2 injection, as this could be a sign of intestinal ischemia related to successive injections of CO2 [11]. Therefore, one should generally have a delay of two to three minutes between subsequent CO2 injections [12]. Finally, imaging of the infratibial vessels is generally limited with CO2 and may require switching the system to contrast or utilizing direct injection of CO2 with a catheter placed in the below‐the‐knee popliteal artery [13]. Extravascular ultrasound (EVUS) has become a critical tool in safe arterial access and efficient vascular access [14]. Intraprocedural use of EVUS can also be useful in achieving procedural success by allowing controlled intraluminal wire reentry for complex chronic total occlusion crossing [15]. Intravascular ultrasound (IVUS) is a valuable tool in endovascular assessment of accurate vessel sizing, stenosis area determination, and visualization of the composition of arterial plaque (Figure 9.2). Preintervention IVUS precisely determines vessel size. This may be particularly important for self‐expanding stents with less radial force than balloon‐expandable scaffolds and can avoid both under‐ and over‐sizing [16–18]. IVUS may also inform atherectomy, angioplasty, or lithotripsy device selection by evaluating the degree of calcification within a stenotic segment. Three IVUS sizes are available: standard 0.014″ IVUS, which is also useful in the coronaries, is produced by multiple companies. There are 0.018″ and 0.035″ IVUS systems available from both Boston Scientific and Phillips. The 0.035″ IVUS is useful for large vessels and veins and is typically not necessary for the femoropopliteal segment. A variety of vascular access options and crossing techniques exist to enable success despite challenging anatomy. This section will describe the various access for crossing lesions and their steps. The “Up and Over” Crossover technique for peripheral intervention is the most common and traditional form of access and method of crossing. The radial approach for endovascular interventions is an excellent alternative to femoral access. Unfavorable iliac tortuosity may be overcome more easily from the radial approach. Challenges to radial access remain especially in terms of available equipment, including adequate device length, compatible drug‐coated devices, and embolic protection filters [21]. Steps for Radial Approach: The tibio‐pedal approach for distal entry to a stenosis or occlusion is a necessary component for more complex peripheral intervention. Given the retrograde cap of chronic total occlusions is typically softer than the proximal cap, utilizing pedal access can significantly add to crossiblity of complex and long segment chronic occlusions. Steps to retrograde access and wire crossing (Figure 9.3). Antegrade femoral arterial access allows for ipsilateral intervention sparing the need for crossing‐over technique. Antegrade sheath location can enhance support to allow advancement of equipment and may be particularly useful for popliteal and below‐the‐knee occlusive disease. Antegrade access may be obtained with ultrasound guidance with the probe in a transverse position allowing visualization of the femoral head, common femoral, and superficial femoral/profunda bifurcation. This will ensure safe entry in a compressible segment of the vessel and enable steering into the SFA [22]. Standard short sheaths can be utilized. Access into the common femoral rather than the superficial femoral access may help avoid vascular access complications such as pseudoaneurysms if closure devices are not utilized, however, may require more radiation and longer access times as the access wire tends to move toward the profunda [23]. An important consideration in peripheral interventions is size of the working wire utilized after lesion crossing. In coronary artery interventions, 0.014″ is the standard wire size. In peripheral intervention, operators use crossing catheters to change between wire sizes for compatibility of specialty balloons and atherectomy equipment. See Tables 9.1 and 9.2 for a list of wire sizes associated with various commonly used devices. Attempting to reduce vascular dissection with plain old balloon angioplasty (POBA) is important, given registry data demonstrating that up to 40% of patients may require bailout stenting due to dissections after POBA [24, 25]. In general, POBA is optimally performed at lower pressures with longer inflation times minimizing the number of balloon inflations. This “doctrine” of optimal POBA is based on several small studies showing less vascular dissection with these techniques. Longer versus shorter inflation times were evaluated in a study of less than versus greater than three minutes [26]. Significant dissections occurred less often (22.7% vs. 50.9%, p < 0.001) in the long inflation group [26]. The effect of balloon length on vascular dissections was also evaluated in a study of de novo femoropopliteal stenosis based on the theory that fewer balloon inflations would lead to less dissection at the edge of the treatment segments. One study showed that long balloons (≥220 mm) requiring fewer serial inflations had a significantly decreased incidence of severe dissection than with short balloons (<150 mm) and multiple inflations (47.1% vs. 70.0%, p = 0.019) [27]. Table 9.1 Examples of wire sizes and device types. a Size varies based on individual specifications by manufacturer. Note: list is not comprehensive. Device manufacturers: Dorado, Vascultrack, and Ultrascore (B‐D), Angiosculpt (Philips), Wolverine, Chocolate, SpiderFx (Medtronic), Emboshield and Supera (Abbott), Eluvia (Boston Scientific), Zilver (Cook).
9
Femoropopliteal Arterial Interventions in the Claudicant
Introduction
Patient Evaluation and Indications for Treatment of Femoropopliteal Arterial Pathology
Indications for Revascularization Femoropopliteal Claudication
Vascular Imaging in Endovascular Treatment
Contrast Angiography
CO2 Angiography
Steps to CO2 Angiography
Extravascular and Intravascular Ultrasound
Steps to IVUS Use
Vascular Access and Lesion Crossing Techniques
Steps for Crossover “Up and Over” technique
Radial
Tibio‐Pedal Approach
Antegrade Femoral Access
Working Wire Size and Changing Between Systems
Lesion Preparation
Plain Old Balloon Angioplasty
Device
0.014″
0.018″
0.035″
Semi‐compliant peripheral balloonsa
Yes
Yes
Yes
Dorado
Yes
Drug‐coated balloonsa
Yes
Yes
Angiosculpt balloon
Yes
Yes
Wolverine
Yes
Vascutrak
Yes
Yes
Ultrascore
Yes
Yes
Chocolate
Yes
Yes
Shockwave
Yes
SpiderFx filter
Yes (specialty spider wire replaces 0.014)
Emboshield
Yes (specialized Bare Wire or 0.014″ with 0.018″ tip viper wire)
Peripheral IVUS (Boston Scientific)
Yes
Yes
Yes
Peripheral IVUS (Philips)
Yes
Yes
Yes
Bare‐metal stentsa
Yes
Yes
Yes
Supera
Yes
Eluvia DES
Yes
Zilver DES
Yes
Tack
Yes
Covered stentsa
Yes
Yes
Yes