Arterial access for common coronary and vascular procedures can be obtained via the common femoral artery, radial, ulnar, or brachial arteries. More recently, the subclavian artery and direct aortic access are being used for transcatheter aortic valve replacement procedures. Arterial access site complications are common in interventional procedures, and knowledge of the anatomy, optimal access techniques, and optimal techniques to obtain hemostasis postprocedure are critical to minimize such complications.
Femoral Arterial Access
Introduction
The common femoral artery (CFA) is the most commonly used site for percutaneous arterial access for coronary diagnostic, interventional, structural heart, and peripheral vascular procedures, although transradial access is on the rise in the United States and worldwide. The femoral artery is often favored for its size, ease of insertion, and ability to provide a relatively less tortuous path to the heart.
Anatomic Considerations
The CFA is a continuation of the external iliac artery and passes through the femoral sheath and branches into the superficial femoral artery (SFA) and the profunda femoris artery (PFA) ( Figure 3-1A ). The femoral sheath has three compartments—from medial to lateral—the femoral canal, which contains the efferent lymphatic vessels and lymph node embedded in areolar tissue; the intermediate compartment, which contains the femoral vein; and the lateral compartment, which contains the femoral artery ( Figure 3-1B ). Lateral to the femoral artery and outside the femoral sheath is the femoral nerve. The relationship is important to avoid accidental puncture of the femoral vein or the femoral nerve. The CFA in the femoral sheath is the ideal site for femoral artery cannulation as the artery is large, less tortuous, less affected by atherosclerosis, and sits against the femoral head, making it easier to palpate and also more compressible to achieve effective hemostasis. In addition, the femoral sheath provides effective scaffolding, thereby limiting the spread of hematoma, acting as a tamponade to the arteriotomy site and preventing pseudoaneurysm formation.
Knowledge of the anatomy of the CFA is essential not only to ensure sheath placement at the ideal site to avoid complications but also to troubleshoot difficulties while cannulating the artery. The access site complications are minimized if access is obtained at the “ideal” femoral puncture, which would avoid either a high puncture or a low puncture and also takes into consideration possible anatomic variations of femoral artery bifurcation. The inguinal ligament is usually 15 mm superior to the midfemoral head, and in the majority of cases (approximately 77%), the bifurcation of the femoral artery is below the level of the femoral head. Hence a “target zone” from the midfemoral head to the lower border of the femoral head is ideal ( Figure 3-2 , Zone B). However, the “ideal” spot (even in the 23% of cases with high femoral artery bifurcation) is ~1 cm lateral to the most medial aspect of the femoral head, midway between its superior and inferior borders ( Rupp’s rule ) ( Figures 3-2 and 3-3 ).
A “low” cannulation into the superficial femoral artery or the profunda femoris artery increases the risk of ischemic complications because of the smaller size of these branch arteries; increases the risk of bleeding, hematoma, and pseudoaneurysm due to lack of an underlying compressible bony structure or the scaffolding effect of the femoral sheath resulting in ineffective hemostasis; and increases the risk of arteriovenous fistula as the tributaries of the femoral vein overlie the superficial femoral artery, increasing the risk of through and through puncture to access the artery. On the other hand, a “high” cannulation above the inguinal ligament (above the lower border of the inferior epigastric artery on the femoral angiogram) into the external iliac artery makes it harder to compress the artery due to a lack of underlying bony structure, which increases the risk of retroperitoneal bleeding. In addition, a “high” cannulation of the CFA underneath the inguinal ligament also prevents effective compression by the taut inguinal ligament, thereby increasing bleeding and hematoma.
Preprocedural Considerations
A thorough history and physical examination prior to the procedure may reveal characteristics that indicate the femoral route is not an ideal access site for the patient. Clinically significant history including the indications for the procedure should be obtained and recorded in the patient’s chart. Patients with severe peripheral vascular disease, especially with known severe disease of CFA, those with ileo-femoral bypass grafts or stents, those with a superficial infection at the groin puncture site or morbid obesity, those with heart failure or low back pain who may not be able to lie supine for prolonged periods of time, those on anticoagulation or thrombolytic therapy, those with recent use of a collagen-plug-based vascular closure device (VCD), and those with recent complications of the femoral artery, such as those with a pseudoaneurysm or AV fistula, may not be ideal candidates for femoral access and should be considered for alternatives, such as radial artery access. However, the above conditions by themselves are not absolute contraindications for femoral access, and in many instances, the procedure can be performed using a small size sheath or in other cases by the use of the contralateral femoral artery. In addition to a routine physical examination, inspection of the groin for any signs of infection, palpation of the femoral and distal pulses (bilateral dorsalis pedis, posterior tibial and popliteal arteries), and auscultation for bruits should be performed and documented in the patient’s chart. In addition, a review of prior femoral angiograms, if available, can help plan the optimal location for an ideal femoral arterial puncture. The medications the patient is taking should be reviewed. In addition, laboratory evaluation should include measurement of hemoglobin, hematocrit, platelets, coagulation parameters, creatinine, and electrolytes.
Procedure
One or both the groins should be prepped and draped in a sterile manner. Conscious sedation should be administered using a combination of sedative and analgesic based on local practice and taking into consideration patient age (reduced dose in the elderly) and renal and hepatic functions. Conscious sedation will ensure better patient cooperation during the procedure, although it can be performed using local anesthetic alone. The first step in establishing femoral access is to locate the skin site that corresponds to the “ideal” femoral puncture site. Various external landmarks have been used to access the femoral artery ( Table 3-1 ), but the most popular one is by using fluoroscopic landmarks ( Figure 3-2 ). In the fluoroscopic technique, the femoral head is visualized under fluoroscopy in posterior-anterior (PA) projection, and a metal clamp is then placed on the skin at the lower border of the femoral head. This corresponds to the skin puncture site, and a puncture at this site at a 30° to 45° angle will cannulate the femoral artery, corresponding to the middle of the femoral head, which is the ideal puncture site. The steps involved in femoral artery cannulation are outlined in Table 3-2 . After a femoral sheath is inserted, the side port should be connected to the pressure transducer to obtain a femoral artery pressure waveform. Any dampening of the pressure waveform at this stage may indicate atherosclerosis in the CFA or the external iliac or sheath in a dissection plane. It is highly recommended to obtain a femoral angiogram (30°-45° ipsilateral oblique view) prior to coronary angiography (unless the glomerular filtration rate (eGFR) is low) to ensure correct placement of the femoral sheath in the CFA and to detect any complications such as dissection, perforation, or even presence of severe atherosclerotic disease in the CFA. The ipsilateral oblique view should not be used to determine a “high puncture.” If a high puncture is suspected based on the ipsilateral oblique view, repeat the femoral angiogram in the P-A or the contralateral oblique view may be helpful to confirm the puncture site. Detection of problems at this stage will help plan subsequent procedures before any anticoagulation is administered (deferral of PCI for high stick or any perforation or dissection) and considerations for access site management at the end of the procedure (manual compression vs. VCD). In addition, flushing the sheath between each catheter exchange can prevent the formation of a clot within the sheath.
Skin/inguinal crease | Skin puncture site 2 cm to 3 cm below the midpoint of the skin crease. Disadvantage: Variability in the relationship between the inguinal ligament and skin crease, especially in the morbidly obese, resulting in a lack of consistency in localization of the ideal puncture site ( Figure 3-1A-B ). |
Bony landmarks | Skin puncture site 2 cm to 3 cm below the midinguinal point (midpoint between the anterior superior iliac spine and pubic tubercle). Disadvantage: Variability in the relationship between the inguinal ligament and the midinguinal point, resulting in a lack of consistency in localization of the ideal puncture site. |
Maximal impulse | Skin puncture site at the site of maximal impulse. Disadvantage: Site of maximal pulsation may not correspond to the midfemoral site (ideal puncture site), especially in the obese, resulting in low or high cannulation. |
Fluoroscopic landmark | Skin puncture site at a point that corresponds to the lower border of femoral head on fluoroscopy. Provides the most consistent landmark to the midfemoral CFA site. |
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* Some operators use the nick and tunnel approach at this stage, where a small nick (2-3 mm) is made parallel to the skin crease and an artery forceps is used to create a tunnel. Advantage: Bleeding will manifest as oozing rather than a hematoma. Disadvantage: Need for a separate nick and tunnel if the femoral artery cannulation cannot be obtained at the site of the skin nick.
Special Considerations
Using a Micropuncture Needle
The standard Seldinger needle used for the femoral artery cannulation is an 18-gauge needle. A micropuncture needle is a 21-gauge needle, which decreases the size of the hole by 56% and the flow through the hole by nearly sixfold over a standard 18-gauge needle, potentially decreasing complications from errant sticks or inadvertent back wall punctures. However, there are no robust data to support the routine use of micropuncture in all cases to reduce the risk of femoral access site complications. For access using a micropuncture needle, the skin is entered at the site corresponding to the lower border of the femoral head on fluoroscopy using the 21-gauge needle. Some operators use fluoroscopy before entering the vessel to ensure that the tip of the needle is at the desired site and repositioning as needed. After ensuring blood flow from the hub (may not be as pulsatile), a floppy-tipped 0.018-inch guidewire is then advanced into the CFA and the external iliac artery. Advancing the guidewire under fluoroscopy may be preferred as resistance to advancement is better seen than felt with the finer guidewire of the micropuncture set. The needle is now exchanged for a 4 Fr short catheter with a 3 Fr inner dilator. Both the guidewire and the dilator are removed, at which point there should be pulsatile blood flow, followed by introduction of the 0.035/0.038-inch guidewire and exchange of the 4 Fr catheter to the appropriate size femoral sheath. Alternatively, the inner dilator can be used to perform a femoral angiogram. If the cannulation site is too high or low, the dilator is removed and pressure is applied to ensure hemostasis and reaccess are performed at the optimal location.
Using a SmartNeedle Percutaneous Doppler Vascular Access Device
In patients with a difficult to palpate femoral pulse, the SmartNeedle (Vascular Solutions, Inc., Minneapolis, Minn.) may be helpful. The SmartNeedle consists of a detachable Doppler probe inside the lumen of a standard introducer needle. This is connected to a handheld monitor by a cable and the flow is detected by an audio output. Attach the cable of the needle to the connector on the SmartNeedle monitor, turn the monitor on, and adjust the volume as needed. Test the system by dipping the needle in water and moving it back and forth. An audible Doppler signal should be heard. Flush the needle with saline to remove any air. Now insert the needle through the skin with a saline syringe connected, while listening to the Doppler signal. Express a small amount of saline through the tip to clear any air bubbles. Move the needle in a circular motion while listening to the Doppler flow signal. As the needle approaches the artery, the Doppler signal becomes louder and pulsatile, thus assisting femoral arterial cannulation. Arterial flow may be identified as a pulsatile high frequency sound whereas the venous flow is a low frequency sound. Care must be taken not to palpate the artery/vein while advancing the needle, as this can compress the vein and obliterate the venous signal. Once a Doppler signal is detected, the area should be scanned for the loudest signal and then the needle further advanced in the direction. Once the needle enters the artery, there is a pulsatile flow of blood (may not be as brisk as a regular needle due to the probe in place). The Doppler probe is now removed from the needle, a guidewire is inserted, and the other steps are similar to what is described in Table 3-2 . When compared with a standard needle, the SmartNeedle has been shown to result in a greater proportion of successful femoral arterial cannulations on first attempt and to reduce the risk of hematoma.
Using Ultrasound Guidance
For patients with a difficult to palpate femoral artery pulse, femoral artery cannulation under ultrasound guidance is an option. Arterial cannulation under ultrasound guidance is similar to central venous access using a similar approach. The advantage of this approach is direct visualization of the artery prior to cannulation thereby avoiding cannulation into diseased segments, cannulating branch arteries when there are anatomic variants (high bifurcation), or accidental venous puncture in anatomical variants where the femoral vein (or its tributaries) lies directly above the artery. The disadvantage is the need for a vascular transducer probe and extra time to set up the equipment and for the additional steps involved. The technique involves using a 7-MHz vascular transducer probe draped in a sterile sleeve. The ultrasound is then held at the site of the proposed skin puncture site (determined on fluoroscopy) and moved caudally to visualize the femoral bifurcation and then cranially ( Figure 3-4 ). The femoral artery can be differentiated from the femoral vein, as it is less compressible, by the direction of blood flow on color Doppler ultrasonography, and by a triphasic signal (versus a more monophasic signal for the femoral vein) on pulse Doppler ultrasonography ( Figure 3-5 ). Once a relatively disease-free segment is identified in the CFA, arterial cannulation can be performed under direct ultrasound guidance holding the ultrasound probe in one hand or by a second operator and the needle in the other hand. Local anesthesia is administered around the artery under direct ultrasound guidance. The Seldinger needle is then used and its position adjusted based on the ultrasound image until the artery is cannulated and confirmed by pulsatile blood. An ultrasound probe with an integral needle guide and built-in needle position sensors are now available ( Figure 3-4 ). Together these project on the ultrasound monitor an enhanced virtual image of the needle as it moves through the tissue toward and into the target vessel. Once the path is confirmed on the monitor, the needle is inserted through the needle guide while advancing the needle under direct ultrasound visualization and confirmed by pulsatile blood ( Figure 3-4 ). The guidewire is then inserted and the needle exchanged for an appropriate size femoral artery sheath as described previously.
Ultrasound-guided femoral arterial cannulation has been shown to aid vascular access in patients with an absent palpable pulse or after unsuccessful palpation-guided cannulation. However, the data to support ultrasound-guided femoral arterial cannulation in all patients are rather weak. In a randomized trial of ultrasound-guided puncture versus traditional palpation-guided puncture of the femoral artery, ultrasound guidance significantly decreased the number of attempts needed as well as the time for successful arterial puncture only in patients with a weak arterial pulse and in those with a leg circumference of 60 cm or greater. In contrast, time for vessel cannulation was increased in patients with a strong arterial pulse, and there was no difference in femoral arterial complications. In the Femoral Arterial Access With Ultrasound Trial [FAUST], routine real-time U.S. guidance improved CFA cannulation only in patients with high CFA bifurcations but reduced the number of attempts, time to access, risk of venipunctures, and vascular complications in femoral arterial access.
Femoral Arterial Cannulation in a Challenging Patient Subgroup
Morbidly Obese Patients
Femoral arterial cannulation in morbidly obese patients can be a challenge as the artery may be difficult to palpate, the skin at the ideal puncture site may be excoriated, and the folds of adipose tissue may make femoral access a challenge. Considerations should be given for alternatives such as radial access. However, femoral arterial cannulation using a SmartNeedle or under the guidance of ultrasound and using a micropuncture needle can be particularly helpful. Care must be taken to advance the needle at an angle more than the usual 30° to 45° to avoid a high cannulation. In addition, with the needle in the subcutaneous tissue and before puncturing the artery, it may be helpful to use fluoroscopy to ensure proper positioning of the needle. In addition, a long guidewire should preferably be used when exchanging the needle for a femoral artery sheath, and considerations should be given to using a longer femoral artery sheath to ensure that it is well within the artery.
Patients with Ilio-femoral Bypass Grafts
In patients with ilio-femoral bypass grafts, consideration should be given to alternatives such as radial access or use of the nongrafted side (if available). If femoral access is desirable, consideration should be given to micropuncture with the intention of aiming for the hub of the graft. The micropuncture guidewire should be advanced under fluoroscopy and if resistance is encountered, angiography either through the micropuncture needle or after exchanging the needle for a 3 Fr micropuncture dilator should be considered to roadmap the graft. Once a roadmap is established, either the native artery (if patent) or the graft should be wired.
Patients with Calcified Femoral Artery
In some patients the femoral artery calcification is visible on fluoroscopy and can potentially outline the artery and serve as a roadmap of the artery. In such cases femoral artery cannulation can be performed under direct fluoroscopic guidance, aiming the needle (preferably a micropuncture needle) at the CFA at the center of the femoral head. However, consideration should be given to the fact that the artery could have severe atherosclerotic disease, making closure a challenge and increasing the risk of ischemic limb complications. In addition, heavily calcified arteries are less compressible and hence more prone to bleeding. Consideration should therefore be given an alternative route such as radial access.
Postprocedure Care
The risk of complication with femoral arterial access is directly related to the size of the sheath, and consideration should be given to use the smallest size sheath when possible. In addition, the sheath should be left in the artery for the shortest duration required. The sheath should be removed and hemostasis obtained either by manual compression or by using a vascular closure device as described in the next section. Using the sheath for prolonged periods of time for arterial line access should be avoided, especially for sheaths larger than 4 Fr, and considerations should be given to obtain a radial arterial line for longer term use. Patients should be advised of bed rest and closely monitored during the initial postprocedural period. The duration of the bed rest period depends on the site and size of the vascular access, the means by which hemostasis was achieved, puncture-site stability, and the patient’s medical conditions. The access site and distal pulsations should be periodically monitored. In addition, urinary output, cardiac symptoms, pain, other indicators of systemic complications, and vital signs should be monitored and recorded in the chart. After the period of bed rest, the initial ambulation of the patient must be supervised and closely monitored for bleeding.
Complications
The femoral access site is a frequent source of complications. The rate of complication varies between <1% and >20%, depending on the patient population studied, type of complication, and the definition used. However, there has been a significant decline in the complication rates in the contemporary era despite performance of PCI in older patients and the use of more potent antiplatelet and antithrombotic agents. Femoral access site complications prolong the hospital stay and are associated with a significant increase in cardiovascular events, including death. Femoral access site complication is dependent on several patient-specific and procedure-specific factors. Patient-specific risk factors include older age, female gender, lower body mass index, hypertension, peripheral vascular disease, known bleeding diathesis, severe renal impairment, being on anticoagulation preprocedure and postprocedure, peak activated clotting time, and procedure duration. Procedure-specific risk factors include the use of a larger sheath size (>6 Fr), location of the femoral puncture site, and the use of glycoprotein IIb/IIIa inhibitors.
Bleeding/Hematoma
The femoral arterial access site is a frequent source of bleeding and hematoma. The incidence is around 0.8% to 23% and is the most common access-site-related complication. Patients experiencing major femoral bleeding have a significantly longer postprocedure hospital stay and excess morbidity and mortality in the first 30 days when compared with patients without major femoral bleeding. Contributing factors include a low or high femoral puncture, ineffective manual compression, a back wall femoral arterial wall puncture, accidental puncture of the vein, and the use of glycoprotein IIb/IIIa inhibitors. A hematoma usually presents as swelling surrounding the puncture site, which is often painful and results in difficulty moving the leg and/or skin discoloration. The presentation depends on the size of the hematoma (small <1 cm, medium 1-5 cm, large >5 cm) and the acuity. A large hematoma can present with signs of hemodynamic instability with tachycardia and/or hypotension. Some patients may present with a vasovagal reaction with bradycardia and hypotension due to severe pain and compression of the underlying artery. Treatment includes manual compression at the site of the hematoma, fluid resuscitation/blood transfusion as needed for hemodynamic instability, prolonged bed rest, and interruption/reversal of anticoagulation/antiplatelet agents if necessary. Close monitoring for recurrence by outlining the hematoma and frequent measurement of the girth of the thigh and serial complete blood cell count are important to detect any further bleeding. Rarely surgical evacuation of the hematoma may be required. Many hematoma resolve within a few weeks; however, care must be taken to prevent infection at the site of the hematoma.
Retroperitoneal Hemorrhage
Retroperitoneal hemorrhage, bleeding that occurs behind the serous membrane lining (peritoneum) the walls of the abdomen/pelvis, is usually due to a high femoral puncture above the inguinal ligament (lower margin of the inferior epigastric artery on fluoroscopy) and/or a posterior wall puncture. The incidence is around 0.1% to 0.4% and can be fatal if not recognized early. Risk factors include female gender, low body surface area, high arterial puncture, glycoprotein IIb/IIIa use, and chronic renal insufficiency. Patients usually present with ipsilateral flank or lower back pain, vague abdominal pain, and symptoms and signs of hypotension. Physical examination may show tachycardia and hypotension with Grey Turner’s (bruising/blue discoloration of the flanks) or Cullen’s (bruising/blue discoloration around the umbilicus) sign ( Figure 3-6 ). Often there is no hematoma at the site of the femoral puncture site and the only manifestation may be tachycardia and hypotension, and therefore a high clinical suspicion is required for early diagnosis. Diagnosis can be confirmed by a CT pelvis without contrast ( Figure 3-7 ) or on femoral angiography showing frank extravasation of contrast into the pelvis ( Figure 3-8 ). Treatment includes fluid resuscitation/blood transfusion as needed for hemodynamic instability, prolonged bed rest, and interruption of anticoagulation if necessary. Serial monitoring of blood pressure and a complete blood count should be performed. Definitive treatment for ongoing hemorrhage includes surgery evacuation of the hematoma with local repair of the artery or contralateral femoral arterial access with balloon tamponade at the site of perforation. In most cases prolonged balloon tamponade will effectively seal the leakage, but in some cases a covered stent may be required.
Arteriovenous Fistula
The incidence of anteriovenous fistula ( Figure 3-9A ) formation after femoral artery cannulation is low (<0.2%). The risk fctors for AV fistula include a low/high femoral puncture, multiple access attempts, puncture of the overlying femoral vein or its tributaries, and ineffective manual compression. Patients maybe asymptomatic or present with pain and swelling at the groin site. Rarely patients present with symptoms and signs of increased cardiac output or limb ischemia (intermittent claudication, ulcer) or deep venous thrombosis. On physical examination a bruit may be heard on auscultation and a thrill felt on palpation. Diagnosis is by color Doppler ultrasound and rarely angiography ( Figure 3-9A ) or CT ( Figure 3-9B ) is needed. For small AV fistula and in asymptomatic patients, the treatment is observation and serial ultrasound. Most resolve with time. For large AV fistula, ultrasound-guided compression is the treatment of choice. Other options include use of a balloon tamponade, covered stent, endovascular coils, and if all else fails, surgical repair.
Pseudoaneurysm
A pseudoaneurysm (PSA) is defined as an arterial rupture of one or more layers of its walls, contained by overlying fibromuscular tissue, which communicates with an artery by a neck or sinus tract. The incidence of pseudoaneurysm is 0.3% to 9.0%. Risk factors for pseudoaneurysm include a low femoral puncture site and ineffective manual compression after sheath removal. The patient usually presents with swelling/pain or a large hematoma at the site. A large pseudoaneurysm can present with symptoms of nerve compression (limb weakness and paresthesia). A pseudoaneurysm can rupture causing abrupt swelling and severe pain. A physical examination may reveal a pulsatile mass with a bruit and/or thrill. Diagnosis is made on color Doppler ultrasonography ( Figure 3-10A ). It can also be diagnosed by angiography or CT ( Figure 3-11 ). Treatment depends on the size of the pseudoaneurysm. A small pseudoaneurysm (≤2 cm) usually resolves spontaneously and requires manual/mechanical compression, prolonged bed rest, and cessation of anticoagulation, followed by observation and serial ultrasonography. A large pseudoaneurysm can be treated by ultrasound-guided manual/mechanical compression or ultrasound-guided thrombin injection ( Figure 3-10B ) into the pseudoaneurysm sac. Rarely surgical repair may be required.
Artery Occlusion
Limb ischemia after femoral arterial cannulation is rare with an incidence of <0.8%. It is usually due to occlusion of the artery by thromboembolism. Common risk factors include small caliber artery, peripheral vascular disease, the use of larger size sheaths, low cannulation into the superficial femoral or profunda femoris artery, the use of a vascular closure device with intraarterial components (such as Angio-Seal), or a sheath that is left behind for a prolonged period of time. In addition, digital ischemia may be due to cholesterol emboli ( Figure 3-12 ). Classic signs and symptoms include the five P’s: pain, pallor, paresthesia, pulselessness, and paralysis. Diagnosis is by Doppler ultrasonography studies. Angiography is needed to localize the site of occlusion. Treatment includes anticoagulation, contralateral access, and angiography, with thrombectomy and possible angioplasty or stenting, or intraarterial fibrinolytic administration. In some cases surgical thrombectomy with vascular bypass grafting may be required. In rare cases ischemic complication can be due to the use of a vascular closure device such as Perclose or the Angio-Seal ( Figure 3-13A-C ). In addition to dislodgment of plaque by the footplate of these devices, intraarterial deposition of collagen (with Angio-Seal) or subintimal dissection of the common femoral artery (with Perclose) has been described as the etiology of ischemic complications.
Dissection
Femoral artery dissection is a rare (0.2%-0.4%) complication of femoral artery cannulation. Risk factors include presence of atherosclerosis in the CFA or the external iliac artery, vessel tortuosity, and dissection during advancement of the guidewire or during femoral angiography. Diagnosis is made during femoral angiography and most patients are asymptomatic. In rare cases the patient presents with symptoms and signs of ischemic limb after the sheath is removed. Treatment includes observation as most dissections are retrograde and spontaneously heal. In rare cases if ischemic complications arise, contralateral access and angiography and possible angioplasty or stenting or surgical repair should be considered.
Femoral Neuropathy
Femoral neuropathy is due to injury to the femoral nerve during access and/or compression of the femoral nerve by a hematoma or pseudoaneurysm. The incidence is around 0.2%. Patients present with pain/paresthesia at the femoral access site with radiation down the limb or with leg weakness. Physical examination may reveal focal neurological signs including decreased sensory perception, decreased motor strength, or decreased patellar tendon reflexes. Treatment should be aimed at the underlying cause (hematoma/pseudoaneurysm), treatment of symptoms, and physical therapy.
Groin Site Infection
Access site infection is rare (<0.1%) but can be potentially serious resulting in sepsis. Risk factors include obesity with folds of adipose tissue at the access site, presence of superficial infection at the site of entry, diabetes mellitus, compromised sterile technique during access or closure, prolonged indwelling sheath time, and use of a vascular closure device. Patients present with pain, swelling, discharge at the access site, fever, and/or an increase in the white blood cell count. Treatment includes administration of antibiotics and symptomatic treatment for pain relief. In rare case and especially when a vascular closure device is used, surgical debridement with removal of any indwelling component of the closure device may be necessary. Infection associated with the vascular closure device is an extremely serious complication that requires aggressive medical and surgical intervention and carries high rates of morbidity and mortality. The majority of patients with infection present 7 to 10 days after deployment of the device and need prolonged antibiotic therapy (up to 28 days) and arterial debridement and reconstruction.
Femoral Arterial Access Site Closure
Introduction
Securing hemostasis after performing a procedure via the femoral arterial access is an important part of the procedure, and complications can be serious. The risk of complications (both ischemic as well as bleeding) is directly related to the duration the sheath is left in place. It is therefore recommended that the femoral arterial sheath be left in for the least amount of time possible and removed immediately after diagnostic procedures if no anticoagulation was used. There are four ways of obtaining hemostasis post procedure: (1) manual compression, (2) mechanical compression, (3) assisted compression devices/topical hemostasis accelerators, and (4) VCDs.
Manual Compression
Manual compression is considered the gold standard for obtaining hemostasis after femoral arteriotomy and is the most commonly used hemostasis technique worldwide. Correct technique is essential to ensure adequate hemostasis but also to minimize complications such as bleeding/hematoma and pseudoaneurysm formation. The femoral sheath should be removed immediately following diagnostic procedures if no anticoagulation is used or when the activated clotting time (ACT) is <150 s to 160 s or PTT <45 s when heparin is used, 6 to 8 hours after last enoxaparin dose, 2 hours after stopping bivalirudin or when the fibrinogen level is >150 mg/dL when fibrinolytics are used. VCD should be considered if the sheath is to be removed on a fully anticoagulated patient. The general principles of manual compression include application of pressure at the correct site and for adequate periods of time. It is important to note that the artery puncture site is 2 cm superior and medial to the skin entry site and as such, manual compression should be applied over the arteriotomy site and not directly over the skin puncture site. The duration of compression varies with the size of the catheter and on other factors such as patient’s blood pressure and anticoagulation status. A rough rule is to apply manual compression for 5 minutes for each 1 Fr, although effective hemostasis can be obtained for an arterial sheath of 4 Fr or 5 Fr in under 10 to 15 minutes and for venous sheath of 8 Fr or 9 Fr in under 5 to 10 minutes. Adjunctive use of a mechanical compression device should be considered for compressing the access site for an extended period of time. The steps in manual compression are outlined in Table 3-3 . The advantage of manual compression is that it is associated with the lowest complication rate and there is no foreign body left behind either intraarterial or extraarterial. The disadvantage includes the need to wait for prolonged periods of time for anticoagulation to wear off prior to sheath removal, discomfort (both to the operator and the patient) during the sheath removal, prolonged period of bed rest post manual compression with longer time to ambulation, complications due to ineffective compression (bleeding, hematoma, pseudoaneurysm, or AV fistula formation), and a potential increase in time to hospital discharge. More recently, ambulation as early as 1 hour after removing a 5 Fr or 1.5 hours after removing a 6 Fr sheath has been shown to be safe, thereby decreasing the time to hospital discharge.
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Mechanical Compression
Mechanical compression involves the use of a mechanical device for external compression to obtain hemostasis. This can be used as a stand-alone device (no manual compression) or as an adjunct to manual compression for an extended period of compression. There are two main types of mechanical compression: The C-clamp [CompressAR (Advanced Vascular Dynamics); Clamp Ease (Pressure Products, Inc.)] and pneumatic (FemoStop, Radi Medical Systems AB, St. Jude Medical, Inc.). The C-clamp consists of a flat metal base, a pivoting metal shaft attached to the base, an adjustable arm lever with arm slide, and an upper and lower arm lock mechanism to hold the desired level of pressure ( Figure 3-14A ). The preprocedural considerations are similar to those outlined in Table 3-3 . Raise the arm to the top of the stand and rotate the shaft so that the arm is pointed away from the patient. Position the base of the C-clamp beneath the bed mattress and directly below the patient’s hip on the site of the femoral sheath. Rotate the C-clamp arm into the desired position. Attach a disposable translucent pad to the tip of the C-clamp arm. Palpate the access site 1 cm to 2 cm proximal to the skin entry site and gently lower the C-clamp arm into position, ensuring that the sheath is center to the disc at the V-notch just outside the perimeter of the disc ( Figure 3-14B ). Do not place anything between the pad and the skin including gauze pads. Lock the top lever. With one hand on the arm lever preparing to push down, use the other hand to remove the sheath and immediately apply enough pressure from the arm lever to obtain adequate hemostasis after ensuring adequate bleed back to flush remaining thrombus. Tighten the lever with adequate pressure so as to ensure hemostasis but at the same time ensuring that the peripheral pulse is not fully obliterated ( Figure 3-14C ). If bleeding is noticed, increase pressure as needed. If pulse is obliterated, ensure that this does not last beyond 2 to 3 minutes. When it is time to release compression, gradually raise and lower the arm lever to release pressure at small increments and check the site for any bleeding. If bleeding is noticed, press down on the arm lever until hemostasis is obtained. Repeat the procedure until the C-clamp can be fully removed without any bleeding. Postprocedure care is similar to that outlined in Table 3-3 .
Pneumatic compression devices such as the FemoStop use a small transparent inflatable dome, an adjustable belt placed underneath the patient’s hips, and a pump with a manometer to adjust pressure to an optimal level ( Figure 3-15A ). The preprocedural considerations are similar to those outlined in Table 3-3 . Position the belt underneath the patient’s hips in line with the puncture site, ensuring that the length of the belt is equal on either side of the hip ( Figure 3-15B ). Check pedal pulses and record this in the patient’s chart. Position the dome over the arteriotomy site (1-2 cm cranial and medial to the skin puncture site) and attach the belt to either end, making sure that the arch is level and square across the groin area ( Figure 3-15C ). Retract the sheath far enough to allow the hub to be free from underneath the dome. Pull the belt straps on either end to ensure that the arch is perpendicular to the femoral arteriotomy site. If a venous sheath is used, inflate the dome 20 mm to 30 mm Hg and remove the venous sheath prior to removal of the arterial sheath. Inflate the dome 60 mm to 80 mm Hg, remove the arterial sheath, and quickly increase pressure in the dome 10 mm to 20 mm Hg greater than the patient’s systolic blood pressure or until hemostasis is achieved. After a maximum of 3 minutes of suprasystolic pressure, lower pressure to maintain a palpable pedal pulse while ensuring hemostasis. Postprocedure monitoring is as outlined in Table 3-3 . After an appropriate duration of compression, deflate pressure 10 mm to 20 mm Hg every 2 to 3 minutes until zero. If bleeding ensues, inflate 10 mm to 20 mm Hg or until hemostasis is obtained and wait for 10 minutes before starting to wean off the pressure. Once hemostasis is obtained, dress the site with a transparent sterile dressing as outlined in Table 3-3 . The FemoStop is generally more comfortable for the patient compared with either manual compression or the C-clamp, direct contact with the blood is less, and the manometer allows for accurate control of pressure, potentially permitting patent hemostasis. In addition, it is also approved for ultrasound-guided compression of pseudoaneurysm ( Figure 3-15D ).
Assisted Compression Devices/Topical Hemostasis Accelerators
These consist of topical agents that hasten local clotting at the puncture site and are used along with manual/mechanical compression. The preprocedural considerations are similar to those outlined in Table 3-3 . After cleaning the area around the sheath with antiseptic solution, palpate the artery 1 cm to 2 cm superior and medial to the skin puncture site. Apply firm pressure at the arteriotomy site (not the skin puncture site) and place the hemostasis patch over the puncture site. Ask the patient to take a deep breath in and then exhale while simultaneously removing the sheath, allowing for back bleeding from the tissue tract to help expel any remaining thrombus. The bleeding also helps activate the hemostatic agent on the patch ( Figure 3-16 ). After 3 minutes of occlusive pressure over the arteriotomy site, slowly release pressure while maintaining firm pressure directly over the puncture site and hemostasis pad. Apply sterile gauze and transparent dressing over the pad after hemostasis is obtained. These devices can potentially reduce the duration of manual compression. The commonly available topical hemostasis accelerators are listed in Table 3-4 . The efficacy of topical hemostasis accelerators has been compared with manual compression alone in small randomized trials with variable results, and there are no robust data to suggest that they shorten the time to ambulation.
PRODUCT NAME | ACTIVE AGENT | MECHANISM OF ACTION |
---|---|---|
CELOX Vascular (Advanced Vascular Dynamics) | Chitosan | A natural polysaccharide that works independent of the body’s normal clotting mechanisms. |
D-Stat Dry (Vascular Solutions) | Thrombin based | Thrombin-based agent that accelerates clotting. Other versions have silver chloride for an antimicrobial barrier. |
HemCon Patch PRO (Hemcon) | Chitosan derivative with antibacterial barrier | Positive ionic charge of the polymer attracts and binds red blood cells, promoting hemostasis. Also provides antibacterial barrier. Does not contain procoagulants and is effective on anticoagulated patients. |
Neptune Pad (Biotronik) | Calcium alginate | Facilitates clotting cascade while providing an antimicrobial barrier. |
QuikClot (Z-medica) | Kaolin | Kaolin activates the clotting cascade and platelet adhesion. |
Scion Clo-Sur Plus PAD (Merit Medical Systems, Inc.) | Polyprolate acetate (form of chitosan) | Positive ionic charge of the polymer attracts and binds red blood cells, promoting hemostasis. |
StatSeal ADVANCED (Medline) | Topical hemostatic powder | Stimulates the body’s natural clotting cascade. |
Syvek Patch, PS, NT (Marine Polymer Technologies) | Poly- N -acetyl-gluocosamine | Accelerates clot formation through red blood cell and platelet aggregation. Localized vasoconstrictive effect. |
V + Pad (Angiotech) | d -glucosamine | Stimulates the body’s natural clotting cascade. |