Interventional Cardiology. Группа авторов

entry site (center of the probe) (Figure 2.4). The artery is gently approached by repeated short jabbing movements. The needle will become visible when it enters the imaging plane of the probe. The probe can be slightly tilted to identify the reverberant artifact of the needle’s path to the artery but we recommend to use the same fixed probe angle to image the bifurcation of the common femoral artery to avoid high punctures, When the needle enters the artery insert the wire and use ultrasound again to accurately identify the puncture location. The rest of the procedure follows the standard procedure for vascular access. Sometimes, the vein runs medial and posterior to the artery. Using ultrasound can occasionally be useful to avoid entering artery before venous access and prevent other complications such as arteriovenous fistulae. In a multicenter randomized trial (FAUST trial) ultrasound as compared to fluoroscopic guidance increased common femoral artery cannulation in patients with high femoral bifurcation and improved first pass success rate, reduced the number of attempts, the risk of venipuncture and median time to access [14].

      Hybrid access techniques such as integrating ultrasound with fluoroscopy or guidewire‐aided technique [15] can be helpful to obtain a correct puncture. The first technique involves placing the tip of a forceps at the anticipated arterial entry site at the mid femoral head as identified on fluoroscopy and aiming to puncture not above this landmark and the latter uses the ultrasound artifact from a J‐tipped guidewire placed from a contralateral arterial access inside the target common femoral artery to aid the puncture.

      Micropuncture technique

      Multiple micropuncture kits are being increasingly available for commercial use and the micropuncture technique proved to reduce vascular complications in an exploratory yet prematurely terminated randomized trial [16]. The ideal puncture location is identified by fluoroscopy or ultrasound as described earlier. A 21 Gauge needle (as compared to the standard 18 Gauge needle) is inserted in the artery using the standard Seldinger technique. When blood backflow is observed (take care to be less brisk than with the larger conventional needles), the 0.018 in guidewire is inserted. We suggest that the straight wire on fluoroscopy be followed, as it may engage small arterial branches. A 4 Fr introducer sheath is inserted over the wire and an angiogram performed to assess the puncture location. If the puncture site is correct the procedure follows in the usual manner with sheath upsizing as needed over an 0.035 in normal or stiff guide wire. Otherwise, the 4 Fr sheath is removed and manual compression for 5 minutes is applied before further attempts are made. The main advantage of this approach is that bleeding through these small punctures tends to stop quickly and normally does not recur even under full anticoagulation. Some needles are also longer and more echoreflective than normal Seldinger needles, facilitating US guided punctures.

Femoral access closure

      Manual compression

      Manual compression has been the standard for sheath removal for decades. Classically, after diagnostic catheterizations the technique involves sheath removal after normalization of the activated clotting time (ACT) to <160–180 seconds and direct digital pressures with fingers positioned over the arterial puncture site and one to two fingerbreadths more proximally. The manual pressure should be applied with enough force to allow for a faint palpable distal pulse. Pressure is held for 10–15 minutes, during which hemostasis should be achieved, after which the patient is kept under bed rest for 4–6 hours.

      The use of larger arterial sheaths, more intensive anticoagulation, and antiplatelet regimes associated with coronary and cardiac interventions have led to the need for more prolonged direct pressure to achieve hemostasis and more prolonged bed rest prior to ambulation. A variety of mechanical manual compression aids, such as the Femostop (Radi Medical System, Sweden) and CompressAR C‐clamp (Advanced Vascular Dynamics, Portland, OR), have been developed to relieve the requirement for staff to physically apply prolonged direct digital pressure. A number of studies have compared such devices with direct manual pressure, with most studies finding lower vascular complications with mechanical compression devices [17–19] although a small study (90 subjects) found better results with direct manual pressure [20].

      Clamp devices provide compression without the need to have someone using direct manual pressure. While clamps may be less demanding on personnel, they do not obviate the need for careful supervision of the compression process. If clamps are applied with too much pressure or left in place for too long, they can result in arterial or venous thrombosis. If applied without adequate pressure, bleeding can result. The Femostop (RADI Medical) uses an inflatable bubble to apply pressure to the puncture site. This is our preferred device for compression in fully anticoagulated patients with failed suture closure or large caliber arterial or venous sheaths. The bubble is clear, so the puncture site can be observed directly. The pressure is regulated with a blood pressure cuff bulb. Near systolic pressure (usually 10 mm less than systolic blood pressure) can be applied for 15–30 minutes, and then the pressure can be decreased 10–15 mmHg every 10–20 minutes.

      Even with interventional procedures, there have been some remarkable experiences with ambulation as early as 2 hours after simple manual compression. With the use of bivalirudin, in a study of 100 patients, after a mean manual compression time of 13 minutes, patients were able to ambulate at a mean duration of 2 hours and 23 minutes after sheath removal [21]. Even using heparin, there are various studies suggesting ability to ambulate after 2 hours. Using a regime of a standard heparin dose of 5000 IU and 6 Fr guiding catheters, two studies involving 359 and 907 patients were able to have sheaths removed immediately, with a mean compression time of around 10 minutes and successful early ambulation within 2 hours with no significant excess in puncture site complications [22, 23]. A study with more aggressive anticoagulation (ACT to 300 seconds) and subsequent sheath removal when ACT is less than 150 seconds showed no difference in Site complications between patients ambulating at 2 hours compared to 4 or 6 hours. In this latter study, there are also similar results in a subgroup of patients who received GP IIb/IIIa inhibitors [24]. Thus, manual compression is clearly an acceptable form of puncture site management in all patients.

      Vascular closure devices

A variety of vascular closure devices have been developed to enhance vascular closure without need for prolonged compression. These are deployed at the conclusion of the cardiac catheterization procedure and can be used despite an elevated ACT. Closure devices are classified into four major categories: sutures, plugs, glues, and topical patches (Table 2.1). The current FDA‐approved devices in most common use in the USA are the AngioSeal (Terumo), Perclose, ProStar, and StarClose (Abbott Vascular, Redwood City CA). Hemostatic patches are also approved for use in the USA

Table 2.1 Types of closure devices.

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	Manufacturer	CE Mark	US Approval	Status
Plugs
AngioSeal	Terumo	+	+
Exoseal	Cordis	+	+	Not used frequently in the USA
Femoseal	Terumo	+	–
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