Use of FemoStop® Plus for Intra-Aortic Balloon Pump Removal

The challenge of achieving and maintaining femoral arterial hemostasis following Intra-aortic Balloon Pump (IABP) counterpulsation therapy can be daunting. It is therefore essential to use the right tools and techniques to overcome the potential risks of vascular complications associated with prolonged IABP dwells and their aggressive anticoagulation. Vascular complications abound in critical care patients for many reasons. The restlessness and agitation which parallels long hours of positional discomfort and mechanical ventilation creates a scenario set up for bleeding. Moreover, as their intensive nursing care needs are met, these patients are more physically manipulated and re-positioned than usual to mobilize secretions and so on. Consequently, at the catheter insertion site, there is a time-dependent potential for the creation of small vessel wall tears widening the arteriotomy and thereby increasing the possibility of hemorrhage. A long IABP dwell can also blunt the important vasospastic reflex of initial hemostasis, increasing bleeding risk. Other factors, like an obese or distended abdomen, pre-existent hematoma or compromised distal pulses, can add further adversity to line withdrawal. Successful IABP removal requires enough external compression to overcome these conditions while achieving a precise balance of hemostasis with continuity of distal perfusion. The potential stress to both patient and clinician when dealing with these large bore endovascular devices, however, cannot be understated. Manual and mechanical external compression remain the primary methods for achieving hemostasis. Manual compression, while the oldest approach, requires tactile precision to palpate the femoral pulse while applying vice-like pressure to achieve hemostasis. With the repeated stress of this technique, the clinician may experience wrist joint injuries like carpal tunnel syndrome, which can be disabling and costly. A FemoStop® Plus Femoral Compression System is often a useful instrument over manual compression when performing IABP removal because it can achieve hemostatic harmony while freeing the operator of potential repetitive stress injury. Successful use of a FemoStop device, however, requires an experienced, well-trained clinician who provides a compassionate, attentive approach, skillful preparation and proper follow-through. This skill set, combined with a patient first mindset, will ensure patient safety and comfort for all persons involved, regardless of one’s hemostasis methodology. Approach Initially, the clinician should have knowledge of IABP counterpulsation fundamentals and hemodynamic principles. A clinical situation can change from when the decision for removal was made and the therapeutic wean begins. The acumen that comes with knowledge and experience with these devices verifies the need for IABP removal. Second, a clinician’s comprehensive approach to IABP removal is comprised of experience and responsibility. Pulling sheaths, although necessary, can be viewed as onerous and time-consuming. However, ownership of the task constitutes a leadership role for the responsible clinician that optimizes communication and patient care. Third, IABP sheath removal can be a source of clinician anxiety, especially if there has been a previously negative experience with arterial line removal. This may be unknowingly transferred to the patient, providing a setup for problems. Clinician anxiety can be eased with the assistance of another experienced colleague who can assist should the patient require help with pain and/or vasovagal hypotension. Assessment A close examination of the patient’s overall state, including hemodynamics and the level of pre-existing anxiety and discomfort, is essential. Remember that IABPs are not always put in for hypotension, so you should verify that the blood pressure is appropriate. Examine the sheath site to look for pre-existing hematoma or bleeding. Some IABPs are placed without a sheath, which will have some bearing on how the line is gripped during removal, as described below. Palpate for the femoral pulse and check the baseline condition of distal perfusion by obtaining a Doppler signal of the corresponding pedal pulse. The Activated Clotting Time (ACT) should be known at this point and ideally should be less than 150 seconds. Preparation At this stage, if systolic hypertension exists, management of the blood pressure is important and may require temporary use of parenteral nitrates. Optimal patient comfort should be a priority here. If awake, the clinician should be talking to the patient about the procedure, allergies and anxiety issues, bearing in mind the patient’s participation in the process. Local, and if necessary, parenteral analgesia with possible short-acting conscious sedation blood pressure permitting is often beneficial. Local anesthesia of the affected site with 2% lidocaine is a matter of personal preference, but when given, should be infiltrated parallel to the entry point of the sheath through the skin on either side of the line. The friction of line withdrawal against the skin incision during removal can be very painful. Additional administration of lidocaine in the area where FemoStop dome compression will occur may also minimize discomfort. A small sterile field with the necessary tools includes a sufficient quantity of sterile drapes, towels, 4X4 gauze, a 60cc sterile syringe with an eccentric tip, a one-way valve, masks, sterile gowns, sterile surgical gloves and a topical cleansing solution. The patient is rolled so the FemoStop belt can be circumferentially placed around the posterior area of the lower pelvis, with the device centered near the superior medial areas of the femoral heads. The access site must be constantly observed so adverse events do not occur, such as accidental advancement or partial withdrawal of the catheter. A malpositioned balloon can cause dissection and/or obstruction of any of the branching aortic vessels so patient manipulation should be done cautiously. Usually all sutures are carefully removed after the belt is positioned, in line with the sheath entry point. An external blood pressure cuff should be placed on the patient’s upper extremity, as the arterial pressure transducer will become disabled and close surveillance of the patient’s blood pressure plays a direct role in hemostasis management. The femoral pulse, which is higher than the actual entry site, is palpated before the FemoStop is positioned. If the femoral pulse is difficult to locate, a brief inflation slightly superior and medial to the skin incision while listening to the Doppler pulse in the foot will confirm positioning over the femoral artery. Bony anatomic landmarks like the pubis symphysis and superior iliac crest can be used here, but are usually only helpful in a thin patient. In the morbidly obese patient, the pannus can be an obstacle to external compression. Keeping in mind that the priority is proper exposure of the access site, simply apply nylon tape from the mid-pannus in a superior/lateral direction away from the puncture site, anchoring the other end to the bed rail to minimize any obstruction from the abdomen. If dome inflation does not affect the distal pulse and/or the patient experiences more than just a pressure-like discomfort, simply reposition the dome and retry. The dome can especially cause pain if directly over the sheath hub. Observe the directional plane of the device as the dome inflates. It should primarily be in a downward vector, perpendicular to the coronal plane. If the dome travels upward, belt tension may need to be increased. Likewise, tension should be adjusted if there is any angle to the dome as it is inflated. Observe the manometer numbers. If the pedal pulse disappears with minimal dome inflation, the belt may be too tight. The pedal pulse should be affected (not necessarily obliterated) when the dome pressure is 100-160 mm Hg. Higher pressures and a slightly tighter belt are usually necessary if the abdomen is obese, as the posterior bony support of the femoral artery upon which compression relies may be less. Once the clinician is comfortable with FemoStop positioning, the IABP console can be shut down by turning off the power switch or putting the generator on Standby. One should not disable the IABP until the moment line removal is to occur. The longer the balloon is stagnant in the aorta, the greater the chance of clot formation. Line Removal The IABP line is usually semi-transparent and passes into the body through an arterial sheath. Modern IABP devices automatically extract all gas within the balloon to prevent vessel tear when disabled. However, a simple confirmation requires the 60cc syringe inserted into the balloon gas line with the one-way valve to draw back any residual helium. Another trained provider should be listening to the pedal pulse with a Doppler device. The balloon only is pulled back until resistance is met. The balloon is up against the end of the sheath and now both are simultaneously drawn out by simply gripping both the IABP line and sheath. It is important not to pull the IABP line alone beyond the initial resistance point because if pulled too far into the sheath, tension within the balloon may give it more shape and tear a larger hole through the vessel as it exits the body. If the IABP is sheathless, the apparatus can be pulled directly out as no resistance should be met. Pulling direction should be parallel to the extremity and not upward. As line removal is initiated, FemoStop dome inflation should be commencing. Ideally, as the tip of the balloon exits the body, a small amount (3-4cc) of blood should squirt through to clear any potential clot. With only one or two more pumps of the manometer, initial hemostasis should occur as the pedal pulse disappears. It is a good idea to have gauze ready to clear the area of blood for visualization. The access site should be easily viewed directly through the dome. If the apparatus resists to pulling, the dome pressure may be too high, creating tension by compressing the sheath and the artery together. Simply back down the dome pressure at this point until the resistance lets up, and then proceed. If pulsatile blood is noted under the dome and pressure appears maximal, some temporary manual pressure over the FemoStop dome will likely solve this problem. If initial dome positioning is done properly and the ACT is below 150 seconds, refractory bleeding is unlikely at this point. Obliteration of the pedal Doppler signal should be ideally less than 1 minute. Bulb pressure can be adjusted in decrements of 20 mmHg to match the patient’s systolic pressure over a 5-minute period until a weak but present Doppler pulse is returned to the foot. Often the arterial signal returns well below the systolic pressure reading, so it is important to proceed downward until the signal is returned, provided there is no bleeding. Periodic palpation and if possible, patient communication, to ensure the absence of a new hematoma or signs of retroperitoneal bleeding (sudden back pain, hypotension etc.) should be ongoing. Should bleeding occur, the dome can simply be re-inflated. One of the most common findings immediately seen with hemostasis is skin mottling - a consequence most often from venous compression. This phenomenon will often linger well after arterial flow has been confirmed. With continued downward weaning, this should resolve. If arterial flow is difficult to establish, however, skin mottling may represent embolization and should be considered a vascular emergency. Follow-Up Once the balance of hemostasis with distal perfusion is achieved, this bedside procedure should be documented as a progress note, emphasizing the timing of hemostasis and the return of the Doppler pulse, and the condition of the puncture site and patient before and after IABP removal. The patient should be relatively comfortable, with the FemoStop device feeling snug. The responsible clinician should not leave the patient’s bedside unless: a) there has been at least 10 minutes of hemostasis; b) there is a Doppler pulse in the foot; c) there is no cutaneous sign of venous obstruction. A good rule of thumb for weaning down the bulb pressure is to gradually decrease the manometer by 20mm Hg every 15 minutes over the course of an hour. Often, this wean can be performed by other experienced staff with written instructions or a protocol. With the exception of recalcitrant bleeding or in the case of a newly extubated patient where coughing paroxysms are expected, the device can remain over the site for another 30 minutes at very low or zero pressure for a total of 1 1/2 hours (2-2 1/2 hours if the exceptions exist). If left on for more than 1 hour, periodically loosen the belt and lift the dome off the site to assess for skin trauma. When appropriate, the device can then be gently rolled off, followed by bed rest for another 6-8 hours. Complications, although rare, do occur with mechanical external compression, especially when the device is over-tightened or left on for too long. The most common problem is pain, especially when the FemoStop dome compresses the femoral nerve, which runs alongside the artery and vein in the femoral compartment. Compression of the nerve is manifested as severe, sometimes parasthetic pain that radiates across the thigh in the distribution of the lateral femoral cutaneous nerve. The pain is usually not immediate but intensifies gradually. Often the clinician will be paged long after leaving the patient by a request for a pain medication order. The prudent response should be to return to the bedside and re-evaluate the patient. If femoral nerve compression is suspected, loosening of either side of the FemoStop belt or dome deflation will almost always bring about immediate relief. Skin injury at the dome contact site can occur if the device is neglected. This, however, should not occur if diligence is employed. Therefore, a fully inflated FemoStop dome should not be kept on the skin for long periods of time. Conclusion Taking into consideration institutional and individual variability, an IABP removal protocol with the FemoStop Plus Femoral Compression System is a good idea if just for clinical continuity (see captioned protocol). Keep in mind, however, that the gold standard is effective external compression and how that is achieved may vary depending on the comfort level of the involved clinicians. The key to successful IABP removal is good technique manual or mechanical with an attentive and empathetic approach. These ideals will minimize anxiety and ensure that this bedside procedure is a trivial event in a patient’s hospital stay. FemoStop® Intra-aortic Balloon Pump Removal Protocol Approach 1. Know the fundamentals of IABP technology. 2. Take ownership of the task. 3. If there is clinician anxiety, the presence of another experienced provider is optimal. 4. If appropriate, inform the patient of the steps involved and the importance of patient involvement to minimize anxiety. Preparation 1. Obtain all bedside equipment for sheath removal (gloves, gauze, etc.). 2. Choose the most comfortable method of hemostasis, be it manual or mechanical. 3. Be observant of the patient’s ACT (should be Line Removal 1. Withdraw the balloon catheter until there is resistance. This does not apply with a sheathless catheter as the line can simply be drawn out. 2. While another experienced provider listens to the pedal Doppler signal, grip both the balloon catheter and sheath, withdrawing caudally while simultaneously inflating the Femostop dome. Allow one outward pulsation of blood and quickly wipe with gauze. 3. Be observant. Distal perfusion should be nearly absent. Apply additional dome pressure if evidence of bleeding. 4. Once hemostasis has been established over 3-5 minutes, begin decreasing dome pressure until an easily audible pedal Doppler signal is noted. 5. Re-assess the patient’s blood pressure and comfort level. Continue decreasing dome pressure over the next 5-10 minutes. There should be no evidence of venous obstruction now. Follow Up 1. Document the event with a chart note, including puncture site exam before and after sheath removal, medications given and any comments on the patient’s well-being throughout. 2. Write clear parameters for dome pressure weaning and duration if another provider will be managing the puncture site. A weaning protocol may improve efficiency. 3. Only leave the bedside when the patient is comfortable and never leave the device on for too long. Be sure to interrupt pressure every 3 hours to prevent any skin necrosis. Always be observant! James Armstrong, PA-C, discloses that he is an advisor and speaker for Radi Medical Systems in the area of hemostasis and has received an honorarium for this article. He can be contacted at armtwist@comcast.net

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