Letter to the Editor

Two recent review articles discussing percutaneous arterial closure devices suggest that complication rates are high enough that routine use, especially in diagnostic cases, is not warranted.^1,2 It seems that the use of femoral closure devices have their own set of complications and when they occur, they are often more severe than the standard groin hematoma or rare femoral clot that is seen with the use of manual compression or compression devices. I would therefore like to call your attention to the use of the CompressAR device. These comments are based on personal experience and without any review of case material. However, I can recall only one complication with a patient using this device. It was a retroperitoneal hematoma in a patient on which I did an anti-grade puncture and probably entered the femoral artery too high. I can recall no patients in which we have not been able to use this device successfully and no secondary endo-luminal problems. In 1974, and again in 1985, Semler^3-4 reports the successful utilization of the CompressAR groin compression device (Advanced Vascular Dynamics, A Semler Technologies Company, Portland, Oregon). Based upon the reported value of this device, I began using it in my practice in the 1970’s with considerable success on all patients, especially those who have very protuberant abdomens with highly sloping groin areas. It is the purpose of this communication to call attention to the proper use of this particular femoral compression device. Over the years it has become very apparent to me that this device cannot be used without careful attention to procedural details, and I have developed a number (perhaps too many) of rules concerning its use. These include: 1. The use of this device is appropriate for any and all femoral arterial and venous punctures. 2. It is essential that the base of this device be placed on a solid surface. If the patient is on a mattress, and the device cannot be placed on a solid surface, a cardiac compression board should be placed underneath the hips of the patient to fully stabilize the device. 3. The greater the slope of the groin (due to obesity), the more careful one must be. Placing the device so that the arm points toward the umbilicus, about 30 - 50 degrees, is of value in preventing caudal arm deflection. I do this as a matter of routine in all patients. 4. It is advisable to eliminate all slack in the arm before applying pressure. The arm of the device should therefore be gently pushed toward the feet before it is applied. If not, the arm will tend to deflect toward the feet, especially on sloping surfaces. Only after this is done should pressure be applied to the groin. This is especially true for protuberant abdomens. 5. The disposable pressure pad should be placed over the vascular puncture. This may not be immediately adjacent to the skin puncture site depending on the thickness of the soft tissues of the groin and the angle of the needle at the time of puncture. If the vascular puncture site is not within the anticipated position of the CompressAR disk being used, the site of actual puncture should be clearly marked on the skin surface by the angiographer. This will serve as a guide for removal of the catheter or sheath and application of the CompressAR device by ancillary personnel. This is particularly important if the arterial puncture site is unusually distant from the skin puncture site, as in obese patients, and particularly with ante-grade femoral punctures. As the operator, I usually place the pressure pad myself, pull the sheath, and let the technical personnel do the follow-up. Ancillary personnel, however, are very capable of doing the sheath removal and applying pressure as outlined above. 6. It is important to always check the peripheral pulse before the application of pressure. If it is absent or diminished from its pre-procedural status, it is suggested that an angiogram of the leg be performed before removing the catheter or sheath to establish whether an embolus or other problem has developed. Although rare, this complication has been observed. If distal pulse changes are not detected prior to catheter removal, blame for an arterial occlusion could be placed on the type of closure device that is used rather than a pre-existing embolus that was undetected. I can recall three specific occasions where checking pulses before pulling a sheath resulted in prompt angiography and a correct diagnosis unrelated to the puncture. 7. Pressure is not applied until the catheter or sheath is out of the vessel and there has been a small amount of bleeding. 8. The peripheral pulse should be monitored as the device is applied. A general rule would be to apply the device sufficiently to either audibly or palpably dampen the pulse. 9. If pressure sufficient to dampen the pulses is not adequate to stop bleeding, then additional pressure should be applied. This may require total occlusion of the artery with loss of pulses. Very frequently, after a minute or so, the distal pulses will reappear as the compressed fat is squeezed out laterally. 10. If the pulses do not reappear within a minute or so, the pressure should gradually be reduced until pulses are barely noted. Peripheral pulses should continue to be monitored every few minutes. 11. Although these devices do allow one to do other work, they are not intended for this purpose. It is essential that the patient be monitored carefully since patients do move and devices do slip. 12. It is important to palpate the skin all around the pressure device to note the firmness/softness so that, at follow-up palpations, one may be better able to detect developing subcutaneous bleeding while pressure is being held. 13. While still holding pressure, it is helpful to cleanse the skin around the pressure site since re-bleeding may occur if this is done after pressure is released. 14. When releasing pressure with the right hand, it is important to maintain some back pressure against the arm of the device with the left thumb so that it does not release a large amount of pressure suddenly. The arm should be allowed to retract only a millimeter or so at a time. After 5 minutes, pressure can be released until the pulse is at full strength. At 10 minutes, the remainder of the pressure is released over about five minutes. After 15 minutes, the pressure pad is eased off the skin and the device is removed. These recommended times are applicable to sheaths with up to 9 F. Longer times may be required with larger sheaths or heparinization. For example, maintenance of pressure for up to 45+ minutes can be required in heparinized patients. 15. Finally, apply a Band-Aid to the puncture site. It is not recommended that the skin area be cleansed after application of the Band-Aid as this may restart bleeding. I have not used pressure dressings except in those situations where a) the patient is to be placed immediately on intravenous heparin, b) the blood pressure is inordinately high, or c) there have been problems with bleeding during or following the procedure. 16. For years I have used 6 hours of bed rest. In the past several years, in uncomplicated cases and essentially normal common femoral arteries, I have used only two hours of post procedural bed rest and have not had any problems. At Saint Luke’s Hospital of Kansas City, there is a large cardiac catheterization laboratory, and we often see patients within days of heart catheterization. It is often the policy of the attending cardiologist to have pressure on the groin held by hand. This provides us the opportunity to ask patients which pressure-holding methodology is more comfortable. With rare exception, the CompressAR device is preferred to having the pressure held by hand. A likely explanation for this observation relates to the steadiness with which pressure can be maintained using this device, since the body more easily adjusts to the marked amount of pressure that is used if no motion is present. In my own personal experience with this device in the Radiology Department for nearly 30 years, no significant problems with use of this device have been encountered. It is perhaps worth mentioning the CompressAR is particularly useful in the obese patients because of its stability. It is essential that rule #3 be followed in obese patients. I have found the CompressAR device to be markedly successful at holding the thick groins of these heavy patients. Over the years, I have come to call the CompressAR device my friend, Dr. Able. To help put patients at ease, I most often introduce them to this device as Dr. Able: my friend and able consultant who has had great experience holding groins and does so with a steady hand, great tenacity, and never complains “ no matter how long or hard he has to stay on the job. Email: ddixon@saint-lukes.org

1. Hoffer EK and Bloch RD. Percutaneous Arterial Closure Devices. JVIR 2003; 14:865-885.

2. Koreny M, Riedmuller E, et al. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis, JAMA 2004; 291:350-7.

3. Semler HJ. Experience with an external clamp to control bleeding following transfemoral catheterization. Radiology 1974; 110:225-6.

4. Semler HJ. Transfemoral catheterization: mechanical versus manual control of bleeding. Radiology l985; 154:234-235.