Hemostatic devices are used to stop bleeding from a blood vessel, usually after a medical procedure has opened an artery. During cardiac catheterization, balloon angioplasty or catheter-based procedures, the physician often inserts the catheter through the femoral artery in the patient’s groin. The physician may also use the arteries in the arm, such as the radial or brachial artery.

After the procedure is complete and the catheter has been removed, the bleeding from the femoral artery must be stopped. Traditionally, this involved applying pressure to the wound with fingers for 15 minutes followed by four to six hours of applying pressure (usually with sandbags) directly to the wound. During this time, the patient was forced to remain flat on his or her back, which could cause back pain and other discomfort.

Hemostatic devices were developed to speed recovery time by stopping the femoral artery bleeding more rapidly. There are several types of hemostatic devices. Some administer a substance such as collagen that speeds the body’s natural clotting process and stops the bleeding. Others involve a single stitch in the femoral artery, closing the incision site to stop bleeding. Still others are compression devices that apply pressure consistently.

Some patients may not be appropriate candidates for hemostatic devices. The risk of complications associated with catheter-based procedures remains low, whether or not the hemostatic devices are used.

A hemostatic device is a small tool that may be used to more quickly stop bleeding from the femoral artery after a balloon angioplasty or other catheter-based procedures. Without the device, a patient must lie flat for several hours while healthcare professionals apply constant pressure to the puncture site. 

 During an angioplasty or other catheter-based procedure, a physician makes an opening in a blood vessel (frequently the femoral artery in the groin) and passes a tube into the blood vessel to view it or make repairs. After completion, a hole remains in the artery, which can bleed. For years, medical professionals used direct pressure (sometimes with sandbags) on the incision for up to six hours while the natural clotting process eventually stopped the bleeding.

Hemostatic devices enable the incision to heal or clotting to occur in much less time. These devices function several ways. One type of hemostatic device is inserted into a small sheath at the incision site. The physician then administers a procoagulant substance such as collagen through the device, directly to the incision site. The device and sheath are removed, leaving the substance to more quickly seal the wound. Pressure only needs to be applied to the wound for about five minutes instead of several hours. Within the next six weeks, the procoagulant substance will be absorbed by the body. Until those six weeks have passed, it is generally inadvisable to use the same femoral artery to insert another catheter.

Other devices use a “suture mediated closure system.” This system involves making a single, tiny stitch in the femoral artery to close the incision site. Like the other hemostatic devices, the result is a faster recovery time.

Another device uses a star shaped device that is applied directly on the artery like a staple through a staple gun.

Another hemostatic device includes a cup and belt that compresses the incision, similar to the manner in which direct pressure can compress it.

The main benefit of a hemostatic device is that it can speed recovery and improve a patient’s comfort following a catheter-based procedure. However, some people are not good candidates for hemostatic devices. Patients who are allergic to beef or collagen are not eligible for hemostatic devices that use a procoagulant substance from cows. In addition, procoagulants such as collagen devices depend on the blood’s clotting ability to function properly. Patients taking anticoagulant medication or with clotting disorders may not be appropriate candidates for these types of hemostatic devices. 

Other patients who may not be appropriate for procoagulant hemostatic devices include those with:

Research has suggested that hemostatic devices have the same low risk of complications associated with more traditional strategies of closing the incision site. Although rare, these risks include:

• Bleeding around the point of puncture
• Abnormal heartbeats (arrhythmia)
• Allergic reaction to dye
• Infection
• Blood clots
• Perforation of a blood vessel or other damage to the arteries
• Heart attack
• Stroke
• Air embolism
• Death

People are encouraged to thoroughly discuss with their cardiologist any questions or concerns they may have about the risks and benefits of hemostatic devices.

Preparing questions in advance can help patients to have more meaningful discussions with their physicians regarding their conditions. Patients may wish to ask their doctor the following questions related to hemostatic devices:

1. Do you use hemostatic devices after angioplasty? What types?
   
   
2. Will my medications affect your ability to use a hemostatic device?
   
   
3. Do I need to continue pressure on my incision after I return home?
   
   
4. What symptoms should I watch out for after using a hemostatic device?
   
   
5. Will a hemostatic device hurt?
   
   
6. If you use a hemostatic device now, will that affect future catheterizations at the same site?
   
   
7. Can you still use a hemostatic device if I am pregnant?