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Leanings vary, but devices decrease length of stay for the surgery
Your options for closing the femoral artery access site following catheterization procedures such as diagnostic angiography, angioplasty, stenting, and atherectomy are broadening. In addition to the traditional method of manual compression for percutaneous vascular surgery (PVS), with or without clamping, there are three FDA-approved means available now — two of which rely on collagen plugs, the other on suturing. (See box containing basic information on the three methods, p. 74.)
A fourth arterial closure device, not yet approved, looks promising.
This article is intended to help you compare the suturing and plug methods. It seems clear that any one of those products is more effective and efficient than the manual compression techniques, but which one is best for your facility — and which one saves your facility money and time — should be based on independent testing and experience. We offer here the opinions of various clinicians and administrators across the country who have tried at least one of the devices.
One is Cheryl M. Morgan, RN, a nurse data abstractor at Morton Plant Hospital in Clearwater, FL. She says they either use the Perclose suturing device following their femoral catheterization interventions, or compress the site manually or with a clamp. Even though using the suturing device costs more than using manual compression, she says "it has saved us money because our lengths of stay are definitely shorter and our vascular complications have decreased." (See charts showing that data, p. 75.)
Morgan says patients love the suturing method. "They can get up faster — they hate to lie down for six to eight hours waiting for a clot to form and strengthen at the arterial puncture site."
In addition, her facility’s cardiologists increasingly have been using radial access for caths, and that option is an alternative as well. (See related article on radial access)
"We don’t use VasoSeal or AngioSeal, but plan to run a pilot study on those products soon," Morgan says. "The physicians are happy with the suturing system that we use now, but they want to review other options as well."
This past May, the Food and Drug Administration (FDA) approved a labeling claim of reduced time to discharge for the two new PVS products — both made by the same company — that feature suturing rather than collagen plugs. To comply with the FDA, the devices have to be used for patients who have no other medical conditions requiring hospital observation.
The suturing products, Techstar 6F (six French) and Prostar 8F (eight French), manufactured by Menlo Park, CA-based Perclose, are the only PVS-suturing products on the market approved for that labeling claim. Both have also been granted permission to use the labeling claims of reduced time to hemostasis and ambulation.
The reduced time-to-discharge claims were granted based on two clinical studies, STAND I and STAND II, which showed that diagnostic patients treated with the Perclose devices left the hospital earlier than patients treated with conventional compression methods.1 Time to hemostasis for Perclose patients was 0.3 hours, and time to ambulation was 3.9 hours.
Once a diagnostic or interventional cath is completed and the anticoagulation level normalizes, unless one of the new PVS devices — AngioStat, VasoStat, or the Perclose system — is chosen, the traditional method of stopping blood flow at the groin site is for a nurse or technician to press down on the wound for 20 to 30 minutes or resort to mechanical compression devices such as Femostop or Clamp Ease to create the seal and then monitor for continued hemostasis.
If you use compression, patients have to stay under observation for several hours — sometimes overnight if the procedure is done late in the day. Walking is out of the question until a substantial clot was stabilized. Recovery takes longer if the patient was given anticoagulants.
In the interventional setting, the introducer sheath remains in the patient’s artery, and the compression process can be delayed for up to 12 hours until normal coagulation levels apply. The duration of the recovery period can range from 12 to 30 times the duration of the original procedure, and it is often considered the most difficult component of the procedure for both patient and caregiver. The access leg is kept in a fully extended position, and the head cannot flex for at least six hours. Patients must ask for assistance with feeding and urinating, sometimes have to be restrained, and often complain of leg cramps and back and shoulder pain. Those precautions are taken to prevent complications such as bleeding from the puncture site, hematoma, pseudoaneurysm, and arterial-venous fistula.
Linda Hicks, the coordinator of the cath lab at OSF St. Francis Medical Center in Peoria, IL, says the staff at St. Francis started using the suturing devices in December 1998.
"We’ve absolutely seen a reduced time to discharge with this," she says. "Since 80% of our patients are outpatients — before we had Perclose — if we did them at three in the afternoon, they would have had to be admitted and either stay overnight or be released after three to four hours of bedrest. Now we do them with Perclose, and in an hour they’re home. They don’t have to be admitted to the hospital, and the hospital doesn’t have that admission charge and labor-intensive nursing for no reason other than for the patient to lay there until they can get up and walk."
She says that they have used VasoSeal as well, but "the suturing is more reliable."
John Stewart, the administrative director at Sacred Heart Regional Heart Institute in Pensacola, FL, agrees.
"We use some vascular device [rather than manual arterial compression] on 85% of our cath patients," he says, "and for 75% of those we use the suturing system because our physicians are more comfortable with that, and they can discharge their patients earlier."
Stewart says the cardiovascular staff at his facility has experienced some delays and complications with the collagen plug devices.
"There is some hold time after the procedure because the plugs can be coughed out," he says.
Coughing or sneezing can increase vascular pressure and dislodge the clot, causing bleeding. Also the plugs leave a foreign body beneath the skin for a time, and typically, in the words of Edwin W. Rogers Jr., MD, a cardiologist at Sacred Heart, "the body doesn’t like that." The sutures dissolve over time.
Stewart and Rogers conducted a retrospective analysis measuring LOS and hospital resource utilization following use of the suture-based hemostasis system. In both diagnostic and interventional groups, the duration, nursing intensity, and average cost decreased while patient satisfaction was enhanced.
"Taking into account the cost of the device, we’ve enjoyed an annual savings of $298,000 using the suturing device," says Stewart. That was accomplished because 60% of Sacred Heart’s cath patients are now able to be done on an outpatient basis.
"Our outpatient cath lab costs decreased by 13%, and our inpatients costs decreased by 3%," he adds. "For inpatients, we utilize critical care and progressive care a lot less than we used to. Nearly all our patients go to the floors now without sheaths. Our mean length of stay is one day."
"We don’t intend to eliminate VasoSeal and AngioSeal entirely," Stewart explains. "We don’t utilize them as much as Perclose, but there are situations where they have to be used because suturing isn’t feasible. If a patient presents with a tortuous stick site or a bifurcation of the vessel, the way Perclose deploys, you can’t use it. Also, if there’s a rock-hard calcification, Perclose cannot be used. Rather than use nothing and compress manually, we use VasoSeal or AngioSeal; on those patients, they tend to work well."
Kevin Barnes, RN, clinical nurse in the cardiac cath lab at Scripps Mercy Hospital in San Diego, reports that they use both VasoSeal and AngioSeal, but find that VasoSeal meets their needs more often.
"AngioSeal provides a collagen mechanism to close the artery, but it requires a dissolvable intra-arterial anchor," he explains, "and that can cause problems with patients with peripheral vascular disease. The disk goes on the inside of the artery and opens up to form a seal at the puncture site, and on top of that you tamp a collagen plug. The artery wall is sandwiched between the disk and a collagen plug."
AngioSeal forms a good seal on the artery, Barnes adds, but the disk has to fit exactly flat against the inside of the artery. If there are calcifications and the artery wall is rough, the disk may not fit right and there will be leaking around it."
VasoSeal is entirely extra-arterial and can be used with such patients. "You apply the collagen plug to the top of the artery — a sort of tire patch," he says.
Another reason the cath lab at Scripps uses VasoSeal more than the other collagen sealer is because AngioSeal requires a physician to insert the intra-arterial component. With the VasoSeal, once the case is finished, the physician leaves the care of the groin area to the nurse-tech teams.
"Our nurse-tech team can apply the extra-arterial sealer," Barnes says. They have been inserviced and have gone through a training program. "Our techs do so many — 2,500 cases a year — they have the competency and experience to get good results. While the physician is talking to the family and writing orders, our techs can relieve him of that task."
Barnes says patients are happy with the both of the collagen devices because they can get up sooner than with the manual compression. "The diagnostics get up in two or three hours and move around. They are much more comfortable with improved mobility and ambulation."
Cost Management in Cardiac Care asked Barnes if he’s ever experienced a collagen plug being coughed out. He replies that it does happen but very rarely: "Anytime you apply pressure to an artery from the inside, there can be a problem. The patient has to be warned that if they are going to cough or sneeze, apply a little pressure over the area."
He says if a cough-out happens, the patient might get a small hematoma over the area, "but I don’t see it as a major problem."
Scripps has had no experience with the Perclose systems, but Barnes points out that they require a physician to suture. "Our physicians have decided not to go that way," he says. "I have heard others say that if you are going to use it, the physician has to be very skilled or you can get into problems with it."
CMCC asked others if anyone but a physician could do the suturing. Hicks says the suturing system carries with it a somewhat lengthy training period — about 10 cases — but "once the doctors are proficient, the suturing takes five minutes or less."
The doctors at St. Francis do the suturing now, but, says Hicks, "we can train staff to do it too, if we want to."
Sacred Heart has also opted not to cross-train its nurses or technicians to suture with Perclose. "Sacred Heart is not a teaching facility, and our physicians prefer to do it themselves," says Stewart.
The suturing systems are also more expensive, Barnes points out. "Our physician director of the cardiovascular department has said that if you look at charges, not cost, there’s an $800 savings when we use a collagen product."
Kevin Wolschleger, MD, at St. Joseph’s Hospital and Marshfield Heart Care Clinic in Marshfield, WI, says they haven’t tried Perclose yet, but has it in mind.
"AngioSeal and VasoSeal are equivalent. They have their pluses and minuses, but perform about the same." Marshfield Heart Care performs more than 2,000 cardiac cath procedures and more than 700 interventional procedures each year.
Sandy Charlton, a nurse practitioner who works with the cardiologists at Arkansas Heart Hospital in Little Rock, says they have been using the suturing system for over a year. "We Perclose every single case we do on a daily basis, as long as the patient is a candidate."
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Shrake KL. Vascular sealing devices: Are the advantages sustainable? J Cardiovasc Mgmt 1999; 1:16-19.
Sanborn TA, Gibbs HH, Brinker JA, et al. A multicenter randomized trial comparing a percutaneous collagen hemostasis device with conventional manual compression after diagnostic angiography and angioplasty. J Am Coll Cardiol 1993; 22:1,273-1,279.