Vascular Closure Devices: The Jury is Still Out
Much debate has surrounded which technique—manual compression or vascular closure—is best for hemostasis post-PCI. Now, newer generations of vascular closure devices (VCDs) have been proven to decrease length of stay, improve patient satisfaction and provide earlier time to ambulation. However, gaps in use still exist, due to questions about economic benefits and patient risks.
For example, a recent study compared bleeding rates and vascular complications of closure devices and manual compression in 2,324 patients who underwent PCI procedures (Am J Cardiol 2011;107(11):1619-1623). Of the participants, 1,162 were treated with VCDs and 1,162 were treated with manual compression.
"We found that patients who had closure devices had a significantly lower bleeding rate compared with patients who had hemostasis with manual compression," says the study's senior author David M. Safley, MD, interventional cardiologist at Saint Luke's Mid America Heart and Vascular Institute in Kansas City. Complication rates were 2.4 percent for closure and 5.2 percent for manual compression.
Patients classified as high risk by the National Cardiovascular Data Registry (NCDR) saw the greatest reduction in major bleeding events with closure compared with manual compression, 3.1 versus 10.3 percent. Patients who underwent closure saw an average length of stay of 1.9 days versus the 2.3 days for manual compression.
Another study found complication rates for VCDs (Angio-Seal, St. Jude Medical) and manual compression to be similar, 3.4 percent versus 3.2 percent (Clin Res Cardiol; published online April 2011). However, when vascular closure was used for emergent cardiac catheterizations in both non-STEMI and STEMI patients, the rates of vascular complications increased significantly. These rates were 6.3 percent for vascular closure and 0.9 percent for manual compression.
While the majority of data attests that VCDs may be favorable for patient comfort, closure is still underutilized. "Two factors hinder adoption: costs and complications," says Harold L. Dauerman, MD, director of the cardiovascular cath labs at the University of Vermont in Burlington.
When employing VCDs, physicians should assess three factors:
"The first two are certainly better with closure devices," Dauerman offers, "but the third remains controversial."
Currently, an estimated 30 to 40 percent of U.S. patients undergoing PCI receive a vascular closure device, according to Dauerman. "There is a perceived fear associated with the complication risks of using a device, so some physicians will resort to performing manual compression," he offers.
The second obstacle to adoption is cost. Hospitals are not reimbursed for VCDs. "If you perform a PCI, you get a lump sum payment, but the closure device costs about $200 each. Therefore, it is subtracted from the profit margin of the hospital," Dauerman explains.
As a cost-effective alternative, compression remains the gold standard. "It's cheaper to pull a sheath and hold manual pressure than put in an expensive device," Safley says. Also, compression has a lower risk of complications including infection or embolization, he notes.
Manual compression is "essentially free," because it is performed by a staff member already on the clock, says Safley, who reports an average price tag of a VCD is $150 to $250.
"Many sites have not adopted a routine strategy of using vascular closure devices due primarily to the fact that the medical center will not get reimbursed for them," notes Adhir Shroff, MD, director of the cardiac cath lab at the University of Illinois, Chicago.
Additionally, Shroff says the benefit of early ambulation with a VCD may be less economical for PCI patients who are observed overnight in the hospital. Vascular closure is most advantageous for outpatient procedures, says Shroff, where improved efficiency has a measurable value for the patient and provider. Catheterization patients can ambulate sooner with vascular closure than manual compression, leading to a potential for an early discharge.
Most important is choosing the right patient for vascular closure. Many factors put patients at risk for complication with a VCD, including peripheral vascular disease, improper sheath placement or an abnormally small vessel, Dauerman notes. Conversely, obese patients or those with high or low punctures may not be candidates for manual compression and are better suited for closure due to the heightened risk of pseudoaneurysm and decreased ability to compress.
While VCDs may improve patient satisfaction, is the potential risk of complications worth the risk?
"While these devices may not be safer, they can improve efficiency and patient experience," Shroff says. Currently, no one device outweighs another in terms of safety and efficacy, and usage primarily depends on operator preference, cost and hospital contracts.
Physicians are always seeking to avoid potential complications. One single-center study showed that the addition of bivalirudin (Angiomax, The Medicines Company) to vascular closure devices (Angio-Seal, St. Jude Medical or Perclose A-T, Abbott Vascular) during PCI may help reduce periprocedural bleeds better than manual compression or VCD alone (J Am Medical Assoc 2010;303(21):2156-64).
Marso et al evaluated four groups: 529,246 patients who received manual compression, 363,583 patients who received a vascular closure device, 353,769 patients who were administered bivalirudin and 276,336 patients who received VCD plus bivalirudin.
Bleeding events occurred in the aforementioned groups at rates of 2.8 percent, 2.1 percent, 1.6 percent and 0.9 percent, respectively. Also, patients at a higher risk of bleeding were less likely to be administered bivalirudin therapy when undergoing vascular closure.
Shroff says that many factors—clinical context, patient characteristics and procedural factors—can predict one's risk of bleeding. Using multiple strategies including choice and timing of anticoagulants, proper use of VCDs, smaller-sized catheters and alternative access routes (i.e. the radial approach) can significantly impact a patient's risk of bleeding.
"While you can't modify a patient's characteristics or their presentation, you can incorporate multiple bleeding avoidance strategies," Shroff offers. "In doing so, you can incrementally decrease bleeding risk."
The recent RIVAL trial presented at ACC.11 showed that the transradial approach may improve patient comfort and lower complication rates, but the rates of death, MI, stroke or major bleeding were not reduced (Lancet 2011;377(9775):1409-1420).
Jolly et al randomized 3,507 patients to radial access and 3,514 patients to femoral access and found that rates of adverse events at 30 days occurred in 3.7 percent of radial access patients and 4 percent of the femoral group.
Even Shroff who has adopted the radial approach in 80 percent of patient cases says there will continue to be "aggressive development in the vascular closure space."
The transradial approach is used in 20 to 30 percent of cases at St. Luke's due to the decreased bleeding events, Safley says.
Even with the increased interest, Dauerman doubts radial access usage rates will be more than 20 percent of the U.S. market.
When performing vascular closure, physicians individualize the risk and benefits of manual compression versus closure for their patients. While closure may enhance patient satisfaction, manual compression may be more cost-effective and reduce the risk of complication in certain patients. Until more definitive data emerges, usage may still be determined by physician preference.
Why varied utilization?
A 2008 market research report from Life Science Intelligence estimated that the VCD market would reach $1 billion by 2013; however, there continues to be a wide variation in use.For example, a recent study compared bleeding rates and vascular complications of closure devices and manual compression in 2,324 patients who underwent PCI procedures (Am J Cardiol 2011;107(11):1619-1623). Of the participants, 1,162 were treated with VCDs and 1,162 were treated with manual compression.
"We found that patients who had closure devices had a significantly lower bleeding rate compared with patients who had hemostasis with manual compression," says the study's senior author David M. Safley, MD, interventional cardiologist at Saint Luke's Mid America Heart and Vascular Institute in Kansas City. Complication rates were 2.4 percent for closure and 5.2 percent for manual compression.
Patients classified as high risk by the National Cardiovascular Data Registry (NCDR) saw the greatest reduction in major bleeding events with closure compared with manual compression, 3.1 versus 10.3 percent. Patients who underwent closure saw an average length of stay of 1.9 days versus the 2.3 days for manual compression.
Another study found complication rates for VCDs (Angio-Seal, St. Jude Medical) and manual compression to be similar, 3.4 percent versus 3.2 percent (Clin Res Cardiol; published online April 2011). However, when vascular closure was used for emergent cardiac catheterizations in both non-STEMI and STEMI patients, the rates of vascular complications increased significantly. These rates were 6.3 percent for vascular closure and 0.9 percent for manual compression.
While the majority of data attests that VCDs may be favorable for patient comfort, closure is still underutilized. "Two factors hinder adoption: costs and complications," says Harold L. Dauerman, MD, director of the cardiovascular cath labs at the University of Vermont in Burlington.
When employing VCDs, physicians should assess three factors:
- Patient comfort;
- Early ambulation; and
- Decreased complications.
"The first two are certainly better with closure devices," Dauerman offers, "but the third remains controversial."
Currently, an estimated 30 to 40 percent of U.S. patients undergoing PCI receive a vascular closure device, according to Dauerman. "There is a perceived fear associated with the complication risks of using a device, so some physicians will resort to performing manual compression," he offers.
The second obstacle to adoption is cost. Hospitals are not reimbursed for VCDs. "If you perform a PCI, you get a lump sum payment, but the closure device costs about $200 each. Therefore, it is subtracted from the profit margin of the hospital," Dauerman explains.
As a cost-effective alternative, compression remains the gold standard. "It's cheaper to pull a sheath and hold manual pressure than put in an expensive device," Safley says. Also, compression has a lower risk of complications including infection or embolization, he notes.
Manual compression is "essentially free," because it is performed by a staff member already on the clock, says Safley, who reports an average price tag of a VCD is $150 to $250.
"Many sites have not adopted a routine strategy of using vascular closure devices due primarily to the fact that the medical center will not get reimbursed for them," notes Adhir Shroff, MD, director of the cardiac cath lab at the University of Illinois, Chicago.
Additionally, Shroff says the benefit of early ambulation with a VCD may be less economical for PCI patients who are observed overnight in the hospital. Vascular closure is most advantageous for outpatient procedures, says Shroff, where improved efficiency has a measurable value for the patient and provider. Catheterization patients can ambulate sooner with vascular closure than manual compression, leading to a potential for an early discharge.
Most important is choosing the right patient for vascular closure. Many factors put patients at risk for complication with a VCD, including peripheral vascular disease, improper sheath placement or an abnormally small vessel, Dauerman notes. Conversely, obese patients or those with high or low punctures may not be candidates for manual compression and are better suited for closure due to the heightened risk of pseudoaneurysm and decreased ability to compress.
Can VCD risks be avoided?
Complications associated with closure include device failure, infection and thrombotic events. Bleeding events, the most common potential risk, can increase length of stay by four to six days and increase costs by $6,000 to $8,000 (Am J Cardiol 2003;92(8):930–935).While VCDs may improve patient satisfaction, is the potential risk of complications worth the risk?
"While these devices may not be safer, they can improve efficiency and patient experience," Shroff says. Currently, no one device outweighs another in terms of safety and efficacy, and usage primarily depends on operator preference, cost and hospital contracts.
Physicians are always seeking to avoid potential complications. One single-center study showed that the addition of bivalirudin (Angiomax, The Medicines Company) to vascular closure devices (Angio-Seal, St. Jude Medical or Perclose A-T, Abbott Vascular) during PCI may help reduce periprocedural bleeds better than manual compression or VCD alone (J Am Medical Assoc 2010;303(21):2156-64).
Marso et al evaluated four groups: 529,246 patients who received manual compression, 363,583 patients who received a vascular closure device, 353,769 patients who were administered bivalirudin and 276,336 patients who received VCD plus bivalirudin.
Bleeding events occurred in the aforementioned groups at rates of 2.8 percent, 2.1 percent, 1.6 percent and 0.9 percent, respectively. Also, patients at a higher risk of bleeding were less likely to be administered bivalirudin therapy when undergoing vascular closure.
Shroff says that many factors—clinical context, patient characteristics and procedural factors—can predict one's risk of bleeding. Using multiple strategies including choice and timing of anticoagulants, proper use of VCDs, smaller-sized catheters and alternative access routes (i.e. the radial approach) can significantly impact a patient's risk of bleeding.
"While you can't modify a patient's characteristics or their presentation, you can incorporate multiple bleeding avoidance strategies," Shroff offers. "In doing so, you can incrementally decrease bleeding risk."
Future and beyond
"Currently there is a large push toward the radial approach," says Dauerman, who, along with his colleagues, has adopted transradial PCI in 40 percent of cases. The overall U.S. adoption rate is only about 6 percent.The recent RIVAL trial presented at ACC.11 showed that the transradial approach may improve patient comfort and lower complication rates, but the rates of death, MI, stroke or major bleeding were not reduced (Lancet 2011;377(9775):1409-1420).
Jolly et al randomized 3,507 patients to radial access and 3,514 patients to femoral access and found that rates of adverse events at 30 days occurred in 3.7 percent of radial access patients and 4 percent of the femoral group.
Even Shroff who has adopted the radial approach in 80 percent of patient cases says there will continue to be "aggressive development in the vascular closure space."
The transradial approach is used in 20 to 30 percent of cases at St. Luke's due to the decreased bleeding events, Safley says.
Even with the increased interest, Dauerman doubts radial access usage rates will be more than 20 percent of the U.S. market.
When performing vascular closure, physicians individualize the risk and benefits of manual compression versus closure for their patients. While closure may enhance patient satisfaction, manual compression may be more cost-effective and reduce the risk of complication in certain patients. Until more definitive data emerges, usage may still be determined by physician preference.