31-05-2012, 10:52 AM
Vascular closure devices
[attachment=23626]
INTRODUCTION
In the early 1990s, ~6% of patients undergoing percutaneous coronary intervention (PCI) developed peripheral vascular complications, of which 22–25% received a blood transfusion and 21–38% required vascular surgical repair.1,2 Recently, the rate of vascular complications has declined to approximately 2%.3–6 However, the 1-year mortality rate for patients with peripheral vascular complications was 7.5% compared with 1.1% for patients without such complications.2 Peripheral vascular complications prolong hospitalization and nearly double mean hospital costs (from $9,583 to $18,350).2
Arterial access sites were managed exclusively with manual compression (MC) and bed rest for 30 years after Seldinger introduced his technique of percutaneous arterial access in 1959. However, MC necessitates interruption of anticoagulation and requires considerable time and resources (i.e., wait for activated clotting time to decrease and maintain MC for 15–30 minutes with a 6 French [Fr] sheath). Also, MC requires prolonged bed rest, which is associated with patient discomfort, back pain and urinary retention.
MANUAL COMPRESSION
MC remains the “gold standard” in achieving hemostasis of an arteriotomy site. With MC, the sheath can be removed immediately after a diagnostic procedure, but is delayed (often 2–4 hours) after an interventional procedure to allow the activated clotting time to decrease to < 170 seconds. As the sheath is removed, firm manual pressure is placed over the femoral artery, typically 2 cm proximal to the skin entry site. Firm pressure is held for 10 minutes, then slightly less firm pressure for 2–5 minutes, then light pressure while applying a pressure dressing. Pressure should be maintained longer for larger sheath sizes and in the setting of anticoagulation. If bleeding persists, MC is maintained for an additional 15 minutes. Once hemostasis is achieved, bed rest is recommended for 6–8 hours. When VCDs fail, MC is used to achieve hemostasis.
PASSIVE VASCULAR CLOSURE DEVICES
Hemostasis pads. Several hemostasis pads, including Chito-Seal (Abbott Vascular, Redwood City, Calif.), Clo-Sur PAD (Scion Cardiovascular, Miami, Fl.), SyvekPatch (Marine Polymer Technologies, Inc., Danvers, Mass.), Neptune Pad (Biotronik, Berlin, Germany) and D-Stat Dry (Vascular Solutions, Minneapolis, Minn.) can be used in conjunction with MC. The pads are coated with procoagulant material to enhance coagulation and hemostasis.9,10 Hemostasis pads have been analyzed in small randomized trials with patients undergoing diagnostic or interventional coronary procedures10–12 or peripheral percutaneous interventions.9 Technical failure was reported in 5–19% of Clo-Sur PAD cases,11,12 and in 8% of D-Stat Dry cases.13 Compared with MC, no difference in complication rates was observed with the Chito-Seal, Clo-Sur PAD or SyvekPatch,10–12,14 whereas the D-Stat Dry reduced vascular complication rates15 and the Neptune Pad increased the risk of minor bleeding (15% vs. 3%).9 Compared with MC, the Neptune Pad9 and Clo-Sur PAD11,12 improved patient and physician comfort. Hemostasis pads did not shorten the time to ambulation compared with MC.9,10 The clinical utility of hemostasis pads is questionable since their influence on hemostasis is small and they do not reduce the time to ambulation.
ACTIVE VASCULAR CLOSURE DEVICES
Cardiva Catalyst (Boomerang)
The Cardiva Catalyst (Cardiva Medical, Inc., Sunnyvale, Calif.) uniquely facilitates hemostasis through the existing arterial sheath, although MC is still required. The Cardiva Catalyst is indicated for diagnostic or interventional procedures with sheath sizes up to 7 Fr. The device is inserted through the existing sheath. Once the tip is within the arterial lumen, a conformable 6.5 mm disk is deployed, similar to an umbrella. The sheath is removed and the disk is gently pulled against the arterial wall, where it is held in place by a tension clip. The disk, which is coated with protamine sulfate, provides temporary intravascular tamponade, facilitating physiologic vessel contraction and thrombosis. After 15 minutes of “dwell time” (120 minutes for interventional cases) the device is withdrawn and light MC is held for 5 minutes. The Cardiva Catalyst successfully facilitated hemostasis in 99% of 96 patients undergoing diagnostic catheterization with a 5 Fr sheath without any major vascular complications and with minor complications in 5% (rebleeding during bed rest).22 Most patients can ambulate 90 minutes after a diagnostic procedure with this device. The Cardiva Catalyst device does not leave any material behind in the body, which minimizes the risk of ischemic and infectious complications and allows for repeat vascular access. The Cardiva Catalyst is compatible with most patients and has been used successfully in limited numbers of patients with peripheral vascular disease (6 patients), profunda artery or femoral bifurcation arteriotomies (19 patients), internal jugular arteriotomies (18 patients), and in pediatric patients.
CONCLUSION
MC remains the gold standard for achieving hemostasis at a vascular access site. The FemoStop and ClampEase have high success rates in achieving hemostasis and can be used safely in most patients. Other than the FemoStop and ClampEase, VCDs improve patient comfort. All active VCDs shorten the time to hemostasis and ambulation to a relatively similar degree. The incidence of major complications is increased by VasoSeal, reduced by Angio-Seal, and reduced by Perclose in diagnostic cases. The safety of VCDs cannot be assumed due to “class effect” and nearly all individual trials are underpowered to detect differences in complication rates, so the safety of other individual VCDs is unclear. In the absence of puncture site-related risk factors, VCDs as a whole appear to have little influence on complication rates and patients at high baseline risk for bleeding due to clinical factors may benefit from VCDs. VCDs increase the risk of leg ischemia, groin infection, and complications requiring surgical repair, which are rare with MC. Screening with femoral angiography prior to VCD placement and avoidance of VCDs in the presence of puncture site-related risk factors might reduce the risk of vascular complications.
[attachment=23626]
INTRODUCTION
In the early 1990s, ~6% of patients undergoing percutaneous coronary intervention (PCI) developed peripheral vascular complications, of which 22–25% received a blood transfusion and 21–38% required vascular surgical repair.1,2 Recently, the rate of vascular complications has declined to approximately 2%.3–6 However, the 1-year mortality rate for patients with peripheral vascular complications was 7.5% compared with 1.1% for patients without such complications.2 Peripheral vascular complications prolong hospitalization and nearly double mean hospital costs (from $9,583 to $18,350).2
Arterial access sites were managed exclusively with manual compression (MC) and bed rest for 30 years after Seldinger introduced his technique of percutaneous arterial access in 1959. However, MC necessitates interruption of anticoagulation and requires considerable time and resources (i.e., wait for activated clotting time to decrease and maintain MC for 15–30 minutes with a 6 French [Fr] sheath). Also, MC requires prolonged bed rest, which is associated with patient discomfort, back pain and urinary retention.
MANUAL COMPRESSION
MC remains the “gold standard” in achieving hemostasis of an arteriotomy site. With MC, the sheath can be removed immediately after a diagnostic procedure, but is delayed (often 2–4 hours) after an interventional procedure to allow the activated clotting time to decrease to < 170 seconds. As the sheath is removed, firm manual pressure is placed over the femoral artery, typically 2 cm proximal to the skin entry site. Firm pressure is held for 10 minutes, then slightly less firm pressure for 2–5 minutes, then light pressure while applying a pressure dressing. Pressure should be maintained longer for larger sheath sizes and in the setting of anticoagulation. If bleeding persists, MC is maintained for an additional 15 minutes. Once hemostasis is achieved, bed rest is recommended for 6–8 hours. When VCDs fail, MC is used to achieve hemostasis.
PASSIVE VASCULAR CLOSURE DEVICES
Hemostasis pads. Several hemostasis pads, including Chito-Seal (Abbott Vascular, Redwood City, Calif.), Clo-Sur PAD (Scion Cardiovascular, Miami, Fl.), SyvekPatch (Marine Polymer Technologies, Inc., Danvers, Mass.), Neptune Pad (Biotronik, Berlin, Germany) and D-Stat Dry (Vascular Solutions, Minneapolis, Minn.) can be used in conjunction with MC. The pads are coated with procoagulant material to enhance coagulation and hemostasis.9,10 Hemostasis pads have been analyzed in small randomized trials with patients undergoing diagnostic or interventional coronary procedures10–12 or peripheral percutaneous interventions.9 Technical failure was reported in 5–19% of Clo-Sur PAD cases,11,12 and in 8% of D-Stat Dry cases.13 Compared with MC, no difference in complication rates was observed with the Chito-Seal, Clo-Sur PAD or SyvekPatch,10–12,14 whereas the D-Stat Dry reduced vascular complication rates15 and the Neptune Pad increased the risk of minor bleeding (15% vs. 3%).9 Compared with MC, the Neptune Pad9 and Clo-Sur PAD11,12 improved patient and physician comfort. Hemostasis pads did not shorten the time to ambulation compared with MC.9,10 The clinical utility of hemostasis pads is questionable since their influence on hemostasis is small and they do not reduce the time to ambulation.
ACTIVE VASCULAR CLOSURE DEVICES
Cardiva Catalyst (Boomerang)
The Cardiva Catalyst (Cardiva Medical, Inc., Sunnyvale, Calif.) uniquely facilitates hemostasis through the existing arterial sheath, although MC is still required. The Cardiva Catalyst is indicated for diagnostic or interventional procedures with sheath sizes up to 7 Fr. The device is inserted through the existing sheath. Once the tip is within the arterial lumen, a conformable 6.5 mm disk is deployed, similar to an umbrella. The sheath is removed and the disk is gently pulled against the arterial wall, where it is held in place by a tension clip. The disk, which is coated with protamine sulfate, provides temporary intravascular tamponade, facilitating physiologic vessel contraction and thrombosis. After 15 minutes of “dwell time” (120 minutes for interventional cases) the device is withdrawn and light MC is held for 5 minutes. The Cardiva Catalyst successfully facilitated hemostasis in 99% of 96 patients undergoing diagnostic catheterization with a 5 Fr sheath without any major vascular complications and with minor complications in 5% (rebleeding during bed rest).22 Most patients can ambulate 90 minutes after a diagnostic procedure with this device. The Cardiva Catalyst device does not leave any material behind in the body, which minimizes the risk of ischemic and infectious complications and allows for repeat vascular access. The Cardiva Catalyst is compatible with most patients and has been used successfully in limited numbers of patients with peripheral vascular disease (6 patients), profunda artery or femoral bifurcation arteriotomies (19 patients), internal jugular arteriotomies (18 patients), and in pediatric patients.
CONCLUSION
MC remains the gold standard for achieving hemostasis at a vascular access site. The FemoStop and ClampEase have high success rates in achieving hemostasis and can be used safely in most patients. Other than the FemoStop and ClampEase, VCDs improve patient comfort. All active VCDs shorten the time to hemostasis and ambulation to a relatively similar degree. The incidence of major complications is increased by VasoSeal, reduced by Angio-Seal, and reduced by Perclose in diagnostic cases. The safety of VCDs cannot be assumed due to “class effect” and nearly all individual trials are underpowered to detect differences in complication rates, so the safety of other individual VCDs is unclear. In the absence of puncture site-related risk factors, VCDs as a whole appear to have little influence on complication rates and patients at high baseline risk for bleeding due to clinical factors may benefit from VCDs. VCDs increase the risk of leg ischemia, groin infection, and complications requiring surgical repair, which are rare with MC. Screening with femoral angiography prior to VCD placement and avoidance of VCDs in the presence of puncture site-related risk factors might reduce the risk of vascular complications.