ExoSeal device impressive
ExoSeal device impressive
Chicago, IL - A new vascular closure device with a bioabsorbable plug has shown impressive results in a pivotal multicenter trial, ECLIPSE. The device, named ExoSeal (Cordis), also has a unique deployment mechanism, Dr Shing-Chiu Wong (New York Presbyterian Hospital, NY), told a late-breaking clinical-trials session at the AmericanCollegeofCardiology2008ScientificSessions/i2Summit-SCAIAnnualMeeting.
Wong reported that the use of ExoSeal in ECLIPSE significantly shortened bleeding time and enabled patients to get up and walk around far sooner than when manual compression was applied to the groin. There were no 30-day access-site complications reported with the device.
Discussant Dr Timothy A Sanborn (Northwestern University Feinberg School of Medicine, Chicago, IL) congratulated the investigators and said this new-generation vascular closure device appears to be "very attractive, with a good safety profile and ease of use." In addition, the device has the advantage of not having an intraluminal component, and "compared with other currently available vascular closure devices, it might be more useful in peripheral vascular disease or, more important, in patients with arteriotomies right in the femoral bifurcation," he commented.
Significant improvements in time to hemostasis and ambulation
Wong explained that although there are several vascular closure devices on the market, they do have some limitations. ExoSeal consists of a feltlike plug made of polyglycolic acid (PGA) that completely dissolves into carbon dioxide and water over about three months. It can be used following diagnostic angiography or interventional procedures and is anchored in place on top of the puncture in the femoral artery, after the catheter is removed. Because none of the plug is inserted into the artery itself, it does not interfere with blood flow. By comparison, manual compression involves exerting pressure on the femoral artery by hand or through use of a weight or clamp, a process that can be uncomfortable for patients. Following manual compression, it can take as long as 20 minutes for the bleeding to stop and several hours before the patient can get up from lying flat in bed.
In the study, 401 patients aged 18 to 85 years—half of whom were undergoing diagnostic angiography and half an interventional procedure—were recruited from 17 medical centers. Of these, 90% were being examined or treated for coronary disease and the remaining 10% for peripheral disease. Patients were randomly assigned to treatment with the ExoSeal (n=257) or to manual compression (n=144). There were two primary efficacy end points: time to hemostasis (TTH) and time to ambulation (TTA). The major safety composite end point was vascular injury requiring surgical treatment, access-site related bleeding, or access-site related infection.
The ExoSeal device was put into place in an average of just one minute and was used successfully in 89.1% of patients. There was no difference in procedural success between the ExoSeal and manual-compression groups (91.8% and 91.0%, respectively). However, the average time to cessation of bleeding, TTH, was significantly shorter in patients treated with the ExoSeal (4.38 minutes vs 20.05 minutes, p<0.0001). Similarly, patients treated with the vascular closure device were able to get out of bed and walk around far sooner, within a TTA of just 2.5 hours, on average, with the ExoSeal, as compared with 6.2 hours with manual compression (p=0.028). There were no reported 30-day access-site-related complications in either cohort.
"We demonstrated that ExoSeal compares favorably with manual compression following diagnostic and interventional procedures," said Wong. "It enables early ambulation and, potentially, early discharge from the hospital following the procedure."
Next step: Put the device to tougher challenges
In his discussion, Sanborn did note some differences in secondary safety end points with the device compared with control—5.3% rebleeding, 1.7% hematoma >6 cm, and 0.8% retroperitoneal hematoma. "This does warrant further monitoring," he said, "and raises the question as to whether these were related to slippage of the PGA plug away from the arteriotomy, as there is no anchor with this device."
However, he also commented on the "remarkable zero" findings with regard to the primary safety end point and the particularly beneficial effects of the device among patients who also received GP IIb/IIIa inhibitors (around 10% to 15% of the study population). The differences in the primary efficacy end points were even more marked in this population, with a ninefold difference in TTH and a 50% reduction in TTA with the ExoSeal device compared with manual compression, he noted.
Wong said the next research step will be to put the ExoSeal to tougher challenges. "Further investigation is needed to delineate the device's applicability in patients with access puncture sites at or below the branch point of the femoral and iliac arteries and in patients with mild or moderate peripheral vascular disease," he said. "Comparative studies of efficacy and patient comfort with the ExoSeal and other vascular closure devices will also be intriguing."
Chicago, IL - A new vascular closure device with a bioabsorbable plug has shown impressive results in a pivotal multicenter trial, ECLIPSE. The device, named ExoSeal (Cordis), also has a unique deployment mechanism, Dr Shing-Chiu Wong (New York Presbyterian Hospital, NY), told a late-breaking clinical-trials session at the AmericanCollegeofCardiology2008ScientificSessions/i2Summit-SCAIAnnualMeeting.
Wong reported that the use of ExoSeal in ECLIPSE significantly shortened bleeding time and enabled patients to get up and walk around far sooner than when manual compression was applied to the groin. There were no 30-day access-site complications reported with the device.
Discussant Dr Timothy A Sanborn (Northwestern University Feinberg School of Medicine, Chicago, IL) congratulated the investigators and said this new-generation vascular closure device appears to be "very attractive, with a good safety profile and ease of use." In addition, the device has the advantage of not having an intraluminal component, and "compared with other currently available vascular closure devices, it might be more useful in peripheral vascular disease or, more important, in patients with arteriotomies right in the femoral bifurcation," he commented.
Significant improvements in time to hemostasis and ambulation
Wong explained that although there are several vascular closure devices on the market, they do have some limitations. ExoSeal consists of a feltlike plug made of polyglycolic acid (PGA) that completely dissolves into carbon dioxide and water over about three months. It can be used following diagnostic angiography or interventional procedures and is anchored in place on top of the puncture in the femoral artery, after the catheter is removed. Because none of the plug is inserted into the artery itself, it does not interfere with blood flow. By comparison, manual compression involves exerting pressure on the femoral artery by hand or through use of a weight or clamp, a process that can be uncomfortable for patients. Following manual compression, it can take as long as 20 minutes for the bleeding to stop and several hours before the patient can get up from lying flat in bed.
In the study, 401 patients aged 18 to 85 years—half of whom were undergoing diagnostic angiography and half an interventional procedure—were recruited from 17 medical centers. Of these, 90% were being examined or treated for coronary disease and the remaining 10% for peripheral disease. Patients were randomly assigned to treatment with the ExoSeal (n=257) or to manual compression (n=144). There were two primary efficacy end points: time to hemostasis (TTH) and time to ambulation (TTA). The major safety composite end point was vascular injury requiring surgical treatment, access-site related bleeding, or access-site related infection.
The ExoSeal device was put into place in an average of just one minute and was used successfully in 89.1% of patients. There was no difference in procedural success between the ExoSeal and manual-compression groups (91.8% and 91.0%, respectively). However, the average time to cessation of bleeding, TTH, was significantly shorter in patients treated with the ExoSeal (4.38 minutes vs 20.05 minutes, p<0.0001). Similarly, patients treated with the vascular closure device were able to get out of bed and walk around far sooner, within a TTA of just 2.5 hours, on average, with the ExoSeal, as compared with 6.2 hours with manual compression (p=0.028). There were no reported 30-day access-site-related complications in either cohort.
"We demonstrated that ExoSeal compares favorably with manual compression following diagnostic and interventional procedures," said Wong. "It enables early ambulation and, potentially, early discharge from the hospital following the procedure."
Next step: Put the device to tougher challenges
In his discussion, Sanborn did note some differences in secondary safety end points with the device compared with control—5.3% rebleeding, 1.7% hematoma >6 cm, and 0.8% retroperitoneal hematoma. "This does warrant further monitoring," he said, "and raises the question as to whether these were related to slippage of the PGA plug away from the arteriotomy, as there is no anchor with this device."
However, he also commented on the "remarkable zero" findings with regard to the primary safety end point and the particularly beneficial effects of the device among patients who also received GP IIb/IIIa inhibitors (around 10% to 15% of the study population). The differences in the primary efficacy end points were even more marked in this population, with a ninefold difference in TTH and a 50% reduction in TTA with the ExoSeal device compared with manual compression, he noted.
Wong said the next research step will be to put the ExoSeal to tougher challenges. "Further investigation is needed to delineate the device's applicability in patients with access puncture sites at or below the branch point of the femoral and iliac arteries and in patients with mild or moderate peripheral vascular disease," he said. "Comparative studies of efficacy and patient comfort with the ExoSeal and other vascular closure devices will also be intriguing."
| Wong is a consultant for Cordis. Sanborn reports no relevant conflicts of interest. |
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