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A multicenter randomized trial comparing a percutaneous collagen hemostasis device with conventional manual
T A Sanborn1, H H Gibbs, J A Brinker
1Department of Medicine, New York Hospital-Cornell Medical Center, New York 10021.
Insights
A new collagen hemostasis device significantly reduces bleeding time after cardiac procedures compared to manual compression. This device also shortens patient recovery time, allowing for quicker ambulation without increasing complication risks.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Vascular Access Management
Background:
- Peripheral vascular complications and patient discomfort are common after invasive cardiac procedures.
- Conventional compression methods lead to prolonged bed rest and morbidity.
Purpose of the Study:
- To compare a novel percutaneous collagen hemostasis device with conventional compression.
- To evaluate hemostasis time and vascular complication incidence.
Main Methods:
- Prospective, multicenter, randomized trial.
- Comparison of a vascular hemostasis device versus conventional compression techniques.
- Assessment of hemostasis duration and vascular complication rates.
Main Results:
- Hemostasis time was significantly reduced with the device (4.1 min) vs. conventional compression (17.6 min) after diagnostic catheterization.
- Time to ambulation was also reduced with the device, particularly after angioplasty.
- No significant increase in major vascular complications was observed with the device.
Conclusions:
- The collagen hemostasis device effectively reduces puncture site hemostasis and ambulation times.
- The technology shows promise for improving patient recovery without increasing complication risks.
- Further research is needed to determine its impact on hospital stay and costs.
Objectives:
A new percutaneous collagen hemostasis device was compared with conventional compression techniques after diagnostic catheterization and angioplasty.
Background:
Peripheral vascular complications after diagnostic catheterization or more complex interventional procedures, as well as the discomfort of manual compression and prolonged bed rest, represent significant morbidity for invasive cardiac procedures.
Methods:
A prospective, multicenter, randomized trial was designed to compare the hemostasis time in minutes and the incidence of vascular complications in patients receiving a vascular hemostasis device with those undergoing conventional compression techniques.
Results:
After diagnostic catheterization, hemostasis time was significantly less with the vascular hemostasis device than with conventional manual compression (4.1 +/- 2.8 min [n = 90 patients] vs. 17.6 +/- 9.2 min [n = 75], p < 0.0001). This difference was greater in patients undergoing angioplasty and was unrelated to the anticoagulation status (4.3 +/- 3.7 min [n = 71 not receiving heparin], 7.6 +/- 11.6 min [n = 85 receiving heparin], 33.6 +/- 24.2 min [n = 134 control patients not receiving heparin], p < 0.0001 vs. control patients). The time from the start of the procedure to ambulation was slightly less after diagnostic catheterization in patients treated with the device (13.3 +/- 12.1 h vs. 19.2 +/- 17.8 h, p < 0.05). It was also less in patients who underwent angioplasty when the device was used after discontinuation of anticoagulation (23.0 +/- 11.1 h, without heparin), as compared with control compression techniques (32.7 +/- 18.8 h, p < 0.0001). Time to ambulation was even shorter (16.1 +/- 11.1 h, p < 0.0001) in patients in whom the device was placed immediately after angioplasty while they were still fully anticoagulated with a prolonged activated clotting time (336 +/- 85 s). There were no major complications (surgery or transfusion) after diagnostic catheterization and a low incidence of major complications in patients who underwent angioplasty (0.7% in control patients, 1.4% with the device without heparin, 1.2% with the device and heparin, p = NS). After angioplasty, there was a trend toward fewer hematomas when the device was used in the absence of heparin (4.2% vs. 9.7% in control patients, p = 0.14).
Conclusions:
A new vascular hemostasis device can significantly reduce the puncture site hemostasis time and the time to ambulation without significantly increasing the risk of peripheral vascular complications. The role of this technology in reducing complications, length of hospital stay and cost remains to be determined.