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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
1Cardiology Division, Department of Medicine, Starr 445, New York Hospital-Cornell Medical Center, 525 East 68 Street, New York, NY 10021, USA.
Insights
A novel percutaneous collagen hemostasis device significantly reduces puncture site hemostasis time and speeds ambulation after cardiac catheterization. This vascular hemostasis device offers a promising alternative to conventional compression, improving patient recovery without increasing complications.
Area of Science:
- Cardiovascular Interventions
- Vascular Access Management
- Medical Device Technology
Background:
- Peripheral vascular complications and prolonged recovery are common after cardiac catheterization and angioplasty.
- Conventional manual compression and extended bed rest contribute to patient morbidity.
- There is a need for improved hemostasis techniques to reduce complications and enhance patient comfort.
Purpose of the Study:
- To compare the efficacy of a new percutaneous collagen hemostasis device against conventional compression.
- To evaluate hemostasis time and the incidence of vascular complications.
- To assess the impact on patient ambulation time after invasive cardiac procedures.
Main Methods:
- A prospective, multicenter, randomized trial was conducted.
- Patients undergoing diagnostic catheterization and angioplasty were randomized to receive the hemostasis device or conventional compression.
- Key outcomes measured included hemostasis time, time to ambulation, and vascular complication rates.
Main Results:
- The hemostasis device significantly reduced hemostasis time compared to conventional compression (4.1 min vs. 17.6 min, p < 0.0001).
- Time to ambulation was also significantly shorter with the device, particularly after angioplasty (16.1 h vs. 32.7 h, p < 0.0001).
- The device demonstrated a low incidence of major vascular complications, comparable to conventional methods.
Conclusions:
- A new vascular hemostasis device effectively reduces puncture site hemostasis time and time to ambulation.
- The device does not significantly increase the risk of peripheral vascular complications.
- Further research is needed to determine its role in reducing 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 the 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 hours vs. 19.2 +/- 17.8 hours, 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 hours, without heparin), as compared with control compression techniques (32.7 +/- 18.8 hours, 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).
Conclusion:
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.