Author + information
- Received January 11, 1993
- Revision received April 15, 1993
- Accepted April 21, 1993
- Published online November 1, 1993.
- Timothy A. Sanborn, MD, FACCa,∗,
- Harry H. Gibbs, MB, BSa,
- Jefrey A. Brinker, MD, FACC∗,
- William D. Knopf, MD, FACC†,
- Edward J. Kosinski, MD‡ and
- Gary S. Roubin, MD, PhD, FACC§
- ↵∗Address for correspondence: Timothy A. Sanborn, MD, Cardiology Division, Starr 445, New York Hospital-Cornell Medical Center, 525 East 68 Street, New York, New York 10021.
Objectives. A new percutaneous collagen hemostasis device was compared with conventional compression techniques after diagnostic catheterization and angioplasty.
Background. Peripheral vascular complications 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 states (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.
☆ A complete list of participating centers and investigators appears in the Appendix. This study was supported in part by Datascope Corporation, Oakland, New Jersey. It was presented in part at 41st Annual Scientific Sessions of the American Heart Association, November 1992.
- Received January 11, 1993.
- Revision received April 15, 1993.
- Accepted April 21, 1993.