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Immediate arterial hemostasis after cardiac catheterization: initial experience with a new puncture closure device
U T Aker1, K R Kensey, R R Heuser
1Missouri Baptist Medical Center, St. Louis.
Insights
A new bioabsorbable device effectively achieves arterial hemostasis after cardiac catheterization, with 91% successful deployment and minimal complications. Heparin use was linked to increased need for supplemental pressure.
Area of Science:
- Cardiovascular Medicine
- Biomaterials Science
Background:
- Invasive cardiovascular procedures like catheterization and angioplasty carry risks of arterial bleeding.
- Achieving prompt and effective arterial hemostasis is crucial for patient safety and reducing complications.
Purpose of the Study:
- To evaluate the safety and efficacy of a novel bioabsorbable device for achieving arterial hemostasis following invasive procedures.
Main Methods:
- A prospective study involving 30 patients undergoing diagnostic catheterization or coronary angioplasty.
- Deployment of a novel bioabsorbable device through an arterial sheath to seal the arterial wall defect.
- Assessment of hemostasis success, need for supplemental pressure, and complications, with ultrasound follow-up.
Main Results:
- Successful device deployment in 91% of attempted cases (29/32).
- Achieved successful hemostasis in 29 patients, with 19 immediate and complete.
- Heparin use was significantly associated (P=0.05) with the need for supplemental pressure.
Conclusions:
- The novel bioabsorbable hemostasis device demonstrates high deployment success and effective hemostasis in patients undergoing invasive cardiovascular procedures.
- While generally safe, heparin administration may increase the likelihood of requiring supplemental pressure for hemostasis.
- No significant adverse events like transfusion or surgical repair were noted, and late follow-up showed no device-related pathology.
Abstract:
A novel device for obtaining arterial hemostasis after invasive procedures was tested in 30 patients undergoing diagnostic catheterization (26 patients) or coronary angioplasty (4 patients). The device is deployed through an arterial sheath and forms a positive mechanical seal both inside and outside the defect in the arterial wall. The components are all bioabsorbable. Thirteen patients received a heparin bolus during the catheterization procedure. The activated clotting time recorded in 15 patients just prior to device deployment averaged 264 sec. 29 of 32 attempted device deployments were successful (91%); and the remaining 3 devices pulled completely out as called for by design in the event of incomplete deployment. Twenty-nine patients ultimately achieved successful hemostasis using the device, with the other patient receiving manual hemostasis. Of these 29, hemostasis was immediate and complete in 19 patients. Light digital pressure was required in another 8 patients for less than 5 min. There was minor delayed bleeding requiring supplemental light pressure in several cases. A total of 11 patients required supplemental pressure in addition to the hemostasis device. The use of bolus heparin was significantly (P = 0.05, Fisher's exact test) related to the requirement for supplemental pressure. Three patients developed hematomas, one of which was present prior to device deployment. The other two patients had received bolus heparin. No patient required transfusion or surgical repair. There was no change in the ankle/brachial systolic blood pressure index after device deployment or at late (30-60 day) follow-up. Ultrasound studies revealed no significant pathology relative to the device.(ABSTRACT TRUNCATED AT 250 WORDS)