PubMed · 4779797
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P Graystone. 1973. Ground hazard indicators.. https://pubmed.ncbi.nlm.nih.gov/4779797/
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OBJECTIVES: The authors studied the safety and efficacy of the Cardiva Boomerang vascular closure device in patients undergoing diagnostic cardiac catheterization. BACKGROUND: Conventional vascular closure devices (sutures, collagen plugs, or metal clips) have been associated with catastrophic complications including arterial occlusion and foreign body infections; furthermore, they cannot be utilized in patients with peripheral vascular disease or vascular access site in a vessel other than the common femoral artery. The Cardiva Boomerang device facilitates vascular hemostasis without leaving any foreign body behind at the access site, can be used in peripheral vascular disease, and can be used in vessels other than the common femoral artery METHODS: A total of 96 patients undergoing transfemoral diagnostic cardiac catheterization were included in this study, including 25 (26%) patients with contraindications to conventional closure devices. Femoral angiography was performed prior to deployment of the Cardiva Boomerang closure device. Patients were ambulated at 1 hr after hemostasis was achieved. RESULTS: The device was successfully deployed and hemostasis achieved with the device alone in 95 (99%) patients. The device failed to deploy in 1 (1%) patient and required conversion to standard manual compression. Minor complications were observed in 5 (5%) patients. No patients experienced major complications including femoral hematoma > 4 cm, red blood cell transfusion, retroperitoneal bleed, arteriovenous fistula, pseudoaneurysm, infection, arterial occlusion, or vascular surgery. CONCLUSIONS: The Cardiva Boomerang device is safe and effective in patients undergoing diagnostic cardiac catheterization using the transfemoral approach, facilitating early ambulation with low rates of vascular complications.
Acute myocardial infarction during pregnancy is rare but may be associated with high risk complications. We present a very rare case about an acute myocardial infarction with anterior ST elevation in a 40-year-old woman, at 38th week of gestational period. The coronary arteriograms showed a diffuse left coronary vasospasm. The coronary arteriography at puerperium showed no organic narrowings. This is the first case with a well documented coronary artery vasospasm in pregnancy. Management should follow the usual principles of care for acute myocardial infarction. However, selection of diagnostic and therapeutic approaches may be greatly influenced by fetal safety.
OBJECTIVE: Electrophysiology (EP) catheter reprocessing is widespread and previous studies have examined clinical performance, sterility and safety of these reprocessed devices. Here we compare the intrinsic engineering characteristics, electrical, mechanical and safety, between new and reprocessed devices. MATERIALS AND METHODS: New (58 devices) and clinically used (five times)/reprocessed (165 devices) EP catheters from five manufacturers were employed to examine and compare catheter electrode continuity, electrode isolation, electrical leakage current, shaft torsion and stiffness characteristics as well as tip buckling and bond strengths. RESULTS: Electrode continuity, isolation and leakage currents for both new and reprocessed EP catheters were within acceptance criteria for electrode continuity (<30 Omega) and shaft electrical leakage (<0.5 mA) as well as electrode isolation (>200 Omega). In addition, reprocessed catheters were equivalent when compared with their new counterparts. While catheter shaft torque forces varied five fold amongst manufacturers, comparison between new and reprocessed devices within a manufacturer showed no significant differences. Likewise shaft stiffness showed no significant difference between new and reprocessed devices. Average tip buckling forces for all catheters were substantially below the acceptance criteria of 0.45 lb (between 0.04 and 0.1 lb) with differences between new and reprocessed catheters not being significant. All bond strengths for both new and reprocessed catheters exceeded the acceptance criteria specified in ISO 10555-1. CONCLUSIONS: This study found that reprocessed EP catheters which had undergone five actual clinical use/reprocessing cycles met and exceeded acceptance criteria specified by industry standards as well as individual manufacturer's criteria for both electrical and safety characteristics. We conclude that reprocessed EP catheters exhibit electrical, mechanical and safety characteristics which are equivalent to their new counterparts.