Papers by Abdel Malek Baba Ahmed
The Journal of invasive cardiology, 2010
The objective of the study was to assess the efficacy and safety of a novel vascular closure devi... more The objective of the study was to assess the efficacy and safety of a novel vascular closure device, the Angio-Seal Evolution (EVCD), in patients undergoing routine cardiac catheterization (CATH) and intervention (PCI) via a retrograde femoral artery access. Successful use of current-generation vascular closure devices is highly dependent on operator methodology. To reduce dependence on operator technique, the EVCD was modified to automate the closure process, specifically the compaction of the extravascular collagen sponge that creates a sandwich under pressure against the intra-arterial anchor. This was a prospective ten-site registry including 1,004 patients undergoing 1,010 procedures with in-laboratory closure using the EVCD after CATH and PCI. The primary outcome measure was the rate of major vascular complications, and secondary outcomes were deployment success, time to hemostasis and in-hospital rates of minor vascular complications through 30 days. Clinical trial identifier...
Journal of the American College of Cardiology, 2010
Background: The use of vascular closure devices (VCDs) has been subject to a significant learning... more Background: The use of vascular closure devices (VCDs) has been subject to a significant learning curve. The Angio-Seal Evolution vascular closure device was developed to automate the compaction of the anchor-collagen sandwich, potentially reducing the dependence of device efficacy and safety on operator experience. Methods: The Angio-Seal Evolution closure device (EVCD) was placed in 1,004 patients by 44 investigators at 10 sites undergoing cardiac catheterization (CATH) or intervention (PCI) from retrograde femoral artery access. Prior VCD and registry EVCD experience were assessed for each investigator. In-hospital and 30-day clinical follow-up including device deployment success, and major and minor vascular complications (VC) were obtained in all patients. The registry was approved by the Institutional Review Board of each site. Results: The EVCD was successfully deployed in 1,001/1,004 (99.7%), and hemostasis was achieved by device in 983/1,004 (97.9%). Any VC occurred in 28/1,004 (2.8%) of all pts., 4/575 (0.7%) of CATH, and 24/429 (5.6%) of PCI. EVCD deployment success and VC were similar with prior VCD experience of <500 and >500, p>0.05. Any VC occurred in 3.5% of the first half of each investigator's EVCD registry use vs. 2.0% in the last half, p=0.18. EVDC deployment success was 99.6% in the first half of each investigator's EVCD registry use vs. 99.8% in the last half, p=1.00. Conclusions: Successful Angio-Seal Evolution device deployment success and the rate of any vascular complications were similar in regards to both prior VCD experience and Evolution registry use. Thus, the Angio-Seal Evolution device was adopted without evidence of a significant learning curve.
Journal of the American College of Cardiology, 2010
Background: Propensity analyses of newer generations of vascular closure devices, in particular t... more Background: Propensity analyses of newer generations of vascular closure devices, in particular the Angio-Seal device, suggest that they may be equally or potentially superior to manual compression after femoral artery access in both safety and efficacy. However, whether VCDs are equally as safe in patients at high risk for vascular complications (VC) is not known. Accordingly, we sought to evaluate the adjusted risk of a vascular complication in the Angio-Seal Evolution registry. Methods: This was a prospective multicenter observational registry, clinical trial identifier NCT 00817349. The Angio-Seal Evolution closure device (EVCD) was placed in 1,004 patients undergoing cardiac catheterization (CATH) or intervention (PCI) from retrograde femoral artery access. Inhospital and 30-day clinical follow-up was obtained in all patients. Protocol specified outcomes primary outcomes: major vascular complications; secondary outcomes: device deployment success; time to hemostasis; and minor vascular complications. The registry was approved by the Institutional Review Board of each site. Results: The EVCD was successfully deployed in 1,001/1,004 (99.7%), and hemostasis was achieved by device in 983/1,004 (97.9%). Any VC occurred in 28/1,004 (2.8%) of all pts, 4/575 (0.7%) of CATH, and 24/429 (5.6%) of PCI; with major VC in 4/1,004 (0.4%) of all pts, 1/575 (0.2%) of CATH, and 3/429 (0.7%) of PCI. Univariate predictors of any VC for all pts was PCI (vs. CATH); for major VC were younger age and hypertension; and for minor VC PCI were PCI, EVCD 8 Fr device; and hx CVA. Multivariate predictors of any VC were younger age, CVA, diabetes, and PCI; of major VC was younger age; and for minor VC was PCI. Subgroups traditionally at higher risk for VC such as women, history of vascular disease, procedure for STEMI were not predictors of VC. Conclusions: Use of the novel automated Angio-Seal Evolution VCD after femoral artery access for CATH and PCI was highly successful, and associated with very low rates of minor and major vascular complications. The device was as effective and safe in patients traditionally at high risk for vascular complications such as women and PCI for STEMI as were those without these characteristics.
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Papers by Abdel Malek Baba Ahmed