2. Molina Allen This presentation was prepared for COHP 450, Section VL1, taught by Dr. Njoku.

3.   Purpose:  Explore two methods used to achieve hemostasis after a cardiac catheterization  Assess the strengths and weaknesses of each in relation to decreasing the time to ambulation  PICO Question:  In cardiac patients post percutaneous coronary intervention (PCI), does the use of a vascular closure device to achieve hemostasis improve early ambulation rates compared to manual pressure? Introduction

4.   Key Words: cardiac catheterization, percutaneous coronary intervention (PCI), hemostasis, perclose, starclose, angioseal, manual pressure, PCI complications, hematoma, femoral approach, hemostasis after cardiac intervention  Search Engines: Google, National Institutes of Health, FLITE, Medscape, and Wiley  Search Results: Newspaper, Journals, Articles, Abstracts, Texts, Reviews Literary Search

5.  Behan, M., Large, J., Patel, N., Lloyd, G., & Sulke, A. (2007). A randomised controlled trial comparing the routine use of an angio- seal STS device strategy with conventional femoral haemostasis methods in a district general hospital. International Journal of Clinical Practice, 61(3), 367-372. Retrieved from doi: 10.1111/j.1742-1241.2006.01229.x Gregory, D., Midodzi, W., & Pearce, N. (2013). Complications with angio-seal vascular closure devices compared with manual compression after diagnostic cardiac catheterization and percutaneous coronary intervention. Journal of Interventional Cardiology, 26(6), 630-638. Retrieved doi: 10.1111/joic.12070 Articles

6.   Both articles compare and contrast the use of vascular closure devices (VCD) with manual compression in the goal of achieving hemostasis after a percutaneous coronary intervention (PCI). The PICO question presented is in direct relation to the articles. This presentation intends to answer the question based on the information provided by the results of the research posed in each article. Rationale

7.  Methodology Behan et al.  Theory  “Femoral artery closure devices reduce the time to haemostasis and ambulation following coronary angiography” (Behan et al., 2007).  Study & Design  Randomized trial  Males  Approx. age 65  Angio-Seal – 107 (74)  Manual Compression 99 (98)  Analysis by intention to treat  Unpaired Student’s t- test  Mean values-standard deviation  P-values < 0.05 Significant

8.  Methodology Gregory et al.  Univariate Analysis  2-sided P-value < 0.05 Significant  Multivariate Logistic Regression Analysis  Propensity score adjusted analysis  Theory  Use of vascular closure device (VCD) challenges manual compression as, “... gold standard for achieving hemostasis for 60 years” (Gregory et al., 2013).  Study & Design  Secondary analysis from database between 2006-2010  Over 19 years of age  Cardiac catheterization or PCI  Sample size of 11,897  VCD – 59.4%

9.  Findings Behan et al. Gregory et al.  VCD use decreased:  Bruising  Time lying flat  Pain  Time in hospital

10.  Ethical Considerations Behan et al.  Eastbourne District General Hospital: Cardiac Department  Authors state no conflict of interest  Demographics between two control and trial groups very similar  Subjects were all males Gregory et al.  Study approved  Human Investigations Committee of Memorial University and Eastern Health.  Sample size for VCD three times manual pressure group (prospensity score adjusted)  Non-randomization of VCD group

11.   Behan et al.  Consistency  Control and trial groups similar  3 consultants/3 registrar grade operators  Angio-Seal trained by St. Jude representative  5 french sheath  Nursing follow-up 1 week post procedure  Patient questionnaire Article Analysis

12.   Gregory et al.  Large study sample  Cardiac Catheterization Database Nurses  Research Nurse Managed  All VCD procedures completed by Interventionalists  No residents/fellows  Minor Complications  Hematoma, pseudoaneurysm, arteriovenous fistula  Major Complications  Vascular occlusion, loss of distal pulse, retroperitoneal bleed, complication during procedure Article Analysis

13.   Increase probability of PCI being day procedure  VCD promoted:  Early mobilization  Less major/minor complications (Gregory et al., 2013)  “... Considerable waits for this procedure... The newest version of this device allows rapid mobilisation of uncomplicated coronary angiography patients”(Behan et al., 2007).  Regarding vascular complications: “...PCI sample, the risk was 49% lower if a VCD was used” (Gregory et al., 2013). EBP Contribution

14.   Communication  Policy  Standardize employment of VCD with PCI  Femoral Approach  Nursing Standards  Assessment/Evaluation  Post procedure patient instructions  Implications  Decreased hospital stay  Increased patient ratio  Increased reimbursement (Behan et al., 2007) Article Relevance

15.   Barriers  Education  Expense  Time  Training  Efficiency  Complications related to competency (Gregory et al., 2013) Article Relevance

16.  Continuing Research  “The size of this study did not allow for the evaluation of rare complications such as infection” (Behan et al., 2007)  PICO: In cardiac patients post PCI, what are the rates of infection when a VCD is utilized to achieve hemostasis compared to manual pressure?  “... There may be potential unmeasured confounding, a limitation of observational studies such as the current study... Physician’s experience in the use of VCDs was not available” (Gregory et al., 2013)  PICO: Does a physician’s experience in utilizing VCDs to achieve hemostasis influence the rate of complications in patients who have had a PCI over achieving hemostasis with manual compression? Article Relevance

17.   VCD Use vs. Manual Compression  Increased comfort  Decreased time to mobilization  Decreased complications  Utilized less in high risk patients  Required certain criteria  Femoral approach site  Increased use may decrease days hospitalized  Allow for increased number of patients to be treated Conclusion

18.  References Behan, M., Large, J., Patel, N., Lloyd, G., & Sulke, A. (2007). A randomised controlled trial comparing the routine use of an angio- seal STS device strategy with conventional femoral haemostasis methods in a district general hospital. International Journal of Clinical Practice, 61(3), 367-372. Retrieved from doi: 10.1111/j.1742-1241.2006.01229.x Gregory, D., Midodzi, W., & Pearce, N. (2013). Complications with angio-seal vascular closure devices compared with manual compression after diagnostic cardiac catheterization and percutaneous coronary intervention. Journal of Interventional Cardiology, 26(6), 630-638. Retrieved doi: 10.1111/joic.12070