Abstract
The aim of this study was to evaluate the application of evidence-based practice in the management of complication for patients with an indication for percutaneous coronary intervention, using the PICO elements. The study was conducted by comparing the complications, safety, and efficacy of the use of vascular closing devices (VCD) and manual compression (MC) following a PCI procedure in previously published studies. The findings of four studies were used to formulate the conclusion of this study and to answer the study’s PICO question. From the studies, it was found that the use of VCD resulted in fewer risks of complications, shorter hospital stay, shorter time-to-hemostasis, shorter time-to-ambulation and fewer costs incurred. The study concluded that the use of VCD in patients following PCI procedures was safer and had higher efficacy in comparison with the MC.
Introduction
Percutaneous Coronary Intervention (PCI) is a nonsurgical technique indicated for obstructive coronary artery disease for opening up the narrowed arteries. The main site for the PCI is the femoral artery, despite the increasing preference for the radial artery. The high number of patients with cardiovascular disease in the United States and globally translates to a widespread use of femoral catheterization as an intervention measure. Walter et al (2017) reported that approximately 845,000 diagnostic and 304,000 therapeutic catheterizations were performed in 2008 in Germany. This high rate of PCI indication calls attention to the complications that follow the procedure.
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Access site complications that follow coronary angiography include bleeding, hematoma, vascular complications, and infection. According to Hassan et al (2013), vascular access complications result in 0.5 – 16.8% morbidity following the coronary intervention procedures. Hemostasis and complication management of the access puncture site can be achieved by two ways, i.e. by insertion of a vascular closing device (VCD) and through manual compression. Manual compression has been the widely used method of the two since the adoption of PCI. The adoption and use of VCDs have seen a slow rise over the decades. This is attributed to their high prices without a corresponding proof of superiority or remarkable performance over the MC. Studies point out that the rate of complications varies with the method of complication management, albeit other underlying factors such as the operator’s experience, duration of the MC and the introducer size. Existing studies do not conclusively determine whether manual compression or the vascular closure devices have reduced complication and morbidity rates. However, some studies have linked VCDs to higher efficacy and safety in comparison to MC.
The increasing number of patients with coronary disease and PCI indications requires finding an alternative to the routine MC that will result in an improved patient care without a corresponding increase in cost. Currently, the available alternative to MC is the use of VCD, despite their use in PCI patient management remaining controversial. The efficacy and applicability of VCD in reducing access site complications has not been exhaustively evaluated. The types of vascular closing devices vary all aimed at reducing PCI related complications. In line with Jean Watson’s theory of human caring, the role of nurses in PCI patient management is providing maximum care thereby minimizing intervention associated complications and morbidity.
PICO and PS
A PICO format is used to provide an effective quantitative research question. The study’s PICO question is: Among post-percutaneous coronary intervention (PCI) patients (P), does the use of vascular closure device for hemostasis (I), compared to manual compression(C), has less complication (O).?
The PS format is an alternative way of formulating a research question, where the population of interest (P) and the situation (S) are identified. The PS format would be used when the outcomes i.e. complications are unknown or for the qualitative evaluation of the intervention. The study PS question is: What is the experience of Post percutaneous coronary intervention patients (P) with hemostasis devices (S) (Vascular closure devices/manual compression)?
Literature
In the search for current literature pertaining to complications of percutaneous coronary intervention complications, four studies were selected and included in the research. The search words used in finding the studies were percutaneous coronary intervention complications , manual compression of the femoral puncture site and vascular closing devices (VCD). The findings of three studies were used to develop the research’s conclusion. All three studies were published in the Elsevier journal.
A study titled by Walter et al (2017) compares the costs, hospitalization period, and complication rates between VCDs and manual compression methods for PCI patients in a German university hospital setting. Both diagnostic and interventional catheterization procedures were evaluated in the study. According to the study, there was a significant cost reduction in both procedures when a VCD was used. Also, all risk groups had a shorter hospitalization period and lower complication rates when a VCD was used. The complication risk rate could only be inferred from the overall catheterization procedures as a result of the overall low number of complications. The reduction in costs is attributed to the lower costs incurred for infrastructure, nurses, and physicians due to the shortened hospitalization of the patients. Also, the reduced relative risks associated with the use of VCD allowed for earlier ambulation of the patient. On overall, the study pointed out that the use of VCD in following PCI is better than MC.
Another study published in 2017 by Dahal et al (2017) evaluated the efficacy and safety of MC with VCD of PCI or coronary angiography performed through femoral artery access. According to the study, prolonged immobility, access-related complications, and discomfort are associated with femoral artery procedures. The study was conducted by performing a meta-analysis of randomized clinical trials obtained by searching EMBASE, MEDLINE, Cochrane CENTRAL and other relevant English language studies published from inception till September 30, 2016. 44 studies with a total sample size of 18,802 were included in the study. The main outcomes and complications evaluated for the PCI patients were large hematoma (> 5 cm), time-to-bleeding, pseudoaneurysm, time-to-ambulation, and major bleeding. From the study findings, the use of VCD resulted in a lower time-to-hemostasis. The mean difference in TTH between MC and VCD was 11.21 minutes at a 95% confidence interval. MC was associated with a higher risk of hematoma formation and a higher time-to-ambulation. On the other hand, the use of VCD resulted in lower risk of major bleeding, pseudoaneurysm and other adverse events (i.e. AV fistula, infections, need for surgery, and ipsilateral leg ischemia.) On the overall, the study found out that the use of VCD in patient management following PCI or coronary angiography was safer than manual compression of the femoral artery access site.
A third study by Hassan, Hassan-Ali & Ali (2013) aimed to determine the efficacy and safety of VCD in percutaneous coronary intervention indications in comparison to manual compression. The prospective study involved 206 patients undergoing diagnostic coronary angiography. Of these patients, 106 used the manual compression while 100 patients used the VCD to attain arterial hemostasis. According to the study findings, MC had a higher time-to-hemostasis. However, there was no significant difference between the two groups (1.5 min). 90% of the patients using VCD had success with the device as only 10 patients had device failure. There were no major adverse effects in the two study groups. The difference in minor complications between the two groups was 0.4%, with a higher value experienced in the MC group. The minor complications reported in both cases were mainly oozing and ecchymosis. The occurrence of large hematoma was 1.8% in MC patients and 1% in the use of VCD. The study observed that there was a high success rate with the use of VCD with little difference in the complication rate and time-to-hemostasis in comparison with manual compression.
Results
The use of VCD for patients undergoing percutaneous coronary intervention or coronary angiography is a more effective and safer procedure than manual compression. The use of VCD has shown a reduction in the risks of complications, faster hemostasis, shorter hospital stay, and time-to-ambulation. This causes a significant reduction in costs and better patient management.
Nursing Theory
Jean Watson’s theory of human caring can be effectively applied in patient management using the vascular closing devices. The core elements of Watson’s theory are an authentic presence, creating a caring-healing environment, demonstrating loving-kindness and equanimity, and cultivation of wholeness beyond ego. The elements of this theory can be put into practice in different ways in the course of the patient management. VCD’s have demonstrated reduced complication risks and shorter hemostasis and ambulation time. This promotes the healing environment for the patient, as the patient’s recovery time is shortened. The nurse plays an integral role in the use of the devices. Most patients are new to the concept of VCDs and as such, constant education and monitoring is required for its use to attain the maximum success. Training and monitoring require the nurse’s authentic presence. This creates a bond between the burse and the patient.
Providing the patient with a better healing alternative is benevolence on the part of the nurse. Through this, the nurse demonstrates the element of loving-kindness and equanimity as the patient’s welfare is put before personal institutional gains. Studies have shown that the use of VCDs reduces the hospitalization and medical expenses incurred by the patient, which in other instances would have been a loss for the healthcare provider. Nurses and healthcare providers, viewed through the lens of the business world, would benefit more if the patient had a longer hospital stay or spent more on his/her treatment.
References
Walter, J., Vogl, M., Holderried, M., Becker, C., Brandes, A., Sinner, M. F., ... & Maschmann, J. (2017). Manual compression versus vascular closing device for closing access puncture site in femoral left-heart catheterization and percutaneous coronary interventions: a retrospective cross-sectional comparison of costs and effects in inpatient care. Value in Health , 20 (6), 769-776.
Dahal, K., Rijal, J., Shahukhal, R., Sharma, S., Watti, H., Azrin, M., ... & Lee, J. (2018). Comparison of manual compression and vascular hemostasis devices after coronary angiography or percutaneous coronary intervention through femoral artery access: A meta-analysis of randomized controlled trials. Cardiovascular Revascularization Medicine , 19 (2), 151-162.
Hassan, A. K., Hasan-Ali, H., & Ali, A. S. (2013). A new femoral compression device compared with manual compression for bleeding control after coronary diagnostic catheterizations. The Egyptian Heart Journal , 66 (3), 233-239.
