Nursing Outcomes Percutaneous Coronary Interventions

346An estimated 561,000 percutaneous coronary interventional (PCI) procedures were performed in the Unites States during 2000.1In recent years,many healthcare-related groups have shown interest in outcomes of patients undergoing various proce-dures including PCI. Certifying agencies such as the Centers for Medicare and Medicaid Services (CMS)and the Joint Commission on Accreditation of Hospital Organizations (JCAHO), business coali-tions, and third-party payors expect healthcare providers to provide care based on peer-reviewed evi-dence published in the scientific literature.In the case of acute coronary syndromes, the indica-tors (described as core measures) are based on the pub-lished guidelines from the American Heart Association and American College of Cardiology.2These measures include indicators such as the time from door to elec-trocardiogram (ECG), door to needle, and door toBarbara Leeper,MN,RN,CCRNClinical Nurse Specialist, Cardiovascular Services, Baylor University Medical Center, Dallas, Tex.Corresponding authorBarbara Leeper, MN, RN, CCRN, Cardiovascular Services, Baylor University Medical Center, 3500 Gaston Ave, Dallas, TX 75246 (e-mail: bobbil@).Nursing OutcomesPercutaneous Coronary InterventionsBarbara Leeper, MN, RN, CCRNPercutaneous coronary interventional (PCI) procedures are commonly performed in the United States. The process of caring for this patient population has changed dramatically over the last 10 years, with many of the changes being driven by an evolution in the knowledge baseunderlying nursing practice. The purpose of this article is to provide a summary and critique of nurse-sensitive outcomes related to patients undergoing PCI procedures and to identify gaps in the literature to provide recommendations for future research. Nursing research on indicators related to costs of care, morbidity, symptom management, functional status, patient/family knowledge, patient responses, behavior, and home/occupational function following PCI are discussed in this review.KEY WORDS:acute coronary syndromes,coronary angioplasty,nursing outcomes,percutaneous coronary interventionsopen vessel time. Other measures address the initiation of aspirin and beta blockade within 24 hours of admis-sion and at discharge, with the addition of an angiotensin-converting enzyme (ACE) inhibitor if the patient’s left ventricular ejection fraction is less than 40%. While these are important indicators for the assessment of adherence to published guidelines, they are not necessarily specific to nursing. When one con-siders that nurses are often responsible for implement-ing processes and working through a multidisciplinary team to assure that the indicators are being addressed and thresholds are being met, the essential contribu-tions of nurses become obvious.The process of care for patients undergoing PCI has changed dramatically in the last decade, with many of the changes being driven by advances in nursing prac-tice. Fields and Thomason 3identified potential areas for the development of outcome indicators for patients undergoing coronary angioplasty procedures as part of the quality improvement (QI) program at their facility. These included, but were not limited to, elec-trocardiographic changes, hemodynamic stability,hematoma formation, artery reocclusion, patient knowledge of procedure, and patient knowledge of discharge guidelines. These and other outcomes are addressed in this review.Percutaneous Coronary Interventions347The purpose of this article is to summarize and critique the literature on nurse-sensitive outcomes in patients undergoing PCI procedures and to identify gaps in the literature to provide recommendations for future research. A nurse-sensitive o utco me was defined as a result partially or wholly influenced by nursing care. These outcomes were identified by a search of the Medline and Citations in Nursing and Allied Health Literature (CINAHL) databases for the years 1990 to 2003. Relevant research articles were identified using the key words coronary angioplasty, percutaneous coronary interventions, and acute coronary syndromes linked with the term nursing outcomes. The articles produced by this procedure were reviewed to determine if they met the following criteria: (1) one or more of the authors were nurses or (2) the article referred to nursing care. This review does not include every located reference, but includes those citations that reflect outcomes likely to be nurse sensitive. The intention of this review is to pro-vide direction for those wishing to explore the relationships between nursing practice and patient outcomes following PCI procedures. Outcomes addressed in this article include cost of care, mortal-ity and morbidity, symptom management, functional status, patient and family knowledge, patient responses, and behavior.Costs of CareF ew studies addressing PCI patients’ financial out-comes affected by nursing practice were located. One reason for the paucity of research in this area is the difficulty determining where patients should be transferred following a PCI procedure. Should patients be transferred to the coronary care unit (CCU) following PCI once they have recovered, or would it be more appropriate to place them on a cardiac telemetry/progressive care unit? Outcomes related to changes in practice have often been assessed through an institution’s QI program rather than through scientific research.For example, Sullivan et al4examined the oppor-tunity to improve the process of care for patients fol-lowing a PCI, with the goal of improving utilization of their CCU beds. The standard of care for patients at this facility was to send patients to the CCU for monitoring for 24 hours and then to transfer them to the telemetry unit from which they would be dis-charged 24 hours later. After reviewing the charac-teristics of their patient population, they determined that 80% of post-PCI patients were stable enough to be transferred to the telemetry unit from the catheter-ization laboratory. F ollowing mandatory education and competency testing of the telemetry unit staff, they began sending patients to the telemetry unit fol-lowing PCI, which significantly reduced hospital length of stay (LOS) from 4.93 to 3.70 days (P=.001) and reduced costs associated with the pro-cedure. There were no significant differences in com-plication rates.4Another group reported reducing hospital costs by $1736 per uncomplicated PCI case when they imple-mented a collaborative practice team.5These are examples of how existing research can be used to change practice in a safe, cost-effective manner for this particular group of patients. An important limi-tation of these projects is that they were QI projects rather than controlled clinical studies.Time to Ambulation after PCIOther factors that have been studied by nurses also have contributed to reductions in hospital LOS and costs. Many nurse researchers have studied the rela-tionship between time to mobilizing the patient fol-lowing sheath removal and complication rates.6–10 Investigators have examined ambulation at 3 hours versus 6 hours, 4 hours versus 6 hours, and 6 hours versus 8 hours following cardiac catheterization and/or PCI. Generally, no difference in bleeding inci-dence was detected among the groups,6–10regardless of the interval between the procedure and ambula-tion. Nurses also have studied the safety and feasibil-ity of patient ambulation 2 hours after elective PCI with stenting using 6 French catheters and low-dose heparin.11The researchers concluded that ambula-tion was safe in this situation. The only factor found to influence bleeding following PCI was clotting time; there was a higher probability of patients devel-oping a hematoma the day following the procedure if the activated clotting time (ACT) was high (>200 sec-onds) (P=.0034).9Thus, it appears that checking the ACT prior to sheath removal to assure that the level is less than 180 seconds may be more important than bed rest.Limitations of these studies include small sample sizes and failure to control for additional proce-dures that were performed. Patients had a variety of procedures including balloon angioplasty, direc-tional coronary atherectomy, and/or stent deploy-ment. As coronary intervention procedures become less invasive and move from the operating suite to the cardiac catheterization laboratory, well-designed studies will be needed to examine the influence of early mobilization on postprocedure complications.Morbidity OutcomesResearch on the impact of nursing care on morbidity in patients who have undergone a PCI procedure has348Journal of Cardiovascular Nursing❘September/October 2004focused on removal of femoral sheaths, including who removes the sheaths, the technique for sheath removal, and the use of mechanical compression devices to apply pressure. In addition, monitoring for acute clo-sure and/or ischemic episodes following PCI is an important aspect of nursing care that affects morbidity. Sheath Removal IssuesArterial sheath removal was initially performed only by physicians, which delayed removal when physi-cians were not available. Unavailability of physicians resulted in patients being immobilized for a longer period of time, which placed them at greater risk for complications and thus an extended hospital LOS.Schickel et al12developed a protocol for sheath removal by nursing staff after PCI. F ollowing staff training and competency verification, 200 patients who had undergone a PCI procedure were followed. When nurses removed the sheath, 23 patients (11.5%) experienced complications: vasovagal response (8.5%), hematoma formation (4%), and a perfusion deficit to the leg, requiring femoral embolectomy and repair (n=1). Using a historical cohort for comparison, the authors concluded that there were no significant differences in complication rates when sheath removal was performed by nurses or was performed by physicians. Use of a historical comparison group represented a major limitation of their study because of the potential for sampling bias. The authors examined only the effect of sheath removal by nurses on complication rates and did not assess patient comfort, LOS, or cost implications.12 Others have reported similar QI projects with com-parable outcomes.5,13Mechanical Versus Manual CompressionThere have been many nursing studies comparing manual compression to mechanical compression and the length of time required to achieve hemosta-sis at the femoral access site.14–16These studies have included small and large samples of patients under-going a variety of PCI procedures including balloon angioplasty and directional coronary atherectomy. Various types of mechanical compression devices have been studied, including the C-clamp and the Femo-Stop®.14–16Study results suggest that the time required to achieve hemostasis is shorter with mechanical rather than manual compression. Generally, no differences in hematoma formation and bleeding events have been found when the use of manual compression and C-clamp were com-pared. However, use of the F emo-Stop device was associated with a higher incidence of hematoma for-mation when compared with the use of manual compression.16Use of Vascular Closure DevicesVascular closure devices were developed to reduce complications and decrease patient immobilization following PCI. These devices—collagen-based plugs and different types of sutures—are inserted by physi-cians following the PCI procedure. While selection and use of these devices are not nurse sensitive, nurs-ing management of these patients following the PCI procedure includes close observation of the insertion site for hematoma formation and other bleeding complications. Therefore, nurses have posed ques-tions regarding how these devices affect bleeding following PCI. Researchers have reported that com-plete hemostasis is achieved with these devices, but hemostasis may take longer in patients who have undergone a PCI procedure.17Female gender was a predictor of access site complications, suggesting that women may require pressure to be applied/ maintained at the insertion site for a longer period of time.17Impact of Platelet InhibitorsPlatelet inhibitors, including the glycoprotein IIbIIIa inhibitors (GPIIbIIIa) and other anticoagu-lant agents, are being used prior to, during, and following PCI procedures. Nurses have studied practices and outcomes (ie, femoral complications) related to the administration of one of these agents.18–21Specifically, the incidence of bleeding complications associated with the use of femoral closure devices, mechanical compression devices, and manual compression in patients receiving GPIIbIIIa inhibitors were compared.18,20Blankenship and colleagues22analyzed vascular access site bleeding from 3 major PCI trials for the purpose of quantifying the reduction in vascular bleeding complications, especially in those attributa-ble to abciximab. The incidence of major and minor vascular access site bleeding in the non-abciximab (heparin plus placebo) group progressively decreased from 8.2% to 5.8% to 1.7% (P<.001) with each successive trial.22The incidence of major bleeds at the vascular access site was greater in patients who received abciximab as compared to those who received a placebo in the initial study (odds ratio=3.2; P<.001). However, there was no differ-ence in major bleeding in patients who received abcix-imab in subsequent trials. The researchers attributed the reduction in vascular access site bleeding compli-cations to improved heparin and abciximab dosing as well as improved vascular access site management.22 An important limitation is that different doses of abciximab and heparin were used in these trials.Others have commented on the underappreci-ated hemorrhagic complications following PCI pro-cedures. Aguirre and Gill23described the incidencePercutaneous Coronary Interventions349of majo r hemo rrhage(a decrease in hemoglobin≥5g/dL) following PCI procedures as varying widely from 0.4% to 16%, stressing the importance of decreasing this complication. Limitations of many of these studies include small sample sizes, vari-ability in the intervention procedures, and the types of devices used to achieve hemostasis at the inser-tion site. Clearly, more research is needed in which the management of the femoral insertion site fol-lowing administration of platelet inhibitors and other agents that affect bleeding times are stan-dardized.Juran et al24conducted an important study, Standards of Angioplasty Nursing Techniques to Diminish Bleeding Around the Groin (SANDBAG), which examined the effects of nursing interventions following PCI. This prospective, multicenter clinical trial examined the effect of nursing interventions on bleeding at the femoral access site following PCI, with or without the administration of an antiplatelet agent along with heparin and aspirin. A secondary purpose was to recommend a standard of care to minimize bleeding complications. Nursing interven-tions included patient education regarding the use of a special mattress while the sheath was in place, inspection of the dressing postprocedure, restraint of the affected leg, removal of the femoral sheaths, and application of manual pressure or mechanical pres-sure following sheath removal. It is important to note that this nursing substudy was part of a large clinical trial, Integrilin to Manage Platelet Aggregation to Prevent Coronary Thrombosis II (IMPACT II), a study of patients who had under-gone angioplasty.The SANDBAG study was a descriptive, correla-tional study of 4010 patients.24The researchers reported minimal differences in bleeding outcomes for patients regardless of the nursing interventions that were implemented. Bleeding events were the same regardless of complete bedrest, log rolling, ele-vating the head of the bed 30°, type of wound dress-ing applied following sheath removal, frequency of assessment of the vascular access site, and adminis-tration of pain medication. Predictors of increased bleeding included removal of the sheath by nurses, followed by manual pressure; prolonged time between sheath removal and ambulation by the patient; and patients, complaints of nausea, vomit-ing, and back pain (P<.001). Removal of the sheath, while the platelet inhibitor was being infused, was associated with less bleeding (P<.001).24Recommendations for nursing practice included maintaining a nurse-to-patient ratio of 1:5 or less, removing sheaths within 4 to 6 hours or as soon as possible, and medicating patients for comfort. They concluded that the head of the bed can be raised to 30°and that patients should be allowed to ambulate 8 hours after the sheath is removed. Sandbags were not effective in minimizing bleeding and contributed to patient discomfort.24All of these studies related to morbidity demon-strate that outcomes immediately following PCI are nurse sensitive. Clearly, nursing practice impacts the potential for complications surrounding sheath removal and after sheath removal.Acute RestenosisContinuous ST-segment monitoring following PCI procedures is used to identify the onset of acute coronary artery closure. Drew and colleagues25 reported that the lead demonstrating the greatest ST-segment deviation during the PCI procedure (max ST lead) was useful for detecting ischemic events follow-ing the procedure. While the number of studies in this area is limited, there is a growing body of evi-dence regarding the important contribution of con-tinuous ST-segment monitoring.26The few studies that have been reported are well designed and care-fully conducted, lending credence to these results. Symptom ManagementPatients who undergo PCI procedures frequently expe-rience pain. Patients often complain of severe back pain caused by lying in a supine position for several hours following the procedure. Patients also experi-ence another episode of extreme pain when sheaths are removed. Nurses have studied the effects of bed position on patient comfort as well as the use of local infiltration of an anesthetic agent into the insertion site prior to sheath removal on episodic pain. Effects of Body Position on Back PainMany practitioners believe that the patient’s bed should remain flat while femoral sheaths are in place. Maintaining the patient in a supine position for pro-longed periods of time is often associated with com-plaints of severe back pain and other discomfort. A few studies have examined the effects of postproce-dure head-of-bed elevation. Nurses have studied pain and other outcomes in patients with the head of bed elevated at 15°to 60°compared to maintaining the patient in a supine position.6,27–30 No significant dif-ferences were reported regarding complaints of headache, dizziness, bleeding, diminished pulses, and hematoma formation.6,27–30Patients maintained in a supine position reported higher levels of pain.27 Other nurses have examined comfort and head-of-bed elevation in patients with flexible sheaths as com-pared to comfort associated with standard sheaths.29,30350Journal of Cardiovascular Nursing❘September/October 2004Another research group conducted a randomized controlled trial (N=100) to determine if a specifi-cally designed exercise program, or an alternating air mattress, or both were effective in alleviating back pain following PCI.31The combination of exercise and the alternating air mattress was more effective in alleviating back pain following PCI than was either measure alone.Limitations of these studies included differences in procedures (ie, some patients underwent coronary angiography while others had coronary angioplasty) limiting the generalizability of the findings. In addi-tion, the studies included small sample sizes. Although some of these studies reported only pilot-data, the results are promising. This is a fertile area for further study.Insertion Site Pain ManagementThere have been a few studies of local infiltration of an anesthetic agent to reduce pain and discomfort dur-ing the process of sheath removal. Some nurse researchers reported that the use of lidocaine locally just prior to sheath removal did not significantly reduce patient perceptions of pain.32,33Reynolds et al34suggested that some patients might require analgesics to reduce discomfort associated with removal of the introducer sheath. There is a paucity of data in this area. More randomized controlled studies are needed to assess the effect of local infiltration of the sheath site prior to sheath removal on pain.Areas for further research of care following PCI procedures include investigating the effects of alterna-tive therapies, such as music therapy, guided imagery, etc, on patient comfort levels. Another research ques-tion is who should inject the local anesthetic—nurses or physicians? There is very limited information regarding standards of practice in this area. Quality of LifeFunctional StatusSeveral studies of functional status following PCI have been conducted by nurses, including patient perceptions of complications and treatment benefits of PCI in the early postdischarge recovery period.35–37Patients reported symptoms of groin dis-comfort (pain, bruising, and swelling). Most patients reported that the PCI procedure had “made things better,” indicating that they experienced less dyspnea, less fatigue, and improved exercise tolerance, and believed their recovery was good based on the absence of chest pain. In one small study, patients (N=11) reported having low energy levels (an unexpected find-ing), which interfered with their ability to resume nor-mal activities.36Conclusions to be drawn from these studies are limited by the small sample sizes.Nurses have also studied factors related to func-tional status during the late recovery period (3.9 and 10 months following the procedure).37–39Some researchers suggest that patients undergoing PCI pro-cedures should have their functional status assessed prior to the procedure for the purpose of identifying patients at risk for poor outcomes.38This informa-tion could be used to design targeted interventions to assist patients to restore their physical and functional status following the PCI procedure.38Eastwood39studied lifestyle pattern changes in men 3 months following PCI. Study results sug-gested that a positive psychological perspective on health predicted positive lifestyle changes. Some patients reported that responsibility for care of children or elderly family members negatively affected their ability to integrate lifestyle changes. Patients also reported difficulty maintaining their exercise programs following return to work and were reluctant to participate in cardiac rehabilita-tion on the basis of their perception that exercise was not really necessary.39These studies had major limitations, including the use of a cross-sectional design and instrument bias. Patient follow-up was often early in the follow-up with a range of 2 weeks to 1 year postprocedure. The majority of the patients were male, which limits gen-eralizability, and the sample sizes were small. Longitudinal studies that include preprocedure and postprocedure assessment of patient status are needed if we are to identify patients at greater risk for problems following PCI.Home and Occupational FunctionWhile patients respond to disease processes and pro-cedures differently, the same may be said for post-procedure resumption of activities at home and return to work. Generally, research has shown that patients who undergo uncomplicated PCI can easily resume activities at home and at work. Gulanik et al40demonstrated the usefulness of a home activ-ity assessment tool that could be used to guide the tailoring of postprocedure discharge teaching on the basis of patient responses.40Psychological FunctionSeveral researchers have measured the effect of PCI on emotions, functioning, and overall quality of life. Generally, researchers have demonstrated improve-ment in health and functioning, a decrease in state anxiety, and an increase in physical functioning following PCI procedures.41–44Percutaneous Coronary Interventions351Tooth et al45measured the effect of precoronary angioplasty education and counseling on postproce-dure knowledge and psychological status in patients (n=40) and their spouses (n=40) as compared to a control group who did not receive education and counseling. Patient knowledge improved and anxiety decreased at 4 months in the intervention group as compared to the control group. At 11 months post-procedure, the spouses in the experimental group demonstrated improved quality of life while the spouses in the control group did not.45Other researchers compared quality of life in patients undergoing coronary artery bypass grafting (CABG) surgery or PCI. In a study of uncertainty, symptoms, and the influence of social support 3 months postprocedure, White and F rasure-Smith46 found that patients who underwent a PCI procedure experienced more uncertainty than did patients who underwent CABG surgery (P<.05). Patients with high social support had less uncertainty and lower psychological stress (P<.05).46In another study of patients examined 3 months after PCI, 44% had recurring angina.47One recom-mendation from this study was that PCI patients should be educated about the potential for recurrent angina and how to manage it. Englehart48conducted a similar study comparing quality of life at 6 months in patients undergoing CABG and PCI. The PCI group experi-enced decreased angina severity and improved percep-tion of their health status than did CABG group.48 Gulanick49conducted a qualitative study to describe the angioplasty experience from the patient’s perspective. Two-hour, taped focus group interviews were conducted with 45 patients (26 males, 19 females) who had undergone PCI procedures 3 to 18 months previously. Most of the patients described positive experiences. Negative themes included anger over unmet comfort needs, and feeling dehumanized and frustrated with the lack of control in decision making about the procedure.49Although generally well designed, the studies in this area are limited by their descriptive nature and short follow-up intervals. These studies do, however, reveal important aspects of patient education that nurses should consider in clinical practice. KnowledgeWhen is the best time to teach the patient about PCI and what content should be taught? Nurses have compared outcomes in patients who received pread-mission education and counseling focusing on car-diac knowledge and cardiac risk factors to those of patients receiving usual care. In one study,50patients were assessed 4 months following their procedure. Knowledge and physical activity improved over time for both groups (P=.00), but the experimental group had a significant reduction in serum choles-terol levels (P=.02) at follow-up.50In a comprehensive review of the literature, Genz51 described perceived learning needs and patient con-cerns during the early recovery period following PCI. Learning priorities of patients prior to hospital dis-charge were informational and survival management. Patients wanted information about the outcome of the procedure, cardiac anatomy and physiology, risk factors, lifestyle changes, and medications. Regarding survival skills, patients wanted to learn how to man-age their cardiac symptoms at home.51These studies provide nurses with information about patients learn-ing needs and the potential beneficial effects of coun-seling patients during a “teachable moment.”BehaviorRisk Factor ModificationSome patients may be overly optimistic about their health status following PCI and may perceive little need to modify their coronary artery disease risk fac-tors. McKenna et al52assessed smoking and exercise habits by patient self-report before and after PCI (n=209). All risk factors (serum cholesterol, body mass index, and lack of exercise) except smoking were reduced following PCI (P<.001).52Surprisingly,smok-ing increased significantly (P<.001), including the number of cigarettes that patients smoked daily. This is an important study conducted with a large sample size that provides findings in need of further exploration. Effects of Cardiac RehabilitationAs the LOS following PCI procedures has decreased to less than 24 hours in many facilities, and in some cases, PCI has become an outpatient procedure, the opportu-nity to identify a teachable moment with the patient and family has dwindled considerably as patients recover at home. Therefore, participation in an outpatient rehabili-tation/education program might be a beneficial approach to help patients modify lifestyle, improve quality of life, and return to work, and this is exactly what Ben-Ari and colleagues53demonstrated in response to participation in a 12-week rehabilitation program. Other researchers have reported similar results.54,55Kimble56examined the relationship between patient cognitive appraisal of PCI and subsequent participation in a cardiac risk-reduction behavior program 2 weeks after discharge from the hospital. Patients reported that PCI was minimally invasive and beneficial.56Their heart disease was perceived to be only mild to moderate. In spite of a stable percep-tion of disease threat, patients reported risk-reduc-tion behaviors in the areas of diet and exercise.56。