Same-day discharge after angioplasty for peripheral vascular disease: Is it a safe and feasible option?

Same-day discharge after angioplasty for peripheral vascular disease: Is it a safe and feasible option?

Vol. XXXII No. 3 JOURNAL OF VASCULAR NURSING www.jvascnurs.net PAGE 119 Same-day discharge after angioplasty for peripheral vascular disease: Is it...

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Vol. XXXII No. 3

JOURNAL OF VASCULAR NURSING www.jvascnurs.net

PAGE 119

Same-day discharge after angioplasty for peripheral vascular disease: Is it a safe and feasible option? Paula Maher, BSc, RN, HDip

Peripheral vascular disease affects 20% of the population >55 years of age. Patients who become symptomatic are managed by a number of technique’s including medical management, percutaneous angioplasty, bypass surgery, and in nonreconstructable situations, limb amputation. Clinicians treating patients by means of angioplasty have traditionally carried out these procedures on an inpatient basis. Limited resources and pressure on the availability of inpatient beds has necessitated clinicians to reevaluate how many of these patients are managed. Treating suitable patients as day cases is an attractive option that frees up resources and is financially advantageous. This paper examines the feasibility of sameday discharge after angioplasty, with a particular emphasis on achieving safe patient outcomes. It explores how advances in endovascular technologies and techniques have contributed to making same-day discharge an ever more feasible option. Nurse led pre-admission clinics run by specialist nurses facilitate safe and appropriate patient selection, where patients at risk for postprocedural problems can be identified effectively based on predefined clinical criteria. (J Vasc Nurs 2014;32:119-124)

Peripheral vascular disease (PVD) affects approximately 20% of the population >55 years of age and an estimated 27 million individuals in the Western World.1 Atherosclerosis, which is responsible for PVD, is a complex and insidious condition, and among the primary causes of death in the UK.2 The management of PVD is multdimensional. It involves modification of atherosclerotic risk factors to prevent coronary and cerebrovascular events, as well as symptomatic treatment of disease.3 When lifestyle modification and medical treatment options have been exhausted, progressing disease may necessitate peripheral angioplasty, bypass surgery, and limb amputation in severe cases. Angioplasty is a long-established treatment in the management of PVD. It can provide excellent results for critical limbrestoring blood flow, improving symptoms, and reducing the risk of amputation. Traditionally, peripheral angioplasty has been carried out on an inpatient basis. However, limited health care resources and pressure for inpatient beds has led many consultants to consider the feasibility of performing angioplasty on a day-case basis. This paper explores same-day discharge after angioplasty for PVD and considers its feasibility in terms of delivering safe and adequate patient outcomes. The technological advances that have made peripheral angioplasty less invasive are consid-

From the Trinity College and St. James Hospital, Dublin, Ireland. Corresponding author: Paula Maher, BSc, RN, HDip, St. James Hospital, James Street, Dublin 8, Ireland (E-mail: [email protected]). 1062-0303/$36.00 Copyright Ó 2014 by the Society for Vascular Nursing, Inc. http://dx.doi.org/10.1016/j.jvn.2014.01.001

ered. Furthermore, criteria for selecting patients suitable for same-day discharge are deliberated. A review of the current literature attempts to establish whether day-case angioplasty is safe and, if so, from whom is it safe (Table 1). Does it allow outcomes referred to in the 2013 ‘Cardiovascular Disease Outcomes Strategy,’ in particular experience of care and safety of that care to be achieved?4 Is it cost-effective, while ensuring that quality outcomes for patients are not compromised?

PVD PVD is a chronic arterial occlusive disease of the lower extremities.5 PVD is included under the umbrella of cardiovascular diseases, conditions linked by collective risk factors, whereby patients diagnosed to have one such condition often have related coexisting morbidities.4 These include coronary artery disease, hypertension, stroke, diabetes, hypercholesterolemia, chronic kidney disease, vascular dementia, and PVD. The prevalence of PVD is estimated at 20% of the population >60 years of age, many of whom have no symptoms with just 4% presenting with intermittent claudication manifesting as leg pain.4 Generally, symptoms occur when arterial obstruction of the vessel lumen reaches 50%–70%.6 Patients may present with intermittent claudication, rest pain, or critical limb ischemia with ulceration and gangrene depending on the progression of their disease. The most common symptom is intermittent claudication defined as a ‘‘reproducible lower extremity muscular pain induced by exercise and relieved by short periods of rest.’’1 History, physical examination, and specific vascular investigations will help to determine whether a patient has claudication or critical limb ischemia. Noninvasive investigations involve measuring the ankle and brachial artery systolic blood pressures (ABI), interpretation of velocity wave form, duplex ultrasonography, and magnetic resonance angiography. An ABI of <0.9 is highly

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TABLE 1 LITERATURE REVIEWED

Author

Publication Date

Procedure

Yee19

2004

Percutaneous coronary intervention

Heyde14

2007

Kasthuri20

2007

Huang15

2008

Herman13

2011

Number of Procedures

75; initial phase of trial 1st 50 patients remained in hospital overnight. In 2nd phase all remaining 25 patients underwent same-day discharge. Percutaneous 800; 403 patients coronary randomized to sameintervention day discharge and 397 to overnight stay Peripheral 183; all same-day angioplasty discharge Peripheral 401; 144 diagnostic and angiography/ 257 interventional; angioplasty all same-day discharge

Percutaneous coronary intervention

Method of Hemostasis

Complications

Closure device

None

Manual compression

0.5% in same-day discharge group and 0.3% in overnight stay None

Manual compression

Femoral closure 6.2% in diagnostic devices used in 141/ angiography group; 401 (35.2%) of 15.2% in procedures; the interventional group remaining (64.8%) underwent digital compression 130; 106 via radial Femoral closure device None access and 24 via the used in all 24 femoral route; all procedures same-day discharge

sensitive for and indicative of PVD. The lower the ABI reading is, the greater the restriction of arterial blood flow.5

TREATMENT OPTIONS Treatment options include nonoperative management or revascularization. Effective management of PVD combines risk factor reduction with endovascular and operative intervention when indicated. Risk factor reduction includes smoking cessation, anti-lipid therapy, blood pressure control, weight management, glycemic control, exercise, anti-platelet therapy, and podiatry.6 Health promotion is essential to the optimal management of PVD influencing disease progression, quality of life, and long-term prognosis. Health professionals in the UK refer to the National Institute for Health and Clinical Excellence (NICE) for advice on the management and care of patients with specific conditions such as PVD. NICE publishes national clinical guidelines and recommendations using the best available evidence to promote high-quality care and optimize patient outcomes. In 2012, NICE published clinical guideline 147: ‘The Diagnosis and Management of lower limb Peripheral Arterial Disease’.7 This guideline strongly reinforces the need for patient

information advocating that PVD sufferers must be included in the decision-making process and be taught to ‘‘understand the course of the disease and what they can do to help prevent disease progression.’’7 The benefits of supervised exercise programs in improving symptoms of patients with intermittent claudication are well-documented. NICE recommends supervised exercise programs be made available to all patients with intermittent claudication. Advice, support, and treatment regarding smoking cessation, diet and weight management are also highlighted by NICE as essential health promotion measures. Pharmacologic therapies used in the management of PVD may include antiplatelet and anti-hypertensive medications, lipid-modifying therapy, and vasodilators.8 When lifestyle modification and medical treatment options have been exhausted, patients with progressing disease may require peripheral angioplasty, bypass surgery, or limb amputation. Although traditionally vascular bypass surgery has been the standard of care, advancements in technology and technique permit ‘‘endovascular techniques to be applied to an ever increasing number of patients.’’9 Aronow summaries the indications for angioplasty to include lifestyle limiting claudication, critical limb ischemia, and vasculogenic impotence.5

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ANGIOPLASTY Angioplasty is a long-established treatment in the management of PVD. It can provide excellent results for the critical limb-restoring blood flow, improving symptoms and reducing the risk of amputation. Morris-Stiff et al10 concur, stating that angioplasty is now the treatment of choice for most anatomic locations with level 1 evidence for treating both lifestyle-limiting claudication and critical limb ischemia. The risk factors and morbidity associated with surgical bypass are much greater than for angioplasty, which has been demonstrated to provide comparable results. As such, angioplasty is now the standard treatment for lesions affecting the lower limb arterial tree.11 The procedure involves inflating a balloon catheter in a narrowed or blocked segment of the artery. Blood flow is improved when the inflated balloon causes breaks in the plaque and pushes it back against the wall of the artery, reopening the vessel.12 Conventionally, peripheral angioplasty has been performed as an inpatient procedure.

SAME-DAY DISCHARGE The feasibility of same-day discharge after angioplasty for PVD has not been widely reported. In contrast, there have been numerous studies in the area of percutaneous coronary intervention (PCI). Although the access used was more often through the radial artery, there are a number of studies exploring same-day discharge for angioplasty employing a femoral approach. A study of 130 patients by Herman13 assessed the complications in the first 24 hours after angioplasty for PCI. Of the 130 patients involved in the study, 24 cases were performed using the femoral access route with the remainder all undergoing radial approaches. A femoral closure device was used successfully in each of the 24 patients undergoing femoral approaches and there were no reported complications requiring readmission to hospital in any of the patients, irrespective of approach. The researcher concluded that same-day discharge was efficacious and safe after elective percutaneous intervention. Nevertheless, this study is limited by its relatively small sample size and, given that the majority of procedures were performed using a radial approach, its generalization to angioplasty for PVD, which employs a femoral approach, is questionable. However, these findings are consistent with a considerably larger study by Heyde et al,14 which hypothesized that sameday discharge would not lead to more complications. All 800 participants in this trial were scheduled for elective PCI by femoral approach and randomized to same-day discharge or overnight hospital stay. Access was achieved through the femoral route using 5- or 6-Fr guiding catheters. The sheath was removed immediately after the procedure and manual pressure applied and maintained using a pressure bandage. After 4 hours of bed rest, patients were ambulated and triaged to determine suitability for same-day discharge. In total, 403 patients were randomized to same-day discharge and 397 to overnight hospital stay. During or immediately after angioplasty, 67 of the 403 patients in the same-day discharge group developed an indication for extended hospital stay, as did 80 of the 397 in the overnight stay group. Indications for extended stay were identified from predefined clinical and angiographic criteria. These indications included

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a suboptimal angiographic result, vessel dissection, thrombus, perforation with guide-wire, and occluded coronary artery. Clinical indications included chest pain, electrocardiographic changes, congestive heart failure, and complicated hemostasis. Results demonstrated that same-day discharge after elective angioplasty can be performed safely in most patients. Furthermore, it establishes that patients at risk for postprocedural complications can be identified effectively in a day-case setting on the basis of predefined clinical and angiographic criteria.

CRITERIA AND PATIENT SELECTION These criteria are outlined in a study by Huang,15 which demonstrated a comparable complication rate for day-case peripheral angioplasty in a nurse-led unit. This is among the few published studies exploring the feasibility of same-day discharge after angioplasty for PVD. The study was conducted over a 10year period whereby 401 day-case peripheral angiograms were performed (144 diagnostic and 257 interventional). Patients were pre-assessed for suitability and routine screening investigations were performed included full blood count, platelet count, renal function tests, and coagulation parameter tests. Contraindications were identified as poorly controlled blood pressure, renal impairment, poor glycemic control, significant cardiac disease, and irreversible coagulopathy. Patients meeting the criteria underwent angiography with a standard femoral puncture and a 4/5-Fr sheath. Postprocedure, the puncture site was closed using a femoral closure device or manual compression. Patients were mobilized 2 to 4 hours postprocedure and discharged if there were no apparent complications. The nurses provided instructions regarding puncture site care and activity before discharge. Patients deemed unsuitable for discharge were admitted as appropriate; 24-hour follow-up was conducted by specialist nurses over the telephone. Data was collected from standardized day-case notes and included demographic details, comorbidities, dates of pre-assessment and intervention, procedural details and postprocedure complications. In the interventional group, there were 65 of 257 immediate complications including puncture site minor hemorrhage, puncture site pain, hypoglycemia, vasovagal attack, urinary retention, contrast reaction, and hypertension. In total 17 of the 257 had major complications, including large puncture site hematoma, abdominal pain, urinary retention, retroperitoneal hematoma, distal arterial embolus, and flow-limiting arterial dissection. The overall hospital admission rate for the interventional group was 5.8% for vascular complications only. In total, 109 of the 401 procedures were conducted on diabetics (27.2%) with no increased complication rate in this group. This suggests that the criteria for day-case angioplasty for PVD should not exclude diabetic patients with good glycemic control. Closure devices were used in 141 cases and the remainder had digital compression. Where closure devices were used the median length of stay postprocedure was 3 hours as opposed to 4 hours for manual compression. There was no difference in complications between the manual compression and closure device groups. The researchers concluded that a protocol facilitating appropriate patient selection through preassessment is essential to a successful day-case angioplasty service. Furthermore, they

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advocate the use of current technology and techniques in making this a safe and cost-effective option.

TECHNOLOGICAL ADVANCEMENTS Madia16 asserts how developments in endovascular devices have significantly expanded treatment options for patients with PVD, even in high-risk groups or those with ‘disease previously not amenable’ to angioplasty. References to technological advancements in the literature focus on femoral closure devices and smaller access systems, which limit the insult to the artery. Rowe et al9 suggest that ‘‘lower profile delivery systems, sub intimal recanalization techniques, contrast agents with less nephrotoxicity, and more widespread surgical expertise have facilitated the expansion of endovascular technology.’’ The research suggests that such advances have made the possibility of performing routine angioplasty on a day-case basis evermore feasible. The development of lower profile systems of 4-, 5-, and 6-Fr diameter has meant a significant reduction in the size of access arterial holes.17 As such, peripheral angioplasty can now be performed with minimal complications, bringing into question the appropriateness of routine hospitalization for these procedures.18 In consideration of the advances that have made day-case angioplasty more feasible, Cleveland et al17 advocates the use of aspirin and clopidogrel in reducing the need for postprocedure anticoagulation as well as limiting the risk of thrombosis, thus making same-day discharge safer. The recommended daily dose of Aspirin for the treatment of PVD is 75325 mg daily and for clopidogrel is 75 mg.3 The development of femoral closure devices is considerably influential and yet remains controversial. These devices are designed to close the femoral artery puncture site achieving immediate hemostasis and facilitating early ambulation. A feasibility study by Yee et al19 aimed to determine if one such closure device, the Angio-Seal would allow safe early mobilization after femoral access for PCI. The Angio-Seal device uses ‘‘an intra-arterial anchor to draw a small amount of collagen, attached to it by a suture, against the puncture site.’’19 The study included 75 patients undergoing elective coronary stenting through a femoral approach. The closure device was used at the completion of each procedure and patients were mobilized at 4 hours. In the initial phase of the trial, the first 50 patients remained in hospital overnight and in phase 2 the remaining 25 were discharged 10 hours postprocedure after satisfactory assessment of suitability for same-day discharge. Hospital discharge was not delayed as a result of puncture site bleeding or hematoma in any of the patients in the study and the researchers concluded that same-day discharge was feasible using this closure device. However, the sample size was relatively small and only hemodynamically stable patients were included, so generalization should be taken with caution. Nonetheless, findings are consistent with a study such as that of Huang’s discussed above.15 In this study, the feasibility of femoral closure devices was demonstrated both by a reduction in length of stay postprocedure and notably no difference in complications between the manual compression and closure device groups. Despite evidence to the contrary, Nazir et al11 assert that manual compression remains the criterion standard for achieving hemostasis. This view is corroborated in the previously described

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study of 800 patients by Heyde et al.14 A femoral closure device was not used because the researchers were of the view that the effects of closure devices on puncture related complications compared with manual compression were questionable. This idea is further substantiated in a study by Kasthuri et al,20 which considered the safety of peripheral angioplasty using nurse-led admission, discharge, and follow-up procedures without the use of closure devices. A total of 183 patients were recruited to this study over a 2-year period. In the same period, 374 patients underwent inpatient procedures and overall 33% (183) of all angioplasties were conducted as day cases. Angioplasty was performed generally using a 6-Fr sheath. At completion of the procedure, the groin sheath was removed and manual pressure was applied. No closure devices were used. Patients remained supine for 3 hours and were then mobilized progressively. They were discharged at 5 hours, providing no complications were apparent. Admission was arranged for any patient deemed unsuitable for discharge. One patient was admitted for ventricular failure and another as a result of distal embolization. A further 4 patients were admitted for social reasons. All same-day discharge patients were contacted by a nurse the next working day after the procedure to assess their recovery and identify any concerns. During telephone calls, five patients complained of significant groin tenderness and were asked to return. Of these, one was found to have a false aneurysm. The large majority of patients had no issue. The study affirms the use of digital compression in achieving hemostasis and questions the necessity for closure devices. Additionally, this study demonstrated the range of specialist nursing skills required for day-case angioplasty. These were outlined to include pre-assessment in establishing suitability for day-case treatment, assisting during the procedure, and monitoring and discharging patients postprocedure. Cleveland recommended that pre-assessment to determine suitability may be most efficiently performed by specialist nurses working to agreed protocols.17

NURSE-LED CLINICS Nurse-led preadmission clinics, where patients can be assessed for suitability using clear predefined criteria, have evolved to facilitate appropriate patient selection for day-case angioplasty. According to Cleveland et al, these clinics facilitate superior quality assessment where specialist nursing staff can provide better continuity of assessment in particular where the turnover of medical staff is high.17 The previously described study by Huang et al evaluated day-case angiography in a dedicated nurse-led and administrated unit.15 In a secondary consideration, this study explored patient acceptability of nursing administration and viewed overall safety as compared with physician led units. Nurses working in the unit were given specific in house training and were required to attend an external 4 month course designed to increase their knowledge and help them achieve the skills necessary to assess, implement and evaluate care in patients undergoing day-case angioplasty. Pre-defined criteria were devised collaboratively with vascular surgeons, diabetic specialists, radiologists and nurses. Where contraindications for day-case angiography were identified by the nurse, the patient was referred for inpatient care. At the pre-assessment visit, nurses assessed suitability of patients for same-day discharge,

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arranged routine screening investigations, provided patient information leaflets and confirmed admission arrangements. Patient acceptability of nurse-led care was assessed using a standard questionnaire with 45 patients over a 12 month period. Results demonstrated that nurse led pre-assessment significantly reduced anxiety and was highly valued by patients with 42 of 45 patients (93%) judging the standard of nursing care to be excellent and the remaining 3 (7%) as acceptable. Generalization is limited due to the relatively small sample size but nonetheless this study supports the idea that patients are quite accepting of nurse-led care. Further studies exploring patient’s experiences and perceptions would be helpful. Overall safety compared with physician led units was evident in the relatively low incidence of major complications with rates being well within acceptable limits.

PATIENT SATISFACTION Patient acceptance of and preference for same-day discharge post angioplasty has been alluded to throughout the literature. The previously described study by Heyde et al. included a patient satisfaction survey.14 Using a scale of 0 to100, the same-day discharge group gave a 5.0 higher mean score (78.6) for the discharge procedure compared with overnight stay group (73.6). There were no significant differences between scores on patient information, treatment by personnel, and the patient’s subjective opinion on the effect of the procedure. Asked for their preference in event of repeat procedure, 73% of same-day discharge patients said they would prefer same-day discharge versus 32% in the overnight stay group. Patient satisfaction is often dependent on how well they are counselled prior to the procedure. Appropriate provision of information leaflets will ensure a higher satisfaction score. This is in line with the NICE recommendations that patients with PVD be provided with both oral and written information throughout the course of their treatment. Specialist vascular nurses are well placed to ensure this requirement is fulfilled.

COST-EFFECTIVENESS Circulation related problems comprising PVD are treated at a cost to the National Health Service (NHS) of £7.72billion ($12.61billion) annually.4 Cuts in healthcare budgets and increased emphasis on fiscal management have further driven the case for same-day discharge. Healthcare professionals are obliged to re-examine the means by which quality patient outcomes may be achieved. Akopian and Katz18 suggest that as the number of angioplasties increase and resources become scare, surgeons ‘need to be aware of cost-effective and efficient practice options’. Potential cost savings achievable through same-day discharge are suggested throughout the literature. Yee et al19 suggest that same-day discharge would relieve the pressure on hospital beds and resources and provide cost saving implications for current health care systems with limited resources. In the fore mentioned study by Huang et al,15 a costeffectiveness analysis was conducted comparing the cost saving of an overnight bed. Cost savings were estimated modestly at V75,187.50 ($103,381.63) over the 10-year period of the study. Furthermore, in the last 12 months in which 88 patients underwent day cases, bed cost saving were V16,500 ($22,685.89).

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More significant cost savings are apparent in a study by Akopian and Katz exploring the cost benefits of day-case angioplasty.18 The study hypothesized that patients undergoing angioplasty for intermittent claudication did not require hospital admission. All 97 patients undergoing a total of 112 interventions over a 27-month period were prospectively enrolled in the trial. Angioplasty was conducted through the femoral route and the Angio-Seal Closure device described previously was used at the end of each procedure. Patients were ambulated within 1 hour of the procedure providing successful placement of the closure device. They were then considered for discharge 2 hours postprocedure if no complications were apparent. Cost analysis was performed on an actual cost basis as opposed to patient charges. The cost for a 1-hour stay in the observation unit was $115 as opposed to $1,800 for an overnight stay in an inpatient bed. Same-day discharge was successful in 103 of 112 procedures. The average cost for patients discharged the same day was $320 compared with $1,800 for those requiring an overnight stay. In all, 92% of patients were discharged and there was no unplanned readmission or deaths. Of the 8% admitted, more than half of these were for social as opposed to medical reasons. This study demonstrates significant cost savings from day-case angioplasty and affirms that patient outcomes are not compromised by this standard of care.

CONCLUSION This paper has demonstrated that same-day discharge after angioplasty for PVD is feasible and safe in appropriately selected patients. Nurse-led preadmission clinics, whereby patients can be assessed for suitability using clear predefined criteria, are highly effective in appropriate patient selection. They facilitate superior quality assessment, where specialist nursing staff can provide better continuity of assessment in particular where the turnover of medical staff is high.17 The research has demonstrated that patients at risk of postprocedural problems can be identified effectively so long as predefined discharge criteria are applied. Same-day discharge for peripheral angioplasty measures well, both in terms of experience of care and safety of that care in line with the 2013 Cardiovascular Disease Outcomes Strategy.4 Much of the research exploring same-day discharge after angioplasty has been concentrated in the area of PCI. Larger randomized studies are needed in peripheral angioplasty to ascertain if results in the PCI population are truly applicable to this patient cohort. Nonetheless, of the limited number of studies considering same-day discharge for peripheral angioplasty, the evidence is convincing. Technological advances have largely contributed to the feasibility of same-day discharge. Lower profile delivery systems and femoral closure devices seem to be the most significant advances both in terms of limiting insult to the femoral artery and achieving adequate hemostasis at the puncture site, thus facilitating early ambulation. This paper has demonstrated that daycase peripheral angioplasty will allow for a higher throughput in units where the pressure on inpatient beds precludes an optimal volume of admissions. Furthermore, the cost savings achieved by this method cannot be ignored and in conclusion is the standard of care that should be applied to this selected group of patients.

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12. Jane S, Dorgan S. Management of patients on the ward. vascular disease - a handbook for nurses. Cambridge, UK: Cambridge University Press; 2005:121-9. 13. Herman BA. Safety of same day discharge following percutaneous coronary intervention. Heart Lung Circ 2011;20(6): 353-6. 14. Heyde GS, Koch KT, de Winter RJ, et al. Randomized trial comparing same-day discharge with overnight hospital stay after percutaneous coronary intervention: results of the Elective PCI in Outpatient Study (EPOS). Circulation 2007; 115(17):2299-306. 15. Huang DY, Ong CM, Walters HL, et al. Day-case diagnostic and interventional peripheral angiography: 10-year experience in a radiology specialist nurse-led unit. Br J Radiol 2008;81(967):537-44. 16. Madia C. Medical and surgical management of peripheral arterial disease. JAAPA 2012;25(9):52-6. 17. Cleveland T, MacDonald S, Morgan R, et al. Day case angiography and intervention. In: Beard JD, Murray S, editors. Pathways of care in vascular surgery. Worcester, UK: Trinity Press; 2002:77-86. 18. Akopian G, Katz SG. Peripheral angioplasty with same-day discharge in patients with intermittent claudication. J Vasc Surg 2006;44(1):115-8. 19. Yee KM, Lazzam C, Richards J, et al. Same-day discharge after coronary stenting: a feasibility study using a hemostatic femoral puncture closure device. J Interv Cardiol 2004; 17(5):315-20. 20. Kasthuri R, Karunaratne D, Andrew H, et al. Day-case peripheral angioplasty using nurse-led admission, discharge, and follow-up procedures: arterial closure devices are not necessary. Clin Radiol 2007;62(12):1202-5.