ADVERTISEMENT
Original Contribution
Same-Day Discharge is Feasible and Safe in the Majority of Elderly Patients Undergoing Elective Percutaneous Coronary Interventi
July 2010
Same-Day Discharge is Feasible and Safe in the Majority of Elderly Patients Undergoing Elective Percutaneous Coronary Intervention
ABSTRACT: Background. Same-day discharge after elective percutaneous coronary intervention (PCI) is safe in the majority of patients. However, the elderly have more comorbidities and less favorable coronary and peripheral arterial anatomy, which may preclude safe same-day discharge after PCI. We assessed the feasibility and safety of same-day discharge in an elderly cohort of patients. Methods. A total of 1,580 consecutive patients undergoing elective PCI in a single center between January 2001 and January 2009 were included in the study. We compared the outcomes of elderly patients aged 75 or older to control patients under the age of 75 years. Patients were examined 6 hours post procedure and discharged if there were no complications. Results. Of the 1,580 study patients 212 (13.4%) were elderly and 1,365 (86.6%) were younger controls. The elderly were more likely to be female, hypertensive and to have had previous coronary artery bypass graft (CABG) surgery and less likely to be smokers or to have hyperlipidemia (all p 1 Furthermore, elderly patients have been shown to have effective symptom resolution2,3 and to have equivalent or even greater improvements in quality of life compared to younger patients after percutaneous coronary intervention (PCI).4,5 On this basis, elderly patients are increasingly being referred for PCI. Same-day discharge following PCI reduces bed occupancy, is cost effective and is popular with patients.6,7 A number of randomized trials and observational studies have previously established the safety of this approach.7–14 Furthermore, Small et al demonstrated that patients can be safely triaged to same-day discharge if a good angiographic result is achieved and they have an uncomplicated 6-hour post-PCI observation period.15 There are a number of potential reasons why elderly patients may be less suitable for same-day discharge following PCI. Elderly patients are more likely to have comorbidities such as previous myocardial infarction, impaired left ventricular function, peripheral vascular disease and renal impairment.16,17 In addition they are also more likely to have multivessel disease and complex or calcified coronary lesions.18,19 Given these findings, it is no surprise that previous studies investigating outcomes in the elderly following PCI have documented an increased risk of periprocedural vascular complications, myocardial infarction and death.18,20 The aim of this study was to assess whether the advantages of same-day discharge after elective PCI can safely be extended to include the elderly. Methods Study population. All patients undergoing elective PCI at a single tertiary referral center between January 2001 and January 2009 were considered for same-day discharge. Patients aged 75 years or older were included in the elderly cohort. The remaining cohort of patients formed the control group. Elective PCI was performed in 1,607 patients during this period. Only 27 (1.7%) of these patients were considered ineligible for the day-case program and therefore excluded from the study. Of these patients, 10 were elderly. The exclusions were due to inadequate social circumstances (19 patients), a requirement for in-hospital dialysis the next day (3 patients), planned overnight admission after complex bifurcation stenting or rotablation (2 patients), planned overnight observation due to a previous contrast reaction (1 patient) and preexisting renal failure requiring intravenous hydration and renal function testing the next day (1 patient). Data were collected retrospectively in the first 500 patients and prospectively in the remaining patients. Ethical approval was obtained from the Wellington Regional Ethics Committee. Procedural details. Patients were informed of the intention for same-day discharge at the time of the initial clinic review (Figure 1). Patients were further reminded of the discharge plans in booking correspondence and also at the time of preassessment, which was performed within a week of the procedure. Patients were advised to stay with a companion and to have access to a telephone following discharge on the day of the procedure. All patients living more than thirty kilometres from the hospital were advised to stay locally on the day of discharge. All patients were pretreated with aspirin. Clopidogrel 300 mg was administered at the time of the procedure for all patients until September 2003, from which point all elective PCI cases were preloaded with a 300 mg dose on the day prior to the procedure. Unfractionated heparin was used in the majority of cases (maximum dose 100 U/kg). Bivalirudin has recently become available and was used in 41 (3.5%) of the cases. The route of vascular access and use of closure devices was at the discretion of the operator. Stents were sized to a ratio of 1.1:1.0. The use of the glycoprotein IIb/IIIa inhibitor abciximab was also at the discretion of the operator. Clopidogrel was prescribed for 1 month following deployment of bare-metal stents and for 3 to 12 months following insertion of drug-eluting stents. Elective procedures were scheduled first on the list, with the intention that these cases be completed prior to mid-day. Femoral sheath removal was performed when the activated clotting time was less than 170 seconds, followed by ambulation 4 hours later. Radial sheaths were removed immediately after the procedure and a compression device was applied for at least 60 minutes with immediate ambulation. From January 2005 all patients undergoing elective PCI had a CK-MB and/or troponin T measured 6 hours post procedure to assist in the detection of silent periprocedural myocardial infarction and to monitor the safety of the day-case program. Prior to this, cardiac enzymes were measured if an ischemic event was suspected or overnight admission was required. All patients were assessed 6–8 hours post procedure by a cardiologist regarding their suitability for same-day discharge. Patients were admitted if there was a suboptimal angiographic result, evidence of periprocedural myocardial ischemia or infarction, access site complications, late sheath removal, if they required a glycoprotein IIb/IIIa infusion or at the discretion of the interventionist after complex cases. Review at an outpatient clinic 4–6 weeks post procedure was arranged. Data collection and definitions. Patient demographics, procedural variables and outcomes were obtained from review of the cardiac catheterization database and medical records. Clinical follow-up data at 24 hours and 30 days were obtained from review of cardiology clinic follow-up letters, hospital medical records, the national admissions database and by contacting general practitioners. Lesion complexity was classified according to the modified American Heart Association/American College of Cardiology (AHA/ACC) Classification.21 Angiographic success was defined as 2x the upper limit of normal or a troponin T > 0.15 ng/ml. Target vessel revascularization (TVR) was defined as the requirement for either emergency coronary artery bypass graft surgery (CABG) or urgent repeat PCI to the index artery. Major adverse cardiac events (MACE) included death, TVR or myocardial infarction. Statistical analysis. Continuous variables are presented as mean ± standard deviation and categorical variables as percentages. Normality assumptions were met for continuous variables. Univariate analysis of variables was performed using the Student’s t-test for continuous variables and either chi-square or Fisher’s exact test for categorical variables. A p-value Results Patient, lesion and procedural characteristics. Elderly patients were excluded from the day-case program more frequently than control patients (4.5% vs. 1.2%; p = 0.02). However, exclusion was infrequent and predominantly due to inadequate social circumstances. Of the 1,580 study patients 212 (13.4%) were elderly with the remaining 1,365 (86.6%) forming the control group. The patient demographics and clinical characteristics are shown in Table 1. The elderly cohort had a median age of 77 (range 75–92) years compared to 62 (29–74) for controls. The elderly were more likely to be female, hypertensive and to have had a previous CABG, but less likely to be hyperlipidemic or current smokers (all p Discussion To our knowledge this is the first study to assess the safety and efficacy of same-day discharge in elderly patients undergoing elective PCI. The strength of our study is the large cohort size along with the fact that almost all (98.3%) patients undergoing elective PCI (including ad hoc PCI following elective angiography) at our institution during the study period were included. Despite the high rates of same-day discharge, the frequency of complications within 24 hours of discharge was very low (7–14 and high-risk patients with complicated lesions (type B2 or C) if they had an uncomplicated 6-hour post-PCI observation period.15 However, the mean age of patients in these studies has been ≤ 65 years, which is similar to the mean age of our control group. This suggests that although some elderly patients may have been included in these studies, many have been excluded. This study is the first to demonstrate that same-day discharge can safely be achieved in a high proportion (84%) of elderly patients. This rate of same-day discharge is not only comparable to that achieved in our control group, but is also significantly higher than that achieved in most of these previous studies of day-case PCI. We believe that there are a number of factors that contributed to the high rate of same-day discharge that we achieved. In our experience, informing patients early of the intention to discharge them on the same day as the procedure as well as careful discharge planning prior to admission allows many social issues that may be a barrier to same-day discharge to be overcome. Secondly, the use of a suboptimal angiographic result or evidence of periprocedural complications as criteria to determine the need for overnight admission rather than preprocedural clinical or lesion characteristics greatly increases the number of patients potentially eligible for same-day discharge. Finally, a review of the patients by the cardiologist who performed the procedure 6 hours after the procedure is integral to achieving optimal and appropriate same-day discharge. Consistent with studies in octogenarians undergoing PCI,18 we found that elderly patients were twice as likely as younger patients to require overnight admission due to access-site complications, all of which were related to femoral artery access sites. These access-site complications could potentially be reduced by the use of radial access, which has been shown to reduce the incidence of hematoma formation and bleeding in elderly patients.22 Interestingly, all 19 elderly patients who had a radial approach in our study were successfully discharged on the same day. An alternative approach for procedures using the femoral approach is to use bivalirudin, which has been shown to reduce major bleeding in the elective setting23 and also allows for earlier sheath removal and ambulation. Finally, while the use of vascular closure devices may seem to be an attractive strategy for improving the time to ambulation in out-patient programs, they have not been shown to reduce vascular complications. Furthermore, there are no data on the use of closure devices in the elderly who may have a different risk-to-benefit profile. From the Department of Cardiology, Wellington Hospital, Wellington, New Zealand. The authors report no financial relationships or conflicts of interest regard- ing the content herein. Manuscript submitted March 1, 2010, provisional acceptance given March 11, 2010, final version accepted April 14, 2010. Address for correspondence: Dr. Scott Harding, Department of Cardiology, Wellington Hospital, Private Bag 7902, Wellington South, New Zealand. E-mail: Scott.Harding@ccdhb.org.nz References1. Simons LA. Epidemiologic considerations in cardiovascular diseases in the elderly: International comparisons and trends. Am J Cardiol 1989;63:5H–8H. 2. TIME Investigators. Trial of invasive versus medical therapy in elderly patients with chronic symptomatic coronary-artery disease (TIME): A randomized trial. Lancet 2001;358:951–957. 3. Pfisterer M. Long-term outcome in elderly patients with chronic angina managed invasively versus by optimal medical therapy. Four-year follow-up of the randomized trial of invasive versus medical therapy in elderly patients (TIME). Circulation 2004;110:1213–1218. 4. Kähler J, Lütke M, Weckmüller J, et al. Coronary angioplasty in octogenarians. Qual- ity of life and costs. Eur Heart J 1999;20:1791–1798. 5. Seto TB, Taira DA, Berezin R, et al. Percutaneous coronary revascularization in eld- erly patients: Impact on functional status and quality of life. Ann Intern Med 2000;132:955–958. 6. Banning AP, Ormerod OJ, Channon K, et al. Same day discharge following elective percutaneous coronary intervention in patients with stable angina. Heart 2003;89:665. 7. Khatri S, Webb JG, Carere RG, et al. Safety and cost benefit of same-day discharge after percutaneous coronary intervention. Am J Cardiol 2002;90:425–427. 8. Ziakas AA, Klinke BP, Mildenberger CR, et al. Safety of same-day-discharge radial per- cutaneous coronary intervention: A retrospective study. Am Heart J 2003;146:699–704. 9. Dalby M, Davies J, Rakhit R, Mayet, et al. Feasibility and safety of day-case trans- femoral coronary stenting. Catheter Cardiovasc Interv 2003;60:18–24. 10. Bertrand OF, Larochellière RD, Rodés-Cabau J, et al. A Randomised study compar- ing same-day home discharge and abciximab bolus only to overnight hospitalization and abciximab bolus and infusion after transradial coronary stent implantation. Cir- culation 2006;114:2636–2643. 11. Heyde G, Koch K, Winter R, Dijkgraaf M. Randomized trial comparing same-day discharge with overnight hospital stay after percutaneous coronary intervention. Cir- culation 2007;115:2299–2306. 12. Slagboom T, Kiemeneij F, Laarman GJ, Van der Wieken R. Outpatient coronary an- gioplasty: Feasible and safe. Catheter Cardiovasc Interv 2005;64:421–427. 13. Koch KT, Piek JJ, Prins MH, et al. Triage of patients for short term observation after elective coronary angioplasty. Heart 2000;83:557–563. 14. Gilchrist IC, Nickolaus MJ, Momplaisir T. Same-day transradial outpatient stenting with a 6-hr course of glycoprotein IIb/IIIa receptor blockade: A feasibility study. Catheter Cardiovasc Interv 2002;56:10–13. 15. Small A, Klinke P, Siega AD, et al. Day procedure intervention is safe and complica- tion free in higher risk patients undergoing transradial angioplasty and stenting. The discharge study. Catheter Cardiovasc Interv 2007;70:907–912. 16. Kobayashi Y, Mehran R, Mintz GS, et al. Comparison of in-hospital and one-year outcomes after multiple coronary arterial stenting in patients >80 years old versus those 80 years). Am J Cardiol 2006;98:1334–1339. 21. Ellis S, Vandormael M, Cowley M, et al. Coronary morphologic and clinical deter- minants of procedural outcome with angioplasty for multivessel coronary disease: implications for patient selection: Multivessel Angioplasty Prognosis Study Group. Circulation 1990;82:1193–1202. 22. Jaffe R, Hong T, Sharieff W, et al. Comparison of radial versus femoral approach for percutaneous coronary interventions in octogenarians. Catheter Cardiovasc Interv 2007;69:815–820. 23. Lincoff AM, Bittl JA, Harrington RA, et al, for the REPLACE-2 Investigators. Bi- valirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial. JAMA 2003;289:853–863. 24. Applegate R, Sacrinty M, Kutcher M, et al. Propensity score analysis of vascular com- plications after diagnostic cardiac catheterization and percutaneous coronary inter- vention 1998–2003. Catheter Cardiovasc Interv 2006;67:556–562.