Patient Satisfaction is Comparable to Early Discharge versus Overnight Observation after Elective PCI (see full title below)
- Volume 21 - Issue 9 - September, 2009
- Posted on: 9/1/09
- 0 Comments
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ABSTRACT: Background. Previous investigation has suggested that early discharge after percutaneous coronary intervention (PCI) is feasible and safe, but these studies have utilized largely radial approaches or been conducted in non-U.S. cohorts. We sought to assess patient satisfaction, safety and cost of a strategy of selective early discharge in U.S. patients undergoing PCI via a femoral approach with contemporary adjunctive pharmacologic and hemostasis agents. Methods and Results. Patients with stable coronary artery disease undergoing elective PCI were prospectively recruited and randomized to either routine care, with an overnight hospital stay, versus early discharge 2 hours following successful PCI with adjunctive bivalirudin therapy and a femoral arterial closure device at the end of the procedure. The primary endpoints were safety and patient satisfaction as measured by a validated patient satisfaction survey during the index hospital stay and at 30 days. A total of 39 patients were randomized, with 20 to routine care and 19 to early discharge. There was no difference in major safety endpoints including death, non-fatal MI, urgent target lesion revascularization and thrombolysis in myocardial infarction (TIMI) major bleeding, with none in either group. Mean patient satisfaction scores were similar and high in both groups (89.6 for early discharge patients and 90.7 for routine care patients, p = 0.68). There was lower cost in the early discharge group, with a mean cost of $8,604 versus $10,565 in the routine care group (mean difference $1,961, 95% confidence interval, -$96 to $4,017). Conclusion. Patients undergoing elective PCI for stable coronary artery disease may have similar safety and satisfaction with early discharge when using a careful strategy that incorporates optimal stent and hemostasis results and contemporary adjunctive anticoagulation therapy, with lower cost. This strategy may serve as a basis for a larger-scale randomized trial.
J INVASIVE CARDIOL 2009;21:464–467
Key words: PCI, angioplasty, stent, coronary artery disease, cost
More than 1.2 million percutaneous coronary interventions (PCIs) were performed in the United States in 2005.1 Periprocedural mortality rates have declined to < 0.1%, with major complication rates of 2.3%.1 These changes are due in large part to increased use of stents, in particular, and of newer adjunctive pharmacologic agents that have favorably influenced acute procedural outcomes. As complication rates have continued to decrease, especially in select, stable coronary artery disease patients with complete procedural success, the benefits of an overnight observation period may be mitigated.
Several observational series have suggested that early discharge after PCI is feasible and safe.2–11 Two recently published randomized, controlled studies showed comparable mortality and ischemic complication rates in a total of 1,805 patients.12,13 The only small, U.S. randomized trial was conducted prior to stent use.9
The anticipated benefits of adopting an outpatient approach to PCI are improved patient satisfaction and decreased cost. Prior studies have been either limited in methodology or based in other countries. The preferences and costs of an exclusively U.S. cohort may not necessarily replicate those in other countries; patient expectations and fears may vary in the American culture compared with other countries, adjunctive medication differences may affect costs, and perceived safety of treating various lesion types may be different in U.S. operators. In addition, a femoral approach is routine in the U.S., and many prior non-U.S. studies did not use this as the dominant access method.
We designed and performed a pilot study to assess patient satisfaction, as well as feasibility and safety of a strategy of selective early discharge in American patients undergoing PCI via a femoral approach and receiving contemporary adjunctive pharmacologic and hemostasis agents. We additionally sought to determine the cost benefit of early discharge by using actual cost data.
Patient selection. Patients were recruited prospectively from two centers (Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center) in Philadelphia. Informed consent was obtained from each patient prior to the procedure and approval for the protocol was obtained from the Institutional Review Board of the University of Pennsylvania. Only patients with stable coronary artery disease with optimal final angiographic results after PCI were eligible for participation. Patients known to be at higher risk for ischemic and vascular complications were excluded from the study. This included patients with acute coronary syndromes (ACS) including unstable angina, non-ST-elevation myocardial infarction (NSTEMI), ST-elevation MI (STEMI), or recent MI (in the past 30 days). Other exclusions were age > 75 years, ejection fraction < 30%, previous MI, inadequate social support at home for recovery, increased risk for infection, severe renal dysfunction (creatinine > 2.2), bleeding diathesis or anemia, intraprocedural vascular access site complications, saphenous vein graft intervention, interventions involving the left main coronary artery, thrombus seen prior to intervention, ACC Type-C lesions and any previous intervention on the same vessel requiring radiation therapy. Procedures requiring adjunctive devices such as rotational or direct atherectomy, laser excision and angioplasty procedures without stent use were also excluded. As the study protocol evaluated patients undergoing femoral approach to PCI, only those eligible for vascular closure device, determined by arteriogram, were included.
Procedural methods. PCI was performed in standard fashion via a femoral approach. During PCI all patients received adjunctive intravenous bivalirudin at a dose of 0.75 mg/kg bolus, followed by a continuous intravenous infusion at 1.25 mg/kg/hour until the end of the procedure. All patients received aspirin (325 mg) and clopidogrel (600 mg) immediately post procedure if not previously administered. A vascular closure device (Angio-Seal™, St. Jude Medical, St. Paul, Minnesota) was deployed immediately upon termination of the procedure to achieve hemostasis. Once satisfactory coronary and vascular immediate results were achieved, patients were eligible for randomization to early discharge or overnight stay in the hospital.
Early discharge group. Patients randomized to early discharge were observed for 2 hours post procedure in the catheterization laboratory recovery unit. If vascular complications or bleeding occurred during this time, they were admitted for routine in-patient care; if not, patients were discharged. Serum hemoglobin, platelet count and cardiac panel were drawn 6 hours post procedure and the following morning by a visiting study nurse and the out-patient laboratory. Patients were contacted by the responsible nurse/physician for admission to the hospital if the hemoglobin was decreased from baseline by > 1.5 gm, if the hemoglobin was < 10, if platelets were < 100,000 or decreased by > 100,000, or if creatine kinase or troponin I was 2 times above the upper limit of normal. Patients without complications post PCI in the out-patient group were discharged to a nearby hotel with a responsible family member. Routine care group: Those patients randomized to routine care were admitted to the hospital after completion of PCI. Patients in both groups received a phone call 30 days post discharge to assess for further ischemic or vascular events, other complications and to reassess patient satisfaction.
Outcomes. The primary endpoints were patient safety and satisfaction as measured by the Press Ganey patient satisfaction survey (Press Ganey Associates, Inc.). Major safety endpoints included death, nonfatal MI, urgent target lesion revascularization and thrombolysis in myocardial infarction (TIMI) major bleed. Minor endpoints included minor bleeding and readmission to the hospital. Hospitalization cost was a secondary endpoint.
Patient satisfaction and cost assessment. The Press Ganey patient survey is a validated questionnaire that reports scores up to 100 to assess patient satisfaction in the in-patient setting. Only validated, standard questions from the questionnaire were used (Appendix I). Question categories included: admission details, nur-sing, physician, personnel, tests and treatments, meals, patient family and visitors. Patients were given a validated response scale of very poor, poor, fair, good and very good. Patients were also asked the following question:
If given a choice, when would you prefer to be discharged to your home after this coronary stent procedure?
• The morning after the procedure;
• Later the same day (2–4 hours after the procedure);
• No preference.
The response to this question was not summed with the scoring of the Press Ganey survey. Both measures were used to assess patient satisfaction and preferences in the early discharge and routine care groups on the day after the procedure, as well as at 30 days. Actual in-patient costs were obtained with patient-specific medical billing data.
Statistical analysis. Continuous variables were compared using a Student’s t-test. Categorical variables were compared with a Fisher’s exact test. All results are based on an intention-to-treat analysis.
Patients were recruited between September 2004 and July 2006. A total of 39 patients were enrolled. Twenty patients were randomized to routine care and 19 were randomized to early discharge. One patient, who was randomized and discharged after a post-PCI intensive care stay, was excluded from the study for failing to meet inclusion criteria, having multiple exclusion criteria and for protocol violation. There were no significant differences between the two groups in terms of patient and angiographic characteristics (Table 1).
Safety. Seventeen of 19 patients (89%) randomized to early discharge were successfully discharged early. One patient had minor puncture-site bleeding at the 2-hour point and was admitted to have a pressure bag applied. The bleeding resolved and the patient was discharged the following morning with a normal vascular ultrasound. A second patient reported dizziness at the 2-hour point and remained in the hospital for observation without complication. There were no ischemic, bleeding or vascular complications in either group after 1 day. Thirty-day follow up was obtained for all patients. There were no predefined major complications at 30 days. Two patients, 1 from each group, presented to the hospital within 30 days, but neither required intervention (Table 2). One patient in the in-patient group presented to the emergency room 1 week later for malaise, but was not admitted and did not require further treatment. One patient randomized to same-day discharge presented to the emergency room with chest pain 14 days after PCI. Cardiac catheterization showed a patent stent, and the patient was discharged without intervention.
Patient satisfaction and discharge preference. Press Ganey satisfaction questionnaires were completed by 95% of patients after 1 day (Table 3). Overall satisfaction was high in both groups. Mean scores were 89.6 for early discharge patients and 90.7 for routine care patients (p = 0.68). Satisfaction questionnaires were completed by 95% of patients at 30 days (Table 3, Figure 1). The scores remained high and similar between groups (94.8 vs. 97.0; p = 0.27).