eAppendix. Sample Patient Education Handout for Same-Day Discharge Following PCI.
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Shroff A, Kupfer J, Gilchrist IC, et al. Same-Day Discharge After Percutaneous Coronary Intervention: Current Perspectives and Strategies for Implementation. JAMA Cardiol. 2016;1(2):216–223. doi:10.1001/jamacardio.2016.0148
The evolution of percutaneous coronary intervention (PCI) has led to improved safety and efficacy, such that overnight observation can be avoided in some patients. We sought to provide a narrative review of the current literature regarding the outcomes of same-day discharge (SDD) PCI and to describe a framework for the development of an SDD program.
A literature search of PubMed was performed for human studies on SDD PCI published in English from January 1, 1995, to July 31, 2015. We reviewed the studies between June and September 2015. After literature review, we included reports of randomized clinical trials, observational studies, meta-analyses guidelines, and consensus statements in a narrative review. Compared with overnight observation, there was no increase in adverse events (bleeding, repeat coronary procedures, death, or rehospitalization) among patients in these studies who were discharged on the same day of their PCI procedure. Same-day discharge was associated with significant cost savings and was preferred by patients.
Conclusions and Relevance
The available evidence supports the safety of SDD in selected patients after PCI. Specific programmatic features are important to the successful implementation of SDD after PCI. Greater adoption of SDD programs after PCI has the potential to improve patient satisfaction, increase bed availability, and reduce hospital costs without increasing adverse patient outcomes.
The primary benefits of same-day discharge after percutaneous coronary intervention (SDD-PCI) are related to improved patient satisfaction, decreased length of hospital stay (LOS), and better resource use of health care dollars. Historically, PCI has been considered an inpatient or short-stay procedure, usually involving up to 24 hours of observation. The clinical basis of this practice is rooted in the short history of PCI when acute ischemic events from abrupt vessel closure or vascular access complications were common and occasionally life threatening. Technological advances, such as systematic stent implantation and improvements in adjunctive pharmacotherapy, have addressed the risk of acute ischemic events.1-3 In this context, a shorter period of postprocedural observation appears reasonable based on published data evaluating short-term outcomes.4-6
The aim of this document is to highlight how SDD-PCI in appropriate patients is the natural next step in the evolution of PCI. Specifically, this article will review the existing literature on this topic, discuss the economic ramifications of this modification in clinical practice, detail commonly cited barriers to widespread adoption, and provide a framework to develop an SDD-PCI pathway.
In 2009, the Society for Cardiovascular Angiography and Interventions published the first formal consensus statement attempting to define appropriate use of same-day and outpatient status in the catheterization laboratory.7 Using the existing literature, the authors put forth a classification scheme for estimating the appropriate level of care after a successful coronary intervention. Exclusions for SDD-PCI included abnormal renal function, age older than 70 years, insulin-requiring diabetes mellitus, contrast allergy, presence of any chronic comorbidity, multivessel disease, proximal left anterior descending disease, bifurcation disease, left main disease, saphenous vein graft or internal mammary disease, and use of glycoprotein IIB/IIIA inhibitors.
This consensus document has 2 important limitations. First, it conflates the term outpatient with same-day discharge. Outpatient, in this context, refers to a reimbursement classification and is not necessarily based on either the origin of the patient before PCI or the destination of the patient after PCI. It also does not refer to a specific LOS after the procedure. Second, the conservative recommendations would exclude most patients now undergoing PCI regardless of their procedural outcome from SDD. Indeed, the limitations of these exclusion criteria were illustrated in a case series8 of 100 consecutive patients discharged safely on the same day as their PCI during a period just predating the publication of the 2009 guidelines.7 Only 15% of these patients actually fit the definitions for appropriate SDD, with most having features considered higher risk by the consensus statement.8 A priori factors based on age and other preexisting conditions should not necessarily present a barrier to SDD unless those conditions necessitate hospitalization.9,10
The primary objective of this article is to provide a narrative review of data related to SDD-PCI. A literature search of PubMed was performed for human studies in English from January 1, 1995, to July 31, 2015. We used the terms “angioplasty” or “PCI” and “outpatient,” “day-case,” “ambulatory,” and “same day.” We reviewed the studies between June and September 2015. Three of us (A.S., J.K., and S.V.R.) reviewed the results. Randomized clinical trials, observational studies, meta-analyses, and guidelines statement or consensus opinion documents were included. Searches were not limited to specific journals, no formal quality criteria were applied, and formal meta-analytic techniques were not used.
The timing of procedural complications is an important consideration in the discharge process. Early complications include abrupt vessel closure (including major side branches), acute stent thrombosis, and access site complications. Quiz Ref IDDelayed complications that might occur several hours after a successful PCI include access site bleeding, non–access site bleeding, development of congestive heart failure, delayed contrast reactions, subacute stent thrombosis, complications related to sedation, and arrhythmias. In a cohort study11 of 450 PCI patients, most complications that would result in delayed discharge were identified within 6 hours of PCI. A larger, higher-risk patient cohort corroborated these earlier findings.12 Both studies noted that the likelihood of complications occurring beyond 6 hours after PCI, especially during the period of overnight observation, was extremely low.
Randomized clinical trials comparing SDD with overnight observation after PCI have found SDD to be safe (Table). For example, the Elective PCI in Outpatient Study (EPOS)14 compared SDD-PCI with overnight stay in 800 patients undergoing elective PCI. Same-day discharge after PCI was not inferior to overnight stay with respect to the primary end point of 24-hour death, myocardial infarction, coronary artery bypass surgery, repeat PCI, or puncture-related complications. Overall, 18% of patients in the SDD-PCI group were transitioned to extended stay because of procedural complications, such as acute vessel closure (1%), coronary dissection (1%), occlusion of major side branch (2%), exchange to guiding catheters greater than 6F (2%), and suboptimal angiographic result (2%). A similar finding was noted in the observational Same-Day TransRadial Intervention and Discharge Evaluation (STRIDE) study11 of patients undergoing transradial PCI.
The Canadian Early Discharge After Transradial Stenting of Coronary Arteries (EASY) Study13 randomized patients who had undergone a successful PCI to overnight stay vs SDD-PCI and included 1005 patients (18% with elevated cardiac troponins at baseline), representing a higher-risk cohort. At 30 days13 and at 1 year,18 there was no difference in the composite primary end point, defined as death from any cause, myocardial infarction, unplanned revascularization, major bleeding, access site complications, or rehospitalization. The results suggest that, after a successful transradial PCI, patients could be safely discharged home the same day of their procedure even in a high-risk cohort treated with an aggressive anticoagulation regimen.
In a systematic review and meta-analysis comparing SDD-PCI with overnight stay,19 the clinical risk profile of patients in the SDD group was similar to that of those hospitalized overnight. No clinically important differences in comorbidities, procedural characteristics, multivessel PCI, high-risk lesions, access site, or use of vascular closure devices were noted between the 2 groups. At 30 days, there were no measurable differences in the incidence of total complications or major adverse cardiovascular events between the 2 groups. These results were subsequently confirmed in a separate meta-analysis.20
Quiz Ref IDThe choice of radial or femoral access does not appear to influence the safety of SDD-PCI.14,21,22 A large, nationally representative study5 from the US National Cardiovascular Data Registry compared patients who had PCI and then were discharged the same day of the procedure with those who were observed overnight. Overall, 1.25% (1339 of 107 018) of eligible patients were discharged the day of the procedure. Femoral access was used in 96% of these cases, and 33% had interventions on high-risk lesions. In-hospital bleeding complications occurred at a similar frequency in both groups (0.37% in the SDD cohort and 0.41% in the overnight stay group). At 2 days and 30 days after the procedure, there were no differences in the incidence of death or rehospitalization between the 2 cohorts. These data demonstrate that SDD-DC is not necessarily dependent on the specific route of vascular access but on ensuring that hemostasis is achieved without vascular or bleeding complications.
In summary, there are considerable peer-reviewed published data showing that SDD-PCI in appropriately selected patients is safe. The overall incidence of bleeding and vascular-related complications is low, and there does not appear to be increased risk of mortality or rehospitalization related to the index procedure.
Strategies to safely shorten LOS in selected patients has resulted in cost savings across many procedural specialties. For example, SDD after uncomplicated appendectomy or thyroid surgery has been shown to reduce resource use and costs without compromising quality.23,24 Similarly, SDD-PCI has the potential to offer economic advantages and substantial cost savings.
Using data from the Canadian EASY Study,25 SDD-PCI was associated with a 50% relative reduction in health care system costs (mean saving, Can $1141 [US $1086] per patient). Savings were mainly attributable to a reduction in resource use that accompanies an overnight stay. European studies have also reported cost savings. For example, savings in the EPOS14 amounted to approximately US $350 per patient, while those reported by Le Corvoisier et al10 were in the range of €1210 (US $1523) per patient. The differences in cost savings between trials may reflect variations in patient populations, absence of randomization and use of historical controls, radial vs femoral access, and lack of a standard costing methodology between hospitals and countries.
The subgroup of PCI patients who are typically considered for SDD are classified as outpatients with respect to reimbursement. In the United States, federal hospital reimbursement for outpatient procedures (including PCI) falls under the Outpatient Prospective Payment System by the Centers for Medicare & Medicaid Services. For 2015, Medicare reimbursements for an outpatient PCI with 1 or 2 drug-eluting stents (Ambulatory Payment Classification 0229 and 0319) were US $9624 and US $14 841, respectively.26 Under this bundled payment system, strategies that can reduce costs will result in a more favorable economic outcome for the medical center. It has been estimated that the US health care system could save between US $200 and US $500 million per year if 50% of the patients undergoing PCI in the United States were discharged the same day.27 It should be noted that the shift of PCI to an outpatient procedure has also shifted some of the cost to the patient, primarily in the form of increased copayments.
While these savings may change as the reimbursement landscape continues to evolve, it is clear that SDD after uncomplicated PCI has the potential to use fewer hospital resources and decrease the intensity of care without compromising safety. In addition, there are indirect cost savings associated with SDD-PCI, such as the potential for reducing medical errors and complications, increasing bed availability for new patients, and cost-savings for medical centers.
The successful implementation of SDD-PCI relies on 5 essential domains. These include (1) accurate assessment of suitability for SDD; (2) excellent procedural outcomes; (3) rapid and reliable stabilization of the vascular access site, allowing for early and safe ambulation; (4) reliable provision of dual antiplatelet therapy (DAPT); and (5) postprocedural patient education, routine early follow-up, and tracking of outcomes.
A number of tools have been developed to help aid in predicting PCI-related risk and mortality based on a combination of clinical, anatomic, and procedural characteristics.28-30 Although these models are well studied and validated, they were not developed for low-risk outpatient PCI, nor were they designed to measure the short-term residual risk after a successful PCI procedure. Percutaneous coronary intervention—related mortality risk is primarily driven by clinical acuity, such as urgency of the procedure, presence of shock, advanced symptomatic heart failure, and cardiac arrest within 24 hours—features that are unlikely to be present in patients referred for outpatient coronary PCI. Most of the PCI risk attributable to global risk factor models occurs during the actual PCI procedure, but among patients with an uncomplicated procedure and the absence of unstable clinical features, the residual postprocedural risk appears to be low and clusters primarily around vascular access issues and hemostasis. Quiz Ref IDFactors like frailty, health literacy (understanding the nature of the procedure), and the presence of social support may be more important in determining suitability for SDD-PCI.
The evolution in PCI equipment (eg, the use of smaller-profile equipment), techniques, and adjunctive pharmacology has led to more reliable acute PCI results, which in turn has allowed for SDD to be considered. In the era before the routine use of coronary stents, the results of balloon dilation were not always predictable and often complicated by vessel dissection, recoil, and acute closure, resulting in myocardial infarction or necessitating urgent or emergent coronary artery bypass graft (CABG) surgery.31 With the introduction of coronary stents, acute procedural success became more reliable; however, the aggressive use of antithrombotic therapy and large-bore arterial access increased the risk of vascular access complications and bleeding.32,33 At that time, aspirin, dipyridamole, low-molecular-weight dextran, and high-dose heparin were frequently used during and immediately after the procedure while transitioning to dose-adjusted oral anticoagulation therapy. As a result, vascular access site complications were common, and LOS after PCI averaged 5.8 days.
The development of techniques for optimal stent deployment, smaller-profile catheters, and more potent oral platelet inhibitors, along with the use of lower doses of unfractionated heparin, significantly changed the clinical landscape and the need for extended hospitalization after coronary stenting. Studies demonstrated that using DAPT yielded similar rates of stent thrombosis, with fewer vascular complications compared with the dose-adjusted anticoagulation therapy.34 The LOS in the DAPT group was 3.1 days vs 7.4 days in the warfarin sodium–treated group. Ongoing advancements have led to a steady increase in the safety profile of PCI. The most recent data from the National Cardiovascular Data Registry CathPCI Registry show that elective PCI has a success rate of 99.2%, a 0.17% risk of emergent CABG, a 0.47% risk of urgent CABG, and in-hospital mortality of 0.65%.35
Any patient considered for SDD-PCI should have an optimal procedural outcome, defined as a successful PCI (excellent angiographic result, without significant residual stenosis after stenting, and Thrombolysis in Myocardial Infarction 3 flow without dissection or thrombus), no compromise (ie, reduced flow) of a side branch at least 2 mm in diameter, and no postprocedural chest pain. The occurrence of any of these events should prompt consideration of longer postprocedural stay.
Anticipation of vascular complications related to access site bleeding or vessel disruption has been one of the main drivers of extending the hospital observation period. However, a reduction in vascular access site complications has occurred steadily during the past decade, primarily due to (1) adoption of radial access, (2) refinement of femoral access and sheath removal, (3) reduction in the size of the arterial sheath, and (4) use of vascular closure devices to achieve femoral hemostasis, as well as a combination of these measures.
After transradial access for cardiac catheterization was first reported in a 1989 study,36 Kiemeneij et al37 described its application for PCI. Adoption of transradial access has progressed steadily during the past 2 decades.38,39 The primary benefits of radial access include reduced vascular access complications, improved patient comfort, and decreased recovery time compared with femoral access. Several other clinical trials have demonstrated reduced mortality compared with a femoral approach in high-risk patients.40-44
Femoral access has also become safer during the past decade.45 Complication rates initially in the range of 3% to 6% have been reduced to approximately 2% in several studies.46-48Quiz Ref ID Improved safety with femoral access during this time was likely due to refinement in arterial access (including routine fluoroscopy, micropuncture techniques, and ultrasound), development of improved pharmacologic therapy, reduction in sheath size, and changes in sheath removal techniques.49-53 For example, reducing the French size of the arterial sheath may reduce vascular access–related complications and bleeding by 50%.3,54 Although controversy may still exist regarding the safety of vascular closure devices, the available data show that vascular closure devices reduce the time to hemostasis and ambulation compared with manual compression, thus making them attractive when considering SDD-PCI.55,56
Dual antiplatelet therapy is essential after PCI with stents. Its use is a core component in the prevention of stent thrombosis as well as recurrent myocardial infarction. When stent thrombosis occurs, nonadherence to DAPT is commonly cited as a risk.57 Patient education surrounding the indication, adverse effects, and duration of DAPT after PCI is an integral activity during the patient’s stay. Quiz Ref IDThere are several common factors that contribute to nonadherence, including lack of patient understanding of the importance of DAPT, cost, and medical errors, and nonadherence is common after PCI.58-60 Therefore, it is imperative that health care professionals develop a plan to ensure that each patient has a clear understanding of what medications, including DAPT, are to be taken and to facilitate the procurement of the patient’s medications, preferably before discharge.61
Based on the available data, a period of 4 to 6 hours of postprocedural observation appears sufficient. Centers may also need to consider the time of day in the decision to send a patient home the same day as the PCI. Written discharge instructions with definite prompts or teach-backs and pictures can assist patients and families to understand common complications and how to manage them. All of this information should also be provided to patients and their caregivers as enduring content in printed form (eAppendix in the Supplement). Patients should also be provided with a contact name and number that can serve as a safety net if complications occur overnight. Informed patients will decrease the need for readmission.62 All patients must be contacted the following day to assess for complications, address any further questions, and confirm receipt of and adherence to DAPT.
In terms of the mechanics of developing the program, the details need to be tailored to each medical center or group of health care professionals. The focus should be on developing a standardized protocol to identify patients with favorable clinical features who undergo successful PCI procedures and have not developed complications during a specified observation period. Based on published data, between 25% and 35% of low-risk PCI patients may not be suitable for SDD.13
The Table lists the published, randomized clinical trials as well as their respective inclusion and exclusion criteria. These published articles, in combination with existing guidelines, can serve as a starting point that can be modified to fit the needs of any specific program. The development of this clinical pathway requires the input of several groups within the medical center. Physicians, care extenders, nursing, hospital administration, and recovery unit staff are all stakeholders. Creating a protocol and care pathway with the involvement of these groups will improve the likelihood of a successful program.
As a general principle, patient selection should focus on patients not requiring prolonged observation due to comorbid conditions or particularly high-risk features that could be exacerbated during the PCI procedure. Suitable patients should have an uncomplicated PCI procedure, without requirement for prolonged parenteral antithrombotic agents, and a stable vascular access site. They should be at their baseline level of ambulatory ability at the time of discharge. If complications develop during the recovery period or there is any concern that the patient or his or her social support is unable to provide safe care at home, the patient should remain in the hospital overnight. A clear provision to obtain DAPT, postprocedural education, and follow-up are required elements of an SDD program.
Preprocedural staff should have an important role in facilitating SDD protocols. Well-developed screening tools established by each institution can assist in the identification of higher-risk patients who will require overnight care or observation or have limited cognitive or social resources. Suitable patients should be targeted to undergo procedures earlier in the day, which will allow recovery or observation to be completed at a reasonable time.
Catheterization laboratory professionals (nurses and technologists) serve as the next step in the care pathway. There may be procedural events that deem otherwise eligible patients to no longer be candidates for SDD. At the completion of the case, the catheterization laboratory personnel should discuss the patient’s eligibility and timing for discharge with the attending physician. Dedicated postprocedural order sets will greatly facilitate the remainder of the patient’s stay and direct the care efficiently.
Recovery area staff will observe for procedural complications, such as bleeding, access site complications, chest pain, heart failure, and contrast reactions. Before discharge, patients should be at their baseline functional status. Clear discharge protocols and criteria should exist so that caregivers can send patients home efficiently.
In the United States, most patients are observed overnight after elective PCI. Therefore, one barrier to adoption of SDD-PCI is physician inertia with respect to changing practice. Because a growing body of evidence suggests a real hazard of hospitalization from adverse events, such as infectious colonization, accidents, drug errors, and posthospitalization stress syndromes,63-65 one approach to overcoming this barrier is to realize that the patient may be safer at home than in the hospital. In addition, emerging data confirm a patient preference for SDD.15,66-68
A recent analysis of malpractice claims against cardiologists identifies that the most common causes of lawsuits involve failure to diagnose conditions, particularly acute coronary syndromes and aortic dissections.69 An analysis of cardiac catheterization–related litigation in the United States suggests that most of the legal risk is a direct result of adverse events during the procedures (improper performance), with the outcome of death most likely to result in a lawsuit.70 Expected risks of a procedure do not equate to malpractice, but deviations from standard practice expose the physician to a potential lawsuit if an adverse outcome results. Clear communications with the patient and family about the potential risks after discharge and a plan on how to react to an unexpected event, including a safety net, are important measures for both patient safety and the prevention of legal liability.
In the clinical trials (Table), crossover to overnight admission may have underestimated some of the potential adverse outcomes of SDD. Indeed, some adverse events, such as acute stent thrombosis, could have devastating consequences if they occur outside the hospital setting. However, clinical judgment is critical to the real-world success of such a program. If there is any concern about an adverse outcome or a suboptimal angiographic PCI result, the patient should not be discharged home. Nonetheless, as with all findings of clinical trials, health care professionals will likely apply the results to a broader patient population than that represented in the trials. A patient may misperceive his or her own risk and medical condition because the procedure (ie, PCI) was short and painless. Patient education and medication review are critical during the recovery period and should be reinforced at subsequent follow-up visits.
Due to advancements in technique, pharmacology, and technology, PCI is much safer and is commonly practiced throughout the world. Length of stay has decreased steadily since the procedure was first introduced, such that most patients are now discharged within 24 hours of their procedure. Although the current practice is to observe patients overnight to monitor for complications, many patients can be safely discharged on the same day of their PCI. In this article, we have assembled the recent scientific literature on this topic and set forth the present opportunities and barriers to implementation of this practice. Promoting early discharge for stable PCI recipients will benefit patients, caregivers, medical centers, and payers. Same-day discharge after low-risk cases is the next step in the evolution of PCI.
Accepted for Publication: January 27, 2016.
Corresponding Author: Adhir Shroff, MD, MPH, Department of Medicine, University of Illinois at Chicago, 840 S Wood St, Mail Code 715, Ninth Floor, Chicago, IL 60607 (email@example.com).
Published Online: March 30, 2016. doi:10.1001/jamacardio.2016.0148.
Author Contributions: Dr Shroff had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: All authors.
Acquisition, analysis, or interpretation of data: Shroff, Gilchrist, Caputo, Bertrand, Pancholy.
Drafting of the manuscript: Shroff, Kupfer, Gilchrist, Bertrand, Pancholy, Rao.
Critical revision of the manuscript for important intellectual content: Shroff, Gilchrist, Caputo, Speiser, Bertrand, Rao.
Administrative, technical, or material support: Shroff, Speiser, Bertrand.
Study supervision: Shroff, Gilchrist, Bertrand, Rao.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest, and none were reported.