Curr Cardiol Rep (2014) 16:470 DOI 10.1007/s11886-014-0470-y
INTERVENTIONAL CARDIOLOGY (S RAO, SECTION EDITOR)
Same Day Discharge After Elective Percutaneous Coronary Intervention Ian C. Gilchrist
# Springer Science+Business Media New York 2014
Abstract Same-day percutaneous coronary intervention (PCI) is a reality with modern interventional equipment and pharmaceutical agents. Elective PCI is rarely an inpatient procedure and is now predominantly considered an outpatient procedure. Approaches to safely manage elective patients through same-day PCI have been well described in the literature and demonstrate no safety signal compared with overnight monitoring in the elective patient. With the costs of elective PCI being time dependent in comparison to fixed reimbursement of outpatient care, the efficiencies to bed utilization offered by same-day PCI make this attractive from an efficiency view point. Patient satisfaction improves with same-day discharge. The potential for cost-efficient care can only be maximized if health care providers view this shift to outpatient PCI care as an impetus to improve the whole care process rather than an administrative change with no effect on actual patient care. Same-day PCI is effective and can be integrated into modern health care.
Keywords Cardiac catheterization . Radial artery . Femoral artery . Outcomes . Percutaneous coronary intervention (PCI) . Complications . Outcome . Economics . Patient satisfaction . Bleeding . History . Coronary artery disease . Disease management . Outpatient care . Inpatient care . Nursing care . Social support . Closure device . Cardiac stent . Bivalirudin . Heparin . Cost-effectiveness . Same day discharge
This article is part of the Topical Collection on Interventional Cardiology I. C. Gilchrist (*) College of Medicine, Heart and Vascular Institute, Pennsylvania State University, 500 University Drive, Hershey, PA 17033, USA e-mail: [email protected]
Introduction Advances in techniques and technology used to treat coronary artery disease in the cardiac catheterization laboratory have triggered a quantum shift in the location of care for percutaneous coronary interventions (PCI) from the acute inpatient setting to the outpatient area. This shift has been met with enthusiasm by United States (US) payers who no longer will pay for acute admission for elective PCI, and with resistance by some providers concerned about patient outcomes and hospitals concerned about revenue drop in this transformation of care. Physician fees have not been directly affected by this shift. Nevertheless, physicians have been resistive to these changes [1] for a multitude of reasons including; inertia, concerns of patient safety, ignorance about the changing outcomes of PCI procedures, and newer payer expectations for hospital reimbursement, and a lack of training in newer interventional techniques such as transradial and advanced femoral access techniques. The purpose of this paper is to review the contributions of the multiple advances in PCI and defuse some residual concerns that define the present state of same day PCI, specifically in the United States but also relevant internationally.
Technological and Pharmacologic Advances Interventional cardiology has evolved rapidly since its introduction to mainstream cardiology in the late 1970’s by Andreas Gruentzig. Quickly embraced by the cardiovascular community, it spawned the new subspecialty of interventional cardiology and an explosion of advances both in the understanding of cardiac disease and the therapeutic options. During this evolution, angioplasty balloon catheters have been refined and stents developed. With stents, the fear of acute closure and potential need for surgical coronary artery
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revascularization was greatly diminished. The ability of the interventionalist to self-rescue from unexpected complications has become so routine that surgical back-up is no longer required. Stent technology has further evolved into more deliverable systems and has been combined with coatings to modify the healing process and reduce restenosis. Equipment has become smaller, and delivery catheters reduced from 9French (F) internal diameter to 5F. Paralleling advances in equipment design has been a growing understanding of effective periprocedural pharmacologic therapy. This is perhaps best exemplified by a broadened understanding of platelet function and how to modify it. Not only has routine antiplatelet therapy advanced through potent intravenous glycoprotein (GP) IIb/IIIa receptor inhibitors to present day oral P2Y12 platelet receptor inhibitors, but adjunctive antithrombin therapy has also evolved. The initial requirement for warfarin on initial marketing of the Palmaz-Schatz [2] and Gianturco-Roubin stent [3] was antiquated by the superior performance of oral antiplatelet therapy and higher pressure stent deployment [4] that markedly simplified poststent pharmacology. The use of heparin intraprocedural has been refined and titrated to effect [5, 6] while newer agents such as the direct thrombin inhibitor bivalirudin have now, in many cases, replaced heparin by demonstrating a shorter and more predictable effect and modestly improved safety [7].
Evolution of PCI Technique PCI techniques first arrived in the late 1970s at a time when brachial cutdown techniques were being rapidly replaced by percutaneous transfemoral access techniques in the cardiac catheterization laboratory. The ability of the femoral artery to accept the large diameter catheters required of early interventional equipment was a fortunate coincidence as it fostered refinement of these technologies without critical limitations being imposed by femoral artery diameter. While the transfemoral approach was technically less demanding and easier to teach than the cutdown techniques it replaced, when combined with evolving potent antithrombotic and antiplatelet regimens, the specter of access site bleeding from unsecured arterial hemostasis became a focus of concern. In the US, a plethora of closure devices were developed and marketed to help the cardiologists control the femoral access site, while in other parts of the world a shift to the radial artery provided an answer to access site control. In effect, the shift to radial and, to a lesser extent, improved vascular closure devices for the femoral artery, provided the safe hemostasis [8] that could be combined with superior stent performance and pharmacologic understanding that would permit percutaneous coronary revascularization to become a same day procedure. The present-day transition to transradial from transfemoral access is an evolutionary change in technique analogous to the
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shift from brachial cutdown to percutaneous transfemoral techniques several decades prior and provides a safer procedure for patients [9, 10]. Building on an initial experience with transradial techniques, the potential for same day PCI discharge was explored by Dr. Kiemeneij starting in 1994 [11–14] in the era of oral anticoagulation for stents. While most cardiologists maintained their transfemoral patients in the hospital for days while transitioning from heparin to warfarin, Dr. Kiemeneij was preemptively starting warfarin as an outpatient until the INR was therapeutic, placing the stent transradially, and immediately discharging the patient home, in essence demonstrating the proof-of-principle for same day PCI. This promising experience not only showed the potential for same day PCI, but also demonstrated the use of transradial in fully anticoagulated patients that most femoral operators would dismiss as unsafe for access. While a shift to transradial virtually eliminates the problem of significant vascular access complications such as bleeding [15•], further refinements in femoral technique and especially pharmacology have also contributed to the safety of PCI procedures [16•]. While the predilection of US cardiologists for vascular closure devices has often been noted as a reason for the slow US adaption of transradial techniques, there has been a broadened understanding of the importance of fastidious femoral techniques in procedural outcome. Whether or not a femoral closure device is used, recent trials have demonstrated a marked improvement in bleeding outcomes during transfemoral procedures that have permitted patients to be safely ambulated to discharge on the same day [17•, 18]. The concept of same day PCI was demonstrated in the US with transfemoral [19] and transradial [20] same day discharge not long after the early European reports as some operators put technologic advances and improved outcomes together to modify US practice patterns. Resistance to change permeated the overall US cardiovascular system and transformation was slow. Same day discharge is a risk to hospital reimbursement due to the lower rate of payment under the Ambulatory Payment Classification category, which may explain the lack of widespread uptake and the high rate of hospital admission for 1 night’s stay. Ultimately, this resistance to change was broached with expectations from the US government that these PCI procedures be performed in the outpatient setting and the recognition that “inappropriate” inpatient billing would be met with stiff fines thru audits [21].
Evolution in Payer Expectations Concomitantly the InterQual Criteria (McKesson Corporation, San Francisco, USA) used by many payers to justify admission criteria changed the indication for PCI admission in 2007. No longer was an elective PCI entitled to default
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inpatient status, but now only complicated procedures or patients with underlying condition that otherwise needed acute in patient care could be admitted. Initial reimbursement between inpatient and outpatient reimbursement for the hospital was set to the disadvantage of outpatient care and produced a strong financial incentive to justify inpatient admissions. Subsequent to the changes in InterQual Criteria, adjustments to reimbursement for outpatient procedures [22] and pass-through of certain higher cost pharmaceuticals, utilization of outpatient PCI was made financially more attractive. Another factor was the successful efforts of the Department of Justice and the Centers for Medicare and Medicaid Services’ (CMS) Recovery Audit Contractor (RAC) program [21] that provided the final push to the outpatient unit for PCI care for most US hospitals. The threat of significant fines and penalties, retroactively applied, made admitting elective PCI’s financially risky.
Same Day vs Outpatient Procedures: What is the Difference? Discussions about same day procedures are often confused with the designation of whether the patient is an outpatient or inpatient in the US. Even society guidelines have confused this issue [23]. The designation of inpatient or outpatient status is a billing status and defines the reimbursement the provider receives. Inpatient designation carries the requirement to meet certain requirements, usually comorbidities or acute medical conditions that are documented in the medical record. If these requirements are not met, the patient is considered an outpatient whether that patient is actually occupying an inpatient bed, observation unit bed, or outpatient recovery bed. The CMS manual defines observation care is a welldefined set of specific, clinically appropriate services, which include ongoing short term treatment, assessment, and reassessment before a decision can be made regarding whether patients will require further treatment as hospital inpatients or if they are able to be discharged from the hospital [24]. In reality, observational care is outpatient care. Observational care defines that the patient is potentially in a transition of care status but does not define an intermediate reimbursement between inpatient and outpatient. In late 2013, the definition of outpatient vs inpatient was refined once again to assume that an inpatient designation requires a stay, or an admitting expectation that the stay in the hospital will include at least 2 midnights. This latest definition does not obviate the need for proper documentation to justify the status as an inpatient in an acute care hospital [25]. On admission, if the practitioner has a reasonable expectation that the Medicare patient will require care over at least 2
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midnights, acute admission will be generally considered appropriate even if the patient ultimately is discharged earlier, as long as medical record justification exists. This documentation may face a RAC audit risk. Acute admission spanning more than 2 midnights, in general, will be considered reasonable admissions. A same-day procedure is one where the patient arrives and leaves the same calendar day as the procedure. This does not define whether the patient could have been designated as an outpatient or inpatient, although the new double-midnight definitions for inpatient status makes inpatient status much more difficult to meet for a same-day procedure. Short of being designated as an inpatient, the reimbursement for the hospital and physician in the US is the same whether the patient is discharged the same day as the procedure or stays overnight. While the reimbursement is the same, costs are time dependent both from direct costs of supplies and labor and also include costs of lost opportunity from an occupied bed. Hospitals that simplistically attribute a fixed cost to PCI recovery may be missing the opportunity to recognize efficiency savings from same-day discharge vs overnight care.
Patient Selection for Same-Day Discharge Appropriate patient selection for same-day discharge has been somewhat controversial and has been, in part, clouded by physician resistance to change. Since elective PCI is an outpatient procedure, at least in the US, the question no longer is inpatient or outpatient but rather whether the patient is stable enough to go home the same day as the procedure. Several years ago, the Society for Cardiac Angiography and Intervention (SCAI) attempted to codify the profile of the optimal same-day discharge patient [23]. Unfortunately, the schema proposed was very conservative and relied primarily on preprocedural variables of risk for PCI rather than postprocedural markers for impending complications. These characteristics have been challenged [26•, 27–29] as being relatively arbitrary, especial in the transradial subgroup. A variety of groups have published their experience with same-day discharge. Patient profiles have ranged from relatively well patients [30] reminiscent of SCAI guidelines to those at higher risk that included acute coronary syndromes [31, 32] with troponin release who would in general not be considered elective. The common finding from the growing list of published experiences is that despite risk strata, patients do well. Even patients in the sickest cohorts that were eliminated from same-day discharge had outcomes that were remarkably good [33, 34] especially if they experienced no intraprocedural complications. A recent meta-analysis of all available literature comparing same-day vs overnight recovery PCI was developed from 13 different studies involving of over 111,000 patients. This included both transradial and
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transfemoral series. Despite the large numbers of patients reported, the meta-analysis was unable to resolve a hazard to same-day discharge [17•], a finding that was subsequently confirmed independently in a similar analysis [18]. While the present data does not provide statistical proof of equivalency or risk, it suggests any difference is clinically so small that a very large, and realistically unlikely, study would be required to definitively resolve the issue. The best predictor of an adverse postprocedural event is an intraprocedural complication that results in an unstable arterial wall such as a dissection or side branch loss [35]. Once the procedure is complete, baseline characteristics have not been particularly helpful in defining risk as the recovery progresses. This observation should not be surprising as elective patients by definition have been relatively stable as outpatients prior to the procedure. Assuming that the PCI has been free of complications, these stable patients should be in the same, if not better, condition after a procedure that improved coronary artery flow. While debate continues on the medical profile of the perfect same day discharge, most authors agree that an overriding principle is reliable social support for the night after discharge to act as a safety net [36]. Without readily available assistance, it is potentially risky to send the patient home alone in case bleeding, or other event that might incapacitate the patient, occurs. Most operators have advocated for institutional safety nets such as 24-hour call in phone line and mandatory next day contact with the patient to confirm a satisfactory recovery. With good home support, the very elderly and even those with dementia have been successfully managed as same day discharges alleviating the risks of overnight hospitalization and disorientation.
Optimal Pharmacologic Therapy PCI has seen a marked improvement and simplification of antithrombotic therapy over its evolution. Early PCI therapy was as much a kitchen-sink approach based on a crude understanding of what agents worked and what was beneficial. Modern therapy should include pre-existing aspirin use and a P2Y12 inhibitor started either before or as soon as possible after the decision to stent has been made [37]. For elective procedures, it would be unusual to expect GP IIb/IIIa use although their use has been previously noted in the sameday setting using US Food and Drug Administration (FDA) off-label, bolus, or short infusion regimens [20, 38, 39]. Elective patients who presently require initiation of intravenous antiplatelet therapy during a PCI for bail-out indications in the setting of dual, oral, antiplatelet therapy usually have experienced a procedural complication that would warrant longer postprocedural observation and might preclude same-day discharge.
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On the background of effective dual-antiplatelet therapy, control of the thrombin system is also required transiently during the intracoronary portion of the procedure. Classically, this is done with activated clotting time (ACT)-controlled heparin dosing, but success is possible with a wide variety of heparin-like agents as long as the degree of anti-thrombosis effect is equivalent in dose. In the US, the use of bivalirudin has overtaken the use of heparin for elective PCI [16•]. This direct thrombin inhibitor is noted to reduce bleeding complications both at the access site and non-access site organs without a loss in efficacy vs heparin regimens [40•]. It has a shorter half-life than heparin, a property that is potentially advantageous in securing vascular hemostasis for early discharge, and bivalirudin is unlikely to cause a drop in platelet counts. The benefits are weighed against the higher acquisition costs and lack of pharmacologic reversibility of bivalirudin. While the costs may be passed through using so called J-Codes in the US on an individual patient level that improves hospital reimbursement, the net cost to the healthcare system remains.
Vascular Approach At present there is an international shift in PCI from a predominantly transfemoral to that of transradial approach. Outside of the US multiple countries now have a majority of their coronary procedures done transradial [41•]. In the US transradial uptake has been somewhat delayed and only recently has demonstrated the start of a rapid dissemination [15•]. Transradial by its nature of low risk for bleeding access has been popular outside of the US for same-day discharge and permits participation of even patients on oral antithrombotic agents such as warfarin after PCI. In the US, and other areas regions of low radial penetration, transfemoral access has been successfully used to allow sameday discharge. Typically this requires a little longer observation time vs the radial approach in acknowledgement of the potential fallout from femoral access bleeding. In European and outside the US, manual compression of the access site has been used successfully for same-day discharge. US operators have been primarily using closure devices to back up their femoral hemostasis. Whether closure devices can really reduce vascular complications is a subject of debate. Despite this debate, the overall rate of femoral access complications has dropped with time and may be related to the use of these devices, newer antithrombotic regimens, or a better appreciation of the hazards of access site bleeding and concurrent greater care in access site management [42•]. Transradial access clearly carries the general benefits of certainty in stable hemostasis and patient satisfaction over transfemoral access even in the setting of bivalirudin use [43•]. This does not preclude the experienced femoral operator
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who practices good femoral technique from having a successful same-day discharge program. The femoral access site management has to be meticulous to avoid later vascular bleeding that could interfere with same-day discharge or result in significant late complications if it occurs after discharge.
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hospital. By the time discharge is planned, the patient needs to feel well and be confident that discharge is appropriate.
Safety Net/Risk Management Optimal Same-Day PCI Results A variety of models can be used to gauge the overall risk of the PCI procedure on the patient, but most take a preprocedural prospective. Most of this risk is dissipated during the in-lab portion of the procedure. In other words, if a prospectively identified high-risk patient undergoes the acute procedure without developing a complication in the catheterization laboratory, the subsequent risk after the procedure is low [28]. Multiple clinical trials of PCI have noted an almost lack of events in otherwise stable patients in the period between 4 and 24 hours after PCI when any difference between same-day and next-day discharge might manifest [33, 44]. The lowest risk recovery occurs in the patient who has had no ischemic complications during the stent procedure. The artery was opened without loss of side branch perfusion, without loss of flow down the target vessel such as noreflow, and any instability of the vessel wall is protected by stent at the conclusion of the procedure. Intra-procedural hemodynamics was stable without acute heart failure and no significant electrical instability. In addition, other rare complications, such as coronary perforation, may also make one hesitant to send the patient home the same-day. This postprocedural state of risk is distinctly different than the risk the patient potentially represented prior to the procedure. The acute procedural risk is driven by demographics and underlying disease status while the postprocedural risk is driven by the acute success or failure of the actual procedure. With an uneventful, successful PCI with adequate pharmacologic therapy, there is little risk postprocedure that can be avoided by monitoring the patient overnight [45].
Optimal Recovery While there is almost a honeymoon period between hours 4– 24 after PCI when further complications are almost unexpected, there still exists the time between 1 and 4 hours where the patient has to demonstrate stable recovery. Optimal results rarely manifest complications after leaving the catheterization laboratory, although, complications that do occur tend to manifest in the first couple of hours. Events in this period may alter the initial plan to potentially discharge the same day. Ischemic chest pain, intolerance of oral feeding, poor urine output or retention, and access site bleeding may all suggest a slower recovery and a need for longer observation in the
The concept that coronary revascularization could be done as a same day procedure would be considered an impossibility 30 years ago and is a great technologic advance. This advance though is not possible without adequate social support for the patient after discharge. Many patients and referring doctors may not understand that same-day discharge is a reality and families need to be prepared up front for this possibility. Preprocedural teaching including educating the family and developing an understanding for the patient’s support resources is critical to a safe same-day program. Most physicians are ill equipped to access these aspects of patient care and often advanced practice nurses or other well-trained medical staff are better able to navigate this aspect of the patient’s care. If it is apparent that the patient has no support to help the night after the procedure, same-day discharge is probably not advisable and an overnight stay should be anticipated. Once the patient is in the preprocedure staging area, the existence of the home support should be confirmed and all involved reinforced on the probably same-day discharge. Elective PCI is highly successful and most will be able to be discharged home, although the potential need to keep the patient overnight should not be totally excluded from the family support until same-day discharge is a reality. During the recovery period, the staff confirms the continued support at home, and if the procedure and recovery is uneventful, the patient is ultimately asked about their comfort level for same-day discharge. If preparation has been complete, it is very unusual for a patient to request an overnight stay. In my own practice I have had patients request discharge into the early morning hours if that was what was necessary to go home the same-day after a late procedure. Patients rarely view hospitals as a source of safety and most would rather be home. Education is often raised as a reason to keep a patient overnight. After all, the patient has a serious disease and long-term risk factor modification and an in-depth instruction is needed. That may be true, but many serious diseases such as cancer are presently managed as an outpatient. In addition, after a patient who has probably not slept well the night before the procedure, who has been rendered sedate during the procedure, and who is then further sleep-deprived as the staff follows vital signs all night will not be receptive to long-term teaching. By the following morning, the eagerness of patients and families to be discharged home may preclude any actual understanding of discharge instructions.
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A more reasonable approach involves focused teaching. Focusing on specific important information the patient and family needs to understand may accelerate a patient’s understanding of the issues. In the case of PCI, the 2 most important aspects that need to be understood are (1) where to call for help, and (2) insuring dual-antiplatelet therapy is continued after discharge. By focusing on these 2 aspects of care between the home support and the patient, one can be confident of a successful early discharge. Typically, a phone number is provided to the patient and the home support to use if an issue arises after discharge regardless of the time of night. The provision of this medical contact gives both the discharging staff and the patient confidence that professional help is available if the need arises and builds confidence for discharge. Dual antiplatelet therapy after discharge can be started in a variety of ways. Best approaches most likely involve some proof of either filling the prescriptions by showing the pills to the discharging staff or demonstrating a concrete plan on how the prescription is being filled after discharge. Verbalizing an understanding on the part of the patient of the consequences of not talking appropriate dual-antiplatelet therapy helps cement the importance of this step. Same-day discharge should not pretend to provide a full spectrum of teaching about coronary artery disease, but rather focuses on the critical portion the patient needs to know and is able to understand at the moment. Ultimately, long-term completion of the disease teaching is needed [46], but whether the patient goes home the same or next day, neither incident of care is appropriate for sound education. Most same day discharge programs follow-up discharge with patient contact within 24–48 hours. This contact insures a safe transition to the outpatient setting and the execution of the discharge plan with dual antiplatelet therapy. It also gives the patient time to bring up any concerns that might have arisen during the period immediately surrounding discharge. This contact with the well-rested patient is a good point to quickly reinforce the in-hospital teaching and then confirm that the patient has longer-term plans for follow-up that will continue the teaching for long-term disease management. Using an approach outlined above, a multilayer safety net for the patient’s same-day discharge is activated. Expectations and planning starts before the procedure so there are no surprises. Expectations of the patient and home support are laid out for the recovery and the adequacy of the recovery is supported by the patient’s desire to be discharged the same day. Postdischarge escape routes for complications or concerns are outlined and understood by all involved, and ultimately the providers make contact with the patient after discharge to confirm success. With such due diligence, risk exposure whether it is to the patient’s health or the provider’s liability is minimized and the rewards of same-day discharge maximized.
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Cost Savings Despite the need for the transition to outpatient care, how to optimize this new care process financially has been poorly addressed. For many hospitals, payer policy changes resulted in patients’ admission status being changed from inpatient to outpatient with little attention to the care process changes that should have also taken place. The numbers of elective PCI patients being discharged the same-day over the last few days has remained very low [47•] despite this significant change in reimbursement policy suggesting an on-going need for hospital administration to better understand their cost effectiveness. Costs can be calculated a variety of ways and the use of implied costs or assumed costs to simplify economic calculation are especially common in the health care industry and can skew one’s understanding of the truth. Simplistically, reimbursement is essentially the same to the hospital and doctor regardless of whether the patient stays overnight or goes home the same day. Both, most likely, will be considered outpatients under the 2 Midnight Rule and the reimbursement is fixed. To maintain a patient in a bed requires time and effort on part of the hospital and the longer the bed is occupied the lower the net reimbursement on an hourly basis is obtained from that bed. In addition, the longer the bed is occupied, the greater the chance that a complication related to hospitalization [36] may occur that could further elevate costs without necessarily raising reimbursement. In addition, while the bed is occupied, new patients as new sources of revenue can’t occupy the bed and a loss of opportunity for revenue occurs. In net, same day discharge maximizes reimbursement by discharging as early as possible, but not so early as it risks complications from a hasty discharge [48, 49]. Many hospital care pathways for PCI patients were developed before same-day discharge was conceived. Shifts to same-day care with either advanced femoral artery care or transradial procedures represent more than a simple shift in catheterization laboratory technique. Instead, it presents to the enterprising health care system an opportunity to revamp its PCI pathways and develop novel multidisciplinary pathways to provide specialized care to these patients without the overhead of inpatient status. Those that have adapted to this new reality have seen the benefits of programmatic renovation of their care plans [50]. On the other hand, assigning a fixed cost to PCI recovery regardless of actual time resource used wastes the potential for the savings to be derived from same-day discharge. Likewise, if the hospital is unable to fill the unoccupied beds, the early discharge of the patient does not represent an opportunity to treat another sicker patient who clinically requires inpatient care. The question of transradial or femoral as the preferred access has been a subject of debate. Outside of the US, the shift to transradial drove the shift to same day procedures. Recently in the US, the relatively modest use of same day
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discharge has been dominated by femoral operators [47•]. Careful vascular techniques using transfemoral approach has markedly lowered access site complications, although ultimately the lowest complications come in the hands of experienced radial operators. In addition, several groups have demonstrated a cost advantage to transradial driven by equipment, procedural, and length-of-stay costs that suggest a significant cost-effectiveness advantage to radial [51].
Patient Satisfaction Satisfaction with the health care experience is become an important metric in the scramble to measure the results of health care. When the discussion turns to same-day discharge memories of controversies over “drive-through deliveries” [52] often surface and questions about patient satisfaction develop. The patient experience is different with same-day PCI. While hospitalization offers for many reassurances and time for respite for some medical (and obstetric) condition, the diagnosis of heart disease is frightening to many patients and they naturally want to feel safe and secure. Home with one’s family or social support may be the greatest source of security as opposed to continue hospitalization [53]. The opportunity to retreat back to one’s home is likely what some patients desire to process the events and diagnosis that they have just learned. Studies indicate that patients discharged the same day are typically very satisfied with their experience [46, 54, 55] including those undergoing ad hoc PCI [56]. They will usually demand similar treatment in the future if needed, and do not view same-day discharge as a perversion of standard medical care.
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and inconvenience of hospitalization, but also the health care system in general can benefit from the advances in medical science. Compliance with Ethics Guidelines Conflict of Interest Ian C. Gilchrist has received consulting fees from The Medicines Company, Inc., Accumed, Inc., and Abbott Vascular, Inc. Human and Animal Rights and Informed Consent This article does not contain any studies with human or animal subjects performed by any of the authors.
References Papers of particular interest, published recently, have been highlighted as: • Of importance 1.
2.
3.
4.
5.
Conclusions Outpatient PCI is the de facto reimbursement standard for PCI in the US and is widely practiced around the world. With advances in pharmacology and technology, the recovery from PCI can be predictably accomplished with the confines of same-day discharge antiquating the concept that PCI is an overnight procedure. While a variety of potential pitfalls can affect the post-PCI patient that might make same-day discharge not attractive, most elective patients can be considered for same-day discharge under the right circumstances. Sameday PCI needs advance consideration, uneventful catheterization laboratory procedures and early recovery, combined with the confirmed presence of responsible social support to be available for the patient the night after discharge. Finally, a safety net with an escape plan for the patient should be in place prior to discharge to give confidence in coverage for all possibilities for both the providers and patient. Through same-day discharge not only can the patient avoid the hazards
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Bottner RK, Blankenship JC, Klein LW, et al. Current usage and attitudes among interventional cardiologists regarding the performance of Percutaneous Coronary Intervention (PCI) in the outpatient setting. Catheter Cardiovasc Interv. 2005;66:455–61. Serruys PW, de Jaegere P, Kiemeneij F, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. N Engl J Med. 1994;331: 489–95. Hearn JA, King III SB, Douglas Jr JS, et al. Clinical and angiographic outcomes after coronary artery stenting for acute or threatened closure after percutaneous transluminal coronary angioplasty. Initial results with a balloon-expandable, stainless steel design. Circulation. 1993;88:2086–96. Schömig A, Neumann F-J, Kastrati A, et al. A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary-artery stents. N Engl J Med. 1996;334:1084–9. Chew DP, Bhatt DL, Lincoff AM, et al. Defining the optimal activated clotting time during percutaneous coronary intervention: aggregate results from 6 randomized, controlled trials. Circulation. 2001;103:961–6. Tolleson TR, O’Shea JC, Bittl JA, et al. Relationship between heparin anticoagulation and clinical outcomes in coronary stent intervention: observations from the ESPRIT trial. J Am Coll Cardiol. 2003;41:386–93. Lincoff AM, Bittl JA, Harrington RA, et al. Bivalirudin 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;289:853–63. Marso SP, Amin AP, House JA, et al. Association between use of bleeding avoidance strategies and risk of periprocedural bleeding among patients undergoing percutaneous coronary intervention. JAMA. 2010;303:2156–64. Kiemeneij F, Laarman GJ, Odekerken D, Slagboom T, van der Wieken R. A randomized comparison of percutaneous transluminal coronary angioplasty by the radial, brachial and femoral approaches: the ACCESS study. J Am Coll Cardiol. 1997;29:1269– 75. Kern MJ. Cardiac catheterization on the road less traveled: navigating the radial vs femoral debate. JACC Cardiovasc Interv. 2009;2:1055–6.
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16.•
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22. 23.
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26.•
27.
Kiemeneij F, Laarman GJ, Slagboom T, Stella P. Transradial Palmaz-Schatz coronary stenting on an outpatient basis: results of a prospective pilot study. J Invasive Cardiol. 1995;7:5A–11. Kiemeneij F, Laarman GJ, Slagboom T, van der Wieken R. Outpatient coronary stent implantation. J Am Coll Cardiol. 1997;29:323–7. Slagboom T, Kiemeneij F, Laarman GJ, van der Wieken R, Oderkerken D. Actual outpatient PTCA: the results of the OUTCLAS pilot study. Catheter Cardiovasc Interv. 2001;53:204–8. Slagboom T, Kiemeneij F, Laarman GJ, Van der Wieken R. Outpatient coronary angioplasty; feasible and safe. Catheter Cardiovasc Interv. 2005;64:421–7. Feldman D, Swaminathan R, Kaltenbach L, et al. Adoption of radial access and comparison of outcomes to femoral access in percutaneous coronary intervention: an updated report from the NCDR (2007–2012). Circulation. 2013;127:2295–306. Most recent look at transradial growth in the United States using data from the NCDR. Subherwal S, Peterson ED, Dai D, et al. Temporal trends in and factors associated with bleeding complications among patients undergoing percutaneous coronary intervention: a report from the National Cardiovascular Data CathPCI Registry. J Am Coll Cardiol. 2012;59:1861–9. NCDR based analysis of bleeding with PCI and factors associated with bleeding. Abdelaal E, Rao SV, Gilchrist IC, et al. Same-day discharge compared with overnight hospitalization after uncomplicated percutaneous coronary intervention: a systematic review and metaanalysis. JACC Cardiovasc Interv. 2013;6:99–112. Recent metaanalysis of same-day discharge compared with overnight admission including both radial and femoral approaches showing no evidence for harm, but statistically unable to prove non-inferiority due to low event rates. Brayton KM, Patel VG, Stave C, de Lemos JA, Kumbhani DJ. Same-day discharge after percutaneous coronary intervention: a meta-analysis. J Am Coll Cardiol. 2013;62:275–85. Wilentz JR, Mishkel G, McDermott D, et al. Outpatient coronary stenting using the femoral approach with vascular sealing. J Invasive Cardiol. 1999;11:709–17. Gilchrist IC, Nickolaus MJ, Momplaisir T. Same-day transradial outpatient stenting with a 6-hr course of glycoprotein llb/llla receptor blockade: a feasibility study. Catheter Cardiovasc Interv. 2002;56:10–3. The Medicare Recovery Audit Contractor (RAC) Program: an evaluation of the 3-year demonstration. 2008;2. (http://www.cms. gov/RAC/Downloads/RAC%20Evaluation%20Report.pdf). Resnic FS. The case for outpatient coronary intervention: balancing charges and discharges. Circulation. 2007;115:2248–50. Chambers CE, Dehmer GJ, Cox DA, et al. Defining the length of stay following percutaneous coronary intervention: an expert consensus document from the Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2009;73:847–58. Medicare Benefit Policy Manual, CMS Pub. 100-02, Chapter 6, §20.6; and Medicare Claims Processing Manual, CMS Pub. 10004, Chapter 4, §290.1. FY 2014 Inpatient Prospective Payment System (IPPS)/LongTerm Care Hospital (LTCH) final rule (CMS-1599-F). http:// www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ AcuteInpatientPPS/FY2014-IPPS-Final-Rule-Home-Page. html. Accessed 15 Oct 2013. Gilchrist IC, Rhodes DA, Zimmerman HE. A single center experience with same-day transradial-PCI patients: a contrast with published guidelines. Catheter Cardiovasc Interv. 2012;79:583–7. Review of 100 patient co-incidental with release of SCAI guidelines for same-day suggesting guidelines are too restrictive. Ziakas A, Klinke P, Mildenberger R, et al. Safety of same day discharge radial PCI in patients under and over 75 years of age. Int Heart J. 2007;48:569–78.
Curr Cardiol Rep (2014) 16:470 28.
29.
30.
31.
32.
33.
34.
35.
36.
37.
38.
39.
40.•
41.•
42.•
Ranchord AM, Prasad S, Seneviratne SK, et al. Same-day discharge is feasible and safe in the majority of elderly patients undergoing elective percutaneous coronary intervention. J Invasive Cardiol. 2010;22:301–5. Bagur R, Bertrand OF, Rodés-Cabau J, et al. Comparison of outcomes in patients 70 years versus
INTERVENTIONAL CARDIOLOGY (S RAO, SECTION EDITOR)
Same Day Discharge After Elective Percutaneous Coronary Intervention Ian C. Gilchrist
# Springer Science+Business Media New York 2014
Abstract Same-day percutaneous coronary intervention (PCI) is a reality with modern interventional equipment and pharmaceutical agents. Elective PCI is rarely an inpatient procedure and is now predominantly considered an outpatient procedure. Approaches to safely manage elective patients through same-day PCI have been well described in the literature and demonstrate no safety signal compared with overnight monitoring in the elective patient. With the costs of elective PCI being time dependent in comparison to fixed reimbursement of outpatient care, the efficiencies to bed utilization offered by same-day PCI make this attractive from an efficiency view point. Patient satisfaction improves with same-day discharge. The potential for cost-efficient care can only be maximized if health care providers view this shift to outpatient PCI care as an impetus to improve the whole care process rather than an administrative change with no effect on actual patient care. Same-day PCI is effective and can be integrated into modern health care.
Keywords Cardiac catheterization . Radial artery . Femoral artery . Outcomes . Percutaneous coronary intervention (PCI) . Complications . Outcome . Economics . Patient satisfaction . Bleeding . History . Coronary artery disease . Disease management . Outpatient care . Inpatient care . Nursing care . Social support . Closure device . Cardiac stent . Bivalirudin . Heparin . Cost-effectiveness . Same day discharge
This article is part of the Topical Collection on Interventional Cardiology I. C. Gilchrist (*) College of Medicine, Heart and Vascular Institute, Pennsylvania State University, 500 University Drive, Hershey, PA 17033, USA e-mail: [email protected]
Introduction Advances in techniques and technology used to treat coronary artery disease in the cardiac catheterization laboratory have triggered a quantum shift in the location of care for percutaneous coronary interventions (PCI) from the acute inpatient setting to the outpatient area. This shift has been met with enthusiasm by United States (US) payers who no longer will pay for acute admission for elective PCI, and with resistance by some providers concerned about patient outcomes and hospitals concerned about revenue drop in this transformation of care. Physician fees have not been directly affected by this shift. Nevertheless, physicians have been resistive to these changes [1] for a multitude of reasons including; inertia, concerns of patient safety, ignorance about the changing outcomes of PCI procedures, and newer payer expectations for hospital reimbursement, and a lack of training in newer interventional techniques such as transradial and advanced femoral access techniques. The purpose of this paper is to review the contributions of the multiple advances in PCI and defuse some residual concerns that define the present state of same day PCI, specifically in the United States but also relevant internationally.
Technological and Pharmacologic Advances Interventional cardiology has evolved rapidly since its introduction to mainstream cardiology in the late 1970’s by Andreas Gruentzig. Quickly embraced by the cardiovascular community, it spawned the new subspecialty of interventional cardiology and an explosion of advances both in the understanding of cardiac disease and the therapeutic options. During this evolution, angioplasty balloon catheters have been refined and stents developed. With stents, the fear of acute closure and potential need for surgical coronary artery
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revascularization was greatly diminished. The ability of the interventionalist to self-rescue from unexpected complications has become so routine that surgical back-up is no longer required. Stent technology has further evolved into more deliverable systems and has been combined with coatings to modify the healing process and reduce restenosis. Equipment has become smaller, and delivery catheters reduced from 9French (F) internal diameter to 5F. Paralleling advances in equipment design has been a growing understanding of effective periprocedural pharmacologic therapy. This is perhaps best exemplified by a broadened understanding of platelet function and how to modify it. Not only has routine antiplatelet therapy advanced through potent intravenous glycoprotein (GP) IIb/IIIa receptor inhibitors to present day oral P2Y12 platelet receptor inhibitors, but adjunctive antithrombin therapy has also evolved. The initial requirement for warfarin on initial marketing of the Palmaz-Schatz [2] and Gianturco-Roubin stent [3] was antiquated by the superior performance of oral antiplatelet therapy and higher pressure stent deployment [4] that markedly simplified poststent pharmacology. The use of heparin intraprocedural has been refined and titrated to effect [5, 6] while newer agents such as the direct thrombin inhibitor bivalirudin have now, in many cases, replaced heparin by demonstrating a shorter and more predictable effect and modestly improved safety [7].
Evolution of PCI Technique PCI techniques first arrived in the late 1970s at a time when brachial cutdown techniques were being rapidly replaced by percutaneous transfemoral access techniques in the cardiac catheterization laboratory. The ability of the femoral artery to accept the large diameter catheters required of early interventional equipment was a fortunate coincidence as it fostered refinement of these technologies without critical limitations being imposed by femoral artery diameter. While the transfemoral approach was technically less demanding and easier to teach than the cutdown techniques it replaced, when combined with evolving potent antithrombotic and antiplatelet regimens, the specter of access site bleeding from unsecured arterial hemostasis became a focus of concern. In the US, a plethora of closure devices were developed and marketed to help the cardiologists control the femoral access site, while in other parts of the world a shift to the radial artery provided an answer to access site control. In effect, the shift to radial and, to a lesser extent, improved vascular closure devices for the femoral artery, provided the safe hemostasis [8] that could be combined with superior stent performance and pharmacologic understanding that would permit percutaneous coronary revascularization to become a same day procedure. The present-day transition to transradial from transfemoral access is an evolutionary change in technique analogous to the
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shift from brachial cutdown to percutaneous transfemoral techniques several decades prior and provides a safer procedure for patients [9, 10]. Building on an initial experience with transradial techniques, the potential for same day PCI discharge was explored by Dr. Kiemeneij starting in 1994 [11–14] in the era of oral anticoagulation for stents. While most cardiologists maintained their transfemoral patients in the hospital for days while transitioning from heparin to warfarin, Dr. Kiemeneij was preemptively starting warfarin as an outpatient until the INR was therapeutic, placing the stent transradially, and immediately discharging the patient home, in essence demonstrating the proof-of-principle for same day PCI. This promising experience not only showed the potential for same day PCI, but also demonstrated the use of transradial in fully anticoagulated patients that most femoral operators would dismiss as unsafe for access. While a shift to transradial virtually eliminates the problem of significant vascular access complications such as bleeding [15•], further refinements in femoral technique and especially pharmacology have also contributed to the safety of PCI procedures [16•]. While the predilection of US cardiologists for vascular closure devices has often been noted as a reason for the slow US adaption of transradial techniques, there has been a broadened understanding of the importance of fastidious femoral techniques in procedural outcome. Whether or not a femoral closure device is used, recent trials have demonstrated a marked improvement in bleeding outcomes during transfemoral procedures that have permitted patients to be safely ambulated to discharge on the same day [17•, 18]. The concept of same day PCI was demonstrated in the US with transfemoral [19] and transradial [20] same day discharge not long after the early European reports as some operators put technologic advances and improved outcomes together to modify US practice patterns. Resistance to change permeated the overall US cardiovascular system and transformation was slow. Same day discharge is a risk to hospital reimbursement due to the lower rate of payment under the Ambulatory Payment Classification category, which may explain the lack of widespread uptake and the high rate of hospital admission for 1 night’s stay. Ultimately, this resistance to change was broached with expectations from the US government that these PCI procedures be performed in the outpatient setting and the recognition that “inappropriate” inpatient billing would be met with stiff fines thru audits [21].
Evolution in Payer Expectations Concomitantly the InterQual Criteria (McKesson Corporation, San Francisco, USA) used by many payers to justify admission criteria changed the indication for PCI admission in 2007. No longer was an elective PCI entitled to default
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inpatient status, but now only complicated procedures or patients with underlying condition that otherwise needed acute in patient care could be admitted. Initial reimbursement between inpatient and outpatient reimbursement for the hospital was set to the disadvantage of outpatient care and produced a strong financial incentive to justify inpatient admissions. Subsequent to the changes in InterQual Criteria, adjustments to reimbursement for outpatient procedures [22] and pass-through of certain higher cost pharmaceuticals, utilization of outpatient PCI was made financially more attractive. Another factor was the successful efforts of the Department of Justice and the Centers for Medicare and Medicaid Services’ (CMS) Recovery Audit Contractor (RAC) program [21] that provided the final push to the outpatient unit for PCI care for most US hospitals. The threat of significant fines and penalties, retroactively applied, made admitting elective PCI’s financially risky.
Same Day vs Outpatient Procedures: What is the Difference? Discussions about same day procedures are often confused with the designation of whether the patient is an outpatient or inpatient in the US. Even society guidelines have confused this issue [23]. The designation of inpatient or outpatient status is a billing status and defines the reimbursement the provider receives. Inpatient designation carries the requirement to meet certain requirements, usually comorbidities or acute medical conditions that are documented in the medical record. If these requirements are not met, the patient is considered an outpatient whether that patient is actually occupying an inpatient bed, observation unit bed, or outpatient recovery bed. The CMS manual defines observation care is a welldefined set of specific, clinically appropriate services, which include ongoing short term treatment, assessment, and reassessment before a decision can be made regarding whether patients will require further treatment as hospital inpatients or if they are able to be discharged from the hospital [24]. In reality, observational care is outpatient care. Observational care defines that the patient is potentially in a transition of care status but does not define an intermediate reimbursement between inpatient and outpatient. In late 2013, the definition of outpatient vs inpatient was refined once again to assume that an inpatient designation requires a stay, or an admitting expectation that the stay in the hospital will include at least 2 midnights. This latest definition does not obviate the need for proper documentation to justify the status as an inpatient in an acute care hospital [25]. On admission, if the practitioner has a reasonable expectation that the Medicare patient will require care over at least 2
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midnights, acute admission will be generally considered appropriate even if the patient ultimately is discharged earlier, as long as medical record justification exists. This documentation may face a RAC audit risk. Acute admission spanning more than 2 midnights, in general, will be considered reasonable admissions. A same-day procedure is one where the patient arrives and leaves the same calendar day as the procedure. This does not define whether the patient could have been designated as an outpatient or inpatient, although the new double-midnight definitions for inpatient status makes inpatient status much more difficult to meet for a same-day procedure. Short of being designated as an inpatient, the reimbursement for the hospital and physician in the US is the same whether the patient is discharged the same day as the procedure or stays overnight. While the reimbursement is the same, costs are time dependent both from direct costs of supplies and labor and also include costs of lost opportunity from an occupied bed. Hospitals that simplistically attribute a fixed cost to PCI recovery may be missing the opportunity to recognize efficiency savings from same-day discharge vs overnight care.
Patient Selection for Same-Day Discharge Appropriate patient selection for same-day discharge has been somewhat controversial and has been, in part, clouded by physician resistance to change. Since elective PCI is an outpatient procedure, at least in the US, the question no longer is inpatient or outpatient but rather whether the patient is stable enough to go home the same day as the procedure. Several years ago, the Society for Cardiac Angiography and Intervention (SCAI) attempted to codify the profile of the optimal same-day discharge patient [23]. Unfortunately, the schema proposed was very conservative and relied primarily on preprocedural variables of risk for PCI rather than postprocedural markers for impending complications. These characteristics have been challenged [26•, 27–29] as being relatively arbitrary, especial in the transradial subgroup. A variety of groups have published their experience with same-day discharge. Patient profiles have ranged from relatively well patients [30] reminiscent of SCAI guidelines to those at higher risk that included acute coronary syndromes [31, 32] with troponin release who would in general not be considered elective. The common finding from the growing list of published experiences is that despite risk strata, patients do well. Even patients in the sickest cohorts that were eliminated from same-day discharge had outcomes that were remarkably good [33, 34] especially if they experienced no intraprocedural complications. A recent meta-analysis of all available literature comparing same-day vs overnight recovery PCI was developed from 13 different studies involving of over 111,000 patients. This included both transradial and
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transfemoral series. Despite the large numbers of patients reported, the meta-analysis was unable to resolve a hazard to same-day discharge [17•], a finding that was subsequently confirmed independently in a similar analysis [18]. While the present data does not provide statistical proof of equivalency or risk, it suggests any difference is clinically so small that a very large, and realistically unlikely, study would be required to definitively resolve the issue. The best predictor of an adverse postprocedural event is an intraprocedural complication that results in an unstable arterial wall such as a dissection or side branch loss [35]. Once the procedure is complete, baseline characteristics have not been particularly helpful in defining risk as the recovery progresses. This observation should not be surprising as elective patients by definition have been relatively stable as outpatients prior to the procedure. Assuming that the PCI has been free of complications, these stable patients should be in the same, if not better, condition after a procedure that improved coronary artery flow. While debate continues on the medical profile of the perfect same day discharge, most authors agree that an overriding principle is reliable social support for the night after discharge to act as a safety net [36]. Without readily available assistance, it is potentially risky to send the patient home alone in case bleeding, or other event that might incapacitate the patient, occurs. Most operators have advocated for institutional safety nets such as 24-hour call in phone line and mandatory next day contact with the patient to confirm a satisfactory recovery. With good home support, the very elderly and even those with dementia have been successfully managed as same day discharges alleviating the risks of overnight hospitalization and disorientation.
Optimal Pharmacologic Therapy PCI has seen a marked improvement and simplification of antithrombotic therapy over its evolution. Early PCI therapy was as much a kitchen-sink approach based on a crude understanding of what agents worked and what was beneficial. Modern therapy should include pre-existing aspirin use and a P2Y12 inhibitor started either before or as soon as possible after the decision to stent has been made [37]. For elective procedures, it would be unusual to expect GP IIb/IIIa use although their use has been previously noted in the sameday setting using US Food and Drug Administration (FDA) off-label, bolus, or short infusion regimens [20, 38, 39]. Elective patients who presently require initiation of intravenous antiplatelet therapy during a PCI for bail-out indications in the setting of dual, oral, antiplatelet therapy usually have experienced a procedural complication that would warrant longer postprocedural observation and might preclude same-day discharge.
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On the background of effective dual-antiplatelet therapy, control of the thrombin system is also required transiently during the intracoronary portion of the procedure. Classically, this is done with activated clotting time (ACT)-controlled heparin dosing, but success is possible with a wide variety of heparin-like agents as long as the degree of anti-thrombosis effect is equivalent in dose. In the US, the use of bivalirudin has overtaken the use of heparin for elective PCI [16•]. This direct thrombin inhibitor is noted to reduce bleeding complications both at the access site and non-access site organs without a loss in efficacy vs heparin regimens [40•]. It has a shorter half-life than heparin, a property that is potentially advantageous in securing vascular hemostasis for early discharge, and bivalirudin is unlikely to cause a drop in platelet counts. The benefits are weighed against the higher acquisition costs and lack of pharmacologic reversibility of bivalirudin. While the costs may be passed through using so called J-Codes in the US on an individual patient level that improves hospital reimbursement, the net cost to the healthcare system remains.
Vascular Approach At present there is an international shift in PCI from a predominantly transfemoral to that of transradial approach. Outside of the US multiple countries now have a majority of their coronary procedures done transradial [41•]. In the US transradial uptake has been somewhat delayed and only recently has demonstrated the start of a rapid dissemination [15•]. Transradial by its nature of low risk for bleeding access has been popular outside of the US for same-day discharge and permits participation of even patients on oral antithrombotic agents such as warfarin after PCI. In the US, and other areas regions of low radial penetration, transfemoral access has been successfully used to allow sameday discharge. Typically this requires a little longer observation time vs the radial approach in acknowledgement of the potential fallout from femoral access bleeding. In European and outside the US, manual compression of the access site has been used successfully for same-day discharge. US operators have been primarily using closure devices to back up their femoral hemostasis. Whether closure devices can really reduce vascular complications is a subject of debate. Despite this debate, the overall rate of femoral access complications has dropped with time and may be related to the use of these devices, newer antithrombotic regimens, or a better appreciation of the hazards of access site bleeding and concurrent greater care in access site management [42•]. Transradial access clearly carries the general benefits of certainty in stable hemostasis and patient satisfaction over transfemoral access even in the setting of bivalirudin use [43•]. This does not preclude the experienced femoral operator
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who practices good femoral technique from having a successful same-day discharge program. The femoral access site management has to be meticulous to avoid later vascular bleeding that could interfere with same-day discharge or result in significant late complications if it occurs after discharge.
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hospital. By the time discharge is planned, the patient needs to feel well and be confident that discharge is appropriate.
Safety Net/Risk Management Optimal Same-Day PCI Results A variety of models can be used to gauge the overall risk of the PCI procedure on the patient, but most take a preprocedural prospective. Most of this risk is dissipated during the in-lab portion of the procedure. In other words, if a prospectively identified high-risk patient undergoes the acute procedure without developing a complication in the catheterization laboratory, the subsequent risk after the procedure is low [28]. Multiple clinical trials of PCI have noted an almost lack of events in otherwise stable patients in the period between 4 and 24 hours after PCI when any difference between same-day and next-day discharge might manifest [33, 44]. The lowest risk recovery occurs in the patient who has had no ischemic complications during the stent procedure. The artery was opened without loss of side branch perfusion, without loss of flow down the target vessel such as noreflow, and any instability of the vessel wall is protected by stent at the conclusion of the procedure. Intra-procedural hemodynamics was stable without acute heart failure and no significant electrical instability. In addition, other rare complications, such as coronary perforation, may also make one hesitant to send the patient home the same-day. This postprocedural state of risk is distinctly different than the risk the patient potentially represented prior to the procedure. The acute procedural risk is driven by demographics and underlying disease status while the postprocedural risk is driven by the acute success or failure of the actual procedure. With an uneventful, successful PCI with adequate pharmacologic therapy, there is little risk postprocedure that can be avoided by monitoring the patient overnight [45].
Optimal Recovery While there is almost a honeymoon period between hours 4– 24 after PCI when further complications are almost unexpected, there still exists the time between 1 and 4 hours where the patient has to demonstrate stable recovery. Optimal results rarely manifest complications after leaving the catheterization laboratory, although, complications that do occur tend to manifest in the first couple of hours. Events in this period may alter the initial plan to potentially discharge the same day. Ischemic chest pain, intolerance of oral feeding, poor urine output or retention, and access site bleeding may all suggest a slower recovery and a need for longer observation in the
The concept that coronary revascularization could be done as a same day procedure would be considered an impossibility 30 years ago and is a great technologic advance. This advance though is not possible without adequate social support for the patient after discharge. Many patients and referring doctors may not understand that same-day discharge is a reality and families need to be prepared up front for this possibility. Preprocedural teaching including educating the family and developing an understanding for the patient’s support resources is critical to a safe same-day program. Most physicians are ill equipped to access these aspects of patient care and often advanced practice nurses or other well-trained medical staff are better able to navigate this aspect of the patient’s care. If it is apparent that the patient has no support to help the night after the procedure, same-day discharge is probably not advisable and an overnight stay should be anticipated. Once the patient is in the preprocedure staging area, the existence of the home support should be confirmed and all involved reinforced on the probably same-day discharge. Elective PCI is highly successful and most will be able to be discharged home, although the potential need to keep the patient overnight should not be totally excluded from the family support until same-day discharge is a reality. During the recovery period, the staff confirms the continued support at home, and if the procedure and recovery is uneventful, the patient is ultimately asked about their comfort level for same-day discharge. If preparation has been complete, it is very unusual for a patient to request an overnight stay. In my own practice I have had patients request discharge into the early morning hours if that was what was necessary to go home the same-day after a late procedure. Patients rarely view hospitals as a source of safety and most would rather be home. Education is often raised as a reason to keep a patient overnight. After all, the patient has a serious disease and long-term risk factor modification and an in-depth instruction is needed. That may be true, but many serious diseases such as cancer are presently managed as an outpatient. In addition, after a patient who has probably not slept well the night before the procedure, who has been rendered sedate during the procedure, and who is then further sleep-deprived as the staff follows vital signs all night will not be receptive to long-term teaching. By the following morning, the eagerness of patients and families to be discharged home may preclude any actual understanding of discharge instructions.
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A more reasonable approach involves focused teaching. Focusing on specific important information the patient and family needs to understand may accelerate a patient’s understanding of the issues. In the case of PCI, the 2 most important aspects that need to be understood are (1) where to call for help, and (2) insuring dual-antiplatelet therapy is continued after discharge. By focusing on these 2 aspects of care between the home support and the patient, one can be confident of a successful early discharge. Typically, a phone number is provided to the patient and the home support to use if an issue arises after discharge regardless of the time of night. The provision of this medical contact gives both the discharging staff and the patient confidence that professional help is available if the need arises and builds confidence for discharge. Dual antiplatelet therapy after discharge can be started in a variety of ways. Best approaches most likely involve some proof of either filling the prescriptions by showing the pills to the discharging staff or demonstrating a concrete plan on how the prescription is being filled after discharge. Verbalizing an understanding on the part of the patient of the consequences of not talking appropriate dual-antiplatelet therapy helps cement the importance of this step. Same-day discharge should not pretend to provide a full spectrum of teaching about coronary artery disease, but rather focuses on the critical portion the patient needs to know and is able to understand at the moment. Ultimately, long-term completion of the disease teaching is needed [46], but whether the patient goes home the same or next day, neither incident of care is appropriate for sound education. Most same day discharge programs follow-up discharge with patient contact within 24–48 hours. This contact insures a safe transition to the outpatient setting and the execution of the discharge plan with dual antiplatelet therapy. It also gives the patient time to bring up any concerns that might have arisen during the period immediately surrounding discharge. This contact with the well-rested patient is a good point to quickly reinforce the in-hospital teaching and then confirm that the patient has longer-term plans for follow-up that will continue the teaching for long-term disease management. Using an approach outlined above, a multilayer safety net for the patient’s same-day discharge is activated. Expectations and planning starts before the procedure so there are no surprises. Expectations of the patient and home support are laid out for the recovery and the adequacy of the recovery is supported by the patient’s desire to be discharged the same day. Postdischarge escape routes for complications or concerns are outlined and understood by all involved, and ultimately the providers make contact with the patient after discharge to confirm success. With such due diligence, risk exposure whether it is to the patient’s health or the provider’s liability is minimized and the rewards of same-day discharge maximized.
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Cost Savings Despite the need for the transition to outpatient care, how to optimize this new care process financially has been poorly addressed. For many hospitals, payer policy changes resulted in patients’ admission status being changed from inpatient to outpatient with little attention to the care process changes that should have also taken place. The numbers of elective PCI patients being discharged the same-day over the last few days has remained very low [47•] despite this significant change in reimbursement policy suggesting an on-going need for hospital administration to better understand their cost effectiveness. Costs can be calculated a variety of ways and the use of implied costs or assumed costs to simplify economic calculation are especially common in the health care industry and can skew one’s understanding of the truth. Simplistically, reimbursement is essentially the same to the hospital and doctor regardless of whether the patient stays overnight or goes home the same day. Both, most likely, will be considered outpatients under the 2 Midnight Rule and the reimbursement is fixed. To maintain a patient in a bed requires time and effort on part of the hospital and the longer the bed is occupied the lower the net reimbursement on an hourly basis is obtained from that bed. In addition, the longer the bed is occupied, the greater the chance that a complication related to hospitalization [36] may occur that could further elevate costs without necessarily raising reimbursement. In addition, while the bed is occupied, new patients as new sources of revenue can’t occupy the bed and a loss of opportunity for revenue occurs. In net, same day discharge maximizes reimbursement by discharging as early as possible, but not so early as it risks complications from a hasty discharge [48, 49]. Many hospital care pathways for PCI patients were developed before same-day discharge was conceived. Shifts to same-day care with either advanced femoral artery care or transradial procedures represent more than a simple shift in catheterization laboratory technique. Instead, it presents to the enterprising health care system an opportunity to revamp its PCI pathways and develop novel multidisciplinary pathways to provide specialized care to these patients without the overhead of inpatient status. Those that have adapted to this new reality have seen the benefits of programmatic renovation of their care plans [50]. On the other hand, assigning a fixed cost to PCI recovery regardless of actual time resource used wastes the potential for the savings to be derived from same-day discharge. Likewise, if the hospital is unable to fill the unoccupied beds, the early discharge of the patient does not represent an opportunity to treat another sicker patient who clinically requires inpatient care. The question of transradial or femoral as the preferred access has been a subject of debate. Outside of the US, the shift to transradial drove the shift to same day procedures. Recently in the US, the relatively modest use of same day
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discharge has been dominated by femoral operators [47•]. Careful vascular techniques using transfemoral approach has markedly lowered access site complications, although ultimately the lowest complications come in the hands of experienced radial operators. In addition, several groups have demonstrated a cost advantage to transradial driven by equipment, procedural, and length-of-stay costs that suggest a significant cost-effectiveness advantage to radial [51].
Patient Satisfaction Satisfaction with the health care experience is become an important metric in the scramble to measure the results of health care. When the discussion turns to same-day discharge memories of controversies over “drive-through deliveries” [52] often surface and questions about patient satisfaction develop. The patient experience is different with same-day PCI. While hospitalization offers for many reassurances and time for respite for some medical (and obstetric) condition, the diagnosis of heart disease is frightening to many patients and they naturally want to feel safe and secure. Home with one’s family or social support may be the greatest source of security as opposed to continue hospitalization [53]. The opportunity to retreat back to one’s home is likely what some patients desire to process the events and diagnosis that they have just learned. Studies indicate that patients discharged the same day are typically very satisfied with their experience [46, 54, 55] including those undergoing ad hoc PCI [56]. They will usually demand similar treatment in the future if needed, and do not view same-day discharge as a perversion of standard medical care.
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and inconvenience of hospitalization, but also the health care system in general can benefit from the advances in medical science. Compliance with Ethics Guidelines Conflict of Interest Ian C. Gilchrist has received consulting fees from The Medicines Company, Inc., Accumed, Inc., and Abbott Vascular, Inc. Human and Animal Rights and Informed Consent This article does not contain any studies with human or animal subjects performed by any of the authors.
References Papers of particular interest, published recently, have been highlighted as: • Of importance 1.
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Conclusions Outpatient PCI is the de facto reimbursement standard for PCI in the US and is widely practiced around the world. With advances in pharmacology and technology, the recovery from PCI can be predictably accomplished with the confines of same-day discharge antiquating the concept that PCI is an overnight procedure. While a variety of potential pitfalls can affect the post-PCI patient that might make same-day discharge not attractive, most elective patients can be considered for same-day discharge under the right circumstances. Sameday PCI needs advance consideration, uneventful catheterization laboratory procedures and early recovery, combined with the confirmed presence of responsible social support to be available for the patient the night after discharge. Finally, a safety net with an escape plan for the patient should be in place prior to discharge to give confidence in coverage for all possibilities for both the providers and patient. Through same-day discharge not only can the patient avoid the hazards
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Bottner RK, Blankenship JC, Klein LW, et al. Current usage and attitudes among interventional cardiologists regarding the performance of Percutaneous Coronary Intervention (PCI) in the outpatient setting. Catheter Cardiovasc Interv. 2005;66:455–61. Serruys PW, de Jaegere P, Kiemeneij F, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. N Engl J Med. 1994;331: 489–95. Hearn JA, King III SB, Douglas Jr JS, et al. Clinical and angiographic outcomes after coronary artery stenting for acute or threatened closure after percutaneous transluminal coronary angioplasty. Initial results with a balloon-expandable, stainless steel design. Circulation. 1993;88:2086–96. Schömig A, Neumann F-J, Kastrati A, et al. A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary-artery stents. N Engl J Med. 1996;334:1084–9. Chew DP, Bhatt DL, Lincoff AM, et al. Defining the optimal activated clotting time during percutaneous coronary intervention: aggregate results from 6 randomized, controlled trials. Circulation. 2001;103:961–6. Tolleson TR, O’Shea JC, Bittl JA, et al. Relationship between heparin anticoagulation and clinical outcomes in coronary stent intervention: observations from the ESPRIT trial. J Am Coll Cardiol. 2003;41:386–93. Lincoff AM, Bittl JA, Harrington RA, et al. Bivalirudin 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;289:853–63. Marso SP, Amin AP, House JA, et al. Association between use of bleeding avoidance strategies and risk of periprocedural bleeding among patients undergoing percutaneous coronary intervention. JAMA. 2010;303:2156–64. Kiemeneij F, Laarman GJ, Odekerken D, Slagboom T, van der Wieken R. A randomized comparison of percutaneous transluminal coronary angioplasty by the radial, brachial and femoral approaches: the ACCESS study. J Am Coll Cardiol. 1997;29:1269– 75. Kern MJ. Cardiac catheterization on the road less traveled: navigating the radial vs femoral debate. JACC Cardiovasc Interv. 2009;2:1055–6.
470, Page 8 of 9 11.
12.
13.
14.
15.•
16.•
17.•
18.
19.
20.
21.
22. 23.
24.
25.
26.•
27.
Kiemeneij F, Laarman GJ, Slagboom T, Stella P. Transradial Palmaz-Schatz coronary stenting on an outpatient basis: results of a prospective pilot study. J Invasive Cardiol. 1995;7:5A–11. Kiemeneij F, Laarman GJ, Slagboom T, van der Wieken R. Outpatient coronary stent implantation. J Am Coll Cardiol. 1997;29:323–7. Slagboom T, Kiemeneij F, Laarman GJ, van der Wieken R, Oderkerken D. Actual outpatient PTCA: the results of the OUTCLAS pilot study. Catheter Cardiovasc Interv. 2001;53:204–8. Slagboom T, Kiemeneij F, Laarman GJ, Van der Wieken R. Outpatient coronary angioplasty; feasible and safe. Catheter Cardiovasc Interv. 2005;64:421–7. Feldman D, Swaminathan R, Kaltenbach L, et al. Adoption of radial access and comparison of outcomes to femoral access in percutaneous coronary intervention: an updated report from the NCDR (2007–2012). Circulation. 2013;127:2295–306. Most recent look at transradial growth in the United States using data from the NCDR. Subherwal S, Peterson ED, Dai D, et al. Temporal trends in and factors associated with bleeding complications among patients undergoing percutaneous coronary intervention: a report from the National Cardiovascular Data CathPCI Registry. J Am Coll Cardiol. 2012;59:1861–9. NCDR based analysis of bleeding with PCI and factors associated with bleeding. Abdelaal E, Rao SV, Gilchrist IC, et al. Same-day discharge compared with overnight hospitalization after uncomplicated percutaneous coronary intervention: a systematic review and metaanalysis. JACC Cardiovasc Interv. 2013;6:99–112. Recent metaanalysis of same-day discharge compared with overnight admission including both radial and femoral approaches showing no evidence for harm, but statistically unable to prove non-inferiority due to low event rates. Brayton KM, Patel VG, Stave C, de Lemos JA, Kumbhani DJ. Same-day discharge after percutaneous coronary intervention: a meta-analysis. J Am Coll Cardiol. 2013;62:275–85. Wilentz JR, Mishkel G, McDermott D, et al. Outpatient coronary stenting using the femoral approach with vascular sealing. J Invasive Cardiol. 1999;11:709–17. Gilchrist IC, Nickolaus MJ, Momplaisir T. Same-day transradial outpatient stenting with a 6-hr course of glycoprotein llb/llla receptor blockade: a feasibility study. Catheter Cardiovasc Interv. 2002;56:10–3. The Medicare Recovery Audit Contractor (RAC) Program: an evaluation of the 3-year demonstration. 2008;2. (http://www.cms. gov/RAC/Downloads/RAC%20Evaluation%20Report.pdf). Resnic FS. The case for outpatient coronary intervention: balancing charges and discharges. Circulation. 2007;115:2248–50. Chambers CE, Dehmer GJ, Cox DA, et al. Defining the length of stay following percutaneous coronary intervention: an expert consensus document from the Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2009;73:847–58. Medicare Benefit Policy Manual, CMS Pub. 100-02, Chapter 6, §20.6; and Medicare Claims Processing Manual, CMS Pub. 10004, Chapter 4, §290.1. FY 2014 Inpatient Prospective Payment System (IPPS)/LongTerm Care Hospital (LTCH) final rule (CMS-1599-F). http:// www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ AcuteInpatientPPS/FY2014-IPPS-Final-Rule-Home-Page. html. Accessed 15 Oct 2013. Gilchrist IC, Rhodes DA, Zimmerman HE. A single center experience with same-day transradial-PCI patients: a contrast with published guidelines. Catheter Cardiovasc Interv. 2012;79:583–7. Review of 100 patient co-incidental with release of SCAI guidelines for same-day suggesting guidelines are too restrictive. Ziakas A, Klinke P, Mildenberger R, et al. Safety of same day discharge radial PCI in patients under and over 75 years of age. Int Heart J. 2007;48:569–78.
Curr Cardiol Rep (2014) 16:470 28.
29.
30.
31.
32.
33.
34.
35.
36.
37.
38.
39.
40.•
41.•
42.•
Ranchord AM, Prasad S, Seneviratne SK, et al. Same-day discharge is feasible and safe in the majority of elderly patients undergoing elective percutaneous coronary intervention. J Invasive Cardiol. 2010;22:301–5. Bagur R, Bertrand OF, Rodés-Cabau J, et al. Comparison of outcomes in patients 70 years versus
