Outpatient Percutaneous Coronary Intervention: Has Its Time Come?

Abstract: In the context of the rising health-care costs in the United States and the fact that approximately 1 million percutaneous coronary intervention (PCI) procedures are performed in the United States annually with a cost approaching $10 billion, reducing the cost associated with this frequently performed effective procedure has become paramount.  Government and insurance-based methods have focused upon appropriate utilization and, in some cases, payment has been denied for procedures deemed inappropriate. While curtailing procedures may sometimes be reasonable, this approach is fraught with trouble, as individualized patient care does not fit neatly into population-based concepts of appropriateness. Therefore, alternative means to minimize expenditures should be entertained.  Chief among these is the potential to reduce costs associated with PCI from prolonged inpatient stays for a procedure that, thankfully, has become significantly safer as it has maintained its efficacy.  In this position paper, we discuss the theme of same-day discharge versus overnight stay after PCI as a cost-saving strategy, and pinpoint some criteria that can help to guide such a decision while preserving maximal patient safety and both patient and physician satisfaction. 

J INVASIVE CARDIOL 2014;26(12):E171-E173

Key words: editorial, same-day discharge, practice management

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Dear Editor:

In spite of the decline in cardiovascular disease mortality rates in many high-income countries since the 1970s,^1,2 it is still the leading cause of death in the United States (US) and worldwide, especially in low and middle-income countries, where its morbidity and mortality have increased at a fast rate.³ 

Since its development by Andreas Gruentzig in 1977, percutaneous coronary intervention (PCI) adoption accelerated throughout the world to become one of the most common procedures. When performed appropriately, it is proved to improve symptoms, quality of life, and survival. It accounted for 3.6% of all operating room procedures performed in the US in 2011.⁴

The overnight stay for observation is still the current standard of care for patients undergoing uncomplicated elective PCI.⁵ Post PCI, patients can have different complications, including bleeding, abrupt vessel closure, stent thrombosis, myocardial infarction, and renal failure.⁶ In a 2010 report from the Agency for Healthcare Research and Quality, over 50% of cholecystectomies, 70% of transurethral prostatectomies, and 90% of hernia repairs were being performed in the ambulatory setting, compared with only 6.8% of PCIs.⁷ The ongoing advancements in stents, medications, the radial approach, and arterial closure devices have made same-day discharge of post-PCI patients more feasible than before, especially in the scope of looking for new strategies to reduce health-care costs in the US. 

Same-Day Discharge Vs Overnight Stay

The safety profile. Taking the decision of same-day discharge vs the standard overnight stay of a patient post PCI has been a controversial and multifactorial topic.  Undoubtedly, patient safety should always be the main priority. Many studies have shed a light on this key factor. Nascimento et al⁸ evaluated a total of 188 cases (with 93 discharged the same day and 95 discharged after an overnight stay) following elective PCI with similar procedural characteristics. In spite of the fact that the same-day discharge group had older age, more prior PCI, and more prior coronary artery bypass graft (CABG) surgery than the overnight stay group, no significant difference in the net adverse cardiovascular effect (NACE; ie, death, myocardial infarction [MI], stroke, target vessel revascularization, vascular complication, and major bleeding) rate was found between the groups at 48 hours (0 [0%] vs 2 [2.1%]; P=.25) or at 30 days (3 [3.2%] vs 6 [6.3%]; P=.26), and the study concluded that same-day discharge after PCI was safe and feasible in the population studied.

Brayton et al⁹ conducted a meta analysis of 37 studies (n=12,803 patients), including 7 randomized controlled trials (RCTs; n=2738) and 30 observational studies (n=10,065) reporting outcomes of patients discharged on the same day post PCI. Two composite outcomes were prespecified: (1) death, MI, or target lesion revascularization (TLR); and (2) major bleeding or vascular complications. The vascular access site was predominantly transradial in the randomized cohort (60.8%) and transfemoral in the observational cohort (70.0%). In the RCTs, no difference was seen between same-day discharge and routine overnight observation with regard to death/MI/TLR (odds ratio [OR], 0.90; 95% confidence interval [CI], 0.43-1.87; P=.78) or for major bleeding/vascular complications (OR,1.69; 95% CI, 0.84-3.40; P=.15). In observational studies, the primary outcome of death/MI/TLR occurred at a pooled rate of 1.00% (95% CI, 0.58%-1.68%), and major bleeding/vascular complications occurred at a pooled rate of 0.68% (95% CI, 0.35%-1.32%). The study concluded that in selected patients undergoing largely elective PCI, same-day discharge was associated with a low rate of major complications and appeared to be as safe as routine overnight observation.

Patient satisfaction. In addition to safety, patient satisfaction should be considered in any decision regarding early discharge of any patient post PCI. Kim et al¹⁰ compared a total of 298 patients undergoing elective PCI via femoral access at 2 medical centers who were randomized to same-day (n=150) or next-day (n=148) discharge. The primary outcome was high patient coping scores during the 7 days after discharge, defined as scores <20 on the validated post-discharge coping difficulty scale. Safety outcomes, clopidogrel adherence, and patient preferences were secondary outcomes. Before discharge, patients randomized to same-day and next-day discharge were similar with respect to sociodemographic and clinical characteristics. High-coping ability, assessed 7 days after PCI, was present for 79% of patients randomized to same-day discharge and for 77% of patients randomized to next-day discharge. The difference in high coping ability, 2 (95% CI, -7 to 11), did not cross the non-inferiority threshold of -12% (P<.001 that same-day discharge is not non-inferior to next-day discharge). At 30 days after PCI, clopidogrel adherence, physician and emergency room visits, and hospitalization were similar in the 2 randomization groups. At 30 days after PCI, 79% of patients randomized to same-day discharge reported satisfaction with the timing of their discharge compared with 49% of those randomized to next-day discharge (P<.001). At 30 days, only 9% of patients randomized to same-day discharge reported wanting to have stayed in the hospital longer, whereas 37% of those randomized to next-day discharge reported that they would have preferred earlier discharge (P<.001). When asked their preferences for discharge timing if they had another PCI procedure, 80% of those randomized to same-day discharge and 68% of those randomized to next-day discharge stated they would prefer going home the day of the procedure. Only 9% and 20% of patients in the same-day and next-day discharge groups, respectively, reported they would want to stay in the hospital overnight if they had another PCI procedure, whereas between 10% and 15% of each group reported no timing preference.

The study concluded that same-day discharge after PCI was associated with patient-reported and clinical outcomes similar to those of next-day discharge and was preferred by most patients.

How to Decide

The medical history and the age, creatinine, and ejection fraction (ACEF) score. The ACEF score can be used in assessing risk and providing prognostic information in patients undergoing PCI. It is calculated as: age (in years) / left ventricular ejection fraction (%) +1 if creatinine is >2 mg/dL.

Wykrzykowska et al¹¹ assessed the value of the ACEF score in predicting major adverse cardiac events (MACEs), which were considered the primary endpoint and defined as the composite of cardiac death, MI, and clinically indicated TVR, within 12 months in patients undergoing PCI. ACEF score was calculated in 1208 out of 1707 patients enrolled in the trial. Initial ACEF score calculation and classification into low ACEF (<1.0225), medium ACEF (≥1.0225 and ≤1.277), and high ACEF (>1.277) showed that patients with higher ACEF score were more likely to be females, smokers, with diabetes mellitus,  hypertension, prior history of MI, concomitant peripheral vascular disease, and present with unstable coronary syndrome. Conversely, patients with low ACEF score were more likely to be hypercholesterolemic, have a family history of heart disease, and present with stable angina or ST-segment elevation MI. By the end of the study, the composite endpoint of cardiac death, MI, and TVR occurred in 7.9% of low ACEF patients, 10.4% of medium ACEF patients, and 13.9% in high ACEF patients (hazard ratio [HR], 1.34; P<.01). Cardiac death occurred in 0.7% of patients with low ACEF scores, 2.2% of patients with intermediate ACEF scores, and 4.5% of patients with high ACEF scores (HR, 2.22; P<.01). MI occurred in 2.5% of patients with low ACEF scores, 5.2% of patients with intermediate ACEF scores, and 7.6% of patients with high ACEF scores (HR, 1.6; P<.01). Clinically indicated TVR occurred in 5.4% of patients with low ACEF scores, 6.5% of patients with intermediate ACEF scores, and 8% of patients with high ACEF scores (HR, 1.22; P<.16 [statistically non-significant]). These numbers led to the conclusion that ACEF score may be a simple way to stratify risk of events in patients treated with PCI with respect to mortality and risk of MI and at the same time showed an association between particular elements in the past medical history of patients and particular ACEF score subgroups.

Radial access vs femoral access. Although it is still used less often than femoral access, the adoption of radial access for PCI (r-PCI) has increased over the past few years in the US and worldwide. A recent retrospective study conducted by Feldman et al¹² on 2,820,874 procedures from 1381 sites performed between January 2007 and September 2012 showed an increase in the proportion of r-PCI procedures from 1.2% in the first quarter of 2007 to 16.1% in the third quarter of 2012 and accounted for 6.3% of total procedures from 2007 to 2012 (n=178,643). The same study proved that r-PCI was associated with lower vascular and bleeding complications when compared to traditional transfemoral access.

Arterial closure devices versus manual compression. Another strategy that can be considered is the use of arterial closure devices (ACDs) vs manual compression. Allen et al¹³ propensity matched patients receiving ACDs to those with manual compression to evaluate a primary endpoint of National Cardiovascular Data Registry (NCDR)-defined major bleeding and a secondary endpoint of major bleeding stratified by previously developed NCDR bleeding risk categories. Bleeding events that required transfusion, prolonged hospital stays, and/or decreases in hemoglobin ≥3.0 g/dL were included. Length of stay, defined as days after PCI until discharge, was also evaluated. Secondary analysis of bleeding and complication rates between ACD types (suture vs collagen plug) was performed. A total of 2324 patients were included in the final propensity matching: 1162 with ACDs and 1162 with manual compression.

Major bleeding was reduced in ACD patients compared to those with manual compression (2.4% vs 5.2%; P<.001), and NCDR high-risk patients receiving ACDs had the greatest reduction in major bleeds (3.1% vs 10.3%; P<.001). Length of stay (1.9 ± 1.9 days vs 2.3 ± 5.3 days; P<.01) and pseudoaneurysms (0.3% vs 1.1%; P=.03) were decreased in ACD patients. Suture-based devices revealed a lower composite event rate than collagen-plug ACDs (1.4% vs 3.4%; P=.048). The study concluded that ACD use was associated with reductions in NCDR major bleeding, length of stay, and pseudoaneurysms in PCI patients.

Conclusion

In the light of the increasing demand of finding new cost-saving strategies to reduce the overall high health-care costs in the US health system, the decision of same-day discharge vs overnight stay for post-PCI patients can be challenging. Although overnight stays are still the standard of care, the same-day discharge strategy looks promising in all aspects.

In this regard, with patient safety and satisfaction of utmost priority, many criteria like medical history, ACEF score, the use of radial access instead of femoral access, and the use of ACD instead of manual compression can make same-day discharge easier to approach and a more appropriate choice.

References

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6. Rao SV, Kaltenbach LA, Weintraub WS, et al. Prevalence and outcomes of same-day discharge after elective percutaneous coronary intervention among older patients. JAMA. 2011;306(13):1461-1467.
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8. Nascimento FO, Pineda AM, Benjo A, et al. Same-day discharge or overnight stay after percutaneous coronary intervention: comparison of net adverse cardiovascular events. J Invasive Cardiol. 2014;26(5):204-208.
9. 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(4):275-285. 
10. Kim M, Muntner P, Sharma S, et al. Assessing patient-reported outcomes and preferences for same-day discharge after percutaneous  coronary intervention: results from a pilot randomized, controlled trial. Circ Cardiovasc Qual Outcomes. 2013;6(2):186-192. 
11. Wykrzykowska JJ, Garg S, Onuma Y, et al. Value of age, creatinine, and ejection fraction (ACEF score) in assessing risk in patients undergoing percutaneous coronary interventions in the ‘all-comers’ LEADERS trial. Circ Cardiovasc Interv. 2011;4(1):47-56. 
12. Feldman DN, Swaminathan RV, Kaltenbach LA, et al. Adoption of radial access and comparison of outcomes to femoral access in percutaneous coronary intervention: an updated report from the national cardiovascular data registry (2007-2012). Circulation. 2013;127(23):2295-2306. 
13. Allen DS, Marso SP, Lindsey JB, Kennedy KF, Safley DM. Comparison of bleeding complications using arterial closure device versus manual compression by propensity matching in patients undergoing percutaneous coronary intervention. Am J Cardiol. 2011;107(11):1619-1623.

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From the ¹University of Tennessee Health Science Center, Department of Medicine, Division of Cardiovascular Diseases, Memphis, Tennessee; ²St. Vincent Charity Medical Center, Department of Medicine, Cleveland, Ohio; ³Ain Shams University School of Medicine, Cairo, Egypt; and ⁴Winthrop University Hospital, Department of Medicine, Division of Cardiovascular Diseases, Mineola, New York/SUNY Stony Brook Medical School, New York. 

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.

Submitted September 4, 2014 and accepted September 8, 2014.

Address for correspondence: Rami Khouzam, MD, 1614 Dogwood Creek Dr, Germantown, TN 38139. Email: khouzamrami@yahoo.com