The feasibility and safety of same day discharge for all comers after elective percutaneous coronary interventions

Abstract

Background

The safety of same day discharge (SDD) after percutaneous coronary interventions (PCI) has been demonstrated in several studies. However, SDD was only allowed in patients meeting strict criteria. We aimed to evaluate the feasibility and safety of SDD following elective-PCI in all comers.

Methods

In 2012, we implemented a strategy of SDD for all elective PCI (no exclusion) but admissions were allowed at the discretion of the treating physician. We assessed the feasibility and safety of this approach in consecutive patients who underwent elective PCI at WVU.

Results

Out of 3355 patients who underwent PCI between 2012 and 2016, 691 (21%) presented electively. Radial access was utilized in 480 (69.5%). Same day discharge was achieved in 539/691 (78%), and there was no difference between patients who had SDD and those who were admitted with regards to the 30-day major adverse cardiovascular and cerebrovascular events (3.2% vs. 3.5% respectively, P = 0.195). Predictors of SDD failure were procedural complications (OR 12.08, 95%CI 2.20–57.8. P = 0.002), use of Glycoprotein IIB-IIIA inhibitors (OR 3.45, 95%CI 1.067–11.41, P = 0.039), femoral access (OR 2.067, 95%CI 1.25–3.419, p = 0.005), anemia (OR 1.80, 95%CI 1.06–3.04, P = 0.029), home distance ≥60 miles (OR 1.68, 95%CI 1.03–2.72, P=0.037).

Conclusion

SDD is feasible in the majority of all-comers after elective PCI, and is not associated with increase in adverse events at 30-days. Certain procedural and patient’s characteristics predict SDD failure. If validated in prospective studies, these factors can possibly be integrated in a predictive tool to aid in triaging patients, post-elective PCI.

1. Introduction

Contemporary advancements in pharmacotherapy and coronary stent technology have led to significant improvement in the outcomes of percutaneous coronary interventions (PCI) [1–5]. These excellent PCI outcomes along with the increasing adoption of radial artery access resulted in a mounting interest in same day discharge (SDD) following elective PCIs. Same day discharge leads to improved patient satisfaction, better quality of care, and lower cost without an associated increase in adverse cardiovascular events [6,7,24]. Despite its demonstrated safety, the nationwide adoption of SDD following elective PCI has been variable but overall surprisingly limited [15,18]. One limiting factor is the lack of consensus on the appropriate eligibility criteria for SDD. Current criteria for SDD in contemporary practice are derived from inclusion/exclusion criteria set in clinical trials and from a consensus document released by the Society for Cardiovascular Angiography and Interventions [8]. These strict criteria, albeit plausible, can lead to exclusion of the majority of patients from consideration of SDD after elective PCI. In addition, many of these criteria were extracted from post-PCI mortality prediction models that were not specific to elective PCI [9,10,11,25,26] (e.g., included acute presentations: cardiogenic shock and recent myocardial infarction).

Our study aims to: (1) Assess the safety and success rate of a novel lenient SDD strategy for all patients following elective PCI. (2) - Investigate the predictors of hospital admission in patients who were planned for SDD but were admitted for observation.

2. Methods

2.1. Study population

We included patients who underwent percutaneous coronary intervention (PCI) at the West Virginia University- Ruby Memorial Hospital, from May 1st, 2012 to February 28th, 2016. We retrospectively collected baseline demographics, clinical characteristics, discharge status (SDD vs. admission), procedural details, major adverse cardiovascular events at 30 days follow up.

2.2. Study endpoints

The primary feasibility endpoint was the success rate in SDD applying our lenient criteria (planned SDD for all comers but admissions allowed at the discretion of the treating physician). In our study SDD was achieved if the patient returned home or to a nonmedical facility (e.g. a hotel) the same working day (before midnight). SDD failed, if the patient kept in the hospital beyond the midnight of the same working day, for any reason.

The primary safety endpoint was major adverse cardiac and cerebrovascular events (MACCE) (death, stroke, myocardial infarction, and repeat revascularization). Secondary safety endpoint included other complication including procedural complications, bleeding, and acute kidney injury (AKI). The latter was defined as a rise in serum Creatinine of >50%.

Data on the vital status (alive vs. not), and complications were obtained from detailed review of the patient’s electronic medical records. Our medical records are connected via a statewide collaboration to other hospitals in our small state. Hence, events that are occurred during hospitalizations within the state or documented in outpatient visits are typically captured in our electronic medical records. In addition, we have a mandatory routine 30-day post PCI visit and data from these visits were available in >95% of patients.

2.3. Statistical analysis

Descriptive statistics were presented as frequencies with percentages for categorical variables. Univariate and multivariate logistic regression was performed to estimate odds ratios (OR) with 95% confidence intervals (CI) to determine predictors of SDD failure. Variables included in the logistic regression model were: age, gender, BMI, obesity (BMI ≥ 30) hemoglobin, anemia, chronic renal insufficiency, thrombocytopenia, distance between home residence and the hospital (≥60 miles,) procedural start time (Am vs. PM), access site (radial vs. femoral), PCI target, concomitant procedures, number of lesion treated, number of stents implanted, total stent length ≥40 mm Glycoprotein IIb/IIIa inhibitors use, Fluoroscopy time, total contrast volume, preprocedure oral antiplatelet loading, in-hospital complications. We used IBM-SPSS Version 22 (IBM Corporation, Armonk, New York) and Excel 2013 (Microsoft Corporation, Redmond, Washington) for all statistical analysis.

3. Results

During the study period, 3355 PCIs were performed at our hospital, of which 691 (21%) were performed in patients presenting electively. Age was 65 ± 10.6 years (32% age > 70), and 36% were females. Comorbidities were frequent: 27% of patients had reduced left ventricular systolic function (LVEF<50%), 53% were obese (BMI > 30), 44% were diabetics, and 20% had chronic kidney disease (Table 1). Radial access was utilized in the majority of patients (69.5%), and Glycoprotein IIb/IIIa inhibitors were used in 13%. Adjunctive intracoronary assessment with intravascular ultrasound and/or functional flow reserve was undertaken in 21.6% of patients, and multivessel PCI was required in 21.9%. Complex lesions were not infrequently treated; PCI of left main coronary stenosis, chronic total occlusions, and internal mammary artery or vein graft lesions, were performed in 2.6%, 13.5%, and 6.4%, respectively. Procedural details are outlined in (Table 2).

Table 1.

Baseline characteristics of the study population.

Demographics	All	SDD	Overnight	p-Value
Age-mean (SD), y	65 ± 10.6	63 ± 10	66 ± 11	0.011
Age >70 years	220 (31.8%)	162 (30.1%)	58(38.2%)	0.058
Female	248 (35.9%)	195(36.2%)	53(34.9%)	0.766
Distance from hospital (miles)	50 ± 41	47.3 ± 36.9	60.5 ± 53	0.529
Distance ≥ 60 miles	218 (31.5%)	153 (28.4%)	65(42.8%)	0.001
Medical history
Hypertension	653 (94.5%)	510(94.6%)	143(94.1%)	0.796
Hyperlipidemia	657(95.1%)	516(95.7%)	141(92.8%)	0.135
Diabetes mellitus	306 (44.3%)	233(43.2%)	73(48%)	0.293
Known CAD	565 (81.8%)	447(82.9%)	118(77.6%)	0.135
History of CABG	157(22.7%)	128(23.7%)	29(19.1%)	0.225
History of CVA	85 (12.3%)	68(12.6%)	17(11.2%)	0.635
LV dysfunction (EF < 50)	185 (26.8%)	130(24.1%)	55(36.2%)	0.003
Atrial fibrillation	71 (10.3%)	50(9.3%)	21(13.8%)	0.104
Obesity (BMI ≥30)	366 (53%)	292(54.2%)	74(48.7%)	0.361
Anemia	152 (22%)	99(18.4%)	53(34.9%)	0.000
CKD (GFR < 60)	137 (19.9%)	92(17.1%)	45(29.6%)	0.001
Thrombocytopenia	64(9.3%)	52(9.6%)	12(7.9%)	0.552
Clinical presentation  Angina	613(88.7%)	358(90.5%)	90(82.2%)	0.016
Others	78 (11.3%)	51(9.5%)	27(17.8%)	0.016
Positive Stress Test	286 (41.4%)	222 (41.2.5%)	64(42.1%)	0.839
Laboratory data
Hemoglobin g/dL	14 ± 1.65	14.2 ± 1.6	13.5 ± 1.8	0.038
Serum creatinine mg/dL	1.01 ± 0.6	1 ± 0.34	1.08 ± 0.44	0.135
GFR	57.3 ± 7.3	58 ± 7	55 ± 9	0.035
Platelet (×1000/μL)	224 ± 65.7	224 ± 67	223 ± 60	0.463

SDD: same day discharge; SD: standard deviations; y: years; CAD: coronary artery disease; CABG: coronary artery bypass graft; CVA: cerebrovascular accident; LV: left ventricle; EF: ejection fraction; BMI: body mass index; CKD: chronic kidney disease; GFR: glomerular filtration rate; g: gram; dL: deciliter; mg: milligram; μL: microliter.

Table 2.

Procedural details of study population.

	All	SDD	Overnight	p-Value
Access site
Radial	480 (69.5%)	390(72.4%)	90(59.2%)	0.002
Femoral	211 (30.5%)	149 (27.6%)	62(40.8%)
Lesion characteristics:
Left main (protected)	50(7.2%)	45(8.3%)	5(3.3%)	0.033
Proximal LAD	127(18.4%)	97(18%)	30(19.7%)	0.625
LIMA/SVG	44 (6.4%)	35(6.5%)	9(5.9%)	0.230
Left circumflex	170 (24.6%)	125(23.2%)	45(29.6%)	0.105
Right coronary artery	197 (28.5%)	156(28.6%)	41(27%)	0.626
No. lesions treated	1.3 ± 0.65	1 ± 1	1 ± 1	0.006
No. of stents	1.25 ± 0.86	1 ± 1	2 + 1	0.000
Total stent length (mm)	26 ± 20	24 ± 19	33 ± 24	0.001
Total stent >40 mm	142(20.5%)	92(17.1%)	50(32.9%)	0.000
Bifurcation	67 (9.7%)	51(9.5%)	16(10.5%)	0.695
CTO	93 (13.5%)	75(13.9%)	18(11.8%)	0.508
Type of PCI				0.028
DES	556 (80.5%)	432(80.1%)	124 (81.6%)
BMS	33 (4.8%)	20(3.7%)	13(8.6%)
PTCA (no stent)	102 (14.7%)	87(16.1%)	15(9.9%)
GP IIb IIIa	89 (12.9%)	63(11.7%)	26(17.1%)	0.009
Oral antiplatelet load	291(42.2%)	234(43.4%)	57(37.5%)	0.213
Fluoroscopy time (minutes)	21.7 ± 14.8	20.1 ± 14.4	27.7 ± 15	0.005
Contrast load (ml)	190 ± 76.5	182 ± 72	220 ± 86	0.001
Concomitant procedures				0.064
IVUS/FFR	149 (21.6%)	118(21.9%)	31(20.4%)
RHC	6 (0.9%)	6(1.1%)	0
Atherectomy laser/rotablader	8 (1.2%)	3(0.6%)	5(3.3%)
SVG filter	6 (0.9%)	5(0.9%)	1(0.7%)

SDD: same day discharge; LAD: left anterior descending artery; LIMA: left internal mammary artery; SVG: saphenous vein graft; No.: number; mm: millimeters; CTO: chronic total occlusion; PCI: percutaneous coronary intervention; DES: drug eluting stent; BMS: bare metal stent; PTCA: percutaneous coronary angioplasty; GP IIb IIIa: Glycoprotein 2b 3a inhibitor; IVUS: intravascular ultrasound; FFR: fractional flow reserve; RHC: right heart catheterization.

The primary feasibility endpoint of SDD was achieved in 78% of patients. The primary safety endpoint (MACCE at 30 day), was similar between patients who were discharged same day vs those who were admitted following elective PCI (3.2% versus 3.3% respectively; Hazard Ratio: 0.935 [95% CI, 0.345–2.533]; P = 0.894) (Table 3). In-hospital procedural bleeding, complications, and utilization of GP IIb/IIIa inhibitors were the strongest predictors of hospital admission following PCI. Femoral access, long distance of 60 miles or more from hospital, and anemia also correlated with hospital admission (Table 4). The results of the univariate regression analysis are provided in Supplementary Table 1.

Table 3.

30-Day outcomes of the study population.

	All	SDD	Overnight	p-Value
Same day discharge	539 (78%)			N/A
Overnight stay	152 (22%)
In hospital complications				0.000
Any	19 (2.7%)	4(0.7%)	15(9.9%)
Major bleeding	18 (2.6%)	4(0.7%)	14(9.2%)
AKI	1 (0.1%)	0(0%)	1(0.7%)
30 days complications:
MACCE	22 (3.3%)	17 (3.2%)	5(3.3%)	0.863
Death	1 (0.1%)	1(0.2%)	0(0%)	0.603
ACS	20 (2.9%)	14 (2.6%)	6(3.9%)	0.331
Stroke/TIA	1 (0.1%)	1(0.2%)	0(0%)	0.603
Target vessel revascularization (PCI)	4 (0.6%)	2(0.4%)	2(1.3%)	0.159
Target vessel revascularization (CABG)	0(0%)	0(0%)	0(0%)	N/A

SDD: same day discharge; AKI: acute kidney injury; MACCE: major adverse cardiac and cerebrovascular events; ACS: acute coronary syndrome; TIA: transient ischemic attack; PCI: percutaneous coronary intervention; CABG: coronary artery bypass graft.

Table 4.

Multivariate logistic regression analysis for predictors of same day discharge failure.

Variable	OR	95% C.I.	P value
Post procedure bleeding	12.079	(2.52–57.8)	0.002
Glycoprotein 2B3A inhibitors infusion	3.449	(1.067–11.141)	0.039
Access site (Femoral)	2.067	(1.25–3.419)	0.005
Anemia	1.795	(1.061–3.036)	0.029
Distance (≥60 miles)	1.676	(1.031–2.723)	0.037
Right coronary artery lesion	0.422	(0.186–0.955)	0.038

OR: odds ratio; C.I.: confidence interval.

4. Discussion

The main findings of our study are: (1) A lenient strategy for routine SDD in all comers following elective PCI was successful in most patients (78%) and was not associated with an increased adverse safety event. (2) Certain patient’s and procedural characteristics are associated with in-hospital admission following planned SDD.

Patients who undergo PCI have traditionally been admitted for overnight observation [19]. Laarman G J, et al. first introduced same day discharge after PCI via brachial artery in 1994; then Fiemeneij F, et al. studied SDD after PCI via radial artery in 1997 [19,20]. Few years later Koch et al. performed >1000 outpatient elective PCI via femoral artery approach [21]. However, this concept did not gain wide acceptance initially due to the fear of missing major adverse events (mainly stent thrombosis, late vascular complication, and arrhythmia) in the first 24 h following PCI. In 2015, only 6.3% of patients undergoing elective PCI in the United States were discharged on the same day [24]. However, the dramatic improvement in PCI equipment, pharmacotherapy, and outcomes has led to a growing interest in SDD. In the past decade, several studies were conducted to answer three main questions with regards to SDD: (1) is it safe? (2) does it reduce cost? (3) does it increase patient’s satisfaction? [7,12–14,16,17] These studies provided confirmatory answers to all these questions, suggesting a ‘clear path’ towards further utilization of SDD at the national level is well supported. A recent large systematic review by Shroff et al. including (2293 patients from clinical trials and 107,018 patients from studying the US National Cardiovascular Data Registry) addressed the safety question and showed no increase in adverse events (bleeding, repeat coronary procedures, death or re-hospitalization) among patients who were discharged the same day after elective PCI compared to those who were observed overnight [8]. The cost effectiveness of SDD has been shown in a large Canadian study (the Early Discharge After Transradial Stenting of Coronary Arteries (EASY) Study), which showed that SDD was associated with 50% relative risk reduction in health care cost, translating to a mean saving per patient of $1086.6. A recent study by Amin et al. demonstrated an average saving of ~5000$ per PCI if SDD is utilized [24]. Finally, patient satisfaction score has been shown to be significantly higher with SDD rather than with overnight observation [14].

Despite the demonstrated safety and benefits, the applicability of SDD has been hampered by a major dilemma; which patients should we exclude from SDD? Studies that assessed the safety of SDD excluded patients with high-risk features such as: abnormal renal function, age over 70 years, insulin-requiring diabetes mellitus, contrast allergy, multi-vessel disease, proximal LAD disease, bifurcation disease, left main disease, saphenous vein graft or internal mammary disease, and those who received glycoprotein IIb/IIIa inhibitors [8]. These strict exclusion criteria can lead to excluding a large number of patients in whom SDD may be safe and feasible. Interestingly, despite these highly selective criteria, SDD was possible in only 81–88% of patients enrolled in these trials [12,13]. The main question in our study is that we hypothesized that this novel approach, if proven safe and effective, can then be applicable to a larger population of patients. The findings of our study document that a lenient strategy for routine SDD following elective PCI patients has a similar success rate (78%) compared with what has been reported in studies with strict exclusion criteria. Indeed, if we apply the exclusion criteria outlined above to our cohort, 97.4% of our patients would have been excluded from consideration of SDD; in other words, only 2.6% of patients had none of the SCAI exclusion criteria. This can partially explain the very low rates of SDD following elective PCI (<2%) in the United States, as reported in a large study of patients enrolled in the US National Cardiovascular Data Registry and by the recent nationwide analysis by Amin et al. [15,24]

Reasons for hospital admission in patients who were eligible for SDD have also not been well studied. Previous studies reported that patients were transitioned to overnight stay due to these complications: abrupt vessel closure, stent thrombosis acute or subacute, access site complications, non-access site bleeding, heart failure, contrast reactions, and arrhythmia [22,23]. In our study in-hospital bleeding complications (OR: 12.08), use of GPIIb-IIIa inhibitors (OR: 3.45), femoral access (OR: 2.06), anemia (OR: 1.79), distance from the hospital 60 miles or more (OR:1.68) were the main significant predictors of hospital admission (p < 0.05). Notably, total stent length, total contrast volume, diabetes, renal insufficiency, and lesion complexity did not correlate with the need for hospital admission.

Limitations: this study is subject to the inherent limitations and biases of retrospective single institution registries. The main limitation pertaining to our study is the selection bias, especially that overnight admission was totally left to the discretion of the interventional cardiologist. Confounding factors such as individual practice patterns, physician experience, etc. cannot be fully excluded. However, the rate of SDD after elective PCI was similar among all interventionalists, all of whom had 5+ years’ experience in PCI. Another limitation pertains to the coding of the procedural indication: two third of the patients were coded as unstable angina but yet received elective PCI. However, this is likely due to the issues surrounding the coding of unstable angina in the era of high-sensitivity Troponin and unlikely to reflect a truly diverse pathophysiology in our patient cohort as suggested in other studies [27,28]. Other limitations include the small sample size with its attendant issues (inability to calculate credible odds ratios, inability to explain some counterintuitive findings [e.g., right coronary artery PCI being predictive of SDD, etc.]). Nonetheless, our study was meant to serve as a ‘proof of concept’ to assess whether a lenient SDD strategy is associated with reasonable success and safety in real-world practice. Further larger scale studies are needed to confirm the findings of our study.

5. Conclusion

In summary, our study suggests that a lenient SDD strategy after elective PCI for all-comers is both safe and feasible. Certain procedural and patient’s characteristic can predict the need for hospital admission in patients presenting for elective PCI. Our findings may have important clinical and economic implications. However, further validation of these data in larger scale prospective studies is warranted.