key: cord-0867286-7bgem52h
authors: Taxiarchi, Paraskevi; Kontopantelis, Evangelos; Kinnaird, Tim; Curzen, Nick; Banning, Adrian; Ludman, Peter; Shoaib, Ahmad; Rashid, Muhammad; Martin, Glen P.; Mamas, Mamas A.
title: Adoption of same day discharge following elective left main stem percutaneous coronary intervention
date: 2020-07-30
journal: Int J Cardiol
DOI: 10.1016/j.ijcard.2020.07.038
sha: a8595559134e2e703e5e9d156ac0027f5c1a9119
doc_id: 867286
cord_uid: 7bgem52h

BACKGROUND: This study sought to investigate the safety and feasibility of same day discharge (SDD) practice and compare clinical outcomes to patients admitted for overnight stay (ON) undergoing elective left main stem (LMS) percutaneous coronary intervention (PCI). ON observation is still widely practiced in highly complex PCI as the standard of care, with no previous data comparing clinical outcomes in patients undergoing LMS PCI. METHODS: We analysed 6452 patients undergoing elective LMS PCI between 2007 and 2014 in England and Wales. Multiple logistic regressions and the BCIS risk model were used to study association between SDD and 30 day mortality. RESULTS: SDD rates almost doubled from 19.9% in 2007 to 39.8% in 2014 for all LMS procedures and increased from 20.7% to 41.4% for unprotected LMS cases during the same study period. There was a significant increase in procedural complexity with higher use of rotational atherectomy, longer stents and multivessel PCI. SDD was not associated with increased 30 day mortality (OR 0.70 95%CI 0.30–1.65) in the overall LMS PCI cohort and the results were similar in unprotected LMS (OR 0.48 95%CI 0.17–1.41) and those requiring ON stay (OR 0.58 95%CI 0.25–1.34). CONCLUSIONS: We did not find evidence that SDD is not safe or feasible in highly complex LMS PCI procedures despite increasing procedural complexity with no significant increase in 30 day mortality rates.

The adoption of same day discharge (SDD) following percutaneous coronary intervention (PCI) is increasingly common, being driven by financial pressures, a need for improved bed utilization, and patient preference for shorter length of stay. In reality, this practice varies widely amongst different healthcare systems and clinicians. Whilst clinical trials [1] [2] [3] [4] [5] , observational studies [6] [7] [8] [9] [10] [11] [12] and meta-analyses [13, 14] have investigated SDD for its feasibility and safety compared to overnight (ON) admission, only a few single centre studies have examined the effectiveness of SDD practice in more complex elective cases [15] [16] [17] [18] .

Treatment of unprotected left main coronary artery disease with PCI has increased over the last decade following the favourable results of randomised clinical trials comparing PCI and coronary artery bypass grafting (CABG), [19] [20] [21] [22] and may account for up to 5% of contemporary PCI cases [23] . Nevertheless, PCI of unprotected left main stem (LMS) carries a higher risk in part because of the large amount of myocardium at risk with, and also because the treatment often involves the use of complex bifurcation techniques, with more than 80% of lesions being distal LMS bifurcations. [24] To the best of our knowledge, none of the prior studies that examined the safety of SDD have focused on LMS PCI cases, while many excluded (unprotected) LMS PCI or cited LMS PCI as one of the reasons for ON stay, [5, [25] [26] [27] [28] [29] [30] which was in line with the 2009 guidelines from the Society for Cardiovascular Angiography and Interventions (SCAI) [31] . In the United Kingdom, the evolution of PCI practice means that many elective PCI LMS patients are now discharged on the same day [32] despite safety having not been previously assessed in this population. The most recent guidelines for LMS PCI [33] and for SDD following PCI [34] do not discuss the appropriateness of such practice. The last published consensus for the length of stay following elective PCI recommended that the decision on hospital admission or SDD should depend on overall patient outcome (i.e. stable Patient, successful Procedure, structured Program), rather than on individual procedural angiographic and procedural characteristics [34] . However, operators may not feel comfortable when the safety of SDD for more complex patients who have not been formally evaluated.

In this study, we aimed to investigate the temporal changes in the distribution of SDD practice in LMS PCI and unprotected LMS PCI cases in England and Wales, as well as the changing clinical characteristics and complexity of cases that were treated as SDD. We also J o u r n a l P r e -p r o o f aimed to examine which clinical and procedural characteristics were independently associated with SDD within the LMS PCI cases. Finally, we studied the independent predictors of 30-day mortality and examined the difference between the observed 30-day mortality rate to the expected calculated by the British Cardiovascular Intervention Society (BCIS) 30-day mortality risk model [35] , by discharge status.

This retrospective study analysed data from patients that underwent elective LMS PCI from 1 January 2007 to 31 December 2014 in England and Wales. The BCIS collects data on all PCI procedures in the UK. Data input on every case is mandated by the UK Good Practice guidelines and is a specified responsibility of consultant operators as part of their revalidation by the General Medical Council. The data collection is coordinated by the National Institute of Cardiovascular Outcomes Research (NICOR) via a centralized electronic database. The BCIS-NICOR registry comprises 113 variables, including clinical variables, procedural parameters, and patient outcomes. The dataset's quality has been recently described in detail. [36] Mortality tracking was undertaken by NHS Digital linkage to Office for National Statistics mortality records, using the NHS number that provides a unique identifier for any person registered with the NHS in England and Wales. Because it is a legal requirement for all deaths in the UK to be registered, these life status data are considered robust.

Our analysis included elective cases, for patients with stable angina, aged between 18 and 100 years old, and who underwent uncomplicated LMS PCI (PCI procedures that did not sustain an in-hospital complication) at an NHS centre in England and Wales. These elective cases are considered to be potentially eligible for SDD. Cases with missing discharge status, age, sex, or mortality data were excluded from the analysis. LMS PCI was defined as any PCI case, where the left main lesion was attempted (either on its own or with other lesions).

Protected LMS are defined as a patient with a graft to either the left anterior descending artery or the left circumflex. Severity of LMS lesion prior the procedure is defined as stenosis J o u r n a l P r e -p r o o f local health services, now reorganised into NHS Regions, and calendar year were considered in the analysis to explore geographic differences in practice over time.

In our population, 30 [38, 39] . Each finalized imputed dataset was evaluated for its consistency with the original through summary statistics and assessment of convergence. All subsequent analyses were performed in each imputed dataset individually, the results of which were then pooled according to Rubin's rules [40] .

We used the unimputed data to produce graphs to display LMS prevalence over time (from 2007 to 2014) within the elective cohort. Similarly, we graphically displayed SDD change over time within the LMS. We also created spatial maps to depict temporal changes of SDD prevalence within the LMS cohort regionally in England and Wales. We investigated the temporal changes of all the variables that were included in the analysis within the SDD and the ON stay cohorts separately. At the same time, we fitted an appropriate regression model for each available variable (i.e. linear model for continuous, logistic for binary, multinomial logistic for nominals and ordinal logistic for ordered variables), to examine for differences in the distributional changes over time between the two cohorts.

Next, using the imputed data, we fitted a multiple logistic regression model with indication of SDD as the outcome and with all variables of interest, plus the year of the procedure, as covariates to examine the variables independent associations with SDD. For any groups of variables that resulted in multicollinearity, these variables were grouped J o u r n a l P r e -p r o o f together; Variance Inflation Factors (VIFs) were estimated to ensure there was no multicollinearity in the final model.

We also observed the changes of 30-day mortality rates for the SDD and the ON stay cohorts separately and compared them to the expected mortality values estimated via the BCIS risk model [35] , a well validated model published in 2016. We manually estimated the observed and expected mortality risks in each of the imputed datasets and pooled them to the mean to obtain single estimations. We fitted a multiple logistic regression to assess whether SDD was independently associated with observed 30-day mortality after controlling for all other available variables.

Finally, as sensitivity analyses, we followed the same approach outlined above, but: a) focused on unprotected LMS only cases; and b) included complicated ON stay cases.

Complication records are displayed in Supplementary Table 2; in short, these refer to patients that sustained any type of procedural, arterial or bleeding complications peri or post procedural, or presented adverse hospital outcomes.

We used the statistical software Stata version 15 and an alpha level of 5% all through the data analysis.

Following all the exclusion criteria as presented in Figure 1 Table 5 ).

Over time, we observed significant changes in the procedural characteristics for the overall LMS cohort, particularly in the SDD group, suggesting that SDD were increasingly complex. Rotational atherectomy was increasingly used over time, from 1.1% in 2007 to 6 .4% in 2014, although its use was consistently lower compared to the ON, which ranged from 7.6% to 13.8%, respectively. Intravascular imaging use also increased for both the SDD and ON stay cohorts (from 28.9% to 35.9 and from 22.6% to 37%, respectively), as did the use of longer stents (from 20.5 to 30.2 mm and from 22.2 to 29.3mm, respectively).

Multivessel PCI was increasingly attempted in the SDD cases, from 38.4% in 2007 to 61.6% in 2014, which applies for the cases that underwent LMS PCI and one or more vessels were also attempted, while use of penetration catheters increased from 0% to 1.4%. Adoption of radial access was more frequent over time in the SDD cohort (from 24.1% to 58.3%) compared to the ON stay (from 17.8% to 51%). Finally, we found that increasing numbers of patients were receiving warfarin in both cohorts (from 2% to 3.6% and from 1.3% to 3.3% for SDD and ON cases respectively), whereas the use of glycoprotein IIb/IIIa inhibitor sharply decreased, from 13.7% to 2.4% and from 28.4% to 7.1% for SDD and ON admitted cases respectively. Similar patterns were observed for the unprotected LMS cases J o u r n a l P r e -p r o o f (Supplementary Table 4 ) and when complicated ON cases were included (Supplementary Table 6 ). OR=0.25 (95% CI 0.10-0.62) for SDD respectively. As for overall LMS, renal disease, use of rotational atherectomy and prior peripheral vascular disease were also independently associated to ON stay within the unprotected LMS cases. SDD was more common in those patients in whom PCI was performed transradially PCI, OR=1.80 (95% CI 1.51-2.14). SDD practice for the unprotected LMS also increased over calendar time, after adjustment for casemix (OR=1.10, 95% CI 1.05-1.14).

Supplementary Table 8 Figures 3 and 4) .

SDD was not independently associated with 30-day mortality for the overall LMS cohort, after a case-mix adjustment, with OR=0.72 (95% CI 0.31-1.71, P=0.459) ( Tables 9 and 10 ).

This paper presents the first study to examine the adoption of SDD in patients that underwent elective left main PCI and its relationship to complexity from a healthcare system where SDD is currently the standard of care in elective PCI. [32] We show that the prevalence of SDD for the LMS PCI has increased from 20% to 39% over our study period, although ON monitoring still remains the most common model of treatment for elective LMS PCI cases.

Our analysis suggests that LMS PCI SDD cases are increasingly complex, increasingly undertaken in older patients, who were increasingly comorbid and with increasingly complex disease patterns such those that underwent PCI with rotational atherectomy use or with multivessel PCI. In spite of more complex LMS PCI cases increasingly being undertaken as SDD J o u r n a l P r e -p r o o f cases, 30-day mortality rates were in line with those estimated by the national risk score prediction model suggesting that SDD is not inferior to ON stay in higher risk cases that underwent LMS PCI. Finally, our analysis suggests significant regional heterogeneity of SDD adoption for LMS-PCI, which strengthens the need for national guidelines.

Previous studies examining the safety of SDD after PCI have excluded (unprotected) LMS cases or have actively included them in the criteria for hospital admission. [5, [25] [26] [27] [28] [29] [30] In studies in which LMS PCI was not a formal exclusion criterion, only small numbers of LMS PCI as SDD were undertaken, [2-4, 9, 12, 32, 41] which makes studying outcomes in this cohort of patients challenging. In the present analysis we observed a 2-fold increase in the adoption of SDD for elective LMS PCI and at the same time we observed increasingly comorbid patients treated as SDD, characterised by the greater prevalence of poor left ventricular function, valvular heart disease and comorbidities, such as diabetes, peripheral vascular disease, previous stroke, hypertension and renal dysfunction. The complexity cases also increased over time in the SDD group, i.e. use of rotational atherectomy or penetration catheters and multiple attempted vessels, suggesting that operators feel more comfortable of discharging cases of higher risk on the same day. Our data demonstrate that factors such as old age, female gender, peripheral vascular disease, renal impairment, use of glycoprotein IIb/IIIa inhibitor, rotational atherectomy, penetration catheters, and multivessel PCI are independently associated with ON observation. Previous studies have shown an independent association of many of these clinical and procedural features, in addition to LMS, with death and major adverse cardiac events, and contemporary PCI risk scores include them as risk factors. [35, [42] [43] [44] [45] Our study results show that the transradial access site was increasingly used for LMS SDD PCI, and was the strongest independent predictor of SDD, after adjustment of patient case-mix. This is consistent with our recent study that examined access site practice for LMS PCI which showed that transradial PCI was associated with shorter length of stay and reduced in-hospital complications. [23] Patients with LMS disease are at higher risk for adverse clinical outcomes compared with patients undergoing PCI to other areas of the coronary circulation because anticipation of serious complications is high and admission to ON observation is commonly practised.

The EXCEL randomised controlled trial reported 4.9% major adverse cardiac or cerebrovascular events (MACCE), including death, stroke or myocardial infarction, at 30 J o u r n a l P r e -p r o o f days. [46] A similar RCT focusing on unprotected LMS, reported 0.02% MACCE events at 30 days, including death, non-procedural MI, repeat revascularisation and stroke. [47] To examine the safety of SDD in LMS diseased patients after PCI, we compared the observed 30-day mortality for both SDD and ON stay with predicted values of 30-day mortality, which were calculated from the BCIS mortality risk model -a risk adjustment model used for national public reporting of PCI outcomes. With this method we added an analysis were direct comparison between SDD and ON was avoided, as higher risk cases, will always be more likely to involve ON stay, and a direct comparison between SDD and ON would therefore tend to favour outcomes associated with SDD. In addition, we have excluded cases with peri-or early post-procedural complications, since these cases are, by default, admitted to ON observation, and early complications are highly associated with post-discharge major adverse events [48] [49] [50] . Our data show that the observed 30-day mortality rates for SDD were in line with those predicted from the BCIS model, even though the risk profile of the SDD cases after elective LMS PCI has increased over time. These results show no evidence that SDD after LMS PCI is not safe or feasible for patients selected by the usual criteria. In addition, our data may suggest that even if SDD patients were admitted for overnight observation, this would not prevent the mortality outcome. Most of patients' mortality was recorded at 3 days following PCI, apart from one case were mortality was recorded at the first day following PCI and there is uncertainty of whether overnight stay would prevent that event due to lack of data regarding the exact timing of death (i.e. early in the morning or late at night).

A previously published study examining the variation of SDD practice following elective PCI among different healthcare systems and practitioners, showed that only 14% of cardiologists practiced SDD in the US, 32% in Canada and 57% in the UK. At that study, 2% of the US cardiologists and 11% of the non-US reported SDD for LMS PCI. However, 59% of all the practitioners included in the study were unaware of any official guidelines for SDD after elective PCI in general and, therefore, after elective LMS PCI in particular. [51] In 2009, SCAI published a document defining the appropriate length of stay after elective PCI stating that LMS diseased cases should be always admitted for ON observation. [31] However, elective PCI has evolved to a safer procedure with less adverse outcomes driven by advancements in technology, medication and access site changes, [52] and more recent guidelines about the length of stay or about LMS PCI provide no information about the appropriateness of SDD following elective PCI. [33, 34] This lack of information results in J o u r n a l P r e -p r o o f uncertainty at the operator level which may explain the significant heterogeneity in adoption of LMS PCI SDD that we have observed. More detailed guidelines, informed by an evolving evidence basis, such as data presented in this analysis, are required, and are of even higher significance during the current era of the Covid-19 pandemic as SDD is equivalent to shortened length of stay in the hospital which subsequently provides: (i) less exposure of patients to the virus, and (ii) increased bed availability for the increased demand in the hospitals due to Covid-19.

The present study has several limitations. First, this is an observational study and patients were selected for SDD or ON stay based on operator's discretion. Our data do not provide insight on whether the decision for SDD was taken before the PCI procedure was undertaken (intention to treat) or if the operator's decision for SDD was altered due to periprocedural complexity or emergence of complications during the observational period.

Second, the present analysis also lacks information about the length of the post-PCI observational period, the time of day that the procedure was undertaken, patient preference, family preference, patient circumstance (living distance from the hospital and presence of a companion in case of complications), procedural concerns or other factors that are likely to inform a clinicians' decision for SDD. Similarly, our dataset does not include information about radial lounge monitoring, which has been found to be associated with increase in SDD, although no study has examined their association specifically for LMS PCI. [53, 54] In addition we are uncertain how operators choose which patients are SDD or are kept in for ON monitoring, how much of it relates to lesion / procedural complexity and how much is informed by local practices / guidelines. Third, our dataset only captures 30-day mortality outcomes and lacks information on post-discharge complications, such as MI, stroke, target vessel revascularization, or unplanned readmissions which limits the safety endpoints we are able to study. Nevertheless, significant major complications post discharge in the SDD cohort would have been manifest with an increased mortality risk at 30-days that we have not observed. Furthermore, ON monitoring would only capture complications sustained in the first 24 hours. Fourth, the limited number of deaths after SDD LMS-PCI did not allow us to examine which SDD patients' characteristics are associated with higher mortality risk and perhaps distinguish those patients for whom SDD is safe and feasible after elective LMS PCI.

Finally, our analysis only includes data from 2007 to 2014 which raises questions about more contemporary practice of SDD in the elective LMS setting.

Journal Pre-proof J o u r n a l P r e -p r o o f SDD following elective LMS PCI has become increasingly adopted in England and Wales, with increasingly complex cases undertaken over time, in elderly patients with more complex disease requiring rotational atherectomy, and with a greater prevalence of comorbidities, such as diabetes, previous stroke and peripheral vascular disease. Our analysis, found no evidence that SDD for LMS PCI is not safe in terms of 30-day mortality, and may help inform guidelines in this complex group of patients.

J o u r n a l P r e -p r o o f Table 1 J o u r n a l P r e -p r o o f 

Assessing patient-reported outcomes and preferences for same-day discharge after percutaneous coronary intervention: results from a pilot randomized, controlled trial

Randomized trial comparing same-day discharge with overnight hospital stay after percutaneous coronary intervention: results of the Elective PCI in Outpatient Study (EPOS)

A randomized study comparing same-day home discharge and abciximab bolus only to overnight hospitalization and abciximab bolus and infusion after transradial coronary stent implantation

One-year clinical outcome after abciximab bolus-only compared with abciximab bolus and 12-hour infusion in the Randomized EArly Discharge after Transradial Stenting of CoronarY Arteries (EASY) Study

Same-day discharge after coronary stenting and femoral artery device closure: A randomized study in stable and low-risk acute coronary syndrome patients

Association of Same-Day Discharge After Elective Percutaneous Coronary Intervention in the United States With Costs and Outcomes

Ambulatory transradial percutaneous coronary intervention: a safe, effective, and cost-saving strategy

Safety of sameday-discharge radial percutaneous coronary intervention: a retrospective study

Prevalence and outcomes of same-day discharge after elective percutaneous coronary intervention among older patients

Outcome and safety of same-day-discharge percutaneous coronary interventions with femoral access: a single-center experience

Ambulatory discharge after transradial coronary intervention: Preliminary US single-center experience (Same-day TransRadial Intervention and Discharge Evaluation, the STRIDE Study)

A single center experience with same-day transradial-PCI patients: a contrast with published guidelines

Same-day discharge compared with overnight hospitalization after uncomplicated percutaneous coronary intervention: a systematic review and meta-analysis

Same Day Discharge versus Overnight Stay in the Hospital following Percutaneous Coronary Intervention in Patients with Stable Coronary Artery Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

The feasibility and safety of ambulatory percutaneous coronary interventions in complex lesions

Feasibility and safety of same-day discharge after complex percutaneous coronary intervention using forearm approach

Safety and feasibility of sameday discharge after percutaneous coronary intervention for chronic total occlusion: a single center observational cohort study

Safety of same-day discharge after percutaneous coronary intervention with orbital atherectomy

Randomized Trial of Stents Versus Bypass Surgery for Left Main Coronary Artery Disease: 5-Year Outcomes of the PRECOMBAT Study

Randomized comparison of percutaneous coronary intervention with sirolimus-eluting stents versus coronary artery bypass grafting in unprotected left main stem stenosis

Acute and late outcomes of unprotected left main stenting in comparison with surgical revascularization

Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial

Access Site and Outcomes for Unprotected Left Main Stem Percutaneous Coronary Intervention: An Analysis of the British Cardiovascular Intervention Society Database

Outcomes After Left Main Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting According to Lesion Site: Results From the EXCEL Trial

Transradial approach percutaneous coronary interventions in an out-patient clinic

Safety and Feasibility of Outpatient Percutaneous Coronary Intervention in Selected Patients: A Spanish Multicenter Registry

Assessment of clinical outcomes related to early discharge after elective percutaneous coronary intervention: COED PCI

Outpatient coronary angioplasty: feasible and safe

Actual outpatient PTCA: results of the OUTCLAS pilot study

Day case transradial coronary angioplasty: a fouryear single-center experience

Defining the length of stay following percutaneous coronary intervention: an expert consensus document from the Society for Cardiovascular Angiography and Interventions. Endorsed by the American College of Cardiology Foundation

Same-Day Discharge After Elective Percutaneous Coronary Intervention: Insights From the British Cardiovascular Intervention Society

Guidelines on myocardial revascularization

Length of stay following percutaneous coronary intervention: An expert consensus document update from the society for cardiovascular angiography and interventions

A contemporary risk model for predicting 30-day mortality following percutaneous coronary intervention in England and Wales

British Cardiovascular Intervention Society registry framework: a quality improvement initiative on behalf of the National Institute of Cardiovascular Outcomes Research (NICOR)

Outcome-sensitive multiple imputation: a simulation study

Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls

Multiple imputation using chained equations: Issues and guidance for practice

Multiple Imputation after 18+ Years

An audit of outcomes after same-day discharge post-PCI in acute coronary syndrome and elective patients

The Toronto score for in-hospital mortality after percutaneous coronary interventions

Combined anatomical and clinical factors for the long-term risk stratification of patients undergoing percutaneous coronary intervention: the Logistic Clinical SYNTAX score

Enhanced mortality risk prediction with a focus on high-risk percutaneous coronary intervention: results from 1,208,137 procedures in the NCDR (National Cardiovascular Data Registry)

Impact of bleeding on mortality after percutaneous coronary intervention results from a patient-level pooled analysis of the REPLACE-2 (randomized evaluation of PCI linking angiomax to reduced clinical events), ACUITY (acute catheterization and urgent intervention triage strategy), and HORIZONS-AMI (harmonizing outcomes with revascularization and stents in acute myocardial infarction) trials

Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease

Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial

Access and non-access site bleeding after percutaneous coronary intervention and risk of subsequent mortality and major adverse cardiovascular events: systematic review and meta-analysis

Retroperitoneal Hemorrhage After Percutaneous Coronary Intervention: Incidence, Determinants, and Outcomes as Recorded by the British Cardiovascular Intervention Society

Stroke following percutaneous coronary intervention: type-specific incidence, outcomes and determinants seen by the British Cardiovascular Intervention Society 2007-12

Variation in practice and concordance with guideline criteria for length of stay after elective percutaneous coronary intervention

Same day discharge after elective percutaneous coronary intervention

Evaluation of a protocol for same-day discharge after radial lounge monitoring in a southern Swiss referral percutaneous coronary intervention centre

Impact of a dedicated "radial lounge" for percutaneous coronary procedures on same-day discharge rates and bed utilization

BMS=Bare mare stent

CABG=Coronary Artery Bypass Graft; CI=Confidence Interval; DES=Drug-eluting stent; ECG=Electrocardiogram; GP=Glycoprotein; LVEF=Left ventricular ejection fraction

LMS=Left Main Stem; MI=Myocardial infarction; MVL=Multivessel; ON=Overnight stay; OR=Odds Ratio

SDD=Same Day Discharge

SHA=Strategic Health Authorities

We gratefully acknowledge the contributions of all hospitals and

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