RAISE-EMR is a randomized evaluation of physician preference a commercially available radial artery introducer sheath at 3 physically separate sites within NYU Langone Health: NYU Manhattan, NYU Brooklyn, and NYU Long Island (Mineola, NY). Unique patients planned to undergo a catheterization procedure were identified for possible randomization if there was at least 1 planned 6-French radial artery access site. As observed in standard clinical workflow, the clinical team was aware, and the patient was not aware of which radial artery introducer sheath was used at the time of physician evaluation.

The study was deemed non-human subject research and approved by the NYU Langone Health Quality Improvement Oversight Committee as a quality improvement project. This project was undertaken as a Quality Improvement Initiative at NYU Langone Health, and as such was not formally supervised by the Institutional Review Board per institutional policies. This study was funded by NYU Langone Health as an investigator-initiated study, and the study investigators collaborated with NYU Langone Heart’s Data Hub under NYU Langone Health’s Medical Center of Information Technology. This quality improvement study is registered at clinicaltrials.gov (NCT02135939).

The sheath introducers chosen for evaluation in this study are the 2 commercially available sheath introducers clinically used by physicians for invasive coronary angiography and/or PCI via radial artery access at NYU Langone Health. The Prelude Ideal (Merit Medical, South Jordan, UT, USA) and Glidesheath Slender (Terumo Interventional Systems, Somerset, NJ, USA) are both thin-walled sheath introducers. The 6-French Prelude Ideal sheath (11 cm length) has an outer diameter of 2.44 mm, inner diameter of 2.24 mm, dilator body of 2.20 mm, and a dilator length of 17 cm, while the 6-French Glidesheath Slender (10 cm length) also has an outer diameter of 2.44 mm, inner diameter of 2.22 mm, dilator body of 2.14 mm, and a dilator length of 15.7 cm. ^, At NYU Long Island, the 6-French Prelude Wave sheath (11 cm length) was used, which has an outer diameter of 2.48 mm, inner diameter of 2.23 mm, dilator body of 2.22 mm, and a dilator length of 17 cm.

The study began at all 3 cardiac catheterization laboratories at NYU Langone Health on October 20, 2025. Although the expected sample size was reached on November 6, 2025, enrollment continued until the end of the institution’s next EMR change cycle on November 25, 2025.

All unique patients planned to undergo a catheterization procedure via at least 1 planned 6-French radial artery access approach were identified. As part of the standard clinical workflow, all attending interventional cardiologists provide a mandated pre-procedure attestation note in Epic before the nursing team can move the respective patient into the cardiac catheterization laboratory for their procedure. This attestation note is a uniform template across the NYU Langone Health enterprise ( Figure 1 ). Within this template, intended access site is selected from an Epic SmartList, thereby capturing eligible patients.

Attending interventional cardiologist’s mandated pre-procedure attestation note template.

The only patient procedures not identified for randomization were those who were already enrolled and randomized in this quality improvement study previously (ie, unique patients were included), and those for whom the mandated pre-procedure attestation was exempt (ie, emergency procedures).

Epic-randomization was achieved through the utilization of the Epic OurPractice Advisory (OPA) framework. With the selection of “at least one 6-French radial” in the Epic SmartList shown in the mandated pre-procedure attestation ( Figure 1 ), a background data element was discretely filed. Upon signing the associated note, the OPA framework evaluated for the presence of that planned access selection. When clicking “Enact” in the OPA pop-up to confirm physician participation for the identified patient procedure in the quality improvement study ( Figure 2 ), Epic performed a coin flip randomization function and result in a value of 0 or 1. A value of 0 and 1 was then assigned by the OPA to a discrete encounter SmartData Element to hold and represent the assigned randomized sheath for the case. The randomization function has the ability to randomize values in a range of 0 to n-1 values, based on the assigned value of n in the function (in this case, n = 2). The assignment of the introducer sheath was noted on the catheterization laboratory status board for each patient ( Figure 3 ), which informed the nursing staff which introducer sheath would be used in that particular procedure.

Pop-up window to confirm physician participation in the quality improvement study.

Status of study participation as a hover icon on the Epic Status Board. for each case.

To ensure consistent communication with the nursing team for any patient randomized in this quality improvement study, when a member of the nursing team marked “Wheels in” per standard clinical workflow, an OPA pop-up appeared with the sheath the patient was assigned to by randomization ( Figure 4 ). The nursing team member was instructed to (1) open the assigned sheath type for the procedure; (2) inform the attending, fellow-in-training, or physician assistant who was obtaining access of the sheath assignment; and (3) then mark “Completed.” If the person marking “wheels in” was not a member of the clinical care team, acknowledgment could be deferred. If initial acknowledgment was deferred, nurses would see the OPA reappear on the next chart open by a nursing team member.

Our Practice Advisory pop-up window to be completed a member of the nursing team after patient is moved into the procedure room.

The NYU Langone cardiac catheterization laboratory maintains a data variable dictionary of all standard variables and outcomes of interest for quality improvement purposes. This data variable dictionary was created in conjunction with NYU Langone Heart’s Data Hub so that variables of interest may be automatically collected from Epic in a consistently defined manner. All data elements were exported by NYU Langone Heart’s Data Hub from the EMR using this data variable dictionary for analysis at the end of the study period.

Co-variables

Demographics are identified from structured elements in Epic, including age (none missing), sex (none missing), and self-identified race (6.0% missing).

Medical comorbidities are captured using structured elements from the Epic Cupid procedure report and Systematized Nomenclature of Medicine (SNOMED) codes as follows:

• 1.

  Presence of obesity is defined as a body mass index (BMI) of ≥30 kg/m ², with weight documented in the procedure encounter and height documented within 1 year prior to the procedure. In the absence of a documented BMI (0.4% missing), obesity is defined by the documentation of Class III obesity in the procedure report.

• 2.

  Prior coronary revascularization is defined as prior PCI or prior coronary artery bypass graft surgery documented in the procedure report.

• 3.

  Prior myocardial infarction is defined as documented in the procedure report or presence of related SNOMED codes (see appendix).

• 4.

  Presence of cerebrovascular disease is defined as prior hemorrhagic or ischemic stroke, prior transient ischemic attack, or carotid stenosis documented in the procedure report or presence related SNOMED codes (see appendix).

• 5.

  Presence of peripheral artery disease is defined as prior peripheral artery revascularization, ankle-brachial index of <0.9, claudication with non-palpable peripheral pulses, peripheral artery stenosis >50%, known abdominal aortic aneurysm, renal artery stenosis, or subclavian artery stenosis documented in the procedure report.

• 6.

  History of congestive heart failure is defined as documented left ventricular ejection fraction (LVEF) <50% in the procedure report or, if not reported in the report, on the most recent transthoracic echocardiogram within 1 year prior to the procedure. In the absence of a documented LVEF (45.7% missing), congestive heart failure is defined as history of heart failure with reduced left ventricular ejection fraction documented in the procedure report or presence of related SNOMED codes (see appendix).

• 7.

  Presence of diabetes mellitus is defined as documentation in the procedure report or presence of related SNOMED codes (see appendix), documented outpatient prescription of insulin within the past year, or the most recent Hemoglobin A1c within 3 years prior to the procedure as ≥6.5% (37.5% missing). Insulin treatment is defined as documentation in the procedure report or outpatient prescription of insulin in the EMR within the 1 year prior to the procedure.

• 8.

  Presence of hypertension is defined as presence of related SNOMED codes (see appendix).

• 9.

  Presence of dyslipidemia is defined as presence of related SNOMED codes (see appendix) or outpatient prescription of a lipid lowering medication (atorvastatin, fluvastatin, lovastatin, pravastatin, pitavastatin, rosuvastatin, simvastatin, ezetimibe, colestipol, cholestyramine, colsevelam, evolocumab, alirocumab, niacin, bempedoic acid, fenofibrate, gemofibrozil, fenofibric acid, omega-3 acid ethyl esters, or icosapent ethyl) in the EMR within the one year prior to the procedure.

• 10.

  Presence of atrial arrhythmias is defined as documentation in the procedure report or presence of related SNOMED codes (see appendix).

• 11.

  Kidney disease is defined as the most recent glomerular filtration rate (GFR) within 90 days prior to the procedure of <60 mL/min/1.73m ². In the absence of a documented GFR (10.1% missing), kidney disease is defined as documentation in the procedure report or presence of related SNOMED codes (see appendix). Among patients with kidney disease, the presence of end-stage renal disease is defined as the most recent GFR within 90 days prior to the procedure as <15 mL/min/1.73m ² or documentation of treatment with dialysis in the procedure report or presence of related SNOMED codes (see appendix). In cases where there is a discrepancy between the procedure report and SNOMED code, the most recent GFR prior to the procedure was trusted.

• 12.

  Chronic lung disease is defined as documentation in the procedure report or the presence of related SNOMED codes (see appendix).

• 13.

  Tobacco use is defined as documentation in structured elements in Epic, the procedure report, or presence of related SNOMED codes.

• 14.

  Type of procedure is defined as documented in the procedure report.

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