Table 5

Invasive Therapeutic Intervention Data Elements and Definitions

Element NameElement Definition
Pacemaker implantation
  • If a pacemaker was placed during this admission, indicate what type of device:

  • • Single chamber

  • • Dual chamber

  • • CRT

  • • CRT-D

  • • CRT-P

  • • Biventricular

  • • Pacer

Temporary pacemakerTemporary pacemaker placed during this admission
ICD
  • An ICD may be placed for:

  • • VF

  • • Symptomatic VT

  • • Asymptomatic VT

  • • Other (specify)

  • • Inducible VT/VF at electrophysiological study

  • • Syncope

  • • Primary prevention for patients in high-risk heart failure group

  • The brand, model number, and serial number of the device may be recorded.

Noninvasive stress testingIndicate if the patient underwent exercise or pharmacological stress testing with or without echocardiographic or radionuclide imaging.
Date of noninvasive stress testingIndicate the date of exercise or pharmacological stress testing with or without echocardiographic or radionuclide imaging.
Noninvasive angiogram
  • Indicate if the patient underwent 1 of the following:

  • • MR angiogram

  • • Multislice CT scan

Maximum stenosis by vessel (LAD, LCx, RCA, LM, graft)
  • Stenosis represents the percentage occlusion, from 0% to 100%, associated with the identified vessel systems. Percent stenosis at its maximal point is estimated to be the amount of reduction in the diameter of the “normal” vessel proximal to the lesion. For the denominator, take the maximum internal lumen diameter proximal and distal to the lesion. In instances where multiple lesions are present, enter the highest percentage stenosis noted. The systems of interest are as follows and should include major branch vessels of >2 mm diameter:

  • • Greatest stenosis assessed in the LAD or any major branch vessel

  • • Greatest stenosis assessed in the LCx or any major branch vessel

  • • Greatest stenosis assessed in the RCA or any major branch vessel

  • • Greatest stenosis assessed in the LM

  • • Greatest stenosis assessed in bypass graft

Maximal or submaximal stress testMaximal stress test (symptom limited) or submaximal test (e.g., modified Bruce protocol ending with stage 1 or stage 2)
Ischemia result (positive, negative, equivocal, nondiagnostic test)
  • • Positive: new exercise-induced ischemic horizontal or downsloping ST-segment depression ≥0.10 mV or new ST-segment elevation ≥0.10 mV in a noninfarct territory, as compared with the baseline tracing (in the absence of electrocardiographic confounding such as LV hypertrophy, digoxin-induced changes, or LBBB)

  • • Negative: normal exercise test. No significant exercise-induced ST shift or chest pain suggestive of angina and a normal hemodynamic response to exercise with adequate workload to test cardiac reserve.

  • • Equivocal: exercise-induced chest pain considered to be angina in the absence of significant ischemic ST change.

  • • Nondiagnostic test: negative as defined above, but level of exercise insufficient to adequately test cardiac reserve (e.g., <85% of age-predicted maximum heart rate achieved) or exercise-induced electrocardiographic changes in the presence of LBBB, LVH, or other known confounders.

LVEF assessedIndicate whether the patient had LVEF assessed via invasive (i.e., LV gram) or noninvasive (i.e., echo, MR, CT or nuclear) testing before or during the admission.
Resting LV systolic function: global function—ejection fraction
  • Indicate the ejection fraction category. Choose 1 of the following:

  • • Hyperdynamic: >70%

  • • Normal: 50%–70% (midpoint 60%)

  • • Mild dysfunction: 40%–49% (midpoint 45%)

  • • Moderate dysfunction: 30%–39% (midpoint 35%)

  • • Severe dysfunction: <30%

  • Note: If no diagnostic report is in the medical record, a value documented in the medical record is acceptable.

Diagnostic coronary angiographyIndicate if the patient had diagnostic coronary angiography. This is defined as the passage of a catheter into the aortic root or other great vessels for angiography of the native coronary arteries or bypass grafts supplying native coronary arteries. This element would NOT include noninvasive CT angiography.
Diagnostic coronary angiography date/timeIndicate the date and time the patient had diagnostic coronary angiography, defined as the passage of a catheter into the aortic root or other great vessels.
Culprit artery
  • This is the vessel considered to be responsible for the ACS. The investigator should use his or her judgment in choosing the primary vessel. In cases in which this is difficult to determine (despite correlation of electrocardiographic changes and angiographic data), the vessel supplying the largest territory of myocardium should be selected:

  • • LAD

  • • LCx

  • • RCA

  • • LM

  • • Graft

  • • Unknown

  • Note: “None” should be considered if there is no apparent coronary vessel lesion that could be responsible for evidence of ischemia.

Culprit artery TIMI flow
  • TIMI grade flow in the culprit artery is defined as follows:

  • • Grade 0 (no perfusion): There is no antegrade flow beyond the point of occlusion.

  • • Grade 1 (penetration without perfusion): The contrast material passes beyond the area of obstruction but “hangs up” and fails to opacify the entire coronary bed distal to the obstruction for the duration of the cineangiographic filming sequence.

  • • Grade 2 (partial perfusion): The contrast material passes across the obstruction and opacifies the coronary bed distal to the obstruction. However, the rate of entry of contrast material into the vessel distal to the obstruction or its rate of clearance from the distal bed (or both) is perceptibly slower than its entry into or clearance from comparable areas not perfused by the previously occluded vessel (e.g., the opposite coronary artery or the coronary bed proximal to the obstruction).

  • • Grade 3 (complete perfusion): Antegrade flow into the bed distal to the obstruction occurs as promptly as antegrade flow into the bed from the involved bed and is as rapid as clearance from an uninvolved bed in the same vessel or the opposite artery.

LM stenosis percent
  • The best estimate of the most severe percent stenosis in the LM coronary artery. This does not include collaterals. Indicate the following:

  • • Percent stenosis of the LM coronary artery.

  • • If no stenosis, then enter 0%.

  • • If data are not available, indicate “not available.”

  • Stenosis: Stenosis represents the percent diameter reduction, from 0 to 100, associated with the identified vessel systems. Percent stenosis at its maximal point is estimated to be the amount of reduction in the diameter of the “normal” reference vessel proximal to the lesion. In instances where multiple lesions are present, enter the single highest percent stenosis noted.

  • Note: If the patient only has a PCI (without a diagnostic catheterization at the same sitting), it is acceptable to use prior and recent catheterization lab visit information, even if at another institution.

Proximal LAD and first diagonal branches percent stenosis
  • Indicate the best estimate of the most severe percent stenosis in the proximal LAD and first diagonal coronary artery branches of ≥2.0 mm in diameter as determined by angiography. This does not include collateral circulation. Indicate the following:

  • • Percent stenosis of the proximal LAD and first diagonal branches.

  • • If no stenosis, then enter 0%.

  • • If data are not available, indicate “not available.”

  • Stenosis: Stenosis represents the percent diameter reduction, from 0 to 100, associated with the identified vessel systems. Percent stenosis at its maximal point is estimated to be the amount of reduction in the diameter of the “normal” reference vessel proximal to the lesion. In instances where multiple lesions are present, enter the single highest percent stenosis noted.

  • Note: If the patient only has a PCI (without a diagnostic catheterization at the same sitting), it is acceptable to use prior and recent catheterization lab visit information, even if at another institution.

Mid/distal LAD, D2, and D3 percent stenosis
  • Indicate the best estimate of the most severe percent stenosis in the mid/distal LAD and diagonal coronary artery branches after the first diagonal of ≥2.0 mm in diameter as determined by angiography. This does not include collateral circulation. Indicate the following:

  • • Percent stenosis of the mid/distal LAD, D2, and D3.

  • • If no stenosis, then enter 0%.

  • • If data are not available, indicate “not available.”

  • Stenosis: Stenosis represents the percent diameter reduction, from 0 to 100, associated with the identified vessel systems. Percent stenosis at its maximal point is estimated to be the amount of reduction in the diameter of the “normal” reference vessel proximal to the lesion. In instances where multiple lesions are present, enter the single highest percent stenosis noted.

  • If the patient only has a PCI (without a diagnostic catheterization at the same sitting), it is acceptable to use prior and recent catheterization lab visit information, even if at another institution.

Circ, OMs, LPDA, and LPL branches percent stenosis
  • Indicate the best estimate of the most severe percent stenosis in the Circ, OMs, LPDA, and LPL coronary artery branches of ≥2.0 mm in diameter as determined by angiography. This does not include collaterals. Indicate the following:

  • • Percent stenosis of the Circ, OMs, LPDA, and LPL branches.

  • • If no stenosis, then enter 0%.

  • • If data are not available, indicate “not available.”

  • Stenosis: Stenosis represents the percent diameter reduction, from 0 to 100, associated with the identified vessel systems. Percent stenosis at its maximal point is estimated to be the amount of reduction in the diameter of the “normal” reference vessel proximal to the lesion. In instances where multiple lesions are present, enter the single highest percent stenosis noted.

  • If the patient only has a PCI (without a diagnostic catheterization at the same sitting), it is acceptable to use prior and recent catheterization lab visit information, even if at another institution.

RCA, PDA, RPL, and AM branches percent stenosis
  • Indicate the best estimate of the most severe percent stenosis in the RCA, PDA, RPL, and AM branches of ≥2.0 mm in diameter as determined by angiography. This does not include collaterals. Indicate the following:

  • • Percent stenosis of the RCA, PDA, RPL, and AM branches.

  • • If no stenosis, then enter 0%.

  • • If data are not available, indicate “not available.”

  • Stenosis: Stenosis represents the percent diameter reduction, from 0 to 100, associated with the identified vessel systems. Percent stenosis at its maximal point is estimated to be the amount of reduction in the diameter of the “normal” reference vessel proximal to the lesion. In instances where multiple lesions are present, enter the single highest percent stenosis noted.

  • If the patient only has a PCI (without a diagnostic catheterization at the same sitting), it is acceptable to use prior and recent catheterization lab visit information, even if at another institution.

Ramus percent stenosis
  • Indicate the best estimate of the most severe percent stenosis in the ramus artery (if present) of ≥2.0 mm in diameter as determined by angiography. This does not include collaterals. Indicate the following:

  • • Percent stenosis of the ramus.

  • • If no stenosis, then enter 0%.

  • • If data are not available, indicate “not available.”

  • Stenosis: Stenosis represents the percent diameter reduction, from 0 to 100, associated with the identified vessel systems. Percent stenosis at its maximal point is estimated to be the amount of reduction in the diameter of the “normal” reference vessel proximal to the lesion. In instances where multiple lesions are present, enter the single highest percent stenosis noted.

  • If the patient only has a PCI (without a diagnostic catheterization at the same sitting), it is acceptable to use prior and recent catheterization lab visit information, even if at another institution.

Catheterization contraindicationIndicate if catheterization was not performed. Contraindications may include patient refusal, advanced age, patient not a candidate for revascularization, DNR order, active bleeding, and clinical contraindications/severe comorbidities.
Reperfusion Therapy
Reperfusion therapy: reperfusion candidate
  • Indicate if the patient is a candidate for reperfusion therapy for treatment of STEMI. Reperfusion therapy includes thrombolysis and primary PCI. Choose 1 of the following:

  • • Yes

  • • No

Reperfusion therapy: type of reperfusion
  • If the patient received reperfusion therapy, indicate the type of reperfusion. Choose all that apply:

  • • Primary PCI

  • • Thrombolytic therapy

PCI
 PCIIndicate if the patient underwent PCI, placement of an angioplasty guidewire, balloon, or other device (e.g., stent, atherectomy, brachytherapy, or thrombectomy catheter) into a native coronary artery or CABG for the purpose of mechanical coronary revascularization.
 Catheterization lab arrival date/timeIndicate the date and time the patient arrived at the catheterization lab where the PCI was being performed as documented in the medical record.
 First device activation date/time
  • Indicate the date and time the first device was activated regardless of the type of device used. Use the earliest time from the following:

  • • Time of first balloon inflation

  • • Time of first stent deployment

  • • Time of first treatment of lesion (thrombectomy/aspiration device, laser, rotational atherectomy)

  • • If the lesion cannot be crossed with a guidewire or device (and thus none of the above apply), use the time of guidewire introduction.

  • Please note that this is a process measure about the timeliness of treatment. It is NOT a clinical outcomes measure based on TIMI flow or clinical reperfusion. It does not matter whether the baseline angiogram showed TIMI 3 flow or if the final post-PCI angiogram showed TIMI 0 flow. What is being measured is the time of the first mechanical treatment of the culprit lesion, not the time when TIMI 3 flow was (or was not) restored.

 PCI indication
  • Indicate the primary reason PCI was performed or attempted. Choose 1 of the following:

  • • Immediate, primary PCI for STEMI

  • • Stable following successful reperfusion or completed infarction after STEMI

  • • Rescue PCI (after failed full-dose lytics for STEMI)

  • • PCI for NSTEMI

  • • Other

 Nonsystem reason for delay in PCI
  • Indicate if there is documentation of a reason for a delay in doing the first PCI after hospital arrival by a physician/advanced practice nurse/physician assistant. System reasons for delay are NOT acceptable.

  • • Difficult vascular access

  • • Cardiac arrest and/or need for intubation before PCI

  • • Patient delay in providing consent for procedure

  • • Difficulty crossing the culprit lesion during PCI procedure

  • • Other

  • • None

 Stent placedIndicate if a stent was placed in the affected coronary artery.
 Stent type
  • Indicate the type of stent if a stent was placed in the affected coronary artery.

  • Choose all that apply:

  • • Drug-eluting stent

  • • Bare metal stent

  • • Other stent

 Number of stents placedNumber of stents placed. The exact type of stent should be collected.
Thrombolytics
 Thrombolytics type
  • If the patient received reperfusion therapy with thrombolytics, indicate the type of thrombolytics used. Choose 1 of the following:

  • • Alteplase

  • • Reteplase

  • • Streptokinase

  • • Tenecteplase

  • • Other

 Thrombolytics doseIf the patient received reperfusion therapy with thrombolytics, indicate the strength of dose of the thrombolytics. Choose 1 of the following:
  • Full dose

  • Reduced dose

 Thrombolytics start date/time
  • If the patient received reperfusion therapy with thrombolytics, indicate the time of either the first bolus or the beginning of the infusion.

  • Note: If the facility receives a transfer patient with ongoing infusion, record the time that the infusion was started at the transferring facility.

 Nonsystem reason for delay of thrombolytics
  • Indicate if there is documentation of a nonsystem reason for delay in initiating thrombolytic therapy >30 min from the time of first facility arrival (including an ambulance capable of administering thrombolytic therapy).

  • Note: A patient being transferred into a facility is not considered a nonsystem reason for delay.

Contraindications for reperfusion therapy
 Contraindication to PCI
  • Indicate why PCI was not performed as reperfusion therapy. Choose 1 of the following:

  • • Noncompressible vascular puncture(s)

  • • Active bleeding on arrival or within 24 h

  • • Quality-of-life decision

  • • Anatomy not suitable for primary PCI

  • • Spontaneous reperfusion (documented by catheterization only)

  • • Patient/family refusal

  • • DNR order in place at time of treatment decision

  • • Prior allergic reaction to IV contrast

  • • Facility is not a PCI center

  • • Other

 Contraindication to thrombolytics
  • Indicate why thrombolytics were not administered as reperfusion therapy. Choose 1 of the following:

  • • Known bleeding diathesis

  • • Recent bleeding within 4 wk

  • • Recent surgery/trauma

  • • Intracranial neoplasm, AV malformation, or aneurysm

  • • Severe uncontrolled hypertension

  • • Suspected aortic dissection

  • • Significant close head or facial trauma within previous 3 mo

  • • Active peptic ulcer

  • • Traumatic CPR that precludes thrombolytics

  • • Ischemic stroke within 3 mo except acute ischemic stroke within 3 h

  • • Any prior intracranial hemorrhage

  • • Pregnancy

  • • Prior allergic reaction to thrombolytics

  • • DNR order in place at time of treatment decision

  • • Patient/family refusal

  • • Other

Other Invasive Therapeutic Interventions
 CABG surgeryIndicate if the patient underwent CABG surgery during this admission.
 CABG surgery date/timeIndicate the date and time the patient entered the operating room suite or the first time surgery was documented on the operating room report.
 IABPIndicate if IABP was used during this admission.
 Circulatory support
  • Indicate if circulatory support was provided during this admission and which type:

  • • IABP

  • • Tandem Heart

  • • Impella

  • • ECMO

  • • LVAD

  • • BiVAD

  • • Other

 Pulmonary artery catheterIndicate if a pulmonary artery (Swan Ganz) catheter was used during this admission.
 VentilatorIndicate the need for intubation and respiratory support on a ventilator. Include the date and time the patient was put on and taken off the ventilator.

ACS indicates acute coronary syndrome; AM, acute marginal; AV, arteriovenous; BiVAD, biventricular assist device; CABG, coronary artery bypass graft; Circ, circumflex; CPR, cardiopulmonary resuscitation; CRT, cardiac resynchronization therapy; CRT-D, cardiac resynchronization therapy defibrillator; CRT-P, cardiac resynchronization therapy pacemaker; CT, computed tomography; D2 diagonal branch 2; D3 diagonal branch 3; DNR, do not resuscitate; ECG, electrocardiogram; ECMO, extracorporeal membrane oxygenation; IABP, intraortic balloon pump; ICD, implantable cardioverter-defibrillator; IV, intravenous; LAD, left anterior descending; LBBB, left bundle-branch block; LCx, left circumflex; LM, left main; LPDA, left posterior descending artery; LPL left posterolateral; LV, left ventricle; LVAD, left ventricular assist device; LVEF, left ventricular ejection fraction; LVH, left ventricular hypertrophy; MR, magnetic resonance; NSTEMI, non-ST-segment elevation myocardial infarction; OM, obtuse marginal; PCI, percutaneous coronary intervention; PDA, posterior descending artery; RCA, right coronary artery; RPL, right posterolateral; STEMI, ST-segment elevation myocardial infarction; TIMI, Thrombolysis in Myocardial Infarction; VF, ventricular fibrillation; and VT, ventricular tachycardia.