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The IAC Standards and Guidelines for Cardiovascular Catheterization Accreditation

Click here for a printer-friendly PDF of the Cardiovascular Catheterization Standards

Part B:
Process

Section 1B: Procedures and Protocols

STANDARD – Procedure Overview

1.1B The cardiovascular catheterization procedure overview described below is not intended to be a comprehensive list of requirements to perform a case, nor does it list every step necessary for every patient. It represents an overview of the general steps to perform a typical elective case in order to provide a context for the overall requirements of this accreditation program. A facility may find it helpful to use this description to create an institutional template to be used as a reference when analyzing outcomes.

(See Guidelines below for further recommendations.)

1.1.1B The facility must assure that appropriate staff members with BLS, ACLS and PALS certification are present during the procedure.

1.1.2B Appropriate staff must be available to assist the patient should an adverse event occur during the procedure and/or during recovery.

(See Guidelines below for further recommendations.)

1.1.3B All staff must observe adherence to:

1.1.3.1B standardized uniformly applied universal precautions in every aspect of patient care;

1.1.3.2B national patient safety goals (e.g., medication safety);

1.1.3.3B infection control measures consistent with CDC and OSHA guidelines.

1.1.4B When in the presence of ionizing radiation, all staff must observe proper radiation safety techniques to include, but not limited to: wearing radiation protective garments; thyroid shield, vest with skirt or full-length apron or full-length jacket. Garments must meet a lead equivalent of 0.5mm with a weight per unit area of 7 kg/m2. Alternatively, staff may use a floor-mounted/portable radiation protection cabin and a ceiling- or gantry-mounted suspended radiation protection system. However, all staff using these systems must be able to completely fit behind these lead barriers whenever radiation is being used.

STANDARD – Procedure Requirements

1.2B Prior to performance of the procedure:

1.2.1B An adequate supply of devices approved by the FDA for marketing or investigational use must be available. This includes, but is not limited to: diagnostic catheters, therapeutic catheters and implantable devices.

1.2.2B Appropriate pharmacologic agents must be readily available for use during the procedure. The facility must have policy in place for the oversight of distribution for pharmacologic agents by a clinical pharmacist.

1.2.3B Proper identification of the patient and planned procedure must be carried out prior to puncture according to national patient safety goals and the proper patient name or identification (ID) must be present on the imaging system.¹⁹ This must be performed immediately before the initiation of the procedure when all key personnel are present.

All procedures, performed with or without moderate sedation and/or with or without general anesthesia, must be explained to the patient and/or the parents or guardians of those unable to give informed consent. Consent must be obtained in a manner consistent with the rules and regulations required by the hospital or facility. During the use of moderate sedation and/or general anesthesia there must be methods in place to assess the patient’s level of consciousness pre-procedure and throughout the procedure. Written policies must exist for the use of conscious sedation including, but not limited to:

1.2.3.1B type of sedatives and appropriate dosing; and

1.2.3.2B monitoring during and after the examination.

(See Guidelines below for further recommendations.)

1.2.4B A fire safety evaluation must be performed prior to the start of the procedure whenever there is potential for a flammable substance to be used in the presence of oxygen.^{26,27,28,28,49} This must be performed immediately before the initiation of the procedure when all key personnel are present.

1.2.5B History and physical examination must be performed within 30 days and should be in the chart and include documentation of relevant laboratory testing, medications, allergies and bleeding disorders.

1.2.6B Cardiovascular assessment, must be documented.

1.2.6.1B Patients undergoing a cardiovascular catheterization procedure will undergo cardiovascular assessment prior to and following the procedure to document pre-procedural status, post-procedural status and evaluate for any procedural complications. Cardiovascular assessment must include, but not limited to:

i. pre-procedure assessment:

· heart rate and rhythm;

· blood pressure;

· symptoms;

· comorbidity(s);

· medications and allergies;

· other.

ii. post-procedure assessment:

· heart rate and rhythm;

· blood pressure;

· symptoms;

· complication(s);

· other.

1.2.7B When applicable, laboratory testing should be carried out and documented in the medical record to include, but not limited to: electrolytes, blood urea nitrogen (BUN), creatinine, complete blood count (CBC), blood type and screen (if indicated, within 30 days of the procedure). Prothrombin time (INR), if taking warfarin and pregnancy test (in females of childbearing age) should be performed within 24 hours of procedure. If pre-procedure laboratory testing is performed outside the facility, the results of that testing must be included inside the facility’s medical record (e.g., intake history and physical). Positive blood cultures must also be documented in the facility’s medical record and interpreted by the responsible physician.

1.2.7.1B A policy must designate which procedures require type and crossmatch for the availability of blood products.

1.2.8B When applicable, antithrombotic therapy should be administered prior to the procedure, during the procedure and after the procedure.

1.2.9B For any procedure, to include but not limited to: PCI, valve interventions, septal closure, etc., administration of an appropriate antibiotic within one hour before intervention is required.

1.2.10B Paddle or self-adhesive external defibrillation pads must be available prior to the onset and for the duration of the procedure.

1.2.10.1B When using self-adhesive external defibrillation pads, they must be placed on the patient’s chest prior to the onset of the procedure.

1.2.11B The facility must have a process to address procedural complications (refer to Standard 3.1.2C).

1.2.12B The operator must be aware of prior PCI and CABG data and review the associated prior imaging and/or report(s), if available.

1.2.13B The operator must be aware of all device and lead hardware present, including those in use and previously abandoned.

1.2.14B Procedure preparation must also include:

1.2.14.1B intravenous access appropriate for patient size and procedure performed;

1.2.14.2B continuous electrocardiographic monitoring;

1.2.14.3B blood pressure monitoring (invasive or non-invasive); and

1.2.14.4B when applicable, skin prep to allow for emergent pericardiocentesis, thoracotomy, sternotomy and cardio-pulmonary bypass.

(See Guidelines below for further recommendations.)

1.3B During the performance of the procedure:

1.3.1B Standard Advance Cardiac Life Support (ACLS) and Pediatric Advanced Life Support (PALS) medications must be available, according to Standard 2.4.3.8A.

1.3.2B Physiologic monitoring must include continuous electrocardiographic monitoring:

1.3.2.1B blood pressure monitoring (invasive or non-invasive);

1.3.2.2B pulse oximetry; and

1.3.2.3B capnography may be used (if appropriate).

1.3.3B Intravenous access for administration of fluids and medications must be in place.

1.3.4B Radiation must be monitored during the procedure.⁴⁵

1.3.4.1B Radiation use must be consistent with the “as low as reasonably achievable” principle or ALARA radiation safety guidelines.

1.3.5B Adequate anticoagulation should be monitored with activated clotting time (ACT) throughout the procedure.

1.3.6B Acquisition of representative diagnostic or pre-, intra- and post-intervention angiographic imaging.

1.3.7B Acquisition of representative pre-, intra- and post intervention ultrasound imaging, when applicable:

1.3.7.1B Ultrasound imaging may include one or more of the following:

i. transthoracic echocardiography (TTE);

ii. transesophageal echocardiography (TEE);

iii. intracardiac echocardiography (ICE); and

iv. intra-vascular ultrasound (IVUS).

1.4B Following the performance of the procedure:

1.4.1B Perform and document post-procedure basic cardiovascular evaluation to assess for new complications prior to moving the patient off the table.

1.4.1.1B The facility must have a protocol in place to address post-procedure complications.

1.4.2B Assessment of blood pressure and the status of the puncture site.

1.4.2.1B Blood pressure must be controlled post-procedure according to the facility protocol.

1.4.2.2B The facility must have a protocol in place to address sheath removal and personnel appropriate to manage sheath removal.

1.4.3B A post-procedure note in the patient’s chart must be generated summarizing the procedure and addressing any immediate complications and the patient’s status at the end of the procedure.

1.4.3.1B Complications may include, but not limited to^{7, 19,22, 59}:

i. acute renal failure;

ii. acute stroke/transient ischemic attack (TIA) or other neurologic events;

iii. arrhythmias requiring treatment;

iv. cardiac arrest;

v. cardiac perforation;

vi. cardiac tamponade;

vii. cardiac valve injury;

viii. contrast reaction;

ix. conduction block;

x. coronary perforation;

xi. excess radiation dose;

xii. hematoma;

xiii. hemothorax;

xiv. intracranial hemorrhage;

xv. lead dislodgement;

xvi. myocardial infarction:

· rise and fall of cardiac biomarkers;

· ECG changes with or without symptoms; and

· imaging evidence of regional loss of viable myocardium at rest in the absence of a non-ischemic cause.

xvii. pericardial effusion;

xviii. peripheral embolus;

xix. pneumothorax;

xx. stent thrombosis;

· other adverse events:

o stent loss;

o retained foreign body;

o guidewire fracture;

o other.

xxi. sudden cardiogenic shock;

xxii. vascular complications requiring treatment or intervention:

· major drop in hemoglobin (>3.0 g/l) or requirement for blood transfusion;

· major bleeding;

· access site vascular injury;

· retroperitoneal hemorrhage;

· arterial access vessel occlusion or dissection;

· access site infection;

· DVT/pulmonary embolism;

· dissections; pseudoaneurysms;

· arteriovenous (AV) fistula;

· stent loss – peripheral;

· other.

xxiii. other.

(See Guidelines below for further recommendations.)

1.4.4B The patient must be moved to an appropriate setting such as a separate periprocedural area, the general cardiology floor, or a cardiac critical care/intensive care/step down unit with the equipment and trained personnel necessary to perform cardiovascular and hemodynamic monitoring and assessment. When appropriate, continuous telemetry should be available for the evaluation of heart rhythm. The environment for post-procedural care should be appropriate for patient age and development. When appropriate, the nursing and physician staff should be experienced in the care of pediatric and congenital cardiovascular catheterization patients.

1.4.5B Document post-procedure cardiovascular assessment within approximately 24 hours and/or prior to discharge.

1.4.6B Document discharge instructions for patient and/or family.

(See Guidelines below for further recommendations.)

1.4.7B Radiation usage as recorded by the angiographic system (i.e., fluoro time, DAP, mGy/cm) during the procedure must be documented in the final procedure report as defined in Fluoroscopy: Equipment and Instrumentation and referenced in the NCDR Statement Number 11: Report 168²⁹ (refer to Appendix B).

STANDARD – Procedure Interpretation and Reports

1.5B Provisions must exist for the timely reporting of examination data.

1.5.1B There must be a policy in place for communicating critical results.

1.5.2B Preliminary reports and/or post-procedural note(s) can only be issued by a physician and/or physician assistant or nurse practitioner under the direction of the interpreting physician. There must be a policy in place for communicating any significant changes between the preliminary and final reports.

1.5.3B Routine inpatient cardiovascular catheterization procedures must be interpreted by a qualified physician within 24 hours of completion of the examination. Outpatient studies must be interpreted by the end of the next business day. The final verified (by the interpreting physician) signed report must be completed within 48 hours after interpretation or two business days for outpatient procedures.

1.6B Adult diagnostic catheterization reporting must be standardized in the facility. Complete information regarding all components of the procedure must be documented in the medical record, although the exact format of data reporting may vary among institutions. Generally, reporting is accomplished with a physician-authored procedure or operative note, a nursing or technical record, and an anesthesia or sedation record. In cases where procedural sedation is administered by non-anesthesia nursing staff, the sedation record may be included within the nursing record.

1.6.1B The nursing or technical record must include all technical aspects of the procedure, unless recorded in the anesthesia record, to include but may not be limited to:

1.6.1.1B Demographics:

i. name and/or identifier of the facility;

ii. name and/or identifier of the patient;

iii. date of birth and/or age of the patient; 

iv. date of the study;

v. type of study;

vi. name or initials of technical, nursing and ancillary staff participating in the cardiovascular catheterization procedure; and

vii. name of the performing physician(s):

· primary operator; and

· secondary operator (if applicable).

1.6.1.2B Baseline data:

i. height;

ii. weight;

iii. gender;

iv. baseline heart rate, blood pressure prior to the start of the procedure; and

v. allergies.

1.6.1.3B Procedural data, when applicable:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. systemic oxygen saturation and/or pO2;

v. physician scrub-in time;

vi. percutaneous access time;

vii. activated clotting time(s) (ACT), if applicable;

viii. arterial blood gas, if applicable;

ix. type of sedation (general anesthesia vs. moderate sedation vs. no sedation);

x. medications administered;

· dose; and

· time given.

xi. vascular access:

· sites;

· sheath size; and

· sheath-in time.

xii. hemodynamic data;

xiii. sheath removal;

xiv. fluoroscopic exposure:

· fluoroscopy time, and one or more of the following;

· radiation dose (i.e., mGy);

· dose-area product.

xv. contrast agent(s), if used, the following must be documented:

· name of contrast(s);

· volume(s) injected; and

· other data, as required.

xvi. diagnostic imaging - imaging to demonstrate adequate opacification of coronary artery segment(s)³⁰:

· angiographic projections for optimal visualization of the coronary artery segments.

Comment: For angiographic projections for optimal visualization of the left and right coronary artery segments.

(See Guidelines below for further recommendations.)

xvii. additional imaging and measures, when applicable:

· intravascular ultrasound (IVUS);

· intracardiac echocardiography (ICE);

· transthoracic and/or transesophageal echocardiography;

· method of measuring flow reserve (e.g., IFR, FFR, etc.);

· other imaging and measures, as required.

xviii. other data/information, as required.

Comment: Facilities must have the ability to measure lesion significance by one of the standard accepted flow mediated technologies and applicable staff must be able to demonstrate proficiency in the use of said technology.

1.6.1.4B Post-procedural data:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. level of consciousness;

v. oxygenation; and

vi. hemostasis.

1.6.2B The anesthesia record must include all aspects of the procedure relating to anesthesia or sedation, and the patient’s response to anesthesia or sedation:

1.6.2.1B Pre-procedural data:

i. height;

ii. weight;

iii. gender;

iv. anesthesia risk assessment;

v. baseline blood pressure prior to the start of the procedure; and

vi. allergies.

1.6.2.2B Procedural data:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. medications administered;

· dose; and

· time given.

v. level of anesthesia/sedation;

vi. oxygenation;

vii. capnography measures, if applicable;

viii. activated clotting time(s) (ACT), if applicable; and

ix. arterial blood gas, if applicable.

1.6.2.3B Post-procedural data:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. level of consciousness; and

v. oxygenation.

1.6.3B All physicians interpreting adult diagnostic catheterization procedures must agree on uniform diagnostic criteria and a standardized report format. The report must be free of internal inconsistencies and accurately reflect the content and results of the study, including any pertinent positive and negative findings particularly those relative to the indication for exam. The report must include but may not be limited to⁴⁶:

1.6.3.1B Demographics:

i. date of the study;

ii. name and/or identifier of the facility;

iii. name and/or identifier of the patient;

iv. type of study;

v. indication for the study; and

vi. name of the performing physician(s):

· primary operator; and

· secondary operator (if applicable).

1.6.3.2B A summary of the technical aspects of the procedure including (when applicable):

i. vascular access sites:

· catheter type and size

ii. catheter placement;

iii. other.

1.6.3.3B A summary of the results of baseline adult diagnostic catheterization testing including (when applicable);

i. description of coronary anatomy;

ii. description of angiographic projections performed for optimal visualization of the coronary artery segments³⁰;

iii. description of abnormality;

iv. percent stenosis of the affected coronary artery(s);

v. left ventricular function;

vi. hemodynamic measurements;

vii. acute complication(s);

viii. post-procedure recommendations;

ix. other.

1.6.3.4B The final report must be completely typewritten, including the printed name of the interpreting physician. The final report must be reviewed, signed and dated manually or electronically by the interpreting physician. Electronic signatures must be password protected and indicate they are electronically recorded. Stamped signatures or signing by non-physician staff is unacceptable.

1.6.3.5B A summary/conclusion of the results of the procedure, including any positive and negative findings or adverse outcomes.

1.6.3.6B If appropriate, need for additional studies and/or procedures based on the results of the procedure being reported.


Comment: An accurate, succinct impression (e.g., normal, abnormal, stable). This must clearly communicate the result(s) of the procedure. This final conclusion must resolve the clinical question or provide guidance for further studies to do so.

Comment: A record of pre-procedural and post-procedural physiologic measures and laboratory data must be maintained and immediately available when referencing the final report.

1.7B Percutaneous Coronary Intervention (PCI) reporting must be standardized in the facility. Complete information regarding all components of the procedure must be documented in the medical record, although the exact format of data reporting may vary among institutions. Generally, reporting is accomplished with a physician-authored procedure or operative note, a nursing or technical record, and an anesthesia or sedation record. In cases where procedural sedation is administered by non-anesthesia nursing staff, the sedation record may be included within the nursing record.

1.7.1B The nursing or technical record must include all technical aspects of the procedure, unless recorded in the anesthesia record, to include but may not be limited to:

1.7.1.1B Demographics:

i. name and/or identifier of the facility;

ii. name and/or identifier of the patient;

iii. date of birth and/or age of the patient; 

iv. date of the study;

v. type of study;

vi. name or initials of technical, nursing and ancillary staff participating in the cardiovascular catheterization procedure; and

vii. name of the performing physician(s):

· primary operator; and

· secondary operator (if applicable).

1.7.1.2B Baseline data:

i. height;

ii. weight;

iii. gender;

iv. anesthesia risk assessment;

v. baseline heart rate, blood pressure prior to the start of the procedure; and

vi. allergies.

1.7.1.3B Procedural data, when applicable:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. systemic oxygen saturation and/or pO2;

v. physician scrub-in time;

vi. percutaneous access time;

vii. activated clotting time(s) (ACT), if applicable;

viii. arterial blood gas, if applicable;

ix. type of sedation (general anesthesia vs. moderate sedation vs. no sedation);

x. medications administered:

· dose; and

· time given.

xi. vascular access:

· sites;

· sheath size; and

· sheath-in time.

xii. hemodynamic data;

xiii. sheath removal;

xiv. fluoroscopic exposure:

· fluoroscopy time, and one or more of the following;

· radiation dose (i.e., mGy);

· dose-area product.

xv. contrast agent(s), if used, the following must be documented:

· name of contrast(s);

· volume(s) injected; and

· other data, as required.

xvi. angiographic imaging to demonstrate affected coronary artery segment(s)³⁰:

· angiographic projections for optimal visualization of the affected coronary artery segment(s).

(See Guidelines below for further recommendations.)

xvii. additional imaging and measures, when applicable:

· intravascular ultrasound (IVUS);

· intracardiac echocardiography (ICE);

· transthoracic and/or transesophageal echocardiography;

· method of measuring flow reserve (e.g., IFR, FFR, etc.);

· other imaging and measures, as required.

xviii. interventional data;

· site of lesion(s);

· intervention type(s);

· intervention data;

o angioplasty, when applicable:

1. number of inflation(s);

2. inflation pressures (atm) and duration of inflation(s);

3. other.

o device, when applicable;

1. number of device(s);

2. site of placement(s);

3. manufacturer(s);

4. device identification information;

model; and

serial number.

5. size(s)/length(s);

6. other.

· percent stenosis pre-and post-intervention;

· other.

xix. other data/information, as required.

Comment: Facilities must have the ability to measure lesion significance by one of the standard accepted flow mediated technologies and applicable staff must be able to demonstrate proficiency in the use of said technology.

1.7.1.4B Post-procedural data:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. level of consciousness;

v. oxygenation; and

vi. hemostasis.

1.7.2B The anesthesia record must include all aspects of the procedure relating to anesthesia or sedation, and the patient’s response to anesthesia or sedation.

1.7.2.1B Pre-procedural data:

i. height;

ii. weight;

iii. gender;

iv. anesthesia risk assessment;

v. baseline blood pressure prior to the start of the procedure; and

vi. allergies.

1.7.2.2B Procedural data:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. medications administered;

· dose; and

· time given.

v. level of anesthesia/sedation;

vi. oxygenation;

vii. capnography measures, if applicable;

viii. activated clotting time(s) (ACT), if applicable;

ix. arterial blood gas, if applicable.

1.7.2.3B Post-procedural data:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. level of consciousness;

v. oxygenation; and

vi. post procedural infusion(s), when applicable.

1.7.3B All physicians interpreting Percutaneous Coronary Intervention (PCI) procedures must agree on uniform diagnostic criteria and a standardized report format. The report must be free of internal inconsistencies and accurately reflect the content and results of the study, including any pertinent positive and negative findings particularly those relative to the indication for exam. The report must include but may not be limited to⁴⁶:

1.7.3.1B Demographics:

i. date of the study;

ii. name and/or identifier of the facility;

iii. name and/or identifier of the patient;

iv. type of study;

v. indication for the study; and

vi. name of the performing physician(s):

· primary operator; and

· secondary operator (if applicable).

1.7.3.2B A summary of the technical aspects of the procedure including (when applicable):

i. vascular access sites:

· catheter type and size

ii. catheter placement;

iii. other.

1.7.3.3B A summary of the results of PCI including (when applicable);

i. description of coronary anatomy;

ii. type of intervention;

iii. device type;

· location;

· size;

· manufacturer;

· other.

iv. post intervention percent stenosis;

v. post intervention ventricular function;

vi. post intervention ECG changes;

vii. hemodynamic measurements;

viii. measured flow reserve results (e.g., IFR, FFR, etc.);

ix. acute outcome;

x. acute complication(s);

xi. post intervention result;

xii. post-procedure recommendations;

xiii. other.

Comment: Facilities must have the ability to measure lesion significance by one of the standard accepted flow mediated technologies and applicable staff must be able to demonstrate proficiency in the use of said technology.

1.7.3.4B The final report must be completely typewritten, including the printed name of the interpreting physician. The final report must be reviewed, signed and dated manually or electronically by the interpreting physician. Electronic signatures must be password protected and indicate they are electronically recorded. Stamped signatures or signing by non-physician staff is unacceptable.

1.7.3.5B A summary/conclusion of the results of the procedure, including any positive and negative findings or adverse outcomes.

1.7.3.6B If appropriate, need for additional studies and/or procedures based on the results of the procedure being reported.

Comment: An accurate, succinct impression (e.g., normal, abnormal, stable). This must clearly communicate the result(s) of the procedure. This final conclusion must resolve the clinical question or provide guidance for further studies to do so.

Comment: A record of pre-procedural and post-procedural physiologic measures and laboratory data must be maintained and immediately available when referencing the final report.

(See Guidelines below for further recommendations.)

1.8B Valve intervention reporting must be standardized in the facility. Complete information regarding all components of the procedure must be documented in the medical record, although the exact format of data reporting may vary among institutions. Generally, reporting is accomplished with a physician-authored procedure or operative note, a nursing or technical record, and an anesthesia or sedation record. In cases where procedural sedation is administered by non-anesthesia nursing staff, the sedation record may be included within the nursing record.^{14,15,16,31,37,38,39,40}

1.8.1B The nursing or technical record must include all technical aspects of the procedure, unless recorded in the anesthesia record, to include but may not be limited to:

1.8.1.1B Demographics:

i. name and/or identifier of the facility;

ii. name and/or identifier of the patient;

iii. date of birth and/or age of the patient; 

iv. date of the study;

v. type of study;

vi. name or initials of technical, nursing and ancillary staff participating in the cardiovascular catheterization procedure; and

vii. name of the performing physician(s):

· primary operator; and

· secondary operator (if applicable).

viii. cardiovascular catheterization procedure.

1.8.1.2B Baseline data:

i. height;

ii. weight;

iii. gender;

iv. anesthesia risk assessment;

v. baseline heart rate, blood pressure prior to the start of the procedure; and

vi. allergies.

1.8.1.3B Procedural data, when applicable:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. systemic oxygen saturation and/or pO2;

v. physician scrub-in time;

vi. percutaneous access time;

vii. activated clotting time(s) (ACT), if applicable;

viii. arterial blood gas, if applicable;

ix. type of sedation (general anesthesia vs. moderate sedation vs. no sedation);

x. medications administered:

· dose; and

· time given.

xi. vascular access:

· sites;

· sheath size; and

· sheath-in time.

xii. hemodynamic data;

xiii. transcatheter cerebral embolic protection (TCEP), when applicable:³⁸

· site of placement; and

· manufacturer;

xiv. sheath removal;

xv. fluoroscopic exposure:

· fluoroscopy time, and one or more of the following;

· radiation dose (i.e., mGy);

· dose-area product.

xvi. contrast agent(s), if used, the following must be documented:

· name of contrast(s);

· volume(s) injected; and

· other data, as required.

xvii. angiography;

· type of contrast(s);

· for each angiogram:

o time of injection;

o site;

o dose (ml);

o injection rate (ml/sec);

o inflation pressures (atm);

o rise time; and

o projection angles.

· other.

xviii. additional imaging, when applicable:

· intravascular ultrasound (IVUS);

· intracardiac echocardiography (ICE);

· transthoracic and/or transesophageal echocardiography;

· other imaging, as required.

xix. interventional data;

· affected valve(s);

· intervention type(s);

· interventional data:

o valvuloplasty, when applicable:

1. balloon diameter(s);

2. number of inflation(s);

3. for transcatheter aortic valve replacement (TAVR):
pre-procedure evaluation of the distance between the aortic annulus and coronary ostia;

4. for TAVR: when applicable, intra-procedure documentation of rapid ventricular pacing;

5. for TAVR: when applicable; documentation of intra-procedure annual predilatation;

6. for TAVR: post-procedure evaluation of the degree of aortic regurgitation;

7. for transcatheter mitral valve replacement (TMVR): pre-, intra-, and post-procedural regurgitant gradients;

8. for transcatheter tricuspid valve replacement (TTVR) in a conduit: evaluation of inner dimension of the conduit to assess for the presence of a suitable anchor point;

9. for transcatheter pulmonary valve replacement (TPVR) in a conduit: angiograms between each sequential balloon size to rule out conduit tear;

10. for TPVR: coronary evaluation to rule out compression with RVOT stenting;

11. For TPVR: type, number and dilation diameter of pre-stent(s)

12. inflation pressures (atm) and duration of inflation(s);

13. other.

o valve:

1. site of placement(s);

2. manufacturer(s);

3. device identification information:

model; and

serial number.

4. size(s);

5. degree of pre-valve implant stenosis and regurgitation;

6. degree of post-valve implant stenosis and regurgitation;

7. other.

· when applicable, device removal;

· other.

xx. other data/information, as required.

(See Guidelines below for further recommendations.)

1.8.1.4B Post-procedural data:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. level of consciousness;

v. systemic oxygen saturation; and

vi. method of hemostasis

1.8.2B The anesthesia record must include all aspects of the procedure relating to anesthesia or sedation, and the patient’s response to anesthesia or sedation:

1.8.2.1B Pre-procedural data:

i. height;

ii. weight;

iii. gender;

iv. anesthesia risk assessment;

v. baseline blood pressure prior to the start of the procedure;

vi. baseline oxygen saturation; and

vii. allergies.

1.8.2.2B Procedural data:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. medications administered:

· dose; and

· time given.

v. level of anesthesia/sedation;

vi. oxygenation;

vii. capnography measures, if applicable;

viii. activated clotting time(s) (ACT), if applicable; and

ix. arterial blood gas, if applicable.

1.8.2.3B Post-procedural data:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. level of consciousness; and

v. oxygenation.

1.8.3B All physicians interpreting valve intervention procedures must agree on uniform diagnostic criteria and a standardized report format. The report must be free of internal inconsistencies and accurately reflect the content and results of the study, including any pertinent positive and negative findings particularly those relative to the indication for exam. The report must include but may not be limited to^{14,15,16,31,37,38,39,40,46}:

1.8.3.1B Demographics:

i. date of the study;

ii. name and/or identifier of the facility;

iii. name and/or identifier of the patient;

iv. type of study;

v. indication for the study; and

vi. name of the performing physician(s):

· primary operator; and

· secondary operator (if applicable).

1.8.3.2B A summary of the technical aspects of the procedure including (when applicable):

i. vascular access sites;

ii. transcatheter cerebral embolic protection (TCEP) sites;³⁶

iii. catheter placement;

iv. transseptal access technique;

v. detailed description of the procedure;

vi. other.

1.8.3.3B A summary of the results of valve intervention including;

i. description of valve anatomy to include pre-intervention annulus measurements;

ii. detailed report of hemodynamics and oximetry data;

iii. detailed description of angiography;

iv. valvular function;

· when applicable, percent stenosis pre- and post-intervention;

· when applicable, grade of regurgitation; and

v. ventricular function of the affected side;

vi. type of intervention and results;

vii. device(s) used (new):

· size;

· type; and

· manufacturer.

viii. hemodynamic measurements and interpretation;

ix. complete diagnosis list;

x. recommendation for ongoing management;

xi. procedural complication(s);

xii. other.

1.8.3.4B The final report must be completely typewritten, including the printed name of the interpreting physician. The final report must be reviewed, signed and dated manually or electronically by the interpreting physician. Electronic signatures must be password protected and indicate they are electronically recorded. Stamped signatures or signing by non-physician staff is unacceptable.

1.8.3.5B A summary/conclusion of the results of the procedure, including any positive and negative findings or adverse outcomes.

1.8.3.6B If appropriate, need for additional studies and/or procedures based on the results of the procedure being reported.

Comment: An accurate, succinct impression (e.g., normal, abnormal, stable). This must clearly communicate the result(s) of the procedure. This final conclusion must resolve the clinical question or provide guidance for further studies to do so.

Comment: A record of pre-procedural and post-procedural physiologic measures and laboratory data must be maintained and immediately available when referencing the final report.

1.8.3.7B Procedures requiring the routine use of transesophageal echocardiography must be performed in an IAC-accredited facility.

(See Guidelines below for further recommendations.)

1.9B Structural heart intervention reporting must be standardized in the facility. Complete information regarding all components of the procedure must be documented in the medical record, although the exact format of data reporting may vary among institutions. Generally, reporting is accomplished with a physician-authored procedure or operative note, a nursing or technical record, and an anesthesia or sedation record. In cases where procedural sedation is administered by non-anesthesia nursing staff, the sedation record may be included within the nursing record.

Comment: Refer to Appendix B for examples qualifying structural heart interventions procedure types.

1.9.1B The nursing or technical record must include all technical aspects of the procedure, unless recorded in the anesthesia record, to include but may not be limited to:

1.9.1.1B Demographics:

i. name and/or identifier of the facility;

ii. name and/or identifier of the patient;

iii. date of birth and/or age of the patient; 

iv. date of the study;

v. type of study;

vi. name or initials of technical, nursing and ancillary staff participating in the cardiovascular catheterization procedure; and

vii. name of the performing physician(s):

· primary operator; and

· secondary operator (if applicable).

1.9.1.2B Baseline data:

i. height;

ii. weight;

iii. gender;

iv. anesthesia risk assessment;

v. baseline heart rate, blood pressure prior to the start of the procedure; and

vi. allergies.

1.9.1.3B Procedural data, when applicable:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. systemic oxygen saturation and/or pO2;

v. physician scrub-in time;

vi. percutaneous access time;

vii. activated clotting time(s) (ACT), if applicable;

viii. arterial blood gas, if applicable;

ix. type of sedation (general anesthesia vs. moderate sedation vs. no sedation);

x. medications administered:

· dose; and

· time given.

xi. vascular access:

· sites;

· sheath size; and

· sheath-in time.

xii. hemodynamic data;

xiii. sheath removal;

xiv. fluoroscopic exposure:

· fluoroscopy time and one or more of the following:

o radiation dose (i.e., mGy);

o dose-area product.

xv. angiography:

· type of contrast(s);

· for each angiogram:

o time of injection;

o site;

o dose (ml);

o injection rate (ml/sec);

o inflation pressures (atm);

o rise time; and

o projection angles.

· other.

xvi. use of additional imaging, when applicable:

· intravascular ultrasound (IVUS);

· intracardiac echocardiography (ICE);

· transthoracic and/or transesophageal echocardiography;

· other imaging, as required.

xvii. interventional data:

· anatomic location of the intervention;

· intervention type(s);

· intervention data;

o plasty, when applicable:

1. balloon diameter, length and type;

2. number of inflation(s);

3. inflation pressures (atm) and duration of inflation(s);

4. other.

o device used (new and abandoned), when applicable:

1. number of device(s);

2. site of placement(s);

3. manufacturer(s);

4. device identification information:

model; and

serial number.

5. size(s);

6. other.

· other.

xviii. other data/information, as required.

1.9.1.4B Post-procedural data:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. level of consciousness;

v. oxygenation; and

vi. hemostasis.

1.9.2B The anesthesia record must include all aspects of the procedure relating to anesthesia or sedation, and the patient’s response to anesthesia or sedation:

1.9.2.1B Pre-procedural data:

i. height;

ii. weight;

iii. gender;

iv. anesthesia risk assessment;

v. baseline blood pressure prior to the start of the procedure; and

vi. allergies.

1.9.2.2B Procedural data:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. medications administered;

v. level of anesthesia/sedation;

vi. oxygenation;

vii. capnography measures, if applicable;

viii. activated clotting time(s) (ACT), if applicable; and

ix. arterial blood gas, if applicable.

1.9.2.3B Post-procedural data:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. level of consciousness; and

v. oxygenation.

1.9.3B All physicians interpreting structural heart intervention procedures must agree on uniform diagnostic criteria and a standardized report format. The report must be free of internal inconsistencies and accurately reflect the content and results of the study, including any pertinent positive and negative findings particularly those relative to the indication for exam. The report must include but may not be limited to⁴⁶:

1.9.3.1B Demographics:

i. date of the study;

ii. name and/or identifier of the facility;

iii. name and/or identifier of the patient;

iv. type of study;

v. indication for the study; and

vi. name of the performing physician(s):

· primary operator; and

· secondary operator (if applicable).

1.9.3.2B A summary of the technical aspects of the procedure including (when applicable):

i. vascular access sites;

ii. catheter placement;

iii. transseptal access technique;

iv. detailed description of the procedure;

v. other.

1.9.3.3B A summary of structural heart intervention including (when applicable):

i. detailed description of anatomy;

ii. detailed report of hemodynamics and oximetry data;

iii. detailed description of angiography;

iv. description of ventricular systolic and diastolic function, when measured;

v. description of valvar function, when measured;

vi. type of intervention and results;

vii. device(s) used (new):

· size;

· type; and

· manufacturer.

viii. hemodynamic measurements and interpretation;

ix. complete diagnosis list;

x. recommendation for ongoing management;

xi. procedural complication(s);

xii. other.

1.9.3.4B The final report must be completely typewritten, including the printed name of the interpreting physician. The final report must be reviewed, signed and dated manually or electronically by the interpreting physician. Electronic signatures must be password protected and indicate they are electronically recorded. Stamped signatures or signing by non-physician staff is unacceptable.⁴⁶

1.9.3.5B A summary/conclusion of the results of the procedure, including any positive and negative findings or adverse outcomes.

1.9.3.6B If appropriate, need for additional studies and/or procedures based on the results of the procedure being reported.

Comment: An accurate, succinct impression (e.g., normal, abnormal, stable). This must clearly communicate the result(s) of the procedure. This final conclusion must resolve the clinical question or provide guidance for further studies to do so.

Comment: A record of pre-procedural and post-procedural physiologic measures and laboratory data must be maintained and immediately available when referencing the final report.

(See Guidelines below for further recommendations.)

1.10B Complex ACHD intervention reporting must be standardized in the facility. Complete information regarding all components of the procedure must be documented in the medical record, although the exact format of data reporting may vary among institutions. Generally, reporting is accomplished with a physician-authored procedure or operative note, a nursing or technical record, and an anesthesia or sedation record. In cases where procedural sedation is administered by non-anesthesia nursing staff, the sedation record may be included within the nursing record.

Comment: Refer to Appendix B for examples qualifying structural heart interventions procedure types.

1.10.1B The nursing or technical record must include all technical aspects of the procedure, unless recorded in the anesthesia record, to include but may not be limited to:

1.10.1.1B Demographics:

i. name and/or identifier of the facility;

ii. name and/or identifier of the patient;

iii. date of birth and/or age of the patient; 

iv. date of the study;

v. type of study;

vi. name or initials of technical, nursing and ancillary staff participating in the cardiovascular catheterization procedure; and

vii. name of the performing physician(s):

· primary operator; and

· secondary operator (if applicable).

1.10.1.2B Baseline data:

i. height;

ii. weight;

iii. BSA;

iv. gender;

v. baseline heart rate, blood pressure, and oxygen saturation prior to the start of the procedure; and

vi. allergies.

1.10.1.3B Procedural data, when applicable:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. systemic oxygen saturation and/or pO2;

v. physician scrub-in time;

vi. percutaneous access time;

vii. activated clotting time(s) (ACT), if applicable;

viii. arterial blood gas, if applicable;

ix. type of sedation (general anesthesia vs. moderate sedation vs. no sedation);

x. medications administered:

· dose; and

· time given.

xi. vascular access:

· sites;

· sheath size; and

· sheath-in time.

xii. pressure waves recorded during the case;

xiii. oximetry data;

xiv. assumed or measured V02, when using Fick for cardiac output;

xv. hemoglobin, when using Fick for cardiac output;

xvi. sheath removal time;

xvii. pre- and post-procedural pedal pulse exam when using femoral arterial access;

xviii. fluoroscopic exposure:

· fluoroscopy time and one or more of the following:

o radiation dose (i.e., mGy);

o dose-area product.

xix. angiography:

· type of contrast(s);

· for each angiogram;

o time of injection;

o site;

o dose (ml);

o injection rate (ml/sec);

o inflation pressures (atm);

o rise time; and

o projection angles.

· other.

xx. use of additional imaging, when applicable:

· intravascular ultrasound (IVUS);

· intracardiac echocardiography (ICE);

· transthoracic and/or transesophageal echocardiography;

· other imaging, as required.

xxi. interventional data; and

· anatomic location of the intervention;

· intervention type(s);

· intervention data;

o plasty(s), when applicable:

1. balloon diameter, length and type;

2. number of inflation(s);

3. inflation pressures (atm);

4. other.

o device(s) used (new and abandoned), when applicable:

1. number of device(s);

2. site of placement(s);

3. manufacturer(s);

4. device identification information:

model; and

serial number.

5. size(s);

6. other.

· other.

xxii. other data/information, as required.

1.10.1.4B Post-procedural data:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. level of consciousness;

v. systemic oxygen saturation; and

vi. method of hemostasis.

1.10.2B The anesthesia record must include all aspects of the procedure relating to anesthesia or sedation, and the patient’s response to anesthesia or sedation:

1.10.2.1B Pre-procedural data:

i. height;

ii. weight;

iii. gender;

iv. anesthesia risk assessment;

v. baseline blood pressure prior to the start of the procedure;

vi. baseline oxygen saturation; and

vii. allergies.

1.10.2.2B Procedural data:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. medications administered:

· dose; and

· time given.

v. level of anesthesia/sedation;

vi. oxygenation;

vii. capnography measures, if applicable;

viii. activated clotting time(s) (ACT), if applicable; and

ix. arterial blood gas, if applicable.

1.10.2.3B Post-procedural data:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. level of consciousness; and

v. oxygenation.

1.10.3B All physicians performing complex ACHD intervention procedures must agree on uniform diagnostic criteria and a standardized report format. The report must be free of internal inconsistencies and accurately reflect the content and results of the study, including any pertinent positive and negative findings particularly those relative to the indication for exam. The report must include but may not be limited to⁴⁶:

1.10.3.1B Demographics:

i. date of the study;

ii. name and/or identifier of the facility;

iii. name and/or identifier of the patient;

iv. type of study;

v. indication for the study; and

vi. name of the performing physician(s):

· primary operator; and

· secondary operator (if applicable).

1.10.3.2B A summary of the technical aspects of the procedure including (when applicable):

i. vascular access sites;

ii. catheter placement;

iii. transseptal access technique;

iv. detailed description of the procedure;

v. other.

1.10.3.3B A summary of the results of complex ACHD intervention including (when applicable):

i. detailed description of anatomy;

ii. detailed report of hemodynamics and oximetry data, when available, in a congenital heart diagram;

iii. detailed description of angiography;

iv. description of ventricular systolic and diastolic function, when measured;

v. type of intervention and results;

vi. device(s) used (new):

· size;

· type; and

· manufacturer.

vii. hemodynamic measurements and interpretation;

viii. complete diagnosis list;

ix. recommendation for ongoing management;

x. procedural complication(s);

xi. other.

1.10.3.4B The final report must be completely typewritten, including the printed name of the interpreting physician. The final report must be reviewed, signed and dated manually or electronically by the interpreting physician. Electronic signatures must be password protected and indicate they are electronically recorded. Stamped signatures or signing by non-physician staff is unacceptable.

1.10.3.5B A summary/conclusion of the results of the procedure, including any positive and negative findings or adverse outcomes.

1.10.3.6B If appropriate, need for additional studies and/or procedures based on the results of the procedure being reported.

Comment: An accurate, succinct impression (e.g., normal, abnormal, stable). This must clearly communicate the result(s) of the procedure. This final conclusion must resolve the clinical question or provide guidance for further studies to do so.

Comment: A record of pre-procedural and post-procedural physiologic measures and laboratory data must be maintained and immediately available when referencing the final report.

(See Guidelines below for further recommendations.)

1.11B Pediatric cardiovascular catheterization reporting must be standardized in the facility. Complete information regarding all components of the procedure must be documented in the medical record, although the exact format of data reporting may vary among institutions. Generally, reporting is accomplished with a physician-authored procedure or operative note, a nursing or technical record, and an anesthesia or sedation record. In cases where procedural sedation is administered by non-anesthesia nursing staff, the sedation record may be included within the nursing record.

1.11.1B The nursing or technical record must include all technical aspects of the procedure, unless recorded in the anesthesia record, to include but may not be limited to:

1.11.1.1B Demographics:

i. name and/or identifier of the facility;

ii. name and/or identifier of the patient;

iii. date of birth and/or age of the patient; 

iv. date of the study;

v. type of study;

vi. name or initials of technical, nursing and ancillary staff participating in the cardiovascular catheterization procedure; and

vii. name of the performing physician(s):

· primary operator; and

· secondary operator (if applicable).

viii. cardiovascular catheterization procedure.

1.11.1.2B Baseline data:

i. height;

ii. weight;

iii. BSA;

iv. gender;

v. baseline heart rate, blood pressure and oxygen saturation prior to the start of the procedure; and

vi. allergies.

1.11.1.3B Procedural data, when applicable:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. systemic oxygen saturation and/or pO2;

v. physician scrub-in time;

vi. percutaneous access time;

vii. activated clotting time(s) (ACT), if applicable;

viii. arterial blood gas, if applicable;

ix. type of sedation (general anesthesia vs. moderate sedation vs. no sedation);

x. medications administered;

xi. vascular access:

· sites;

· sheath size; and

· sheath-in time.

xii. pressure waves recorded during the case;

xiii. oximetry data;

xiv. assumed or measured V02, when using Fick for cardiac output;

xv. hemoglobin, when using Fick for cardiac output;

xvi. sheath removal time;

xvii. pre- and post-procedural pedal pulse exam when using femoral arterial access;

xviii. fluoroscopic exposure⁴⁵:

· fluoroscopy time, and one or more of the following:

o radiation dose (i.e., mGy);

o dose-area product.

xix. angiography;

· type of contrast(s);

· for each angiogram;

o time of injection;

o site;

o dose (ml);

o injection rate (ml/sec);

o inflation pressures (atm);

o rise time; and

o projection angles.

· other.

xx. use of additional imaging, when applicable:

· intravascular ultrasound (IVUS);

· intracardiac echocardiography (ICE);

· transthoracic and/or transesophageal echocardiography;

· other imaging, as required.

xxi. interventional data; and

· anatomic location of the intervention;

· intervention type(s);

· intervention data;

o plasty(s), when applicable;

1. balloon diameter, length and type;

2. number of inflation(s);

3. inflation pressures (atm);

4. other.

o device(s) used (new and abandoned), when applicable;

1. number of device(s);

2. site of placement(s);

3. manufacturer(s);

4. device identification information;

model; and

serial number.

5. size(s);

6. other.

· other.

xxii. other data/information, as required.

1.11.1.4B Post-procedural data:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. level of consciousness;

v. systemic oxygen saturation; and

vi. method of hemostasis.

1.11.2B The anesthesia record must include all aspects of the procedure relating to anesthesia or sedation, and the patient’s response to anesthesia or sedation:

1.11.2.1B Pre-procedural data:

i. height;

ii. weight;

iii. body surface area (BSA);

iv. gender;

v. anesthesia risk assessment;

vi. baseline blood pressure prior to the start of the procedure;

vii. baseline oxygen saturation; and

viii. allergies.

1.11.2.2B Procedural data:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. medications administered;

v. level of anesthesia/sedation;

vi. oxygenation;

vii. capnography measures, if applicable;

viii. activated clotting time(s) (ACT), if applicable; and

ix. arterial blood gas, if applicable.

1.11.2.3B Post-procedural data:

i. blood pressure;

ii. heart rate;

iii. rhythm;

iv. level of consciousness; and

v. oxygenation.

1.11.3B All physicians performing/interpreting pediatric cardiovascular catheterization and intervention procedures must agree on uniform diagnostic criteria and a standardized report format. The report must be free of internal inconsistencies and accurately reflect the content and results of the study, including any pertinent positive and negative findings particularly those relative to the indication for exam. The report must include but may not be limited to⁴⁶:

1.11.3.1B Demographics:

i. date of the study;

ii. name and/or identifier of the facility;

iii. name and/or identifier of the patient;

iv. type of study;

v. indication for the study; and

vi. name of the performing physician(s):

· primary operator; and

· secondary operator (if applicable).

1.11.3.2B A summary of the technical aspects of the procedure including (when applicable):

i. vascular access sites;

ii. catheter placement;

iii. transseptal access technique;

iv. detailed description of the procedure;

v. other.

1.11.3.3B A summary of the results of baseline pediatric cardiovascular catheterization testing including (when applicable):

i. detailed description of anatomy;

ii. detailed report of hemodynamics and oximetry data, when available, in a congenital heart diagram;

iii. detailed description of angiography;

iv. description of ventricular systolic and diastolic function, when measured;

v. type of intervention and results;

vi. device(s) used (new):

· size;

· type; and

· manufacturer.

vii. hemodynamic measurements and interpretation;

viii. complete diagnosis list;

ix. recommendation for ongoing management;

x. procedural complication(s);

xi. other.

1.11.3.4B The final report must be completely typewritten, including the printed name of the interpreting physician. The final report must be reviewed, signed and dated manually or electronically by the interpreting physician. Electronic signatures must be password protected and indicate they are electronically recorded. Stamped signatures or signing by non-physician staff is unacceptable.

1.11.3.5B A summary/conclusion of the results of the procedure, including any positive and negative findings or adverse outcomes.

1.11.3.6B If appropriate, need for additional studies and/or procedures based on the results of the procedure being reported.

Comment: An accurate, succinct impression (e.g., normal, abnormal, stable). This must clearly communicate the result(s) of the procedure. This final conclusion must resolve the clinical question or provide guidance for further studies to do so.

Comment: A record of pre-procedural and post-procedural physiologic measures and laboratory data must be maintained and immediately available when referencing the final report.

(See Guidelines below for further recommendations.)

STANDARD – Procedure Volumes

1.12B The procedure volume must be sufficient to maintain proficiency in procedure performance and interpretation.^6,33,34,35

1.12.1B The facility must have specific privileging requirements for individual operators to perform cardiovascular catheterization procedures to include, but not limited to: adult diagnostic catheterization, percutaneous coronary intervention (PCI), valve interventions, structural heart interventions, complex adult congenital heart disease (ACHD) and pediatric cardiovascular catheterization.

(See Guidelines below for further recommendations.)

Section 1B: Procedures and Protocols
Guidelines

1.1B            All physicians and staff are required to be familiar with identifying all potential procedural complications and understand their role in managing them.

                    As many management strategies for arrhythmias require chronic and/or periprocedural anticoagulation, careful evaluation, assessment and planning are needed.

1.1.2B        Because of the complexity of the cardiovascular catheterization procedures, patient safety and positive outcomes are critically dependent on the skill levels of the staff. Additional staff is needed as the complexity of the case increases and more equipment is required.

                    Laboratory staffing recommendations include, but are not limited to:

· Staff physicians must have prerequisite training and appropriate credentialing that reflects expertise in the management and treatment of acquired and congenital cardiovascular disease.

· It is desirable that anesthesia services be an integral part of clinical practice in the cardiovascular catheterization laboratory.

· Advanced practice nurses (APNs) and physician assistants (PAs) should be used in areas where they will have a maximum impact on patient care and where they can assume roles and responsibilities unique to their training and certification.

· At least one registered nurse should be present for every invasive procedure in the cardiovascular catheterization laboratory.

· Industry representatives should function according to clear policies under the direction of the laboratory manager, staff or physician.

· As needed, additional laboratory staff should include, but are not limited to: registered nurses (RNs), EP specialists/technologists, radiological technologists and certified nurse practitioners (NPs) and Physician Assistants (PAs).

· Additional appropriately-trained personnel should be provided to staff patient preparation, recover and OR areas.

· Other key personnel that are important for the safe and efficient function of the laboratory include: quality improvement (QI) staff, information technologists, biomedical engineers, scheduling coordinators, purchasing, inventory and supply personnel and housekeeping.

1.2B            For patients undergoing cardiovascular catheterization procedures, additional preparation may be required on a case-by-case basis, such as typing and crossmatching of blood products in select patients and immediate availability of thoracic surgical backup.

1.2.3B        A complete description of the procedure, including the anticipated success rates and possible complications, is best delivered in the outpatient setting before the cardiovascular catheterization procedure.

                    Health care facilities should insist that clinicians administering or supervising the administration of moderate sedation meet the requirements of the American Society of Anesthesiologists.

1.4.3.1B     Complication definitions include, but are not limited to^{22-28, 64}:

Acute Renal Failure: A sudden decline in kidney function as evidenced by either increasing creatinine   and/or decreasing urine output necessitating emergent renal dialysis.

Cardiac Arrest: “Sudden” cardiac arrest is the sudden cessation of cardiac activity so that the victim becomes unresponsive, with no signs of circulation. If corrective measures are not taken rapidly, this condition progresses to sudden death. Cardiac arrest should be used to signify an event as described above that is reversed, usually by CPR, and/or defibrillation, or cardiac pacing. Sudden cardiac death should not be used to describe events that are not fatal. 

Cardiac Perforation: May or may not be symptomatic and may or may not be self-sealing. It can be documented by migration of catheters/leads to the epicardial surface, resulting in pain and/or hypotension, pericardial effusion, cardiac tamponade, failure to capture, or pacing/defibrillator lead capture of the diaphragm, phrenic nerve or intercostals muscle of sufficient magnitude requiring repositioning.

Cardiac Valve Injury: Results when the manipulation of catheters and/or leads results in a tear in a valve leaflet or chordae tendinae and manifests as a new regurgitant murmur after the procedure.

Conduction Block: The condition upon which injury to the specialized cardiac conduction system occurs as a result of catheter/lead manipulation and/or ablative therapy. It can manifest as a new right/left bundle branch block or complete heart block. 

Coronary Perforation: When the manipulation of catheters and/or leads in the coronary sinus results in a tear of the coronary sinus endothelium with dissection into the coronary sinus leading to perforation of the coronary sinus and the development of a pericardial effusion.

Hematoma: A collection of blood in a defined anatomic space requiring reoperation, evacuation or blood transfusion.

Hemothorax: An accumulation of blood in the thorax.

Lead Dislodgement: When movement of a lead requires reoperation after completion of the procedure.

Myocardial Infarction: Evidenced by any of the following:

• In the absence of catheter ablation, detection of the rise and/or fall of cardiac biomarkers (preferably troponin) with at least one value above the 99^th percentile of the upper reference limit (URL) together with evidence of myocardial ischemia with at least one of the following²⁷:

o symptoms of ischemia;

o ECG changes indicative of new ischemia (new ST-T changes or new left bundle branch block [LBBB]);

o development of pathological Q waves in the ECG;

o imaging evidence of new loss of viable myocardium or new regional wall motion abnormality; or

o fixed (non-reversible) perfusion defects on nuclear radioisotope imaging (e.g., MIBI, thallium). 

• In the context of a recent catheter ablation procedure, any of the following criteria²⁸:

o detection of ECG changes indicative of new ischemia (new ST-T changes or new LBBB), which persist for more than one hour;

o development of new pathological Q waves on an ECG; or

o imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.

Pericardial Effusion: The accumulation of fluid in the pericardial space greater than a small physiological amount but not necessitating the performance of pericardiocentesis to either prevent or treat pericardial tamponade. 

Pericardial Tamponade: The accumulation of fluid in the pericardial space that necessitates the performance of pericardiocentesis to either prevent or treat hemodynamic compromise.

Peripheral Embolus: The acute occlusion of an artery resulting from embolization of a cardiac or proximal arterial thrombus that does not immediately autolyse. 

Pneumothorax: The presence of air in the thorax sufficient to require insertion of a chest tube.

Transient Ischemic Attack (TIA) or Stroke:

• TIA is a brief episode of neurologic dysfunction caused by focal brain, spinal cord, or retinal ischemia without acute infarction.

• Stroke is defined as infarction of central nervous system tissue.

Venous Obstruction: as related to distally to the vascular access site, documented by swelling, pain and discoloration of an extremity and confirmed by some imagine technique demonstrating >50% diameter reduction in the affected vein.

1.4.6B        The decision for patient discharge takes into account procedural detail, patient age and health status, potential for complications (such as blood loss), and the ability of the patient (or caregivers) to evaluate signs of concern.

1.6.1.3B xvi         Angiographic projections and optimal visualization of left and right coronary artery segments include:

i. Left Main (LM) coronary anatomy:

a) AP/RAO 5-10 degrees, Cranial 35-45 degrees;

b) AP/RAO 5-15 degrees, Caudal 30 degrees;

c) LAO 35-40 degrees, Cranial 25-35 degrees; and

d) LAO 40-50 degrees, Caudal 25-40 degrees.

ii. Left Anterior Descending (LAD) coronary artery:

a) AP/RAO 5-10°, Cranial 35-45°;

b) RAO 30-45°, Caudal 30-40°;

c) Lateral, Caudocranial 10-30°; and

d) LAO 35-40°, Cranial 25-35°.

iii. Left Circumflex (LCX) coronary artery:

a) AP/RAO 5-10°, Cranial 35-45°;

b) AP/RAO 5-15°, Caudal 30°; and 

c) RAO 30-45°, Caudal 30-40°.

iv. Obtuse Marginal (OM) coronary artery:

a) AP/RAO 5-15°, Caudal 30°.

v. Right Coronary Artery (RCA):

a) AP/RAO 5-10°, Cranial 35-45°;

b) LAO 35-40°, Cranial 25-35°;

c) Lateral, Caudocranial 10-30°; and

d) RAO 30- 45°.

vi. Posterior Descending Artery (PDA);

a) AP/RAO 5-10°, Cranial 35-45°.

vii. Posterior Left Ventricular (PLV) coronary artery:

a) AP/RAO 5-10°, Cranial 35-45°.

viii. Left Internal Mammary Artery (LIMA):

a) Lateral, Caudocranial 10-30°.

1.7.1.3B, 1.8.1.3B, 1.9.1.3B, 1.10.1.3B, 1.11.1.3B        Adequate anticoagulation should be monitored with activated clotting time (ACT) throughout the procedure.

Sedation records must include, but are not limited to the following information:

· type of sedation (e.g., moderate sedation vs. general anesthesia);

· name of medication(s);

· dose(s) and times(s) given;

· route(s) of delivery;

· staff administering medication; and

· other data, as required.

1.8B            TAVR Program¹⁴

Institutional volume	1,000 catheterizations/400 PCI per year
Interventionalist	100 Structural procedures lifetime or 30 left-sided structural per year of which 60% should be balloon aortic valvuloplasty (Left-sided procedures include EVAR, TEVAR, BALLOON AORTIC VALVE [BAV], aortic valve [AV] and mitral valve [MV] prosthetic leak closures and ventricular septal defect [VSD] closures). Atrial septal defect/patent foramen ovale (ASD/PFO) closure are not considered left-sided procedures.
Device training	Suitable training on devices to be used
Surgical program	50 total AVR per year of which at least 10 aortic valve replacement (AVR) should be high-risk (STS score >6). Minimum of two institutionally-based cardiac surgeons in program (more than 50% time at hospital with surgical program).
TAVR Surgeon	100 AVR career, at least 10 of which are “high-risk” (STS score 6) or 25 AVR per year or 50 AVR in two years and at least 20 AVR in last year prior to TAVR initiation. · Experience with, and management of, peripherally inserted cardiopulmonary bypass · Experience with open retroperitoneal exposure of, and surgical intervention on, the iliac arteries · Suitable training on devices to be used
Data registry	All cases should be submitted to a national clinical database
Existing programs	>18 months: 30 TAVR (total experience) <18 months: 2 per month

    TMVR Program¹⁵

Institutional volume	1,000 catheterizations/400 PCI per year
Interventionalist	50 structural procedures per year (including ASD/PFO and trans-septal punctures Suitable training on devices to be used
Surgical program	25 total mitral valve procedures per year, of which at least 10 must be mitral valve repairs.
Data registry	All cases should be submitted to a national clinical database.
Existing programs	15 mitral (total experience) Ongoing CME (or nursing/technologist equivalent) of 10 hours per year of relevant material
New programs	Because the indications are not defined, no volume criteria can be proposed yet. Assuming approval would be for high-risk cohorts, 10%-15% mortality rate at 30 days, similar to registry or published data 65% 1-year survival rate Ongoing CME (or nursing/technologist equivalent) of 10 hours per year of relevant material

                    TPVR Program¹⁶

Institutional volume	150 congenital/structural heart disease catheterizations per year
Interventionalist	100 diagnostic and therapeutic cases/year including 50 congenital/structural heart intervention cases per year
	Experience with stent implantation for branch pulmonary arteries and conduit stenosis board-certified/eligible or the equivalent in interventional cardiology, pediatric cardiology or thoracic surgery
Device training	Suitable training on devices to be used
Surgical program	The program is associated with a congenital/structural open-heart program that performs >100 open surgical cases or the program is an adult-congenital cardiac program that performs 25 adult-congenital cardiac operations per year
	There should be ECMO capabilities in the institution for the rare case when needed
Data registry	All cases should be submitted to a national clinical database
Outcomes	Patients should have 80% freedom from reintervention at one year

    TTVR Program³¹

Institutional volume	150 congenital/structural heart disease catheterizations per year
Interventionalist	100 diagnostic and therapeutic cases/year including 50 congenital/structural heart intervention cases per year
Device training	Suitable training on devices to be used
Surgical program	The program is associated with a congenital/structural open-heart program that performs >100 open surgical cases or the program is an adult-congenital cardiac program that performs 25 adult-congenital cardiac operations per year
Data registry	All cases should be submitted to a national clinical database

1.8.1.3B     Interventional Data (TAVR)⁴⁰

                    TAVR pre-procedure imaging: Initial evaluation of the aortic valve anatomy, morphology and function by transthoracic echocardiography is recommended with additional multi-modality imaging as needed.

                    TAVR pre-procedure evaluation: Assessment should include:

· aortic valve morphology and function;

· left ventricular geometry;

· annular sizing; and

· measurements of the aortic root.

Additional assessment should include assessment of the vascular anatomy to be used for access and the transport/deployment of the device.

TAVR periprocedural evaluation: Use of transesophageal imaging is useful to assess valve placement, valvular regurgitation and gradients and procedural complications.  

1.12B         Procedure Volumes

A facility should perform a minimum number of invasive cardiovascular catheterization and/or device procedures annually to maintain proficiency in procedure performance and interpretation.^6,33,34,35

                    Facilities performing procedures for patients with congenital/structural heart disease should include the following³³:

· Valve Interventions: For TPVR ≥ 150 congenital/structural heart cases

· Structural Heart Interventions: ≥ 150 congenital/structural heart cases

· Complex ACHD: ≥ 150 congenital/structural heart cases

· Pediatric Cardiovascular Catheterization: ≥ 150 congenital/structural heart cases

As stated, each member of the medical staff should perform a minimum number of invasive cardiovascular catheterization procedures to maintain proficiency in procedure performance and interpretation. Similarly, each member of the nursing and technical staff should assist in a minimum number of invasive cardiovascular catheterization procedures. The total volume of studies interpreted and performed by each staff member may be combined from sources other than the applicant facility. Lower volumes than those recommended here, however, should not dissuade a facility that is otherwise compliant with the IAC Cardiovascular Catheterization Standards from applying for accreditation.^6,33,34,35

Centers specializing in pediatric and adult congenital heart disease may need to perform a relatively large percentage of complex congenital heart interventions to meet the challenges of patient size and anatomy. It is recommended that pediatric and adult congenital interventional procedures be performed at experienced centers.³³

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