Defining Quality in the Cath Lab

Sridevi Pitta, MD, MBA, FSCAI

Jayant Bagai MD, FSCAI

Disclosures

• Pitta, Sridevi: No relevant relationships with commercial interests to

disclose.

• Bagai, Jayant: No relevant relationships with commercial interests to

disclose.

Quality as it relates to patient care

• Quality is a science that involves ensuring that appropriate structural and

process elements are in place to achieve the best patient selection and the best

patient outcomes

• Quality, at the patient level, ensures providing the right procedure to the right

patient at the right time in the right way

Structural

Domain

Process

Domain

Outcomes

Domain

Evaluation of quality in the Cath Lab

• Quality can be evaluated in three broad areas or

“domains”

Structural Domain

• Refers to the context in which care is delivered (hospital, cardiac

catheterization lab (CCL) and its human resources)

• Examples:

• Hospital and CCL infrastructure

• CCL Quality Improvement (QI) committee

• Staff education, training and specialty certification

• Institutional PCI volume

Process Domain

• Refers to the processes and procedures for delivering care

• Examples:

• System-related (pre-procedure checklists, STEMI/hypothermia

protocols, D2B time, patient turnaround, adequacy of ancillary services)

• Patient care related (quality of angiograms, CCL documentation and

reporting)

• Guideline-related (dual antiplatelet therapy or DAPT, statin post MI,

infection control, radiation safety, appropriateness use criteria or AUC)

• Cost and utilization related (supplies, length of stay and readmission

post PCI)

Outcome Domain

• Refers to the consequence of care delivered

• Examples:

• PCI risk-adjusted mortality

• Morbidity due to radiation, contrast nephropathy, bleeding, stroke

• Patient satisfaction

QI tools

Root Cause Analysis (RCA)

• Retrospective analysis which evaluates the cause of failure after the event has

occurred

• Required by The Joint Commission (TJC) for sentinel events

• Typically represented by a cause and effect or “fishbone” or Ishikawa diagram

• Examples in CCL- analysis of medication or communication errors, adverse

events discussed in Morbidity and Mortality Improvement (MM&I) conference,

slow case turnover

Physician/Team Factors

Adverse patient outcome-

major femoral bleeding

Location of

Patient Factors

Procedure factors

Example of fish-bone diagram for MMI

Major domain categories (bold) are

“bones”. Subsidiary “ribs” added as

needed.

Low BMI

Female

PAD

High bifurcation

Sheath removal technique

High/low stick

Staff education

8F sheath, GPI

Lack of ultrasound or fluoroscopy

VCD failure, off label use

Critical pathways

Post PCI order set

Process factors

Using RCA for MM&I

FOCUS-PDSA

• Find a problem or process to improve

• Organize a team

• Clarify the current process

• Understand the process, variations and the root cause(s) of the problem

• Select the improvement or intervention

• Plan

• Do

• Study

• Act

PDSA

Plan

• Define the current situation and process

• Define specifically what you are trying to accomplish

• Obtain buy-in from key stakeholders and identify ways to counteract resistance to change

• Develop a plan to implement the improvement and how to test the change

• Implement the plan

• Record any unexpected events and other observations

Study

• Monitor outcomes

• Determine if the interventions improved the process/problem

• Evaluate need for modifications to the approach and identify additional area for improvement

Act

• Decide if it is appropriate to implement the plan broadly, modify or discard it

• Determine if processes can be improved further.

Failure mode and effects analysis

• Prospective (analysis performed before event has taken place), unlike RCA which is retrospective

• Identifies probability, possible mode(s), timing and impact of failure

• Develops action plan to follow in case event occurs

• “Fish-bone” or Ishikawa diagram can be used during analysis

• Example in CCL- prevention of radiation induced skin damage

• Recognize risk factors and probability for radiation induced injury (obesity, complex PCI, especially chronic

total occlusion (CTO) PCI, prior radiation exposure/damage, faulty equipment)

• Gain awareness of implications of radiation damage (skin ulceration, malignancy)

• Develop prospective action plan if high radiation exposure were to occur (establish limits for hard stop,

change to 7.5 fps during case, stage additional PCI, close follow-up of patient and reporting)

Total Quality Management

• Stresses importance of multidisciplinary or cross-organizational approach

• System wide emphasis on importance of quality, measurement, empowerment and continuous

improvement

• Examples in CCL-

• Development of multi-disciplinary team of nurses, physicians, NPs and pharmacists/pharmacy residents to

ensure post PCI compliance with DAPT, statins and smoking cessation

• Coordination of care with patient’s primary care physician to ensure adequate follow-up post PCI and

medication counselling

• Focus on cost/value equation

• Aim is “doing better with less (cost)”

• Example in CCL-choosing lower cost equipment of equivalent efficacy and safety in cath lab

inventory, after consultation with physicians and staff in cath lab

Lean production

Case example of quality issue in CCL

• Physicians and CCL staff complain about the long turnaround between

cases.

• CCL, holding room staff and physicians are blaming each other,

contributing to stress and low morale

• RCA and PDSA techniques can be applied to resolve this issue

Main Problem-

write this on

far right, with

horizontal line

leading out

from it, going

from right to

left

Categories of

causes as

branches leading

from the

horizontal line

leading to main

problem

All possible reasons

for the cause, leading

out from the cause

category boxes

Using PDSA to resolve quality issues

• Plan: focus group consisting of holding room and CCL charge nurses, CCL

Director, patient representative, bed manager and discharge coordinator

• Do: electronic charting, eliminate need to give report more than once, discharge

patients from holding room in timely manner, physicians asked to place post-

cath orders and speak with family immediately after case, use pre-procedure

checklist to keep next patient ready

• Study: measure reduction in turn around time and obstacles to implementation

of plan

• Act: Decision made to implement plan after significant reduction noted in

turnaround

Question 1- A 67-year-old obese male with chronic kidney disease is scheduled for coronary

angiography via the R radial artery for atypical chest pain. A 60-70% distal circumflex stenosis

is noted, and a decision is made to perform PCI. The procedure is lengthy due to poor guide

support, proximal tortuosity and poor quality images. 350 ml of contrast is used with a

fluoroscopy time of 26 minutes and Air Kerma of 3.2 Gy. The patient is discharged the day

following PCI and presents to an outside hospital 1 week later with severe renal failure.

Quality assessment and improvement is required in which of the following domains

A. Structural domain

B. Process domain

C. Outcome domain

D. All three domains

Correct Answer: D

• Quality assessment in this case with an adverse patient outcome (contrast-

induced acute kidney injury) should focus on all three domains. There is

potential for quality improvement in the structural (outdated cath lab

equipment with high x-ray output), process (non-utilization of

appropriateness use criteria before performing PCI on a lesion with

borderline angiographic severity with non-limiting symptoms and no

functional testing) and outcome (education and close monitoring for

radiation and contrast induced injury) domains.

Question 2- A 56-year-old diabetic male weighing 290 lbs. is scheduled for PCI on a

chronically occluded left circumflex coronary artery. Dual injection is planned. The

procedure is expected to be challenging due to presence of calcification, tortuosity and

prior failed attempt. Which of the following QI tools can be used to improve patient

outcomes?

A. Root cause analysis

B. Lean production

C. Failure mode and effects analysis

D. PDSA

Correct Answer: C

• This case is likely to be associated with high radiation dose delivered to the

patient. By recognizing this before the case, efforts can be made prospectively to

lower radiation dose by using a lower frame rate, fluoro save, last image hold,

collimation, dose spreading, monitoring table height and using shallower working

angles. A hard stop limit can be decided if the occlusion is not crossed by a wire.

This is an example of failure mode and effects analysis. RCA is used to determine

the cause of an event retrospectively (i.e. after its occurrence). Lean production

is not a relevant tool in this case as it focuses on cutting cost and utilization. PDSA

cycles are also applied retrospectively.

Question 3- You are concerned about quality issues in a case involving a 63 year old man

who suffered a stroke surrounding PCI. The patient was restless on the cath lab table and

required large doses of sedation. 4 hours after being transferred to the floor, a nurse

discovered him to be unresponsive and not breathing. He was emergently intubated and

treated for respiratory failure with CO2 retention. CT imaging 12 hours later showed a large

MCA territory stroke. He was outside the window for reperfusion and sustained a severe

neurological deficit. Which of the following quality issues does this event raise concern

about?

A. Structural domain

B. Process domain

C. Both A and B

D. Neither A or B

Correct Answer: C

• This patient likely suffered a stroke during or soon after the procedure.

Unfortunately due to the confounding effect of the sedation and CO2

retention, he was treated for respiratory failure. Inclusion of q 1 hour

neurochecks in the order set with immediate notification of the procedural

MD/Neurology for any mental status change post PCI as part of the post-

PCI process/system of care could have resulted in earlier diagnosis of stroke

and possible reperfusion with improved neurological outcome. In addition,

improved staff education (structural domain) could have resulted in

improved outcome as well.

Operator Staff and Training

Requirements

Mazen Abu-Fadel, MD, FSCAI

Jayant Bagai, MD, FSCAI

Christine Gasperetti, MD, FSCAI

Disclosures:

• Abu-Fadel, Mazen. No relevant relationships with commercial

interests to disclose.

• Bagai, Jayant. No relevant relationships with commercial interests to

disclose.

• Gasperetti, Christine. Boston Scientific, PI. Abiomed, Honoraria.

Cath Lab Staff Required Qualifications

Type of Staff Degrees Experience Training

Licensed Nurse One or more of following- RN, APRN,

BSN, NP-C, CNS, CVRN, CRN, RCIS

At least 6 months experience

in critical care (ICU, ER, cath

lab)

BLS and ACLS (PALS), > 15

hours of documented

accredited CE relevant to

heart disease every 3 years,

including 1 hour of radiation

safety training every 3 years

Licensed Technologist RCIS or RT (R) meeting either cardiac

or cardiovascular interventional

radiography qualification

> 1 year of full-time

equivalent experience as CV

cath technologist/specialist

under direct supervision of

personnel meeting pathway

(as in column on left)

BLS, recommended ACLS

(PALS), >

15 hours of

documented accredited CE

relevant to heart disease

every 3 years, including 1

hour of radiation safety

training every 3 years

All staff must comply at all times with all federal, state and local laws and regulations, including but not limited

to laws relating to licensed scope of practice, facility operations and billing requirements.

Core/Basic Competencies

• Nurse

• Administering and monitoring conscious sedation

• Assessment and monitoring clinical status of patient

• Theoretical and practical knowledge of medications used in cath lab

• Knowledge of radiation safety, infection control and hemodynamic support

• Communicating with patient care team, patient and patient’s family

• Technologist

• Recording patient history and clinical data; recording physiological data

• Patient positioning, selection of radiation exposure parameters, imaging and archival

• Thorough understanding of equipment, supplies, troubleshooting

• Assisting physician as scrub person; circulating and procuring supplies if needed

Cath Lab Manager Qualifications

Type of Staff Degrees Experience Training

Cath Lab Manager Appropriately credentialed

technologist and/or nurse with RCIS

certification

Minimum of 5 years

experience (preferably in a

cardiac catheterization lab)

with strong leadership

qualities.

BLS and ACLS (PALS), > 15

hours of documented

accredited CE relevant to

heart disease every 3 years,

including 1 hour of radiation

safety training, every 3 years

• Leadership through motivation,

positive communication, team building

and accountability

• Operations planning

• Maintaining safety and regulatory

standards

• Quality monitoring and management

• Budgeting and resource allocation

• Personnel management

• People management/leadership

• Supervision of day to day performance

• New staff coaching and assessment

• Problem solving skills

• Communication

• Feedback, performance improvement counseling

• Compliance and safety

• Supports delivery of quality patient care

• Monitors staff training and compliance

• Implements area specific policies and guidelines

• Manages PDSA cycles

• Demonstrates clinical knowledge to coach staff

• Identifies and addresses customer service issues

• Planning and organization

• Resource management

• Provides input for budget

Responsibilities of Cath Lab

Manager

Responsibilities of Clinical Staff

Leader (CSL)

Staff education and certification

• Society of Invasive Cardiovascular Professionals (SICP)

• Established in 1993, recommends educational curriculum for invasive

Cardiovascular Technologists (CVT)

• Now merged with Alliance of Cardiovascular Professionals (ACVP) professional

society

• 2015 Educational Guidelines for Invasive Cardiovascular Technology Personnel

in the Cardiovascular Catheterization Laboratory

Staff credentialing

• Cardiovascular Credentialing International (CCI)

• Credentialing organization for invasive CVTs, including both RN and RT(R) staff

• Registered Cardiovascular Invasive Specialist (RCIS) Certification after passing exam; endorsed

by ACC

• SICP recommends at least one RCIS per cath lab

• Requires renewal after 1 year; then every 3 years with fees and continuing education

• RCIS examination overview

• Commission on Accreditation of Allied Health Education Programs (CAAHEP) and

Joint Review Committee on Education in Cardiovascular Technology (JRC-CVT)

• Develop accreditation standards and guidelines for post-secondary educational programs in

invasive CVT

• CAAHEP-accredited invasive cardiovascular program graduates eligible to sit for RCIS exam

Ongoing education, training and assessment

• Written and practical exam recommended;

materials available from CCI and SCIP

• Additional training and skills assessment for

complex procedures- coronary (CTO,

atherectomy, high-risk PCI, mechanical

circulatory support), endovascular (carotid,

stroke, EVAR, TEVAR) and structural (TAVR,

MitraClip, perivalvular leak closure, LAA

occlusion, valve-in-valve and percutaneous

MV replacement)

• Mentorship and cross-training

• Annual skills review with remedial process

• Continuing education credits, webcasts,

conference attendance- concept of “lifelong

learning”

Operator (MD) Requirements

• Successful completion of COCATS Level III training undertaken during a dedicated

Interventional Cardiovascular (IC) training program

• ABIM certification in IC and maintenance of certification (MOC) are strongly

recommended

• ABIM Recertification-traditional 10-year MOC exam or new 2-year knowledge check-

in MOC exam

• Minimum volume of 50 PCIs per year, averaged over a 2-year period, to maintain

competency

• 30 CME hours every 2 years

Harold JA et al. ACCF/AHA/SCAI 2013 Update of the Clinical Competence

Statement on Coronary Artery Interventional Procedures

Operator PCI volume

• Operator volume is only one of several factors that should be considered when

assessing an individual operator's competence

• Other factors to consider include (but are not limited to): performance of

additional noncoronary cardiovascular interventional procedures, lifetime

experience, ABIM certification in IC, attendance at educational symposiums, CME

credits, and simulation courses

• Operators performing<50 PCIs/year should not be denied privileges or excluded

from performing PCI based solely on their procedural volume

• Alternate pathways (independent institutional committee or an external review

organization) to evaluate performance of low-volume (<50 PCIs annually)

operators should be established and monitored

Qualifications of Cath Lab Director

• MD or DO with board certification in Cardiology/Interventional Cardiology (Adult

or Pediatrics)

• Minimum 5 years of experience with strong leadership qualities

• BLS and ACLS certified

• Completion of radiation safety training

• Leadership, team management and communication skills

Responsibilities of Cath Lab Director

• Oversight, review and updates of cath lab policies and clinical practices

• Establishment and monitoring of QI programs and conferences (MMI, cath conference)

• Establish criteria for MD credentialing and recredentialing

• Periodic performance review (OPPE, FPPE), recommendations for renewal of privileges

• Review performance of trainees and staff and provide necessary training to personnel

• Ensure adequate resources and safe use of equipment; inventory decisions,

procurement and budgeting

• Oversight of patient scheduling, referral services, post-procedure reporting and

tracking of quality measures (including appropriate use and complications)

• Conflict resolution, team building

Daggubati et al. Chin Med J. 127. 1194-6

A. Many consider those with higher PCI volumes to be better operators. Because Dr. X is a high-

volume operator, it can be assumed that there are no quality issues in his cases with adverse

events.

B. Dr. Y performs 60 PCIs/year but his volume has lesser impact on patient given his lifetime

experience of performing PCI with good outcomes and high institutional PCI volume.

C. During the past 10 years, overall PCI volume has diminished, with mean annual PCI volume of

59. Operators performing <25 cases/year are now considered to low-volume operators.

D. During the past 10 years, overall PCI volume has diminished, with mean annual PCI volume of

59. Operators performing > 400 cases/year are now considered to high-volume operators.

Question 1- During MM & I conference, questions were raised regarding the effect of PCI

volume on quality of procedures. Which of the following is correct?

Answer: B

A 2013 ACCF/AHA/SCAI publication lowered the minimum annual PCI volume (averaged over 2

years) to 50. In addition, a significant interaction has been noted between operator and institutional

PCI volume, with lower rates of in-hospital mortality and CABG in patients undergoing PCI by

operators performing > 75 PCIs/year in hospitals performing > 400 PCIs/year . Answer A is incorrect-

while high volumes are not discouraged, case volume is not a substitute for quality and

appropriateness. Answer C is incorrect-operators performing <50 cases per year are considered to

have low volumes. Answer D is incorrect-operators performing >100 cases per year (averaged over 2

years) are considered to have high volumes. Operators performing 50-100 cases per year are

considered to have intermediate volume.

Harold JG et al. ACCF/AHA/SCAI 2013 update of the clinical

competence statement on coronary artery interventional procedures.

J Am Coll Cardiol. 2013;62:357–396.

A. There was no difference in risk-adjusted in-hospital mortality between low (< 50),

intermediate (50-100) and high volume (> 100) operators

B. Operators with higher volumes were more likely to be found in the North and

Midwest

C. Procedural success was similar for all operator volumes

D. PCIs performed by high-volume operators were more often in patients with STEMI

than those performed by intermediate- or low-volume operators

Question 2- A study by Fanaroff et al assessing 4 million PCIs performed by

>10,000 operators at >1500 centers confirmed that operators who continue

to achieve higher volumes have been found to have lower mortalities. Which

of the following is true?

Answer: B

In this study, operators in the western part of the U.S. had the lowest annual

volumes, followed by operators from the South, Midwest, and North. Answer

A is incorrect-adjusted risk of in-hospital mortality was higher for PCI

procedures performed by low- and intermediate-volume operators

compared with those performed by high-volume operators. Answer C is

incorrect- while procedural success rates were > 92 % for all operators,

success rate was highest (94.2% vs. 93.3% vs. 92.6%) and the risk of new in-

patient dialysis was lowest for high-volume operators. Answer D is incorrect-

PCIs performed by low-volume operators were more often in patients with

STEMI/emergency PCIs than those performed by intermediate- or high-

volume operators

Fanaroff AC et al. J Am Coll Cardiol. 2017 Jun 20;69(24):2913-2924.

A. Hire her immediately

B. Inform her that she does not qualify as she does not have at least 6 months of critical

care experience before working in the cath lab

C. Inform her that she will need a period of supervision and on the job training

D. Hire her if she has BLS, ACLS training

Question 3- You are trying to hire a new nurse for the cath lab. One of the

candidates has excellent recommendations and appears to be competent,

friendly and dedicated. She has worked in same day surgery for 3 years. As

the nurse manager, you should-

Answer: B

While good work ethic, personal attributes and required certification

are important considerations for hiring new cath lab staff, critical care

experience in the ICU for at least 6 months, and ideally 1 year are

generally required before a nurse can work in the cath lab for the first

time. This is due to the high complexity and rapid changes in patient’s

clinical status that can occur in the cath lab, which requires significant

prior experience of assessing and managing critically ill patients.

Procedural Quality

Jayant Bagai MD, Christine Gasperetti MD, Cesar Jara MD, Faisal Latif

MD, John Messenger MD, Sri Pitta MD, Bonnie Weiner MD.

Contents

• Continuous Quality Improvement (CQI)

• Quality Monitoring and Reporting (NCDR/CathPCI)

• Benchmarking

• Performance review

• CQI is an iterative method to evaluate operational approaches and

remedy deficiencies

• CQI should be an essential component of each PCI program

• Primary emphasis-

• Evaluation of program structure, processes, outcomes of care

• Evaluation of individual operator quality

Continuous Quality Improvement (CQI)

SCAI standards for QI in Interventional Cardiology Part 1_Klein L et al

2011 ACCF/ACA/SCAI PCI guidelines

1. Identification of quality indicators

2. Systematic data collection using standard definitions

3. Data analysis with benchmarking to determine areas for improvement

4. Development of plan to correct deficiencies

5. Systematic repeat data collection to determine effect of corrective action

5 elements of CQI program

Klein LW et al. CCI. 2011;77(7):927-35

• Composition

• Cardiac Cath Lab (CCL) Director

• CCL Administrative Director

• Interventional and Non-Interventional Cardiologists

• CCL administrator/manager and staff

• Objectives

• PCI quality indicators- identification and monitoring

• Performance assessment (for-cause review, random case review)

• Serious adverse event review (Morbidity and Mortality Conference)

CQI Committee

• Quality metrics

• Support self assessment and quality improvement at the local (provider, hospital, and/or

health care system) level

• Examples include completeness of documentation and angiographic quality

• Performance measures

• Include process, structure, efficiency or outcome measures

• Developed by ACC/AHA task force using defined criteria and some are endorsed by the NQF

• Suitable for external comparisons, public reporting and possibly pay-for-performance

• Examples include risk-adjusted mortality, bleeding and discharge medications post-PCI

Quality Indicators

2008 ACC/AHA classification of care metrics

2014 ACC/AHA performance measures for PCI

2017 STEMI and NSTEMI performance measures

• NCDR

• QI resource developed by ACC in 1997

• Collects and reports data to measure and compare quality of cardiovascular care

with help of registries

• CathPCI registry

• Assesses characteristics, treatments and outcomes of patients undergoing diagnostic

coronary angiography & PCI

• Measures adherence to guidelines, performance standards and appropriate use

criteria for coronary revascularization

Quality Monitoring and Reporting

Link to NCDR CathPCI registry

• Quality assessment is also important for diagnostic cardiac catheterization cases

• Many facilities do not report diagnostic cath data to NCDR due to logistic reasons such

as case volume and cost of data abstraction

• Internal review, self assessment and monitoring trends then become key to ensure

quality documentation, reduction of access site complications, angiographic quality

and tracking percentage of normal studies

Quality assessment for diagnostic cardiac catheterization

• A benchmark is a standard or point of reference against which things may be compared or

assessed

• Comparison with benchmarks (benchmarking) allows for assessment of performance

relative to other institutions

• Benchmarking must be risk-adjusted for certain outcome measures to account for

patient characteristics, complexity and type of procedures

• NCDR provides quarterly risk-adjusted benchmark reports to compare an institution and

operator’s performance with other institutions/operators

Benchmarking

Interpretation of NDCR reports

Sample Report from NCDR

Rolling 4 Quarter Reports

• Outlier values are opportunities to learn. They might represent:

• Actual poor performance

• Unusual cases

• Misinterpretation of physician documentation or incomplete documentation

• Incomplete data entry by abstractors

• Can improve quality by:

• Shifting the curve by improving performance on every case by a little bit

• Reviewing unusual behavior, e.g., performing elective PCI on intermediate lesion

without documented ischemia

• Accurate, complete documentation and physician oversight to help data abstractors

Troubleshooting sub-optimal performance measures

• Hospital performance below the 25

percentile of event rate for all US hospitals reporting

to CathPCI Registry

• Example

• Post-PCI Risk Adjusted All-Cause Mortality (RAM)

 50th percentile or median: 1.83%

 10th percentile: 3.17%  25th percentile: 2.47%  75th percentile: 1.37%

 90th percentile: 1.01%

• Important to look at quarterly trends, in addition to rolling quarters, to identify early

changes that can be addressed proactively

• After interventions are undertaken, look at change in outcome in the next quarter

• “Topping out”- difference in performance between the 10th and 90th percentile is small

(98% rate of aspirin prescription on discharge vs. 99%) and likely clinically insignificant

Thresholds for Concern

• The CathPCI Registry data collection form was updated to version 5 (v.5) in 2018

• Key New Data Elements

• Details about the timing and type of mechanical support devices

• Cumulative air kerma as a patient radiation-exposure parameter

• Surgical turndown and patient refusal for surgery

• Frailty assessment

• Hypothermia details and timing

• Details of out-of-hospital cardiac arrest

• Assessment of fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) in all scenarios to

identify ischemia-producing lesions and to support AUC for PCI

CathPCI v.5

SCAI Tip of the Month on CathPCI v.5

CathPCI v.5 form

CathPCI data dictionary v5.0

New Dashboard Design CathPCI v.5

New CathPCI v.5 metrics and measures

• Median time to immediate PCI for in-house

STEMI (in minutes)

• Proportion of PCI and diagnostic procedures

in which all 3 radiation dose measurements

were recorded

• Composite major adverse events post-PCI

• Proportion of PCI patients referred to cardiac

rehabilitation at discharge

• Median post-procedure length of stay for PCI

patients with uncomplicated STEMI (in days)

• Proportion of STEMI and NSTE-ACS patients

prescribed high-dose statin at discharge

• Purpose and importance

• Mechanism for process improvement

• Quality remediation policies and records are reviewed by accrediting agencies, such as The Joint

Commission (TJC), Accreditation for Cardiovascular Excellence (ACE) and Det Norkse Veritas (DNV)

• Required by ACGME, if site is a fellowship training program

• Delivery of quality care may be taken into account for recredentialling providers

• Robust policies are important to prevent legal action

• Adherence to policies should be ensured

• 4 Ps essential to peer review process

• Protection of Patients, Participants and Process

Performance and peer review

• Engage all team members in quality goals and expectations

• Fair, rational and transparent quality assessment policies

• Clear definitions of complications

• Definitions aligned with independent sources/references

• NCDR CathPCI Registry, The Joint Commission standards

• Independent chart abstractors collect information on post-discharge adverse events/ readmissions

• Clear definitions of performance issues

• Independent adjudication process, if necessary (e.g., review by outside entity)

• Independent/objective benchmarking

• NCDR™ CathPCI Registry

• HealthGrades

• Accreditation for Cardiovascular Excellence (ACE)

• Private counseling of serious/persistent outliers

• Clear probation and termination policies

Key Principles

Ongoing Professional Practice Evaluation (OPPE) Focused Professional Practice Evaluation (FPPE)

Ongoing assessment of MD competency and behavior

Conducted by CCL Director or Quality Officer

Required by TJC

Examples of criteria for evaluation- procedure outcome,

morbidity and mortality data, length of stay, readmission

Data sources- chart review, direct observation, discussion with

peers

Information used to determine whether to renew, limit, or

revoke privileges

There should be a mechanism for evaluating the performance

of the CCL Director as well

Required to evaluate competence for all privileges for new

providers and newly requested privileges for existing

practitioners , regardless of board certification/experience

Also performed when question arises regarding ability to

provide safe, high-quality care

A corrective action plan is devised on the basis of a FPPE with

need for follow-up regarding plan’s efficacy

TJC criteria for FPPE

• Written policy detailing review process mandatory

• Cases and reviewers selected randomly by CCL Director or designate

• 5-10% of cases per operator (suggested minimum 10 cases/year)

• Diagnostic and PCI cases included

• Following are evaluated-

• Appropriateness based on AUC

• Quality of the angiogram

• Intraprocedural decision making- conformity to guidelines

• Procedural complications- prevention, recognition and management

• Contrast and radiation use

• Overall procedural results and areas for improvement

• Completeness and accuracy of cath report and procedural documentation

Random case review

2017 AUC for SIHD

2014 structured reporting

• Aim- quality improvement rather than punitive

• Objective- Open review and assessment of complications following invasive cardiovascular procedures by a

formal phase of care (pre-procedure, intra-procedure, post-procedure) analysis to achieve consensus

regarding preventability of event

• Types of events suitable for M&M

• In-lab death or death within 30 days of procedure

• In-lab cardiac arrest

• Emergency CABG

• Stroke

• Unanticipated PCI (for vessel dissection during cath, acute stent thrombosis)

• Major vascular complication

• Serious anaphylactoid reaction

• Respiratory depression due to sedation, requiring intubation

• Serious medication error, wrong procedure

• Cases with excessive radiation and/or contrast resulting in skin damage/acute kidney injury

Cath lab Morbidity, Mortality and Improvement Conference (MM&I)

• Should occur at least quarterly

• Case MD should ideally be present

• Begins with announcement “MM& I are medico-legally confidential. All the data and conclusions

of this conference are not to be discussed outside of this conference except as part of a

performance improvement project.”

• Case presentation, chronology of hospital course

• In-depth and evidence based hypothesis

• Identify all major quality concerns potentially resulting in adverse outcome

• Identify potentially contributory structural and process issues

• Root cause analysis identifying all major contributing causes using fish-bone diagram

• Assign level of care based on standardized grading criteria

• Propose solutions and process improvements

Suggested format for MM&I

Question 1- Your CCL QI committee asks you to review the following NCDR data for your facility with

regard to PCI in-hospital risk adjusted mortality.

(Question 1) Based on the metrics and benchmark presented, what will be your advice to the CCL QI

committee?

a. Your facility’s PCI in-hospital risk-adjusted mortality (RAM) is below the 25

percentile and the committee

should immediately initiate a root-cause analysis.

b. Your facility’s PCI in-hospital RAM is likely inaccurate, and you recommend looking at the observed

mortality as a better indicator.

c. Your facility’s PCI in-hospital RAM is below the 50

percentile; you recommend reviewing mortality cases

from the last quarter to better understand the report.

d. Your facility’s PCI in-hospital RAM is above the 50

percentile; you recommend to reviewing mortality cases

from the last four quarters to better understand the report.

e. Your facility’s PCI in-hospital RAM is above the 25

percentile, you recommend to move on with next item

in agenda.

Correct answer- c

• Looking at the display graphic, the facility’s 2010Q3 (third quarter of year 2010) RAM falls within

the “brackets”, which represent the 25

-75

percentile margins, but is closer to the 25

percentile, and corrective actions may need to be taken once more information is available about

the specific cases (mortality is one of the metrics can be looked into detail because of the limited

number of cases which need review, compared, for example, with radiation dosing that requires

review of all cases). Answer a is therefore incorrect.

• Answer b is also incorrect, because the observed mortality does not take into account predicted

mortality based on patient risk. On the other hand, the risk-adjusted mortality is the ratio of

observed divided by expected mortality, and this ratio tends to decrease once severity of illness is

included.

• Answer d is incorrect as the facility is below the 50

percentile- the middle bar of the bracket.

• Answer e is contrary to the basic principles of data analysis, benchmarking and instituting

corrective actions.

Question 2-Your CCL QI committee is trying to determine the cause for an unexpectedly high PCI in-

hospital risk-adjusted mortality (RAM). Which of the following are possible explanations?

a. Your facility’s PCI in-hospital RAM is accurate. A new operator had had a higher than expected PCI

mortality; a focused professional practice evaluation (FPPE) should be considered.

b. Your facility’s PCI in-hospital RAM is inaccurate. The cath lab data abstractor was away for a month and a

substitute abstractor was entering data in his absence.

c. Your facility’s PCI in-hospital RAM is accurate, however there was an unusual number of extremely ill

patients that render the RAM formula less precise.

d. Your facility’s PCI in-hospital is RAM is inaccurate; there was incomplete and missing data entry by some

physicians.

e. All of the above

Correct answer- e

• This question highlights the need for quarterly review of data outliers with the cath lab quality

team and accurate capture of risk to ensure valid comparisons against benchmarks.

• Option a represents the effect on an outlier on a quality metric. Recognition and appropriate

corrective action is required in this case.

• Option b emphasizes the importance of accurate data entry by a data abstractor who is very

familiar with the facility and its health professionals and electronic medical record (EMR).

• Option c is a sobering reminder that RAM formulas sometimes do not reflect the actual expected

mortality in high acuity cases. Some facilities can have RAM < 50

percentile and still be providing

above average care to a higher proportion of very sick patients, whereas other facilities can have

> 50

percentile RAM due to avoidance of high acuity cases.

• Option d is probably the most common reason for inaccurate RAM, specially when the EMR does

not allow direct data element collection (requiring data abstractors to review consultations,

progress notes, operative reports, etc, looking for data elements which accurately reflect acuity

and complexity of treated patients).

Question 3-Regarding professional practice evaluation, which statement is FALSE?

a. OPPE is periodic assessment of physician competency and behavior with defined areas of assessment and

evaluation.

b. In the peer review process, the CCL QI committee must behave equitably and transparently to ensure

fairness to the operator, quality for the patient, and credibility for the committee.

c. FPPE is performed regularly for every physician, with clear criteria for evaluation and use of an external

source if required.

d. Random case review should evaluate quality indicators such as procedure appropriateness, quality of

angiogram, decision making process, radiation and contrast use, documentation and complication

prevention and management.

e. High rates of adverse events identified in random reviews, longer length of stays, pattern of unnecessary

procedures or sentinel events can trigger a FPPE.

Correct answer-c

• Ongoing professional practice evaluation (OPPE) is performed for every physician, including the medical

director of CCL, with clear criteria for evaluation, transparency and independent objective benchmarking.

This is different from a focused professional practice evaluation (FPPE), which is triggered for high rates of

adverse events identified in random reviews, longer length of stays, pattern of unnecessary procedures or

sentinel events. It is also performed for new providers and when a provider wishes to add new privileges. A

FPPE must have clear criteria for evaluation, monitoring plan, duration of supervision of performance and

external reviewers used if required. There should be clearly defined and objective medical staff bylaws and

CCL policy regarding how this information can be used to renew, limit, or revoke privileges.

• Options b and d summarize the non-punitive and fair aspect of peer review (Protection of Patients,

Participants and Process) and elements included in random case review, respectively.

Question 4-Regarding Cath Lab MM&I, which statement is FALSE?

a. It is a non-punitive and confidential review and assessment of complications (both in-hospital and within

30 days) following invasive cardiovascular procedures by a formal phase of care (pre-procedure, intra-

procedure, post-procedure) analysis to achieve consensus regarding preventability of event.

b. Should be performed at least quarterly and physician involved in case should ideally be present.

c. It is an open forum, and participants are encouraged to discuss details and findings with others to improve

outcomes and prevent future complications.

d. Types of events suitable for an M&M conference include serious medication error, excessive radiation or

contrast leading to patient risk or harm.

e. The purpose of MM&I is non-punitive quality improvement, with a proposed plan for improvement to

prevent future similar adverse events.

Correct answer-c

• Adverse event review or MM&I conferences are commonly used during medical training as an educational

tool. There may be a misconception that their purpose is to target or blame the individuals involved in a

case. Instead, MM&I is non-punitive and meant to improve care through a systematic analysis of the

procedure (pre, intra and post). There should be a clear performance plan for improvement or policy

changes with follow up to determine the effectiveness of the plan. It is not an “open forum”; rather it is

strictly confidential. The data and conclusions of this conference are not to be discussed outside of this

conference, except as part of a performance improvement project.

Question 5- Your CCL QI committee reviews the last quarter NCDR report and there is a significant

increase in the risk adjusted bleeding of PCI cases as well as an increase in the proportion of acute

kidney injury (AKI). Which of the following represents a quality metric as opposed to a performance

measure regarding these data analysis?

a. Percentage use of ultrasound to get vascular access.

b. Percentage of radial cases in the cath lab.

c. Percentage of proper documentation of BMI and eGFR.

d. Percentage of use of evidence-based hydration protocol .

e. All of the above.

Correct answer-e

• While the importance of performance measures and quality metrics is known, the difference between them

is sometimes not quite clear. Both are measurements or metrics; however only performance measures are

suitable for public reporting, external comparisons, and possibly pay-for performance programs. Risk

adjusted bleeding risk and rates of AKI are both performance measures. All the options mentioned in the

question, however, are quality metrics that can be used internally at the local level for self-assessment and

improve quality. Eventually some of these can become performance measures. For instance, radial access

has been shown to lower major bleeding, vascular complications, acute kidney injury and mortality, and in

the future, may be included as a performance measure.

Facility and Environmental Issues

Tami Atkinson, MD, FSCAI

Jayant Bagai, MD, FSCAI

Huu Tam D. Truong, MD, FSCAI

Disclosures

• Atkinson, Tami. No relevant relationships with commercial interests to disclose.

• Bagai, Jayant. No relevant relationships with commercial interests to disclose.

• Tam Truong, Huu. No relevant relationships with commercial interests to

disclose.

Facility and Environmental Issues

Purpose

• To review the following facility/environmental issues related to daily CCL practice:

• Infection Control

• Radiation Safety

• Equipment and Maintenance

• Information Storage and Inventory

Intended Audience

• CCL directors, hospital administrators, interventionalists, nurses, technologists, advanced

practice providers, SCAI QIT Champions

Infection Control

• All CCL and hybrid operating rooms should have sterility/infection control protocols in place

• Universal precautions should be followed

• High Risk Patients (for staff exposure)

• Screening for blood borne pathogens is not routinely performed

• Wearing two pairs of gloves reduces inner glove punctures by 60% (not proven to prevent transmission of

hepatitis or HIV)

• Cap, mask, eye protection are encouraged

• Skin Puncture or Laceration

• Report immediately and follow institutional guidelines

• CDC has published guidelines for management of occupational exposure

• Vaccination

• Vaccination against Hepatitis B is encouraged for all CCL employees

Chambers, CE et al. CCI 2006;67:78-86

Infection Control

Room Type

Ventilation

Requirements

Patient Preparation

Operators

Ancillary Personnel

Procedure Environment

Cardiac

Cath Lab /

Hybrid OR

• Positive-pressure

room

• Air exchange >15-20

per hour

•

Electric clippers for hair

removal

•

Chlorhexidine prep to

skin

•

Sterile drapes

•

Hand washing or sanitizer

•

Hospital based scrub attire

•

Sterile gowns & gloves

***Masks, eye shield and

protective caps (optional but

may be required per

state/institutional policy)

•

Hospital based scrub

attire

•

Cap

•

Gloves when in contact

with sterile field

• Mask, eye protection are

optional

• Keep doors to CCL closed,

except to allow passage

of patients, equipment

and essential personnel

•

Equipment near catheter

entry site should be

covered

•

Equipment near sterile

field should have sterile

covers

Hybrid OR

specific

(Must

meet local

guidelines)

• Positive-pressure

room

• Air exchange >20-25

per hour

Same as above

•

Masks, eye shield and

protective caps required

Same as above

•

Same as above

Chambers, CE et al. CCI 2006;67:78-86

Infection Control

• Cleaning:

• The CCL should be thoroughly cleaned once a day and spot-cleaned with trash

removal between cases

• Blood-contaminated drapes, gowns, gloves, and sponges should be discarded in

containers labeled as healthcare waste

• Sharps should be placed in puncture-proof containers

• Consider scheduling cases with high infectious risk at the end of the day, followed by

terminal clean (example- C. difficile, MRSA, VRE, patients with droplet precautions)

• Multi-dose vials:

• Should be avoided, unless used with an approved device to protect against backflow

Summary of radiation doses and units

Absorbed dose

(Deterministic effect)

Amount of radiation energy absorbed by

tissue per mass of tissue. Skin typically

receives the highest absorbed dose.

Peak skin dose (PSD) is the absorbed dose at the skin location

that has received the highest dose. This quantity is used to

predict a skin injury. Not usually measured; can be estimated

if needed.

Unit: Gray (Gy)

1 Gy= 1 Joule of radiation

energy absorbed per unit

tissue.

Effective dose

(Stochastic effect)

Calculated by adding the mean dose

absorbed by organ multiplied by a

weighting factor for that organ (highest

for bone marrow, lung, stomach, breast;

least for skin).

Approximate measure of potential harm from cancer. Takes

into account susceptibility of different tissues.

Unit: Sievert (

Sv)

Effective dose of cardiac cath

is 2

-16 mSv compared with

0.02 mSv for chest x

-ray.

Air kerma (Ak) or

Reference Ak or

a,r

Energy per unit mass absorbed by air at

assumed location

of skin.

Cumulative Ak is displayed on monitor

- meant to estimate

patient skin dose. Non

-stationary position of X-ray tube will

over

-estimate and lower table position will under-estimate

patient dose.

Unit: milli Gray (

mGy)

KERMA

-area product

(KAP) or Dose

-area

product (DAP) or P

Total energy absorbed across entire

exposed skin/incident on the patient.

Product of Ak and cross

-section area of X-ray beam. Used to

estimate stochastic risk such as radiation induced cancer to

patient and staff.

Units: Gy.cm

, cGy.cm

mGy.cm

Radiation Safety

• Follow the principle of ALARA (as low as

reasonably achievable)

• Each facility must have a radiation safety

program

• Staff radiation safety training and its

documentation are essential

• Patient radiation dose must be

monitored and recorded

• Includes fluoroscopy time, total air kerma at

the interventional reference point (IRP) (K

Gy) and air kerma area product (PKA,

Gy*cm2)

• Document substantial radiation dose

level (SRDL) as shown on right

Chambers CE, et al. CCI 2011;77:546-56

Radiation Safety

Methods to lower patient

dose

Methods to lower operator

dose

Methods to lower both

patient and operator dose

•

Raise table height

•

“Spread the dose” by moving tube

•

Avoid high magnification (changing from

22 cm to 17 cm doubles dose rate)

•

Keep patient’s arms away from x-ray

tube

•

Limit beam-on time especially in obese

patients

•

Establish “hard-stops” for elective

complex PCI (e.g. CTO)

•

Wear adequate protective garments

(lead apron and leaded glasses)

•

Increase distance from x-ray tube (dose

rate is proportional to the inverse of the

square of the distance from the source)

•

Use under and over-table shielding

against scatter

•

Lower the detector as close to patient

as possible

•

Use robotic PCI if available

•

Limit beam-

on time (do not step on pedal

unless looking at screen,

•

Use “virtual” collimation,

•

Last-image hold

•

Only “tap” on fluoro pedal if needed

•

Keep detector close to patient

•

Minimize steep angles

•

Limit cine- use fluoro save/store

•

Use lower frame rate (7.5 fps) and “Eco”

dose setting

•

Use collimation

•

Keep arms/hand out of beam

Post procedure monitoring and documentation

AK 5

-10 Gy (DAP > 500 Gy.cm

)

•

Patients should be educated regarding potential skin changes and call the

Interventionalist if seen.

•

Patients should be contacted at 30 days.

•

Phone calls may be sufficient if A

k, r

< 10 Gy, with an office visit if questions arise

or adverse skin effect suspected.

AK > 10 Gy (DAP > 1,000 Gy.cm

)

•

Qualified physicist should promptly perform a detailed analysis to calculate PSD.

•

Patient should return for an office visit at 2-4 weeks with examination for

possible skin effects.

PSD > 15 Gy

• Hospital risk management should be contacted within 24 hours with appropriate

notification to the regulatory agencies.

•

This exposure represents a Joint Commission Sentinel Event.

Radiation Safety

Chambers CE, et al. CCI 2011;77:546-56

Essential Cath Lab Equipment

• Imaging equipment and archival storage system

• Multichannel physiologic monitoring (minimum of 2 pressure & 3 ECG

channels) with real-time and archived physiologic, hemodynamic and rhythm

monitoring

• X-ray system with periodic and documented preventive maintenance

• Includes image quality, dynamic range, modulation transfer function, fluoroscopic

spatial resolution, field of view size accuracy, low contrast resolution, automatic

exposure control and maximum table-top exposure rate

• Adequate inventory for the scope of services provided

• Disposable supplies

• Equipment for management of complications and emergencies

• Daily checks and quality control to be performed (see table on right)

Cath Lab Daily Checklist

Emergency Equipment

Code Cart Checked

Temporary pacemaker & defibrillator

tested

Pericardiocentesis tray in room

Check IABP & Impella consoles/catheters

Covered stents, coils, etc.

Quality Control Daily Check

ACT machine & blood gas analyzers

X-ray System

System turns on

Cine and fluoroscopy work

Table moves

Hemodynamic system turns on

Information Storage and Inventory

• Reporting system should be linked with hospital information system

• Linking inventory and billing creates a seamless interface to provide an accessible report,

enhanced inventory management and can verify billing

• Compliance with the 1996 Health Insurance Portability and Accountability Act (HIPAA) is required

• Disaster recovery is essential to any archival storage system

• Image Storage

• Compliance with HIPAA requirements include minimum of 6 years of storage, but requirements vary by state

• https://www.hhs.gov/sites/default/files/ocr/privacy/hipaa/administrative/securityrule/pprequirements.pdf?language=es

• Link to state requirements

• https://www.healthit.gov/sites/default/files/appa7-1.pdf

Question 1- You are performing PCI on a complex left main bifurcation lesion with a

planned two-stent technique. You reviewed the diagnostic images and the view that

best delineates the bifurcation is LAO 40, caudal 35. You wish to attain optimal results,

while following the principle of ALARA (as low as achievable). Which of the following

strategies would result in higher radiation dose?

A. Collimate to the region of the bifurcation.

B. Raise the table as high as possible and lower the image detector as low as possible.

C. Change the field of view from 20 cm (8 inches) to 16 cm (6 inches).

D. Use intracoronary imaging to aid in stent sizing and post-stent deployment assessment.

E. Wire the vessels and perform pre-dilation at shallow angles and move to steep LAO-caudal for

stent deployment.

Answer: C

• Changing the field of view (FOV) from 20 cm to 16 cm (higher

magnification) will significantly increase the radiation dose. With

modern imaging systems, diagnostic image quality is often achieved

at 25 cm (10 in) FOV so higher magnification than 20 cm is rarely

needed. All the other choices are best practices to reduce radiation

doses to the patient and operator.

Question 2- You are a high-volume operator and have received several letters from the

radiation safety officer regarding your high monthly dose. Your standard practice

includes using 7.5 frame/s fluoro acquisition, 25 cm (10 inch) field of view, collimation,

frequent fluoro save and collimation, keeping the table at elbow height and positioning

the image detector close to the patient. Which of the following is likely to reduce your

recorded badge dose?

A. Change from a two-piece lead to a one piece lead apron.

B. Use a RADPAD

scatter shield

C. Use very brief cine to store images of balloon and stent deployments.

D. Change field of view to 20 cm (8 inches).

E. Use digital subtraction angiography for femoral angiograms instead of fluoro save.

Answer: B

• This operator is already using best practices to reduce radiation dose but still has high operator dose

due to high-volume.

• Using a RADPAD scatter shielding has been shown to significantly reduce operator dose in randomized

controlled trial (ref: Vlastra W et al. Circ Cardiovasc Interv. 2017;10:e006058.)

• Choice A – the badge is worn outside the lead so this would not change the recorded dose. Also, the

difference between a two-piece vs one-piece lead apron is mainly preference. The absolute thickness

of the lead equivalent is typically the same.

• Choice C – brief cine to store images is a older practice that’s highly discouraged, less radiation is

delivered using fluoro save.

• Choice D - increasing the magnification and will increase the dose.

• Choice E – using DSA will use deliver significantly higher dose.

Question 3- You are advancing a TAVR delivery system and wish to see both the tip

of the wire in the left ventricle and the valve as it traverses from the abdominal

aorta to the aortic root. Which of the following is the best strategy to optimize this

process and minimize radiation?

A. Use standard coronary acquisition settings and pan the table as you advance

the delivery system.

B. Change the acquisition from 7.5 to 15 frames/second.

C. Drop the table height.

D. Change the field of view to a lower magnification setting.

E. Raise the image detector.

Answer: D

• By lowering the magnification, the operator can see the wire tip and

the valve at the same time without needing to pan the table. This will

also lower the radiation dose.

• All the other choices would increase the radiation dose unnecessarily.

Question 4- You are hired as a new director of a cath lab. You have run into several

instances in which emergency equipment, such as temporary pacemakers,

malfunction when they are needed. Which of the following is the appropriate

strategy?

A. Purchase new equipment.

B. Assign the cath lab manager to perform a daily checklist including emergent

equipment and report to you if there are issues.

C. Hire a new cath lab manager.

D. File an incident report.

E. Accept that these are expected events.

Answer: B

• Performing a daily checklist is a quality assurance practice to ensure

critical equipment are functional.

Question 5- Your vascular surgery colleague notified you that he has performed a

second incision and drainage for femoral access infection post cardiac catheterization in

a month. Which of the following is unlikely to improve this problem in the future?

A. Use vascular closure device instead of manual compression.

B. Use electric clippers for hair removal instead of a razor.

C. Use chlorhexidine-based prep.

D. Instruct the technologist to prep the site at the location of the puncture first and move to

the periphery with an ever-widening circular motion.

E. Use universal precautions for all cases.

Answer: A

• Using vascular closure device does not reduce infection but is

associated with higher rate of infection. (Noori VJ, Eldrup-Jørgensen

J. J Vasc Surg. 2018 Sep;68(3):887-899.)

• All the other choices are best practices to reduce access site infection.

Care Coordination

Craig Beavers, MD, FSCAI

Jayant Bagai, MD, FSCAI

Disclosures

• Beavers, Craig No relevant relationships with commercial interests to disclose.

• Bagai, Jayant No relevant relationships with commercial interests to disclose.

Care Coordination with Referring Physicians

Purpose

• To provide education to the referring physician on common

pre- and post-procedural issues in patients undergoing

invasive/interventional procedures in the cardiac cath lab

• To foster a collaborative effort regarding our mutual patients in

the important area of aftercare

Intended Audience

• Primary Care/Referring physicians, interventionalists, nurses,

advanced practice providers, SCAI QIT Champions

Objectives

• Discuss risk factors for contrast nephropathy following cardiac catheterization

• Describe current recommendations on duration of withholding anticoagulation

prior to cardiac catheterization

• Summarize current recommendations on duration of dual antiplatelet therapy

after percutaneous coronary intervention (PCI)

• Manage patients who require both oral anticoagulation and dual antiplatelet

therapy post-PCI

Contrast-induced acute kidney injury (CI-AKI)

• Identify patients at increased risk for CI-AKI using Mehran Score

• Assess appropriateness of cardiac cath in patients at high risk, i.e. Mehran

score > 10 (example- age > 75 + diabetes + anemia + eGFR 40-60= Mehran

score 11)

• Hold ACE inhibitor, NSAID and diuretic 24-48 hour pre-cath in patients with

renal insufficiency/ increased risk of CI-AKI

• Hold metformin 24 hours pre- and resume 48 hours post cardiac cath (check

Cr prior to restarting if pre-existing renal insufficiency)

• N-acetyl-L-cysteine (mucomyst) is no longer recommended

Recommended durations for withholding DOACs

Drug

Cr Cl (ml/min)

Hold time for low bleeding risk

(diagnostic cardiac cath via radial

access)

Hold time for uncertain, moderate or

high bleeding risk (diagnostic cardiac

cath via femoral access, any PCI)

Apixaban or

Rivaroxaban

> 30

24 hours

48 hours

-29

36 hours

No data, consider holding

> 72 hours

< 15

No data, consider holding

> 48

hours

Dabigatran

> 80

24 hours

48 hours

-79

36 hours

72 hours

-49

48 hours

96 hours

-29

72 hours

120 hours

< 15

No data, consider holding

> 96 h

No data

Hold warfarin 5 days prior to cardiac cath aiming for INR < 1.7 on day of procedure

Tomaselli GF et al. JACC. 2017;70(24):3042-3067

Zukkoor, Choudhury Pre-procedural DOAC guidance

Elective Percutaneous Coronary Intervention or Acute Coronary Syndrome

and Need for Anticoagulation

Concern about thrombotic risk

prevailing (PCI for acute coronary

syndrome, complex PCI, h/o stent

thrombosis, high DAPT score)

Concerns about high bleeding risk prevailing

(HAS-BLED score >3)

Triple therapy (oral anticoagulant +

aspirin

81mg + clopidogrel) x 1 month

Dual therapy (clopidogrel + oral anticoagulant)

x 6 months

Dual therapy (clopidogrel + oral

anticoagulant) x 6 months

Dual therapy (oral anticoagulant plus

clopidogrel)

for additional 11 months

Oral anticoagulant alone after 12 months

Oral anticoagulant alone after 6 months

Oral anticoagulant + 81 mg aspirin after 6

months

Oral anticoagulant alone after 12 month

Average thrombotic and bleeding risk

(PCI for stable CAD)

DOAC preferred over warfarin. Do not use prasugrel as component of triple therapy

Dual Antiplatelet Therapy (DAPT) Duration

Stable Coronary Artery

Disease

High Bleeding Risk

1 month of DAPT a

t minimum, ideally up to 3 months

Low Bleeding Risk

-6 months of DAPT at minimum, consider longer if high

thrombotic risk

Non

-ST

Segment Elevation MI

High Bleeding Risk,

Low Thrombotic Risk

6 months of DAPT a

t minimum

Low Bleeding Risk, High

Thrombotic Risk

12 months of DAPT at m

inimum

High Bleeding Risk, High

Thrombotic risk

3 months DAPT with aspirin + ticagrelor followed by 9

months ticagrelor alone

ST Segment Elevation MI

High Bleeding Risk

6 months of DAPT a

t minimum of , ideally up to 12 months

Low Bleeding Risk

12 months of DAPT at m

inimum

Angiolillo DJ, et al. Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention TWILIGHT. JACC 2020

Use of prolonged DAPT therapy > 12 months

• In patients with ACS treated with PCI, who have

tolerated DAPT without bleeding complication for 12

months, and who are not at high bleeding risk (prior

bleeding on DAPT, coagulopathy, oral anticoagulant

use) continuation of DAPT for > 12 months may be

reasonable (Class IIB recommendation)

• DAPT score > 2- favorable risk-benefit ratio for

prolonged DAPT

• DAPT score < 2- unfavorable risk-benefit ratio for

prolonged DAPT

Variable

Points

Age

> 75

Age 65 to < 75

Age < 65

Current smoker

Diabetes

MI at presentation

Prior PCI or MI

Stent diameter < 3 mm

Paclitaxel eluting stent

CHF or LVEF < 30%

PCI of bypass graft

Components of DAPT score

Interruption of DAPT for surgery

• P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) can be interrupted for surgery after 6 months

of therapy post-PCI

• Interruption of P2Y12 inhibitors for elective surgery can be considered after 3 months and before

6 months of therapy post-PCI, if risk of bleeding during surgery > risk of stent thrombosis

• Low dose aspirin should be continued in peri-operative period (i.e. patient should not suddenly

stop all antiplatelet therapy)

• The timing of restarting clopidogrel, prasugrel or ticagrelor depends on risk of surgical bleeding

• There are emerging data suggesting safety of 1 month DAPT after PCI with drug eluting stents

(DES) for stable CAD and 6 months DAPT after PCI with DES for ACS

Proton Pump Inhibitors (PPIs) and Antiplatelet Therapy

Routine use of a PPI is not recommended for patients at low risk of

gastrointestinal bleeding, who have much less potential to benefit from

prophylactic therapy

I IIa IIbIII

No Ben efit

I IIa IIbIII

PPI use is reasonable in patients with increased risk of gastrointestinal

bleeding (advanced age, concomitant use of warfarin, steroids,

nonsteroidal anti-inflammatory drugs, H. pylori infection) who require

DAPT

PPI should be used in patients with history of prior GI bleeding who

require DAPT

I IIa IIbIII

Question 1- A 64-year-old woman (68kg) is scheduled for diagnostic left heart

catheterization via radial artery . Her CHA2DS2VASc is 3 (diabetes, female) and she takes

apixaban 5mg twice daily (CrCL 100mL/min, SCr 1.0mg/dL)). Which of the following is

the recommended duration for holding anticoagulation based on ACC guidelines?

a. Stop apixaban 48 hours prior to procedure

b. Stop apixaban 24 hours prior to procedure

c. Stop apixaban 12 hours prior to procedure

d. Stop apixaban 12 hours prior to procedure and administer andexanet alfa

Correct Answer: B

• Diagnostic coronary angiography via radial access is considered to have a low risk

of bleeding, and therefore holding apixaban for 24 hours prior to the procedure is

supported 2017 ACC expert consensus decision pathway for periprocedural

management

• It is important to be aware that patients may require femoral access for coronary

angiography in the event of failure of radial access.

• Femoral access carries a moderate to high risk of bleeding and requires a 48 hour

hold in patients with normal renal function.

• The same applies to patients who may need PCI as opposed to just diagnostic

angiography.

Question 2- A 45-year-old patient underwent PCI and DES placement in the mid

right coronary artery for stable angina. She is placed on clopidogrel 75mg daily

and aspirin 81mg daily. The patient is considered to have both low thrombotic

and bleeding risk. Which duration best represents the recommended duration

of DAPT based on current guidelines?

a. 1 month.

b. 3 months.

c. 6 months.

d. 12 months

Correct Answer: C

• Given the patient’s low bleeding risk, low thrombotic risk and stenting for an elective

procedure, the minimum recommended duration of therapy based on the 2016

ACC/AHA focused update on duration of DAPT is 6 months (Answer C).

• If her bleeding risk were higher, a shorter DAPT duration of 3 months may be

reasonable.

• Had the PCI been performed due to ACS, the recommended duration would have

been 12 months for both a DES and bare metal stent (BMS).

• A 1 month duration of DAPT is recommended if the patient had received a BMS for

stable angina.

Question 3- Which of the following is the most appropriate

recommendation prior to elective coronary angiography in an anemic

patient with abnormal renal function?

a. Administer N-acetyl-L-cysteine prior to and after catheterization

b. Administer sodium bicarbonate prior to catheterization

c. Hold metformin 24 hours pre- and 48 hours post-catheterization

d. Administer 1 unit of packed red blood cells

Correct Answer: C

• Holding metformin for 24 hours before and 48 hours after exposure to

iodinated contrast is recommended due to the potential for lactic acidosis in

the event of severe renal failure due to CI-AKI.

• Several well-designed clinical trials have yet to elucidate the benefit of N-

acetyl-L-cysteine nor sodium bicarbonate in prevention of contrast induced

nephropathy (Answers a and b are incorrect).

• There has been no data routinely providing packed red blood cells prevents

CKI (Answer d is incorrect).

Question 4- A 70-year-old patient with DM and prior MI who underwent PCI with DES

placement for ACS angina 18 months ago wants you to refill his prescription for clopidogrel.

He also takes daily low dose aspirin. He informs you that he was told by his Cardiologist that

he need to take clopidogrel “for the rest of his life”. What is current evidence regarding

prolonged DAPT beyond the recommended 12 months in ACS patients?

a. Current guidelines do not support DAPT beyond 12 months under any scenario

b. Current guidelines state that continuation of DAPT beyond 12 months may be reasonable

in patients who have not experienced bleeding on DAPT and are low risk for bleeding

c. Long term DAPT is not associated with increased risk of bleeding

d. Prolonged DAPT should be considered in patients with a DAPT score < 2

Correct answer: B

• Prolongation of DAPT beyond 12 months can be considered in patients who are at low risk of

bleeding and have not experienced bleeding while on DAPT. Answer a is therefore incorrect.

• On the basis of studies of DAPT in post-MI patients, extended DAPT for approximately 18 to 36

months leads to an absolute decrease in ischemic complications of ~1-3% and an absolute

increase in bleeding complications of ~1%. (Answer c is therefore incorrect.) Currently there is no

data to support “lifelong” DAPT in such patients.

• The DAPT score is a useful tool to determine the risk-benefit of extended DAPT. Patients who are

younger (< 65 years), and increased ischemic risk (history of MI, diabetes, CHF, CABG) with a DAPT

score > 2 have a favorable risk-benefit ratio for prolonged DAPT. (Answer d is therefore incorrect.)

Question 5- A 70-year-old patient with a CHA

-VASc score = 4, HAS-BLED score =

3 on long-term anticoagulation for atrial fibrillation (AF) undergoes PCI with a DES

for ACS. What is the recommended combination of antiplatelet and anticoagulant

therapy?

a. Aspirin+ clopidogrel + warfarin x 12 months

b. Apixaban + clopidogrel x 6 months, followed by apixaban + aspirin x 6 months

c. Aspirin + clopidogrel + Warfarin x 6 months

d. Aspirin + prasugrel + apixaban x 6 months, then apixaban + aspirin x 6 months

Correct answer- b

• This patient has both high ischemic (stroke and MI) and bleeding risk. In the AUGUSTUS trial, patients

with AF and recent ACS or PCI for stable angina treated with a P2Y

inhibitor (clopidogrel in > 90%) +

apixaban without aspirin for 6 months resulted in less bleeding (7.3%) and fewer hospitalizations,

without significant differences in the incidence of ischemic events, than a combination of P2Y12

inhibitor (usually clopidogrel) + warfarin + aspirin for 6 months (bleeding rate 18.7%). The

combination of apixaban + clopidogrel was also associated with less bleeding compared with warfarin +

clopidogrel. Answer b is therefore correct and Answer c is incorrect.

• Triple therapy with aspirin + clopidogrel + warfarin x 12 months is associated with a very high risk (44%

in the WOEST trial) of bleeding and not recommended in this patient with high risk of bleeding at

baseline. (Answer a is therefore incorrect)

• Prasugrel should not be used as a component of “triple therapy” due to high risk of bleeding. Answer d

is therefore incorrect.

Lopez et al. NEJM. 2019;380:1509-24

Dewilde WJ et al. Lancet. 2013;381(9872):1107-15