Transcript Thomas M. Bashore, MD, FACC, FSCAI

Thomas M. Bashore, MD, FACC, FSCAI
Professor of Medicine & Clinical Chief of Division of Cardiology at Duke University Medical Center
No Relevant Disclosures
Background
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Prior Consensus Document – 2001
Primarily a Reference Source
The Evolution of the Cardiac Catheterization Laboratory in the
Last Decade
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From a Diagnostic to a Therapeutic Laboratory
Shift from Coronary to Mixed Coronary and NonCoronary
Move toward Outpatient Procedures
Increase in Laboratories Without On-site CV Surgery
Increasing Importance of QA/QI Program and Benchmarking
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Scrutiny of Both Operator and Laboratory
Changes in X-ray Imaging and Emphasis on Radiation Safety
Hybrid Cardiac Catheterization Laboratory
Pediatric Cardiac Catheterization Laboratory
The Writing of Consensus Documents
Current Landscape
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Up to 85% of hospitals provide some type of invasive
cardiovascular services*
Up to half of procedures done in some cath labs are now noncoronary
Up to 1/3 of cardiac cath lab facilities do not have on-site CV
surgery
60% of all PCI now ad hoc procedures
Risk of cardiac cath and PCI very low
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Diagnostic Risk <1%
Elective PCI Risk <2%
Primary PCI Risk <4%
Risk of Emergency CABG – 2 per 1000 cases
*Levit
K. Agency for Healthcare Quality and Research (2009)
Suggested Patient Exclusions
When No On-site CV Surgery
Facility Requirements in
Settings Without CV Surgery
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Outlines requirements necessary for performance of
invasive cardiovascular procedures in setting without
CV surgery
Outlines requirements necessary for performance of
primary PCI in settings without CV surgery (reaffirms
2009 STEMI/PCI Guidelines*). Consensus is must
have 24/7 coverage.
Importance of a close relationship with a sponsoring
hospital having CV surgery
*2009 ACCF/AHA STEMI/PCI Guidelines. JACC 2009;54:2204
Quality Assurance &
Quality Improvement Programs
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Reviews data collection process
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Direct patient-care related indicators
System-specific indicators
Guidelines-driven indicators
Cost-related indicators
Outcome-related indicators
■ Physical outcomes: individual physicians and the laboratory
■ Service outcomes: access, DTB time, satisfaction scores
SCAI Quality Improvement Toolkit
Accreditation for Cardiovascular Excellence
Basic Components of a QA/QI System
Operationalizing a QA/QI Program
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Data event forms
Minimal components of the Standard Cath
Report
Tracking radiation exposure
Encourages use of a National Database for all
cardiac catheterization laboratories (NCDRCathPCI)
Minimum Volume Numbers
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Both institutional and operator minimal volume numbers to be
addressed by 2012 ACCF/AHA/SCAI Competency
Committee (currently embargoed)
Cath Standards Document
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Reviews major adverse cardiac or cerebrovascular event rates
in differing settings
Acknowledges higher patient risk in lowest volume laboratories.
Higher risk if operator has low volume in low volume facility.
FOCUS : LESS ON NUMBERS AND MORE ON EVERY
LABORATORY HAVING A ROBUST AND FUNCTIONING
QA/QI SYSTEM IN PLACE
Training Requirements
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Review of Current Formal Training to Achieve Competency
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Diagnostic cardiac catheterization
PCI
Peripheral vascular disease
Structural heart disease
Acknowledges roles of non-invasive cardiologists and noncardiology specialists
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Vascular radiology
Vascular surgery
Cardiothoracic anesthesia
Cardiothoracic surgery
Highlights of Patient Preparation Suggestions
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Within 4 weeks (unless clinical or med change)hemoglobin, platelet count, electrolytes, creatinine
Eliminate routine protime (unless known or suspected liver
disease, warfarin therapy or known hematologic condition)
Reduce NPO time: Am Soc Anesthesia guidelines- 2 hours
after clear liquids, 4 hours after light meal. Hydration more
important than NPO status.
Beta-HCG in women of child-bearing age: urine or serum.
OK within 2 weeks of procedure.
Highlights of Patient Preparation Suggestions
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Antiplatelet and antithrombin agents
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Continue ASA
Warfarin- d/c 3 days prior. Femoral cath OK if INR 1.8
or less. Radial cath OK if INR 2.2 or less. May do
radial on full dose warfarin. Avoid vitamin K.
Newer factor lla (dabigatran) and Xa inhibitors
(rivaroxaban) becoming available. For dabigatran
(normal GFR) holding 2 doses results in 25% of
baseline; holding 4 doses results in 5-10% baseline.
Rec: hold 2 doses, resume after 48 hours.
Follow recent Am Coll Chest Physician Guidelines*
*Chest 2012;141:1S
Reducing Contrast Nephropathy
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Identify Risks- eGFR<60, Diabetes
Manage medications-avoid NSAIDs, but ACE-I Ok
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Manage intravascular volume
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Hydrate (Normal saline or sodium bicarb) 1.0-1.5
ml/kg/min 3-12 hours prior and 6-12 hours post
Minimize contrast volume
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Acetylcysteine no longer recommended
Aim for max contrast= 3.7 x eGFR
Either low osmolar or iso-osmolar contrast
Follow-up creatinine in 48 hours if at risk
Procedural Issues
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Time Out
Sterile Technique
Medications
New Technical Issues (not in prior document)
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Intracoronary Hemodynamics
Pulmonary Hypertension Evaluation
Low gradient, low output Aortic Stenosis
Devices to Augment Cardiac Output
Intracoronary Ultrasound and Doppler
Post-Procedural Issues
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Vascular Hemostasis
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Routine
Use of Vascular Closure Devices*
Medications
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Pain Control
Hypertension
Hypotension and Vagal Reactions
*AHA Scientific Statement. Circulation 2010;122:1882.
Personnel Issue Definitions
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Attending Physician
Teaching Attending
Secondary Operators (including trainees)
Physician Extenders
Nursing Personnel
Non-nursing Personnel
The Hybrid Cardiac Catheterization Laboratory
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Staffing
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Location
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Team approach. Team and personnel may vary depending on
procedure. Best to have dedicated personnel.
Must meet needs for both cardiac cath and open heart surgery. Larger
size (minimum 750 sq. ft. ; 1000 sq. ft. ideal)
Clean corridor, scrub alcove, separate control room
Room and Floor Design Recommendations
Special Needs
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Examples: Lighting (bright for surgeons, dim for cardiologists), Gantry
mounting, Access to radiology PACS, Multiple Monitors for intracardiac
echo or TEE, etc., Special tables (for x-ray, Trendelenburg moves)
Example Procedures for Hybrid Room
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Surgical vascular access for large endovascular devices
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When conversion to open surgical suite may be necessary
Hybrid treatments
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PCI plus minimally invasive CABG or valve surgery
Iliac stenting plus CABG
Apical access for percutaneous paravalvular leak closure
Electrophysiologic Procedures
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Percutaneous aortic valve replacement
Thoracic and abdominal aortic stents
Large-bore percutaneous ventricular assist devices
Endomyocardial/epicardial ablation
Implantable defibrillator
Removal of pacer leads
Emergency Procedures
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ECMO
Emergency Thoracotomy
Ethical Concerns
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Cardiology under greater scrutiny with highly publicized cases,
appropriateness guidelines, questions of overuse of testing or
device implantation, the need to reduce medical costs, etc.
Primary physician obligation always to put the patient first
Section reviews varied topics
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Operator assistant fees, Fee sharing and splitting, Unnecessary
services, Informed consent, Ethics of teaching, Clinical research,
Hospital employment
X-ray Imaging and Radiation Safety
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Cardiologists in general are poorly trained
Reviews basics of image formation and summarizes major
changes in imaging chain over last decade
Reviews biological risks of radiation
Monitoring
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Single badge on collar OK. 2 badges (one under lead if
pregnant)
Defines radiation safety terms
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Stochastic risk- mutations or cancer risk
Deterministic- tissue loss (i.e. skin injury)
X-ray Imaging and Radiation Safety
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Defines Dose-Area-Product
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Defines Interventional Reference Point
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Correlates with stochastic injury
Correlates with deterministic injury
Reviews Maximal Recommended Dose Exposure
Outlines Measures to Reduce Radiation Exposure
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Patient
Operator
Special Concerns for Pediatric
Catheterization Laboratory
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120 laboratories in the U.S.
Must accommodate both children and adults
Risks of cardiac catheterization in kids much higher than in adults.
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Outlines differences from adult laboratory
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Complications: 10% of diagnostic; 19% of interventional
Death or Major Adverse Events: 2% diagnostic, <4% interventional
Access site may greatly vary
Focus on structural issues
3/4ths of procedures are therapeutic in nature
Common use of anesthesia
Frequent need to hold patients overnight
Baseline lab often not needed
Medications vary depending on condition, child size, etc.
Importance of Radiation Safety
Importance of a Rigorous QA/QI Program
Highlights of New Cath Standards Document
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Defines current landscape
Markedly liberalizes patient exclusions for facilities without onsite CV surgery
Outlines facility requirements for performance of elective and
emergency PCI in sites without CV surgery. Recommends all
primary PCI sites are 24/7.
Defers minimum volume numbers to Competency Committee
(currently embargoed)
Focuses on operationally setting up a robust QA/QI program
and benchmarking results- to be described later in this
presentation.
Highlights of New Cath Standards Document
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Patient prep- eliminates routine protimes and reduces NPO
time- favoring hydration over fasting
Contrast nephropathy- eliminates acetylcysteine, suggests
max contrast dose, focuses on hydration
Procedural issues- includes time out and both structural and
coronary imaging procedures
Outlines recommendations for developing and staffing a hybrid
cath lab
Outlines newest changes in x-ray imaging and ways to
document and reduce radiation dose
Updates pediatric catheterization laboratory issues
3. Quality Assurance Issues in the
Cardiac Catheterization Laboratory
SCAI Mission Statement
SCAI promotes excellence in
invasive and interventional
cardiovascular medicine
through physician education
and representation, and the
advancement of quality
standards to enhance patient
care.
Quality Assurance Issues for the
Cardiac Catheterization Laboratory
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QA/QI Components
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Clinical Proficiency
Peer Review
Equipment maintenance
Radiation Safety
Continuous QA / QI Program
Clinical Proficiency & Peer Review
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Catheterization Laboratories should have a dedicated program
specific for the cath lab, assoc. with hospital
Peer Review component to promote clinical proficiency and not be
punitive.
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Outcome driven reviews
Random case quality reviews
Feedback loop essential
Table 11, essential components to the QA/QI process
Table 11. Basic Components of the Continuous Quality
Improvement Program for the Cardiac Catheterization
Laboratory
1. Committee with chairman and staff coordinator
2. Database and data collection
3. Data analysis, interpretation, and feedback
4. QA (quality assurance) /QI (quality improvement) implementation
5. Goals outlined to eliminate outliers, reduce variation, and enhance performance
6. Tools available to accomplish data collection and analysis
7. Feedback mechanisms in place
8. Educational provisions for staff and operators
9. Incorporation of practice standardization/guidelines
10. Professional interaction and expectation
11. Incentives for high quality metrics
12. Adequate financial support for QI personnel
13. Administrative oversight and action plans
14. Thresholds for intervention
15. Appropriateness assessment
Quality Indicators
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Structural Indicators
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Process Indicators
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Staff Credentialing
Procedure related therefore more difficult to measure and
validate: appropriateness, pt. transport, infection control, length
of stay Table 12
Outcomes Indicators
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MACCE, PCI success, Table 13.
Table 12. Examples of Patient Management/Process Indicators
Direct Patient Care-Related
Indicators
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Quality of angiographic studies
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Report generation/quality of
interpretation
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Appropriateness
System-Specific Indicators
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Patient transport/lab turnover/bed
availability
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Pre-procedure assessment process
and adequacy
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Emergency response time
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CT/anesthesia/respiratory
care/perfusion performance
Guidelines-Driven Indicators
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Infection control
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Patient radiation dose (use of all available dose
indicators, not only fluoroscopy time)
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Treatment protocols (radiographic contrast issues,
drugs usage)
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Procedure indications
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New device use
Cost–Related Indicators
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Length of stay pre/post procedure
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Disposables needed
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Quality and adequacy of supplies
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Number and qualification of personnel/staffing
Table 13. Outcomes-Related Indicators
I. Physical Outcomes
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Individual Physician MACCE
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Death
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Stroke/nerve injury
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MI
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Respiratory arrest
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Perforation of vessel of heart with sequellae
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Nerve injury
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Emergent CT surgery
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Access site complications
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Access site complications requiring surgery
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Rate Based Outcomes (outcomes related to volume)
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Diagnostic cardiac catheterization completion rates
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PCI success rates
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Normal cardiac catheterization rates
II. Service Outcomes
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Access to facility
information
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Door-to-balloon times
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Satisfaction surveys
III. Financial Outcomes
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Procedural costs (as
laboratory and as
individual physician)
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Risk management/litigation
costs
Patient Outcomes in the
Diagnostic Cath Lab
Rate of Normal Catheterizations
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Defined as <50% stenosis
Previous data 25%
Recent Data 40%
Reassessment of criteria for Low Risk
Labs (Table #5)
Diagnostic Accuracy & Adequacy
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Coronary engaged/ opacified
Identification of grafts and anomalou
vessels
Completeness of hemodynamics
<1% of studies
Specific Complication Rates Following Diagnostic Catheterizations
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MACCE (Major Adverse Cardiac or CV events:<1-2%
Access Site Complications
Cerebrovascular Complications-<1/1,000
Patient Outcomes After PCI
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MACCE-Databases, Benchmarking, Risk Adjusted
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Table 8, Assessment of Proficiency in PCI-Medical Dir.
Tables 1, 9, 10 NCDR/NRMI Database Complications
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Overall, stent era, STEMI/Primary PCI
Ad hoc PCI
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PCI performed at same time as diagnostic cath
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Blankenship et al SCAI CCI, out later this year
Data Collection, Analysis,
& Intervention
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Data Collection
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Data Analysis
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Necessary FTE’(s) required for best results
Validation of data
Results of database evaluated not just “filed”
Regular reporting to staff
Intervention
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Improve patient care not punitive to outliers
Tools Available for CQI
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Practice Protocols
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AUC criteria
Scorecards, non-punitive
Counseling
CME, board certification
Identify outliers
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Table 14. Data Quality Event Review Form.
Representative Data Collection Form
Focus on improving the low
physician
Administrative policy to
address “uncorrectable”
Patient Data
Patient Name:________________________ Age:______ ID#:_____________
Procedure:________________ Physician:________________
Date:__________
Reason for Review:
Potential for Patient Safety:______________; Sentinel
Event:_______________
Mortality: In Lab_________; In Hospital___________ 30 Day_____________
Morbidity: Neuro:________; Vascular:___________; Coronary:__________;
Arrhythmia:________; Renal:___________; Radiation:_________
Other:_________________________________________________________
_
Case Summary:__________________________________________
Risk Group: Average/Low
High
Salvage
Clinical
Process Review: Appropriate
Uncertain
Inappropriate
Indication :______________________________________________________
_
Technique :_____________________________________________________
__
Management :___________________________________________________
___
Related to: Disease:______; Provider:_____; System:_____;
Preventable:_________; Not Preventable:________;
Comments:________________
Recommendations:____________________________________________
Reviewer:______________________________________
Recommendation by Committee: ________________________________
Specific Issues
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The Non-cardiologist Performing Cardiac Cath
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National Database Utilization
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NCDR, voluntary, risk-adjusted outcomes
Participation strongly encouraged in national or regional
Catheterization Laboratory Reporting Requirements
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Non-physicians should not be independent operators
Sample report in ECD, table 15; more standards to come?
Storage of Information (Length and Type)
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HIPAA compliant, hospital integration, long term archival
Equipment Maintenance
& Management
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Essential
Component to
Cath Lab QA/QI
Both Vendor
dependent and
Vendor
Independent
Radiation Safety
training as an
adjunct to
process
Documentation
Table 16. Performance Characteristics of Radiographic Imaging
Systems
Category
System
measure
Example
Image quality
Dynamic range
Modulation transfer function
Component
Fluoroscopy and cine spatial resolution
measures (not
Fluoroscopy field of view size accuracy
inclusive)
Collimator tracking and alignment
Low contrast resolution
Record and fluoro mode automatic exposure control
under standard conditions and at maximum output
Calibration of integrated radiation dose meters
Radiation Safety Program
Personnel:
Physician,
Staff, and Physicist
“Radiation
Conscious”
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Training and CME
Film Badge Compliance
Justification/ALARA
Consent Forms
Chart Documentation
Patient Follow-up
CQI program for PCI
Chambers CE, Fetterly K, Holzer R, Lin PJP, Blankenship JC, Balter S, Laskey WK. Radiation Safety
Program for the Cardiac Catheterization Laboratory. Cath and Card Interv. 2011 77: 510-514.
2011 PCI Guidelines
3.1 Radiation Safety Recommendation
Class I
Cardiac catheterization laboratories should routinely record
relevant patient procedural radiation dose data (e.g.., total air
kerma at the interventional reference point (Ka,r), air kerma area
product (PKA), fluoroscopy time, number of cine images), and
should define thresholds with corresponding follow-up protocols
for patients who receive a high procedural radiation dose. (Level
of Evidence: C)
Volume Criteria
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Minimum case volumes for
diagnostic cardiac catheterization:
The authors found no data to support
the use of minimum case volumes as
an indicator of physician quality in
performing diagnostic cardiac
catheterization. Instead, they state that
an effective quality assurance program
is the key to ensuring that cardiac
catheterization studies are
appropriate, and performed and
interpreted correctly. A second, related
document slated to publish later this
year will address minimal case volume
for physicians who perform PCI
procedures.
Press Release: Tuesday, May 8, 2012, 2:00 PM
Cardiac Diagnostic Cath &
PCI
Table 17. Summary of Training
Requirements in Diagnostic and
Interventional Cardiac Catheterization
Modified from Jacobs et al. (169). J Am
Coll Cardiol. 2008;51:355-61.
Training
Area
Level of
training
Cumulative Duration
of Training (Months)
1
Minimal
Number of
Procedures
100
Diagnostic
catheterization
2
200 (300 total)
8
Interventional
catheterization
3
250
20
4
Peripheral Vascular
TRAINING REQUIREMENTS FOR CARDIOVASCULAR PHYSICIANS
Table 18. Formal Training to
Achieve Competence in
Peripheral Vascular CatheterBased Interventions
• Diagnostic coronary angiograms —300 cases (200 as the supervised primary operator)
• Duration of training*—12 months
• Diagnostic peripheral angiograms—100 cases (50 as supervised primary operator)
• Peripheral interventional cases —50 cases (25 as supervised primary operator)
TRAINING REQUIREMENTS FOR INTERVENTIONAL RADIOLOGISTS
• Duration of training —12 months
• Diagnostic peripheral angiograms—100 cases (50 as supervised primary operator)
• Peripheral interventional cases —50 cases (25 as supervised primary operator)
TRAINING REQUIREMENTS FOR VASCULAR SURGEONS
• Duration of training—12 months||
• Diagnostic peripheral angiograms¶—100 cases (50 as supervised primary operator)
• Peripheral interventional cases —50 cases (25 as supervised primary operator)
• Aortic aneurysm endografts—10 cases (5 as supervised primary operator)
What is ACE
•
Accreditation for Cardiovascular Excellence (ACE) is an independent,
objective, physician run not-for-profit organization dedicated to
implementing an accreditation process that uses guidelines, peer reviewed
literature, and appropriate use criteria to
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Background
– Began full operation 2009
– Standards based on guidelines, current literature
• Including this ECD
• Revised yearly
– Or more frequently if science demands
– Current Accreditation Programs
• Carotid Artery Stenting
• Cath/PCI
– Other Review Programs
• Data Integrity
• “Low Volume” Operator
• External Peer Review
• Appropriate Use Reviews
• Customized Programs
Experience to Date
• Accreditation:
– 10 Cath/PCI Accreditation Reviews
• 7 additional applications in process
– 1 Carotid Artery Stenting Accreditation Review
• Other Reviews
– 1 Low volume operator review
– 1 Process and Data integrity review
– 1 External Peer Review
• Cath/PCI
• PVD
Pathway to Accreditation
•
•
•
•
•
Initial Application
– Review by Nurse and Physician Reviewers
• Policies and Procedures
• Demographics, Appropriate Use, Outcome Measures, Standard Quality
Metrics
• Internal Peer Review Process
Nurse Site Visit
– Validation of NCDR reported data
– Process and Facility Review
Physician Data and Angiographic Review
– Report
• Deficiencies and Corrective Action Plans
• Recommendation for Accreditation, Provisional Accreditation or Denial
– Physician Site Visit for cause
ACE Board Approval
Ongoing support to implement corrective action plans
• Shared experiences
• Best Practices
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Results: Quality Assurance Process (n=10 Facilities)
100%
10%
90%
80%
20%
20%
20%
40%
50%
70%
60%
50%
90%
40%
30%
20%
80%
80%
80%
60%
20%
10%
0%
30%
Integrated
Review for
Major
Individual Administration
Quality
Quality
Diagnostic Complication
Operator
Involvement Conference
Program Exists Accuracy and
Reviews
Complications
Quality
Reviewed
Does Not Meet
Partially Meets
Meets ACE Criteria
Results: Quality Assurance Process (n=10 Facilities)
100%
90%
20%
20%
20%
80%
50%
70%
60%
50%
50%
40%
Does Not Meet
Partially Meets
20%
80%
80%
Meets ACE Criteria
30%
20%
30%
30%
10%
0%
Review for
Major Complication Individual Operator
Diagnostic Accuracy
Reviews
Complications
and Quality
Reviewed
Random Case
Reviews
RESULTS: Indications for Procedures
N
%
Stable Angina
43
6.9%
NSTEMI
75
12.0%
STEMI
47
7.5%
Chest Pain
136
21.7%
Valvular Heart
Disease
Heart Failure
11
1.8%
16
2.6%
Other
146
23.3%
Positive/abnormal
stress test
Prior
revascularization
Dyspnea/SOB
77
12.3%
28
4.5%
21
3.4%
Arrhythmia
6
01.0%
No indication
recorded
Cardiomyopathy
11
1.8%
9
1.4%
• Multiple indications could be
selected per patient
• Most Common “other”
indications
• Unstable Angina (24.0%)
• Class 3 or 4 Angina (3.4%
each)
• Unknown (3.4%)
• Indications for the procedures
varied significantly between
institutions (p<0.0001 for all
indication categories)
RESULTS: Quality Metrics (n=441)
100%
90%
Unknown
Not Adequate
Inconsistent
Too Few
Too Many
Not Adequate
Inconsistent
Adequate
Appropriate
Adequate
80%
70%
60%
Indeterminant
No
50%
40%
30%
20%
Yes
10%
0%
P value for
variability by
facility
Pre Procedure
Lesion
Number of Views Opacification
Evidence of Characterization
Ischemia
<0.0001
0.0039
0.0519
<0.0001
In Lab Assessment: First
Lesion
100%
90%
80%
70%
60%
12%
28%
16%
4%
4%
Inadequate Study
4%
Indeterminant
50%
40%
30%
76%
Not Ischemia Producing
Lesion
Ischemia Producing Lesion
56%
20%
10%
0%
IVUS*
FFR*
• In Lab Assessment of any type was performed in only 8% of cases reviewed
• *There was significant variation between institutions in these parameters
p<0.0001
Outcomes
• Quality of Final Result: First Lesion (n=275)
Indeterminant
7%
Not Adequate
• Adequacy of Result based
on:
• Angiographic Result
• Adequacy of Imaging
of Result
• Clinical Utility of
Procedure
4%
Adequate
89%
P value for
variability by
facility
0.0008
RESULTS: Selected Appropriate Use Determination
Variables for Non-Emergent Procedures (n=144)
100%
91%
90%
95%
94%
83%
80%
70%
60%
61%
61%
50%
50%
50%
38%
40%
30%
20%
10%
0%
49%
Yes
29%
28%
No
Not Available
15%
11%
8% 10%
1%
9%
5%
7%
6%
Unknown
Outcomes
• Overall Case Assessment: All
Patients (n=453)
80%
70%
60%
50%
40%
30%
20%
10%
0%
• Overall Case Assessment: Non ACS
Patients (n=333)
70%
P value for
variability by
facility
23%
8%
<0.0001
70%
60%
50%
40%
30%
20%
10%
0%
66%
26%
8%
0.0011
Other Outcome Characteristics: All
PCI Patients (n=258)
100.0%
90.0%
92.3%
89.2%
87.1%
80.0%
70.0%
60.0%
Yes
50.0%
No
40.0%
Data Unavailable
30.0%
20.0%
10.0%
0.0%
9.7%
10.2%
2.7%
Attributable ReAdmission
7.4%
1.2%
30 Day Mortality
0.4%
30 Day CIN
There was significant variation between institutions in these parameters
p<0.0001
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