Cardiac Catheterization & Stent Implantation

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1 Reducing Overutilization of Interventional ti Cardiology Procedures: Cardiac Catheterization & Stent Implantation David F. Kong, MD, AM Associate Professor of Medicine, Division of Cardiology Duke University Medical Center Amy Marr, MD, MPH, Associate Medical Director AllMed Healthcare Management

2 Overview Overutilization within cardiology departments Addressing overutilization issues in interventional cardiology Assessing compliance with evidence-based guidelines Ensuring proper documentation Identifying physicians knowledge, attitudes and competencies: credentialing and privileging Measuring gpatient outcomes Interventional cardiology procedures: cardiac catheterization and stent implantation Potential ti risks and complications Role of external peer review in ensuring quality of patient care and safety

3 Overutilization, Abuse, and Fraud Within Cardiology Departments: t Widespread d Scrutiny Recent high-profile cases have shed light on the widespread extent of questionable physician and hospital practices The U.S. attorney s office in Miami is investigating allegations that patients underwent unnecessary cardiac catheterizations and stent implantations at facilities owned by the largest for-profit hospital chain in the United States Three Maryland Hospitals exceed state average for stent procedures by 20-30% U.S. Senate Committee on Finance concludes fraud. One operator sentenced to 97 months in federal prison, 6 others face civil lawsuits and administrative actions, including loss of license. Abelson et al. Hospital chain inquiry cited unnecessary cardiac work. New York Times. August 6, 2012.

4 Guidance Documents Expert consensus based on evidence Class I - Evidence and/or general agreement that a given procedure or treatment is beneficial, useful, and effective. Class IIa Conflicting evidence and/or divergence of opinion about the usefulness/efficacy of a procedure or treatment. Weight of evidence/opinion is in favor of usefulness/efficacy. Class IIb - Usefulness/efficacy is less well established by evidence/opinion. Class III - Evidence and/or general agreement that a procedure/treatment e eat e t is not useful/effective ul e ect and in some cases may be harmful.

5 Guidance Documents Appropriate Use Criteria Technical panel vote; not necessarily all experts Organized by indication Each panelist scores indication on a scale of 1 to 9; rating determined by median score. Appropriate generally acceptable, reasonable, and likely to improve outcomes. Uncertain may be acceptable and may be reasonable, but with uncertainty indicating that more information is required to classify the indication. Inappropriate Not generally acceptable or reasonable, and unlikely to improve outcomes.

6 How common are inappropriate interventional ti procedures? Acute - Acute - Uncertain Inappropriate 0% 1% Non-Acute PCI Acute - Appropriate 70% Non-Acute PCI 29% Appropriate 15% Uncertain 11% Inappropriate 3% Chan et al. JAMA. 2011;306:53-61.

7 Some hospitals have more inappropriate interventional ti procedures than others Analysis of 500,154 PCIs at 1,091 hospitals, Chan et al. JAMA. 2011;306:53-61.

8 Addressing Overutilization Issues in I t ti l C di l Interventional Cardiology

9 Hospitals Face Quality & Compliance Issues Overutilization compromises patient safety and outcomes Optimal patient care relies on: Compliance with evidence-based guidelines Thorough documentation of medical history and exams Identification of physicians knowledge, attitudes, and competencies Stringent credentialing and privileging requirements require more comprehensive peer reviews, especially for high-risk procedures

10 Assess Compliance With Evidence-Based Guidelines ACC: interventional cardiologists should practice according to evidence-based guidelines Appropriateness Criteria for Coronary Revascularization developed by the ACCF and other key specialty and subspecialty societies In general, support the use of coronary revascularization (i.e., procedures that restore blood flow to the heart) for patients with acute coronary syndromes and combinations of significant symptoms Revascularization of asymptomatic patients or patients with low-risk findings on noninvasive testing and minimal medical therapy viewed less favorably Patel et al. J Am Coll Cardiol. 2009;53: Patel et al. J Am Coll Cardiol. 2012;59:

11 Ensure Proper Documentation Thorough physician documentation is critical for reimbursement of interventional cardiology procedures Incomplete documentation can affect patient outcomes and may increase risk of liability and malpractice claims

, cardiovascular, renal gastrointestinal, peripheral vascular, pulmonary, neuro) Any history of contrast

12 Essential Components of Documentation Medical history Patient s history of present illness Comorbidities Indications for the procedure Previous cardiovascular/endovascular procedures Review of systems (e.g., cardiovascular, renal gastrointestinal, peripheral vascular, pulmonary, neuro) Any history of contrast reaction, bleeding or thrombosis Physical examination Focus on heart and vascular system Assessment and documentation of peripheral pulses

13 Physician Credentialing Identify Physicians Knowledge, Attitudes & Competencies Protects patients from harm by verifying that a physician meets an organization s standards Reviews information regarding g the physician s: License, experience, certification, education, training Malpractice and adverse clinical occurrences Clinical judgment Character by investigation and observation Potential conflicts of interest

14 Physician Privileging Recognizes physician qualifications and competency Defines a physician s scope of practice and the clinical services he or she may provide Based on demonstrated competence A data-driven process Beyond certification examinations, impartial assessment and review of cases ensure that clinicians are prepared p to be privileged to perform procedures Frey et al. Circulation. 2012;125:

15 Physician Privileging: Determining Physician Qualifications Involves gathering information with which to decide the types of care, treatment, and services or procedures that a practitioner will be authorized to perform in a specific setting Factors to consider Setting-specific characteristics (e.g., adequacy of the facilities, equipment, number and type of qualified support personnel and resources) Physician s education, training (residency and/or fellowship), and clinical experience (number of procedures performed with satisfactory outcomes) Training for coronary intervention does not qualify a clinician to perform all catheter-based treatments Frey et al. Circulation. 2012;125:

16 Physician Privileging: Interventional Qualifications Guideline Standards Board Certification: ABIM established interventional cardiology board certification in 1999 Elective/urgent PCI should be performed by operators with acceptable annual volume ( 75 procedures) at high-volume centers (>400 procedures) with on-site cardiac surgery Operators doing < 75 procedures/year should only work at institutions doing > 600 procedures/year. An institution with a volume of < 200 procedures per year, unless in an underserved d region, should carefully consider whether it should continue to offer this service ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. J Am Coll Cardiol. 2011;58(24):e44-e122. e122

17 Optimizing the Process of Physician Credentialing & Privileging il i Requires qualified and objective physician-controlled peer review, with decisions that are: Fair and without conflicts of interest Based on dated, detailed documentation Confidential and protected Documented physician performance should be measured against criteria that are: Directly related to quality of patient care Established through common legal, professional, and administrative practices Endorsed by a formal consensus process Publicly available Set minimum annual case volume requirement standards (by type of procedure) and assess individual risk-adjusted adverse outcomes

Consequences of Retaining or Contracting

18 Consequences of Retaining or Contracting Incompetent t Providers Potential legal l liability for any injuries i to patients Exclusion from federal and state health benefit program participation Loss of commercial contracts Loss of accreditation by healthcare standards organizations

19 ACC/SCAI Cardiology Training Standards Area Noninvasive cardiologist ICU procedures only Diagnostic catheterization independent operator Interventional catheterization independent operator Cath lab/program director Level Minimal Number of Procedures Cumulative Duration of Cath Lab Training (Months) Minimal Cumulative Number of Cases Diagnostic Diagnostic InterventionaI Board-certified interventional cardiologist with at least 5 years experience after completion of training, including an aggregate experience of at least 1000 coronary interventional procedures. Jacobs et al. J Am Coll Cardiol. 2008;51(3):

20 Measure Patient Outcomes Track quality assurance measures for cardiac catheterization and stent implantation Postprocedural mortality Stroke Vascular complications Participation in regional or national registries Helps ensure standardized data definitions Track clinical outcomes beyond discharge to 30 days postprocedure Provides insights into effectiveness of current treatments, and issues regarding follow-up care and patient satisfaction with care provided

21 Interventional Cardiology Procedures

22 Cardiac Catheterization An invasive imaging procedure used to: Evaluate or confirm the presence of coronary artery disease, valve disease, or disease of the aorta Evaluate heart muscle function Determine the need for further treatment (e.g., interventional procedure such as stent implantation, coronary artery bypass graft [CABG] surgery) Performed by inserting a catheter t through h an artery and/or vein Catheter is advanced to the heart and pressures measured Contrast dye is injected with simultaneous X-ray motion pictures to visualize the coronary arteries and the pumping action of the heart

23 Approach Femoral vs. Radial

24 Coronary Anatomy on X-ray Angiography Left Main Artery Left Circumflex (LCX) Left Anterior Descending (LAD) Post PCI of LAD Right Coronary (RCA) Principles of Imaging Evaluate all anatomy from at least 2 views ~ 90 0 apart Arteries seen in different projections

(atherectomy) t Excimer laser Cutting balloon Aspiration thrombectomy t Can be performed during

25 Coronary Interventional Procedures Nonsurgical treatments used to open narrowed coronary arteries to improve blood flow to the heart Balloon angioplasty Stent implantation Rotoblator t (atherectomy) t Excimer laser Cutting balloon Aspiration thrombectomy t Can be performed during a diagnostic cardiac catheterization when a blockage is identified, or scheduled as a separate procedure

26 Stent Placement

27 Timing of Cardiac Catheterization When should a cardiologist take a patient to the cath lab? Two basic patient groups Those with myocardial damage (STEMI or + enzymes) Acutely occluded vessel (STEMI) or shock Emergency cath within 90 minutes NSTEMI/severe or worsening sx/bp/ecg Urgent cath within several hours Those without known myocardial damage Only patients with recurrent pain and unfavorable ECG/functional study/hemodynamics taken urgently

28 Complications of Catheterization and PCI J Am Coll Cardiol 1999:33:1756 Major Complications SCAI Registry (%) Mortality 0.11 Myocardial infarction 0.05 Cerebrovascular accident 0.07 Arrhythmias 0.38 Vascular complications 0.40 Contrast reaction Hemodynamic complications 0.26 Perforation 0.03 Other complications 0.28 Total major complications 1.70

29 Procedural Risk Interventional Thinking How many lesions / How many vessels? 1. Multiple or complex targets may make CABG preferable. 2. Significant lesion - 50% diameter reduction = 75% cross-sectional area reduction What are the anatomic obstacles: 1. Is the vessel completely occluded? For how long? 2. Is it difficult to deliver equipment to the lesion (i.e. angluated, tortuous, calcified vessels)? 3. Is there a branch at risk / with disease? Is there a location associated risk? 1. Ostial lesion left main or LAD 2. Vein Grafts propensity for thrombus / embolization Are there patient characteristics that change risk? Creating An External Peer Review Policy

30 Role of External Peer Review in Ensuring Quality of Patient t Care & Safety

31 External Peer Review Ensures Quality of Care Ongoing evaluation of hospital practitioners ensures excellence in physician performance and the highest standard of care for patients External peer review allows hospitals to perform: In-depth evaluation of sentinel events Credentialing and re-credentialing Privileging vleg g and re-privileging ep g Proctoring Ongoing measurement and monitoring of physician performance

32 Internal vs. External Peer Review Internal peer review Peer review committees composed primarily of in-house personnel often lack the resources to help the hospital achieve their performance improvement goals Social and professional relationships lead to conflicts of interest External peer review Avoids conflicts of interest that can arise from economic, professional, or social ties among physicians within a single institution May be an effective solution for hospitals that lack adequate physician resources to conduct timely performance analyses

33 Systematic External Peer Review as a Risk Reduction Strategyt Reduces medical errors through objective evaluations performed in a nonpunitive, educational context that supports a culture of continuous improvement Improves quality of care and patient t safety Physicians know that their work will be objectively evaluated at regular intervals by board-certified specialists with ih the same credentials and from similar il practice settings Uncovers problematic practice patterns and physicianand hospital-level issues that need to be addressed before they turn into claims

34 Conclusions Reducing the number of unnecessary procedures can improve efficacy of cardiac catheterization and stent implantation, as well as prevent significant potential risks and complications Professional societies face the ongoing challenge of developing appropriate use criteria for invasive interventional cardiology procedures Complex clinical case presentations make the assessment of appropriateness of interventional ti cardiology procedures especially challenging Transparent, collaborative, and standardized review of cases can help to ensure that procedures are performed in appropriate patients

35 Questions and Answers

36 Thank you for attending. All attendees will receive, via , a copy of the slide deck from today s presentation as well as a link to the recorded webinar. For more information, contact us at: AllMed Healthcare Management, Inc. 621 SW Alder Street, Suite 740 Portland, OR (800) info@allmedmd.com d

2017 Cardiology Survival Guide

2017 Cardiology Survival Guide Chapter 4: Cardiac Catheterization/Percutaneous Coronary Intervention A cardiac catheterization involves a physician inserting a thin plastic tube (catheter) into an artery