White Paper: Reducing Overutilization of Implantable

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1 White Paper: Reducing Overutilization of Implantable Cardioverter-Defibrillators (ICDs) & the LifeVest For Hospital Groups, ASCs, and Specialty Medical Facilities Executive Summary Recent data suggest that about 20% of patients in the United States who receive an ICD do not meet current guidelines for patient selection. Unnecessary implantation increases risk of mortality and serious complications. The LifeVest is a wearable cardioverter defibrillator (WCD) designed to perform the same functions as an ICD, but is worn outside the body and is, therefore, noninvasive. The LifeVest may provide protection as a bridge to ICD implantation or cardiac transplantation, and it may be useful in higher-risk patients who are being considered for ICD implantation but do not meet criteria yet for implantation. Careful patient selection for LifeVest usage and ICD implantation may help to prevent significant potential risks and complications, as well as to improve the efficacy of these devices. Recently high-profile cases have shed light on the widespread extent of questionable physician and hospital practices, underlying the importance of transparency and unbiased peer review in order to ensure that quality of care meets professionally recognized standards. Introduction Hospitals continue to face increased pressure to demonstrate that cardiology procedures meet strict medical necessity criteria and guidelines. The use of implantable cardioverter-defibrillators (ICDs) has steadily increased since 1985, when the U.S. Food and Drug Administration (FDA) first approved ICDs. Once considered a treatment of last resort for patients surviving cardiac arrest, the indications for ICD implantation have evolved to include primary prevention for patients at a high risk for sudden cardiac death (SCD). A study published in 2011 found that more than 20% of patients who received ICDs in the United States did not meet sanctioned guidelines for patient selection. These patients had a significantly higher rate of in-hospital mortality and post-procedure complications. However, it should be noted that one of the main reasons that these ICDs did not fall under the guidelines was because they were implanted too soon. Many patients who received ICDs outside of the guidelines had low heart function and were at high risk of deadly heart rhythms. For cases in which implantation of an ICD may be inappropriate or delayed, a wearable cardioverter defibrillator such as the LifeVest may be an option. The LifeVest, which was approved by the FDA in 2001, may provide protection as a bridge to ICD implantation or cardiac transplantation. In addition, it may be useful in higher-risk patients who are being considered for ICD implantation but do not yet meet criteria for implantation. Although the WCD can be worn for years, typically the device is used for several months as temporary protection against SCD. Implantable Cardioverter-Defibrillators How They Work The ICD is a surgically implanted device designed to constantly monitor an individual s heart rate, recognize ventricular fibrillation (VF) or ventricular tachycardia (VT), and deliver an electric shock to terminate these arrhythmias in order to reduce the risk of sudden death. Implantable cardioverter-defibrillators have been shown to be effective in the prevention of sudden death in patients who have experienced a life-threatening clinical event associated with sustained ventricular tachyarrhythmia, patients who have had a prior myocardial infarction (MI) and reduced left ventricular ejection fraction (LVEF), and patients who have cardiac risk factors that place them at risk for SCD. AllMed Healthcare Management Inc. 1

2 Indications Indications for implantable ICDs can be divided into two broad categories: secondary prophylaxis against SCD and primary prophylaxis. For secondary prophylaxis, an ICD is recommended as initial therapy in survivors of cardiac arrest due to VF or hemodynamically unstable VT. The indications for ICD implantation as primary prophylaxis against SCD are classified as follows: ACC/AHA Class I Cardiac arrest secondary to VF without reversible cause Structural heart disease and sustained VT Syncope of undetermined origin, inducible VT or VF at electrophysiology study (EPS) LVEF <35% due to prior MI, at least 40 days post-mi, or New York Heart Association (NYHA) Class II or III Nonischemic dilated cardiomyopathy with an ejection fraction (EF) 35% LVEF 30% due to prior MI, at least 40 days post-mi LVEF <40% due to prior MI, inducible VT or VF at EPS ACC/AHA Class IIa Unexplained syncope, significant LV dysfunction, and nonischemic cardiomyopathy Sustained VT and normal or near-normal ventricular function Hypertrophic cardiomyopathy with one or more major risk factors Arrhythmogenic right ventricular dysplasia/cardiomyopothy (ARVD/C) with one or more risk factors for SCD Long QT syndrome, syncope or VT while receiving beta-blockers Nonhospitalized patients awaiting heart transplant Brugada syndrome and syncope Brugada syndrome and VT Catecholaminergic polymorphic VT, syncope or VT while receiving beta-blockers Cardiac sarcoidosis, giant cell myocarditis, or Chagas disease Potential Complications Acute surgical complications associated with ICD implantation include : Pain Bleeding Pneumothorax Hemothorax Cardiac perforation with or without pericardial effusion and tamponade (sometimes requiring urgent drainage) Pulseless electrical activity following intraoperative defibrillation threshold testing Subacute ICD complications include : Pain Infection Pocket hematoma Wound dehiscence Lead dislodgement Deep venous thrombosis (DVT) Upper extremity edema Degradation of lead function Potential chronic complications include: Device-related pain Lead fracture Inappropriate shocks Erosion of device through skin Immunologic rejection (rare) 2

3 Risk Factors for Developing Complications The acute risk of implantation is small but is increased by multiple factors, including: Age >70 years Female NYHA Class III or IV heart failure Atrial fibrillation Prior valve surgery Chronic lung disease Blood urea nitrogen (BUN) >30 mg/dl Re-implantation for reasons other than battery change Dual-chamber ICD Biventricular ICD Non-elective ICD implant In addition, physician level of training and level of specialty certification have been shown to affect the risk of adverse events associated with ICD implantation. An ICD registry analysis found that physicians who implant more ICDs have lower rates of procedural complications and in-hospital mortality, regardless of hospital procedure volume, physician specialty, and type of ICD implanted. The LifeVest How It Works The LifeVest is a wearable cardioverter defibrillator designed to perform the same functions as an automatic ICD, but is worn outside the body and therefore is noninvasive. The device is intended to be worn continuously, since the purpose of the device is to constantly monitor the patient s electrocardiogram (ECG) and detect life-threatening ventricular tachyarrhythmias (i.e., VT or VF). If the device detects VT or VF above a programmable preset rate, it delivers a defibrillating pulse to the heart through electrodes in an attempt to restore an effective rhythm. The LifeVest communicates with the patient through voice and display messages, tones, or alarms, and vibration against the skin. When an arrhythmia is detected, the device instructs the patient to stop the impending shock by pressing a response button to avoid receiving a shock while conscious. The wearable components of the LifeVest include a monitor, battery pack, alarm module, electrode belt, garment, and holster. The nonwearable components include a battery charger, modem, modem cable, computer cable, diagnostic tester, and a Web-based data storage and retrieval system that allows physicians to access patient data using a Web browser and Internet connection. Indications The LifeVest is indicated for adult patients who are at risk for sudden cardiac arrest and who are not candidates for or who refuse an ICD. The device may provide protection as a bridge to ICD risk stratification and possible implantation for highrisk patients following acute MI, patients diagnosed with cardiomyopathy, and those who have undergone coronary artery bypass graft (CABG) surgery or percutaneous coronary angioplasty (PTCA). Potential Complications A very small percentage of patients may receive an unnecessary shock while wearing the LifeVest. Some patients may complain that the LifeVest is uncomfortable to wear and, therefore, may not wear it continuously. The LifeVest should be worn at all times, except when a patient is showering or bathing. 3

4 The LifeVest is contraindicated in patients with an active ICD and should not be used in patients who: Qualify for an ICD or already have an operating ICD Are under age 18 Have a vision or hearing problem that may interfere with reading or hearing the LifeVest messages Are taking a medication that would interfere with pushing the response buttons on the LifeVest alarm module Are unwilling or unable to wear the device continuously, except when bathing or showering Are pregnant or breast feeding Are of childbearing age and not attempting to prevent pregnancy Are exposed to excessive electromagnetic interference (EMI) from machinery (e.g., powerful electric motors, radio transmitters, power lines, electronic security scanners) How External Peer Review Helps Hospitals Monitor Performance Outcomes for ICD Implantation and LifeVest Usage When properly executed, external peer review, which supplement, not replace, hospitals internal peer review processes, can reduce medical errors through objective evaluations performed in a nonpunitive educational context that supports a healthy culture of continual improvement. Increased transparency and accountability results from physicians knowing that their work will be objectively evaluated at regular intervals by board-certified specialists with the same credentials and from similar practice settings, thereby leading to improved quality of care and patient safety. Ongoing evaluation of physicians can also uncover problematic practice patterns, as well as physician- and hospital-levels issues that need to be addressed. Unlike internal peer review, which looks only at sentinel events, external peer review can help hospitals to discover, highlight, and deal with physician performance issues quickly and efficiently before patient complaints, legal action, or an audit. In addition, external peer review avoids conflicts of interest that can arise from economic, professional, or social ties among physicians within a single institution. It may also be an effective solution for hospitals that lack adequate physician resources to conduct timely performance analysis. An external peer review program helps hospital administrators identify and correct any potential problems before they occur. Specific cardiac procedures and device usage can be evaluated systematically to determine medical necessity in accordance with sanctioned guidelines. Ongoing monitoring and identification of potential overutilization in advance of outside auditing processes allows hospitals to take remedial action, including tightening of clinical criteria, providing additional training to physicians, and taking other corrective measures that protect all parties. An ongoing external peer review program is a cost-effective solution to improve quality of patient care while overcoming potential barriers to effective peer review, including conflicts of interest, uncompensated time, time limitations, sham reviews, and economic profiling. Hospitals can identify issues before they spiral out of control, as well as reduce risk of liability, demonstrate commitment to patient safety, and improve compliance with evidence-based guidelines. Conclusions Hospitals and physicians should be prepared to precisely document clinical qualifying events that consistently adhere to sanctioned guidelines for ICD implantation and LifeVest usage. Even as new data are incorporated into guidelines and registries, there will always be outlier cases. In reviewing these cases, hospitals not only need to consider the evolving medical evidence, but also must take into account any conflicts of interest involving friendships and/or competition among the members of the medical staff. External peer review facilitates the objective review of sensitive cases and al- 4

5 lows for hospitals and physicians to honor their commitment to safe, timely, appropriate, and compliant care for every patient. Bibliography Al-Khatib SM, Hellkamp A, Curtis J, et al. Non-evidence-based ICD implantations in the United States. JAMA. 2011;305: Epstein AE, DiMarco JP, Ellenbogen KA, et al. ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008;51(21):e1-62. Freeman JV, Wang Y, Curtis JP, Heidenreich PA, Hlatky MA. Physician procedure volume and complications of cardioverter-defibrillator implantation. Circulation. 2012;125: Haines DE, Wang Y, Curtis J. Implantable cardioverter-defibrillator registry risk score models for acute procedural complications or death after implantable cardioverter-defibrillator implantation. Circulation. 2011;123: Zoll LifeVest Web site. Available at: Accessed February 21, About AllMed Healthcare Management AllMed provides external peer review solutions to leading hospital groups and ASCs, nationwide. AllMed offers MedEval (SM) and MedScore (SM), which help facilities improve physician performance through both periodic and ongoing case reviews at the individual or departmental levels. Services are deployed through PeerPoint, AllMed s state-of-the-art medical review portal. For more information on how AllMed can help your organization improve the quality and integrity of healthcare, contact us today at info@allmedmd.com. 621 SW Alder St., Suite 740 Portland, OR