Appropriateness of implantable cardioverter-defibrillator device implants in the United States.

BACKGROUND: The appropriate use criteria (AUCs) are a diverse group of indications aimed to better evaluate the benefits of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy. OBJECTIVE: The purpose of this study was to quantify the proportion of ICD and cardiac resynchronization therapy with defibrillator (CRT-D) implants as appropriate, may be appropriate (MA), or rarely appropriate (RA) on the basis of the AUC guidelines. METHODS: This is a multicenter retrospective study of patients within the National Cardiovascular Data Registry undergoing ICD implantation between April 2018 and March 2019 at >1500 US hospitals. The appropriateness of ICD implants was adjudicated using the AUC. RESULTS: Of 309,318 ICDs, 241,438 were primary prevention implants (78.1%) and 67,880 secondary prevention implants (21.9%); 243,532 (79%) were mappable to the AUC. For primary prevention, 185,431 ICDs (96.4%) were appropriate, 5660 (2.9%) MA, and 1205 (0.6%) RA. For secondary prevention, 47,498 ICDs (92.7%) were appropriate, 2581 (5%) MA, and 1157 (2.3%) RA. A significant number of RA devices were implanted in patients with New York Heart Association class IV heart failure who were ineligible for advanced therapies (53.9%) and those with myocardial infarction within 40 days (18.1%). The appropriateness of the pacing lead was more variable, with 48,470 dual-chamber ICD implants (62%) being classified as appropriate, 29,209 (37.4%) MA, and 448 (0.6%) RA. Among CRT-D implants, 63,848 (82.2%) were appropriate, 9900 (12.7%) MA, and 3940 (5.1%) RA for left ventricular pacing. A total of 99,754 implants were deemed appropriate but excluded from Centers for Medicare & Medicaid Services National Coverage Determination. More than 92% of hospitals had an RA implant rate of <4%. CONCLUSION: In this large national registry, 95% of mappable ICD and CRT-D implants were considered appropriate, with <2% of RA implants. Nearly 100,000 appropriate implants are excluded by Centers for Medicare & Medicaid Services National Coverage Determination.

ACC/AATS/AHA/ASE/ASNC/HRS/SCAI/SCCT/SCMR/STS 2019 Appropriate Use Criteria for Multimodality Imaging in the Assessment of Cardiac Structure and Function in Nonvalvular Heart Disease: A Report of the American College of Cardiology Appropriate Use Criteria Task Force, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and the Society of Thoracic Surgeons.

This document is the second of 2 companion appropriate use criteria (AUC) documents developed by the American College of Cardiology, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons. The first document1 addresses the evaluation and use of multimodality imaging in the diagnosis and management of valvular heart disease, whereas this document addresses this topic with regard to structural (nonvalvular) heart disease. While dealing with different subjects, the 2 documents do share a common structure and feature some clinical overlap. The goal of the companion AUC documents is to provide a comprehensive resource for multimodality imaging in the context of structural and valvular heart disease, encompassing multiple imaging modalities. Using standardized methodology, the clinical scenarios (indications) were developed by a diverse writing group to represent patient presentations encountered in everyday practice and included common applications and anticipated uses. Where appropriate, the scenarios were developed on the basis of the most current American College of Cardiology/American Heart Association Clinical Practice Guidelines. A separate, independent rating panel scored the 102 clinical scenarios in this document on a scale of 1 to 9. Scores of 7 to 9 indicate that a modality is considered appropriate for the clinical scenario presented. Midrange scores of 4 to 6 indicate that a modality may be appropriate for the clinical scenario, and scores of 1 to 3 indicate that a modality is considered rarely appropriate for the clinical scenario. The primary objective of the AUC is to provide a framework for the assessment of these scenarios by practices that will improve and standardize physician decision making. AUC publications reflect an ongoing effort by the American College of Cardiology to critically and systematically create, review, and categorize clinical situations in which diagnostic tests and procedures are utilized by physicians caring for patients with cardiovascular diseases. The process is based on the current understanding of the technical capabilities of the imaging modalities examined.

Left ventricular hypertrophy and antiarrhythmic drugs in atrial fibrillation: impact on mortality.

BACKGROUND: Despite sparse clinical data, current atrial fibrillation (AF) guidelines favor amiodarone as a drug of choice for patients with left ventricular hypertrophy (LVH). OBJECTIVE: This study tested the hypothesis that patients with persistent AF and LVH on nonamiodarone antiarrhythmics have higher mortality compared to patients on amiodarone. METHODS: In an observational cohort analysis of patients who underwent cardioversion for AF, patients with LVH, defined as left ventricular wall thickness ≥1.4 cm, by echocardiogram prior to their first cardioversion, were included; clinical data, including antiarrhythmic drugs and ejection fraction (LVEF), were collected. Mortality, determined via the Social Security Death Index, was analyzed using Kaplan-Meier and Cox proportional hazards models to determine whether antiarrhythmic drugs were associated with higher mortality. RESULTS: In 3,926 patients, echocardiographic wall thickness was available in 1,399 (age 66.8 ± 11.8 years, 67% male, LVEF 46 ± 15%, septum 1.3 ± 0.4, posterior wall 1.2 ± 0.2 cm), and 537 (38%) had LVH ≥1.4 cm. Among 537 patients with LVH, mean age was 67.5 ± 11.7 years, 76.4% were males, and mean LVEF was 48.3 ± 13.3%. Amiodarone was associated with lower survival (log rank P = 0.001), including after adjusting for age, LVEF, and coronary artery disease (P = 0.023). In propensity-score matched cohorts with LVH treated with no drugs, nonamiodarone antiarrhythmic drugs (non-AADs), or amiodarone (N = 65 each group), there was early lower survival in patients on amiodarone (P = 0.05). CONCLUSIONS: Patients with persistent AF and LVH on non-AADs do not have higher mortality compared to patients on amiodarone. Importantly, these findings do not support amiodarone as a superior choice in patients with LVH.

The disconnect between the guidelines, the appropriate use criteria, and reimbursement coverage decisions: the ultimate dilemma.

Recently, the American College of Cardiology Foundation in collaboration with the Heart Rhythm Society published appropriate use criteria (AUC) for implantable cardioverter-defibrillators and cardiac resynchronization therapy. These criteria were developed to critically review clinical situations that may warrant implantation of an implantable cardioverter-defibrillator or cardiac resynchronization therapy device, and were based on a synthesis of practice guidelines and practical experience from a diverse group of clinicians. When the AUC was drafted, the writing committee recognized that some of the scenarios that were deemed "appropriate" or "may be appropriate" were discordant with the clinical requirements of many payers, including the Medicare National Coverage Determination (NCD). To charge Medicare for a procedure that is not covered by the NCD may be construed as fraud. Discordance between the guidelines, the AUC, and the NCD places clinicians in the difficult dilemma of trying to do the "right thing" for their patients, while recognizing that the "right thing" may not be covered by the payer or insurer. This commentary addresses these issues. Options for reconciling this disconnect are discussed, and recommendations to help clinicians provide the best care for their patients are offered.

ACCF/AHA/ASE/ASNC/HFSA/HRS/SCAI/SCCT/SCMR/STS 2013 multimodality appropriate use criteria for the detection and risk assessment of stable ischemic heart disease: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Failure Society of America, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons.

The American College of Cardiology Foundation along with key specialty and subspecialty societies, conducted an appropriate use review of common clinical presentations for stable ischemic heart disease (SIHD) to consider use of stress testing and anatomic diagnostic procedures. This document reflects an updating of the prior Appropriate Use Criteria (AUC) published for radionuclide imaging (RNI), stress echocardiography (Echo), calcium scoring, coronary computed tomography angiography (CCTA), stress cardiac magnetic resonance (CMR), and invasive coronary angiography for SIHD. This is in keeping with the commitment to revise and refine the AUC on a frequent basis. A major innovation in this document is the rating of tests side by side for the same indication. The side-by-side rating removes any concerns about differences in indication or interpretation stemming from prior use of separate documents for each test. However, the ratings were explicitly not competitive rankings due to the limited availability of comparative evidence, patient variability, and range of capabilities available in any given local setting. The indications for this review are limited to the detection and risk assessment of SIHD and were drawn from common applications or anticipated uses, as well as from current clinical practice guidelines. Eighty clinical scenarios were developed by a writing committee and scored by a separate rating panel on a scale of 1-9, to designate Appropriate, May Be Appropriate, or Rarely Appropriate use following a modified Delphi process following the recently updated AUC development methodology. The use of some modalities of testing in the initial evaluation of patients with symptoms representing ischemic equivalents, newly diagnosed heart failure, arrhythmias, and syncope was generally found to be Appropriate or May Be Appropriate, except in cases where low pre-test probability or low risk limited the benefit of most testing except exercise electrocardiogram (ECG). Testing for the evaluation of new or worsening symptoms following a prior test or procedure was found to be Appropriate. In addition, testing was found to be Appropriate or May Be Appropriate for patients within 90 days of an abnormal or uncertain prior result. Pre-operative testing was rated Appropriate or May Be Appropriate only for patients who had poor functional capacity and were undergoing vascular or intermediate risk surgery with 1 or more clinical risk factors or an organ transplant. The exercise ECG was suggested as an Appropriate test for cardiac rehabilitation clearance or for exercise prescription purposes. Testing in asymptomatic patients was generally found to be Rarely Appropriate, except for calcium scoring and exercise testing in intermediate and high-risk individuals and either stress or anatomic imaging in higher-risk individuals, which were all rated as May Be Appropriate. All modalities of follow-up testing after a prior test or percutaneous coronary intervention (PCI) within 2 years and within 5 years after coronary artery bypass graft (CABG) in the absence of new symptoms were rated Rarely Appropriate. Pre-operative testing for patients with good functional capacity, prior normal testing within 1 year, or prior to low-risk surgery also were found to be Rarely Appropriate. Imaging for an exercise prescription or prior to the initiation of cardiac rehabilitation was Rarely Appropriate except for cardiac rehabilitation clearance for heart failure patients.

Implantable cardioverter-defibrillator FDA safety advisories: Impact on patient mortality and morbidity.

BACKGROUND: A significant proportion of implantable cardioverter-defibrillators (ICDs) have been subject to Food and Drug Administration (FDA) advisories. The impact of device advisories on mortality or patient care is poorly understood. Although estimated risks of ICD generators under advisory are low, dependency on ICD therapies to prevent sudden death justifies the assessment of long-term mortality. OBJECTIVE: To test the association of FDA advisory status with long-term mortality. METHODS: The study was a retrospective, single-center review of clinical outcomes, including device malfunctions, in patients from implantation to either explant or death. Patients with ICDs first implanted at Cleveland Clinic between August 1996 and May 2004 who became subject to FDA advisories on ICD generators were identified. Mortality was determined by using the Social Security Death Index. RESULTS: In 1644 consecutive patients receiving first ICD implants, 704 (43%) became subject to an FDA advisory, of which 172 (10.5%) were class I and 532 (32.3%) were class II. ICDs were explanted before advisory notifications in 14.0% of class I and 10.1% of class II advisories. Among ICDs under advisory, 28 (4.0%) advisory-related and 15 non-advisory- related malfunctions were documented. Over a median follow-up of 70 months, 814 patients died. Kaplan-Meier 5-year survival rate was 65.6% overall, and 64.2, 61.1, and 69.3% in patients with no, class I, and class II advisories, respectively (P = .17). CONCLUSIONS: ICD advisories impacted 43% of the patients. Advisory-related malfunctions affected 4% within the combined advisory group. Based on a conservative management strategy, ICDs under advisory were not associated with increased mortality over a background of significant disease-related mortality.

The impact of left ventricular size on response to cardiac resynchronization therapy.

UNLABELLED: Patients with nondilated (NDCM) or severely dilated cardiomyopathies (SDCM) have been underrepresented in clinical trials of cardiac resynchronization therapy (CRT). We examined changes in left ventricular ejection fraction (LVEF) and survival in patients with NDCM or SDCM compared with those with traditionally studied moderately dilated cardiomyopathy. METHODS: We evaluated 800 consecutive patients undergoing the original implantation of a biventricular pacemaker between January 2004 and August 2007. For inclusion, patients had a baseline and pre-CRT echocardiogram, an LVEF ≤40%, a US social security number, and New York Heart Association class II to IV symptoms on standard medical therapy. Patients with a follow-up echocardiogram >2 months after device implantation were included in an analysis of remodeling. Using multivariate models, the impact of baseline left ventricular end-diastolic diameter (LVEDD) on change in LVEF and all-cause mortality was assessed. RESULTS: A total of 668 patients met inclusion criteria and were included in the assessment of mortality. Four hundred seventy-one had an appropriately timed follow-up echocardiogram and were included in the analysis of remodeling. Patients in all 3 groups realized improvements in LVEF (%) after CRT as follows: NDCM (n = 137; LVEDD ≤5.5 cm) 10.0 ± 12.7, P < .001; moderately dilated cardiomyopathy (n = 233; LVEDD 5.6-6.9 cm) 8.2 ± 11.3, P < .001; and SDCM (n = 101; LVEDD ≥7.0 cm) 5.4 ± 9.4, P < .001. In multivariate analysis, baseline LVEDD was inversely associated with change in LVEF (parameter estimate -3.13 ± 0.56, P < .001) and directly associated with increased all-cause mortality (hazard ratio 1.25 [1.05-1.47] P = .01). CONCLUSION: Patients with NDCM and SDCM experience significant improvements in LVEF after CRT. The degree of baseline left ventricular dilatation before CRT is an important predictor of subsequent changes in LVEF and survival.

Aggregate national experience with the wearable cardioverter-defibrillator: event rates, compliance, and survival.

OBJECTIVES: The purpose of this study was to determine patient compliance and effectiveness of antiarrhythmic treatment by the wearable cardioverter-defibrillator (WCD). BACKGROUND: Effectiveness of the WCD for prevention of sudden death is dependent on event type, patient compliance, and appropriate management of ventricular tachycardia/ventricular fibrillation (VT/VF). METHODS: Compliance and events were recorded in a nationwide registry of post-market release WCDs. Survival, using the Social Security Death Index, was compared with survival in implantable cardioverter-defibrillator (ICD) patients. RESULTS: Of 3,569 patients wearing the WCD (age 59.3+/-14.7 years, duration 52.6+/-69.9 days), daily use was 19.9+/-4.7 h (>90% of the day) in 52% of patients. More days of use correlated with higher daily use (p<0.001). Eighty sustained VT/VF events occurred in 59 patients (1.7%). First-shock success was 76 of 76 (100%) for unconscious VT/VF and 79 of 80 (99%) for all VT/VF. Eight patients died after successful conversion of unconscious VT/VF (89.5% survival of VT/VF events). Asystole occurred in 23 (17 died), pulseless electrical activity in 2, and respiratory arrest in 1 (3 died), representing 24.5% of sudden cardiac arrests. During WCD use, 3,541 of 3,569 patients (99.2%) survived overall. Survival occurred in 72 of 80 (90%) VT/VF events and 78 of 106 (73.6%) for all events. Long-term mortality was not significantly different from first ICD implant patients but highest among patients with traditional ICD indications. CONCLUSIONS: Compliance was satisfactory with 90% wear time in >50% of patients and low sudden death mortality during use. Survival was comparable to that of ICD patients. However, asystole was an important cause of mortality in sudden cardiac arrest events.