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JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY VOL. ª 2014 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION PUBLISHED BY ELSEVIER INC. 1 -, NO. -, 2014 ISSN 0735-1097/$36.00 http://dx.doi.org/10.1016/j.jacc.2014.08.003 55 APPROPRIATE USE CRITERIA 2 56 3 ACC/AAP/AHA/ASE/HRS/ SCAI/SCCT/SCMR/SOPE 2014 Appropriate Use Criteria for Initial Transthoracic Echocardiography in Outpatient Pediatric Cardiology 4 5 6 7 8 9 10 11 12 13 57 58 59 60 61 62 63 64 65 66 67 14 A Report of the American College of Cardiology Appropriate Use Criteria Task Force, 68 15 American Academy of Pediatrics, American Heart Association, American Society of 69 16 Echocardiography, Heart Rhythm Society, Society for Cardiovascular Angiography and 70 17 Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular 71 18 Magnetic Resonance, and Society of Pediatric Echocardiography 72 19 73 20 74 21 75 22 76 23 24 25 26 27 Q1 Writing Group for Robert M. Campbell, MD, FACC, FAHA, FAAP, FHRS, Wyman W. Lai, MD, MPH, FACC, FASE Echocardiography Chair Leo Lopez, MD, FACC, FAAP, FASE in Outpatient Pediatric Cardiology Ritu Sachdeva, MD, FACC, FAAP, FASE 77 78 79 Pamela S. Douglas, MD, MACC, FAHA, FASE 80 Benjamin W. Eidem, MD, FACC, FASE 81 28 82 29 83 Robert M. Campbell, MD, FACC, FAHA, FAAP, FHRS, Richard Lockwood, MD** 31 Chair* G. Paul Matherne, MD, MBA, FACC, FAHAyy 85 32 Pamela S. Douglas, MD, MACC, FAHA, FASE, Moderator* David Nykanen, MD, FACCzz 86 30 Rating Panel 33 84 Catherine L. Webb, MD, FACC, FAHA, FASEyy 87 Robert Wiskind, MD, FAAP* 88 34 Louis I. Bezold, MD, FACC, FAAP, FASEy 35 William B. Blanchard, MD, FACC, FAHA, FAAP* 89 36 Jeffrey R. Boris, MD, FACC* 90 37 Bryan Cannon, MDz 38 Gregory J. Ensing, MD, FACC, FASEx 39 Craig E. Fleishman, MD, FACC, FASEjj Pediatric Echocardiography representative. {Society for Cardiovascular 93 40 Mark A. Fogel, MD, FACC, FAHA, FAAP{ Magnetic Resonance representative. #Society of Cardiovascular Computed 94 41 B. Kelly Han, MD, FACC# 42 Shabnam Jain, MD, MPH, FAAP* 43 Mark B. Lewin, MDjj *American College of Cardiology representative. yAmerican Academy of Pediatrics representative. zHeart Rhythm Society representative. xAmerican Society of Echocardiography representative. jjSociety of Tomography representative. **Health Plan representative. yyAmerican Heart Association representative. zzSociety for Cardiovascular Angiography and Interventions representative. 44 45 46 91 92 95 96 97 98 This document was approved by the American College of Cardiology Board of Trustees in June 2014. The American College of Cardiology requests that this document be cited as follows: 99 100 47 Campbell RM, Douglas PS, Eidem BW, Lai WW, Lopez L, Sachdeva R. ACC/AAP/AHA/ASE/HRS/SCAI/SCCT/SCMR/SOPE 2014 appropriate use criteria 101 48 for initial transthoracic echocardiography in outpatient pediatric cardiology: a report of the American College of Cardiology Appropriate Use Criteria 102 49 50 Task Force, American Academy of Pediatrics, American Heart Association, American Society of Echocardiography, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and 103 Society of Pediatric Echocardiography. J Am Coll Cardiol 2014;XX:xxx-xx. 104 51 This document is copublished in the Journal of the American Society of Echocardiography. 105 52 Copies: This document is available on the World Wide Web site of the American College of Cardiology (www.acc.org). For copies of this document, 106 53 54 please contact Elsevier Inc. Reprint Department, fax (212) 633-3820, e-mail [email protected]. Permissions: Modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the American College of Cardiology. PGL 5.2.0 DTD JAC20491_proof 12 September 2014 3:25 pm ce 107 108 2 Campbell et al. JACC VOL. -, NO. -, 2014 -, 2014:-–- AUC for Pediatric Echocardiography 109 Appropriate Manesh R. Patel, MD, FACC, Chair Pamela S. Douglas, MD, MACC, FAHA, FASE 163 110 Use Criteria Christopher M. Kramer, MD, FACC, FAHA, Co-Chair Robert C. Hendel, MD, FACC, FAHA, FASNC 164 111 Task Force Bruce D. Lindsay, MD, FACC 165 112 Steven R. Bailey, MD, FACC, FAHA, FSCAI Leslee J. Shaw, PhD, FACC, FASNC, FAHA 166 113 Alan S. Brown, MD, FACC L. Samuel Wann, MD, MACC 167 114 John U. Doherty, MD, FACC, FAHA Joseph M. Allen, MA 168 115 169 116 170 117 118 119 120 121 122 123 124 125 126 127 ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . XX 130 131 9. DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . XX 1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . XX 2. METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . XX Figure 1. AUC Development Process . . . . . . . . . . . . . . . xx 3. GENERAL ASSUMPTIONS . . . . . . . . . . . . . . . . . . . . . XX Figure 2. Factors Influencing Outcomes of an Imaging Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . xx 4. DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . XX 5. ABBREVIATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . XX 136 137 6. RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . XX 138 139 7. TRANSTHORACIC ECHOCARDIOGRAPHY IN 140 OUTPATIENT PEDIATRIC CARDIOLOGY: 141 APPROPRIATE USE CRITERIA (BY INDICATION) . . . . . XX 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 Assumptions and Definitions . . . . . . . . . . . . . . . . . . . . xx Indications and Ratings . . . . . . . . . . . . . . . . . . . . . . . . . xx Comparison with the Adult Cardiology AUC . . . . . . . . xx Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xx 134 135 Figure 5. Palpitaions and Arrhythmias . . . . . . . . . . . . . xx Figure 6. Murmur . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xx 132 133 172 PREFACE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . XX 128 129 171 TABLE OF CONTENTS Table 1. Palpitations and Arrhythmias . . . . . . . . . . . . . xx Use of AUC to Improve Care . . . . . . . . . . . . . . . . . . . . . xx 10. CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . XX APPENDIX A Appropriate Use Criteria for Initial Transthoracic Echocardiography in Outpatient Pediatric Cardiology: Participants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xx APPENDIX B Relationships With Industry (RWI) and Other Entities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xx 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 ABSTRACT Table 2. Syncope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xx 197 198 Table 3. Chest Pain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xx The American College of Cardiology (ACC) participated in 199 a joint project with the American Society of Echocardi- 200 Table 4. Murmur . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xx ography, the Society of Pediatric Echocardiography, and 201 Table 5. Other Symptoms and Signs . . . . . . . . . . . . . . . xx several other subspecialty societies and organizations to 202 Table 6. Prior Test Results . . . . . . . . . . . . . . . . . . . . . . . xx Table 7. Systemic Disorders . . . . . . . . . . . . . . . . . . . . . . xx Table 8. Family History of Cardiovascular Disease in Patients Without Signs or Symptoms and Without Confirmed Cardiac Diagnosis . . . . . . . . . . . . . . . . . . . . . xx Table 9. Outpatient Neonates Without Post-Natal Cardiology Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . xx establish and evaluate Appropriate Use Criteria (AUC) for 203 the initial use of outpatient pediatric echocardiography. 204 Assumptions for the AUC were identified, including the 205 fact that all indications assumed a first-time transthoracic 206 echocardiographic study in an outpatient setting for pa- 207 tients without previously known heart disease. The defi- 208 nitions for frequently used terminology in outpatient 209 pediatric cardiology were established using published 210 157 guidelines and standards and expert opinion. These AUC 211 158 serve as a guide to help clinicians in the care of children 212 159 160 161 162 8. FLOW DIAGRAMS FOR COMMON PATIENT SYMPTOMS . . . . . . . . . . . . . . . . . . . . . . . . . XX Figure 3. Chest Pain . . . . . . . . . . . . . . . . . . . . . . . . . . . . xx Figure 4. Syncope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xx with possible heart disease, specifically in terms of when 213 a transthoracic echocardiogram is warranted as an initial 214 diagnostic modality in the outpatient setting. They are 215 also a useful tool for education and provide the 216 PGL 5.2.0 DTD JAC20491_proof 12 September 2014 3:25 pm ce JACC VOL. -, NO. -, 2014 Campbell et al. -, 2014:-–- 3 AUC for Pediatric Echocardiography 217 infrastructure for future quality improvement initiatives increase in the utilization of such technologies. As these 271 218 as well as research in healthcare delivery, outcomes, and imaging technologies and clinical applications continue to 272 219 resource utilization. advance, the healthcare community needs to understand 273 220 To complete the AUC process, the writing group iden- how best to incorporate these options into daily clinical 274 221 tified 113 indications based on common clinical scenarios care and how to choose between new and long-standing, 275 222 and/or published clinical practice guidelines, and each established imaging technologies. In an effort to res- 276 223 indication was classified into 1 of 9 categories of common pond to this need and to ensure the effective use of 277 224 clinical presentations, including palpitations, syncope, advanced diagnostic imaging tools and procedures, the 278 225 chest pain, and murmur. A separate, independent rating AUC project was initiated. The AUC in this document have 279 226 panel evaluated each indication using a scoring scale of 1 been developed in order to promote effective patient 280 227 to 9, thereby designating each indication as “Appropriate” care, better clinical outcomes, and improved resource 281 228 (median score 7 to 9), “May Be Appropriate” (median utilization. This set of AUC should be useful not only for 282 229 score 4 to 6), or “Rarely Appropriate” (median score 1 to pediatric cardiologists, but also for general pediatricians 283 230 3). Fifty-three indications were identified as Appropriate, and family practitioners, who are frequently the first cli- 284 231 28 as May Be Appropriate, and 32 as Rarely Appropriate. nicians to consider the need for this modality. 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 285 Although AUC have been established for echocardiog- PREFACE In an effort to respond to the need for the rational use of services in the delivery of high quality care, the ACC has undertaken a process to determine the appropriate use of cardiovascular imaging and procedures for selected patient indications. AUC publications reflect an ongoing effort by the ACC to critically and systematically create, review, and categorize clinical situations where diagnostic tests and procedures are utilized by physicians caring for patients with known or suspected cardiovascular diseases. The process is based on current understanding of the technical capabilities of the imaging modalities and procedures examined. Although not intended to be entirely comprehensive due to the wide diversity of clinical disease, the indications are meant to identify common scenarios encountered by the majority of contemporary practices. Given the breadth of information they convey, the indications do not directly correspond to the International Classification of Diseases (ICD) system. The ACC believes that careful blending of a broad range of clinical experiences and available evidence-based information will help guide a more efficient and equitable allocation of health care resources in cardiovascular imaging. The ultimate objective of AUC is to improve patient care and health outcomes in a cost-effective manner, but they are not intended to ignore ambiguity and nuance intrinsic to clinical decision-making. Local parameters, such as the availability or quality of equipment or personnel, may influence the selection of certain tests or procedures. AUC thus should not be considered substitutes for sound clinical judgment and practice experience. 1. INTRODUCTION 267 286 raphy in adult patients (1–3), a similar document for pe- 287 diatric patients has not yet been published. This is partly 288 because the scope of such a document would require an 289 impossibly extensive list, if criteria were developed for 290 each congenital cardiac malformation and its variants 291 before and after intervention. Guidelines and standards 292 for performing a pediatric echocardiogram, as well as 293 recommendations 294 for quantification methods, have already been published (4,5). However, the questions 295 often raised by AUC of “when to do” and “how often to 296 297 do” a pediatric echocardiogram still remained. To address these concerns, the American College of 298 Cardiology initiated an AUC document on pediatric 299 echocardiography in the outpatient setting, since outpa- 300 tient care is an important component of clinical pediatric 301 cardiology. Children with heart disease represent a widely 302 varied group of patients, frequently characterized by 303 complex 304 anatomic malformations requiring lifelong follow-up. While echocardiography is the primary diag- 305 nostic modality for children with established congenital 306 and acquired heart disease, the scope of the current 307 document has been limited to first-time outpatient 308 transthoracic patients 309 without previously known cardiac abnormalities. This 310 echocardiographic studies in narrower set of clinical presentations has been chosen 311 because of the high volume of such testing within pedi- 312 atric cardiology. In addition, this initiative has established 313 the infrastructure to develop additional AUC for pediatric 314 and congenital echocardiography in other settings. 315 316 2. METHODS 317 318 This document covers a wide array of potential signs 319 and symptoms associated with cardiovascular disease in 320 pediatric patients. A standardized approach was used to 321 268 Improvements in cardiovascular imaging technologies create different categories of indications with the goal of 322 269 and their application, particularly with increasing thera- capturing actual clinical scenarios, without making the list 323 270 peutic options for cardiovascular disease, have led to an of indications excessively long. Indications were created 324 PGL 5.2.0 DTD JAC20491_proof 12 September 2014 3:25 pm ce 4 Campbell et al. JACC VOL. -, NO. -, 2014 -, 2014:-–- AUC for Pediatric Echocardiography 325 to represent most of the possible uses of echocardiography should be categorized as Appropriate care, May Be 379 326 in the outpatient pediatric setting rather than limiting the Appropriate care, or Rarely Appropriate care, and was 380 327 AUC to indications for which evidence was available. provided the following definition of appropriate use: 381 328 To identify and categorize the indications, a writing An appropriate imaging study is one in which the ex- 329 group of pediatric echocardiography experts was formed pected incremental information, combined with clinical 383 330 of representatives from a variety of organizations and judgment, exceeds the expected negative consequences 1 384 331 societies. Wherever possible during the writing process, by a sufficiently wide margin for a specific indication 385 332 the group members would map the indications to rele- that the procedure is generally considered acceptable 386 333 vant clinical guidelines and key publications or refer- care and a reasonable approach for the indication. 334 ences (See Online Appendix). Once the indications were 335 formed, they were reviewed and critiqued by the parent Median Score 7 to 9: Appropriate test for specific indi- 389 336 AUC Task Force and numerous external reviewers repre- cation (test is generally acceptable and is a reasonable 390 337 senting all pediatric cardiovascular specialties and pri- approach for the indication). 338 mary care. After the writing group incorporated this An appropriate option for management of patients in this 339 initial feedback, the indications were sent to an inde- population due to benefits generally outweighing risks; 393 340 pendent rating panel comprised of additional experts in effective option for individual care plans although not 394 341 the pediatrics and pediatric cardiology realm, before be- always necessary depending on physician judgment and 395 342 ing sent back to the writing group for additional vetting. patient specific preferences (i.e., procedure is generally 396 343 Each indication was then rated and classified as either acceptable and is generally reasonable for the indication). 397 344 “Appropriate care”, “May Be Appropriate care”, or Median Score 4 to 6: May Be Appropriate test for specific 398 345 “Rarely Appropriate care” based on these multiple rounds indication (test may be generally acceptable and may be a 399 reasonable approach for the indication). May Be Appro- 400 346 347 of review and revision (see Figure 1). The rating panel scored each indication as follows: 382 387 388 391 392 priate also implies that more research and/or patient in- 401 selected clinical indications is found in a previous publi- formation is needed to classify the indication definitively. 402 cation, “ACCF Proposed Method for Evaluating the At times an appropriate option for management of pa- 403 tients in this population due to variable evidence or lack of 404 A detailed description of the methods used for rating the 348 349 350 Appropriateness of Cardiovascular Imaging,” (6) as well as 351 the updated version, “Appropriate Use of Cardiovascular agreement regarding the benefits risks ratio, potential 405 352 Technology: Criteria benefit based on practice experience in the absence of evi- 406 353 Methodology Update: A Report of the American College dence, and/or variability in the population; effectiveness 407 354 of Cardiology Foundation Appropriate Use Criteria Task for individual care must be determined by a patient’s 408 355 Force” (7). Briefly, this process combines evidence-based physician in consultation with the patient based on addi- 409 356 medicine and practice experience and engages a rating tional clinical variables and judgment along with patient 410 357 panel in a modified Delphi exercise. Other steps are preferences (i.e., procedure may be acceptable and may be 411 358 convening a formal writing group with diverse expertise reasonable for the indication). 412 359 in pediatric imaging and clinical care, circulating the Median Score 1 to 3: Rarely Appropriate test for specific 413 360 indications for external review prior to being sent to the indication (test is not generally acceptable and is not a 414 361 rating reasonable approach for the indication). 362 expertise and practice areas among the rating panelists, 363 developing a standardized rating package that includes patients in this population due to the lack of a clear benefit/ 417 364 relevant evidence, and establishing formal roles for risk advantage; rarely an effective option for individual 418 365 facilitating panel interaction at the face-to-face meeting. panel, 2013 ACCF ensuring Appropriate an appropriate Use balance of Rarely an appropriate option for management of 415 416 care plans; exceptions should have documentation of the 419 366 The rating panel first evaluated the indications inde- clinical reasons for proceeding with this care option 420 367 pendently. Then, the panel was convened for a face-to-face (i.e., procedure is not generally acceptable and is not 421 368 meeting for discussion of each indication. At this meeting, generally reasonable for the indication). 422 369 panel members were given their scores and a blinded The division of the numerical scores into 3 levels of 423 370 summary of their peers’ scores. After the meeting, panel appropriateness is somewhat arbitrary and the numeric 424 371 members were then asked to independently provide their designations should be viewed as existing on a contin- 425 372 final scores for each indication (See Online Appendix). uum. Further, there may be diversity in clinical opinion 426 373 Although panel members were not provided explicit 374 cost information to help determine their appropriate use 375 ratings, they were asked to implicitly consider cost as an 429 376 additional factor in their evaluation of appropriate use. In 430 377 rating these criteria, the AUC Rating Panel was asked to contrast exposure) and the downstream impact of poor test performance such as 431 378 assess whether the use of the test for each indication delay in diagnosis (false negatives) or inappropriate diagnosis (false positives). 432 for particular clinical scenarios, such that scores in the 427 428 1 Negative consequences include the risks of the procedure (i.e., radiation or PGL 5.2.0 DTD JAC20491_proof 12 September 2014 3:25 pm ce JACC VOL. -, NO. -, 2014 Campbell et al. -, 2014:-–- 5 AUC for Pediatric Echocardiography 433 487 434 IndicaƟon Development Develop list of indicaƟons, assumpƟons, and definiƟons 435 436 437 438 439 440 488 Literature review and Guideline Mapping 489 490 Review Panel >30 members provide feedback 491 492 493 WriƟng Group revises indicaƟons 494 441 495 RaƟng Panel rates the IndicaƟons in two rounds Appropriateness DeterminaƟon 442 443 444 445 446 496 497 1st round – No InteracƟon 498 2nd Round – Panel InteracƟon 499 500 Appropriate Use Score 447 448 501 502 (7-9) Appropriate 449 (4-6) May Be Appropriate 503 450 (1-3) Rarely Appropriate 504 ProspecƟve comparison with clinical records ValidaƟon 451 452 453 ProspecƟve clinical decision aids 505 506 507 454 % Use that is Appropriate, May Be Appropriate, or Rarely Appropriate 455 508 Increase Appropriate Use 509 456 457 510 511 F I G U R E 1 AUC Development Process 458 512 459 513 3. GENERAL ASSUMPTIONS 460 intermediate level of appropriate use should be labeled 461 “May Be Appropriate,” as critical patient or research data 462 may be lacking or discordant. This designation should be 1. This document will address the initial use of outpa- 463 a prompt to the field to carry out definitive research tient transthoracic echocardiography (TTE) during 517 464 investigation whenever possible. It is anticipated that the pediatric (# 18 years of age) outpatient care. Although 518 465 AUC reports will continue to be revised as further data are TTE is also an essential tool in hospitalized patients, 519 466 generated and information from criteria implementation discussion of indications for this use is beyond the 520 467 is accumulated. 514 515 scope of this document. 516 521 468 To prevent bias in the scoring process, the rating panel, 2. This AUC document will not address the use of TTE in 469 by design, included a minority of specialists in pediatric patients with previously known structural, functional, 523 470 echocardiography. Specialists, while offering important or primary electrical cardiac abnormalities. 524 471 clinical and technical insights, might have a natural ten- 3. A comprehensive TTE examination may include 2- 525 472 dency to rate the indications within their specialty as more dimensional, M-mode, and 3-dimensional imaging as 526 473 appropriate than non-specialists. In addition, care was well as spectral and color Doppler evaluation, all of 527 474 taken to provide objective, nonbiased information, in- which are important elements (9–11) to evaluate rele- 528 475 cluding guidelines and key references, to the rating panel. vant 476 The level of agreement among panelists was analyzed 477 based on the RAND Corporation’s BIOMED Concerted 478 Action on Appropriateness rule (8) for a panel of 14 to 479 16 members. As such, agreement was defined as an 480 indication where 4 or fewer panelists’ ratings fell outside 481 the 3-point region containing the median score. cardiac structures and hemodynamics. 522 A 529 comprehensive TTE report includes interpretation of 530 all aspects of the TTE. 4. The use of transesophageal or stress echocardiography will not be addressed in this document. 5. This document assumes that any other more defini- 531 532 533 534 tive diagnostic test, including but not limited to 535 482 Disagreement was defined as occurring when at least 5 electrocardiogram (ECG), chest X-ray, or genetic 536 483 panelists’ ratings fell in both the Appropriate and the testing, when appropriate will be considered prior to 537 484 Rarely Appropriate categories. Any indication having ordering a TTE. 538 485 disagreement was categorized as May Be Appropriate 486 regardless of the final median score. 6. All standard TTE techniques for image acquisition are 539 available for each indication and have a sensitivity 540 PGL 5.2.0 DTD JAC20491_proof 12 September 2014 3:25 pm ce 6 Campbell et al. JACC VOL. -, NO. -, 2014 -, 2014:-–- AUC for Pediatric Echocardiography 541 595 542 596 543 597 544 598 545 Patient 546 Patient Selection Image Acquisition Image Interpretation Results Communication 547 548 Improved Patient Care (Outcomes) Imaging Process 549 550 Laboratory Structure 552 554 605 607 F I G U R E 2 Factors Influencing Outcomes of an Imaging Study (16) 608 609 556 610 557 and specificity similar to those found in the published 558 literature. 559 7. The test is performed and interpreted by qualified 560 individual(s) in a facility that is in compliance with 561 national standards for performing pediatric echocar- 563 603 606 555 562 601 602 604 551 553 599 600 12. If the reason for a test can be assigned to more than 611 one indication, it is classified under the most clinically 612 significant indication. 13. The term family history in this document refers to first-degree relatives only. 14. Cost is considered implicitly in the appropriate use diograms (4). 613 614 615 616 8. AUC is one aspect of quality for imaging procedures determination. Clinical benefits should always be 617 564 occurring at the time of patient selection. Several considered first, and costs should be considered in 618 565 additional factors should be addressed to support relationship to these benefits in order to better convey 619 620 566 high-quality results (see Figure 2). These other factors net value. For example, a procedure with moderate 567 are important but are not covered in this document. clinical efficacy for a given AUC indication should not 621 622 568 9. The range of potential indications for echocardiogra- be scored as more appropriate than a procedure with 569 phy is quite large, particularly in comparison with high clinical efficacy solely due to its lower cost. When 623 570 other cardiovascular imaging tests. Thus, the in- scientific evidence exists to support clinical benefit, 624 571 dications are, at times, purposefully broad to cover an cost efficiency and cost effectiveness should be 625 572 array of cardiovascular signs and symptoms and to considered for any indication. 626 573 account for the ordering physician’s best judgment as 15. For each indication, the rating reflects whether 627 574 to the presence of cardiovascular abnormalities. the echocardiogram is reasonable for the patient ac- 628 575 Additionally, there are likely clinical scenarios that cording to the appropriate use definition, not whether 629 576 are not covered in this document. the test is preferred over another modality. It is not 630 577 10. A qualified clinician has obtained a complete clinical assumed that the decision to perform a diagnostic test 631 578 history and performed the physical examination such has already been made. The level of appropriateness 632 579 that the clinical status of the patient can be assumed also does not consider issues of local availability or 633 580 to be valid as stated in the indication (e.g., an skill for any modality. 634 581 asymptomatic patient is truly asymptomatic for the 16. The category of May Be Appropriate is used when 635 582 condition in question and sufficient questioning of insufficient data are available for a definitive catego- 636 the patient has been undertaken). 583 rization or when there is substantial disagreement 637 584 11. Some indications address whether or not an ECG regarding the appropriateness of that indication. The 638 585 has been obtained and whether or not it reveals designation May Be Appropriate should not be used as 639 586 any abnormalities as influencing the appropriateness grounds for denial of reimbursement. 640 587 of additional echocardiographic assessment. It is 17. This manuscript does not address whether a cardiol- 641 588 beyond the scope of this document to define every ogy consultation is required prior to the echocardio- 642 589 possible clinical scenario involving specific ECG gram unless specified in the indication. 590 abnormalities. Therefore, the term “abnormal ECG” 643 644 4. DEFINITIONS 591 refers to only clinically pertinent ECG findings. 592 Criteria for “abnormal ECG” will be based upon stan- 593 dard published ECG normal values in pediatric pa- Abnormal electrocardiogram (ECG): Electrocardiographic 647 594 tients (12–15). findings regarded as probably or definitely abnormal 648 645 646 PGL 5.2.0 DTD JAC20491_proof 12 September 2014 3:25 pm ce JACC VOL. -, NO. -, 2014 Campbell et al. -, 2014:-–- 7 AUC for Pediatric Echocardiography 649 according to age as well as clinically significant, and murmur, pulmonary flow murmur, physiologic pe- 703 650 including but not limited to ventricular hypertrophy, ripheral pulmonary stenosis, supraclavicular arterial 704 651 atrial enlargement, complete bundle branch block, atrio- bruit, and venous hum; most innocent murmurs are 705 652 ventricular block, prolonged QTc, abnormal T waves or soft (less than or equal to grade 2/6), heard in early 706 653 ST-T wave segments, Wolff-Parkinson-White syndrome, systole, characterized as crescendo-decrescendo 707 654 premature atrial contractions (PACs), premature ventric- type, and may vary with position 708 655 ular contractions (PVCs), supraventricular tachycardia, Pathologic murmur: Murmur that is suggestive of the 709 656 ventricular tachycardia, and Brugada syndrome presence of a cardiovascular abnormality (not clearly 710 657 Arrhythmia: Documented irregular and/or abnormal innocent sounding), including but not limited to 711 658 heart rate or rhythm (Patients with palpitations do not diastolic murmurs, holosystolic murmurs, late sys- 712 659 necessarily have an arrhythmia, and patients with an tolic murmurs, grade 3/6 systolic murmur or louder, 713 660 arrhythmia do not necessarily experience palpitations) continuous murmurs other than venous hums, harsh 714 661 Cardiomyopathy: Disease affecting the structure and/or murmurs, and murmurs that are provoked or be- 715 662 function of the myocardium, including but not limited to come louder with changes in position (from squat- 716 663 hypertrophic, dilated, or restrictive cardiomyopathy, left ting to standing) or during the strain phase of a 717 664 ventricular non-compaction, or arrhythmogenic right Valsalva maneuver 718 665 ventricular cardiomyopathy 719 666 Channelopathy: A clinical syndrome involving a genetic 667 mutation or acquired malfunction of the proteins forming Neurocardiogenic syncope: A type of syncope typically 721 668 the myocardial ion channels (including but not limited to occurring in the upright position, in which the triggering 722 669 Naþ, Kþ, and Ca2 þ) of the cardiovascular electrical sys- of a neural reflex results in a usually self-limited episode 723 of systemic hypotension and/or bradycardia or asystole 724 670 tem, including but not limited to long QT syndrome, short 671 QT syndrome, catecholaminergic polymorphic ventricular 672 673 674 675 676 677 678 679 tachycardia, and Brugada syndrome Chest pain: Physical discomfort in the anterior thoracic region dizziness, weakness, visual changes (such as spots, tunnel buzzing, or muffled hearing), or feeling hot or cold metabolic demands without loss of consciousness Cyanosis: Bluish discoloration of the skin and mucous membranes 682 oximeter; for newborns $24 hours of age, an oxygen 683 saturation that is (a) <90% in the initial screen or in repeat 684 screens, (b) <95% in the right hand and foot on 3 mea- 685 sures, each separated by 1 hour, or (c) a >3% absolute 686 difference in oxygen saturation between the right hand 687 and foot on 3 measures, each separated by 1 hour (17) 688 Echogenic focus: Small bright spot(s) frequently seen on 689 a fetal echocardiogram, usually related to the ventricular 690 papillary muscles and chordae and generally considered a 691 benign finding 692 Hypertension: Average systolic and/or diastolic blood 693 pressure that is $95th percentile for gender, age, and 694 height on 3 or more occasions 695 Murmur: Additional heart or vascular sound due to 696 normal or abnormal turbulent blood flow heard during 697 auscultation 702 727 728 is unable to pump enough blood to meet the body’s borns, an oxygen saturation <95% as measured by pulse 701 Pre-Syncope: A state of experiencing lightheadedness, 729 681 700 ular, and/or forceful beating of the heart 725 726 730 Desaturation: For pediatric patients other than new- 699 Palpitations: An unpleasant sensation of rapid, irreg- 720 vision, or loss of vision), auditory changes (ringing, Congestive heart failure: A condition in which the heart 680 698 Neonate: A child that is less than or equal to 28 days old Syncope: Sudden temporary loss of consciousness asso- 731 732 ciated with a loss of postural tone and with spontaneous 733 recovery that does not require electrical or chemical 734 cardioversion 735 736 5. ABBREVIATIONS AUC ¼ Appropriate Use Criteria ECG ¼ electrocardiogram PAC ¼ premature atrial contraction PVC ¼ premature ventricular contraction TTE ¼ transthoracic echocardiogram 6. RESULTS The final ratings for pediatric echocardiography are listed by indication in Tables 1 to 9. The final score for each indication reflects the median score of the 15 Rating Panel members and has been labeled according to the categories of Appropriate (median 7 to 9), May Be Innocent murmur: Murmur that is consistent with Appropriate (median 4 to 6), or Rarely Appropriate (me- normal blood flow and is determined not to be dian 1 to 3). In the tables, the final score for each indi- related to any structural abnormalities of the heart or cation is shown in parentheses with the ratings. Out of great vessels, including but not limited to Still’s 113 total indications, 53 were considered Appropriate PGL 5.2.0 DTD JAC20491_proof 12 September 2014 3:25 pm ce 737 738 739 740 741 742 743 744 745 746 747 748 749 750 751 752 753 754 755 756 8 Campbell et al. JACC VOL. -, NO. -, 2014 -, 2014:-–- AUC for Pediatric Echocardiography 757 (47%), 28 were considered May Be Appropriate (25%), AUC score is attained. Likewise, Figure 7 (a-d) in the 811 758 and 32 were considered Rarely Appropriate (28%). To see Online Appendix shows flow diagrams grouped by clin- 812 759 the indications listed by Appropriate Use rating, see the ical presentation, such as family history and test 813 760 Online Appendix. The Discussion section highlights findings. 814 761 further trends in scoring. 7. TRANSTHORACIC ECHOCARDIOGRAPHY IN 816 815 762 Figures 3, 4, 5, and 6 illustrate flow diagrams based on 763 common patient symptoms (chest pain, syncope, palpi- OUTPATIENT PEDIATRIC CARDIOLOGY: 817 764 tations and arrhythmias, and murmur) that the clinician APPROPRIATE USE CRITERIA (BY INDICATION) 818 765 can use to narrow down patient information until the 819 766 767 768 769 820 TABLE 1 821 Palpitations and Arrhythmias 822 Indication Appropriate Use Rating Palpitations 770 823 824 771 1. Palpitations with no other symptoms or signs of cardiovascular disease, a benign family history, and no recent ECG R (2) 825 772 2. Palpitations with no other symptoms or signs of cardiovascular disease, a benign family history, and a normal ECG R (1) 826 773 3. Palpitations with abnormal ECG M (6) 827 774 4. Palpitations with family history of a channelopathy R (3) 828 775 5. Palpitations in a patient with known channelopathy M (4) 829 776 6. Palpitations with family history at a young age (before the age of 50 years) of sudden cardiac arrest or death and/or pacemaker or implantable defibrillator placement A (7) 830 778 7. Palpitations with family history of cardiomyopathy A (9) 832 779 8. Palpitations in a patient with known cardiomyopathy A (9) 777 780 781 10. 783 11. 785 786 787 788 789 833 834 ECG Findings 9. 782 784 831 R (3) 835 PACs after the neonatal period R (3) 836 Supraventricular tachycardia A (7) PACs in the prenatal or neonatal period 12. PVCs in the prenatal or neonatal period M (6) 13. PVCs after the neonatal period M (6) 14. Ventricular tachycardia A (9) 15. Sinus bradycardia R (2) 16. Sinus arrhythmia R (1) 790 The number in parentheses next to the rating reflects the median score for that indication. 791 Abbreviations: A ¼ Appropriate; M ¼ May Be Appropriate; R ¼ Rarely Appropriate; ECG ¼ electrocardiogram; PACs ¼ premature atrial contractions; PVCs ¼ premature ventricular contractions. 837 838 839 840 841 842 843 844 792 845 846 793 847 794 848 795 796 TABLE 2 Syncope Indication Appropriate Use Rating 849 850 17. Syncope with or without palpitations and with no recent ECG R (3) 798 18. Syncope with no other symptoms or signs of cardiovascular disease, a benign family history, and a normal ECG R (2) 799 19. Syncope with abnormal ECG A (7) 853 800 20. Syncope with family history of channelopathy M (5) 854 801 21. Syncope with family history at a young age (before the age of 50 years) of sudden cardiac arrest or death and/or pacemaker or implantable defibrillator placement A (9) 22. Syncope with family history of cardiomyopathy A (9) 804 23. Probable neurocardiogenic (vasovagal) syncope R (2) 805 24. Unexplained pre-syncope M (4) 859 806 25. Exertional syncope A (9) 860 807 26. Unexplained post-exertional syncope A (7) 861 808 27. Syncope or pre-syncope with a known non-cardiovascular cause R (2) 862 797 802 803 809 810 The number in parenthesis next to the rating reflects the median score for that indication. Abbreviations: A ¼ Appropriate; M ¼ May Be Appropriate; R ¼ Rarely Appropriate; ECG ¼ Electrocardiogram. PGL 5.2.0 DTD JAC20491_proof 12 September 2014 3:25 pm ce 851 852 855 856 857 858 863 864 JACC VOL. -, NO. -, 2014 Campbell et al. -, 2014:-–- 865 TABLE 3 919 Chest Pain 866 867 868 9 AUC for Pediatric Echocardiography 920 Indication 28. Appropriate Use Rating Chest pain with no other symptoms or signs of cardiovascular disease, a benign family history, and a normal ECG R (2) 921 922 869 29. Chest pain with other symptoms or signs of cardiovascular disease, a benign family history, and a normal ECG M (6) 923 870 30. Exertional chest pain A (8) 924 871 31. Non-exertional chest pain with no recent ECG R (3) 925 872 32. Non-exertional chest pain with normal ECG R (1) 926 873 33. Non-exertional chest pain with abnormal ECG A (7) 927 874 34. Chest pain with family history of sudden unexplained death or cardiomyopathy A (8) 928 875 35. Chest pain with family history of premature coronary artery disease M (4) 929 876 36. Chest pain with recent onset of fever M (6) 930 37. Reproducible chest pain with palpation or deep inspiration R (1) 877 878 879 880 881 38. Chest pain with recent illicit drug use M (6) The number in parenthesis next to the rating reflects the median score for that indication. 931 932 933 934 Abbreviations: A ¼ Appropriate; M ¼ May Be Appropriate; R ¼ Rarely Appropriate; ECG ¼ Electrocardiogram. 935 882 936 883 937 884 938 885 939 886 940 887 941 888 942 889 943 890 TABLE 4 891 Indication 892 Murmur 944 Appropriate Use Rating 945 39. Presumptively innocent murmur with no symptoms, signs, or findings of cardiovascular disease and a benign family history R (1) 946 894 40. Presumptively innocent murmur with signs, symptoms, or findings of cardiovascular disease A (7) 948 895 41. Pathologic murmur A (9) 949 893 896 897 947 950 The number in parenthesis next to the rating reflects the median score for that indication. 951 Abbreviations: A ¼ Appropriate; M ¼ May Be Appropriate; R ¼ Rarely Appropriate; ECG ¼ Electrocardiogram. 898 952 899 953 900 954 901 955 902 956 903 957 904 958 905 906 907 908 959 TABLE 5 Other Symptoms and Signs Indication 960 Appropriate Use Rating 961 42. Symptoms and/or signs suggestive of congestive heart failure, including but not limited to respiratory distress, poor peripheral pulses, feeding difficulty, decreased urine output, edema, and/or hepatomegaly A (9) 962 910 43. Chest wall deformities and scoliosis pre-operatively M (6) 964 911 44. Fatigue with no other signs and symptoms of cardiovascular disease, a normal ECG, and a benign family history R (3) 965 912 45. Signs and symptoms of endocarditis in the absence of blood culture data or a negative blood culture A (8) 966 913 46. Unexplained fever without other evidence for cardiovascular or systemic involvement M (5) 967 914 47. Central cyanosis A (8) 968 915 48. Isolated acrocyanosis R (1) 969 909 916 917 The number in parenthesis next to the rating reflects the median score for that indication. Abbreviations: A ¼ Appropriate; M ¼ May Be Appropriate; R ¼ Rarely Appropriate; ECG ¼ Electrocardiogram. 918 963 970 971 972 PGL 5.2.0 DTD JAC20491_proof 12 September 2014 3:25 pm ce 10 Campbell et al. JACC VOL. AUC for Pediatric Echocardiography 973 TABLE 6 -, NO. -, 2014 -, 2014:-–- 1027 Prior Test Results 974 1028 975 Indication 976 49. 977 50. Genotype positive for cardiomyopathy A (9) 1031 978 51. Abnormal chest X-ray findings suggestive of cardiovascular disease A (9) 1032 979 52. Abnormal ECG without symptoms A (7) 1033 980 53. Desaturation based on pulse oximetry A (9) 1034 981 54. Previously normal echocardiogram with no change in cardiovascular status or family history R (1) 1035 982 55. Previously normal echocardiogram with a change in cardiovascular status and/or a new family history suggestive of heritable heart disease A (7) 1036 984 56. Elevated anti-streptolysin O titers without suspicion for rheumatic fever R (3) 1038 985 57. Chromosomal abnormality known to be associated with cardiovascular disease A (9) 1039 986 58. Chromosomal abnormality with undefined risk for cardiovascular disease M (5) 1040 987 59. Positive blood cultures suggestive of infective endocarditis A (9) 1041 988 60. Abnormal cardiac biomarkers A (9) 1042 989 61. Abnormal barium swallow or bronchoscopy suggesting vascular ring A (7) 983 Appropriate Use Rating Known channelopathy M (4) 1037 990 991 The number in parenthesis next to the rating reflects the median score for that indication. 1045 Abbreviations: A ¼ Appropriate; M ¼ May Be Appropriate; R ¼ Rarely Appropriate; ECG ¼ Electrocardiogram. 1046 993 1047 994 TABLE 7 995 Indication Systemic Disorders 1048 Appropriate Use Rating 996 62. Cancer without chemotherapy M (5) 997 63. Prior to or during chemotherapy in cancer A (8) 999 1000 1043 1044 992 998 1029 1030 64. Sickle cell disease and other hemoglobinopathies A (8) 65. Connective tissue disorder such as Marfan, Loeys Dietz, and other aortopathy syndromes A (9) 1049 1050 1051 1052 1053 1054 66. Suspected connective tissue disorder A (7) 67. Clinically suspected syndrome or extracardiac congenital anomaly known to be associated with congenital heart disease A (9) 1003 68. Human immunodeficiency virus infection A (8) 1057 1004 69. Suspected or confirmed Kawasaki disease A (9) 1058 1005 70. Suspected or confirmed Takayasu arteritis A (9) 1059 1006 71. Suspected or confirmed acute rheumatic fever A (9) 1060 1007 72. Systemic lupus erythematosis and autoimmune disorders A (7) 1061 1008 73. Muscular dystrophy A (9) 1062 1009 74. Systemic hypertension A (9) 1063 1064 1001 1002 1055 1056 1010 75. Renal failure A (7) 1011 76. Obesity without other cardiovascular risk factors R (2) 1065 1066 1012 1013 1014 77. Obesity with obstructive sleep apnea M (6) 78. Obesity with other cardiovascular risk factors M (6) 1067 1068 79. Diabetes mellitus R (3) 80. Lipid disorders R (3) 81. Stroke A (8) 1018 82. Seizures, other neurologic disorders, or psychiatric disorders R (2) 1019 83. Suspected pulmonary hypertension A (9) 1073 1020 84. Gastrointestinal disorders, not otherwise specified R (2) 1074 1021 85. Hepatic disorders M (4) 1075 1022 86. Failure to thrive M (5) 1076 1023 87. Storage diseases, mitochondrial and metabolic disorders A (8) 1077 1024 88. Abnormalities of visceral or cardiac situs A (9) 1078 1015 1016 1017 1025 1026 The number in parenthesis next to the rating reflects the median score for that indication. Abbreviations: A ¼ Appropriate; M ¼ May Be Appropriate; R ¼ Rarely Appropriate. PGL 5.2.0 DTD JAC20491_proof 12 September 2014 3:25 pm ce 1069 1070 1071 1072 1079 1080 JACC VOL. -, NO. -, 2014 Campbell et al. -, 2014:-–- 1081 1082 1083 1084 TABLE 8 11 AUC for Pediatric Echocardiography Family History of Cardiovascular Disease in Patients Without Signs or Symptoms and Without Confirmed Cardiac Diagnosis Indication Appropriate Use Rating 1135 1136 1137 1138 89. Unexplained sudden death before the age of 50 years M (6) 90. Premature coronary artery disease before the age of 50 years R (2) 1087 91. Channelopathy R (3) 1141 1088 92. Hypertrophic cardiomyopathy A (9) 1142 1089 93. Non-ischemic dilated cardiomyopathy A (9) 1143 1090 94. Other cardiomyopathies A (8) 1144 1091 95. Unspecified cardiovascular disease R (3) 1145 1092 96. Disease at high risk for cardiovascular involvement, including but not limited to diabetes, systemic hypertension, obesity, stroke, and peripheral vascular disease R (2) 1146 97. Genetic disorder at high risk for cardiovascular involvement A (7) 1148 1085 1086 1093 1094 1139 1140 1147 1095 98. Marfan or Loeys Dietz syndrome A (7) 1149 1096 99. Connective tissue disorder other than Marfan or Loeys Dietz syndrome M (6) 1150 1097 100. Congenital left-sided heart lesion, including but not limited to mitral stenosis, left ventricular outflow tract obstruction, bicuspid aortic valve, aortic coarctation, and/or hypoplastic left heart syndrome M (6) 1098 1151 1152 1099 101. Congenital heart disease other than the congenital left-sided heart lesions M (5) 1153 1100 102. Idiopathic pulmonary arterial hypertension M (5) 1154 1101 103. Heritable pulmonary arterial hypertension A (8) 1155 1102 104. Pulmonary arterial hypertension other than idiopathic and heritable R (3) 1156 1103 105. Consanguinity R (3) 1104 1105 1157 1158 The number in parenthesis next to the rating reflects the median score for that indication. 1159 Abbreviations: A ¼ Appropriate; M ¼ May Be Appropriate; R ¼ Rarely Appropriate. 1106 1160 1107 1161 1108 1162 1109 1163 1110 1164 1111 1112 TABLE 9 Outpatient Neonates Without Post-Natal Cardiology Evaluation Indication 1165 Appropriate Use Rating 1166 1113 106. Suspected cardiovascular abnormality on fetal echocardiogram A (9) 1167 1114 107. Isolated echogenic focus on fetal ultrasound R (2) 1168 1115 108. Maternal infection during pregnancy or delivery with potential fetal/neonatal cardiac sequelae A (7) 1169 1116 109. Maternal diabetes with no prior fetal echocardiogram M (6) 1170 1117 110. Maternal diabetes with a normal fetal echocardiogram M (4) 1171 1172 1118 111. Maternal phenylketonuria A (7) 1119 112. Maternal autoimmune disorder M (5) 1173 M (6) 1174 1120 113. Maternal teratogen exposure 1121 1122 1123 1175 The number in parenthesis next to the rating reflects the median score for that indication. Abbreviations: A ¼ Appropriate; M ¼ May Be Appropriate; R ¼ Rarely Appropriate. 1124 1176 1177 1178 1125 1179 1126 1180 1127 1181 1128 1182 1129 1183 1130 1184 1131 1185 1132 1186 1133 1187 1134 1188 PGL 5.2.0 DTD JAC20491_proof 12 September 2014 3:25 pm ce Campbell et al. 12 JACC VOL. AUC for Pediatric Echocardiography -, NO. -, 2014 -, 2014:-–- 1189 8. FLOW DIAGRAMS FOR COMMON 1243 1190 PATIENT SYMPTOMS 1244 1191 1245 1192 1246 1193 1247 1194 1248 1195 1249 1196 1250 1197 1251 1198 1252 1199 1253 1200 1254 1201 1255 1202 1256 1203 1257 1204 1258 1205 1259 1206 1260 1207 1261 1208 1262 1210 1211 1212 1263 p r i n t & w e b 4 C=F P O 1209 1213 1264 1265 1266 1267 F I G U R E 3 Chest Pain 1214 1268 1215 Each indication is preceded with a number sign. The rating of A, M, or R is then followed by the median score in parenthesis for that particular indication. *See 1269 1216 Discussion section. Abbreviations: A ¼ Appropriate; M ¼ May Be Appropriate; R ¼ Rarely Appropriate; ECG ¼ Electrocardiogram. 1270 1217 1271 1218 1272 1219 1273 1220 1274 1221 1275 1222 1276 1223 1277 1224 1278 1225 1279 1226 1280 1227 1281 1228 1282 1229 1283 1230 1284 1231 1285 1232 1286 1287 1234 1288 1235 1236 1237 1238 1239 p r i n t & w e b 4 C=F P O 1233 1289 1290 1291 1292 F I G U R E 4 Syncope 1293 1240 Each indication is preceded with a number sign. The rating of A, M, or R is then followed by the median score in parenthesis for that particular indication. 1241 Abbreviations: A ¼ Appropriate; M ¼ May Be Appropriate; R ¼ Rarely Appropriate; ECG ¼ Electrocardiogram; ICD ¼ Implantable Cardioverter Defibrillator. 1242 1294 1295 1296 PGL 5.2.0 DTD JAC20491_proof 12 September 2014 3:25 pm ce JACC VOL. -, NO. -, 2014 Campbell et al. -, 2014:-–- 13 AUC for Pediatric Echocardiography 1297 1351 1298 1352 1299 1353 1300 1354 1301 1355 1302 1356 1303 1357 1304 1358 1305 1359 1306 1360 1307 1361 1308 1362 1309 1363 1310 1364 1311 1365 1312 1366 1313 1367 1314 1368 1315 1369 1316 1370 1317 1371 1318 1372 1320 1321 1322 1373 p r i n t & w e b 4 C=F P O 1319 1323 1374 1375 1376 F I G U R E 5 Palpitations and Arrhythmias 1324 1377 1378 1325 Each indication is preceded with a number sign. The rating of A, M, or R is then followed by the median score in parenthesis for that particular indication. *See 1379 1326 Discussion section. Abbreviations: A ¼ Appropriate; M ¼ May Be Appropriate; R ¼ Rarely Appropriate; ECG ¼ Electrocardiogram; ICD ¼ Implantable Car- 1380 dioverter Defibrillator; PACs ¼ Premature Atrial Contractions; PVCs ¼ Premature Ventricular Contractions. 1327 1328 1381 1382 1329 1383 1330 1384 1331 1385 1332 1386 1333 1387 1334 1388 1335 1389 1336 1390 1337 1391 1338 1392 1339 1393 1340 1394 1395 1342 1396 1343 1344 1345 1346 1347 p r i n t & w e b 4 C=F P O 1341 1397 1398 1399 1400 F I G U R E 6 Murmur 1401 1348 Each indication is preceded with a number sign. The rating of A, M, or R is then followed by the median score in parenthesis for that particular indication. 1349 Abbreviations: A ¼ Appropriate; M ¼ May Be Appropriate; R ¼ Rarely Appropriate. 1350 1402 1403 1404 PGL 5.2.0 DTD JAC20491_proof 12 September 2014 3:25 pm ce 14 Campbell et al. JACC VOL. 1405 -, NO. -, 2014 -, 2014:-–- AUC for Pediatric Echocardiography 9. DISCUSSION 1406 test for an individual patient should not be undermined 1459 because there may be reasons other than those listed in 1460 1407 This is the first report by the American College of Cardi- this document that preclude application of the AUC. The 1461 1408 ology addressing appropriate use in the field of pediatric AUC may also not be applicable if another diagnostic 1462 1409 cardiology. Although the use of AUC for various areas of modality has already proven the diagnosis for which an 1463 1410 cardiovascular imaging in adult cardiology has been echocardiogram was intended. For example, if a vascular 1464 1411 established since 2005, there has not been a tool to ring is confirmed by cardiac magnetic resonance imaging 1465 1412 guide practice in pediatric cardiology (1,18). Given the (MRI), then an echocardiogram will not provide any 1466 1413 high level of utilization of echocardiography in the additional critical information. Even though this indica- 1467 1414 outpatient setting, this topic was chosen as the subject tion is rated as Appropriate in this document, clinical 1468 1415 for the first pediatric AUC, and was intentionally judgment in such scenarios will definitely supersede the 1469 1416 restricted to initial, outpatient, and transthoracic echo- AUC rating. 1470 1417 cardiographic evaluation. Of the various diagnostic mo- The definitions provided in this document were final- 1471 1418 dalities, echocardiography remains the most readily ized by the writing group after it had given due consid- 1472 1419 available, non-invasive and highly diagnostic tool for eration to the current literature and views provided by the 1473 1420 assessing cardiac structure, function and hemodynamics external reviewers and the rating panel. The users of this 1474 1421 in those with suspected cardiac disease. This report will document should be well versed in these assumptions 1475 1422 help and definitions prior to implementing the AUC. 1476 1423 expanding AUC for echocardiography in pediatric pa- 1424 tients as well as AUC for other diagnostic modalities and Indications and Ratings 1478 1425 procedures used in this field. The indications presented in this report were finalized 1479 1480 us establish the infrastructure precedent for 1477 1426 It is important to note the differences between clinical after incorporating the suggestions by the external re- 1427 practice guidelines and AUC (19). The American College of viewers, and the members of the rating panel rated the 1481 1482 1428 Cardiology guidelines have been developed by leaders in indications independently. The median score for each 1429 the field of cardiovascular medicine using evidence- indication became the final rating. In general, the in- 1483 1484 1430 based documents and expert opinion and are in general dications rated as Appropriate included evaluation of 1431 quite broad. Even though AUC are evidence based, new cardiac symptoms or clinical scenarios known to be 1485 1486 1432 they are created around possible clinical scenarios associated with congenital or acquired heart disease in 1433 that are encountered in everyday practice rather than the pediatric population. The indications ranked as 1487 1434 starting evidence. Rarely Appropriate clustered around broad systemic 1488 1435 Echocardiography is the most common imaging modality diseases and family history of conditions that are 1489 1436 used in cardiology, but there is evidence that it may not generally not known to be associated with structural or 1490 1437 be a cost-effective or high-yield diagnostic test for some functional abnormalities detectable by echocardiogra- 1491 1438 indications included in this document (20–29). The AUC phy. Scenarios that were rated as May Be Appropriate, in 1492 1439 address a reasonable role of echocardiography. Each general, involved uncertainty or required additional 1493 1440 individual patient is unique and the possible use of clinical information to better define the appropriateness 1494 1441 echocardiography deserves to be considered in full of the test. 1442 clinical context. It is noteworthy that there are no recent In the pediatric population, chest pain, syncope and 1443 practice guidelines for indications of echocardiography murmur are 3 common reasons for referral of an echo- 1497 1444 in pediatric patients and this report may become a cardiogram in the outpatient setting. For this reason, 1498 1445 clinically useful guide for practitioners (30). tables dedicated to each of these conditions with various 1499 clinical scenarios were included in the current report. 1500 with options based on current 1446 1495 1496 1447 Assumptions and Definitions Although a murmur is one of the most common indica- 1501 1448 Some of the assumptions used while writing this report tions for obtaining an echocardiogram in the pediatric 1502 1449 are important to emphasize. It is assumed that a thor- population, it is well known that a large number of pa- 1503 1450 ough history and physical examination has been per- tients are referred with an innocent murmur that does 1504 1451 formed by a qualified clinician and that use of other not require evaluation with an echocardiogram. The 1505 1452 more diagnostic tests has been considered prior to current document presumes that the clinician has made 1506 1453 ordering an echocardiogram. It is also assumed that the every effort to determine whether the murmur is inno- 1507 1454 echocardiogram is performed and interpreted by quali- cent or not prior to considering the use of an echocar- 1508 1455 fied individuals. Although the AUC ratings listed in this diogram for 1509 1456 report provide general guidance for when transthoracic presumably or clearly innocent murmur has been rated as 1510 1457 echocardiography may be useful in a specific patient Rarely Appropriate in this document. This rating is sup- 1511 1458 population, the role of clinical judgment in ordering the ported by prior publications reporting that examination 1512 (21,31). Echocardiographic PGL 5.2.0 DTD JAC20491_proof 12 September 2014 3:25 pm ce screening JACC VOL. -, NO. -, 2014 Campbell et al. -, 2014:-–- 15 AUC for Pediatric Echocardiography 1513 by a pediatric cardiologist is quite accurate in dis- more than one indication listed in this document could 1567 1514 tinguishing between innocent and pathologic murmurs be applied, clinicians need to use their judgment in 1568 1515 (21,32,33). Pathologic murmurs (including those that are picking the scenario that most closely fits the individual 1569 1516 not clearly innocent after evaluation), along with pre- patient. 1570 1517 sumably innocent murmurs with other signs, symptoms 1518 or findings of cardiovascular disease, were found to be Comparison With the Adult Cardiology AUC 1572 1519 Appropriate for an echocardiogram, since these situa- The current adult cardiology AUC for echocardiography 1573 1520 tions suggest the possibility of a cardiovascular abnor- includes initial and follow-up evaluation in the inpatient 1574 1521 mality as their underlying cause. Of course, the ability to and trans- 1575 1522 make a final diagnosis of innocent murmur after an esophageal, and stress echocardiography (3). In contrast, 1576 1523 echocardiogram for patients meeting either of these this current document is limited to initial outpatient 1577 1524 appropriate indications does not imply that the rationale transthoracic echocardiography. The initial adult car- 1578 1525 for using an echocardiogram to rule out a cardiovascular diology transesophageal 1579 1526 abnormality was not appropriate. echocardiography were published in 2007 (1). After 1580 1571 outpatient AUC for setting using transthoracic transthoracic, and 1527 Chest pain and syncope are 2 other common pre- practical application of these AUC, a revised version was 1581 1528 sentations in the pediatric age group. The etiology for published in 2011. This revised version which is currently 1582 1529 these is generally benign and echocardiography has in use included many more indications and now provides 1583 1530 been shown to be low-yield, unlike in adult patients a more complete range of clinical scenarios (3). Studies 1584 1531 (25–29). For this reason, the indications and their ratings comparing the application of these two AUC in adult 1585 1532 related to chest pain in this document are very different cardiology clinical practice have demonstrated significant 1586 1533 from those in the adult AUC. Syncope with no other improvement in the ability to classify the various clinical 1587 1588 1534 symptoms or signs of cardiac disease has been rated as scenarios using the revised version (34,35). This current 1535 Appropriate in the adult AUC (3), but rated as Rarely report for pediatric patients has certainly benefited from 1589 1590 1536 Appropriate #18), the maturational process and experience gained by the 1537 albeit with additional qualifiers of a benign family AUC in adults (36). Implementation studies in the 1591 1592 for pediatric patients (Indication 1538 history and a normal ECG. The reasonableness of using pediatric population will help us to identify any missing 1539 an echocardiogram as a primary screen versus using an or ambiguous indications that could be addressed in 1593 future revisions. 1594 1540 echocardiographic assessment only after a pediatric 1541 cardiology consultation for evaluation of a murmur, chest In comparing the ratings of various indications in 1595 1542 pain, syncope, or any other indication, depends on many the current document with those in the adult AUC, there 1596 1543 factors and needs to be given due consideration on a were many indications that were rated similarly (3). 1597 1544 case-by-case basis. For example, isolated PACs and sinus bradycardia 1598 1545 Given the complexity of clinical presentations, it is were rated as Rarely Appropriate indications in both 1599 1546 likely that there will be some overlap between the in- documents, while SVT, VT, pathologic murmurs, initial 1600 1547 dications in this document. Several indications share evaluation of suspected pulmonary hypertension, sys- 1601 1548 identical accompanying findings, signs or symptoms, but temic hypertension, and suspected endocarditis were 1602 1549 differ as to the primary patient complaint. As such, the rated as Appropriate in both. However, there were some 1603 1550 ratings were driven in these scenarios by the prevalence striking differences in the ratings of some indications 1604 1551 of the primary presentation and the likelihood of it being such as syncope and chest pain due to variations in the 1605 1552 cardiac-related. For example, non-exertional chest pain most common underlying causes in pediatric versus adult 1606 1553 with abnormal ECG (A [7] #33) and palpitations with patients. 1554 abnormal ECG (M [6] #3) have been rated slightly There are also differences in format. In this report, 1608 1555 differently by the panel even though they both relate to prior test results for which a subsequent echocardiogram 1609 1556 an abnormal ECG. Given the broad definition of an may be ordered are listed separately in Table 7 with 1610 1557 abnormal ECG described in this paper, it is not unex- individual ratings; but in the adult AUC report they are 1611 1558 pected that the ratings for palpitations that may lumped together under one indication (‘Prior testing 1612 1559 accompany more benign ECG findings were a bit lower. that is concerning for heart disease or structural 1613 1560 Similarly, ratings for indications related to symptoms abnormality including but not limited to chest X-ray, 1614 1561 or signs of cardiovascular disease changed slightly baseline scout images for stress echocardiogram, ECG, or 1615 1562 depending on other presenting factors described in the cardiac biomarkers’ (3)), and are rated as Appropriate. 1616 1563 scenarios (#29 – chest pain and signs and symptoms – M The current report also includes a broad list of systemic 1617 1564 [6], #40 – presumptively innocent murmur with signs disorders (Table 7) and scenarios related to family 1618 1565 and symptoms – A [7], and #42 – congestive heart failure history (Table 8) that are not covered in the adult AUC 1619 1566 with signs and symptoms – A [9]). In applying the AUC, if report. 1620 PGL 5.2.0 DTD JAC20491_proof 12 September 2014 3:25 pm ce 1607 16 Campbell et al. JACC VOL. -, NO. -, 2014 -, 2014:-–- AUC for Pediatric Echocardiography 1621 Limitations of this category lies more in recognition of a pattern of 1675 1622 The current AUC report is not fully inclusive of all ordering where a significantly higher number of echo- 1676 1623 possible clinical scenarios and does not include in- cardiograms are requested for the Rarely Appropriate in- 1677 1624 dications for follow-up or inpatient echocardiography. In dications by an individual provider compared with their 1678 1625 addition, it is restricted to the first use of transthoracic peers. Indications rated as May Be Appropriate could be 1679 1626 echocardiography and does not include indications for considered reasonable for obtaining an echocardiogram, 1680 1627 fetal or transesophageal echocardiography. Some of the particularly if the physician taking care of the patient 1681 1628 indications have been purposefully kept broad either determines that it would provide helpful information. 1682 1629 because it was beyond the scope of this report to list each These two categories should not be considered as the 1683 1630 and every possible scenario, or because they were basis for denying insurance coverage or reimbursement 1684 1631 considered fairly uncommon in routine practice. Exam- for the procedure, as individual decision making is 1685 1632 ples of these broad indications include use of illicit drugs, required to determine what is best for each patient. 1686 1633 chest wall deformities, chromosomal abnormalities with Nevertheless, it is important for the clinicians taking care 1687 1634 undefined risk of cardiovascular disease, suspected con- of pediatric patients to recognize that healthcare facil- 1688 1635 nective tissue disorders, neurologic or psychiatric disor- ities, accreditation bodies, or payers for these tests may 1689 1636 ders, gastrointestinal and hepatic disorders and several use this document to ensure quality care and appropriate 1690 1637 indications related to family history. use of financial resources. 1691 1638 Though we have attempted to cover a broad range of Ideally, this document will also serve as an educational 1639 clinical scenarios in this document, we realize that by no and quality improvement tool for addressing the high 1693 1640 means is this list exhaustive. Given the experience with number of Rarely Appropriate referrals for echocardio- 1694 1641 the adult cardiology AUC, it would not be surprising for us grams by individual providers. Experience with the adult 1695 1696 1692 1642 to have missed some common indications. We also echocardiography 1643 recognize that this document does not address the engagement in quality improvement programs, and 1697 1698 AUC has shown that physician 1644 appropriateness, or lack thereof, of not performing echo- tracking and benchmarking of test ordering behavior, has 1645 cardiograms. This underutilization of echocardiography reduced the percentage of inappropriate testing (37). 1699 1700 1646 could result from a lack of availability (equipment, so- Further, lab accreditation organizations such as the 1647 nographer or interpreting cardiologist), denial by payers Intersocietal Accreditation Commission (IAC) require 1701 1702 1648 or lack of insurance, alteration of the management plan attention to AUC as part of their quality improvement 1649 following expert consultation, or lack of sound clinical process (38). Finally, the AUC may provide the basis for 1703 judgment. evaluation of the impact of using AUC, especially as 1704 1650 1651 accessed by online tools, instead of more onerous and 1705 1652 less physician-driven administrative controls on imaging 1706 1653 1654 1655 1656 1657 1658 1659 1660 1661 1662 1663 1664 1665 1666 1667 1668 1669 1670 1671 1672 1673 1674 Use of AUC to Improve Care We foresee several important applications of these AUC in use. the pediatric population. The most obvious use of this document will be to support the clinical decision making 1707 1708 10. CONCLUSIONS of a provider as to the appropriateness of care that they deliver to an individual pediatric patient. It is important This AUC report provides a helpful guide to clinicians in to keep in mind that an Appropriate rating in this docu- determining the reasonable role of initial transthoracic ment should not be misinterpreted as a recommendation echocardiography in the evaluation of pediatric patients to perform an echocardiogram in every patient that meets in an outpatient setting. It also lays the foundation for the indications described herein. Rather, it should be developing AUC in other areas of pediatric cardiology. interpreted as something that would be reasonable to do Furthermore, it can form the basis of designing educa- if the information obtained will help in caring for the tional and quality improvement projects to improve patient. On the other hand, a Rarely Appropriate rating quality of care. Future studies to evaluate implementa- should not be misinterpreted as one in which an echo- tion of these AUC in clinical care will be helpful not only cardiogram should absolutely not be performed. This in identifying any deficiencies in the current document, category was termed as “Inappropriate” in the initial AUC but also in defining ordering patterns for individual documents, but due to significant misperceptions, the practitioners and understanding variations in delivery of AUC Task Force changed the terminology from Inappro- care. We expect that there will be a continued need for priate to Rarely Appropriate to emphasize that individual refinement of these AUC based on any gaps identified patient circumstances do exist where an echocardiogram through this initial effort, changes in evidence-based would be reasonable to perform. Instead of precluding an medicine, and availability of technical and financial echocardiogram in an individual patient, the importance resources. PGL 5.2.0 DTD JAC20491_proof 12 September 2014 3:25 pm ce 1709 1710 1711 1712 1713 1714 1715 1716 1717 1718 1719 1720 1721 1722 1723 1724 1725 1726 1727 1728 JACC VOL. -, NO. -, 2014 Campbell et al. -, 2014:-–- 1729 ACC PRESIDENT AND STAFF Z. Jenissa Haidari, MPH, CPHQ, Senior Research Specialist, 1730 Appropriate Use Criteria 1731 Patrick T. O’Gara, MD, FACC, President 1732 Shalom Jacobovitz, Chief Executive Officer 1733 William J. Oetgen, MD, FACC, Executive Vice President, 1734 1735 1736 17 AUC for Pediatric Echocardiography Lara M. Gold, MA, Senior Research Specialist, Appropriate Science, Education, and Quality 1783 1784 1785 1786 Use Criteria Amelia Scholtz, PhD, Publications Manager, Clinical Policy and Pathways Joseph M. Allen, MA, Senior Director, Clinical Policy and 1787 1788 1789 Pathways 1790 1737 1791 1738 1792 1739 1740 1741 1742 1743 1744 1745 1746 1747 1748 1749 1750 1751 1752 1753 1754 1755 1756 1757 1758 1759 1760 1761 1762 1763 1764 1765 1766 1767 1768 1769 1770 1771 1772 1773 1774 1775 1776 1777 1778 1779 1780 1781 REFERENCES 1793 1. Douglas PS, Khandheria B, Stainback RF, et al. 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Douglas PS. Appropriate use criteria: past, present, future. J Am Soc Echocardiogr 2012;25:1176–8. 1856 1857 1858 1859 1860 1861 1893 1894 1895 1896 1897 1898 1899 1900 1901 1902 37. Imaging in “FOCUS”. Available at: http://www. 1903 cardiosource.org/focus. Accessed January 24, 2014. 1904 38. Echocardiography/ ICAEL: Accreditation Evolved. Available at: http://www.intersocietal.org/echo/. Accessed January 24, 2014. 1905 1906 1907 1854 1855 1891 1892 1908 APPENDIX A. APPROPRIATE USE CRITERIA FOR Montefiore; and Associate Professor of Clinical Pediatrics, INITIAL TRANSTHORACIC ECHOCARDIOGRAPHY Albert Einstein College of Medicine, New York, NY IN OUTPATIENT PEDIATRIC CARDIOLOGY: Ritu Sachdeva, MD, FACC, FAAP, FASE—Associate PARTICIPANTS Professor, Emory University; and Director, Cardiovascular Imaging Research Core, Children’s Healthcare of Atlanta, Sibley Heart Center, Atlanta, GA Writing Group 1909 1910 1911 1912 1913 1914 1915 1862 Robert M. Campbell, MD, FACC, FAHA, FAAP, FHRS— 1863 Chief, Children’s Healthcare of Atlanta Sibley Heart Rating Panel 1864 Center, Professor and Division Director of Cardiology, Robert M. Campbell, MD, FACC, FAHA, FAAP, FHRS, 1865 Department of Pediatrics, Emory University School of Writing Committee Liaison—Chief, Children’s Healthcare 1919 1866 Medicine, Atlanta, GA of Atlanta Sibley Heart Center; Professor and Division 1920 1916 1917 1918 Director of Cardiology, Department of Pediatrics, Emory 1921 University School of Medicine, Atlanta, GA 1922 1867 Pamela S. Douglas, MD, MACC, FAHA, FASE—Past 1868 President, American College of Cardiology; Past Presi- 1869 dent, American Society of Echocardiography, and Ursula Pamela S. Douglas, MD, MACC, FAHA, FASE, Moder- 1923 1870 Geller Professor of Research in Cardiovascular Diseases, ator—Past President, American College of Cardiology; 1924 1871 Duke University Medical Center, Durham, NC Past President, American Society of Echocardiography; 1925 and Ursula Geller Professor of Research in Cardio- 1926 1872 Benjamin W. Eidem, MD, FACC, FASE—Past President, of Pediatric Echocardiography; Past Chair, vascular Diseases, Duke University Medical Center, 1927 Durham, NC 1928 1873 Society 1874 Pediatric & Congenital Heart Disease Council; Past mem- 1875 ber, Board of Directors, American Society of Echocardiog- Louis I. Bezold, MD, FACC, FAAP, FASE—UK Health 1929 1876 raphy; and Professor of Medicine and Pediatrics, Division Care Enterprise Quality Director, Jennifer Gill Roberts 1930 1877 of Pediatric Cardiology, Department of Pediatric and Professor in Pediatric Cardiology, and Vice Chair of Pedi- 1931 1878 Adolescent Medicine, Mayo Graduate School of Medicine, atrics, University of Kentucky, Lexington, KY 1932 1879 Mayo Clinic College of Medicine, Rochester, MN William B. Blanchard, MD, FACC, FAAP, FAHA—Past 1933 1880 Wyman W. Lai, MD, MPH, FACC, FASE—Chair, Pediatric Medical Director of Nemours Children’s Clinic in Pensa- 1934 1881 and Congenital Council Board, American Society of cola, FL; Past President, American Heart Association 1935 1882 Echocardiography; Florida/Puerto Rico Affiliate; Statewide Associate Pediat- 1936 1883 Imaging, Pediatric Echocardiography Laboratory, and ric Cardiology Consultant for Children’s Medical Services, 1937 1884 Congenital Cardiac MRI Program, Division of Pediatric FL; and Medical Director, Florida Association of Chil- 1938 1885 Cardiology, Department of Pediatrics, New York Presby- dren’s Hospitals, FL 1886 terian Morgan Stanley Children’s Hospital, New York, NY 1887 Leo Lopez, MD, FACC, FAAP, FASE—Chair, Pedia- Professor of Pediatrics; Director, Postural Orthostatic 1941 1888 tric and Congenital Heart Disease Council, American Tachycardia Syndrome Program; and Pediatric Cardiolo- 1942 1889 Society of Echocardiography; Director, Pediatric Cardiac gist, Division of Cardiology, Children’s Hospital of Phila- 1943 1890 Non-invasive Imaging at the Children’s Hospital at delphia, Philadelphia, PA 1944 Director of Non-invasive Cardiac Jeffrey R. Boris, MD, FACC, FAAP—Clinical Associate PGL 5.2.0 DTD JAC20491_proof 12 September 2014 3:25 pm ce 1939 1940 JACC VOL. -, NO. -, 2014 Campbell et al. -, 2014:-–- 19 AUC for Pediatric Echocardiography 1945 Bryan Cannon, MD—Associate Professor of Pediatrics, 1946 and Director, Pediatric Arrhythmia and Pacing Service, 1947 Mayo Clinic, Rochester, MN 1948 Gregory J. Ensing, MD, FACC, FASE—Member of the 1949 ASE Pediatric Council Board, and Professor of Pediatrics 1950 and Pediatric Cardiology, University of Michigan CS Mott 1951 Hospital for Children, Ann Arbor, MI Michigan Congenital Heart Center, University of Michigan 1999 Medical School, Ann Arbor, MI 2000 Robert Wiskind, MD, FAAP—President, Georgia Chapter 2001 of the American Academy of Pediatrics; Managing Part- 2002 ner, Peachtree Park Pediatrics, Atlanta, GA 2003 2004 Reviewers 2005 Meryl S. Cohen, MD—Medical Director, Non-Invasive 2006 1952 Craig E. Fleishman, MD, FACC, FASE—President, Soci- 1953 ety of Pediatric Echocardiography; Medical Director, Non- Cardiovascular Laboratory, The Children’s Hospital of 2007 1954 Invasive Cardiac Imaging, The Heart Center at Arnold Philadelphia, Philadelphia, PA 2008 1955 Palmer Hospital for Children; and Associate Professor of Mario J. Garcia, MD, FACC—Chief, Division of Cardiol- 2009 1956 Pediatrics, University of Central Florida College of Medi- ogy, Professor of Medicine and Radiology, and Co-Director, 2010 1957 cine, Orlando, FL Montefiore-Einstein Center for Heart and Vascular Care, 2011 Montefiore Medical Center, The University Hospital for 2012 1958 Mark A. Fogel, MD, FACC, FAHA, FAAP—Professor of 1959 Cardiology and Radiology, University of Pennsylvania 1960 School of Medicine; Past member, Board of Trustees, Michael Gewitz, MD, FACC, FAAP, FAHA—Professor 1961 Society for Cardiovascular Magnetic Resonance; Past and Physician-in-Chief, Pediatric Cardiology, Maria Fareri 2015 1962 member, American College of Cardiology Imaging Coun- Children’s Hospital at Westchester Medical Center; and 2016 1963 cil; Member, Board of Scientific Counselors, National Professor and Vice Chairman, Department of Pediatrics, 2017 1964 Heart Lung and Blood Institute of the National Institute of New York Medical College, Valhalla, NY 2018 1965 Health; and Director of Cardiac Magnetic Resonance, The 1966 1967 the Albert Einstein College of Medicine, Bronx, NY 2013 2014 Willem A. Helbing, MD—Professor of Pediatric Cardiol- 2019 Children’s Hospital of Philadelphia, Division of Cardiol- ogy, Erasmus University Medical Center, Sophia Chil- 2020 ogy, Philadelphia, PA dren’s Hospital, Rotterdam, The Netherlands 2021 1968 B. Kelly Han, MD, FACC—Director of Congenital Cardiac Alexander J. Javois, MD, FACC, FAAP, FSCAI—Assistant 1969 Imaging, Minneapolis Heart Institute and the Children’s Clinical Professor of Pediatrics, University of Illinois 2023 2024 1970 Heart Clinic at the Children’s Hospitals and Clinics of Medical Center, Advocate Children’s Hospital, Oak Lawn, 1971 Minnesota, Minneapolis, MN IL 2022 2025 1972 Shabnam Jain, MD, MPH, FAAP—Associate Professor of Walter H. Johnson, Jr, MD—Professor of Pediatrics, Di- 1973 Pediatrics and Emergency Medicine; Director for Quality, vision of Pediatric Cardiology, Alabama Congenital Heart 2027 1974 Pediatric Emergency Medicine, Emory University; Medi- Disease Center, University of Alabama at Birmingham & 2028 1975 cal Director for Clinical Effectiveness, Children’s Health- Children’s of Alabama, Birmingham, AL 1976 care of Atlanta, Atlanta, GA Ann Kavanaugh-McHugh, MD—Associate Professor of 2026 2029 2030 1977 Mark B. Lewin, MD—Professor and Chief, Division of Pediatrics, and Director of Pediatric Cardiology Imaging 2031 1978 Pediatric Cardiology, University of Washington School of Laboratory, Division of Pediatric Cardiology, Vanderbilt 2032 1979 Medicine; and Co-Director, Heart Center, Seattle Chil- University Medical Center 1980 dren’s Hospital, Seattle, WA 1981 1982 H. Helen Ko, BS, RDMS, RDCS, FASE—Technical Richard H. Lockwood, MD—Associate Medical Director, Excellus Blue Cross Blue Shield, Syracuse, NY 2033 2034 Director/Operations Manager, Pediatric Echocardiogra- 2035 phy, Mount Sinai Medical Center, New York, NY 2036 1983 G. Paul Matherne, MD, MBA, FACC, FAHA—Dammann Seema Mital, MD, FACC, FAHA, FRCPC—Professor of 2037 1984 Professor of Pediatrics, Vice Chair for Clinical Affairs, and Pediatrics, Hospital for Sick Children, University of Tor- 2038 1985 Associate Chief Medical Officer, University of Virginia onto, Toronto, Ontario, Canada 1986 Children’s Hospital, Charlottesville, VA Andrew J. Powell, MD—Associate Professor of Pediat- 2039 2040 1987 David Nykanen, MD, FACC, FRCPC, FSCAI—Member, rics, Harvard Medical School; Senior Associate in Cardi- 2041 1988 Executive Committee, Congenital Heart Disease Council, ology, Department of Cardiology, Boston Children’s 2042 1989 Society Hospital, Boston, MA 1990 ventions; Co-Director, The Heart Center; and Chief, Car- J. Carter Ralphe, MD—Assistant Professor of Pediatrics, 1991 diology and Cardiac Catheterization, Arnold Palmer and Chief, Pediatric Cardiology, University of Wisconsin 2045 1992 Hospital for Children, Orlando, FL School of Medicine & Public Health, Madison, WI 2046 for Cardiovascular Angiography and Inter- 2043 2044 1993 Catherine L. Webb, MD, FACC, FAHA, FASE—Past Chair, Arno AW Roest, MD, PhD—Pediatric Cardiologist, Division 2047 1994 Council on Cardiovascular Disease in the Young, Amer- of Pediatric Cardiology, Department of Pediatrics, Leiden 2048 1995 ican Heart Association; Past Co-Chair, Congenital Heart University Medical Center, Leiden, The Netherlands 2049 1996 Public Health Consortium; Past Board Member, Sub-board Jennifer N. A. Silva, MD—Pediatric Electrophysiology, 1997 of Pediatric Cardiology, American Board of Pediatrics; and Washington University School of Medicine, St. Louis 2051 1998 Professor of Pediatrics and Communicable Diseases, Children’s Hospital, St. Louis, MO 2052 PGL 5.2.0 DTD JAC20491_proof 12 September 2014 3:25 pm ce 2050 20 Campbell et al. JACC VOL. -, NO. -, 2014 -, 2014:-–- AUC for Pediatric Echocardiography 2053 Julia Steinberger, MD, MS—Professor of Pediatrics, and 2054 Dwan Chair of Pediatric Cardiology, University of Min- 2055 nesota Amplatz Children’s Hospital, Minneapolis, MN 2056 Associate Professor of Medicine, Baylor College of Medi- 2107 cine, Houston, TX 2108 L. Samuel Wann, MD – Columbia St. Mary’s Healthcare, Milwaukee, WI 2109 2110 2057 ACC Appropriate Use Criteria Task Force 2058 Steven R. Bailey, MD, FACC, FSCAI, FAHA—Chair, Divi- 2059 sion of Cardiology, Professor of Medicine and Radiology, 2113 2060 Janey Briscoe Distinguished Chair, University of Texas 2114 2061 Health Sciences Center, San Antonio, TX Joseph M. Allen, MA—Senior Director, American Col- 2062 Alan S. Brown, MD, FACC—Medical Director, Midwest 2063 Heart Disease Prevention Center, Midwest Heart Special- 2064 ists, Edward Heart Hospital, Naperville, IL lege of Cardiology, Washington, DC 2111 2112 APPENDIX B. RELATIONSHIPS WITH INDUSTRY 2115 (RWI) AND OTHER ENTITIES 2116 The College and its partnering organizations rigorously 2118 2117 2065 John U. Doherty, MD, FACC, FAHA—Professor of Med- avoid any actual, perceived, or potential conflicts of in- 2119 2066 icine, Jefferson Medical College of Thomas Jefferson terest that might arise as a result of an outside relation- 2120 2067 University, Philadelphia, PA ship or personal interest of a member of the rating panel. 2121 2068 Pamela S. Douglas, MD, MACC, FAHA, FASE—Past Specifically, all panelists are asked to provide disclosure 2122 2069 President, American College of Cardiology; Past Presi- statements of all relationships that might be perceived 2123 2070 dent, American Society of Echocardiography; and Ursula as real or potential conflicts of interest. These statements 2124 2071 Geller Professor of Research in Cardiovascular Diseases, were reviewed by the Appropriate Use Criteria Task 2125 2072 Duke University Medical Center, Durham, NC Force, discussed with all members of the rating panel at 2126 2073 the face-to-face meeting, and updated and reviewed as 2127 Imaging necessary. A table of relevant disclosures by the rating 2128 Writing Group; Director of Cardiac Imaging and Outpa- panel and oversight working group members can be found 2129 2130 Robert C. Hendel, MD, FACC, FAHA, FASNC—Chair, 2074 Appropriate 2075 Use Criteria for Radionuclide 2076 tient Services, Division of Cardiology, Miami University below. In addition, to ensure complete transparency, 2077 School of Medicine, Miami, FL a full list of disclosure information—including relation- 2131 ships not pertinent to this document—is available in the 2132 2078 Christopher M. Kramer, MD, FACC, FAHA—Co-Chair, 2079 AUC Task Force, Ruth C. Heede Professor of Cardiology and 2080 Radiology, and Director, Cardiovascular Imaging Center, 2081 University of Virginia Health System, Charlottesville, VA Online Appendix. 2133 2134 2135 Appropriate Use Criteria for Initial Transthoracic 2082 Bruce D. Lindsay, MD, FACC—Professor of Cardiology, 2083 Cleveland Clinic Foundation of Cardiovascular Medicine, Echocardiography in Outpatient Pediatric Cardiology: Members 2137 2084 Cleveland, OH of the Writing Group, Rating Panel, Indication Reviewers, and 2138 2136 2085 Manesh R. Patel, MD, FACC— Chair, AUC Task Force, AUC Task Force—Relationships with Industry and Other Entities 2139 2086 Assistant Professor of Medicine, Division of Cardiology, (Relevant) 2140 2087 Duke University Medical Center, Durham, NC Note: A standard exemption to the ACC RWI policy is 2141 extended to Appropriate Use Criteria writing groups, 2142 2088 2089 Leslee Shaw, PhD, FACC, FASNC— Professor of Medi- since they do not make recommendations but rather 2143 2090 Raymond F. Stainback, MD, FACC, FASE—Medical Di- prepare background materials and typical clinical sce- 2144 2091 rector of Non-invasive Cardiac Imaging, Texas Heart narios/indications that are rated independently by a 2145 2092 Institute separate panel of experts. 2146 cine, Emory University School of Medicine, Atlanta, GA at St. Luke’s Episcopal Hospital; Clinical 2093 2147 2094 2148 2095 2149 2096 2150 2097 2151 2098 2152 2099 2153 2100 2154 2101 2155 2102 2156 2103 2157 2104 2158 2105 2159 2106 2160 PGL 5.2.0 DTD JAC20491_proof 12 September 2014 3:25 pm ce JACC VOL. -, NO. -, 2014 Campbell et al. -, 2014:-–- 2161 APPENDIX B. CONTINUED 2215 2162 2216 2163 2164 2165 21 AUC for Pediatric Echocardiography Participant Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit 2217 Expert Witness Writing Group 2166 2218 2219 2220 2167 Robert M. Campbell None None None None None None 2221 2168 Pamela S. Douglas None None None None None None 2222 2169 Benjamin W. Eidem None None None None None None 2223 2170 Wyman W. Lai None None None None None None 2224 2171 Leo Lopez None None None None None None 2225 2172 Ritu Sachdeva None None None None None None 2226 2173 2174 2175 2176 2227 Rating Panel Louis I. Bezold None None None None None None William B. Blanchard None None None None None None 2228 2229 2230 Jeffrey R. Boris None None None None None None Bryan Cannon None None None None None None 2179 Gregory J. Ensing None None None None None None 2233 2180 Craig E. Fleishman None None None None None 2234 2177 2178 2181 2182 2183 Gore Medical Supplies Mark A. Fogel None None None Siemens Medical Systems None None B. Kelly Han None None None Siemens Medical Systems None None 2184 2231 2232 2235 2236 2237 2238 2185 Shabnam Jain None None None None None None 2239 2186 Mark B. Lewin None None None None None None 2240 2187 Richard H. Lockwood None None None None 2188 G. Paul Matherne None None None None 2189 David Nykanen None None None None 2190 2191 2241 None None 2242 None None 2243 2244 Catherine L. Webb None None None None None None Robert Wiskind None None None None None None 2192 2193 None Excellus BCBS* 2245 2246 Reviewers 2247 Meryl S. Cohen None None None None None None Mario J. Garcia None None None None None None Michael Gewitz None None None None None None 2197 Willem A. Helbing None None None None None None 2251 2198 Alexander J. Javois None None None None None None 2252 2199 Walter H. Johnson None None None None None None 2253 2200 Ann Kavanaugh-McHugh None None None None None None 2254 2201 Hyun-Sook Helen Ko None None None None None None 2255 2202 Seema Mital None None None None None None 2256 2203 Andrew J. Powell None None None None None None 2257 2258 2194 2195 2196 2204 J. Carter Ralphe None None None None None None 2205 Arno AW Roest None None None None None None 2206 2207 Jennifer Silva None None None None None None Julia Steinberger None None None None None None 2208 (continued on the next page) 2209 2210 2248 2249 2250 2259 2260 2261 2262 2263 2264 2211 2265 2212 2266 2213 2267 2214 2268 PGL 5.2.0 DTD JAC20491_proof 12 September 2014 3:25 pm ce 22 Campbell et al. JACC VOL. -, NO. -, 2014 -, 2014:-–- AUC for Pediatric Echocardiography 2269 APPENDIX B. CONTINUED 2323 2270 2271 2272 2273 Participant Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit 2324 2325 Expert Witness Appropriate Use Criteria Task Force 2274 2326 2327 2328 Steven R. Bailey None None None None None None 2276 Alan S. Brown None None None None None None 2277 John U. Doherty None None None None None None 2331 2278 Pamela S. Douglas None None None None None None 2332 2279 Robert C. Hendel None None None None None None 2333 2280 Christopher M. Kramer None None None None None 2334 2282 Bruce D. Lindsay None None None None None None 2336 2283 Manesh R. Patel None None None None None None 2337 2284 Leslee J. Shaw None None None None None None 2338 2285 Raymond Stainback None None None None None None 2339 2286 L. Samuel Wann None None None None None None 2340 2287 Joseph M. Allen None None None None None None 2275 2281 2288 2289 2290 2291 2292 Siemens Medical Solutions 2329 2330 2335 This table represents the relevant relationships with industry and other entities that were disclosed by participants at the time of participation. It does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of 5% or more of the voting stock or share of the business entity, or ownership of $10,000 or more of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. A relationship is considered to be modest if it is less than significant under the preceding definition. Relationships in this table are modest unless otherwise noted. Names are listed in alphabetical order within each category of review. Participation does not imply endorsement of this document. *Significant (greater than $10,000) relationship. 2341 2342 2343 2344 2345 2346 2293 2347 2294 2348 2295 2349 2296 2350 2297 2351 2298 2352 2299 2353 2300 2354 2301 2355 2302 2356 2303 2357 2304 2358 2305 2359 2306 2360 2307 2361 2308 2362 2309 2363 2310 2364 2311 2365 2312 2366 2313 2367 2314 2368 2315 2369 2316 2370 2317 2371 2318 2372 2319 2373 2320 2374 2321 2375 2322 2376 PGL 5.2.0 DTD JAC20491_proof 12 September 2014 3:25 pm ce