DOI: 10.1542/peds.109.3.544 2002;109;544Pediatrics

Section on Cardiology and Cardiac SurgeryGuidelines for Pediatric Cardiovascular Centers

  

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AMERICAN ACADEMY OF PEDIATRICSSection on Cardiology and Cardiac Surgery

Guidelines for Pediatric Cardiovascular Centers

ABSTRACT. Pediatric cardiovascular centers shouldaim to provide high-quality therapeutic outcomes forinfants and children with congenital and acquired heartdiseases. This policy statement describes critical ele-ments and organizational features of centers in whichhigh-quality outcomes have the greatest likelihood ofoccurring. Center elements include noninvasive diagnos-tic modalities, cardiac catheterization, cardiovascular sur-gery, and cardiovascular intensive care. These elementsshould be organizationally united in centers in whichpediatric cardiac physician specialists and specializedpediatric staff work together to achieve and surpass ex-isting quality-of-care benchmarks.

ABBREVIATIONS. AAP, American Academy of Pediatrics;ECMO, extracorporeal membrane oxygenator; ICU, intensive careunit; ICAEL, Intersocietal Commission for the Accreditation ofEchocardiography Laboratories; VAD, ventricular assist device.

INTRODUCTION

This policy statement supersedes “Guidelinesfor Pediatric Cardiology Diagnostic and Treat-ment Centers” published by the American

Academy of Pediatrics (AAP) in 1991.1 The objectiveof the 1991 statement was to describe the clinical andphysical environment in which the pediatric patientwith heart disease could undergo accurate and safediagnostic and therapeutic procedures. Over the pastdecade, there have been changes in technology andclinical practice that render many aspects of the 1991guidelines incomplete or obsolete. Recognizing thebroadened scope of interaction between medical andsurgical disciplines, this revised policy statement re-designates the pediatric cardiology center as the “pe-diatric cardiovascular center.” The aim of this state-ment is to describe the configuration and criticalelements of the pediatric cardiovascular center inwhich high-quality outcomes have the greatest like-lihood of occurring.

CENTER CONFIGURATIONA pediatric cardiovascular center should be able to

provide all of the sophisticated diagnostic servicesand the full range of treatments, interventions, andsurgeries needed to produce high-quality outcomesin all pediatric patients with congenital and acquiredheart diseases. Physicians and staff should functionas a team and should include adequate numbers ofqualified pediatric cardiologists, pediatric cardiovas-

cular surgeons, pediatric cardiovascular anesthesiol-ogists, pediatric intensive care physicians, and/orneonatologists with special expertise in the care ofcardiac patients, and additional pediatric specialistsrequired for the overall care of patients. Diagnosticelements should include a fully equipped pediatricechocardiography laboratory, a pediatric cardiaccatheterization and electrophysiology laboratory,and appropriate additional facilities and capabilitiesfor comprehensive laboratory and noninvasive diag-nostic evaluations of critically ill children. Therapeu-tic components should include a pediatric cardiaccatheterization laboratory equipped for interven-tional cardiology and transcatheter radiofrequencyablations, a cardiac operating suite suitable for sur-gical treatment of all pediatric cardiovascular pa-tients, an extracorporeal membrane oxygenator(ECMO), and a cardiac intensive care unit (ICU) orpediatric ICU and/or neonatal ICU equipped andstaffed to care for pediatric cardiovascular patients.

Pediatric cardiology practices, which do not havethe configuration and the elements of a pediatriccardiovascular center, may provide triage and emer-gency care, care of strictly medical cardiovascularconditions, and ongoing joint management (togetherwith a center) of patients after surgery or catheterinterventions at the center. This statement does notmake specific recommendations regarding suchpractices.

NONINVASIVE DIAGNOSTIC ELEMENTSA pediatric echocardiographic laboratory is prin-

cipal among a center’s noninvasive diagnostic ele-ments. Existing data suggest that pediatric patientsare not optimally served in laboratories primarilygeared for adult echocardiography2,3; thus, most pe-diatric cardiology programs should have dedicatedpediatric echocardiography laboratories. The AAPendorses accreditation by the Intersocietal Commis-sion for the Accreditation of Echocardiography Lab-oratories (ICAEL) and adherence to the guidelinespromulgated by the American College of Cardiologyand the American Heart Association4 as means toensure pediatric echocardiography laboratory stan-dards are met. For ICAEL accreditation of pediatrictransthoracic, transesophageal, or fetal echocardiog-raphy, a laboratory must show that it has state-of-the-art equipment and facilities suitable for children,follows good technique in recording and reportingexaminations, and is staffed by physicians and tech-nicians trained in pediatric echocardiography. TheICAEL mandates that the laboratory and its mobileor satellite locations are supervised by a medical

The recommendations in this statement do not indicate an exclusive courseof treatment or serve as a standard of medical care. Variations, taking intoaccount individual circumstances, may be appropriate.PEDIATRICS (ISSN 0031 4005). Copyright © 2002 by the American Acad-emy of Pediatrics.

544 PEDIATRICS Vol. 109 No. 3 March 2002

director (pediatric cardiologist) and a technical direc-tor (pediatric echocardiography technician) and setsstandards for training and experience of these indi-viduals. The medical director and other physicianswho interpret echocardiograms and/or perform fetalor transesophageal echocardiography and techni-cians who staff the laboratory or its peripheral sitesmust meet the American Society of Echocardio-graphy’s guidelines for appropriate training5–7 andmust also satisfy ICAEL requirements for ongoingexperience.

Pediatric cardiovascular centers should adhere toAmerican Heart Association guidelines for exercisetesting in pediatric patients.8 Because equipment andexpertise appropriate for pediatric patients areneeded, in most clinical settings, establishment of apediatric exercise laboratory separate from existingadult laboratories is appropriate. Pediatric exerciselaboratories must have a knowledgeable physiciandirector and staff with competence in exercise testingand interpretation in young patients with disordersof varying severity.9 Pediatric resuscitative equip-ment must be immediately available to the labora-tory.

Additional essential noninvasive elements of a pe-diatric cardiovascular center, which should be di-rected by a pediatric cardiologist, include electrocar-diography, holter monitoring, transient arrhythmiamonitoring, and pacemaker evaluation. Proper ap-plication of these tests requires appropriate physi-cian expertise and personnel familiar with theunique requirements of pediatric patients.

Pediatric cardiovascular centers should also haveaccess to tilt-table testing and additional imagingcapabilities, such as magnetic resonance imaging andcomputed tomography. This equipment may beshared with adult patient departments. However, ifshared, a pediatric cardiologist with expertise in thepediatric cardiovascular applications of these modal-ities should collaborate with other specialists to en-sure diagnostic-quality pediatric cardiovascularstudies.

CARDIAC CATHETERIZATIONThe American College of Cardiology and the So-

ciety for Cardiac Angiography and Interventionshave developed catheterization laboratory standards(including recommendations for pediatric catheter-ization laboratories).10 The AAP endorses these stan-dards with respect to the recommendations regard-ing pediatric cardiac catheterization laboratories.

Cardiac catheterization continues to be a definitivediagnostic modality that provides hemodynamic, an-atomic, and electrophysiologic data critical for pa-tient care. Transcatheter therapeutic interventionshave become common but more complicated.11,12

Furthermore, transcatheter radiofrequency ablationhas become the standard definitive treatment ofpathologic tachycardias. Because of the expandedrole of cardiac catheterization, high-quality catheter-ization services are more important than they werein the past.

A number of factors help to ensure high-qualitypediatric cardiac catheterization care. A board-certi-

fied pediatric cardiologist who has additional fel-lowship training (or qualifying experience) in pedi-atric catheterization and interventional proceduresshould direct the pediatric catheterization labora-tory. The pediatric catheterization laboratory direc-tor should have responsibility for all aspects of theadministration and function of the laboratory (in-cluding quality assessment and quality improvementactivities). In addition to technicians trained in pedi-atric catheterization, staffing of every procedureshould include a minimum of 1 board-certified (orboard-eligible) pediatric cardiologist and 1 pediatricnurse with training and experience in pediatric air-way management and sedation.

The pediatric catheterization laboratory shouldhave biplane imaging equipment with a moveableC-arm, immediate replay capabilities (preferablydigital), a physiologic recorder, a blood gas analyzer,a pulse oximeter, an infant warming device, pacingcatheters and an external pacemaker, a defibrillatorand an emergency cart, and a comprehensive inven-tory of pediatric catheters, devices, and expendables.There should be an appropriate ICU available to carefor patients before and after cardiac catheterization,and interventional procedures require the availabil-ity of in-hospital pediatric cardiac surgery backup.

Each cardiac catheterization program should striveto achieve high-quality outcomes with low morbid-ity and mortality. Data should be gathered prospec-tively to document quality of care. There should besystematic review of all case outcomes and proce-dural complications at regular catheterization qual-ity assurance conferences. Recent studies of pediatriccatheterization demonstrate that catheterization-re-lated mortality rates much less than 1% are achiev-able (with mortality essentially confined to emer-gency cases in neonates and high-risk interventionalcases). In addition, an incidence of major complica-tions (defined as potentially life-threatening events)less than 3% is also attainable.13,14 Another studyshowed that fewer than 4% of transcatheter interven-tional procedures should require surgical interven-tion because of complications.15 Furthermore, in ra-diofrequency ablation procedures, data show thatpermanent complete heart block rates less than 2%are common.16 All pediatric cardiac catheterizationlaboratories should strive to achieve and exceedthese benchmarks.

In pediatric cardiac catheterization and interven-tion, data relating outcomes and laboratory or oper-ator case volume are not currently available. How-ever, data indicate that coronary interventionaloutcomes are improved if operators exceed a certainnumber of individual cases annually.17 Given thewide range of procedures performed and the varietyof rare diagnoses treated in pediatric cardiology, pe-diatric cardiology centers performing a small num-ber of catheterizations should restrict the activity to 1or 2 cardiologists so that operators maintain theirclinical skills.

CARDIOVASCULAR SURGERYIn 1991, the American College of Surgeons pub-

lished guidelines for minimal standards in cardiac

AMERICAN ACADEMY OF PEDIATRICS 545

surgery, including recommendations with respect tohospitals operating on children with congenital heartdisease.18 These recommendations are outdated.

In the current era, hospital mortality rates less than1% are achievable for simpler forms of congenitalheart disease (eg, atrial septal defect, ventricular sep-tal defect, coarctation of the aorta), and significantpostoperative morbidity among such patients hasbeen rare.19–22 For more complex lesions, risks aregreater. However, for lesions such as tetralogy ofFallot, complete atrioventricular canal defect, andtransposition of the great arteries without additionalcomplicating defects or conditions, hospital mortal-ity rates less than 5% are attainable.19,23–25 Patientswho have more complex disease or who are more illexperience higher morbidity and mortality but haveusually been best served in experienced surgical en-vironments with consistent excellent outcomesamong patients with more complicated illness. Fur-thermore, to offer patients a full range of surgicaltreatments, centers have offered pediatric cardiactransplant (as centers certified by the United Net-work for Organ Sharing) or have been closely affili-ated with a certified transplant center. All pediatriccardiovascular centers should strive to achieve andsurpass these benchmarks and should provide orhave available heart replacement services.

A major objective of this statement is to describethe surgical environment associated with high-qual-ity outcomes. Surgical outcomes are enhanced byearly patient referral, definitive anatomic and phys-iologic diagnosis, and optimal preoperative andpostoperative care. Parental counseling and planningof the timing and nature of surgical interventionshould be accomplished by a team skilled in the careand treatment of pediatric heart disease and respon-sible for the care of the patient. Team membersshould include cardiac surgeons, cardiologists, anes-thesiologists, intensive care physicians, neonatolo-gists, nurses, and perfusionists.

Expert, experienced congenital heart surgeons arerequired for staffing a pediatric cardiovascular sur-gical program. Surgical training (after cardiac sur-gery residency) requires 2 years of pediatric cardiacsurgery fellowship and additional years working as ajunior staff surgeon in a pediatric and congenitalheart program with high volume and demonstratedhigh-quality outcomes.

A dedicated team of anesthesiologists, perfusion-ists, operating room nurses, and technicians shouldbe available to support all pediatric cardiovascularsurgical procedures. Anesthesiologists should havepediatric and pediatric cardiac anesthetic trainingand experience with expertise in dealing with theproblems arising from complicated interactions be-tween the cardiac pathophysiology, surgical proce-dures, and anesthetic techniques. Perfusionistsshould be dedicated to the pediatric cardiovascularsurgery program and have training, knowledge,and experience with small body perfusion, ECMO,and ventricular assist devices (VADs), including setup, delivery, and maintenance of these systems. Op-erating room nurses should be dedicated pediatric

cardiovascular operating room nurses with training,knowledge, and experience in pediatric cardiac op-erative techniques and requirements. Likewise, tech-nicians should be appropriately trained and experi-enced permanent members of the operating team.

One or more operating rooms should be specifi-cally designated and designed for pediatric cardio-vascular procedures. Each room should be large andshould include a positive-pressure climate controlsystem capable of maintaining humidity at 55% andchanging room temperature by 20°F within 15 to 20minutes. The operating room is best located near thepostoperative ICU. The operating room should beequipped with a cardiopulmonary bypass machine,which can deliver precise volumes at low flowsagainst varying impedance with minimal bloodtrauma. Anesthetic equipment should be suitable forthe smallest patients and appropriate also for adultpatients.

Clinical data on patients who undergo cardiac sur-gery should be recorded prospectively in a compre-hensive database. A quality assurance program re-sponsible for monitoring and evaluating surgicaloutcomes should be in place. This program shouldalso review individual deaths and major complica-tions.

CARDIOVASCULAR INTENSIVE CAREAlthough cardiac intensive care may be required

for patients before surgery, before or after cardiaccatheterization, and for medical conditions, the high-est level of care is most often required for patientsafter cardiac surgery. Thus, the ICU providing carefor cardiovascular patients should be a cardiac unitorganized specifically to provide postoperative carefor pediatric heart patients or it should be a pediatricICU that satisfies AAP guidelines for level I pediatricICUs26 (currently being revised) and/or a subspeci-ality neonatal ICU that satisfies guidelines for peri-natal care.27 Pediatric ICUs and subspeciality neona-tal ICUs should be organized to routinely providepostoperative care for pediatric heart patients.

The ICU should be equipped and staffed to pro-vide the following services 24 hours a day, 7 days aweek: respiratory support, using the full range ofmechanical ventilators and gases (such as nitric ox-ide and carbon dioxide); complete hemodynamicand cardiac rhythm monitoring and recording; car-diac pacing; open- and closed-chest resuscitation andoperating; and ECMO and VADs. Blood gas andbasic biochemistry laboratory determinations, radio-logic services, echocardiography, and cardiac cathe-terization should also be available 24 hours a day, 7days a week.

The ICU staff should include a medical directorwho should have fellowship training, experience,and specific expertise in the postoperative care ofpediatric heart patients. Physicians with primary re-sponsibility for cardiovascular patient care shouldprovide in-house supervision of the unit 24 hours aday, 7 days a week. Coverage by pediatric cardiacsurgeons and pediatric cardiologists capable of per-forming complete echocardiographic assessments

546 GUIDELINES FOR PEDIATRIC CARDIOVASCULAR CENTERS

and cardiac catheterization should be available 24hours a day, 7 days a week. In addition, pediatricsubspecialty physicians and surgeons with expertisein critical disease of all other organ systems shouldbe readily available for consultation. ICU nursesshould have training and experience in the postop-erative intensive care of pediatric heart patients. Thenursing staff should be dedicated to the ICU andsufficient to provide 1-to-1 coverage of all high-acu-ity patients. Appropriate additional staff, such asrespiratory therapy technicians, should also be avail-able 24 hours a day, 7 days a week.

RELATIONSHIP OF THE PEDIATRICCARDIOVASCULAR CENTER TO THE HEALTH

CARE ENVIRONMENTPediatric cardiovascular centers are established

and constituted to provide high-quality cardiac carefor pediatric patients. Centers are usually compo-nents of pediatric tertiary health care systems. Assuch and by definition, centers should support andcomplement related tertiary pediatric programs andcenters.

Even more importantly, pediatric cardiovascularcenters serve patients within family, school, andcommunity environments. To deliver high-qualitycardiac care, centers should partner with primaryhealth care systems and practitioners in cardiovas-cular disease. Center physicians, particularly pediat-ric cardiologists, should maintain ongoing dialoguewith pediatricians and other primary care practitio-ners regarding individual patient care plans andproblems; case management should be a jointproject. In addition, center physicians, in cooperationwith the primary care practice team, should be re-sponsible for education of and communication withfamilies and school and community authorities re-garding all aspects of patients’ cardiovascular care.Other personnel in pediatric cardiovascular centers,such as nurse practitioners, social workers, and pa-tient care representatives, may also be instrumentalin these relationships and activities.

QUALITY OF CAREExisting evidence suggests that certain practices

promote high-quality outcomes. Thus, pediatric car-diovascular centers should strive to 1) participate ina regional health care network, 2) use modern infor-mation technology, and 3) maintain adequate casevolumes to achieve and demonstrate high-qualitytherapeutic outcomes.

Early experience with regional networks for peri-natal and neonatal care and pioneering efforts inregionalizing infant cardiac care by 11 pediatric car-diac centers in 6 states (the New England RegionalInfant Cardiac Program) suggest that participation ina regional network of health care providers results inimproved outcomes for mothers, infants, and chil-dren with heart disease.28–30 Furthermore, theNorthern New England Cardiovascular DiseaseStudy Group has shown that regional intervention,including feedback of outcome data, training in con-tinuous quality improvement techniques, and site

visits to other medical centers, improves hospitalmortality rates associated with coronary artery by-pass surgery.31 In pediatric cardiology, the PediatricCardiac Care Consortium has demonstrated the fea-sibility of quality improvement as the result of par-ticipation in a physician-directed clinical database.32

Moreover, in many areas of health care, regionaliza-tion has been shown to improve access while de-creasing costs, numbers of hospital beds, and inpa-tient days and average length of stay.33–35

Improvements in quality of care have been linkedto information technology and automated informa-tion and decision support systems. There is evidenceto suggest that the number of preventable errors canbe decreased by use of better information systemsthat disseminate knowledge about drugs and makedrug and patient information readily accessible in atimely manner.36 Furthermore, computerized drugorder entry systems have been shown to decrease thenumber of errors37; computerized laboratory datacan alert clinicians to abnormal lab values38; and theuse of a computerized physician order entry, inwhich physicians enter and transmit medication or-ders online, can prevent medication errors attribut-able to misinterpretation of handwritten orders.39

Finally, pediatric heart surgery is one of severalclasses of procedures for which lower mortality rateshave been demonstrated at high-volume hospitals.40

The relation of in-hospital mortality rates to casevolume for congenital heart surgery has been exam-ined in studies using statewide administrative da-ta.41–44 All have shown a significant correlation be-tween improvement in severity-adjusted mortalityrate and increasing institutional case volume. How-ever, institutional case volume explains only a rela-tively small fraction of the variability in outcomesamong pediatric heart surgery programs, and un-common outcomes such as mortality are difficult tomeasure with statistical precision for smaller pro-grams. Thus, although “high volume” ensures a cer-tain degree of quality, there is no consistent relation-ship between quality and “low volume.” It isprobable that a number of low-volume centers haveconsistent and excellent results, but the identifiers ofthese centers have not been elucidated. Quality indi-cators other than in-hospital mortality rates must bedeveloped to aid in the validation of quality, espe-cially in smaller centers.

CONCLUSIONThe quality of outcomes in pediatric cardiovascu-

lar centers is the most important measure of centeractivity. Although outcome assessment in pediatriccardiovascular surgery and intervention is currentlyrudimentary, basic outcome benchmarks are avail-able and have been incorporated into the guidelinesin this statement. Additional outcomes research isongoing, and future guidelines will require modifi-cation to accommodate the results of this research.Nevertheless, the AAP recommends that pediatriccardiovascular centers document and analyze theirindividual outcomes, strive to achieve and surpassexisting quality benchmarks, and commit to contin-

AMERICAN ACADEMY OF PEDIATRICS 547

uous quality improvement methodology in all oftheir programs.

Section on Cardiology and Cardiac Surgery,2000–2001

John W. M. Moore, MD, MPH, ChairpersonRobert H. Beekman III, MDChristopher L. Case, MDDavid A. Danford, MDThomas S. Klitzner, MD, PhDRoger B. B. Mee, MB, ChBJane W. Newburger, MDReginald L. Washington, MD

ConsultantsJ. Timothy Bricker, MDCharles D. Fraser, Jr, MDDerek A. Fyfe, MD, PhDLarry T. Mahoney, MD

StaffLynn Colegrove, MBA

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AMERICAN ACADEMY OF PEDIATRICS 549

DOI: 10.1542/peds.109.3.544 2002;109;544Pediatrics

Section on Cardiology and Cardiac SurgeryGuidelines for Pediatric Cardiovascular Centers

  

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