competence and requirements for training

Dutch guidelines for interventional

cardiology:

institutional

and

operator

competence and requirements for training

W.R.M.Aengevaeren, G.J. Laarman,M.J. Suttorp, J.M.tenBerg,A.J.vanBoven,M.J.de Boer, J.J.Piek, G.V.A.vanOmmen,J.G.F. Bronzwaer, P. Smits, J.W. Deckers

Interventional cardiology is an expandingfield within cardiovascular medicine and today it is

generally acceptedthatcardiologistsrequirespeific training, knowledge and skills. Hospitals where coronary interventions are performed must be properlyequipped and abletoprovide speaalised

care. Percutaneous coronary interventions are

frequentlyused for coronaryrevascularisation.The

publicshould haveconfidence in theuniformity

ofhighqualitycare.Therefore,suchqualityofcare

should be maintained by certification of the individual operators, general guidelines for institutional requirements andformalaudits. The NetherlandsSocietyofCardiology (NVVC)willbe

implementinga new registration systemfor

car-diologistswitha

subspeialisation

that will indude registration for interventional cardiology. The

NVVCasked theWorking Group ofInterventional

Cardiology (WIC) to update the 1994 Dutch

guidelines on operator and institutional

com-petence, and requirements for training in inter-ventionalcardiologyinordertoincorporate them intotheofficial

directives.'

The presentguidelines represent the expertopinion oftheDutch

inter-W.R.M.Aengovaeren

J.M. tenBerg

A.J.vanBoven

J.W.Deckers

Guideline committee for interventionalcardiology GJ.Laarman

MJ.Suttorp

MJ.deBoor J.J.Phek

G.V.A.vanOmmen

J.G.F.Bronzwaor P.Smlts

WorkingGroupof InterventionalCardiology Correspondenceto:W.R.M.Aengevaeren UniversityMedical CentreNijmegen, POBox9101,

6500 HBNijmegen

E-mail:[email protected]

ventional cardiology community and are in

accordancewith internationalregulations.2-7

After two rounds of discussion, the NVVC

approvedtheguidelinesinNovember2004during

the autumnmeeting.

(NethHeartJ2005;13:416-22.)

Keywords: guidelines, interventional cardiology,

cardiovascular medicine

Dutchinterventionalcardiologyischaracterisedby

alimited number ofhigh-volume intervention centres with experienced operators. In 2003 the average numberof procedures percentre was more

than 1500. In general, a high-volume load for operators and institutions is associated with better

outcomes for procedures.26 In the interventional community, the Dutch situation isconsideredideal, and itserves as anexample of how interventional

cardiologyshould beorganised.Therecentexpansion with new interventional centres (Alkmaar, Enschede, Leeuwarden, Rotterdam-Zuid, The Hague and

Arnhem)meansthat a rathercomplete geographical spreadhas beenreached,whichisespeciallyimportant forrapidtreatment ofacute myocardial infarction. The presentcapacityshould be sufficient for thenext

decennium, while assuring ahigh volume load per

centre. The purpose of theseguidelinesisto ensure

and maintain ahigh quality ininterventional

car-diologyinthe Netherlands.Extensivediscussions have been held within theWIC and with representatives of the NVVC about the numbers ofproceduresthat need to be performed in the different sections mentioned in theseguidelines. These numbers may deviate to some extent from guidelines in other countries, butguidelinesarealways adaptedtolocal

insights and expertise in away that ispractical and desirable inthe specificsituation. Included inthe scopeofinterventionalcardiologyaretechniques used for percutaneous coronary interventions, but alsoa

broader group of percutaneous techniques for

procedures involvingthemyocardium,cardiacvalves,

Neth1rlandsHeartJournal,Volume 13, Number 11,November2005 XC

shunts,large thoracic vessels and peripheral vessels such as the carotid arteries. Specific expertise and a

dedicated setting are often required for the latter group ofpercutaneous interventions. The majority of theinterventions involve treatment ofstenoses in the coronary system.Formerly known as percutaneous transluminal coronary angioplasty (PTCA), these pro-cedures are nowreferredtoby the more appropriate term percutaneous coronary interventions (PCI). These guidelinesarebased on scientificpublications

and expert opinion. Resultsofpublishedstudies may have a number of limitations for common practice becauseof selection and publicationbias,differences in medical practice, patient characteristics and

geographic factors.Moreover,conclusionsand state-ments maybecome outdated due to rapid

develop-ments ininterventionalcardiology.56Thestrengthof evidence in this paper is ratedaccordingtothreelevels,

similar to the guidelinesof the European Society of

Cardiology.7

* Level ofevidence A: Data derived from multiple randomisedclinicaltrials or meta-analyses. * Levelof evidence B: Data derived from a single

randomisedtrial ornon-randomisedstudies. * Level of evidence C: Consensus opinion of the

experts.

Coronaryinterventionalproceduresarecomplexand

technically demanding. Optimalperformancerequires anextensiveknowledgeand substantial technicalskills. Complicationsofcoronary interventions are becoming lessfrequent, butoptimaloutcomedependsonproper recognitionand management. The newdevelopments

inpharmacologicaltherapy,technical improvements, noveltechniques,medicalapproaches togetherwith anincreasingcomplexityofcasesmeanthatindividual operators need toundertake continuous education

and invest time and interest in ensuring safe and appropriate patient care.Besides operator experience, institutionalfactorsareimportantforthe successofthe

procedures, such as the radiographic equipment,

adequately trained and experienced nursing and technical staff, hospital facilities, patient logistics,

patientload and adherencetoprotocols. Diagnosis and treatmentofarrhythmias(electrophysiology)isa

separatesubspecialisationwithincardiologyand isnot

includedintheseguidelines.Neitherdo theguidelines provideinformationabout indications orperformance

of theprocedures; these issues are addressed in the

recently published guidelines for percutaneous coronary interventions of the European Society of

Cardiology.8

Training

requirementsforthe

Interventional

cardiologist

The results of PCIs in terms ofsuccess and

com-plication

rates arerelated to the operator's expertise,

caseselection,clinicaljudgementandtechnicalskills.

It isobvious that

patients

undergoingtheseprocedures

should be confident that the operator and nursingstaff

areskilled andwelltrained. During the training, an

interventional cardiologistisrequiredtoperformaset

miniimum numberof procedures as first operator to gain enoughpractical experience.

Requirements to be met before starting official training in interventionalcardiology

* Registration as acardiologist and completion of a course onradiationsafetywithcertification(level

4A).

* Thorough knowledge of the anatomy and

physiology of the large vessels and coronary

circulation.

* Aminimumof 300 diagnosticcardiac catheter-isations as first operator(levelof evidence

C)."13

* The traininghas to befollowedin acentrethat is certified for training in interventional cardiology (see Requirements for interventional centres

providing

training).

* Literature study of interventional cardiology. Specificrequirements will beformulatedinthe near future.

* Positive attitude towards working togetherand sharing experiences with interventional and non-interventionalcolleagues, andthe technical and nursing staffofthecardiaccatheterisationlaboratory. During the training

* Attendance ofat least oneestablished international

course ininterventionalcardiology(PCRorTCT). * Participation in anational course on interventional

cardiologywithanexamination. (Thiscoursewill

bedevelopedinthenearfuture).

* As in any surgical procedure, percutaneous coronary interventions require a high degreeof dexterity to obtain vascular access and technical

skillstomanipulateand operate a varietyofcatheters

anddevices in the circulation. Most of theseskills

can only be acquired by training inactual pro-cedures.

* Knowledge of indications for PCI in different clinical conditions, inrelation to conservative/

medical treatment andsurgicalapproaches.

* Knowledgeofall potential

complications,

including

contrastreactions, bleedingcomplications, and primary managementof these

complications.

* Knowledgeof theadvantages anddisadvantages ofvarious arterialaccesssitesand related

techniques

forhaemostasis andtheabilityto

perform

diag-nosticandinterventional proceduresviathese access sites.

* Knowledge of interventional techniques and featuresofvarious

materials,

suchasballoons,wires andstents.

* Awide casemixshould be treated, including all typesof coronary lesions andconditions, acute

myocardialinfarction and

haemodynamically

un-stablepatients.

* Frequentparticipation in team discussions with the cardiac surgeons on evaluation of diagnostic procedures and on indications for intervention. * Knowledge and experience with intravascular

ultrasound, intracoronaryflow or intracoronary pressuremeasurements in at least 30 cases, aswell

as the interpretation ofthe findings (level of evidence C).

* Knowledgeof PCI with different techniques such asrotablation,directional atherectomy, devices for thrombusremoval,devices for preventionofdistal embolisation, as well as the indications for these procedures.

* Knowledge of special procedures, such as valvuloplasty, closure of ASDs, PFOs and ODBs, removalof foreign bodies and peripheral

inter-ventions.

* Knowledgeof comorbid conditionsof the patient that increase therisk of the procedure, including measureswhich should be undertaken to reduce thecomplications in thesespecificsituations. * Knowledge ofadvanced life support,

pharma-cological interventions, such as anticoagulants and

antithrombotics,treatmentofno-reflow phenomena

and thedifferentdrugsused in this setting. * Knowledge of the indications for, and experience

with, insertion ofan intra-aortic balloon pump and alternative forms ofhaemodynamicsupport, as well asthepotential complications.

* Participation inon-call dutiesunder close

super-vision.

During andatthe endofthetraining

* Performingatleast 300 interventions within one to twoyears, with 200 of these as first operator

(levelof evidenceC).

* Theduration of the training is one yearfull-time,

oratwo-yearperiodwith at least50%of the time involvedininterventionalcardiology.

* The training isformally evaluated at sixmonthly

intervals.

* After six months of training in interventional

cardiology,anevaluation shouldbe carried outby

theprogramme directoras towhether the trainee has made the requiredprogress intechnical skills andknowledge,and is suitable to continue training

ininterventionalcardiology.

After 12 months the progress is evaluated and, in consultation with the trainee, the programme can be extendedforupto twoyearstoenable the trainee to

fulfil alltherequirements.If theprogramme isbeing followedpart-time,the duration ofthe training will beprolongedprorata. Inall cases, the training hasto

becompletedwithin two years.

Qualification

of the interventionalcardiologist Oral and written endorsement is neededfrom the director of the interventional cardiology training

programme that the trainee has fulfilled all the

requirements of the training. After fulfilling all the trainingrequirements, a request for certification can be sent to the committee on interventional cardiology,

withrepresentatives from the WIC and NVVC, which is to be installed.Thiscommittee will be formalised by theConciliumCardiologicuminthe near future. Continuing education andoperator competence

Oncequalifiedasaninterventionalcardiologist, itis

important that the cardiologist continues to carry out PCIs on aregular basis for the maintenance of com-petence and technical skills. Several studies have identified procedural volume as a determining factor for the rate ofcomplicationswith PCI (level ofevidence B).Low-volume operators inhospitalswith anannual volume of<200 to 400 PCI cases a year have a greater incidence of complications in comparison with hospitals where more procedures areperformed (level

ofevidence

B).2"'8'9

Improvedoutcomes wereidentified

with athreshold valueof150 to 200proceduresper operator. However,proceduralvolume isonlyoneof manyfactors contributing to thevariabilityofmeasured

outcomes.'0-'2Caseselection is apotentialpitfallinthe evaluationofcomplication ratesofcoronary

inter-ventions.'3

Operators in hospitals without surgical backup on-site tend toperformlesscomplicated inter-ventionalprocedures. The success rates of coronary interventionsover time have progressively improved

despiteanincreaseinprocedural difficulty,andmore

comorbid disease.8 Part of this success is due to technical improvements in interventional devices,

which often require additional technical skills and

knowledge.Forthat reasoninterventionalprocedures

should be a substantial part of the duties of an

interventionalcardiologist.Operators shouldregularly

seek the help and advice of other interventional

cardiologiststoguaranteeoptimalpatient care.Sharing

experienceswithcolleaguesis animportant issuewithin interventional centres, both formallyandinformally

to

optimise

the processoflearningnewtechniquesand

tackling

new

complications.5"8

Requirementshave been

derived from literature and adapted to the Dutch situation.1-6,8

Requirements for interventional cardiologists * Performingatleast 150 cases a year as first operator

(levelof evidenceC).

* Participationinon-callduties on aregularbasis. * Theoperatorshouldperform aminimum of 30

casesofprimaryPCIforacutemyocardial infarction

annually

(levelof evidence

B).'

* During afive-year periodanexperiencedoperator (>1000 PCIs) may

perform

lessproceduresfor one

ortwoyears,but the total number ofprocedures duringthose five years shouldbe at least 500(level

of evidenceC).3

* Participation in a team with cardiac surgeons to discuss indications for intervention on aregular basis,atleast25timesayear.

NcthcrlandsHeartJournal,Volume13,Number11,November2005 C 418

* Registrationof allprocedures with respect to the baseline features of thepatient, procedure time (from the first puncture to removal of the guiding catheter), fluoroscopy times, material used, outcomeandcomplicationsof the procedure in a certifiedformat.

* Participation in meetings on interventional complicationswithin the institution, four times a year, todiscuss complications ofPCI, new develop-ments, and technologies within interventional cardiology.

* It is strongly recommended to follow formal education(coursesand seminars) in interventional cardiology for at least 30 hours, every twoyears.3

* Operators should keep up to date with the

literature,with technicalimprovements, novel tech-niques, and adjunctive pharmacology in inter-ventionalcardiology.

* The requirements apply equally to cardiologists who are mainlyemployedinanoninterventional centreand who areperforminginterventional cases inthe interventional centre('guest' interventional cardiologists).

* Each operator shouldpersonallyfile all the above requirementsand recommendations for his per-sonal audit.

* Onceevery five years, or soonerdepending on the duration of the licence, avisitation committee including two interventionalcardiologists and one

cardiologistfrom thequalityboard of the NVVC willconduct a formal audit on site, to maintain the

registration.

Institutional requirements Prerequisites

Interventionalcardiology procedures are associated with potentially life-threateningor disabling

com-plications that ingeneral areinverselyrelated to the operator's and the institution's volume of patients.

Significantlyfewercomplicationsoccurred in cardiac catheterisation laboratories performing

.400

PCI procedures a year (level of evidence B).5 Conversely, low-volumehospitals were associated withhigherrates ofemergency coronary arterybypasssurgery and death. The Americanguidelines strongly discourage small surgical coronary bypass programmes to support

angioplastyprogrammes orstartingnewangioplasty

facilitiesnear towell-equipped, high-volume

angio-plasty

centres.5'6

Close cooperation with the cardiac surgeons is

essential for abalanced assessmentof thepatient's options. Elective or acute interventionalprocedures

shouldcontinuouslybecomparedwith standardsof cardiac surgery.Appropriateuseof newtechnologyis

recommendedtokeepuptodate with moredifficult

procedures. Covered stents, drug-eluting stents, intracoronary pressure measurements, intracoronary

ultrasound,anddistal protection have been provento

be of benefit in certain subpopulations of patients. These devices and technology should be readily available.

Allprocedures should be registered in a database, which should at least contain thefollowing:indication for the procedure, the technique performed and materialsused, radiation exposure time,procedure

time(from the first puncture to removal ofthe guiding catheter), the result of the procedure in different vessels,complications in the catheterisation laboratory, coronarybypass surgery, andmortality. Preferablythere should be information at hospital discharge. The requirements are listed below and when necessary discussed per issue.

EmergencyPCI for acute myocardialinfarction PCI in theacute phase of myocardial infarction with its specificcomplications is more complex and requires even moreskillsand experience than routine PCI in the

haemodynamicallystable patient. Anexperienced PCI team(operators, assistingphysicians and nursesin a dedicated setting) isrequired for an optimal resultin

these acutelyill patients. As a consequence primary PCI for myocardial infarction should only be per-formed in centres with a full-time interventional

cardiologyschedule. If these conditions are not

ful-filled,transfer to an interventional centre that routinely

performscomplete PCI is indicated(levelofevidence

B).7"15 Regionallogistics should be improved to enable the directtransport from the patient's home to the interventional centre to decrease thedelay between onsetofsymptoms and PCI. Inaddition, transport of patients withacutemyocardialinfarction forprimary PCI overlargedistances has been proveneffectivein

comparisonwiththrombolysis (levelofevidence

A).'6"7

As the delayintime to primary PCI isrelevant,the transport timebyambulanceto aninterventioncentre

shouldideallybe less than 30 to45minutes. Availabil-ity of primary PCI within a reasonable time and the

specific geographicalsituation mayfavour the discus-sionof the start-up of a new PCI centre. However, a strategyofprehospital thrombolysisinacutemyocardial

infarction with early rescue PCI may have comparable results toprimary PCI (level of evidence B).18 Requirements for the institutions

* At leasttwofully equippedcardiac catheterisation labs withsophisticated digitalhigh-quality

radio-graphiccardiac imaging, withmulti-anglerotation and multiple image manipulation. Two cardiac catheterisation labsare requiredto ensure a

con-tinuingserviceinthecaseof breakdownorduring

servicing(levelof evidenceC). Furthermore,this

willallowfasteraccess tothecathlab for emergency patients.

* Full facilities forcardiopulmonary support and

proceduresundergeneralanaesthesia.

* Intra-aortic balloon pump should be readily

available(levelof evidenceB).

* State-of-the art intravascular ultrasound has to be onhand.

* Physiological measurement systems and

instruments for intracoronary pressure or flow measurements by wire technology (level of evidence B).

* Radiation protection programme to comply with

optimalradiationsafetymeasures.

* Extensive stock and choice of guiding catheters,

balloons,stents, wires andspecialdevices. * Adequate adjunctive medication, such as

IIb/AlIa

inhibitors, must be readily available.

* On-call serviceavailable 24 hours a day, 7 days a week.

* During procedures during on-call hours, an interventional cardiologist and two additional members of the cardiac catheterisation staff (two trainednurses,oronetrained nurseincombination with oneradiologyassistant ortechnical assistant) should be present.

* Allcentresshould have thecatheterisationlaboratory

operationalwithin 30 minutesafter notification for acuteprocedures.

* Each centre should have at least four certified operators to ensure continuityof service and also because of theon-calldemands(levelofevidence C).

* Themirnimumnumberofproceduresinthespecific

Dutch situation should not be less than 600 a year (see also'Requirements for starting interventional

centres').

* For emergencyPCI,externalcommunication and

in-hospital logistics are important for fast and dedicated care. Inpatients with acutemyocardial

infarction,efforts should be made toaccomplisha

'door-to-balloontime' ofnomorethan 30 minutes

inpatients who aretransferred and nomorethan 60 minutes inpatientsprimarilyseenatthe centre's ownemergencycaredepartment(levelofevidence B).7,19,20

* Surgical on-site backup is a heavily debated

subject.21'22

Emergency coronarybypass surgery has been reduced to less than 1.5% of the procedures by the use of stents. In patients sub-mittedfor PCIintheacute phaseofmyocardial infarction, emergency surgery is sometimes

needed because oflife-threateninganatomy or

suboptimalresults ofPCI. Because the intervalto

surgicalrevascularisation may takesometime(on

the basisof first available operation room),it is essential to undertake high-risk PCI in close

contact with the cardiac surgeon. Although

worldwide, a number of centres provide

angio-plastywithout on-sitesurgical backup,itshould beconsideredasuboptimal choice,but sometimes

acceptablegiven thegeographical considerations.5

Therefore, the preferred and recommended

Dutch situationis tohavecardiacsurgery on-site,

although this is no longer a prerequisite.

Immediate discussions with the cardiac surgeons in thecardiaccatheterisation lab are possible on a 24 hours aday, 7 days a week basis. This issue can beaccomplished by phone and in the future

by immediate image transmission by secured

internet communication.

* Regular meetings with the cardiac surgeons to discuss indications for interventional cardiology, cardiac surgery or medical therapy to reach aformal

writtentherapeutic decision are necessary forall

nonacute patients, with a copy to the referring cardiologist.

* Organisation of written and/or oral information about theinterventionalprocedure to the patient, including clear andcomprehensive information about the advantages and disadvantages and

possible

alternativesfor thisprocedure.Thisshould alsoinclude the presence ofsurgicalcoverage. * Postproceduralcare isan important partofthe PCI

procedure. Patient selection forearly discharge

versus close electrocardiographic and

haemo-dynamicmonitoring is important. There should be protocols for sheath removal, mobilisation,

postprocedural medication and how to manage

bleeding complications. General instructions should be given on risk-factormodificationand the medication forsecondary prevention should be checked.

*

Participation

ina

nationwide registration

systemof

PCI set upbythegovernmentincooperation with

theNVVC,NVT and NHS.

Requirements for starting

Interventlonal

centres

Institutions with orwithout cardiac surgery on-site that want to startaPCIprogramme mustfulfilall the requirements mentioned above within a three-year period.

Beforethe start

* Forthe acceptance of new centres, the need from ageographical standpoint (spreadofinterventional

cardiologycentresintheNetherlands) hasto be substantiated.

* There has to be a formalcooperation agreement with oneofthe existing interventional centres

(car-diologyand cardiac surgery) for the purposes of supervision, support,back-up,andtraininginthe initialphase. There has to be agreement about indications for emergencyreferral,procedures in

high-riskcasesrequiringsurgicalback up on-site, organisation of meetings for discussions on

in-dications for PCI and joint meetings on

com-plications.Theseprocedureshave to bedescribed

inprotocols. Thesupervising centre has cardiac surgeryonsite and has beenperformingatleast 800 PCIs a year for at least five years. The supervising centre should be abletocontinuewith

apatientloadofmorethen 800patientsayearafter

full

developmentofthenewPCIcentre.The

super-NetherlandsHeartJourmal,Volume13, Number11,November2005 C

vising centreshould be located nofurther than 30 to45 minutestransport time by ambulance in case of referral for emergency PCI or emergency

surgery.

* Thecentre has to demonstrate that 400 PCIs can bereached within two years and 600 PCIswithin three tofive years on the basis of the number of PCIsthat are generated by the centre itself, added tothe numberof PCIs thatwillbe referredfrom other centres. The willingness and extent of cooperationofthosereferringcentreswith the new centre has to obtained in writing.

* Based on a national population of 16,000,000 and a total of 20 interventional centres, the average adherent population at present is calculated as 800,000people. Correcting for a growth in the number of centres the minimum adherentpopulationfor a centre is set at 600,000 people.

At thestart

* At least twoexperienced and certified operators are

employedby the institution.

* At least twofullyequipped cardiaccatheterisation labswith sophisticated digital high-quality radio-graphic cardiac imaging, withmulti-angle rotation andmultipleimagemanipulation.

* Full facilities for cardiopulmonary support and

proceduresunder general anaesthesia. * Intra-aorticballoon pump.

* State-of-the-art intravascular ultrasound system has tobe onstand-by.

* Physiological measurement systems and

instrumen-tationfor intracoronary pressure or flow measure-mentsby wire technology.

* Radiation protection programme to comply with

optimalradiationsafetymeasures.

* Adequate stock and sufficient choiceof guiding

catheters,balloons,stents, wiresandspecialdevices. * Adequate adjunctive medication, such as

IIb/AIIa

inhibitors,mustbereadilyavailable.

Duringtheestablishmentofacentre

* On-callserviceavailable24hours aday, 7 days a week should beorganisedandeffective within two yearsfrom the start. Until that time a programme

during office hours is acceptable. For urgent procedures outside office hours, patients will be

transportedtothesupervising centre.

* The centre should have the catheterisation labora-toryoperationalwithin30minutesafter notification ofanacuteprocedure.

* Number ofoperators: minimallythree at the end of year two andminimallyfour at the end ofyear three.

* Numberofprocedures:forcentresthat are starting

aninterventional programme the numbermight

beaslowas400 cases ayear aftertwoyears(level

ofevidence

B).5",5

Requirements forInterventional centresproviding

training

Centres thatprovide a formal training ininterventional cardiology have to meet additionaldemands.4'7

* Thedirector of the educational programme, who is theofficial supervisor, should be an interventional cardiologist who has performed the required number ofprocedures and has at least five years experience. Thisindividual should also have dem-onstratedskillsinteaching and have experience in research,demonstrated by a thesis in the cardio-vascular field.

* The institution provides full level A education in cardiology andpreferably also in cardiac surgery. * Interventionalcardiology is organised in a

state-of-the-art manner according to the guidelines

described here.

* Active scientific research in interventional

car-diologyispossible and will be stimulated. * The centre has at least four cardiologists who

participateintheinterventionalproceduresastheir predominant task.

* Cardiac surgery andinterventional radiologyare on-site.

* The institutionperformsatleast 800 interventional procedures a year.

* The technical and nursing staff of the cardiac catheterisationlaboratory are veryexperiencedand there mustbe agood'learning' atmosphere.

* Registration facilities are a necessary prerequisite to allowpersonaland institutional audits.

* Training centres in interventional cardiology will have thesamevisitationprocedures asfillllevel A centreswith trainingprogrammes incardiology. Certiflcation, personalandInstitutionalaudits To maintain a high quality of care, standards for training and performing interventional cardiology procedures willbeimplemented.Avisiting committee within thequalitycontrolboard of the NVVC will be established with professionals in the field of inter-ventionalcardiology together with a member of that board toprovidethe institutionaland individual audit

ona timebasesimilartocurrent visitationoftraining centresincardiology.The committeewill also review outcomesof theproceduresinrelationtoindications for theprocedure. Further,thecommitteewill examine whether theindividual operator and the institution

fuilfil minimal requirements as formulated in the

guidelinesfor interventional cardiologyand whether thereareshortcomingsinpatientcare.The committee may suggestchangesincare tothe localinterventional group and to the management of the institution, or

advice on mattersthathave notbeen introducedor

implementedfor variousreasons.Also,thisnew

com-mittee will be

qualified

to certify trainees in inter-ventionalcardiology,traininginstitutionsand may have

a role in approving institutions for interventional

cardiology. Current institutionsand operatorsin

ventional cardiology will have a retrograde certification for the next five years. Not only are the local hospital factors important but also regional factors must have animportant impact inapprovalofinstitutional com-petence for interventional cardiology to ensure adequate patientload andlogisticson aregional basis. For patientswith heart disease in the Netherlands, regulation of certification is one of the guarantees for

appropriate interventionalcareby properlytrainedand educated interventionalcardiologists.Formalregulation isawaited. U

Rfernces

1 BonnierJJRM, David G, deBoerMJ,etal. Interventional

car-diology II, clinical, procedural and institutional competence. GuidelinesinCardiology, 1994 Mediselect bv, Amersfoort, the Netherlands.

2 Hirschfield JW, JR Ellis SG,Faxon DP.Recommendationsfor the assessmentandmaintenanceofproficiencyincoronary inter-ventional procedures: Statement of the American College of Cardiology.JAmColl Cardiol 1998;31:722-43.

3 Quality managementinthecardiac catheterisation laboratory. Policies and guidelines established by thesociety for cardiac angiography and interventions. Monograph 1999 SCAI 5' edition, Society forCardiac Angiography and Interventions.

4 Jointworking grouponcoronaryangioplasty ofthe British Cardiac Society and British Cardiovascular Intervention Society. Coronary angioplasty: guidelines for good practice and training. Heart 2000;83:224-35.

5 SmithSC,DoveJT,Jacobs AK, KennedyJW,KereiakesD,Kern

MJ,etal.ACC/AHA guidelines for percutaneous coronary inter-vention (Revision of the 1993 PTCA guidelines) Executive summary.Circulation 2001;103:3019-41.

6 BashoreTM,BatesER,Berger PB, Clark DA, Cusma JT, Dehmer GJ,etal.Cardiac catheterizationlaboratory standards. A report of theAmericancollege ofcardiology task forceonclinical expert

consensusdocuments. JAmCoil Cardiol 2001;37:2170-214.

7 Vande Werf F, Ardissino D,BetriuA, Cokkinos DV, Falk E,Fox

KA,etal.Managementofacutemyocardial infarctioninpatients presenting withST-segment elevation. The task forceonthe managementofacutemyocardial infarction of the European societyofcardiology.EurHcartJ2003;24:28-66.

8 Silber S, Albertsson P, Aviles FF,CamiciPG, Colombo A, Hamm C,etal. Guidelines for percuteaneous coronaryinterventions. Eur

HeartJ2005 26:804-47.

9 Hirshfeld JW Jr,BanasJS Jr,Brundage BH, Cowley M, Dehmer

GJ,Ellis SG,etal.AmericanCollegeofCardiologytraining state-ment onrecommendationsfor thestructureofanoptimal adult interventional cardiology training program: a report of the AmericanCollege of Cardiology task forceonclinicalexpert

con-sensusdocuments. JAmCoilCardiol 1999;34:2141-7.

10 EpsteinAJ,RathoreSS,Volpp KGM, KrumholzHM.Hospital percutaneousinterventionvolume andpatientmortality,1998 to 2000: Does theevidence support current procedurevolume

minimums?JAmCoilCardiol2004;43:1755-62.

11 KimmelSE,BerlinJA,LaskeyWKY The relationship between

coronaryangioplasty procedure volume andmajorcomplications. JAMA 1995;274:1137-42.

12 McGrath PD, Wennberg DE, Dickens JD Jr, Siewers AE, Lucas FL,MalenkaDJ, etal. Relation between operator and hospital volume andoutcomesfollowingpercutaneous coronary inter-ventions intheeraof thecoronary stent. JAMA 2000;284:3139-44.

13 Brown DL.Analysis ofthe institutional volume-outcome relations fbr balloon angioplasty andstenting in thestent era inCalifornia.

AmHeartJ2003;146:1071-6.

14 BlockPC, Peterson ED, Krone R,KeslerK, Hannan E,O'Connor GT, etal. Identification ofvariables neededtoriskadjustoutcomes

ofcoronaryinterventions:evidence based guidelinesforefficient data collection. JAm CoUCardiol1998;32:275-82.

15 MagidDJ,CalongeBN,RumsfeldJS, Canto JG,FrederickPD, Every NR, etal., for the NationalRegistryofMyocardial Infarction

2and3Investigators.Relation betweenhospitalprimary

angio-plasty volume and mortality forpatientswithacuteMItreated with

primaryangioplasty vs.thrombolytic therapy.JAMA 2000;284: 3131-8.

16 CantoJG, Every NR,MagidDJ, RogersWJ, Malmgren JA, FrederickPD, etal. Thevolume ofprimary angioplasty procedures and survival afteracutemyocardial infarction. National Registry ofMyocardial Infarction 2 investigators.NEnglJMed2000;342: 1573-80.

17 WidimskyP, BudinskyT,Vori D, Groch L,Zelizko M,Aschermiann

M, etal. onbehalf of thePRAGUEStudyGroup Investigators. Longdistance transportforprimaryangioplastyvs.immediate thrombolysisinacutemyocardial infarction:Finalresultsof the randomized national multicentre trial-PRAGUE-2.EurHeartJ 2003;24:94-104.

18 Andersen HR, Nielsen TI,RasmussenK,Thuesen L,Kelback H, ThayssenP, etal. for the DANAMI-2Investigators.Acomparison

ofcoronaryangioplasty with fibrinolytic therapyin acute

myo-cardial infarction.NEnglJMcd2003;349:733-42.

19 BonnefoyE,LapostolleF, LeizoroviczA,StegG,McFaddenEP,

Dubien PY,etal for theComparisonofAngioplasty and

Pre-hospital ThromboysisinAcuteMyocardialInfarctionstudygroup. Primaryangioplastyversusprehospital fibrinolysisin acute

myo-cardial infarction:arandomised study.lancet2002;360:825-9.

20 De LucaG, Suryapranata H, Ottervanger JP, AntmanEM.Time DelaytoTreatment andMortalityinPrimary Angioplasty for Acute Myocardial Infarction:EveryMinute of Delay Counts.

Circula-tion2004;109:1223-5.

21 AntoniucciD, ValentiR,Migliorini A, Moschi G, TrapaniM, Buonamici P, et al.Relation oftime to treatmentandmortalityin

patients withacutemyocardial infarction undergoing primary cor-onaryangioplasty.AmJCardiol2002;89:1248-52.

22 Singh M, TingHH, BergerPB,GarrattKN, Holmes DRJr, Gersh

BJ.Rationaleforon-sitecardiacsurgeryfor primary angioplasty:

atime for reappraisal. JAmColl Cardiol 2002;39:1881-9. 23 DehmerGJ,Gantt DS.Coronary intervention athospitals without

on-sitecardiacsurgery:Arewepushingtheenvelopetoofar?JAm

Coll Cardiol2004;43:343-5.