SPECIAL ARTICLE

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. ten Berg, A.J. van Boven, M.J. de Boer,J.J. Piek, G.V.A. van Ommen, J.G.F. Bronzwaer, P. Smits, J.W. Deckers

Interventional cardiology is an expanding fieldwithin cardiovascular medicine and today it isgenerally accepted that cardiologists require speifictraining, knowledge and skills. Hospitals wherecoronary interventions are performed must beproperly equipped and able to provide speaalisedcare. Percutaneous coronary interventions arefrequently used for coronary revascularisation. Thepublic should have confidence in the uniformityofhigh quality care. Therefore, such quality ofcareshould be maintained by certification of theindividual operators, general guidelines forinstitutional requirements and formal audits. TheNetherlands Society ofCardiology (NVVC) will beimplementing a new registration system for car-diologists with a subspeialisation that will induderegistration for interventional cardiology. TheNVVC asked theWorking Group ofInterventionalCardiology (WIC) to update the 1994 Dutchguidelines on operator and institutional com-petence, and requirements for training in inter-ventional cardiology in order to incorporate theminto the official directives.' The present guidelinesrepresent the expert opinion of the Dutch inter-

W.R.M. AengovaerenJ.M. ten BergA.J. van BovenJ.W. DeckersGuideline committee for interventional cardiologyGJ. LaarmanMJ. SuttorpMJ. de BoorJ.J. PhekG.V.A. van OmmenJ.G.F. BronzwaorP. SmltsWorking Group of Interventional Cardiology

Correspondence to: W.R.M. AengevaerenUniversity Medical Centre Nijmegen, PO Box 9101,6500 HB NijmegenE-mail: w.aengevaeren@cardio.umcn.nl

ventional cardiology community and are inaccordance with international regulations.2-7After two rounds of discussion, the NVVCapproved the guidelines in November 2004 duringthe autumn meeting. (NethHeartJ2005;13:416-22.)

Keywords: guidelines, interventional cardiology,cardiovascular medicine

Dutch interventional cardiology is characterised bya limited number of high-volume intervention

centres with experienced operators. In 2003 theaverage number of procedures per centre was morethan 1500. In general, a high-volume load foroperators and institutions is associated with betteroutcomes for procedures.26 In the interventionalcommunity, the Dutch situation is considered ideal,and it serves as an example of how interventionalcardiology should be organised. The recent expansionwith new interventional centres (Alkmaar, Enschede,Leeuwarden, Rotterdam-Zuid, The Hague andArnhem) means that a rather complete geographicalspread has been reached, which is especially importantfor rapid treatment of acute myocardial infarction.The present capacity should be sufficient for the nextdecennium, while assuring a high volume load percentre. The purpose of these guidelines is to ensureand maintain a high quality in interventional car-diology in the Netherlands. Extensive discussions havebeen held within theWIC and with representatives ofthe NVVC about the numbers of procedures thatneed to be performed in the different sectionsmentioned in these guidelines. These numbers maydeviate to some extent from guidelines in othercountries, but guidelines are always adapted to localinsights and expertise in a way that is practical anddesirable in the specific situation. Included in thescope ofinterventional cardiology are techniques usedfor percutaneous coronary interventions, but also abroader group of percutaneous techniques forprocedures involving the myocardium, cardiac valves,

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Dutch guidelines for interventional cardiology: institutional and operator competence and requirements for training

shunts, large thoracic vessels and peripheral vesselssuch as the carotid arteries. Specific expertise and adedicated setting are often required for the lattergroup ofpercutaneous interventions. The majority ofthe interventions involve treatment ofstenoses in thecoronary system. Formerly known as percutaneoustransluminal coronary angioplasty (PTCA), these pro-cedures are now referred to by the more appropriateterm percutaneous coronary interventions (PCI).These guidelines are based on scientific publicationsand expert opinion. Results ofpublished studies mayhave a number of limitations for common practicebecause ofselection and publication bias, differencesin medical practice, patient characteristics andgeographic factors. Moreover, conclusions and state-ments may become outdated due to rapid develop-ments in interventional cardiology.5 6 The strength ofevidence in this paper is rated according to three levels,similar to the guidelines of the European Society ofCardiology.7* Level of evidence A: Data derived from multiple

randomised clinical trials or meta-analyses.* Level of evidence B: Data derived from a single

randomised trial or non-randomised studies.* Level of evidence C: Consensus opinion of the

experts.

Coronary interventional procedures are complex andtechnically demanding. Optimal performance requiresan extensive knowledge and substantial technical skills.Complications ofcoronary interventions are becomingless frequent, but optimal outcome depends on properrecognition and management. The new developmentsin pharmacological therapy, technical improvements,novel techniques, medical approaches together withan increasing complexity ofcases mean that individualoperators need to undertake continuous educationand invest time and interest in ensuring safe andappropriate patient care. Besides operator experience,institutional factors are important for the success oftheprocedures, such as the radiographic equipment,adequately trained and experienced nursing andtechnical staff, hospital facilities, patient logistics,patient load and adherence to protocols. Diagnosisand treatment ofarrhythmias (electrophysiology) is aseparate subspecialisation within cardiology and is notincluded in these guidelines. Neither do the guidelinesprovide information about indications or performanceof the procedures; these issues are addressed in therecently published guidelines for percutaneouscoronary interventions of the European Society ofCardiology.8

Training requirements for the InterventionalcardiologistThe results of PCIs in terms of success and com-plication rates are related to the operator's expertise,case selection, clinical judgement and technical skills.It is obvious that patients undergoing these procedures

should be confident that the operator and nursing staffare skilled and well trained. During the training, aninterventional cardiologist is required to perform a setminiimum number of procedures as first operator togain enough practical experience.

Requirements to be met before starting officialtraining in interventional cardiology* Registration as a cardiologist and completion of a

course on radiation safety with certification (level4A).

* Thorough knowledge of the anatomy andphysiology of the large vessels and coronarycirculation.

* A minimum of 300 diagnostic cardiac catheter-isations as first operator (level ofevidence C)."13

* The training has to be followed in a centre that iscertified for training in interventional cardiology(see Requirements for interventional centresproviding training).

* Literature study of interventional cardiology.Specific requirements will be formulated in the nearfuture.

* Positive attitude towards working together andsharing experiences with interventional and non-interventional colleagues, and the technical andnursing staffofthe cardiac catheterisation laboratory.

During the training* Attendance ofat least one established international

course in interventional cardiology (PCRor TCT).* Participation in a national course on interventional

cardiology with an examination. (This course willbe developed in the near future).

* As in any surgical procedure, percutaneouscoronary interventions require a high degree ofdexterity to obtain vascular access and technicalskills to manipulate and operate a variety ofcathetersand devices in the circulation. Most of these skillscan only be acquired by training in actual pro-cedures.

* Knowledge of indications for PCI in differentclinical conditions, in relation to conservative/medical treatment and surgical approaches.

* Knowledge ofall potential complications, includingcontrast reactions, bleeding complications, andprimary management ofthese complications.

* Knowledge of the advantages and disadvantagesofvarious arterial access sites and related techniquesfor haemostasis and the ability to perform diag-nostic and interventional procedures via these accesssites.

* Knowledge of interventional techniques andfeatures ofvarious materials, such as balloons, wiresand stents.

* A wide case mix should be treated, including alltypes of coronary lesions and conditions, acutemyocardial infarction and haemodynamically un-stable patients.

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Dutch guidelines for interventional cardiology: institutional and operator competence and requirements for training

* Frequent participation in team discussions with thecardiac surgeons on evaluation of diagnosticprocedures and on indications for intervention.

* Knowledge and experience with intravascularultrasound, intracoronary flow or intracoronarypressure measurements in at least 30 cases, as wellas the interpretation of the findings (level ofevidence C).

* Knowledge ofPCI with different techniques suchas rotablation, directional atherectomy, devices forthrombus removal, devices for prevention ofdistalembolisation, as well as the indications for theseprocedures.

* Knowledge of special procedures, such asvalvuloplasty, closure ofASDs, PFOs and ODBs,removal of foreign bodies and peripheral inter-ventions.

* Knowledge ofcomorbid conditions ofthe patientthat increase the risk of the procedure, includingmeasures which should be undertaken to reducethe complications in these specific situations.

* Knowledge of advanced life support, pharma-cological interventions, such as anticoagulants andantithrombotics, treatment ofno-reflowphenomenaand the different drugs used in this setting.

* Knowledge of the indications for, and experiencewith, insertion ofan intra-aortic balloon pump andalternative forms ofhaemodynamic support, as wellas the potential complications.

* Participation in on-call duties under close super-vision.

During and at the end of the training* Performing at least 300 interventions within one

to two years, with 200 of these as first operator(level ofevidence C).

* The duration of the training is one year full-time,or a two-year period with at least 50% ofthe timeinvolved in interventional cardiology.

* The training is formally evaluated at six monthlyintervals.

* After six months of training in interventionalcardiology, an evaluation should be carried out bythe programme director as to whether the traineehas made the required progress in technical skillsand knowledge, and is suitable to continue trainingin interventional cardiology.

After 12 months the progress is evaluated and, inconsultation with the trainee, the programme can beextended for up to two years to enable the trainee tofulfil all the requirements. If the programme is beingfollowed part-time, the duration of the training willbe prolonged pro rata. In all cases, the training has tobe completed within two years.

Qualification of the interventional cardiologistOral and written endorsement is needed from thedirector of the interventional cardiology trainingprogramme that the trainee has fulfilled all the

requirements of the training. After fulfilling all thetraining requirements, a request for certification can besent to the committee on interventional cardiology,with representatives from the WIC and NVVC, whichis to be installed. This committee will be formalisedby the Concilium Cardiologicum in the near future.

Continuing education and operator competenceOnce qualified as an interventional cardiologist, it isimportant that the cardiologist continues to carry outPCIs on a regular basis for the maintenance of com-petence and technical skills. Several studies haveidentified procedural volume as a determining factorfor the rate ofcomplications with PCI (level ofevidenceB). Low-volume operators in hospitals with an annualvolume of<200 to 400 PCI cases a year have a greaterincidence of complications in comparison withhospitals where more procedures are performed (levelofevidence B).2"'8'9 Improved outcomes were identifiedwith a threshold value of 150 to 200 procedures peroperator. However, procedural volume is only one ofmany factors contributing to the variability ofmeasuredoutcomes.'0-'2 Case selection is a potential pitfall in theevaluation of complication rates of coronary inter-ventions.'3 Operators in hospitals without surgicalbackup on-site tend to perform less complicated inter-ventional procedures. The success rates of coronaryinterventions over time have progressively improveddespite an increase in procedural difficulty, and morecomorbid disease.8 Part of this success is due totechnical improvements in interventional devices,which often require additional technical skills andknowledge. For that reason interventional proceduresshould be a substantial part of the duties of aninterventional cardiologist. Operators should regularlyseek the help and advice of other interventionalcardiologists to guarantee optimal patient care. Sharingexperiences with colleagues is an important issue withininterventional centres, both formally and informallyto optimise the process oflearning new techniques andtackling new complications.5"8 Requirements have beenderived from literature and adapted to the Dutchsituation. 1-6,8

Requirements for interventional cardiologists* Performing at least 150 cases a year as first operator

(level ofevidence C).* Participation in on-call duties on a regular basis.* The operator should perform a minimum of 30

cases ofprimary PCI for acute myocardial infarctionannually (level ofevidence B).'

* During a five-year period an experienced operator(>1000 PCIs) may perform less procedures for oneor two years, but the total number of proceduresduring those five years should be at least 500 (levelofevidence C).3

* Participation in a team with cardiac surgeons todiscuss indications for intervention on a regularbasis, at least 25 times a year.

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Dutch guidelines for interventional cardiology: institutional and operator competence and requirements for training

* Registration of all procedures with respect to thebaseline features of the patient, procedure time(from the first puncture to removal ofthe guidingcatheter), fluoroscopy times, material used,outcome and complications of the procedure in acertified format.

* Participation in meetings on interventionalcomplications within the institution, four times ayear, to discuss complications ofPCI, new develop-ments, and technologies within interventionalcardiology.

* It is strongly recommended to follow formaleducation (courses and seminars) in interventionalcardiology for at least 30 hours, every two years.3

* Operators should keep up to date with theliterature, with technical improvements, novel tech-niques, and adjunctive pharmacology in inter-ventional cardiology.

* The requirements apply equally to cardiologistswho are mainly employed in a noninterventionalcentre andwho are performing interventional casesin the interventional centre ('guest' interventionalcardiologists).

* Each operator should personally file all the aboverequirements and recommendations for his per-sonal audit.

* Once every five years, or sooner depending on theduration of the licence, a visitation committeeincluding two interventional cardiologists and onecardiologist from the quality board of the NVVCwill conduct a formal audit on site, to maintain theregistration.

Institutional requirements

PrerequisitesInterventional cardiology procedures are associatedwith potentially life-threatening or disabling com-plications that in general are inversely related to theoperator's and the institution's volume of patients.Significantly fewer complications occurred in cardiaccatheterisation laboratories performing .400 PCIprocedures a year (level of evidence B).5 Conversely,low-volume hospitals were associated with higher ratesofemergency coronary artery bypass surgery and death.The American guidelines strongly discourage smallsurgical coronary bypass programmes to supportangioplasty programmes or starting new angioplastyfacilities near to well-equipped, high-volume angio-plasty centres.5'6

Close cooperation with the cardiac surgeons isessential for a balanced assessment of the patient'soptions. Elective or acute interventional proceduresshould continuously be compared with standards ofcardiac surgery. Appropriate use ofnew technology isrecommended to keep up to date with more difficultprocedures. Covered stents, drug-eluting stents,intracoronary pressure measurements, intracoronaryultrasound, and distal protection have been proven to

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

All procedures should be registered in a database,which should at least contain the following: indicationfor the procedure, the technique performed andmaterials used, radiation exposure time, proceduretime (from the first puncture to removal ofthe guidingcatheter), the result of the procedure in differentvessels, complications in the catheterisation laboratory,coronary bypass surgery, and mortality. Preferably thereshould be information at hospital discharge. Therequirements are listed below and when necessarydiscussed per issue.

Emergency PCI for acute myocardial infarctionPCI in the acute phase of myocardial infarction withits specific complications is more complex and requireseven more skills and experience than routine PCI in thehaemodynamically stable patient. An experienced PCIteam (operators, assisting physicians and nurses in adedicated setting) is required for an optimal result inthese acutely ill patients. As a consequence primaryPCI for myocardial infarction should only be per-formed in centres with a full-time interventionalcardiology schedule. If these conditions are not ful-filled, transfer to an interventional centre that routinelyperforms complete PCI is indicated (level ofevidenceB).7"15 Regional logistics should be improved to enablethe direct transport from the patient's home to theinterventional centre to decrease the delay betweenonset ofsymptoms and PCI. In addition, transport ofpatients with acute myocardial infarction for primaryPCI over large distances has been proven effective incomparison with thrombolysis (level ofevidence A).'6"7As the delay in time to primary PCI is relevant, thetransport time by ambulance to an intervention centreshould ideally be less than 30 to 45 minutes. Availabil-ity of primary PCI within a reasonable time and thespecific geographical situation may favour the discus-sion of the start-up of a new PCI centre. However, astrategy ofprehospital thrombolysis in acute myocardialinfarction with early rescue PCI may have comparableresults to primary PCI (level ofevidence B).18

Requirements for the institutions* At least two fully equipped cardiac catheterisation

labs with sophisticated digital high-quality radio-graphic cardiac imaging, with multi-angle rotationand multiple image manipulation. Two cardiaccatheterisation labs are required to ensure a con-tinuing service in the case ofbreakdown or duringservicing (level of evidence C). Furthermore, thiswill allow faster access to the cathlab for emergencypatients.

* Full facilities for cardiopulmonary support andprocedures under general anaesthesia.

* Intra-aortic balloon pump should be readilyavailable (level of evidence B).

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Dutch guidelines for interventional cardiology: institutional and operator competence and requirements for training

* State-of-the art intravascular ultrasound has to beon hand.

* Physiological measurement systems andinstruments for intracoronary pressure or flowmeasurements by wire technology (level ofevidence B).

* Radiation protection programme to comply withoptimal radiation safety measures.

* Extensive stock and choice of guiding catheters,balloons, stents, wires and special devices.

* Adequate adjunctive medication, such as IIb/AlIainhibitors, must be readily available.

* On-call service available 24 hours a day, 7 days aweek.

* During procedures during on-call hours, aninterventional cardiologist and two additionalmembers of the cardiac catheterisation staff (twotrained nurses, or one trained nurse in combinationwith one radiology assistant or technical assistant)should be present.

* All centres should have the catheterisation laboratoryoperational within 30 minutes after notification foracute procedures.

* Each centre should have at least four certifiedoperators to ensure continuity of service and alsobecause of the on-call demands (level of evidenceC).

* The mirnimum number ofprocedures in the specificDutch situation should not be less than 600 a year(see also 'Requirements for starting interventionalcentres').

* For emergency PCI, external communication andin-hospital logistics are important for fast anddedicated care. In patients with acute myocardialinfarction, efforts should be made to accomplish a'door-to-balloon time' ofno more than 30 minutesin patients who are transferred and no more than60 minutes in patients primarily seen at the centre'sown emergency care department (level ofevidenceB).7,19,20

* Surgical on-site backup is a heavily debatedsubject.21'22 Emergency coronary bypass surgeryhas been reduced to less than 1.5% of theprocedures by the use of stents. In patients sub-mitted for PCI in the acute phase of myocardialinfarction, emergency surgery is sometimesneeded because of life-threatening anatomy orsuboptimal results ofPCI. Because the interval tosurgical revascularisation may take some time (onthe basis of first available operation room), it isessential to undertake high-risk PCI in closecontact with the cardiac surgeon. Althoughworldwide, a number of centres provide angio-plasty without on-site surgical backup, it shouldbe considered a suboptimal choice, but sometimesacceptable given the geographical considerations.5Therefore, the preferred and recommendedDutch situation is to have cardiac surgery on-site,although this is no longer a prerequisite.

Immediate discussions with the cardiac surgeonsin the cardiac catheterisation lab are possible ona 24 hours a day, 7 days a week basis. This issuecan be accomplished by phone and in the futureby immediate image transmission by securedinternet communication.

* Regular meetings with the cardiac surgeons todiscuss indications for interventional cardiology,cardiac surgery or medical therapy to reach a formalwritten therapeutic decision are necessary for allnonacute patients, with a copy to the referringcardiologist.

* Organisation of written and/or oral informationabout the interventional procedure to the patient,including clear and comprehensive informationabout the advantages and disadvantages andpossible alternatives for this procedure. This shouldalso include the presence of surgical coverage.

* Postprocedural care is an important part ofthe PCIprocedure. Patient selection for early dischargeversus close electrocardiographic and haemo-dynamic monitoring is important. There shouldbe protocols for sheath removal, mobilisation,postprocedural medication and how to managebleeding complications. General instructionsshould be given on risk-factor modification and themedication for secondary prevention should bechecked.

* Participation in a nationwide registration system ofPCI set up by the government in cooperation withthe NVVC, NVT and NHS.

Requirements for starting Interventlonal centresInstitutions with or without cardiac surgery on-sitethat want to start a PCI programme must fulfil all therequirements mentioned above within a three-yearperiod.

Before the start* For the acceptance ofnew centres, the need from

a geographical standpoint (spread ofinterventionalcardiology centres in the Netherlands) has to besubstantiated.

* There has to be a formal cooperation agreementwith one ofthe existing interventional centres (car-diology and cardiac surgery) for the purposes ofsupervision, support, back-up, and training in theinitial phase. There has to be agreement aboutindications for emergency referral, procedures inhigh-risk cases requiring surgical back up on-site,organisation of meetings for discussions on in-dications for PCI and joint meetings on com-plications. These procedures have to be describedin protocols. The supervising centre has cardiacsurgery on site and has been performing at least800 PCIs a year for at least five years. Thesupervising centre should be able to continue witha patient load ofmore then 800 patients a year afterfull development ofthe new PCI centre. The super-

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Dutch guidelines for interventional cardiology: institutional and operator competence and requirements for training

vising centre should be located no further than 30to 45 minutes transport time by ambulance in caseof referral for emergency PCI or emergencysurgery.

* The centre has to demonstrate that 400 PCIs canbe reached within two years and 600 PCIs withinthree to five years on the basis of the number ofPCIs that are generated by the centre itself, addedto the number of PCIs that will be referred fromother centres. The willingness and extent ofcooperation ofthose referring centres with the newcentre has to obtained in writing.

* Based on a national population of 16,000,000and a total of 20 interventional centres, theaverage adherent population at present iscalculated as 800,000 people. Correcting for agrowth in the number of centres the minimumadherent population for a centre is set at 600,000people.

At the start* At least two experienced and certified operators are

employed by the institution.* At least two fully equipped cardiac catheterisation

labs with sophisticated digital high-quality radio-graphic cardiac imaging, with multi-angle rotationand multiple image manipulation.

* Full facilities for cardiopulmonary support andprocedures under general anaesthesia.

* Intra-aortic balloon pump.* State-of-the-art intravascular ultrasound system has

to be on stand-by.* Physiological measurement systems and instrumen-

tation for intracoronary pressure or flow measure-ments by wire technology.

* Radiation protection programme to comply withoptimal radiation safety measures.

* Adequate stock and sufficient choice of guidingcatheters, balloons, stents, wires and special devices.

* Adequate adjunctive medication, such as IIb/AIIainhibitors, must be readily available.

During the establishment of a centre* On-call service available 24 hours a day, 7 days a

week should be organised and effective within twoyears from the start. Until that time a programmeduring office hours is acceptable. For urgentprocedures outside office hours, patients will betransported to the supervising centre.

* The centre should have the catheterisation labora-tory operational within 30 minutes after notificationofan acute procedure.

* Number of operators: minimally three at the endofyear two and minimally four at the end ofyearthree.

* Number ofprocedures: for centres that are startingan interventional programme the number mightbe as low as 400 cases a year after two years (levelofevidence B).5",5

Requirements for Interventional centres providingtrainingCentres that provide a formal training in interventionalcardiology have to meet additional demands.4'7* The director ofthe educational programme, who

is the official supervisor, should be an interventionalcardiologist who has performed the requirednumber of procedures and has at least five yearsexperience. This individual should also have dem-onstrated skills in teaching and have experience inresearch, demonstrated by a thesis in the cardio-vascular field.

* The institution provides full level A education incardiology and preferably also in cardiac surgery.

* Interventional cardiology is organised in a state-of-the-art manner according to the guidelinesdescribed here.

* Active scientific research in interventional car-diology is possible and will be stimulated.

* The centre has at least four cardiologists whoparticipate in the interventional procedures as theirpredominant task.

* Cardiac surgery and interventional radiology areon-site.

* The institution performs at least 800 interventionalprocedures a year.

* The technical and nursing staff of the cardiaccatheterisation laboratory are very experienced andthere must be a good 'learning' atmosphere.

* Registration facilities are a necessary prerequisiteto allow personal and institutional audits.

* Training centres in interventional cardiology willhave the same visitation procedures as filll level Acentres with training programmes in cardiology.

Certiflcation, personal and Institutional auditsTo maintain a high quality of care, standards fortraining and performing interventional cardiologyprocedures will be implemented. A visiting committeewithin the quality control board ofthe NVVC will beestablished with professionals in the field of inter-ventional cardiology together with a member of thatboard to provide the institutional and individual auditon a time base similar to current visitation of trainingcentres in cardiology. The committee will also reviewoutcomes ofthe procedures in relation to indicationsfor the procedure. Further, the committee will examinewhether the individual operator and the institutionfuilfil minimal requirements as formulated in theguidelines for interventional cardiology and whetherthere are shortcomings in patient care. The committeemay suggest changes in care to the local interventionalgroup and to the management of the institution, oradvice on matters that have not been introduced orimplemented for various reasons. Also, this new com-mittee will be qualified to certify trainees in inter-ventional cardiology, training institutions and may havea role in approving institutions for interventionalcardiology. Current institutions and operators in inter-

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Dutch guidelines for interventional cardiology: institutional and operator competence and requirements for training

ventional cardiology will have a retrograde certificationfor the next five years. Not only are the local hospitalfactors important but also regional factors must havean important impact in approval ofinstitutional com-petence for interventional cardiology to ensureadequate patient load and logistics on a regional basis.For patients with heart disease in the Netherlands,regulation ofcertification is one ofthe guarantees forappropriate interventional care by properly trained andeducated interventional cardiologists. Formal regulationis awaited. U

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