View of Quality of work in catheterization laboratories: percutaneous coronary intervention

(1)

1 Intensive care unit, Franc Derganc General Hospital of Nova Gorica, Šempeter pri Novi Gorici, Slovenia

2 Department of Cardiology, Division of Internal Medicine, University Medical Centre Ljubljana, Ljubljana, Slovenia

Correspondence/

Korespondenca:

Matjaž Klemenc, e: matjaz.

klemenc@bolnisnica-go.si Key words:

catheterization

laboratories; percutaneous coronary intervention;

quality of work Ključne besede:

kateterizacijski laboratoriji;

perkutani posegi na koronarnih arterijah;

kvaliteta dela Received: 4. 2. 2019 Accepted: 21. 3. 2019

en article-lang

10.6016/ZdravVestn.2928 doi

4.2.2019 date-received

21.3.2019 date-accepted

Cardiovascular system Srce in ožilje discipline

Professional article Strokovni članek article-type

Quality of work in catheterization laboratories:

percutaneous coronary intervention Kakovost dela v kateterizacijskih laboratorijih, ki izvajajo perkutane koronarne posege

article-title

Quality of work in catheterization laboratories Kakovost dela v kateterizacijskih laboratorijih alt-title catheterization laboratories, percutaneous

coronary interventions, quality of work kateterizacijski laboratoriji, perkutani posegi na koronarnih arterijah, kvaliteta dela

kwd-group The authors declare that there are no conflicts

of interest present. Avtorji so izjavili, da ne obstajajo nobeni

konkurenčni interesi. conflict

year volume first month last month first page last page

2020 89 1 2 92 106

name surname aff email

Matjaž Klemenc 1 matjaz.klemenc@bolnisnica-

go.si

name surname aff

Matjaž Bunc 2

Igor Kranjec 2

eng slo aff-id

Intensive care unit, Franc Derganc General Hospital of Nova Gorica, Šempeter pri Novi Gorici, Slovenia

Enota za intenzivno nego, Splošna bolnišnica »dr. Franca Derganca« Nova Gorica, Šempeter pri Novi Gorici, Slovenija

1

Department of Cardiology, Division of Internal Medicine, University Medical Centre Ljubljana, Ljubljana, Slovenia

Klinični oddelek za kardiologijo, Interna klinika, Univerzitetni klinični center ljubljana, Ljubljana, Slovenija

2

Quality of work in catheterization laboratories: percutaneous coronary intervention

Kakovost dela v kateterizacijskih laboratorijih, ki izvajajo perkutane koronarne posege

Matjaž Klemenc,¹ Matjaž Bunc,² Igor Kranjec²

Abstract

Over the past 40 years, we have witnessed a remarkable development of interventional cardiology. The steadily increasing number of interventions in the coronary arteries quickly led to the need for a preset, structured recording of work in catheterization laboratories (CLs) and the establishment of quality control mechanisms. National societies of cardiology have established registries that allow comparison of work between regional CLs as well as at the international level. The Societies have also published a number of recommendations, the implementation of which ensures adequate quality and safety of interventions. The current paper describes various approaches to ensuring the quality of the work of CLs, the recommendations of the European Society of Cardiology and an overview of the relevant situation in Slovenia.

Izvleček

V preteklih 40 letih smo bili priče izjemnemu razvoju intervencijske kardiologije. Strmo narašča- joče število posegov na koronarnih arterijah je dokaj hitro privedlo do potrebe po vnaprej določe- nem, strukturiranem beleženju intervencijskega dela kateterskih laboratorijev (KL) in vzpostavit- vi mehanizmov za kontrolo kakovosti opravljenega dela. Nacionalna kardiološka združenja so zato osnovala registre posegov, ki omogočajo primerjavo dela med posameznimi KL, prav tako tudi na mednarodni ravni. Združenja so objavila tudi številna priporočila, katerih izpolnjevanje zagotavlja primerno kakovost in varnost posegov. V prispevku so opisani različni pristopi zag- otavljanja kakovosti dela KL, priporočila Evropskega kardiološkega združenja in opis stanja v Sloveniji.

Cite as/Citirajte kot: Matjaž Klemenc M, Bunc M, Kranjec I. Quality of work in catheterization laboratories:

percutaneous coronary intervention. Zdrav Vestn. 2020;89(1–2):92–106.

DOI: https://doi.org/10.6016/ZdravVestn.2928

1 Introduction

Percutaneous coronary interventions (PCIs), along with coronary artery bypass graftings (CABGs), are standard forms of myocardial revascularization. PCIs have been

Slovenian Medical

Journal

(2)

in clinical use for over 40 years (1) and have recently become more common than CABGs (Figure 1).

Regardless of the method used, myocardial revascularization should be successful and safe. PCI is considered successful when at the end of the intervention, the residual stenosis is less than 10%, the blood flow is completely normal and no major blood clots or embolization oc- curs during the procedure. (2). Significant complications of the intervention (e.g.

death, myocardial infarction [MI], rescue CABG) may occur only rarely; with scheduled procedures, in less than 2% and with urgent circumstances, in less than 4% (3).

The execution of PCIs is constantly changing and advancing; not only is the number of PCI procedures growing – they are also growing in complexity (4). PCIs are increasingly performed in institutions that do not have a permanent cardiovascular surgical service (Figure 2A), the number of treated unstable patients is increasing (Figure 2B), with interventional cardiologists tackling anatomically complex coronary stenoses (Figure 2C), often Figure 1: Frequency of percutaneous and surgical procedures on coronary arteries in years 1991 – 2014. In the last two decades, the number of percutaneous coronary interventions (PCI) has been rising sharply, while the number of surgical procedures (CABG) has been slightly declining.

Legend: CABG – Coronary artery bypass graftings, PCI – Percutaneous coronary interventions.

Taken from the British Cardiovascular Intervention Society.w

using the latest invasive diagnostic and therapeutic methods (Figure 2D). It is un- derstandable that all these changes make it increasingly difficult to ensure the expected success and safety of interventions (2,3). Catheterization laboratories (CL) must therefore be adequately equipped, interventional cardiologists trained and the patient selection in line with daily practice (3). It is essential to establish quality control mechanisms for the work performed and then make the necessary corrections at both regional and national levels (3).

The purpose of our article is to intro- duce different approaches to ensuring the quality of interventional work and to present the latest recommendations of the Eu- ropean Society of Cardiology (ESC) to the readers (6).

2 Quality control of work in catheterization laboratories

2.1 Requirements/

recommendations relating to operators (individuals)

2.1.1 Operator training

Training future specialists is a key activity and the foundation for quality medical services. What is necessary in this complex process is that curricula fit cor- responding university institutions and that there is cooperation between mentors and candidates, along with effective veri- fication of acquired knowledge. Interven- tional cardiology training is specifically focused on the comprehensive identification of cardiovascular diseases and their treatment with interventional methods.

In the United States of America (USA), they have been using a structured curriculum and certification of interventional cardiologists since 1999 (7). In contrast, in the countries of the European Union (EU), there is neither uniform training in the field of interventional cardiology nor certification of interventional cardiologists. Until recently, focused training was

(3)

compulsory only in Spain and the Czech Republic. In the recent years, the ESC, in cooperation with national cardiology associations, has been working to address this shortcoming and make it possible for trained interventional cardiologists to carry out their activities throughout the EU (8,9). The curriculum is already designed to such an extent that it can be presented in its entirety in our paper.

Every good curriculum must contain a core curriculum, along with a comprehensive set of skills that the candidate must master by the end of the specialization (5,8,9). The curriculum for interventional cardiology training consists of a number of theoretical areas that comprehensively describe the discussed cardiovascular diseases and provide the grounds for the use

Figure 2: A. Percutaneous coronary interventions (PCI) in institutions with and without a cardiovascular surgical service (CSS).

B. PCI in patients with stable (red line) and acute coronary syndrome (yellow line).

C. The proportion of PCIs in critical stenoses of the left main coronary artery (purple columns).

D. The number of newer invasive diagnostic methods. IVUS – Intravascular ultrasound, OCT – Optical coherence tomography, FFR – Fractional flow reserve.

All figures taken from the British Cardiovascular Intervention Society (BCIS).

of interventional methods (Table 1). The range of interventional skills is extensive, but at the same time very dynamic; the PCI technique is constantly being improved, and more and more other cardiovascular diseases are within reach for interventional treatment (Table 2).

Interventional cardiology training is generally included in the specialization in internal medicine. In most EU countries, it starts with the so-called “common trunk” training (1 – 2 years), continues with cardiovascular training (3 – 4 years) and concludes with interventional cardiology training (1 – 2 years) (5-8). Future interventional cardiologists must master diagnostic cardiac catheterization before they begin interventional training. The intervention programme itself consists of

Table 1: The contents of the curriculum for specialization in interventional cardiology.

The contents of the curriculum for specialization:

• Anatomy and physiology of the cardiovascular system,

• Pathophysiology of cardiovascular diseases,

• Contrast agents and medications used in interventional procedures,

• Principles of haemostasis and mechanical obstruction of vascular access,

• Angiographic techniques, radiation protection,

• Quantitative analysis of a coronary angiogram, coronary blood flow measurements, intravascular imaging techniques,

• Interventional devices,

• Patient selection, structure of interventional procedures, treatment of patients before and after procedures.

(4)

of interventional methods (Table 1). The range of interventional skills is extensive, but at the same time very dynamic; the PCI technique is constantly being improved, and more and more other cardiovascular diseases are within reach for interventional treatment (Table 2).

Interventional cardiology training is generally included in the specialization in internal medicine. In most EU countries, it starts with the so-called “common trunk” training (1 – 2 years), continues with cardiovascular training (3 – 4 years) and concludes with interventional cardiology training (1 – 2 years) (5-8). Future interventional cardiologists must master diagnostic cardiac catheterization before they begin interventional training. The intervention programme itself consists of

Table 1: The contents of the curriculum for specialization in interventional cardiology.

The contents of the curriculum for specialization:

• Anatomy and physiology of the cardiovascular system,

• Pathophysiology of cardiovascular diseases,

• Contrast agents and medications used in interventional procedures,

• Principles of haemostasis and mechanical obstruction of vascular access,

• Angiographic techniques, radiation protection,

• Quantitative analysis of a coronary angiogram, coronary blood flow measurements, intravascular imaging techniques,

• Interventional devices,

• Patient selection, structure of interventional procedures, treatment of patients before and after procedures.

four semesters. In the first semester, the candidate gets acquainted with the prepa- ration of the patient for the intervention and assists their mentor during PCIs; in the second semester, they begin to perform simple interventions; in the third semester, they perform complex PCIs together with their mentor; in the last semester, they perform all interventions independently. During the last two semesters, the candidate may undertake training also in peripheral vascular, valvular and congenital interventions (8).

The future interventional cardiologist gains appropriate experience primarily through the supervised performance of the interventions themselves, but also through educational activities and research work.

They treat both scheduled and unstable patients, and also those who require a haemodynamic support. The volume of the interventions done undoubtedly has a significant impact on the development of a skilled interventional cardiologist, but it is difficult to determine the exact number of interventions, required during training. Most believe that a candidate must perform 200–250 PCIs in the final year of training, 125 of which they must perform as first operators (5,7).

Educational activities are very important in interventional cardiology training

and they complement manual skills. Insti- tutions usually organise them in the form of regular interventional conferences. Un- der the auspices of the ESC, a comprehensive textbook on interventional cardiology has already been published, and is constantly updated with new findings (10).

Interventions are presented directly or in a suitable format at all important cardiological congresses. Specialized websites (e.g.

www.pcronline.com, www.incathlab.com, www.tctmd.com) have also appeared, providing a wide range of theoretical and practical information to all registered cardiologists; the interventions featured are accompanied also by comments from operators, commentators and the general public. The curriculum estimates for the candidates to acquire at least 240 accredited hours per year (8).

Research is a mandatory part of the subspecialization in interventional cardiology (5,7,8). Candidates can participate in the in-depth analysis of performed interventions, in the clinical monitoring of patients after discharge from the hospital, as well as in independent or multicentric research.

The university institution where interventional cardiologists train must have sufficient staff and technical capacities and a wide range of treated patients. Mentors must be experienced interventional cardiologists who have completed at least 500 PCIs during their practice (5). They must be available to the candidate for advice and practical assistance during all interventions. They assess the candidate’s training on an ongoing basis and direct them to further, more demanding practical work.

The final appraisal and subsequent ap- proval to attend the final exam is given by the director of CL.

The educational institution must have a sufficient amount of interventions available. It must host 800 PCIs per year, treat unstable patients and have a 24/7 interventional service. It must keep abreast of new developments in the field and uti- lize the latest diagnostic and therapeutic

(5)

methods. Part of the curriculum can also be executed in a partner non-university institution. Should that be the case, each candidate must accurately document their interventions and complete the missing programme at the university institution (5).

2.1.2 Certification of interventional cardiologists

A candidate who has completed an accredited interventional programme must pass a final exam to gain a licence. In USA, such an exam is organised by a special commission of the American Board of In- ternal Medicine Interventional Cardiolo- gy (ABIM). In contrast, such a task force is not explicitly mentioned in the EU, but it is expected that it will be appointed by national cardiology associations in cooperation with the ESC. The interventional cardiology exam in the EU will consist of two parts (9). In the first part, the exam- ination commission will check the candidates’ theoretical knowledge with multi- ple-choice questions. 100 such questions are planned, and they will relate to cardiovascular diagnostic examinations and the Table 2: A set of skills that physicians training in IC must master.

A set of skills that physicians training in IC must master:

• Arterial and venous vascular approach,

• Balloon dilatation of coronary arteries,

• Stents,

• PCI in patients with acute coronary syndrome,

• Pericardiocentesis,

• Mechanical circulatory support,

• Intervascular imaging methods,

• Coronary blood flow measurements,

• Embolic protection,

• Coronary vessel wall perforation blockage,

• Rotational atherectomy,

• Foreign body removal from the cardiovascular system,

• Select non-coronary procedures.

implementation or interpretation of coronary and non-coronary interventions. The second part of the exam will be devoted to testing the candidate’s skills in the practical implementation of said interventions.

All those who pass the exam will obtain a license, valid for 10 years. Unsuccessful candidates will be allowed to re-take the exam in the following school year.

2.1.3 Operator Performance Quality Control

A certified interventional cardiologist independently accepts the indication for PCI, plans the procedure and executes it in full. They try to ensure that PCI is successful and safe even in the most adverse circumstances, that the use of angiographic contrast agent is economical, radiation exposure minimal, and that any complications are resolved in the best way possible (5,11). To achieve that, they need to have appropriate cognitive and manual skills, along with sufficient experience. Several criteria are available to assess the suitabil- ity of an interventional cardiologist, such as the volume, success, and safety of their performance. However, even “softer” procedural complications (e.g. bleeding at the arterial access site, renal damage due to angiographic contrast agent) should not be overlooked. The complexity of the interventions must be, after all, taken in- to account when assessing performance (2,3,11).

Despite some concerns, the volume of interventions remains the standard criteri- on for assessing the skills of the operators.

The short-term outcomes for patients, treated by interventional cardiologists with a lesser volume of interventions (< 75 PCIs per year) have been proven to be worse (2). Routine use of coronary stent has diminished these differences to some extent, but has not reduced the incidence of the aforementioned softer complications. It is interesting that the PCI volume has decreased with some experienced interventional cardiologists, also due to si- multaneous invasive coronary blood flow

(6)

measurements and non-coronary interventions.

Diagnostic cardiac catheterizations are associated with a low risk of complications, making it hard to determine a sufficient volume of such procedures for individual operators. It is therefore recommended that the director of CL verifies that the examinations are properly selected, performed and interpreted (3). With percutaneous procedures, it is generally believed that a trained interventional cardiologist must perform at least 50–70 scheduled PCIs or at least 11–18 primary PCIs per year (3,12).

All interventional cardiologists must continuously educate themselves and keep abreast of advances in interventional techniques, devices and ancillary medications. They can get training by visiting other university institutions, international cardiology congresses or through specialized interventional websites (see section 2.1.1.). It is recommended that they collect at least 12–30 accredited attendance hours per year in this manner.

The director of CL must evaluate the proficiency of the employees periodi- cally, preferably every year. They must also recommend, if necessary, appropriate corrective actions (3). Intervention- al cardiologists who have not performed the interventions in the last six months do not require additional training. How- ever, those who have not performed PCI for six months and up to two years must perform a certain number of procedures (e.g. 20–50 PCIs) together with a trained co-worker (5).

2.1.4 Licence renewal

The license to practice as an interventional cardiologist is granted in the United States for 10 years only, after which it must be renewed. (13). Renewal takes place through the ABIM website and is based on a theoretical knowledge test. Candidate proficiency is evaluated in terms of clinical case management (25%), procedural techniques (15%), general cardiovascu-

lar medical science (15%), pharmacology (15%), diagnostic imaging methods (15%) and miscellaneous topics (5%). Recerti- fication has been in effect in USA since 2008 (13), while there is currently no such option in the EU. However, it is anticipat- ed that interventional cardiologists in the EU will also have to renew their operator licenses after 10 years (9).

2.2 Requirements/

recommendations relating to catheterization laboratories 2.2.1 Laboratory structure and operation

A contemporary CL is a complex diagnostic and therapeutic unit in which interventional cardiologists treat patients with both chronic and acute cardiovascular diseases. In university institutions, the intervention service operates 24/7 and im- mediate cooperation with other specialists is also possible (e.g. cardiovascular surgeons, anaesthesiologists, nephrologists, haematologists, neurologists). Most of the listed specialists are also available at other hospitals, but there is no permanent cardiovascular surgical service.

Most PCIs, both scheduled and emergency, can be performed in institutions without a permanent cardiovascular surgical service. However, it is recommended that all CLs operate in accordance with national recommendations and that general hospitals partner with university institutions. The patients with severe complications can therefore be immediately and safely transferred to an appropriate institution (3,5). Some, especially elective or emergency procedures that allow for patient transport, are probably safer to perform in institutions with cardiovascular surgical support (e.g. patients with pulmonary oedema due to advanced coronary heart disease). However, some procedures can only be performed safely in institutions with cardiovascular surgical support (e.g. in patients with pulmonary oedema due to advanced coronary heart disease,

(7)

patients with complicated congenital heart disease, children) (3). Some university institutions also operate a hybrid CL, which performs procedures that require surgical vascular access (e.g. certain percutaneous heart valve insertions) or a collaboration with a cardiovascular surgeon (e.g. com- bined myocardial revascularization), certain electrophysiological procedures and emergency procedures (e.g. insertion of extracorporeal membrane oxygenation [ECMO]).

2.2.2 Staff structure

CL management is a challenging task due to the large volume of patients and complexity of the diseases treated, required multidisciplinary approach, ex- tremely rapid technological development and associated costs. The director of CL must therefore be an experienced interventional cardiologist with at least five years of interventional experience (3).

They must manage training and maintain- ing all the staff’s proficiency, quality assurance and the appropriate development of CL. They can have an assistant manager to help with the administrative work.

At least three independent interventional cardiologists must operate in each CL, and at least six are required if the service is provided 24/7 (5). Each intervention team has at least three cardiovascular medical technicians who assist the interventional cardiologist, record haemodynamic measurement data, and administer medications. In addition to that, at least two radiology engineers are required.

The team must be trained in resuscitation and circulatory support management. CL must also cooperate with IT services and radiation protection experts.

2.2.3 Catheterization laboratory equipment

Trained interventional cardiologists carry a quality intervention program.

However, they do not operate in an emp- ty space; they require a well-equipped and maintained CL (2). There must be at least

one angiography device in each CL; however, due to device failure being inevitable and urgent interventions being common- place, at least two such devices are desir- able. Contemporary angiography devices can improve the quality of the image dis- play and simultaneously reduce radiation.

Advanced computer programs provide quantitative angiographic data and make it easier for an interventional cardiologist to optimally complete an intervention. All obtained data must be stored in a specific digital format (digital imaging and com- munication in medicine compatible format [DICOM]), for at least eight years (5).

The basic consumables are a wide range of catheters, guide wires, dilatation bal- loons and stents. In a contemporary CL, invasive blood flow measurements are also required: e.g. fractional flow reserve [FFR]

and intravascular imaging methods (e.g.

intravascular ultrasound [IVUS], optical coherence tomography [OCT]). In advanced Cls, coronary artery calcification can also be treated with the help of rotational atherectomy. Insertable prosthetic materials (e.g. artificial heart valves) must also be available, in accordance with the direction of an individual CL; the enu- meration of devices for non-coronary interventions, however, goes beyond the purpose of our article. Interventional cardiologists require certain laboratory tests (e.g. coagulation tests, blood gas analysis, electrolyte test, markers for myocardial necrosis). However, devices for treatment of critical cardiovascular events (e.g. de- fibrillator, respirator, aortic pumps or ventricular assist devices, covered coronary stents, transthoracic ultrasound device, pericardiocentesis kits) should also be readily available.

2.2.4 Workload

The volume of performed interventions is an approach to good practice for both individual interventional cardiologists and the CL as a whole which ensures both solid proficiency of the operators and coverage of operating costs. In a CL with

(8)

a large workload, an annual average is 600 scheduled PCIs (2,3,12). CLs with a lesser workload are units that annually host less than 400 PCIs; such CLs must maintain close relationships with partner university institutions.

Special cognitive and technical skills are required to perform a primary PCI.

In this respect, American and European standards differ significantly. Society for Cardiovascular Angiography and Inter- ventions (SCAI) recommends that each institution with 24/7 interventional service yearly performs at least 36 primary PCIs (12). In contrast, the requirements of the British Cardiovascular Intervention Soci- ety (BCIS) are significantly higher: at least 300 primary PCIs should be performed annually in institutions with a 24/7 intervention program, and at least 100 such interventions in institutions in remote areas. BCIS otherwise recommends that laboratories with a small number of interventions are included in the network of centres with 24/7 emergency services (5).

2.2.5 Work quality indicators

Each CL must carefully monitor the performance and safety of its interventional work. It must register all previously selected indicators, send them to the registry of the relevant national centre and act on the feedback (Figure 3).

Indicators of the interventional work quality cover a number of fields, such as the structure of the CL, patient care, sys- temic issues, compliance with national guidelines, the costs and the results of interventions performed. Structural indicators document the training and skills of interventional cardiologists, their education, their volume of work, the awards they have won, their contribution to congresses, their published articles and various certificates. Patient care indicators include the quality of performed procedures and the timeliness and explicitness of the results. System indicators evaluate the management of patients before interventions, the patient turnover in the CL, the functioning of staff and the emergency response. Compliance with the guidelines is reflected in infection control, radiation protection, the use of angiographic contrast agents and medications, the appro- priateness of indications for interventions, and the use of new devices. Cost analysis deals with the duration of hospitalizations, the material used, the adequacy of device stock, and the number of staff. The criteria for the success and safety of interventions is presented in more detail in the introductory chapter.

Particular attention should be paid to the use of angiographic contrast agent and radiation exposure. In most cases, non- ionic, low osmolar contrast media (e.g. io- hexol, iopamidol, iomeron) is used in CLs, while iso-osmolar contrast medium (e.g.

iodixanol) may be better in patients with chronic renal impairment. Angiograph- ic contrast may impair renal function; its usage should thus be closely monitored during the procedure. Renal function before the intervention is determined by Figure 3: Quality control of interventional work: data collection in

individual catheterization laboratories (CLs), registration and analysis in the national centre, recommendations and corrections in a CL in case of a significant deviation.

(9)

the maximum amount of contrast used (maximum contrast volume = contrast agent clearance × 3.7) (12). Advances in angiographic devices and techniques have significantly reduced radiation exposure.

X-ray exposure and consequent biological damage can be expressed in different ways.

It is usually measured with a so-called dose-area product (DAP) or by stress testing individual exposed organs. The exposure of interventional cardiologists may not exceed 50 mSv per year. During the procedure, radiology engineers monitor the radiation received by the patient: the interventional cardiologist is first warned at the exposure of 2 Gy, and then at each following 0.5 Gy increase. If the exposure during the procedure exceeds 5–10 Gy, the patient should be warned of the possible consequences and carefully monitored.

All complications during the procedure should be immediately recorded and analysed at half-yearly intervals. If an individual operator exceeds the permissible number of complications in two half-year periods, they try to determine the cause with the director of CL and find appropriate corrective actions (3).

Regular maintenance and servicing of radiological devices is very important to ensure the quality of interventional work.

Contemporary CLs use a multitude of radiological, electronic and computer parts, all of which must work flawlessly. It is therefore recommended to service the entire system at regular intervals, and cost reduction should not be an excuse.

3 National benchmarking

3.1 Data capture in individual catheterisation laboratories

CLs need to collect comprehensive and accurate data on their work. This refers primarily to the rationale for interventions, the structure of services provided and their results. The Director of CL en- courages interventional cardiologists to promptly enter the data on the work per-

formed into their databases. This enables a constant overview of the functioning of a CL (e.g. the workload of individual interventional cardiologists, the structure of procedures, the occurrence of adverse events). Databases can be a planning tool for CL’s operation with recruitment plans for new interventional cardiologists, material and equipment purchases and im- provement planning.

3.2 Data transfer to the national registry

Each hospital provides information support that allows for an appropriate data capture and its transfer to a national centre (e.g. the task force for quality assurance in a CL). In order to compare the operation of individual CLs, the reports transmitted to the national registry must be uniform- ly structured. Each report should include patient demographics, relevant anamnestic data with cardiovascular risk factors, diagnostic and laboratory test results, list of preoperative medications, indications for the referral to the CL, identification of cardiovascular stability, description of coronary anatomy and intervention performed, possible adverse events during and after the intervention, information on discharge or transfer of the patient. (Table 3).In the United Kingdom, BCIS mon- itors the collection of clinical data, providing a comparison of interventions at a national level (14). BCIS regularly updates this database, so it is constantly abreast of current therapeutic strategies. Structural changes of data are generally few and far between so as not to impede the collection and analysis of data over time.

3.3 Data analysis

Before analysing the data collected from individual CLs, a national centre checks the completeness, consistency and accuracy of the entered data. Complete- ness refers to the proportion of fields with

(10)

Table 3: Report structure for the national PCI registry.

Report structure for the national PCI registry Demographic data

• last name, first name, date of birth, patient ID, gender, weight, height Anamnestic data and risk factors

• smoking, arterial hypertension, dyslipidaemia, cerebrovascular disease, chronic kidney disease, peripheral arterial disease, diabetes

• family history of premature coronary heart disease, previous heart failure, previous myocardial infarction, previous PCI, previous CABG, previous valve surgery

Clinical condition due to which the procedure is required

• coronary heart disease (asymptomatic, stable AP, unstable AP, NSTEMI, STEMI)

• grading of angina (CSS classes 1 – 4)

• AP treatment (beta blockers, calcium antagonists, long-acting nitrates, ranolazine, trimetazidine)

• heart failure (NYHA classes 1 – 4)

• cardiomyopathy, or left ventricular systolic dysfunction

• cardiogenic shock (in the past 24 hours)

• cardiac arrest (in the past 24 hours)

• preoperative assessment before a noncardiac surgery

Previously performed tests for coronary heart disease assessment

• standard stress testing (stationary exercise bicycle, treadmill)

• stress echocardiogram

• myocardial perfusion scintigraphy

• computerized tomography (CT) coronary angiogram Interventional procedure data

• date and time of the procedure

• PCI – diagnostics – other

• radiation data (dose area product, air kerma)

• contrast agent volume

• use of mechanical support (intra-aortic balloon pump, other)

• access site: radial, ulnar, brachial, femoral

• haemostasis mode

Laboratory tests before and after the procedure

• before procedure: troponin, creatinine, haemoglobin, cholesterol, HDL cholesterol

• after the procedure: troponin, creatinine, haemoglobin Coronary anatomy

dominance

• native artery stenosis ≥ 50%

• graft stenosis ≥ 50%

Medication during the procedure (24 hours before and during the procedure)

• anticoagulants (UFH, LMWH, bivalirudin, fondaparinux, warfarin)

• glycoprotein IIb/IIIa inhibitors

• NOAC: apixaban, dabigatran, endoxaban, rivaroxaban

• P2Y₁₂ inhibitors (cangrelor, clopidogrel, prasugrel, ticagrelor)

(11)

missing data, while consistency identifies matches between logically related fields.

The accuracy of records in databases is set out by the degree of agreement between databases and original records from individual CLs (15).

The centre’s experts then calculate the actual performance and safety indicators of the interventional work performed at

certain intervals, based on consolidated data. National indicators are compared with internationally recognized standards (see introductory chapter) and then analysed from the perspective of individual CLs. In the periodic structured reports, in addition to the basic indicators of success and safety of interventions, they also provide other data (e.g. subject structure, Legend: NSTEMI – non-ST segment elevation myocardial infarction; STEMI – ST-segment elevation myocardial infarction; CCS – Canadian Cardiovascular Society; NYHA – New York Heart Association;

UFH - unfractionated heparin; LMWH – low-molecular-weight heparin; NOAC – new oral

anticoagulants; P2Y₁₂ – a type of a purinergic receptor; PCI – percutaneous coronary intervention;

iFR – instant flow reserve; FFR – fractional flow reserve; IVUS – intravascular ultrasound; OCT – optical coherence tomography; TIMI – thrombolysis in myocardial infarction; VT – ventricular tachycardia; VF – ventricular fibrillation; AMI – acute myocardial infarction; PCSK9 – proprotein convertase subtilisin/kexin type 9.

Report structure for the national PCI registry The description of stenoses before the procedure

• artery segment, stenosis % before the procedure, TIMI flow grade before the procedure, previously treated lesions

• complexity of stenosis, length of stenosis, calcifications, bifurcation lesions Description of PCI

• use of guidewires, balloon catheters, stents, DEB, antegrade/retrograde approach for CTOs Invasive diagnostic methods

• iFR/FFR, IVUS, OCT

The description of stenoses after the procedure

stenosis % before the procedure, TIMI flow grade after the procedure Events before and after the procedure

• bleeding (access site, gastrointestinal tract, genitourinary tract, retroperitoneal space)

• VT / VF, cardiac arrest, cardiac tamponade, cardiogenic shock, heart failure, myocardial infarction

• renal failure requiring haemodialysis

• other vascular complications

• cerebrovascular insult (haemorrhagic, ischemic)

• blood transfusion Patient discharge

• status upon discharge: alive (discharge into home care, transfer to another institution, rehabilitation), dead (cause of death: AMI, other heart-related causes, infections, bleeding, malignancies)

• laboratory tests: creatinine, haemoglobin

• medication upon discharge: ACE inhibitors, ARBs, anticoagulants, antiplatelet drugs, NOAC’s, P2Y₁₂ inhibitors, PCSK9 inhibitors, statins

(12)

indications for interventions, intervention structure, intervention trends over a lon- ger period of time (Figure 3).

3.4 Transfer of analysis results to individual laboratories

The national centre, which takes care of the entire data collection, is obliged to report to individual CLs at agreed intervals on their operation. A comparison with national standards is particularly important here. Such a comparison is the tool that each CL uses to improve their quality of work.

3.5 Action in case of insufficient efficiency or safety of

interventions

The reports sent by the national centre to individual CLs at agreed intervals rep- resent an appropriate basis for comparison of the operation of individual CLs in rela- tion to the national average, especially in the case of indicators related to work performance and safety. Should the individual indicators deviate from predetermined limits, the director of CL must take measures to eliminate unwanted deviations.

This includes: 1. encouraging formal and informal discussions between individual operators regarding the handling of particularly complex cases; 2. organisation of meetings between interventional cardiol-

ogists and other physicians involved in the treatment of patients with coronary heart disease in the institution; 3. continuous discussion of new developments in the literature in the field of interventional cardiology; 4. active participation in domestic and international meetings (5).

4 The situation in Slovenia

In Slovenia, all specializations are reg- ulated by the Rules on the types, content, duration and course of specialisations of doctors (15). Interventional cardiology training takes place during the four-year specialization in cardiovascular medicine, in the form of an elective course. Indepen- dent work is intended only for the performance of diagnostic coronary angiog- raphies; during their specialization, each candidate must perform at least 250. How- ever, PCI training seems to be neglected, as the physicians training in IC only have to complete 50 PCIs, and even those are under the guidance of a mentor. A cardiologist who specializes in cardiovascular medicine in Slovenia is therefore not yet an independent PCI operator.

In Slovenia, we do not yet have written recommendations for the assessment of work in CLs or a set minimum scope of interventional work in scheduled or emergency circumstances. Recently, the Ministry of Health did, however, appoint a working group to assess the adequacy of qualifications for performing coronary and peripheral vascular interventions (16).

The task of this commission is to prepare an opinion on the qualifications of future intervention operators, based on submit- ted applications. However, the mentioned Ministry decision is not without fault.

The mentioned issues were discussed in the meetings of the Working Group for Invasive and Interventional Cardiology, but the group did not issue written conclusions, nor did other competent forma issue any appropriate opinions. The authors of this article therefore believe that this article may fill the gap in the records Table 4: European Society of Cardiology’s (ESC) recommendations for

interventional cardiology training.

Recommendation Class Level

Physicians training in IC should perform at least

≥200 PCI procedures as first operators II a C Physicians training in IC should complete formal

training according to a 1–2 year curriculum at CL’s 24/7 with at ≥800 PCIs per year

II a C

Legend: IC – interventional cardiology; PCI – percutaneous coronary intervention; CL – Catheterization laboratory; 24/7 – continuous interventional service.

(13)

and help shape an interventional cardiologist that will meet EU standards, as well as build a contemporary foundation for quality interventional work in Slovenia.

5 Recommendations of the European Society of Cardiology

In 2018, working groups of two Euro- pean cardiovascular associations, the ESC and the European Association for Car- dio-Thoracic Surgery (EACTS), jointly issued recommendations on myocardial revascularization (6). The entire Chap- ter 18 of this comprehensive document is devoted to measures to improve the work of interventional cardiologists and cardiovascular surgeons. In the introduction, the authors emphasize that the results of revascularization procedures, especially those in complex situations, depend on the experience of individual operators, and no less on the experience of the entire team involved in the intervention and in

the post-intervention patient care.

European Society of Cardiology’s (ESC) recommendations for the training of interventional cardiologists are presented in Table 4, and recommendations for volume of interventional procedures for independent operators and CLs Table 5. Recommendations on the registration and monitoring of the results of revascularization procedures and on setting national standards are also interesting. The recommendations expressly apply only to CABGs but are appropriate also for PCIs.

ESC recommends:

• each national association of cardiologists should develop its own standards for assessing the quality of (interventional) work;

• each national association should create a specific database on the implementation and results of revascularization interventions;

• each CL should consistently transfer the results of its revascularization interventions to the national registry.

We conclude that we have enough international and now also Slovenian literature on assessing the quality of interventional work in CLs. The ESC recommendations are clear, although to some extent incom- plete. The authors of this article wish for us to enter the forefront of European cardiologists in the development of contemporary standards for excellence in cardiac interventional work. We are obliged to do this out of respect for our own work and to the satisfaction of the patients entrusted to us.

6 Conclusions

PCI has become the predominant method of myocardial revascularization.

Interventions must be successful and safe and meet internationally recognized standards. To achieve these goals, CLs need to be well-equipped, interventional cardiologists truly trained, and patient selection appropriate to regional practice. Formal Table 5: European Society of Cardiology’s (ESC) recommendations for

the volume of interventional procedures for independent operators and catheterization labs.

Recommendation Class Level

Physicians training in IC should complete ≥75 PCIs

at Cls, with ≥200 PCI per year II a C

Physicians training in IC should complete P-PCI at

CLs with 24/7 service, with ≥400 PCI per year II a C Physicians training in IC should complete >25 LM-

PCIs per year II a C

C-PCs are performed in Cls that have access to

circulatory support and an ICU II a C

CL with <400 PCI per year should collaborate with

a partner academic Cl II a C

Legend: IC – interventional cardiology; PCI – percutaneous coronary intervention; CL – Catheterization laboratory; 24/7 – continuous

intervention service; LM-PCI – percutaneous intervention on the left main coronary artery; C-PCI – complex percutaneous coronary intervention (e.g.

on the left main coronary artery, posterior descending artery, chronic total occlusion of the coronary artery); ICU – Intensive Care Unit.

(14)

training of future interventional cardiologists and subsequent maintenance of their proficiency is currently at the forefront of ESC’s activities. It is essential that the Slovenian Society of Cardiology actively participates in European efforts to make the education and training of Slovenian interventional cardiologists comparable to European standards. University and non-university CLs must be connected in a network of 24/7 interventional activity, and they must be connected by partner- ships. An important step in improving the quality of Slovenian interventional work will undoubtedly be the joint capture of clinical and procedural data and inclusion in the national registry, detailed analysis of this data on a national basis and also from the point of view of individual CLs, comparison with internationally recognized standards, periodic return of analytical reports back to regional CLs and, finally, the implementation of any corrections in day-to-day interventional practice.

7 Abbreviations

• ABIM The American Board of Internal Medicine

• BCIS The British Cardiovascular Inter- vention Society

• CABG: Coronary artery bypass graft-

• ESC: The European Society of Cardiol-ing

• DAP: Dose-area productogy

• ECMO: Extracorporeal membrane oxygenation

• EU: The European Union

• FFR: Fractional flow reserve

• IVUS: Intravascular ultrasound

• CL: Catheterization laboratory

• MI: Myocardial infarction

• OCT: Optical coherence tomography

• PCI: Percutaneous coronary interven-

• SCAI: The Society for Cardiovascular tion Angiography and Interventions

• USA: The United States of America

References

1. Grüntzig A, Hirzel H, Goebel N, Gattiker R, Turina M, Myler R, et al. Percutaneous transluminal dilatation of chronic coronary stenoses. First experiences. Schweiz Med Wochenschr. 1978;108(44):1721-3. PMID:

715409

2. Harold JG, Bass TA, Bashore TM, Brindis RG, Brush JE, Burke JA, et al.; Presidents and Staff; American College of Cardiology Foundation; American Heart Association; Society of Cardiovascular Angiography and Interventions. ACCF/AHA/SCAI 2013 update of the clinical competence statement on coronary artery interventional procedures: a report of the American College of Cardiology Foundation/American Heart Association/American College of Physicians Task Force on Clinical Competence and Training (writing committee to revise the 2007 clinical competence statement on cardiac interventional procedures).

Circulation. 2013;128(4):436-72. DOI: 10.1161/CIR.0b013e318299cd8a PMID: 23658439

3. Bashore TM, Balter S, Barac A, Byrne JG, Cavendish JJ, Chambers CE, et al.; ACCF Task Force Members.

2012 American College of Cardiology Foundation/Society for Cardiovascular Angiography and Interventions expert consensus document on cardiac catheterization laboratory standards update: A report of the American College of Cardiology Foundation Task Force on Expert Consensus documents developed in collaboration with the Society of Thoracic Surgeons and Society for Vascular Medicine. J Am Coll Cardiol. 2012;59(24):2221-305. DOI: 10.1016/j.jacc.2012.02.010 PMID: 22575325

4. Barbato E, Dudek D, Baumbach A, Windecker S, Haude M. Current trends in coronary interventions: an overview from the EAPCI registries. EuroIntervention. 2017;13(Z):Z8-10. DOI: 10.4244/EIJV13IZA2 5. Banning AP, Baumbach A, Blackman D, Curzen N, Devadathan S, Fraser D, et al.; British Cardiovascular

Intervention society. Percutaneous coronary intervention in the UK: recommendations for good practice 2015. Heart. 2015;101:1-13. DOI: 10.1136/heartjnl-2015-307821 PMID: 26041756

6. Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, et al.; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019;40(2):87-165. DOI:

10.1093/eurheartj/ehy394 PMID: 30165437

(15)

7. Jacobs AK, Babb JD, Hirshfeld JW, Holmes DR; Society for Cardiovascular Angiography and Interventions.

Task force 3: training in diagnostic and interventional cardiac catheterization endorsed by the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. 2008;51(3):355-61. DOI: 10.1016/j.

jacc.2007.11.011 PMID: 18206752

8. Di Mario C, Di Sciascio G, Dubois-Randé JL, Michels R, Mills P. Curriculum and syllabus for Interventional Cardiology subspecialty training in Europe. EuroIntervention. 2006;2(1):31-6. PMID: 19755233

9. Dudek D, Van Belle E. Education and training committee – from curriculum to certification.

EuroIntervention. 2017;13:271.

10. Serruys PW, Wijns W, Vahanian A, van Sambeek M, De Palma R. Percutaneous interventional cardiovascular medicine. S.l.: PCR Publishing; 2012.

11. Capodanno D, Buccheri S. Operator volume and mortality in percutaneous coronary intervention: a call for better competency metrics. Eur Heart J. 2018;39(18):1635-7. DOI: 10.1093/eurheartj/ehy144 PMID:

29579187

12. Naidu SS, Aronow HD, Box LC, Duffy PL, Kolansky DM, Kupfer JM, et al. SCAI expert consensus statement:

2016 best practices in the cardiac catheterization laboratory: (Endorsed by the cardiological society of india, and sociedad Latino Americana de Cardiologia intervencionista; Affirmation of value by the Canadian Association of interventional cardiology-Association canadienne de cardiologie d’intervention).

Catheter Cardiovasc Interv. 2016;88(3):407-23. DOI: 10.1002/ccd.26551 PMID: 27137680

13. George JC, Dangas GD. Maintenance of certification in interventional cardiology revisited. JACC Cardiovasc Interv. 2010;3(4):461-2. DOI: 10.1016/j.jcin.2010.03.001 PMID: 20398877

14. British Cardiovascular Intervention Society. Audit results 1991 to present. Lutterworth: BCIS;

1991 [cited 2014 Dec 22]. Available from: http://www.bcis.org.uk/pages/page_box_contents.

asp?pageid=697&navcatid=11.

15. Pravilnik o vrstah, vsebini in poteku specializacij zdravnikov. Ur l RS. 2009(22)(42).

16. Ministrstvo za zdravje. Sklep št. 2717-18-232004 o imenovanju delovne skupine za presojo ustreznosti kvalifikacij za izvajanje posegov na koronarnem in perifernem ožilju. Ljubljana: MZ; 2017 [cited 2014 Dec 22]. Available from: http://www.mz.gov.si.