These guidelines from the British Cardiovascular Intervention Society (BCIS) provide a framework for individuals and centres in the UK to deliver safe and effective percutaneous coronary intervention (PCI). The guidelines supersede those published in 2015, with changes made according to new evidence and international guidelines, as well as data from our national registry.1
Standards
Institutional Facilities
To perform PCI in the UK, at least two cardiac cath labs are required. This will allow for equipment failures and situations where emergency cases may present simultaneously or during a complex elective procedure. In extreme circumstances, a non-cardiac radiological facility may be considered for backup use.
Diagnostic-only cardiac cath labs should be phased out. Patients should be able to have angiography with follow-on PCI when indicated. Future investment in diagnostics in non-PCI centres should focus on CT coronary angiography. The evidence base supports the use of intracoronary pressure wire and intracoronary imaging for diagnostic purposes in selected cases. These ‘interventional diagnostic’ procedures should be performed in PCI centres with full interventional capability, submitted to the national PCI database and undertaken by interventional cardiologists equipped to deal with possible complications.
Imaging
PCI centres need an adequate image storage solution allowing diagnostic and procedural images to be stored accessibly for a minimum of 8 years.2 Centres should have facilities for real-time electronic image transfer to allow discussion of individual cases to facilitate optimal care. A suitable facility is required for image display to be incorporated into the multidisciplinary team (MDT) so that it can function in person and online.
Patient Monitoring
Physiological measurements, including arterial pressures and display of waveforms on multiple simultaneous channels, along with the facility to display and record a range of ECG lead configurations, are necessary during coronary intervention. Patients who receive sedation and/or opiate analgesia should have heart rate, oxygen saturation and – in some settings – capnography monitored throughout the procedure.
Equipment
A wide range of disposable angioplasty equipment, including guide catheters, guide wires, balloons and stents and an appropriate method of inventory and stock control is required. Facilities for monitoring anticoagulation (e.g. activated clotting time) should be available within each cath lab.
Intracoronary imaging with intravascular ultrasound (IVUS) and/or optical coherence tomography (OCT) should be available in every lab to guide PCI management. Intracoronary pressure wire analysis should also be accessible in every lab to guide PCI management. A range of tools for calcium modification, such as cutting balloons, high-pressure balloons, intravascular lithotripsy and/or rotational atherectomy, should be available.
Admission and Recovery
Patients should be admitted to a protected, dedicated admission and recovery unit or lounge for day-case PCI procedures. A day-case facility may facilitate inter-hospital transfers for acute patients requiring intervention. Use of day-case facilities to house unselected emergency medical admissions is unacceptable and will place the PCI service at risk and – in some centres – will interfere with provision of emergency primary PCI (PPCI) for ST-elevation MI (STEMI). Cath lab workflow should be run by a co-ordinator to allow optimal flow through the lab, particularly for non-elective work and inter-hospital transfers.
Vascular Access
Dedicated vascular ultrasound should be available in each PCI centre. Training in its use is required. Femoral arterial and venous access should be obtained using vascular ultrasound. Transradial access may also be guided by ultrasound. The transradial approach should be the default where appropriate.
Complication Management
A range of covered stents, microcatheters and coils are needed to treat coronary perforation. Pericardiocentesis sets should be immediately available within each lab. All cath labs should have rapid access to echocardiography, vascular ultrasound, temporary pacing and haemodynamic support. Emergency drugs, including vasoconstrictors, should be immediately available. Anaesthetic drugs should be easily accessible for emergencies.
Resuscitation Facilities
The Joint British Societies’ guideline on management of cardiac arrest in the cardiac cath lab should help standardise the response to cardiac arrest in cath labs.3 A defibrillator is required in each cath lab and full resuscitation facilities, including an anaesthetic machine, should be readily available. A local mechanism for immediate response by anaesthetic colleagues should be in place to ensure rapid assistance when required. Mechanical cardiopulmonary arrest devices within the cath lab environment are recommended, such that procedures can be completed with ongoing mechanical cardiopulmonary resuscitation in extremis. Mechanical haemodynamic support (intra-aortic balloon pump [IABP] as a minimum) should be available, with appropriate protocols in place for escalation to further support on the same site or transfer if applicable.
Key Updates Since 2015
- Diagnostic-only cardiac cath labs should be phased out.
- Patients should have angiography with follow-on percutaneous coronary intervention (PCI) when indicated.
- Interventional diagnostic procedures should be undertaken in a PCI centre.
- Intracoronary imaging (intravascular ultrasound and/or optical coherence tomography) is required in every centre.
- A protected day-case facility is needed, dedicated to cardiac cath lab use.
- Femoral arterial and venous access should be made with ultrasound guidance.
- PCI centres must have access to emergency echocardiography.
Interventional Staffing
The minimum recommended number of fully trained interventional cardiologists within a PCI centre is three. Greater numbers are needed for a PPCI service (see PPCI below). Some centres have used joint cover arrangements with neighbouring centres to facilitate initiation and development of a PCI service. Such arrangements can help ensure that a cardiac cath lab facility is used to its potential.
The number of allied health professionals (AHP) involved in a PCI procedure will depend on skill mix, procedural complexity and the number of medical staff involved. Effective teamwork and training are essential for good patient outcomes. The AHP team should receive training in imaging and physiology and any new equipment and procedures employed in the cath lab. The MDT is represented within BCIS by the Allied Health Professionals Working Group.
It is recommended that there are two nurses per cath lab, one radiographer and one physiologist during each PCI procedure. A runner or floater nurse is helpful, and a separate co-ordinator. Some cath lab teams run the recovery unit as part of the daily staffing, and this should be considered a high-dependency area. Porters and patient transport dedicated to the cath lab environment are very helpful to workflow.
An Advanced Life Support certificate should be held by senior members of the cath lab team. Other members of the team should hold a minimum of an Intermediate Life Support certificate and be versed in emergencies within the cath lab, with regular opportunities for team training.
Surgical Cover
On-site surgical cover for PCI is not required. Emergency coronary artery bypass grafting (CABG) following PCI is rare. PCI centres without on-site cardiothoracic surgery should have protocols in place for the management of emergency transfer of patients for CABG or other treatment. A protocol should be agreed by the surgical centre with which it works, local networks, commissioners and the ambulance service. The protocol will need to address the training and availability of staff to accompany the patient, including an anaesthetist when required. The emergency transfer of patients should occur within a maximum of 1 hour, with the ability to start cardiopulmonary bypass within 2 hours of the call for surgical intervention. Essential equipment should include a transportable intra-aortic balloon counter-pulsation pump (IABP).
Radiation Protection
For both patients and staff, the cardiac cath lab is associated with potentially damaging levels of exposure to ionising radiation. The complexity of coronary procedures is increasing, and this can lead to increased radiation exposure to operators and other lab staff. Increased exposure has been linked to adverse effects including cancer, skin injury, cataract formation and accelerated atherosclerosis in patients and staff. Awareness, continuous monitoring and review of the risks within the entire cath lab team is essential.
Radiation management should adhere to the ‘ALARA’ (as low as reasonably achievable) principle to limit patient dose and scatter radiation exposure for lab staff. Optimising X-ray system performance allows generation of suitable images from the lowest possible administered dose. Optimised lead-glass barrier protection devices should be used, along with personal protection equipment. All labs should invest in appropriately fitting lead aprons of ≥0.25 mm lead equivalent, thyroid collars and eye protection for all regular staff. Additional protection must be available for emergency and visiting colleagues. For females, personal protection should include the use of additional wearable shielding to improve axillary protection.
It is a legal requirement for the interventional cardiologist to be trained in and compliant with Ionising Radiation (Medical Exposure) Regulations. Operators and staff should ensure that they are well educated in best contemporary practice. Operators should embrace these principles in daily clinical practice by manoeuvres including meticulous attention to personal protective equipment deployment, including lead glasses and the dynamic positioning of shields; limiting high-radiation angles; use of fluoro-store facilities; image-enhancements; and the use of intracoronary imaging.
All cath labs have a designated radiation protection officer, who will liaise with staff to ensure and monitor compliance. Monitoring of dose exposure is mandatory, along with feedback in relation to cumulative dose. For female staff, concerns regarding pregnancy and radiation exposure are an important issue. Abdominal doses recorded under well-maintained lead aprons are minimal and are expected to be well below international thresholds for adverse foetal exposure. To date, there are no data to suggest a significantly increased risk to the foetus of pregnant women associated with this exposure level. Pregnancy should be discussed with the cath lab radiation protection officer as soon as possible, and an individualised and flexible plan for management of exposure and practice developed.
Current cath lab radiography sources are equipped with methods to calculate and record peak skin dose and dose area product. Recording the patient’s dose exposure is mandatory and measures should be in place to recognise patients requiring multiple high-dose exposures (e.g. CT studies followed by PCI or sequential complex interventions). The operator must be aware of the dose delivered during each procedure and informed as doses surpass 2 and 3 Gy during the procedure. The patient should be notified post-procedure if the peak skin dose exceeds 3 Gy and alerted to potential physical consequences.
Key Updates Since 2015
- All team members should have modern, lightweight lead protection.
- Lead protection should be ≥0.25 mm lead equivalent.
- Eye, thyroid and axillary (female staff) protection is required.
- An individual and flexible plan should be agreed between pregnant cath lab staff and the radiation protection officer.
Peri-procedural Care and Consent
Patient preparation, informed consent and ward checklists should be performed as part of local standard operating policies. Attention should be paid to issues that may affect the patient’s ability to lie comfortably during the case.
Consent
The General Medical Council Good Medical Practice and recent Shared Decision-making initiatives require that patients are fully involved in decisions about their care. Patients should be fully informed about and involved in decisions about their care, including details of the procedure, benefits, procedural risks and likelihood of success. Ample time should be allocated to allow the patient to understand and discuss this information. In the elective setting, this is best undertaken in the outpatient clinic, where written information can be provided. Potential serious adverse outcomes should be discussed, including the possibility of death, acute MI, stroke, the requirement for emergency cardiac surgery and complications of vascular access. The likelihood of such events should be drawn from local and/or national statistics and will vary depending on the clinical scenario.
Written consent is advised for all PCI procedures except in an emergency (i.) when verbal consent may be taken together with documentation in the case notes or (ii.) when it is either not possible to find out the patient’s wishes or the patient lacks the capacity to give consent. Formal signing of the consent form may be delegated to a suitably trained and qualified person only if they have sufficient knowledge of the proposed procedure and understand the risks involved. A record of the consent form should be kept in the notes.
WHO Checklist
NHS England expects all hospitals in England and Wales to have a checklist for interventional procedures based on the WHO five-stage approach.4 The WHO checklist has been shown to reduce surgical death and morbidity.5 There are UK data suggesting that use of a cardiology-specific safety checklist may reduce complications related to invasive cardiology procedures including PCI and The British Cardiovascular Society recommends use of a safety checklist in all cardiac cath labs.6 Each unit carrying out invasive procedures is encouraged to localise and formalise safe practice in Local Safety Standards for Invasive Procedures.4
Analgesia/Sedation
PCI procedures can be performed with or without sedation. If sedation or opiate analgesia is given, monitoring of the patient’s oxygen saturation is necessary and capnography may be desirable. Each centre should have a conscious sedation policy and a list of competencies that should be achieved and signed off by those administering and monitoring conscious sedation.
Post-procedural Care
After completion of the PCI procedure, the patient is transferred to an appropriately staffed recovery area, ward or lounge. Transfer may be by walking (no sedation), wheelchair (minimal sedation) or trolley (more than minimal sedation). Details of the procedure, drugs administered and recommendations for post-procedure drug therapy should be handed over to receiving area staff. Subsequent nursing care should include observation of the point of vascular access and intermittent heart rate and blood pressure monitoring. A post-procedural 12-lead ECG should be recorded. Continuous routine ECG monitoring post-PCI is not required in elective cases. Day-case PCI has excellent safety literature.7 Patients in whom procedural concerns have been noted may occasionally need to remain in hospital overnight or be transferred to the regional PPCI centre if emergency reintervention is required out of hours.
Before discharge from hospital, the patient should be given written instructions relating to possible vascular and other complications, an emergency contact number, advice on activity, including driving and advice on prescribed antiplatelet therapy, lipid-lowering and other secondary prevention. Arrangements should include outpatient follow-up and referral to cardiac rehabilitation.
Key Updates Since 2015
- A WHO checklist should be completed pre-procedure with the full team.
- Post-procedure care should be discussed and handed over to the receiving team.
- Discharge information should include an emergency contact number.
- Discharge information should include written instructions on antiplatelet agents and other medication changes.
Procedural Volumes
Institutional Volume
The relationship between procedural volume – both at the institutional and operator level – and patient outcomes is an important consideration in the delivery of PCI services. Practice and repetition enhance performance. Historically, there was a centre–volume mortality relationship; however, with current PCI practice this is no longer seen. In 2000, 200 procedures per annum were set as the volume standard for individual centres, but since 2005 and in the latest guidelines from 2015, 400 procedures per year has been the recommended minimum.1,8,9 Given the lack of evidence of a cut-off at higher levels, we again recommend a minimum centre volume of 200 PCIs per year.
Individual Operator Volume
The volume of procedures carried out by individual operators is also important. PCI is a practical procedure and therefore requires repetition and practice to maintain proficiency. The absolute number of procedures performed by an operator is only one factor that influences patient outcomes. Case-mix, tolerance of risk, procedural aptitude and institutional factors all play a part.
In England and Wales, in an analysis of 133,970 unselected PCI procedures (2013 to 2014) the median operator volume was 135 cases per year. Only 3.1% of cases were undertaken by operators performing fewer than the previous BCIS recommendation of 75 procedures per year. At these volumes, no association between PCI volume and risk-adjusted 30-day mortality was observed.10 Since then there has also been an expansion of non-coronary work, which shares generic skills with PCI and occupies time in the cardiac cath lab. In light of these various factors, the new recommendation is that operators should conduct a minimum of 50 PCI procedures per year. Where numbers drop or are due to drop to fewer than 50 PCI per year, a discussion with the clinical lead should occur to discuss opportunities in the job plan to increase exposure. Buddied cases can be undertaken in order to maintain volume and skills. Although only one operator can be responsible for each PCI case in our dataset, a record of buddied or second operator cases can be kept on local systems and will support appraisal.
Retraining after Absence
Fully trained operators who are absent from practice for <6 months do not need additional training. If the period of absence exceeds 6 months, the operator should undertake buddied cases with an experienced colleague who can agree when the operator is able to work independently again. The number of buddied cases will depend on previous experience and the duration of absence. Cardiologists who have never been trained in PCI and wish to start PCI need full formal interventional training. Individual cardiologists who undertake PCI on multiple sites are responsible for making sure that data from all the sites are sent to the National Institute for Cardiovascular Outcomes Research (NICOR), where the data can then be aggregated for appraisal and revalidation.
Key Updates Since 2015
- PCI centres should undertake ≥200 cases per year
- Operators should undertake a minimum of 50 PCIs per year
Primary PCI for STEMI
Specific professional standards required for centres that provide emergency PPCI for patients with STEMI have previously been developed by BCIS.11 PPCI centres should provide a 24-hour service, 365 days a year and operate an effective pre-alert system to enable rapid activation of the cardiac cath lab team. The diagnostic ECG should be available for electronic transfer to the receiving team. Patients calling the ambulance service who have STEMI should be taken directly to a PPCI centre cath lab, bypassing the emergency department. PPCI centres should undertake a minimum of 100 PPCI procedures per year. Centres performing <200 PPCIs per year should consider whether a network approach that rationalises the number of adjacent PPCI centres would be a better model of care. Specific geographical considerations may preclude this in some remote regions. A STEMI patient self-presenting at a non-PPCI centre within working hours should be treated in the local PCI cath lab if the relevant expertise is available. Out of hours, such patients should be transferred immediately to the PPCI centre. This transfer should be prioritised by ambulance services.
A PPCI centre should have two or more functioning cardiac cath labs and will require sufficient interventionists and cath lab staff to maintain a sustainable rota for the medical and AHP staff.
Out-of-hours Work
Interventional cardiologists should regard their contribution to a PPCI rota as an essential part of their job plan. It is recognised that this will necessitate co-operation between hospitals regarding cross-charging, back-filling of duties and compensatory rest. A sustainable, long-term PPCI rota for Consultants will consist of a minimum of six interventional cardiologists. For centres undertaking more than 400 PPCI, a minimum of eight will be needed.
Out-of-hours interventional cardiology on call should be provided at PPCI centres. There is no requirement for an out-of-hours cath lab rota at non-PPCI hospitals. In the rare event that a patient in a non-PPCI hospital has a late complication or need for emergency reintervention, immediate transfer to a centre that treats a high volume of out-of-hours emergencies is appropriate. It is recommended that interventionists based in non-PPCI hospitals should join the regional PPCI rota where this is not current practice. Such a system will also facilitate AHPs to join PPCI rotas where desired as there should be no need for relevant AHPs to be on call at non-PPCI centres out of hours. It is recognised that this is a change in current working arrangements and may take some time to be introduced. However, it is important that both interventional cardiologists and AHPs have rotas that are sustainable over a long career. Without regional working of this type, the burden of out-of-hours emergency care falls disproportionately on PPCI centre teams.
Primary angioplasty remains a largely Consultant-led service. Fully trained interventional fellows and speciality trainees within 6 months of their Certificate of Completion of Training (CCT) may contribute to a PPCI rota, but a named Consultant needs to be responsible for each case and its management.
A sustainable 24/7 PPCI rota requires a minimum of eight AHPs in each discipline. Rest after PPCI on-call should be incorporated into departmental planning at a minimum of a compensated half day (<400 PPCI per year) or a compensated full day (≥400 PPCI per year). Weekend rota planning will vary depending on whether routine or urgent lists are included.
Interventional centres and networks should plan for the number of cardiologists and AHPs on a rota long term. This should include a reduction or retirement from intensive overnight duties during the later stages of a career. In recent years, many experienced cardiologists have retired early because of the burden of night-time PPCI. From age 55 years, operators should be able to halve the amount of night-time PPCI they do. From age 60, operators should be able to stop doing night-time PPCI but continue doing daytime PPCI, for example, on daytime weekend rotas. This expectation should inform departmental recruitment.
Key Updates Since 2015
- Primary PCI (PPCI) should be provided by designated PPCI centres to which ST-elevation MI (STEMI) patients are taken directly by the ambulance service.
- PPCI centres should run a 24-hour service every day of the year.
- Inter-hospital transfer of STEMI patients should be prioritised by ambulance services.
- PPCI centres doing <200 PPCI per year should consider network amalgamation of services.
- Out of hours, emergency cases should be treated in PPCI centres.
- There is no requirement for an out-of-hours interventional service at non-PPCI sites.
- Job plans for a PCI operator in any centre should include contribution to a PPCI service.
- A PPCI rota requires a minimum of six consultants (<400 PPCI/ year) or eight consultants (≥400 PPCI/year).
- A PPCI rota requires a minimum of eight allied health professionals in each discipline.
- Rest after overnight PPCI on call for cardiologists should be a minimum of a half-day (<400-PPCI/year centres) or a full day (≥400-PPCI/year centres).
- Rest after overnight PPCI for allied health professionals should be a minimum of a half-day compensated (<400-PPCI/year centres) or a full day compensated (≥400-PPCI/year centres).
- Operators aged ≥55 years should be able to halve their night-time PPCI workload.
- Operators aged ≥60 years should be able to come off night-time PPCI duties but continue to provide daytime PPCI.
The Multidisciplinary Heart Team
Since the last version of these guidelines,1 the British Cardiovascular Society, BCIS and Society for Cardiothoracic Surgery have produced updated guidelines on MDT meetings that outline general principles and specific issues related to shared decision-making in the fields of coronary and valvular heart disease.12
It is healthy to acknowledge the limitations of shared medical decision-making in the absence of the patient.13 While the MDT can make a technical recommendation, the clinical appropriateness of that decision requires direct consultation and discussion with the patient. A physician who has met the patient should ideally be present at the MDT.
MDTs should meet at least weekly, with smaller mini-MDTs convened for discussing urgent or emergency patients at other times. Exact arrangements are down to local geography and governance. It is unacceptable to delay patient treatment, and thus potentially prolong in-patient stay, by waiting for the next scheduled MDT. The urgent nature of coronary disease management dictates that the MDT process is agile enough to respond to clinical problems in a timely and appropriate manner.
It is expected that patients with complex coronary disease requiring higher-risk PCI would undergo discussion unless there is an urgent need for PCI. Anatomical subsets that may warrant MDT discussion include complex three-vessel coronary artery disease, complex left main stem (LMS) bifurcation disease and coronary disease including chronic total occlusions (CTOs) or heavily calcified coronary arteries. Ideally, adjunctive ‘interventional diagnostics’ should be performed at the time of the angiogram to allow informed discussion at the MDT. A dedicated MDT coordinator is necessary to help collect the clinical data, document attendance, record consensus guidance in each case and facilitate communication with referring physicians, the patient and the patient notes.
Video conferencing has greatly facilitated attendance of clinicians from more than one centre at the MDT. Regular attendance at a coronary MDT, either virtually or in person, is an essential part of the role of an Interventional Consultant and this should be accommodated in Consultants’ job plans. Trainees should be encouraged to attend MDTs where possible as they offer a valuable learning opportunity.
Key Updates Since 2015
- A physician who has met the patient should ideally be present at the multidisciplinary team (MDT).
- MDTs assess technical and evidential suitability for treatment options.
- Clinical suitability requires in-person discussion with the patient.
- MDT outcomes should be clearly documented in the patient’s medical record.
Specific Interventions
Unprotected Left Main PCI
PCI in the LMS is ideally undertaken by experienced operators within an experienced cath lab team with careful planning. However, this is not always possible in the emergency setting and all operators and PPCI teams must gain experience in left main PCI.
An analysis of the BCIS national database showed an association between operator volume and 1-year patient survival. The lower-volume threshold of minimum operator LMS PCI volume was ≥16 cases per year.14 It is therefore recommended that operators who do fewer than 15 LMS PCI per year should, where possible, perform LMS PCI as a joint procedure with a colleague who does a higher volume of these cases and seek these opportunities to increase their own experience in LMS PCI. Operators may consider referring elective complex LM cases to a colleague who does higher volume LMS PCI.
Use of intra-coronary imaging with either IVUS or OCT is associated with improved clinical outcomes and is therefore recommended for LMS PCI.15 Imaging accurately determines vessel geometry and size, and plaque morphology such that plaque-modification tools and stent technique can be selected appropriately. Post-stent implantation imaging to determine the minimal stent area is recommended as this is associated with improved patient outcomes.16
LMS PCI requires large-diameter drug-eluting stents (DES). Operators need to be familiar with expansion limits, which differ between DES designs. The stepwise provisional philosophy may be the default approach to LMS bifurcation PCI. Operators must have the ability to complete this with a second stent technique where needed.17
Chronic Total Occlusion
CTO PCI requires specific skills. The procedure takes longer, has a lower success rate, higher complication rate and greater cost than non-CTO PCI. As such, most CTO cases should be discussed at an MDT for appropriateness, indication and feasibility before scheduling. Every MDT considering an optimal revascularisation strategy will need access to an expert CTO operator opinion regarding the feasibility of PCI.
Most successful CTO PCI cases are treated by antegrade wire escalation and it is reasonable to expect that many PCI operators will have experience with wire escalation cases. Operators undertaking CTO PCI should be comfortable with dual access, microcatheter choice, guidewire choice, guide extension management and trapping techniques. Cases that are considered likely to need either antegrade dissection/re-entry or retrograde recanalisation should be referred to operators with relevant specialist experience and skills.
CTO procedures should be undertaken electively, on dedicated lists without competing procedures. Operators may work singly with a trainee or as a consultant pair. The maintenance and development of particular skills will require attendance at subspecialty meetings and participation in local discussion networks. Centres doing <400 PCI per year are unlikely to be able to develop or sustain a successful CTO program aiming for a procedural success rate of >90% and, in this setting, referral to dedicated CTO operators is expected. Operators with a speciality interest in CTO procedures should aim to do ≥25 such procedures per year.
Key Updates Since 2015
- Intracoronary imaging is recommended for left main stem PCI.
- Operators doing elective or urgent left main stem PCI should undertake ≥15 such cases per year.
- Chronic total occlusion angioplasty cases should be undertaken in a planned manner by PCI operators with a special interest.
- Chronic total occlusion expertise should be concentrated – ideally, operators should be undertaking ≥25 cases per year.
Governance
National Dataset
Collection of accurate data on PCI procedures and outcomes is required at the individual operator and hospital level. BCIS provides a clinical dataset to allow national collection of results of interventional procedures and comparative audit.18 BCIS oversees and guides the collection and analysis of these data, which are hosted by NICOR.
The hospital Trust must provide appropriate audit and information technology infrastructure and personnel to allow clinicians, assisted by data managers, to collect comprehensive and accurate data and to submit data in compliance with deadlines set by BCIS and NICOR. Each cardiology department should have a designated PCI lead for the audit process. However, the ultimate responsibility for data completeness and accuracy rests with the individual Consultant responsible for the procedure.
Regular internal validation of case ascertainment, data completeness and data accuracy is required. The BCIS dataset requires that information be collected from symptom presentation through to discharge. Systems to collate and record events – particularly those that occur after a procedure – require organisation and funding. Audits to ensure data completeness and accuracy should be performed locally and apply equally to NHS and private centres.
Institutional Audit
Data should be uploaded contemporaneously to inform regular departmental PCI meetings. BCIS reports the results of an analysis of UK-wide PCI activity on an annual basis (available on the BCIS website), while monthly or quarterly results are to be accessed by the centre for use in regular PCI governance meetings. The team should examine and discuss centre and operator volumes, trends and outcomes and benchmark their own activity against national data.
Local PCI governance meetings should include individual case presentations of all mortality and major morbidity with time for open discussion. All operators (including those visiting or participating in the PPCI rota) should be present and the trainees and AHP team invited to contribute. Additional local audits of specific patients or complex lesion subsets are recommended. Random case review is a recommended component of the meeting. Trusts must provide appropriate support for this process of clinical governance to allow collation and analysis of data, time for audit meetings, facilities for presentation and support so that the meeting outcomes can be recorded.
Individual Operator Outcomes
BCIS, in collaboration with NICOR, can provide operators with a detailed breakdown of their own PCI activity that includes process control charts and risk-adjusted outcome analysis. The aim is to provide data for each PCI operator that can be used in the process of annual appraisal and revalidation. Providing data is submitted in a timely manner, these data can and should be obtained throughout the year by the individual operator.
Public Reporting
BCIS, in collaboration with NICOR, will provide a set of analyses at institutional level intended to be understood by the general public. This process has recently been re-initiated following the COVID-19 pandemic, with the intention of providing 3-year rolling data in due course.
Annual Appraisal and Revalidation
An individual operator’s results are likely to be improved by sharing experiences with colleagues. Discussion between operators, both formal and informal, should be part of standard departmental practice. BCIS recommends a minimum of 4 days a year attending national and international meetings relating to cardiovascular intervention. A record of Continued Professional Development is recommended.
Key Updates Since 2015
- PCI governance should include regular review of case volume and outcomes.
- PCI governance should include a Morbidity and Mortality meeting attended by all operators.
New PCI Centres
Previously, a separate document described the recommended development and peer review of new PCI services in the UK.19 The last version of this in 2015 is superseded by this combined document. The recommendations are that the infrastructure and logistical requirements of any new PCI service are identical to those outlined above. To establish this, all sites considering setting up a PCI service should undergo BCIS peer review prior to commencing their service. A checklist for use by the new centre and the BCIS peer review team is included as Supplementary Material.
The development of a new PCI site must be agreed with all the relevant stakeholders through a strategic plan developed with the local cardiac network. Stakeholders include but are not limited to: other hospitals within the network, especially those undertaking PCI; local ambulance trusts; local patient representatives; commissioning bodies; and the local surgical centre. Facilities in existing PCI centres must be fully used. While the need for emergency cardiac surgery is very rare, all new PCI services at hospitals with and without on-site cardiac surgery must agree a written protocol for the provision of emergency cardiac surgical cover with a local service.
It is recognised that a new PCI service may not meet full BCIS Guidance, especially in terms of case volume, from inception. A development period of defined duration should be explicitly included in the planning process. New PCI services should be fully compliant with all BCIS Guidance within 3 years. All new PCI services should therefore ensure that they will be able to carry out at least 200 PCI per year within 3 years of starting.
Once a service is prepared for clinical commissioning, a request for a site review should be made to the Honorary Secretary of BCIS by the Chief Executive of the Trust. The proposed PCI service should not begin until BCIS approval for service initiation, according to these guidelines, is obtained after a formal site visit. The BCIS peer review team will comprise a minimum of two independent interventional cardiologists from outside the region. The BCIS team will review all the documentation outlined in the checklist, which should be available prior to the visit. The visit should allow access to all relevant facilities and stakeholders at the host institute.
At the completion of the visit, the BCIS representatives will submit a report through the Clinical Standards Group to BCIS Council. The ratified report will then be returned to the Trust Chief Executive, with copies to the relevant network and commissioning bodies.
New Primary PCI Centres
A new primary PCI service must provide timely reperfusion therapy to unselected patients with STEMI. These patients range from relatively stable patients with limited myocardial injury to haemodynamically unstable patients with cardiogenic shock, pulmonary oedema, or out-of-hospital cardiac arrest who may require ventilation and intensive care. The design of primary PCI services should be negotiated within clinical networks between PCI centres and commissioners. The agreed service plan will depend on local geography, demographics, ambulance service isochrone maps, access to cath labs, availability of relevant clinical staff, provision of support services and overall service cost. The service plan will need to balance the need to minimise transport times against the requirement for continuous access to an effective and sustainable primary PCI service (both for patients who present via ambulance services or via Accident and Emergency departments). An individual UK hospital that provides a continuous (24 hours, 7 days a week) PPCI service would need to serve a population of 200,000 to expect a minimum number of 100 PPCI procedures per annum. Hospitals expecting to undertake fewer than 200 PPCIs per year should consider wider network solutions in order to have sustainable rotas, unless specific geographic considerations make this unachievable.
New PCI Centres: Key Updates Since 2015
- The recommendations and requirements for a new PCI service are the same as for existing centres.
- All sites considering setting up a PCI service should undergo BCIS peer review prior to commencing the service.
- A checklist for use by the new centre and the British Cardiovascular Intervention Society peer review team is included as Supplementary Material.
Teaching and Training
A training programme must ensure that its trainees acquire a sound knowledge base of the basic principles that underpin the practice of interventional cardiology. It is recommended that training programmes adhere to the recently published Cardiology 2022 curriculum, which reflects an emphasis on competency-based training, assessed by a variety of workplace-based assessments.20 Specific competencies for all CCT holders include investigating potential ischaemic presentations, optimising medication and lifestyle advice for symptomatic and prognostic benefit and liaising with rehabilitation, primary and intermediate care. All trainees should have experience of invasive angiography and be skilled in the referral for, and management of, patients undergoing PCI.
The Joint Royal College of Physicians Training Board (JRCPTB) states that to enter advanced training in coronary intervention, trainees will be competent to perform diagnostic angiography with limited supervision. It is expected that advanced intervention trainees will develop capabilities in patient selection for and performance of elective, urgent and emergency PCI, including access and adjunctive techniques, and the ability to make balanced judgements on the relative benefits of medical therapy, percutaneous and surgical revascularisation. In addition to the procedural capabilities outlined by the JRCPTB, the following important skills should be acquired during higher training:
- Intracoronary imaging: the ability to safely perform and interpret IVUS and/or OCT imaging and be experienced in the use of intracoronary imaging to optimise PCI outcomes.
- Coronary pressure wire measurements for procedural guidance. Fully trained operators should understand and be familiar with the accurate use of the pressure wire, including the assessment of ostial lesions, diffuse and serial lesion disease and outcome post-PCI.
- Distinguishing between acceptable balloon angioplasty results and dissections that require implantation of a coronary stent.
- Use of techniques to treat coronary perforation, specifically balloon occlusion, covered stents and coils.
- Procedural reporting and completion and relevance of database archiving.
Adult structural heart intervention is a growing area in interventional subspecialisation and requires post-CCT training. A brief publication outlining current expectations for training in structural heart disease intervention is available on the BCIS website.
Selection for Advanced Subspecialty Training in Intervention
Training institutions should have a method of selecting PCI trainees. This process varies between institutions and there is no agreed national mechanism. After selection, ongoing formal assessment through the training period is necessary with bidirectional feedback. If it is considered that training would be appropriate for an individual but local circumstances are such that the training cannot be provided, an inter-deanery transfer can be considered. Local arrangements with neighbouring centres should be encouraged for trainees to be able to train in techniques not available at the host institution.
Procedural Numbers and Scope
A trainee is expected to have done an average of ≥200 PCI procedures per year as first operator over the 2 years prior to their Consultant appointment. A review of the trainee’s experience and outcomes should be performed on a regular basis. For the purpose of training, it should be left to the trainer to determine when a trainee has been the principal operator. The trainee must personally perform the procedures under the direction of a recognised trainer. The trainer who takes clinical responsibility for the patient should be immediately available in the cath lab to supervise the trainee.
Education
BCIS recommends that each regional interventional training programme should hold a regular interventional meeting. This should address the core curriculum subject matter and should provide an opportunity to review cases with respect to patient selection, procedure execution, clinical outcome and complications. Participation in mortality and morbidity review by trainees is essential.
Trainees should be active participants in data analysis and presentations and be encouraged to undertake clinical audits. Trainees are encouraged to participate in research activities of their clinical department. They should be offered advice as to the appropriateness and potential benefit to them of undertaking a formal period of research out of programme, usually with the intention of obtaining a higher research degree.
Trainees should spend at least 4 days per year attending appropriate educational meetings, including regional trainee study days. Participation in the specialised BCIS Trainees Courses and Advanced Cardiovascular Intervention meeting, as well as the BCIS Evening Webinar series is recommended. Further relevant opportunities for education come in the form of international fellows’ courses and international meetings. Online or on-demand training opportunities are widely available.
Trainers
Each institution with an interventional training programme should have at least two experienced clinical interventional cardiologists who have each done ≥1,000 PCI procedures in their careers. Each centre will have a designated training programme director who will ensure trainee selection, appraisal and assessment. An interventional training centre needs to be doing ≥600 PCI procedures a year so that trainees can participate in the full spectrum of coronary interventions. We recommend that the number of trainees accepted into a training programme should reflect the institutional volume and the number of trainers available and should allow trainees to meet minimum volume requirements. Generally, a PCI programme should be an integral component of a comprehensive service and should have on-site capabilities including a coronary care unit, cardiac surgery, cardiac intensive care and cardiac imaging including echocardiography, CT and MRI.
High-volume PCI programmes without on-site cardiac surgery provide excellent PCI training and should be considered as equivalent to a surgical centre. It is also expected that trainees will spend at least 1 year within a surgical centre, and that arrangements are made to allow interaction with neighbouring surgical centre interventional trainers, trainees and cardiac surgeons. All trainees should attend and participate in revascularisation MDTs regularly. All PCI trainees should spend at least a year of their training in a centre that provides transcatheter aortic valve implantation to give them some exposure to the procedure, as well as patient selection and a specialised aortic valve MDT.
Trainee Evaluation
The responsibility for trainee evaluation should reside with the Training Director. The trainee and trainer should set aside time to discuss cases and aspects of concern on either side. Regular review of the trainee’s feedback along with the trainer’s feedback, and presentation of that within the Deanery, should occur on an annual basis. The training director, advised by clinical supervisors, should be responsible for confirming that trainees have completed their interventional training satisfactorily as required by the core training requirements.