Royal College of Physicians cardiology review

We have published  a redacted independent review into interventional cardiology procedures and the use of Drug Coated Balloons at NNUH which was undertaken by the Royal College of Physicians.

Why do we use Drug Coated Balloons for some cardiology procedures?

Angioplasty and Stenting are part of a procedure called percutaneous coronary intervention or PCI, which is performed to improve the blood flow from the arteries of the heart to the heart muscle.

Drug Coated Balloon (DCB) treatments have been in clinical use for almost 15 years. DCBs are licensed for use to deliver a drug to prevent re-narrowing of the arteries instead of leaving a stent in the artery.

At NNUH, we have been using DCB since 2009 to treat re-narrowing within existing stents, smaller arteries and bifurcation lesions (areas of narrowing where blood vessels branch), which are proven to respond well to this treatment. In common with other centres around the world, use has gradually expanded to include a wider range of indications including larger arteries and stable and unstable coronary disease (heart attacks).

What does the procedure involve?

Balloon angioplasty is used in the majority of PCI procedures to stretch the narrowed artery and enlarge the channel for blood flow. Routinely a drug eluting stent is implanted, but if a good result is achieved with balloon dilatation, a drug coated balloon can be used instead to deliver a special drug that prevents re-narrowing of the artery and assists in the healing process. Once in position the balloon is inflated over a period of about 30 seconds to deliver the drug to a specific area. The balloon is then deflated and removed leaving only the drug coating behind.

Why did we ask the Royal College of Physicians to carry out a review of our use of DCBs?

This procedure is used nationally and internationally for a range of issues to treat blood vessels of the heart and is used for a broader range of presentations in other European and international centres and it is licensed for all these conditions.

However, there is ongoing debate and research in the cardiology community about using DCB for a broader range of interventions.

Following concerns raised internally, we carried out our own internal review, led by our Deputy Medical Director, which identified a need to improve our consent process and information given to patients. We then invited the Royal College of Physicians to carry out an independent review of our service to see if there were any further recommendations and actions.

Why do we use DCB more than some centres?

The evidence we have suggests that the treatment is as safe and effective as drug eluting stents and our cardiologists see it as a good treatment option in many specific patient groups. DCBs are widely used across the UK. The main rationale for using DCB is that it does not leave permanent metal in the coronary artery and has the potential to allow better coronary artery remodelling compared to standard techniques such as drug eluting stents. Drug coated balloons can help reduce the bleeding risk when treating coronary arteries because shorter courses of blood thinning medication can be used compared to stents.

Our experience is that the practice is safe, acute complications are very rare and patients do well. DCB treatment can simplify procedures for patients where stenting would otherwise be complex. In addition, it can improve outcomes in patients at high bleeding risk (eg patients requiring anticoagulation, or frail patients).

There is clear evidence of the feasibility and safety of using DCB in a busy PCI practice at NNUH and results have been extensively peer reviewed by international experts at different meetings.

Randomised comparisons with drug eluting stents show comparable outcomes in small coronary arteries. NNUH is currently participating in an international multicentre randomised controlled trial comparing DCB and drug eluting stents in larger arteries.

There are a number of high-profile centres across Europe also using DCB more widely. Over the last few years outcomes of patients treated with DCB have been presented at numerous meetings including the Euro PCR and Transcatheter Therapeutics (TCT), which are the best known coronary interventional meetings in the world as well as a specific annual DCB meeting in Birmingham which has been attended by an international audience.

Data published by the British Cardiovascular Intervention Society shows our Trust performs better than the national average on survival 30 days after PCI.

Overall, the outcomes for the department are very good with low 30-day mortality rates for interventional Cardiology procedures to coronary vessels that are significantly better than the national average according to National Audit of Percutaneous Coronary Interventions PCI Hospital Report

The NNUH is a high-volume centre with over 1500 procedures per year.

Our Friends and Family Test scores from patients for the angio-suite remain extremely high with 97.3% of patients rating the service as ‘very good’ and 2.7% as ‘good’.

What have we done since the Royal College review started?

We are making good progress against many of the recommendations made by the Royal College of Physicians and we are confident that this service has been and remains safe for patients.

The main concern raised was in relation to the cardiology department’s use of Drug Coated Balloons outside of current European Society of Cardiology guidelines. There was concern regarding whether or not appropriate consent had been taken before patients received treatment with these devices and whether or not these treatments should have been part of a formal research programme with appropriate ethical approval and patient consent.

We have already taken actions to improve patient information and policies in relation to angioplasty procedures. This includes a revised standard operating procedure for DCB and other procedures to the cardiac blood vessels, refreshed patient information materials and training for staff around the consent process

DCBs continue to be carried out at NNUH and under the recommendations set out by the Royal College of Physicians in the following circumstances
• In-stent restenosis,
• Vessels <3.0mm diameter,
• Vessels >3.0mm diameter if at least one of the following apply:
1. Patient is enrolled in a formal prospective research registry of DCB use with appropriate ethics and R&D approval
2. Patient is enrolled in a formal randomised controlled trial (RCT) of DCB versus second or third generation drug-eluting stent
3. Patient has signed a bespoke consent that clearly highlights the DCB use would be outside UK conventional and guideline-directed practice and has indicated specifically that this is their choice.

The cardiology department has implemented a rigorous process for reviewing PCI outcomes and complications, to ensure learning from these cases.  Outcomes after DCB treatment and compliance with the RCP recommendations are under continual monitoring.

What actions have we taken after the review?

All sixteen clinical cases that were reviewed by the independent service review (ISR) team virtually were re-reviewed by the Trust through its well-established Serious Incident Group that reviews internally reported incidents.

These reviews included participation from Consultant colleagues across a number of specialities, the Deputy Medical Director, the Associate Medical Director for Quality & Safety, and the Associate Director for Quality & Safety, the Associate Director of Patient Experience & Engagement and the Serious Incidents and Family Liaison Officer.

Additionally, we have ensured a comprehensive review through the same process of a further 20 out of 36 patients who suffered from an acute vessel closure within 24 hours of an interventional cardiology procedure in the last 8 years. The Cardiology department reviewed the remaining 16 cases to ensure there were no other significant care or service delivery problems.

The internal reviews found that the many of these cases were complex, and there was evidence of discussion with, and or involvement of colleagues in the decision-making process in most cases (although these discussions were not always documented in the notes). In addition, in several of the cases there was evidence of discussion with colleagues at Papworth, the regional cardiothoracic centre.  We found that the outcomes for patients in 13 of the 16 reviewed by the ISR team were very good or excellent. Of those, 3 of 16 case where the outcomes were concluded to be poor or very poor, duty of candour communications have been completed and the patient and or the family have been contacted. Of the 2 cases that the ISR team graded as having very poor care both had good long-term outcomes.

In terms of the patients concerned, the ISR review team graded 6 of the 16 cases as unsatisfactory and thought 2 of these had very poor care. They concluded that had it not been for the use of DCBs being outside of the accepted guidance at the time, they would have rated the care of 12 of the 16 as good.

Critically, the internal SIG review investigated the actual health outcomes for these 6 patients and concluded that they were excellent or good outcomes for four of the patients and poor for two. These two patients had already been through the SIG process prior to this additional review, the Consultants for these patients and the multidisciplinary team concluded that moderate harm was appropriate for each of these cases, with duty of candour applied in accordance with our SIG process and separate to this review.

Consultants from the cardiology team have fully acknowledged the findings of the internal and external review and formally applied duty of candour with the three patients where their care has been graded as poor. The team will communicate with appropriate patients about the review when providing ongoing care.

We welcome the in-depth review of our service and thank the ISR team for their very clear recommendations which will help us deliver improved quality of care for our patients.

If you are a patient or carer and have any specific queries, you can call 01603 287293 and a trained health professional will aim to call you back within 72 hours.

Published research and data

Data from British Cardiovascular Intervention Society Audit (2020-21).

Drug Coated balloons for small coronary artery disease: an open-label randomised non-inferiority trial

Drug Coated balloons vs drug-eluting stents for the treatment of small coronary artery disease: A meta-analysis of randomized trials

Drug Coated balloons for coronary artery bifurcation lesions: A systematic review and focused meta-analysis

Drug Coated Balloon Angioplasty Versus Drug-Eluting Stent Implantation in Patients With Coronary Stent Restenosis

Efficacy and safety of drug coated balloon in the treatment of acute myocardial infarction: a meta‑analysis of randomized controlled trials

Bare metal or drug eluting stent versus drug coated balloon in non-ST-elevation myocardial infarction: the randomised PEPCAD NSTEMI trial

Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction 

Drug Coated Balloon for De Novo Coronary Artery Disease  

Drug Coated Balloons for Coronary Artery Disease

Duration of dual antiplatelet therapy in elective drug coated balloon angioplasty

Drug Coated Balloons or Drug Eluting Stents – Determining an Optimum Strategy for Patients with High Bleeding Risk

Percutaneous Coronary Intervention in the Elderly: Are Drug coated Balloons the Future?

Long‑term safety of paclitaxel drug coated balloon‑only angioplasty for de novo coronary artery disease