Professor Mike Chester and Unnecessary Stents

I was appointed SR 1995 and trained in interventional cardiology in one of the big specialist heart centres.

I discovered the problem of patients undergoing inappropriate heart procedures (mainly angioplasty and stent) almost immediately after I set up a clinic for end of line angina sufferers in 1997. I got the idea of setting up a refractory angina clinic when two registrars came to me for advice on patients they had seen in clinic. The hefty set of battered notes told a story of repeated procedures and admissions with angina. Between them the two patients had been through a dozen procedures. To my shame I didn’t have a clue what to suggest. I asked around and the answers ranged from something as simple as a TENS machine (which you can buy from a High Street pharmacy) to a heart transplant (which you can’t). The striking thing was that the person who suggested a heart transplant thought it was madness to suggest a TENS machine and vice versa. The most sensible suggestion was from Prof Bob Lewin, a renowned psychologist, who suggested asking the patient what they wanted. It turned out that patients wanted to play a part in what was going on. With input from a group of international experts, I set up a patient centred angina clinic whose core philosophy was to treat patients like grown ups and educate them and their families so they could understand their condition and play a greater role in their own care. Then we’d decide together what was best. From the outset it was obvious that patients have many misconceptions. Most people think angina is a sign the heart is being damaged and that severe narrowings inevitably progress to block and cause a heart attack. Many ‘joined the dots’ and assumed that opening a narrowed artery and holding it open with wire scaffolding (stent) would prevent the impeding disaster. The attitude was: “So what if there’s a risk of the procedure going wrong, it’s better than waiting for the heart attack to happen.”

The truth is and always has been that angioplasty and stents are no better than tablets and a healthy lifestyle at reducing risk, except during a heart attack. The evidence in 1998 was that patients opting for angioplasty were at greater risk of harm not less, but that didn’t stop them queuing up for what they thought was a risk reducing procedure.

It was clear that at least some patients were undergoing angioplasty on a false premise and that meant there was a problem with the consent process. I started mentioning my concerns to colleagues. I began with gentle conversations in the corridor or over coffee. Colleagues listened politely and even admitted it happened, but seemed to think it was someone else’s problem.

Then in late 2002, I came across a patient who died as a result of an inappropriate stent procedure. I told the Medical Director, but he just shrugged it off.

I became a broken record, endlessly nagging about unnecessary procedures and their potentially disastrous consequences but no one was listening.

The Trust Chairman inadvertently brought things to a head in Jan 2003, when he boasted that he had stopped a local newspaper reporting the story. By then everyone knew the “story” and the reaction from interventionally-minded colleagues was predictably aggressive. It didn’t seem to matter that I hadn’t given the story to the media, it was the idea that I could have that seemed to bother them.

It was bad timing for the new clinic. We needed colleagues’ support to expand and a few days later at a specially convened Board of Clinicians meeting the senior surgeon snarled: “You wanted our support. You’ve lost it.”

I may be enlightened but I am a cardiologist so I fought back. At first things seemed to be going well. The chairman admitted he had backed the wrong horse and in Nov 2003, a grievance panel of non executive directors concluded: “The allegations that some invasive procedures are neither necessary nor desirable have been made to management and medical colleagues openly over a period of time. However, positive action is required as a consequence of the statements made on ‘inappropriate procedures’. The Appellant, not just recently, but over a period of several years has made allegations. Whatever the truth in the allegation, it is in the interests of patients, the reputation of the CTC and of the Appellant, that an independent review be undertaken to assess the validity of the allegation.” The statement finished: “It is our view that failure to pursue the suggestions regarding alternatives to invasive procedures made by Dr Chester will be a negligent act on our collective part”.

For the Trust to call for an investigation into my allegation that some patients were undergoing inappropriate procedures seemed like a victory, but shortly afterwards the Chairman resigned unexpectedly.

Criticism is not welcome in specialist Trusts, especially when it is justified. Reprisals and victimization became the order of the day and eventually my team TUPE transferred to a neighbouring Trust because of Trust’s failure: “to protect [us] from reprisals following our expression of a serious concern about clinical practice.” Just before we left on 16 June 2004, I put the concerns to the new Trust chairman who said: “I will not preside over a cover up” (Wasn’t that what Nixon said?) and promised to fully investigate the allegations. Three weeks later, he wrote “As you are no longer an employee of the Trust I do not think it advisable for me to look at any documentary evidence [of wrongdoing] that you have in your possession.

Next the Medical Director fell on his sword after a vote of no confidence but it was too late to stop a review by British Cardiac Society (BCS) on 15 Aug 2004. However, the new Medical Director and new Chairman did manage to persuade them to change the Terms of Reference on the morning of the visit. Over the following months the Trust did its best to persuade the BCS to rule in their favour. In Oct 2004 the non-executive board members who had implicated themselves in collective negligence resigned en masse, citing insurmountable differences with the Chair.

After receiving of legal opinion which according to the cardiac Czar, cost £20,000, the British Cardiac Society withdrew its first and only draft report into the allegation that there was widespread problem of patients were undergoing inappropriate stent procedures. On 16 Dec 2004, the President of the British Cardiac Society (BCS) wrote: “the matter should be referred to a statutory national body with the mandate and resources to undertake, what, in our assessment, could be a lengthy and complex enquiry.”

For the BCS to acknowledge the allegation that cardiologists were performing unnecessary stent procedures was sufficiently credible to warrant a “lengthy and complex enquiry” felt like whistle blower heaven. The BCS thought it would be best for the Trust to present the case against itself to the Healthcare Commission who thought it would be best to conduct an “initial consideration” based on the Trust’s version of event and without visiting the Trust. The first I heard about it was when they advised me there was no problem that needed to be investigated. The Trust Board and the BCS had both strongly recommended a formal investigation, so I appealed. The HCC and the Trust agreed that it would best for all concerned if two of the HCC’s most inexperienced staff should rule on their seniors’ handling of the case. They decided their seniors were right and that an investigation was not necessary after all.

Remarkably, patients who believed they had been duped into having unnecessary procedures were not given an opportunity to provide confidential statements. Colleagues who were willing to come forward in secret were expected to walk the gauntlet and meet the investigators in the Trust executive offices. None came forward. It was almost as if the Trust and the HCC didn’t want to find evidence to support the allegation that a major cardiothoracic centre was performing unnecessary procedures and suppressing anyone who raised concerns.

I had to abandon an Employment Tribunal action when it finally came down to money and how much I could personally risk.  After that I got on with developing my service and raising concerns whenever the opportunity arose. The interventional community carried on as if nothing had happened.

Over the past few years some key evidence has come from the UK and US.

• In 2008 the largest angioplasty trial to date (COURAGE) showed that planned angioplasty produced only a relatively small and temporary improvement and was not cost effective. The following year more procedures were performed than ever before. If stents had been drugs they would have been withdrawn from the market.

• In 2009 the British Cardiovascular Interventional Society (BCIS) produced national registry data that persuaded the cardiac Czar, Roger Boyle to state that 8-12% of planned angioplasty procedures were inappropriate.

• In 2010 a senate Finance Committee found that US Interventional Society had done little to discourage the overuse of angioplasty.

• In 2011, a registry of over 500,000 US patients showed that 11.6% of planned angioplasty were inappropriate.

• In this regard the cardiac Czar and BCIS, which is heavily funded by the angioplasty industry and for most of the past decade had two members of industry on its board, was keeping up with the American Joneses. A former BCIS president is

• US hospitals are facing legal action from patients who claim they have suffered harm from inappropriate procedures.

In the thirteen years since I first put my formal concern to the Trust’s governance manager around 50,000 inappropriate angioplasty procedures have been performed in the UK and on average the patients were no better off than they would have been if they had got their tablets right and got a bit fitter. The cost to the taxpayer is somewhere in the region of £250 million, much of which is probably loaned to us by the countries we buy the equipment from. Who will loan us the money for the negligence claims? Is there an economist in the house?

To date the allegation that thousands of NHS patients have undergone inappropriate procedures remains uninvestigated.

 

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7 Responses to Professor Mike Chester and Unnecessary Stents

  1. Miriam Pryke says:

    Sounds just like the breast cancer screening pogrom to me. Will someone blow the whistle on that?

  2. Wendy taylor says:

    Coiling un- ruptured cerebral aneurysms is very expensive and has very dubious benefit. There is a significant morbidity. These device industries get everywhere and make loads of money.

  3. Simon Border says:

    “In 2009 the British Cardiovascular Interventional Society (BCIS) produced national registry data that persuaded the cardiac Czar, Roger Boyle to state that 8-12% of planned angioplasty procedures were inappropriate.”

    This implies that 88-92% of angioplasty procedures are appropriate

    In 2011, a registry of over 500,000 US patients showed that 11.6% of planned angioplasty were inappropriate.

    This implies that 88.4% of planned angioplasty procedures are appropriate

    You make no reference to the proven value of primary angioplasty for acute MI and proven value of angioplasty in acute coronary syndromes.

    I wonder what is going on here – methinks he doth protest too much …

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  6. Mike Chester says:

    Methinks Simon is not protesting enough. Is he seriously saying that it is acceptable that only 88.4% of these expensive and potentially lethal procedures are appropriate? What is going on here is that I believe we should be aiming for zero inappropriate procedures. The point is obvious if you replace “angioplasty” with another intervention such as “amputation.”

    Incidentally, it is facile to infer that because 10% of procedures are inappropriate it means that the remaining 90% are necessarily appropriate.

    I cut my teeth on angioplasty during heart attacks but I deliberately didn’t make much of angioplasty in the setting of actual or impending heart attacks because I was writing about stable angina. I did say; “The truth is and always has been that angioplasty and stents are no better than tablets and a healthy lifestyle at reducing risk, except during a heart attack.”

  7. john gleave. says:

    hello mike, i am an ex patient of yours, my name is john gleave. well done for speaking up for what you strongly believe in, I am sure you have the evidence to back your opinions. You should be given the right to voice your facts and opinions fairly without being phobed off and gagged. your intrests are soley in the intrests of patients and you say what others are afraid too.. mike remember the old saying god likes a tryer. If my statement makes me a marked man then so be it.. i can bite back too. All the very best mike.. PS.YOU SHOULD BE BACK AT NRAC WHERE YOU BELONG….

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