Was an in-depth situation analysis carried out with regard to the deaths of the four patients who underwent a common heart procedure this week at the Cardiology Institute of the National Hospital of Sri Lanka? This was the question of utmost importance being asked in health circles as the three-member team appointed to probe the [...]


Post procedure deaths at NHS: Was inquiry into mishaps exhaustively carried out?


Was an in-depth situation analysis carried out with regard to the deaths of the four patients who underwent a common heart procedure this week at the Cardiology Institute of the National Hospital of Sri Lanka?

This was the question of utmost importance being asked in health circles as the three-member team appointed to probe the deaths after angiograms submitted its interim report on Friday. (See box)  

With the probe team stating that the “most likely” cause of the deaths was a ‘batch’ of the contrast media used during the procedure, sources said that the same batch had been used at the Jaffna and Karapitiya Teaching Hospitals, without any adverse impact.

“These days, angiograms are a relatively safe test,” stressed a source, while others urged that audits of ‘deaths versus the number of angiogram procedures’ done in heart centres in the state hospitals should be carried out for the past six months.

It is learnt that this particular variety of contrast media imported from the west, which is in the eye of the storm, has been in use for a long time not only in the state sector (at the NHSL and the Lady Ridgeway Hospital for Children in Colombo and Jaffna, Karapitiya, Kurunegala and Kandy Hospitals), but also in the semi-state sector (Sri Jayewardenepura Hospital) and the private sector.

To find the cause of these four deaths or any other deaths during procedures or surgeries in a state hospital, a situation analysis is vital, the Sunday Times learns.

It should look into certain vital aspects, sources said. They should include:

* Was the procedure being done by a Consultant (in this case a Consultant Cardiologist)? If it was being done by Senior Registrars in training, was a Consultant present, as is mandatorily required? While conceding that Senior Registrars need to do such procedures to learn the skills, they should do so under the strict supervision of a Consultant, was the categorical view of numerous health sources, who added that otherwise it would be “totally unacceptable”. What was the patient’s condition before the procedure?

* What was the assessment of the patient? Was the patient severely ill and likely to die during the procedure or was the patient at “least” risk of dying?

* Was the patient’s death due to a failure on the part of the consumables, which in this case would include equipment, drugs, catheter etc., used in the procedure?

Taking up the possibility of the culprit being a certain ‘batch’ of the contrast media, sources pointed out that firstly what should be ascertained is whether it was a new batch, whether the same batch was used in the same hospital and elsewhere and whether the same batch was used only the same day or on different days. If there has been a batch failure, other factors such as transport and storage which could also cause a failure need to be checked out.

Then other drugs such as antibiotics and anti-coagulation (blood-thinning) agents used on these patients also need to be checked out thoroughly, the sources added, while other sources argued that if there was a massive allergy from the contrast media which could lead to death, measures could have been taken to save the patients.

In an angiogram, a special dye (contrast media) and a camera (fluoroscopy) are used to X-ray or map the blood flow in an artery or a vein, sources told the Sunday Times, pointing out that angiograms can look at these blood vessels in the head, arms, legs, chest, back, or stomach.

Angiograms are commonly used to check out the arteries near the heart (coronary angiogram), lungs (pulmonary angiograms), brain (cerebral angiograms), head and neck (carotid angiograms), legs and arms (peripheral) and the aorta (aortogram), it is learnt.

Usually, this procedure is carried out to check out whether the blood flow in blood vessels has been affected by a narrowing or blockage of the blood vessels. It can also find out whether there is an aneurysm (bulge) in a blood vessel.

Angiograms are an important test in checking out coronary artery disease (heart disease) which if goes undetected could lead to patients dying. Heart disease is the No. 1 killer not only in Sri Lanka but also across the world.

Coronary or cardiac angiograms are performed by Cardiologists in Catheterization Laboratories with the patients mostly under sedation rather than general anaesthesia (made unconscious), unlike heart (cardiac) operations (surgeries) which are done on patients who are under general anaesthesia by heart surgeons (cardiac surgeons).

During an angiogram, a thin tube (catheter) is passed into a blood vessel in the groin (femoral artery or vein) or just above the elbow (radial artery) and is guided to the section of the body under investigations. Thereafter, an iodine dye or contrast material is injected into the vessel to make the section clear on X-rays.

Sometimes during an angiogram if severe blockages of heart vessels are detected, the Cardiologists will use the catheter to open a blocked blood vessel using a balloon (angioplasty) or insert a stent, to help resume the blood flow.

Probe team makes recommendations

The three-member committee appointed to probe the four deaths at the Cardiology Institute of the National Hospital of Sri Lanka submitted its interim report to Dr. Palitha Mahipala, Director-General of Health Services, on Friday,

Even before we submitted the report, as we cannot take any risks with the lives of our patients, we recommended the immediate withdrawal of that particular batch of contrast media used in angiograms after which four people died, the committee’s Chairperson, Dr. Lakshmi Somatunga who is also the Deputy Director-General Medical Services 1, told the Sunday Times. The other members of the investigation team are the Chief Executive Officer of the National Medicines Regulatory Authority, Dr. Kamal Jayasinghe and the Senior Assistant Secretary of the Health Ministry, Rohana de Silva.

Two other patients who were also affected in a similar manner, one critically, have recovered, it is learnt.

While Dr. Somatunga said that “most probably” the cause was the contrast media, the committee will be able to come to a final conclusion only after the postmortem findings on the patients come in and a chemical analysis of the contents of the bottles of the contrast media is carried out.

“We will have to await the pathological postmortem as well as laboratory investigation results and reliability checks on the contrast media itself. We will also get an independent third party to carry out a chemical analysis of the contrast media,” she said, adding that it had been supplied by a company in the west which had been doing so for a long time now. When asked whether the same batch of contrast media had been sent to other hospitals, Dr. Somatunga said that it was “mainly used by the NHSL”.

The four patients, one man and three women, who underwent angiograms did not die during the procedure but in the ward, NHSL Deputy Director Dr. Cyril de Silva told the Sunday Times, adding that two others were also affected. However, one of them, a male patient has recovered and been discharged and the other female patient who was on ventilation has also recovered and been moved to the ward from the Intensive Care Unit.

Explaining that there are five units under different Consultant Cardiologists at the NHSL’s Cardiology Institute, he said that two of seven patients who underwent angiograms on November 27 in Catheterization Laboratory (Cath Lab) 2, died after the procedure was concluded and were back in the ward. Meanwhile, two of 13 patients who underwent angiograms on November 28 in Cath Lab 1 also died after being taken to the ward. Two of the four patients who died had also undergone stenting.

When asked how the contrast media could have affected some and not others, Dr. de Silva pointed out that though it could be the same batch, it may have been some bottles which were the cause.

While reiterating that some of the patients who undergo angiograms are affected by severe heart disease with lots of risks, he said that when looking at this unfortunate incident, the “common factor” was the contrast dye.

“Don’t fear angiograms,” Dr. de Silva urged the public, stressing that it is needed to identify heart disease and save lives.

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