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University of Aarhus 2003

The Andersen Patent

Doctor Henning Rud Andersen is only 53 years old, but nevertheless one of the “grand old men” among cardiac specialists. It is all because he got a crazy idea when he was a young registrar.

By Mikkel Hvid

Phoenix, Arizona, 1988. In a huge auditorium at the Arizona Heart Institute, 1,500 cardiac specialists from all over the world are sitting, listening. Among them is Henning Rud ­Andersen, a Danish registrar.

One of the pioneers of balloon dilation is on the podium. He is explaining by means of video clips and overheads how he cures narrowed or blocked coronary arteries. Together with a couple of colleagues, he has invented a ground-breaking device. They have attached an elongated balloon to the tip of a plastic cathe­ter. With the balloon still completely folded up, they have placed a fine ­latticed, metal scaffold over the balloon, which ­squeezes it so thin that they can introduce the catheter through the patient’s vessels until it reaches the coronary artery. When the balloon is inflated, the cylindrical scaffold expands and prevents the artery from collapsing again afterwards.

Balloon dilation using latticed metal tubes (stents) had been described in medical literature, but the technique had not been introduced to Denmark, and it was the first time the 39-year-old Danish registrar had heard the pioneers personally talk about and explain the invention. He was deeply fascinated.

And suddenly something happened. While he was sitting there listening, he came up with an idea. A ridiculous idea. Impossible. It couldn’t be done.

And yet?

Doctor Andersen was no longer listening. He was engrossed in his idea. It was too ridiculous. And irresistible. And ... fantastic.

When the conference was over and Doctor Andersen had flown back to Aarhus, he defined his goal. He wanted to be the first person in the world to insert a valve in the heart without resorting to cardiac surgery.

Try it, try it

The heart valve is Doctor Andersen’s most original and daring idea, but far from the only one. Already during his medical studies, he registered his first patent, and more ­followed.

He gets his inspiration from his mentor, Professor Jørgen Fabricius in Odense.

“I was fascinated by his approach to the subject,” says the now 53-year-old consultant at the Department of Cardiology, Skejby Sygehus. “He experimented a lot. He always encouraged us to find new solutions. Is there a different way of doing it? Is there a better way of doing it? He was always looking for new answers, always trying to test new techniques and forms of treatment. It was very inspiring.”

Heart valve stretched over an inflated balloon.

Pigs’ hearts

Back in Aarhus, Doctor Andersen rushed down to the local butcher to buy some pigs’ hearts. He opened them, cut the heart valve free and placed it on a latticed, metal tube, which he squeezed around a balloon. This was his idea. To introduce the balloon through the vessels to the heart, where he would manoeuvre it into position, and inflate it so that the stent and the valve expanded and became wedged against the cardiac wall. New valve. No scars.

The pig is alive and well

Deep down below Skejby Sygehus is the Institute of Clinical Medicine, where doctors test and develop new technologies and forms of treatment. Today, it is one of the major institutes at the University of Aarhus with 35 clinical professors and about 1,500 affiliated staff in all. Of all the scientific articles in this field published around the world, 0.2% come from this institute. And up to 2,000 pigs are operated on each year as part of the clinical experiments.

However, at that time in the late 1980s, the institute was just a small room, almost a hobby room, and this was where Doctor ­Andersen and his assistants experimented with the new heart valves.

“At that stage, we had really poor working conditions in the basement, so when they had finished operating on the patients upstairs, we sometimes moved the pigs into the oper­ating room,” he says.

The technical solutions were also primitive. They had to construct everything themselves and use whatever means were available. This included different tubes, glue from the DIY centre, etc. However, regardless of what problems they encountered, the researchers stayed on track – new valve, no scars.

“I have always thought,” says Doctor ­Andersen, “that to cut open the entire body is the most primitive form of treatment. The real challenge consists in solving the heart valve problem without maltreating the patient.”

Finally, on 1 May 1989, they succeeded: the first pig survived with a new heart valve.

People shake their heads

Doctor Andersen was excited. He had reached his goal. He had succeeded. The crazy idea was not that crazy after all.

And he was convinced that he would have no trouble having the article about the experiment accepted by one of the major period­icals. Not so. The editors shook their heads.

“Nobody believed us,” says Doctor Andersen. “Neither the periodicals nor the companies that produced heart valves and similar medical equipment. It sounded too crazy.”

Finally, the article was published in the Euro­pean Heart Journal. They sold the patent to a small American company for USD 10,000.

And then nothing more was heard of the idea. Nothing happened. Nobody believed in the Andersen Patent.

Resurrection

Doctor Andersen continued his work with clinical research, evaluating the effect of different forms of treatment. With his experimental research, he developed new techniques and forms of treatment.

In one of the largest patient studies in the world, he documented that balloon dilation is far more effective against blood clots than ­anticoagulants. He spearheaded the study with telemedicine and doctors in special coronary care ambulances, wrote a thesis on blood clots in the heart and started research into new pacemaker techniques.

He was also regularly invited to speak about his invention around the world. Although nobody believed him, he had nevertheless become one of the “grand old men” among cardiac specialists.

Then one day in 1992, the notice appeared. An English doctor had inserted a heart valve in a human being without surgical intervention – using the Andersen Patent.

Today, more than 25 patients have heart valves that were introduced by a balloon. In February, Windhover Information published an eight-page article about the brave new non-surgical world of the heart valve.

The magazine specifically mentions that Edwards Lifesciences, which has a third of the world market for heart valve surgery, had purchased Percutaneous Valve Technologies Inc for about DKK 1 billion. The company had only one asset – the Andersen Patent.

“We were simply ten years ahead of our time,” says Doctor Andersen, who is now convinced that his idea has a future.

“If you had asked me five years ago, the answer would have been no. At that stage, I was convinced the idea was dead. But now I know that its time will come.”

He does not regret that he sold the patent so cheaply back then.

“The task was too big for us, and nobody else in Denmark could handle it. We tried, but it was impossible. The only thing that I regret a bit is that I did not contribute to developing the idea until it could be used in humans. I would have liked to have been part of that,” he says.

Heart valve mounted in latticed metal tube (stent).

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Revised 14.01.2005