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VERITAS

AA

The motto at Harvard, where Hugh Calkins attended medical school, is Veritas.  As a serious and determined young physician in the making, the future Professor of  Medicine at  Johns Hopkins University (Veritas vos liberabit), must have laid eyes on that motto thousands of times—so often that he probably stopped seeing it after a while, its impact literally diminished by degrees until it became intellectual white noise. What likely did stick in his mind was  the Statue of  Three Lies. It is a bronze sculpture of a founding father type  looking out over Harvard Yard.

One supposes it to be a likeness and tribute to the founder of  all things statshoe of three liesCrimson, John Harvard, since that is what is engraved on the base of the statue: John Harvard, Founder, 1638.  But the nickname has it right. Each finely chiseled line is a lie.  The likeness is not that of  John Harvard, who did not found the institution, which was not founded in 1638. And it would have been there in Harvard Yard at the the Statue of  Three Lies  where, as is the custom, a young Hugh Grosvenor Calkins rubbed his hand on the bogus founder’s shoe for luck before turning to take on the world.

The narrative presented by Johns Hopkins via their muscular stable of attorneys goes something like this: Pam Walter grabbed Hugh Calkins by the lapels one day and demanded a catheter ablation procedure.

He tried to talk her out of it. He told her that he didn’t know if it was safe. Hell, he didn’t even know if it worked. Calkins  warned my wife that  catheter ablation for atrial fibrillation is the most dangerous procedure out there.

He told her that what he was really doing up there at Hopkins was conducting a de facto medical trial. He was experimenting with two new ablation techniques and testing out a couple of new mapping catheters. He was trying out the new Biosense Webster Lasso® mapping Catheter and the new basket catheter put out by EP Technologies, a division of Boston Scientific. He was also collecting performance data on  the new Chilli® ablation catheter from Cardiac Pathways, and he told her that she should be aware that Ron Brody, president of the university, was on the board of directors for Medtronic.

He told Pam that he was getting paid in one way or another by all of these outfits, but that Johnson & Johnson was kicking down the salary for the Fellow who would be working on her, so her body would probably be used to experiment with the Lasso® catheter.

These procedures are  sort of like shake-out cruises for new instruments and their operators. He was not running any of this by the FDA, which he considered to be irrelevant, and he was not running any of it by the  Hopkins Internal Review Board either, because they’d rather not know what went on in his EP Lab.

He told Pam that contrary to public perception, going to Hopkins for an ablation was akin to going to the barber college for a haircut—except you don’t get the discount. And since it is a teaching hospital, he would hand the job to a trainee whom she would never meet. The most he could promise was that he would try to stop by at some point during the procedure. All this was made very clear. The smart play would be for her to stick with drug therapy.

But she had the temerity to insist, and they acceded to her wishes.  And when her mitral valve got itself tangled up in a mapping catheter, and things didn’t turn out so well for her, she had the gall to blame Johns Hopkins.

When he’s out on the circuit, giving talks at various cardiology gatherings around the country, Calkins presents his findings with the air of a storied combat vet at the local  American Legion hall.  “I learned a lot of things the hard way about the Lasso® catheter,” he tells the neophytes. “One thing is you can lasso a lot of things with it, including the mitral valve and if you happen to lasso the mitral valve it’s hard to untangle the valve. When we tried to untangle the valve we wound up ripping the valve and having to replace the valve, and I can tell you that was one memorable lasso experience…”

Of course, even the most vivid memories can fade in the fog of litigation. The lawyer here might as well have been deposing the Magic 8-Ball: Did you tell Pam Walter that you did not know if the benefits of the procedure outweighed the risks? 

Reply hazy, try again.

Nevertheless, thanks to court ordered depositions, we have a permanent and public record of how Richard Wu and Hugh Calkins recall the unfolding events of March 25, 2002—and on the subject of who was actually performing the procedure, Calkins puts forth fuzzy scenarios. Contrary to his customary  “showing up to be there during the burn,” as he confided to colleagues at an FDA hearing, on this particular day he would have scrubbed out after the procedure was set in motion, leaving the trainee at the wheel. “I would de-scrub when it’s time to analyze the figures to find out if the vein was isolated. This isn’t just looking at something. It’s very tricky to do this. This is the critical part of the procedure. That’s the part I was performing. That’s what I was doing and then the catheter got entrapped.”

When you are trying to conceal facts, a deposition can be a real minefield. A big claymore for Calkins here is that under no circumstances can he allow himself to admit that the catheter was in the left ventricle of the heart:

So you were performing the critical part of the procedure on the other side of the room when the catheter got itself caught up in the mitral valve muscles. How  exactly did it get there?

“If you ask how is it possible for this catheter to get caught in the mitral valve, the answer is it is possible. It occurred. And you may ask, ‘How can that possibly be?’ And the answer is, One, the atrium is a small structure. And B, [sic] all the pulmonary veins are relatively close to the mitral valve. Three, we don’t have our hands in the atrium.

“As a surgeon, we’re working from the leg, we’re four feet away. So you have a small structure, the heart’s beating, you have a catheter in the heart, the structures are all relatively close together, and obviously the mitral valve dipped back and caught on the catheter. One way or the other, we know for sure the Lasso catheter was stuck in the valve. So it happened.”

This is perhaps the reason that Hugh Calkins is not a surgeon, despite his Freudian desires.  For one thing, my wife does not play center for the Lakers. Her heart is not four feet away from her groin. Also, all of the experts—and quite a few laymen—stand solidly behind the principle that  it’s physically  impossible for a heart valve to make a lunge for anything.

He’s trying to conjure up a picture of  a catheter tip snagging on the leaf of the valve. But this catheter had been fed into the ventricle through the valve, corkscrewing its way down through the  working muscle strings until it hit bottom. The catheter was completely,  deeply and ineluctably tangled at the base of the valve — in the left ventricle of the heart.

Did the catheter get caught in the mitral valve during repositioning to another site?

“It’s hard to know if it was during the positioning, the repositioning or exactly when. What was the question? I don’t know exactly when. I don’t know how the catheter got caught in the valve. That is unknown to me. I know that it did. That’s a fact. How it got caught, I don’t know.”

And who actually repositioned the catheter?

“I don’t know for sure, but I suspect that it was Dr. Wu.”

That was a pretty good hunch  since Calkins wasn’t even scrubbed in when Wu blundered into the wrong heart chamber.

And how did the catheter get so tangled in the muscles of the mitral valve that it ripped the muscles out of  the heart when someone yanked on it?

“Okay.  So the fact we know the mitral valve — the catheter got entangled on the mitral valve. What we don’t know is how it happened. The possibilities are that the catheter, in order for the catheter to get trapped in the valve, the catheter had to be hitting the same location of the valve apparatus. So that could happen in one of two ways. Either the catheter moved toward the valve or the valve moved toward the catheter. If the question is how can the valve move toward the catheter. If there’s regurgitation or prolapse in the valve, the valve can move posterior to the atrium.”

These are not the ramblings of a Bellevue intern gone mad, these are the very considered thoughts of a graduate of Harvard Medical School.

And despite all the hemming and hawing and the dancing, Hugh Calkins knew exactly how the catheter got caught in my wife’s mitral valve. He told his colleagues all about it during a dinner symposium at the Westin Copley Place hotel in Boston in 2006, just before they brought out the crème brulée.

“The lawyers tell you, ‘Well in the package instructions it says to never place the catheter near the mitral valve.’ Well if you know where the pulmonary veins are, they are very near the mitral valve so it’s very hard to not lasso the valve occasionally…” He was more specific when he wrote about it in 2007, two years before he swore truthfulness at a deposition: “Entrapment of the mitral valve apparatus by a mapping catheter results from inadvertent positioning of the catheter into the ventricle with counterclockwise rotation.”

Richard Wu has a rich imagination.

“How many times, before Mrs. Walter, did you participate in a similar procedure in which you were the primary operator…”

“I know I did about 500 procedures…”

“How many where you were operating the catheter …”

“I did somewhere between 250 to 300…”

“How many where you were the primary operator…”

“I think between 30 to 50…”

“With you as the primary operator? Is that what you’re saying?”

“Less than 30.”

I would point out here that ZERO qualifies as fewer than thirty, and that  you  or I or SpongeBob SquarePants could legitimately claim likewise.  Mr. Wu does admit that he first laid eyes on Pam Walter on the morning of the procedure. “I have records stating that I wrote a history and a physical for Ms. Walter at 7 a.m. on March 25th 2002,” he said. He’s not necessarily  swearing to the facts, just to what the record states. By design, reality and the record are two different things.


How did the catheter get tangled in the muscles at the base of the mitral valve, which is located in the ventricle?

“The catheter was in the atrium and the leaflets became entangled—in the atrium—but the mitral valve is tethered to the ventricle.”

Sure. But how did the catheter get into the ventricle?

“It was in the atrium”

Come on.

“If the mitral valve apparatus is in the atrium and entangled with the Lasso, if you pull, you can avulse the muscle  in the ventricle.”

Did you discuss the risks of the procedure with Pam Walter?

“Oh, yes. We went over the consent form before the procedure and we discussed the risks of the procedure. There on the consent form it lists pain and infection and bleeding, damage to blood vessels which may cause a blood clot or require surgical repair, nausea or vomiting from the sedation. The other things we discussed were perforation of the heart or lung which may require emergency intervention, respiratory risks that may require intervention, stroke, myocardial infarction or death. We also specifically discussed a unique complication of the procedure know as pulmonary vein stenosis. I specifically discussed this with Mrs. Walter because she had a pacemaker…”

He went on like that for a while.

Pam’s daughter Kristi and I were with her at 7 a.m. in a patient receiving area. Pam was given a clipboard with forms to fill out and permissions to sign. I stayed with her until she was taken to the pre-op room, which was at 7:30 according to nurses’ notes. Kristi went with her and stayed with her in the pre-op room until 8:10 when, according to the record, Pam was taken to Room One at the EP Lab. She was in the lab at 8:20 and by 8:27  she had been  administered narcotics. None of us saw Wu or Calkins that morning.

And how long did it take Richard Wu to review the history, give her a physical examination and ensure that the informed consent process was faithfully discharged on the morning of the procedure?

“About a half hour,” says Dr. Wu, under oath.

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