A stitch in time: making heart caths easier: a new device allows patients literally to walk away from the table following a heart catheterization without requiring prolonged and painful care of the hole in the artery.
The Closer S System, a device that looks more like a syringe than a sewing machine, makes only one stitch, but that is enough to greatly reduce the trauma for patients who undergo heart catheterization.
More than a million heart caths are performed every year in the U.S. Patients lie on a surgical table under an x-ray scanner while a doctor cuts a tiny slit in the artery in their groin and inserts a catheter with a probe that goes up to their heart.
The procedure is virtually painless, but there always has been one problem--the hole left in the artery.
Traditionally, doctors have stopped the bleeding once the catheter is removed by using an age-old method; they put a hand over the incision and press down hard--sometimes for half an hour or longer--until the blood clots. The patient then has to lie still for six hours. A cough or sudden move can open the wound and doctors have to press again, followed by another six-hour wait.
Such was the procedure ten years ago when Dr, Keith March came back to his office after a long day in the cath lab and told his colleagues, "There just has to be a better way."
"I was that cardiology fellow who was pushing on the femoral artery in people's groins for 30 minutes," says Dr. March, who is now chairman of vascular biology and director of the Indiana Center for Vascular Biology and Medicine at the Indiana University School of Medicine.
"It was a terrible thing to be pushing so hard on someone when you knew you were causing them pain," he says. "Here we were trying to remedy heart problems and instead we were hurting people's backs and legs! I just knew there had to be something that could be devised to eliminate this problem."
Although busy at the time researching ways to target drug and gene delivery to body cells, Dr. March began brainstorming with his colleagues on the more prosaic problem of "rendering compression unnecessary following the removal of a catheter." The solution proved quite a challenge.
How do you quickly patch a hole in an artery without being able to see it--and without causing pain or discomfort to the patient?
The researchers soon focused on three possible ways. "The first was `sewing' or suturing--the tried-and-true method of closure," says Dr. March. "We also explored using a biodegradable polymer that could be placed on the site as a patch or plug--even loading it with drugs to enable the healing process. Our third method was cautery, using a radio frequency."
The polymer eventually was ruled out because foreign substances introduced into the artery might cause embolisms. On the other hand, a cautery method, applying heat, risked damaging the arterial tissue further by actually burning the hole open so it couldn't be closed effectively.
"We finally determined that sewing was our best method," Dr. March says, "but how could we put a sewing machine on a catheter tip? How could we sew an artery without sewing the needle into the opening? In addition, how many stitches would need to be made to secure the hole?"
The researchers experimented with animal-model blood vessels and discovered, to their surprise, that they could close the arterial incision with a single stitch. "We used straws, string, and paper clips to devise a method that would permit a needle to come out of the wound leaving a single stitch in its wake," Dr. March says.
From the original concept, the project moved to prototypes built in the basement of one of Dr. March's colleagues. Then came lab tests and clinical" trials. In all, it took eight years to get a working Closer into cath labs.
Last year, Dr. March's smart sewing machine put the finishing stitch in more than half a million heart-cath procedures, "many more than I could have done in a lifetime," he says. And patients have noticed the difference.
"I had my first heart catheterization before, and it was awful," cardiac patient Harold McKinley recalls. "Someone had to stand on me for half an hour, and then I had to lie still for eight hours.... By the time I could get up, my back was so sore I couldn't walk ... and I had a big ol' bruise on my leg that was tender for weeks." Recently, McKinley had another catheterization procedure performed by Dr. Jeffrey Breall at the veterans' hospital in Indianapolis. Breall employs the new closure device in the six to eight procedures he does daily. This time McKinley got up and was walking just two hours after the surgery.
"The closure is beautiful," says the veteran heart-cath patient. "It's a clean puncture wound with no bleeding. It's really amazing!"
"Closing the artery at the site makes it easier on our patients and allows us to treat more people daily," Dr. Breall says.
With his artery sewing machine a great success, Dr. March now is on to other projects. "I'm looking at ways for people to grow new blood vessels (angiogenesis) using special delivery methods for genes and even using one's own cells to convey the genes," he says. "I like to think that researchers today are working to develop the medicine for tomorrow."
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|Publication:||Saturday Evening Post|
|Date:||Nov 1, 2002|
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