The relationship that led to the first angioplasty surgery

Mythical overtones surround Charles Dotter. The Oregon surgeon with a burning passion for his work changed the medical world forever in 1964 when he performed the world’s first angioplasty. It was the first example of interventional radiology and would lead to all subsequent, minimally-invasive, image-guided techniques.

“It was his disruptive introduction of opening an artery without surgery that started the entire field,” says Dr. Scott C. Goodwin, immediate past president of the Society of Interventional Radiologists. “In the field of interventional radiology, he’s the most important person. He is the person who started the field, and he is the person who first introduced the basic concepts for quite a few various things that are still important.”

Similar descriptions sprinkle throughout various recollections of the man: genius, innovative, amazing. He was an artist, pilot, and adventurer whose outrageous behavior earned him the nickname “Crazy Charlie,” a name he could quickly validate.

Many Dotter stories have reached legendary status. The expert communicator, who at first struggled to convince American doctors of the benefits of putting a catheter into a patient’s heart, used himself as a prop. At an institute, in front of a crowd of clinicians, Dotter stuck a catheter into his own heart. He then directed the doctors to a monitor showing the wave forms coming from his chest.

“No one would describe him as a quiet, politic individual,” Goodwin adds.

No, in fact, most of what you hear about Dotter oscillates between his eccentricities and his genius, but the genius always shines brighter through the medical devices and techniques he developed.

Once he met Bill Cook, a small-time entrepreneur from Indiana who would eventually become one of the nation’s wealthiest men, he found someone with a similar askew view of business that would allow them both to alter history.
 

Kindred spirits

Cook and Dotter were two peas in a pod, says Mark Breedlove, global leader and vice president of Cook Medical. “They were very unique in the way they looked at business and the way they looked at problems,” he says. “They were always looking in other areas that other people haven’t been in. They were kindred spirits.”

The kindred spirits met for the first time at the annual Radiological Society of North America (RSNA) meeting in Chicago in 1963. At the event, Cook stood in his booth behind a table, and noticed a man staring intently at him as he made catheters. When the show closed that evening, the man approached Cook, introduced himself as Charles Dotter (perhaps Crazy Charlie would have left an inappropriate first impression), and asked to borrow a Bunsen burner and tubing. Cook acquiesced under the condition that Dotter return the materials. The next morning, Dotter kept his promise, while presenting Cook with 10 of the most perfectly formed catheters he’d ever seen. All of them sold that day.

At the end of the RSNA event, Dotter asked Cook to visit his house in Portland, Ore., but Cook, who at that time was selling homemade catheters out of a suitcase, refused, saying he couldn’t afford it. Undeterred, Dotter purchased Cook’s plane ticket and let him stay at his house, where the friendship was sealed.

“We discussed wire guide and catheter manufacture, and what he thought the future would be for angiography,” remembered Cook, who died in April 2011. “Once started, his mind went non-stop.”

“From [that first meeting],” Breedlove says, “it was the angioplasty catheter that was actually used in that first patient back in January 1964.”
 

Establishing a partnership

On any given day, at Cook’s headquarters in Bloomington, Ind., workers witnessed, from a distance, the collaboration between the visionary physician and the visionary entrepreneur. The two sat together in a room, Cook taking the role of businessman and Dotter as scientist, and banged out ideas at such a rapid pace that Dotter would break half-a-dozen pencils scribbling notes and sketching possible ideas.

“I imagine it would have been a very interesting dynamic to watch those guys at a dinner,” Breedlove says.

Dotter’s personal touch percolated throughout Cook Medical. Many times, after a prototype was completed, Cook would send it to Dotter in Oregon. Dotter looked at it, tested it, and then related his suggestions to the engineers back in Indiana. His input was so prevalent that both Breedlove and Goodwin acknowledge his fingerprints can still be found on Cook products, from dilators to wire guides to stone removal baskets.

Cook Medical has worked hard to demonstrate how important Dotter and Cook’s collaboration was to manufacturing innovations – keeping accounts of the their friendship, posting videos on its website where people recall the relationship.

The records amplify an old adage: times have changed. Today it’s difficult to channel the same type of relationship. It’s not that physicians in interventional radiology don’t have creative ideas, but the regulatory environment has put such a squeeze on the market that Goodwin says getting a product to market within five years is miraculous. Dotter and Cook practiced with theirs within one.

“I think there are actually more ideas than there have ever been,” Goodwin remarks, “but the regulatory environment is much more stringent than it used to be.”
 

Regulation hurdles today

Regulatory pathways are shorter in Europe, and Goodwin uses that continent’s procedure to contrast those in the United States. Sometimes, Goodwin says, the shorter path can result in safety issues that the U.S. would have caught. On the other hand, many of those devices benefit the populations and lots of patients get improvements in their health that folks in the United States don’t.

“I think we need to be aware that there’s another side of the coin when you have very stringent regulatory policies with a primary focus on safety,” Goodwin says. “I think there needs to be some attention to trying to make a better connection – like there used to be – between approval and reimbursement. If you have one bar for approval by the FDA to get something on the market, and you have a different bar for having a procedure, a medication, or a device paid for, then that delays possible beneficial efficacious effects of a particular technology on the population.”

Goodwin adds that many companies may have abandoned investing in R&D for items that might take decades to pay off in favor of products that promise a short-term return.

“So even if you get something FDA-approved, that doesn’t mean that the government or other payers will actually pay for the utilization of that device,” he says.
 

Maintaining inspiration

Breedlove agrees that adhering to regulations can stymie projects, but he says Dotter and Cook’s initial collaboration still infuses the company. It’s at the core of Cook culture and at the core of Cook’s business model, he says.

“We still have physicians coming to us to this day with product ideas,” Breedlove says. “Now there are more legalities that have to get involved to make sure patents are filed and protections are made, but it can continue to be a collaborative environment, regardless of new legislation.”

Breedlove says most of the company’s breakthroughs come from what he calls “organic development,” meaning the company talks to, works with, and generally consults clinicians while developing a product. He estimates that 95% of the company’s ideas have come from working with a physician.

“No one knows the shortcomings of procedures better than physicians,” he says. “Many of our products literally start on a napkin, [with a physician] saying, ‘Can you do this? I’m having trouble with this procedure.’ We can take those notes back to an engineer and ask him to make it up.

“It’s not as easy with the changed regulatory environment, but still it’s the way Cook does business.”
 

‘If a plumber can do it…’

“There’s evolutionary change and revolutionary change,” Goodwin says. Dotter’s first angioplasty was revolutionary.

People had used catheters and wires for diagnostic purposes before angioplasty, but nobody had used it to treat diseases of an artery.

Dotter’s first angioplasty was performed on an 82-year-old woman who had leg pains and an infected foot. Doctors told her the only option was amputation – a common treatment for such symptoms at the time. But on Jan. 16, 1964, using a wire guide and a coaxial catheter pair, Dotter dilated the woman’s clogged leg artery. She walked out of the hospital soon after on both legs and remained mobile for the rest of her life.

Although crude by current standards, the benefits from that first procedure remain robust. Dotter had the idea for this procedure a year prior in 1963. During an angiogram, he pushed a catheter through an artery in the pelvis and noticed the process opened the artery and restored some blood flow. It reminded Dotter of a plumber’s work, and sparked a thought: “If a plumber can do it for pipes, we can do it for blood vessels.”

“That was the germ of the idea to do angioplasty, then he developed what he called the Dotter dilator set, which was manufactured by Cook,” Goodwin says. “It was a set of serial dilators – basically plastic tubes that were sequentially bigger that you could open up an artery through a stenosis.”

The method of using dilating catheters to open vessels caught on first in Europe, where it was called “Dottering.” Within a decade, it caught on in the U.S. as well, and from it sprung a plethora of innovative techniques and technologies that are still used, including balloon angioplasty, which expands narrowed arteries using a catheter with a balloon on it.

“When you think of all the procedures today that are done through a small incision,” Breedlove says, “whether it’s endoscopy procedures or whether it’s vascular procedures – all of those things really grew from Dr. Dotter’s visions.”

Despite Dotter’s knack for clairvoyance – in 1965, he predicted that transluminal dilation would become the method of choice for managing renal artery stenosis – the evolutionary changes have reached beyond what even he could probably imagine. For example, doctors now treat aortic aneurism through minimally invasive procedures.

“That might have been a stretch back then,” Breedlove says. “We can put these large stent grafts into a groin incision and place them in the biggest blood vessel in the body. Traditionally, that’s a significant surgery.”

As materials have become smaller, angioplasty has become more common on all parts of the body – from a person’s feet to his brain.

“We went from just a basic catheter in a minimally invasive procedure into adding balloons – where doctors can actually control inflation, how long it’s inflated, and the different lengths of the balloon to dilate an artery – to putting stents in the artery, to now putting drug-coated stents in the artery,” Breedlove explains. “Surgery is still a viable option in many cases, but patients have demanded this shift toward minimally invasive procedures. When they can get up and they can walk off a table and go to a recovery room, that makes a big difference.”

Both Breedlove and Goodwin expect innovations to keep coming, especially in the field of regenerative medicine.

“That’s certainly very, very exciting when you think about the possibilities of where that can go: regrowing a kidney or growing blood vessels in your leg,” says Breedlove. “Just a number of different areas where the potential is huge.”

“I could imagine the stem cell scientists eventually being able to develop islet cells that produce insulin from a patient’s own stem cells, so there’d be no rejection issues, and then being able to introduce those into the liver or possibly pancreas,” Goodwin adds. “I think it might be possible to develop gene therapies for various diseases that instead of being introduced intravaneously…can be delivered directly into the site of the disease with catheter techniques.”

Whatever the innovations become, they all share the same source: among the scribbled notes and drawings between two friends in 1963.

Cook Medical
www.cookmedical.com

About the author: Danny English is the associate editor of TMD and can be reached at 330.523.5354 or denglish@gie.net.