by Cheney, Dick
I had cared for hundreds of patients with the same clinical presentation as Mr. Cheney, and the recommendation to proceed with cardiac catheterization was the standard approach. In fact, one week before Cheney’s hospitalization, a large clinical trial had validated this strategy, showing better outcomes in patients whose treatment included an early trip to the cath lab compared to those treated more conservatively. I told Cheney that I knew the cath might be politically awkward at that moment, but it was the correct thing to do, and I did not want political expediency to get in the way of doing what was right.
Mr. Cheney, who appeared remarkably calm, responded, “Nothing is more important,” and agreed that the cath made sense. It would be hard to imagine a more inconvenient time to undergo an invasive procedure, but if Cheney had any anxiety or reluctance to proceed, it didn’t show. I excused myself and left the room in order to make arrangements for the procedure.
In my absence, Mrs. Cheney asked Alan Wasserman, “Tell me, if this were you, would you let him perform this procedure?”
“As a matter of fact, I did.”
• • •
In November 1976, Andreas Gruentzig, a thirty-seven-year-old German-born physician, visited the United States to present his research at the annual scientific sessions of the American Heart Association (AHA). He had moved to Zurich in 1969 and became interested in vascular disease, at the time called “angiology.” Before that, the available methods for treating a narrowed leg vessel mostly involved surgical bypass or the less invasive Dotter technique, in which a series of increasingly larger-diameter rigid catheters were forced into the obstruction. Gruentzig understood that while this method could be effective in the large-caliber superficial femoral artery, which supplies blood to the leg, it could not work in small-diameter vessels and therefore would not be appropriate for use in the heart. Gruentzig had an idea to use a small inflatable balloon to crack open the obstruction, and he and his wife and some colleagues worked in his kitchen to develop a prototype. Because no such catheter existed anywhere, Gruentzig had to develop all the components, making it small enough to deliver into an artery through a puncture in the skin, with a way to inflate and deflate the balloon, and a balloon material strong enough to dilate the sometimes rigid and calcified plaques found in arteries. Gruentzig and his team eventually developed a catheter with a resilient polyvinyl chloride (PVC) balloon mounted on its tip, and in January 1975 he used it to dilate a narrowing in a patient’s iliac artery, a large blood vessel in the pelvis.
A year and a half later at the AHA sessions, Gruentzig shared the results of his balloon technique adapted for use in the coronary arteries. The work, entitled “Experimental Percutaneous Dilatation of Coronary Artery Stenoses,” described experiments in dogs and was delivered as a poster to a group of somewhat doubtful colleagues. Dr. Spencer King III, who would later go on to become a renowned interventional cardiologist, president of the American College of Cardiology, and friend and colleague of Gruentzig, remembered seeing the presentation and thinking, “this will never work.”
Gruentzig’s next step was to attempt his procedure, what is now called percutaneous transluminal coronary angioplasty (PTCA), in a live human heart. There are many considerations that go into planning a first-in-man procedure. What patient or lesion characteristics are ideal? Where should the procedure be performed? What could go wrong? The ideal patient would be someone with a relatively simple coronary narrowing suitable for treatment with a fairly crude, first-generation device. Because a lot could go wrong, Gruentzig decided to perform the first procedures in patients undergoing scheduled heart bypass surgery; should a major complication occur, it would happen in the very controlled environment of the cardiac operating room with a surgical team poised to react.
The risks were many. The inflated balloon could rupture the slender coronary artery, and if that occurred, blood would rapidly fill the pericardial space causing cardiac tamponade, a potentially fatal compression of the heart. During the dilation, fragments of atherosclerotic plaque could break off (embolize) and lodge downstream, blocking flow and precipitating a heart attack. The patient might not tolerate temporary occlusion of the coronary artery and could develop a dangerous ventricular arrhythmia or cardiac arrest. The balloon might burst, becoming trapped in the vessel, or fail to deflate, causing a heart attack. Since this procedure had never before been performed in a human, there was no way to anticipate all the risks.
Although Gruentzig could not find a surgeon in Zurich who would allow him to perform coronary angioplasty during their surgery, Dr. Elias Hanna, a cardiac surgeon in San Francisco, was amenable, and that is where Gruentzig successfully refined his technique prior to attempting the procedure in an awake patient not already destined for open heart surgery.
On September 16, 1977, Adolf Bachmann, a thirty-eight-year-old Swiss insurance salesman with severe chest pain, a tight narrowing in his left anterior descending coronary artery, and a strong desire to avoid cardiac surgery, was brought to Gruentzig’s cath lab in Zurich. Gruentzig later described the index procedure:
Early in the afternoon at a time when the anesthesiologist and the cardiac surgeon were available and no cardiac procedure was underway in the operating room, the patient came to our catheterization laboratory and was catheterized in the usual fashion. . . . The Chief of Cardiology, the cardiac surgeon, anesthesiologist, cardiology and radiology fellows were in the recording room to observe the procedure. The guiding catheter was placed in the left coronary orifice and the dilatation catheter was inserted. . . . The catheter wedged the stenosis so that there was no antegrade flow and the distal coronary pressure was very low. . . . To the surprise of all of us, no ST elevation, ventricular fibrillation or even extrasystole occurred and the patient had no chest pain. . . . After the first balloon deflation, the distal coronary pressure rose nicely. Encouraged by this positive response, I inflated the balloon a second time to relieve the residual gradient. Everyone was surprised about the ease of the procedure and I started to realize that my dreams had come true.
Several successful cases followed, and in November, Gruentzig presented a summary of his initial patients at the annual AHA meeting. Whereas one year earlier, his poster had been met with great skepticism, now his oral presentation was interrupted by a resounding standing ovation. Angioplasty and the field of interventional cardiology had been born, and physician and corporate interest in the new technique exploded.
Dr. Andreas Gruentzig and his wife, Margaret Anne, died on October 27, 1985, when the twin-engine Beechcraft Baron airplane he was flying crashed during a storm into a forest in Forsyth, Georgia.
Exactly ten years to the day after the world’s first coronary angioplasty, Gruentzig’s close friend and colleague, Dr. Spencer King III of Emory University, brought Adolph Bachmann back to the cath lab for a relook. The first coronary artery ever treated with balloon angioplasty was wide open.
Gruentzig was only forty-six years old when he died, but in his too-short life he changed medicine forever, and the technology he pioneered has touched the lives of millions of people.
• • •
Because of GW’s location just seven blocks from the White House and its close proximity to the Capitol and virtually every other federal department, contingency plans are always in place for care of the nation’s leadership, and GW Hospital has perhaps the only emergency room in the United States with a dedicated hotline to the Secret Service.
When Mr. Cheney arrived at the hospital, he was assigned an alias. His pseudonym, Red Adair, was not an attempt to hide his admission, which would have been impossible, but rather a standard procedure designed to help protect the privacy of his clinical data. (The real-life Paul “Red” Adair was a legendary Texas firefighter who became famous for putting out some of the world’s worst oilfield and offshore platform fires.) A Secret Service command post was set up in the hospital administration suite, and a large medical school auditorium across Twenty-Third Street was configured as a med
ia briefing room following the long-standing, prudent practice of keeping the press out of the hospital.
As the East Coast was waking to breaking news, Dick Cheney was being prepped for cardiac catheterization. Prior to transporting him to the cath lab, I did a walk-through with an agent from his Secret Service detail so he could plan the deployment of his personnel. The Secret Service did not post anyone in the procedure room itself; instead they positioned their agents in the control room and hallways surrounding the suite. Over the years, I have been asked many times to allow a patient’s family member, friend, or colleague to be present during a cath, but it’s distracting to have a visitor in the room, and I don’t allow it. I wouldn’t want anyone kibitzing with the pilots when they are landing the plane I’m on, and I extend that same courtesy to my patients while I am working inside their heart.
I gave the staff in the cath lab a brief pregame talk, reminding them that this was a procedure we did several times every day and I knew we would provide this patient the same great care we gave to everyone else. My team didn’t really need that reminder. I’m sure I intended it as much for myself as for them.
Cheney was transported by stretcher to the cath lab and helped onto the narrow padded table by Fernando Najera, a technologist, and Julia Mason, a nurse. I had met Fernando in 1990 on the first day of my cardiology fellowship, and he quickly became a friend. I’ve always admired his dedication to the care of patients with heart disease and his loyalty to GW. Fernando can do a surprisingly good rendition of the famous aria “Nessun Dorma,” and despite the vagaries of my morning mood, he can always make me smile. Julia came to GW in 1998 after working in a cath lab in Saudi Arabia while her husband, a US State Department official, was stationed there. There isn’t another health care professional with any title I have ever worked with whom I have relied on as much, or for whom I have more respect than Julia. The first thing I do every morning when I enter the cath lab is to check if Julia is working that day. Every physician knows that it is the nurses who really keep patients alive, and if I ever get sick, I want Julia to take care of me.
After settling the patient on the table, Julia gave Mr. Cheney Versed, an intravenous Valium-like benzodiazepine, and fentanyl, a narcotic. The cocktail is called, somewhat incorrectly, “conscious sedation,” and it induces a sleepy, relaxed state with retrograde amnesia, the inability to remember what has just occurred. When I entered the room, Cheney appeared to be asleep, covered in a long, blue surgical drape, its two round circular cutouts exposing the skin of both groins.
I turned to my third-year cardiology fellow, Dr. Brian Rah, and handed him the needle.
“Really?” he said.
“Absolutely,” I replied.
I run an interventional cardiology training program in a university teaching hospital and perform all of my procedures with a cardiology fellow. This wasn’t the day to change my routine.
Brian easily entered the right common femoral artery, and together we advanced angiographic catheters to Cheney’s heart.
Before the procedure, I had reviewed Cheney’s images from the catheterization five years earlier, which I performed with Allan Ross. Now I was looking for what had changed.
The right coronary artery (the vessel that caused the 1988 heart attack) was still closed, but its right internal mammary artery bypass was wide open. The circumflex branch (the likely culprit of the 1978 and 1984 heart attacks) was also occluded, as was its bypass, both unchanged compared with the prior catheterization. When we injected dye into the left anterior descending (LAD) coronary artery, we found the problem: the LAD had been bypassed at surgery in 1988, but because the vessel had only moderate disease, the graft never properly developed and was closed, which we already knew. A large branch of the LAD called the diagonal coronary artery, supplying a significant segment of the front and side of the heart, had a tight new narrowing.
“Hey, Dick, do you see that?” I said, trying to get the attention of Dick Katz who was watching on a monitor in the next room.
“See what?” Cheney responded.
“Oh, I’m not calling you, Dick,” I replied, embarrassed, and surprised that he was awake.
Cheney said, “You can call me Dick.”
“No, sir,” I said. “I’m talking to the Dick in the control room.”
Stop talking. You’ve just called at least one of them a dick.
Over the intercom, Katz told me that he did see the diagonal narrowing and he agreed that it was likely the cause of Cheney’s pain.
“I’m going to stent it,” I said.
• • •
In February 1978, a thirty-two-year-old Argentinean physician attended the Society of Interventional Radiology meeting in New Orleans where Dr. Andreas Gruentzig was presenting his new angioplasty procedure. Dr. Julio Palmaz, who had come to the United States the year before to do a radiology residency at the University of California, Davis, listened as Gruentzig described some of the potential complications from angioplasty and how an artery could abruptly close. Palmaz started to think of ways to solve the problem and came up with the novel idea of placing a metallic scaffold inside.
Dr. Palmaz spent years creating prototypes of his new “stent,” beginning with a meshwork of copper wire woven over a pencil in his home. He soon realized that to provide structural rigidity, the points where the wires crossed needed to be fixed, and eventually he crimped his sleeve of metallic meshwork onto an angioplasty balloon. When the balloon was inflated inside a tube, the stent expanded, becoming apposed to the wall, creating an internal scaffold.
While searching for ways to construct his device from a single piece of metal rather than woven stands of wire, Palmaz found a fragment of metal masonry mesh on the floor of his garage, the kind of material used to reinforce concrete or plaster. Two decades later, he described his discovery:
It was total serendipity. . . . I looked at it and thought, “This looks like what I’m trying to do here.” I grabbed it, cut out a small piece, then closed it by pushing it together and bouncing it on the table with a hammer. I realized that the staggered openings were staggered slots when it was closed. I thought, “Well, if I make this pattern in a tube, then, when a balloon expands, it will become a mesh.” And it’s made of a single material. This was the inspiration for the slotted stent.
Palmaz continued to work on stent designs but had difficulty funding his research. In 1985, now the chief of angiography at the University of Texas Health and Science Center in San Antonio, Palmaz met Dr. Richard Schatz, a cardiologist at nearby Brooke Army Medical Center. Schatz knew that a major risk of coronary angioplasty was abrupt vessel closure, a potentially catastrophic event that occurred in 5 to 10 percent of patients, typically caused by balloon-induced disruption of the arterial lining. Also, almost half the vessels treated with angioplasty renarrowed within a few months of the initial procedure, a phenomenon called restenosis. Schatz recognized the need for a technology that might reduce these events. Later that same year, Schatz met Phil Romano at San Antonio’s Dominion Country Club. Romano, a prolific entrepreneur, was the founder of the Fuddruckers and Romano’s Macaroni Grill restaurant chains, and despite the protestations of his lawyer and accountant, he agreed to invest $250,000 in the stent project. Palmaz, Schatz, and Romano formed a business entity they called the Expandable Grafts Partnership, and on March 29, 1988, they were issued US patent 4,733,665 for an “expandable intraluminal graft, and method and apparatus for implanting an expandable intraluminal graft.” The patent abstract describes how the invention works:
An expandable intraluminal vascular graft is expanded within a blood vessel by an angioplasty balloon associated with a catheter to dilate and expand the lumen of a blood vessel. The graft may be a wire mesh.
Johnson & Johnson licensed the new stent in 1988 agreeing to pay the partners $10 million in addition to future royalties. With J&J pouring both money and intellectual resources into product development, clinical trials began for the Palmaz stent, now manufactured
from tubes of stainless steel etched with staggered rows of rectangular slots that created diamond-shaped interstices when expanded. In 1991, the FDA approved the Palmaz stent for use in arteries supplying the leg, and in 1994 the Palmaz-Schatz stent was approved for use in the heart.
Cardiologists enthusiastically embraced the new technology, and the use of stents rose rapidly from 5 percent of interventional procedures in 1994 to almost 70 percent in 1997. In 2009, there were almost 650,000 hospitalizations in the United States involving the implantation of a coronary stent. Stenting made angioplasty safer, vastly reducing the number of patients requiring emergency surgery because of a procedural complication such as a coronary dissection or abrupt occlusion, and enabled increasingly complex lesions to be treated without the need for coronary artery bypass surgery.
Phil Romano’s $250,000 gamble in 1985 would ultimately yield him well over $100 million.
• • •
When I see a patient in the clinic, I always start the appointment by asking about work, family, a recent trip—something personal. No one looks in the mirror and sees a “fifty-eight-year-old white male with atrial fibrillation” or a “seventy-two-year-old female status post LAD stenting,” and when they come to see me, I want them to know that I don’t see them that way either. I once received a card from a patient in whom I had recently repaired multiple coronary arteries. Taped inside was a vacation photo of the patient with his wife, and their two small children, everyone huddled close together in a happy family tangle of sunglasses and smiles. In little kid handwriting, his seven-year-old son wrote, “Thanks for fixing my dad’s heart,” a poignant reminder of how much there had been to lose.
