Saving Lives, Valve By Valve

by Anna Sobkowski

On Sept. 21, 1960, Philip Amundson of Spokane, Wash., disabled with end-stage heart failure, was about to receive a new lease on life. On that day, he would have the world’s first artificial valve successfully implanted in his heart by a young cardiac surgeon and co-developer of the valve, Albert Starr’49. The revolutionary device enabled Mr. Amundson, a 52-year-old farmer whose heart had failed as a result of childhood rheumatic fever, to live another 12 years.

aortic and atrial valvesThe implantation of this mechanical mitral valve, which took place at Oregon Health & Science University in Portland, was the result of years of painstaking work by Dr. Starr and M. Lowell Edwards, a hydraulic engineer with an interest in human blood circulation. Their unprecedented feat ushered in a new era in the treatment of heart disease, one that could barely have been imagined even a decade earlier.

“It was an exciting time,” says Dr. Starr, 84, now director of academic affairs and bioscience development for Providence Health & Services and professor of surgery for Oregon Health & Science University in Portland. “We were at a real turning point in developing the ability to save large numbers of lives.”Albert Starr'49

Until cardiac surgeons began performing the first open heart surgeries in the 1950s, valve repair was a crude affair that could only be attempted by using a “closed” heart technique. Here, the surgeon, working almost blindly, would insert a finger or instrument through a small chest incision into the heart to manipulate the valves.  

Although open heart surgery – during which the rib cage is spread open, the heart is stopped, and blood is routed through a heart-lung machine – made it easier to work on valves, it became apparent that in many patients the valves were too diseased to be saved.

“There was a time before antibiotics were available when streptococcus infections were very common. In a large number of patients, this led to rheumatic fever, an inflammatory process that attacked the mitral valve preferentially, producing scarring and eventual calcification,” says Dr. Starr, who pioneered open heart surgery on the West Coast. Patients who had been stricken with strep-induced rheumatic fever in childhood often would die of heart failure as young adults.

Defects in any of the four heart valves – which regulate blood flow in the heart by opening and closing in response to pressure – also can arise from congenital or degenerative conditions. Dr. Starr and his fellow cardiologists at first had little idea of the magnitude of the problem.

“After our procedure became more widely known, we were inundated with people seeking help, and not just rheumatic fever patients,” says Dr. Starr. “We quickly realized that there were probably hundreds of thousands in the United States and many millions around the world who needed valve replacements. The early history of open heart surgery in adults is basically about valve repair and replacement.”

Developing the first artificial valve, the mitral valve, presented daunting and seemingly insurmountable challenges: The valve would have to last a long time without wearing out and it would have to open and close, under pressure, in the same way the actual valve does. In addition, only a limited number of foreign materials could be placed in the bloodstream without causing rejection.

Mr. Edwards, who suffered from rheumatic fever as a child, and Dr. Starr began their research on animals in 1958. The collaboration was a match made in heaven.

“At that time, there was no such field as ‘bioengineering,’” Dr. Starr says. “The interface between engineering and medicine had not yet formed, especially in the area of implantable devices. I knew more than Lowell did about surgery, but as an engineer he knew a heck of a lot more than I did about hydraulics. We developed a new kind of partnership that had never existed before.” Mr. Edwards went on to develop a company, today called Edwards Lifesciences, a world leader in manufacturing products for heart valve repair.

Working in uncharted territory, Dr. Starr soon realized that implanting a mechanical heart valve was only part of the solution for treating valve disease; a support system for caring for very sick patients before, during, and after surgery also was needed.

“When we started, there were no intensive care units, no easy way to measure cardiac performance, not even proper respirators,” Dr. Starr says. “All the things we take for granted today, such as having ICUs and laboratory backup, simply were not present.”

Dr. Starr spearheaded efforts to improve technology in the OR, such as the use of heart-lung machines in adults (mostly used for children), and created well-coordinated, interdisciplinary teams of cardiologists, cardiac surgeons, nephrologists, hematologists, and psychiatrists. As mechanical valves and support services were refined, operative mortality plummeted from 50 percent to between 3 percent and 4 percent in the six years following the first transplant.

A native New Yorker, Dr. Starr received his BA from Columbia at 18 and his medical degree from P&S at 22. At 23, he was on the front lines in Korea serving in a mobile army surgical hospital unit (known to television viewers as a MASH unit) supervising an abdominal surgical team and operating on soldiers with penetrating wounds of the abdomen. These injured men had to be treated within hours of their injuries or they would die of peritonitis. MASH units were so successful that mortality from such wounds dropped to 5 percent from 100 percent before the creation of the units. 

“That was an incredible learning experience, one that gave me the sense that great things are possible in medicine,” Dr. Starr says.

Back in the United States, Dr. Starr was soon recruited by Oregon Health & Science University to start its open heart surgery program. The prototype he developed, including the methods for valve transplants, was soon emulated in smaller towns and cities throughout the Pacific Northwest and parts of California. 

In 2007, Dr. Starr, with his colleague Alain Carpentier, M.D. – who developed an artificial valve made from biological materials – received the Lasker Award. “Our work was complementary,” Dr. Starr says. “These two types of valves, mechanical and biological, fill the need for heart valves.” 

Today, more than 130,000 heart valve implant or repair operations are performed in the United States each year, still only a fraction of those who actually need the treatment. These numbers are expected to grow as surgical methods become even less invasive. 

The genesis of these procedures can be traced back to the work of Dr. Starr and Mr. Edwards. “Lowell first approached me with the idea of working together to create an artificial heart,” Dr. Starr says of the late Mr. Edwards. “At the time, I felt that was premature. I said, ‘Let’s start with the valves, one valve at a time, beginning with the mitral.’”