This article originally appeared in the Summer 2015 issue of Brigham and Women's magazine.
Nearly a century after pioneering the world’s first heart valve repair, Brigham and Women’s Hospital remains in the vanguard of heart and vascular care, bringing hope and healing to patients, many of whom have run out of options.
Prelude to a new paradigm
One hundred years ago, rheumatic heart disease was the leading cause of death in the U.S. for children and young adults aged 5 to 20 years, and accounted for 60 to 80 percent of adult heart disease. As the most serious and deadly complication of rheumatic fever—a streptococcal infection—rheumatic heart disease causes heart valves to stiffen and, ultimately, fail.
In June 1923, a 12-year-old girl with rheumatic heart disease arrived at the Peter Bent Brigham Hospital (PBBH) dying of mitral stenosis—the stiffening and narrowing of the mitral valve in her heart. Elliott Cutler, MD, a cardiac surgeon at the hospital, with the medical assistance of cardiologist Samuel Levine, MD, saved the girl’s life with the world’s first successful heart valve repair surgery. Cutler later became the second chief of surgery at the hospital, a forerunner of Brigham and Women’s Hospital (BWH).
In 1973, The New England Journal of Medicine celebrated the 50th anniversary of Cutler and Levine’s achievement with an editorial by PBBH cardiac surgeons Lawrence H. Cohn, MD, and John J. Collins, MD, then the hospital’s chief of cardiac surgery. Cohn and Collins hailed the first mitral valve repair as a “singular achievement,” in part because it occurred “in the early 1920s before the development of the heart-lung machine, blood banks, and other currently used sophisticated support facilities.”
“The next cardiac epidemic”
While rheumatic heart disease continues to be a major health problem worldwide, the mortality rate in the U.S. and other developed countries has dropped precipitously since the 1960s, largely due to an increased use of antibiotics to treat and prevent strep throat infections. However, as life expectancies expand and population growth tilts strongly toward the oldest age groups, age-related valvular heart disease is a rapidly growing cause of cardiovascular disease in the U.S. and around the globe.
As in Cutler’s era, there is still no effective medical treatment to cure a dysfunctional heart valve, especially the aortic valve. Uniquely, aortic valve stenosis is closely associated with age-related calcification and degeneration of the valve structures. Symptoms can be managed with medications and lifestyle changes, but valvular heart disease is usually progressive, and the outlook, if left untreated, is still dismal. After the onset of symptoms, patients with severe aortic valve stenosis have a survival rate of 50 percent at two years, and only 20 percent at five years without repair or replacement. Repair or replacement of a defective valve are the only options that markedly reduce the death rates associated with heart valve disease.
The current burden of valvular heart disease results in more than 300,000 heart valve replacement surgeries each year worldwide. The U.S. Census Bureau’s International Data Base estimates that from 2009 to 2050, the world's population aged 85 and older will increase more than fivefold, from 40 million to 219 million. Likewise, some studies anticipate the number of patients requiring heart valve replacement worldwide will triple by 2050, leading one report to describe valvular heart disease as ‘‘the next cardiac epidemic.’’
The advent of minimally invasive cardiac surgery
By the 1990s, the increased success of laparoscopic operations in general surgery—such as gall bladder removal, orthopedic, urological, and gynecological procedures—inspired similar minimally invasive approaches in cardiac surgery, for many of the same benefits:
- Less trauma and pain for the patient
- Faster return to normal activities
- Shorter hospital stay, often reduced by as much as 50 percent over open heart procedures
- Smaller incisions, resulting in less scarring
- Minimal blood loss and less need for blood transfusions
In July 1996, Cohn—then the chief of cardiac surgery at BWH—led a team in New England’s first minimally invasive cardiac surgery, replacing the aortic valve of a 71-year-old man. Instead of opening the man’s entire chest, Cohn’s team operated through a much smaller, eight-centimeter incision in the man’s sternum. Over the next seven years, BWH cardiac surgeons performed more than 1,000 such minimally invasive valve operations and demonstrated outcomes equal to or better than conventional open heart surgery.
"In order to improve the outcomes of valve repair and replacement, we knew we had to do something different,” said Cohn at the 2003 celebration of 80 years of BWH leadership in cardiac surgery. “Knowing BWH has now helped more than 1,000 patients with this procedure is truly something to celebrate."
Hybrid surgeons and technologies for hybrid treatments
By 2006, a new breed of hybrid cardiac surgeons were emerging. The late Michael J. Davidson, MD, was one of the few in the nation to seek additional training in interventional cardiology after completing his cardiac surgery training. Interventional cardiology involves percutaneous catheter-based treatments—such as angioplasty and stenting—for structural heart diseases, as opposed to surgery.
"These are two very different skill sets. Mike was a visionary who knew we were going to be taking care of very complex patients in a completely different manner than we have ever thought about doing,” says Davidson's colleague and close friend, Pinak Shah, MD, director of the Interventional Cardiology Training Program and interim director of the Cardiac Catheterization Laboratory at BWH.
Davidson was instrumental in helping plan and establish BWH’s Cardiac Hybrid Operating Room (OR), one of the first such operating rooms in the country designed to enable cardiac surgeons and interventional cardiologists to work together, as Davidson had envisioned.
The Hybrid OR, which opened in 2009, features a multi-axis imaging system that can be positioned any way the staff needs to perform 3-D angiography (images of the heart and blood vessels), CT-like imaging, and intravascular ultrasound in the operating room. Multi-disciplinary teams of interventional and surgical specialists can perform essential pre- and post-operative imaging directly in the Hybrid OR, avoiding costly complications and reducing risky transfers to separate imaging suites for diagnostic purposes.
A new frontier
In the early 2000s, bioengineers began creating valves that mounted tissue valves (from large animals such as cows and pigs) onto flexible metal frames similar to stents, which could be inserted with catheters threaded through blood vessels, rather than requiring open heart surgery. This offered new hope for cardiac patients considered inoperable: extreme and high risk cardiac patients, including those of advanced age and those who previously had heart surgery.
One example is 82-year-old Mary Walsh, a Rhode Island woman hospitalized near her home with pneumonia in late 2013. While investigating her chronic shortness of breath, Walsh’s BWH-affiliated cardiologists discovered her aortic valve was worn and functioning poorly, an increasingly common occurrence among people 80 and older.
Nearly 20 years before, Walsh had open heart surgery to address a congenital valve defect and coronary artery disease. “It took a long time to get my strength back,” she said. Because of her age, her state of health, and her previous cardiac surgery, Walsh’s risk factors disqualified her for surgical valve replacement. However, she was healthy enough for a nonsurgical valve replacement.
In the spring of 2014, Davidson collaborated with a multidisciplinary team of cardiologists, anesthesiologists, imaging specialists, nurses, and technologists to perform a transcatheter aortic valve replacement (TAVR) percutaneously, through a small incision in Walsh’s leg.
While the TAVR itself was not unusual (BWH performed 100 TAVRs in 2014 alone), Walsh’s procedure was the first performed at BWH using only sedation, instead of general anesthesia. She was alert less than an hour later, experiencing no side effects.
"I can't believe how much better and stronger I feel,” said Walsh the day after surgery.
"These transcatheter valves have been transformational. They’ve given us one of the few life extension therapies in the elderly where we are prolonging life with very high quality,” says Mandeep Mehra, MD, medical director of BWH’s Heart & Vascular Center.
BWH cardiac surgeon Tsuyoshi Kaneko, MD, who trained under Davidson, marvels at the new frontier of TAVR performed with local sedation.
"Recently a man from Maine was referred to us for a TAVR,” Kaneko says. “He traveled down here for the procedure. The very next day he was on a bus with his daughter, heading back home."
Just as the minimally invasive surgical approach Cohn introduced in 1996 proved to be as safe and enduring as open heart procedures, percutaneous heart valve replacements must demonstrate similar safety and durability in order to be recommended for lower risk patients. For now, the percutaneous approach provides a life-extending solution to critically ill people with no surgical options for valve replacement.
"Surgical valves have been around for 40 years,” says Kaneko. “Transcatheter valves have only been around for eight years, and the gap is closing fast."
"We’re very close to this being the standard of care for our interim risk patients, in addition to the high and extreme risk patients we’re already serving,” says Shah. “And we’re working on percutaneous approaches to mitral valve disease, in addition to aortic valve disease."
Nearly a century after Cutler’s bold mitral valve repair to save a young girl’s life, BWH continues to build on its renowned legacy of interdisciplinary, team-based, patient-centered approaches to heart and vascular care.
"Our story is about much more than equipment or the Hybrid OR,” Mehra adds. “Our next horizon will be defined, as it has always been, by the brightest minds working together on problems no one else will tackle. It’s the Brigham Way."