Welcome to the new frontier of cardiac catheterization labs, where medical pioneers are pushing the boundaries of what’s possible in treating heart disease–and winning.
All right, sir, you’re going to feel a little pinch.”
This is how diagnostic catheterization begins at Virginia Commonwealth University’s Pauley Heart Center in Richmond. An 87-year-old man, who earlier was admitted to the emergency room with chest pain and shortness of breath, lies on his back on an x-ray table, awake, with a sheet pulled over him, and hooked up to a few monitors. A doctor numbs the patient’s upper thigh and inserts a catheter into a tiny blood vessel, slowly feeding the long, thin tube into his body, moving it up and toward the man’s chest, all the while talking to the patient and explaining what’s going on.
A real-time, black-and-white X-ray, known as a fluoroscopy, follows the catheter’s journey from the patient’s femoral artery to his beating heart and displays it on a large, flat-panel screen. (The screen and the large, white X-ray machine in the center of the room are part of a new imaging system that enables flexible positioning and live images that can be compared with prior CT and other scans.) Contrast dye is then injected through the catheter, and suddenly, the patient’s coronary arteries appear on the screen as the dark liquid flows through and defines them. It is this image—an angiogram—that will reveal the cause of the man’s chest pain and shortness of breath.
Overseeing the process is renowned interventional cardiologist Dr. George W. Vetrovec, director of VCU’s Cardiac Catheterization Laboratories. Within moments, Vetrovec locates the source of the patient’s chest pain: a narrowed place in one of his heart arteries. Vetrovec explains that it will require a stent—a special mesh metal structure that “looks like the spring in a ballpoint pen, only smaller,” he says.
The patient agrees to the placement of a stent to open his blockage—which begins right away. The stent is carried up via catheter. Although crimped at first, the device expands to fit the man’s arterial walls with the aid of a narrow delivery balloon, inflated when the doctor squeezes one of the triggers on a hand control. As the stent stretches outward, it pushes plaque to the arterial walls, thus widening the passage for better blood flow. Once completed, it is impossible to tell where the narrowed area once existed—it all blends seamlessly on the screen.
This state-of-the-art lab, which debuted in 2013 and includes a glass-windowed control room filled with monitors, is the first to be completed in what Vetrovec describes as a “very comprehensive upgrade of the catheterization and electrophysiology labs” at VCU.
Around the state, leading cardiac centers like VCU’s are improving patient care and survival rates through new and improved catheter-based therapies—and investing big to create labs like this one that will accommodate them. The hybrid suite is one of the most sought-after and expensive of this new generation of labs, costing at minimum $2-$4 million. Part catheterization lab, part operating room, the suite is creating new possibilities for the treatment of cardiac conditions.
Sentara Heart Hospital in Norfolk opened its Hybrid Cardiac Operating Suite—Virginia’s first—in July 2010. “The vision that Sentara had was the ability to create a hybrid lab which allows for multi-disciplinary integration of teams—our electrophysiology, cardiology intervention and cardiothoracic surgery teams being able to come together,” says Matt Hinkle, director of Sentara Heart Hospital’s Cardiac Surgical Services.
The use of combined teams working in hybrid rooms is fairly new. “It’s been percolating for about the last five years but has now really taken hold as the future,” says Sentara cardiothoracic surgeon Dr. Jonathan Philpott. From the patient’s perspective, the new movement “expedites care and opens up new therapies that would not otherwise be available—and in so doing, improves survival and quality of life.”
Stepping inside the operating suite, visitors are immediately struck by its large size and careful organization. The imaging area is at the center of the room; around the perimeter are other areas, including a control room and a nursing station. A 56-inch, split-screen HD monitor provides the teams with immediate access to images and data from 21 different outputs, including angiograms, ultrasound, 3D electrical mapping, CT and MRI. The set-up makes possible the minimally invasive procedures undertaken here, such as laser lead extractions, ablations, balloon valvuloplasties and mitral clips.
Within the sterile environment, physicians also have access to surgical tools, anesthesia and a perfusion station, where a heart-lung machine resides. This enables the teams to convert to an open-heart surgery at a moment’s notice should any problems arise, explains Sentara cardiothoracic surgeon Dr. Joseph Newton Jr.
One procedure that requires the skill sets of both cardiothoracic surgeons and electrophysiologists (EPs) is the hybrid Cox Maze, a much less invasive undertaking than its open-heart predecessor (which involves the breaking of the sternum). The “mini Maze,” as it is also known, “dramatically reduces the incidence of atrial fibrillation”—an irregular heartbeat or arrhythmia that can increase a patient’s risk of stroke or disease, explains Philpott.
Here’s how it works: Once the patient undergoes anesthesia, surgeons create three tiny holes on either side of the chest, “about the size of a pencil eraser,” says Philpott. Then, “the electrophysiologist puts catheters inside the heart to map the electrical signals” and identify the location of the errant electrical impulses causing the afib. Both the surgeon and the EP then burn those areas with radioactive energy. In what sounds like something out of Fantastic Voyage, the EP instruments and a tiny videocamera are delivered to the site by catheter. Amazingly, the patient can typically leave the hospital three to five days post-op.
Heart teams have also enjoyed success with transcatheter aortic valve replacement (TAVR), a safe alternative to surgery for replacing damaged valves in “patients that are either at high or extreme risk for a traditional operation,” says Sentara interventional cardiologist Dr. Paul Mahoney. “We’re able to replace the valve through a catheter in the leg without a surgical incision and achieve results comparable to surgery in this population.” With cardiac surgeon Dr. Jeff Rich, Mahoney performed the first TAVR outside of a research study in Virginia, at Sentara in December 2011. About three interventions now take place each week in the hybrid lab on “TAVR Tuesdays.” (The tiny, ring-like valve is made from mesh stainless steel and cow’s pericardial tissue.)
Although popular for many years in Europe, beginning in 2002, a more grueling regulatory process for medical devices kept TAVR at bay in the U.S. until November 2011, when the FDA finally approved the first transcatheter heart valve—the Edwards SAPIEN, manufactured by Irvine, California-based Edwards Lifesciences.
With FDA approval, leading heart centers in the U.S. began moving full speed ahead, planning hundreds of new hybrid suites—and recruiting more structural heart disease specialists with TAVR training. Carilion Roanoke Memorial Hospital found one in Dr. Jason Foerst, who received his medical degree in the U.S., but completed his structural heart fellowship at University of Dusseldorf. He arrived at Carilion in 2012, the same year the hospital completed its first hybrid room, which cost $3.3 million.
Foerst appreciates the size of Carilion’s 1,200-square-foot suite: “It’s three times the size of a regular cath lab. It allows us the space that we need for a lot of these procedures .… sometimes we have as many as 20 people in the room.”
TAVR patients can remain awake throughout the entire operation, and even watch the valve deploy on the large screen in the room. With open-heart atrial valve replacements (AVR), the average patient remains in the hospital “five to seven days, which is frequently followed by a nursing home stay.” TAVR patients bounce back more quickly, he says. “It’s usually two days and then they go home.”
All the positive publicity for TAVR has created a challenge for Foerst. “Patients hear about this stuff, and they all want a transcatheter approach whether they are an appropriate candidate or not,” he says. The Centers for Medicare and Medicaid Services (CMS) has strict guidelines about who will be approved for TAVR coverage—generally those with severe aortic stenosis (the narrowing of the aortic valve, mainly due to the buildup of calcium) who would be at a high risk of fatality with regular atrial valve replacement surgery.
When Inova Fairfax opened its $7 million hybrid suite in November 2010, it was the first in the Washington, D.C., area. “We designed it from the ground up to meet the needs of increasingly complex procedures requiring the combined capabilities of a cardiac operating room and a cardiac catheterization laboratory,” says Dr. Bryan Raybuck, director of the Cardiac Catheterization Laboratories at Inova Heart and Vascular Institute.
Inova’s was the first hybrid room in the nation with a bi-plane X-ray system that allows doctors to combine 3D CT images of a patient’s heart taken before a procedure into a single image that can then be overlaid with live fluoroscopy. This gives them a clear view of a patient’s anatomy and allows them to plan or “roadmap” their movements in advance. Supporting this system is a special surgical table with a carbon-fiber top that offers near 360-degree radio translucency, permitting X-rays from all angles. When not in use for hybrid procedures, the X-ray table is easily removed and quickly transformed into a standard operating table.
Due to the expense and the expertise required, Raybuck says hybrid suites only make sense for “tertiary care or referral centers with high volumes of interventional cardiac procedures, cardiac surgeries, arrhythmia and structural heart procedures.” Such centers can support the multidisciplinary approach that is the hallmark of the hybrid rooms. In one common procedure, EPs and cardiac surgeons come together for complex extractions of “leads” or wires (that run between the pulse generator and heart) found in pacemakers and defibrillators (also known as Cardiac Implantable Electronic Devices, or CIEDs). “In some cases, we have the surgeons extract the wires for us, because when we remove very old wires, there’s a small chance of piercing the blood vessels or causing a hole in the heart due to adhesions and scarring,” says Carilion cardiac electrophysiologist Dr. Soufian Al Mahameed. In the hybrid room, he says, “we are equipped to open the chest” if bleeding occurs. Surgeons can also help EPs intervene in otherwise hard-to-reach target areas during catheter ablations of complex arrhythmia cases, he says. (Ablations involve using radiofrequency energy or other methods to destroy small areas of heart tissue where abnormal heartbeats may cause an arrhythmia to start.)
The Levinson Heart Hospital at HCA Virginia’s Chippenham Hospital Richmond—one of the busiest afib centers in the state, where more than 2,800 EP procedures were performed last year alone—debuted its estimated $3 million hybrid operating suite in 2011. The lab includes a robotic catheter system, which permits electrophysiologists to control catheters remotely from a workstation. The system means lower doses of radiation for both the patient and physician (like the other hybrid systems) while “allowing for incredible visibility and more precision” of catheter movement, says Chad Christianson, HCA Chippenham’s new chief operating officer. About 400 hybrid Maze procedures have been conducted at Chippenham. The intervention provides an attractive option for “chronic afib patients who cannot control their condition through normal routine management,” he says.
Chippenham’s new room has proven such a success that the hospital recently received approval for a second suite, which will come on line in the summer of 2015 and cost just over $2.2 million. Christianson believes the rooms are an important investment. “It’s where health care is going now, and where technological advances are heading. These hybrid operating suites allow for more minimally invasive approaches, which can result in less blood loss, faster recovery times and better outcomes for patients.”
Back at VCU, the patient who received the stent “is doing well and is improving from a cardiac standpoint,” says Vetrovec. Released from the hospital soon after the procedure, he has been seen in follow-up.
Vetrovec, widely recognized as a pioneer in his field, has been involved in countless clinical trials and has “lived the evolution” of the modern cath lab—starting with performing one of the first PCIs in the U.S. with colleague Dr. Michael Cowley at VCU in July 1979. Now, 35 years later, he is excited about the new procedures made possible with hybrid labs. The bottom line for cath labs? Says Vetrovec, “We’re able to treat higher and higher risk patients.” VCUHealth.org, Sentara.com, CarilionClinic.org, Inova.org, HCAVirginia.com
