Washington-area patients with aortic stenosis can benefit from the latest treatments at Suburban Hospital. The structural heart disease team at Johns Hopkins has developed a transcatheter aortic valve replacement (TAVR) program at Suburban that is now considered a pioneering model for the management of complex valve disease.
TAVR, a minimally invasive procedure to replace the aortic valve, made headlines this spring when two pivotal clinical trials found it to be safe even for patients with a low risk of death from cardiac surgery. Results from the PARTNER3 and EVOLUT trials, presented at the American College of Cardiology’s (ACC) annual meeting in New Orleans and published simultaneously in the New England Journal of Medicine, demonstrated that patient outcomes were superior or at least as good in those treated with TAVR compared with those receiving surgical aortic valve replacement, or SAVR.In August, the U.S. Food and Drug Administration approved TAVR in low-risk patients.
Johns Hopkins Medicine was a participating study site for the EVOLUT trial, and now offers TAVR routinely to low surgical risk patients through a continued access registry study. A patient at Suburban was one of the first to get the procedure through the registry.
In 2015, Johns Hopkins started offering TAVR as a treatment option to patients at Suburban through a multidisciplinary clinic. At that time, patients received the procedure at The Johns Hopkins Hospital in Baltimore, but their evaluation and all follow-up care was conducted at Suburban. Since April 2017, the procedure has been offered at Suburban, thanks to a multidisciplinary team including cardiologists Gregory Kumkumian, medical director of the Cardiac Catheterization Laboratory at Suburban, Rani Hasan, regional medical director for the Structural Heart Disease Program at Suburban, and Eric Lieberman; cardiac surgeons Thomas Matthew, director of the Johns Hopkins Cardiothoracic Surgery program at Suburban, Michael Siegenthaler and Philip Corcoran; and nurse practitioner/program coordinator Mandy Murphy. About 70 patients have been treated so far.
“The results are very encouraging,” says Hasan. “We are in line with or better in most categories than national standards despite being a community-based program.” Adds Kumkumian, “Our length of stay has been excellent, with the majority of our patients being discharged within one to two days. Complication rates are low, and our patient satisfaction is very high. The advantage of having patients in our area be able to have this procedure at their local hospital is really tremendous.”
The program has been an early adopter of a moderate sedation approach for TAVR, Hasan says, which reduces the risk of delirium and prolonged periods of recovery to come off a breathing machine. Patients generally can walk the morning after their procedure and can resume most daily activities within a week.
The ACC and other professional organizations have recently published expert consensus documents detailing how care for patients with complex valve disease should be organized nationwide, says Hasan. The integration between Suburban and The Johns Hopkins Hospitals is a perfect model, he says, with Suburban, a community hospital, having the ability to offer SAVR or TAVR for the majority of cases, and The Johns Hopkins Hospital available in network to manage those with more complex needs.
“We’re going to see an exponential growth in the number of TAVR programs in the coming years with the advent and likely approval of low-risk TAVR by the FDA by the end of the year,” says Hasan. “We’ve come up with a system to provide high-quality care by having close collaboration between our two sites.”
Without TAVR, aortic stenosis is “a very difficult problem to manage,” he adds. “Medications really don’t work, and by the time most patients see us, they are starting to develop signs of congestive heart failure or have established congestive heart failure related to their valve disease.” If this isn’t fixed, patients have a 50% increased risk of dying in the next year or two, he says, and quality of life will deteriorate progressively until the valves are repaired.
TAVR serves as a gateway as Suburban advances toward other modalities to treat structural heart disease, Kumkumian says. “It’s the spark that has quickly moved us forward into the rapidly evolving field of minimally invasive cardiovascular treatments and procedures, allowing us to best serve our community.”
